2024年1月10日发(作者：)

（附录Ⅰ制剂通则）

Appendix Ⅰ General Requirements for Prearations

（丸剂）Ⅰ A Pills

丸剂 系指药材细粉或药材提取物加适宜的黏合剂或其他辅料制成的珠形或类球形制剂，分为蜜丸、水蜜九、水丸、糊丸、蜡丸和浓缩丸等类型。

Pills are spherical or spherical-like solid dosage forms made of finely powdered crude

drugs or crude drug extracts, proper binders or other excipients. They are classified into

honeyed pills, water-honeyed pills, watered pills, pasted pills, concentrated pills waxed

pills and concentrated pills etc.

蜜丸 系指药材细粉以蜂蜜为黏合剂制成的丸剂。其中每丸重量在 0.5g( 含 0.5g)以上的称大蜜丸，每丸重量在0.5以下的称小蜜丸。

Honeyed pills are made of fine powder of crude drugs, using honey as binder. Among

them, pills weighing more than 0.5g (including 0.5g) per pill are big honeyed pills, pills

weighing less than 0.5g per pill are small honeyed pills.

水蜜丸 系指药材细粉以蜂蜜和水为黏合剂制成的丸剂。

Water-honeyed pills are made of fine powder of crude drugs, using honey and water as

binders.

水丸 系指药材细粉以水（或根据制法用黄酒、醋、稀药汁、糖液等）为黏合剂制成的丸剂。

Watered pills are made of fine powder of crude drugs, using water (or yellow rice wine,

vinegar, dilute medicinal juice, dilute syrup) as binder.

糊丸 系指药材细粉以米粉、米糊或面糊等为黏合资剂制成的丸剂。

Pasted pills are made of fine powder of crude drugs, using rice powder rice-paste or

flour-paste as binder.

蜡丸 系指药材细粉以蜂蜡为黏合剂制成的丸剂。

Waxed pills are made of fine powder of crude drugs, using beeswax as binder.

浓缩丸 系指药材或部分药材提取浓缩后，与适宜的辅料或其余药材细粉，以水、蜂蜜或蜂蜜和水为黏合剂制成的丸剂。根据所用黏合剂的不间，分为浓缩水丸、浓缩蜜丸和浓缩水蜜丸。

Concentrated pills are made of condensed extract of crude drugs or partial crude drugs,

mixing with appropriate excipient or fine powder of other crude drugs, using water, honey

or honey and water as binders. They may be classified into concentrated watered pills,

concentrated honeyed pills and concentrated water-honeyed pills based upon the

different binders used in the production.

丸剂在生产与贮藏期间应符合下列有关规定。

The production and storage of pills should comply with the following requirements.

一、除另有规定外，供制丸剂用的药粉应为细粉或最细粉。

1. The powdered drugs for preparing pills are fine or very fine powders, unless specified

otherwise.

二、蜜丸所用蜂蜜须经炼制后使用。按炼蜜程度分为嫩蜜、中蜜和老蜜，制备蜜丸时可根据品种、气候等具体情况选用。除另有规定外，用塑制法制备蜜丸时，炼蜜应趁热加人药粉中，混合均匀，处方中有树脂类、胶类从含挥发性成分的药味时，炼蜜应在60℃左右加人；用泛制法制备水蜜丸时，炼蜜应用沸水稀释后使用。

2. The honey used for honeyed pills production should be processed before using.

According to the degree of processing, it can be divided into primary processed honey,

secondary processed and tertiary processed honey, which may be selected and used to

prepare honeyed pills, depending on the climate and the varieties of honeyed pills. In

preparing big and small honeyed pills by rubbing method, the processed honey should be

added to the drug powder while hot and mixed well, unless specified otherwise. If resin,

gum and volatile drugs are contained in the formulation, the processed honey should be

added at about 60℃;in preparing water-honeyed pills by water spray rotating method, the

processed honey should be diluted with boiling water before using.

三、浓编丸所用药材提取物应按制法规定，采用一定的方法提取浓缩制成。

3. The extract for preparing concentrated pills should be made by extracting and

concentrating according to the certain methods specified under the monograph.

四、除另有规定外，水蜜丸、水丸、浓缩水蜜丸和浓缩水丸均应在80℃以下干燥；含挥发性成分或淀粉较多的丸剂（包括糊丸）应在60℃以下干燥；不宜加热干燥的应采用其他适宜的方法干燥。

4. Unless specified otherwise, water-honeyed pills watered Pills or concentrated

water-honeyed pills, concentrated Watered pills should be dried at a temperature below

80℃; pills containing large amount of volatile constituents or starch (including pasted pills)

should be dried at a temperature below 60℃. Thermolabile pills should be dried with

other proper methods.

五、制备蜡丸所用的蜂蜡应符合本版药典该药材项下的规定。制备时，将蜂蜡加热熔化，待冷却至60℃左右按比例加人药粉，混合均匀，趁热按塑制法制丸，并注意保温。

5. Beewax used for producing waxed pills complies with the requirements specified under

individual monograph in this pharmacopoeia. In preparing melt beewax by heating, then

allow to cool to 60℃ and add drug powders proportionally, mix thoroughly and prepare

the waxed pills using the kneading method while the temperature is maintained.

六、凡需包衣和打光的丸剂，应使用各品种制法项下规定的包衣材料进行包衣和打光。

6. For pills need to be coated and polished, coat with the coating materials and polish as

specified under individual monograph.

七、丸剂外观应圆整均匀、色泽一致。蜜丸应细腻滋润，软硬适中。蜡丸表面应光滑无裂纹，丸内不得有蜡点和颗粒。

7. Pills should be round, integrate and uniform in appearance and colour. Big and small

honeyed pills should appear fine, smooth and oily-moistened, with proper hardness.

Waxed pills should be smooth in apperance without crack, and no drops or granules

found inside the pills the pills.

八、除另有规定外，丸剂应密封贮存。蜡丸应密封井置阴凉干燥处贮存。

8. Unless specified otherwise, Pills should be preserved in tightly closed containers and

waxed pills, in tightly closed containers and stored in a dry place.

丸剂应进行以下相应检查。

Following relevant tests should be carried out for pills.

【水分】照水分测定法（附录Ⅸ H)测定。除另有规定外，蜜丸和浓缩蜜丸中所含水分不得过15. o％；水蜜丸和浓缩水蜜丸不得过12.0％；水丸、糊丸和浓缩水丸不得过9.0％。蜡丸不检查水分。

Determination of water Carry out the method for the determination of water in general

(Appendix Ⅸ H).Unless specified otherwise, big honeyed pills, small honey pills and

concentrated honeyed pills contain not more than15.0% of water, water-honeyed pills,

concentrated water-honeyed pills not more than l2.O per cent, watered pills, pasted pills

and concentrated watered pills not more than 9.0 per cent. No determination of water is

required for waxed pills.

【重量差异】除另有规定外，丸剂按丸数服用的照第一法检查，按重量服用的照第二法检查，均应符合规定。

Weight variation Unless specified otherwise Pills to be taken in pill are examined by

Method 1 and pills to be taken by weight examined by Method 2.

第一法 以一次服用量最高丸数为1份(丸重 1.5g及1. 5g以上的丸剂以1丸为1份；丸重0.015g以上的丸剂一次服用量最高丸数超过10丸的，或丸重0.015g及0.015g以下的丸剂一次服用量最高丸数不足10丸的，以10丸为1份），取供试品10份,分别称定重量，再与标示总量（每丸标示重量X称取丸数）或标示重量相比较（无标示重量的丸剂，与平均重量比较），按表1的规定，超出重量差异限度的不得多于2份，并不得有1份超出限度1倍。

Method 1 Take the largest number of pills in single dosage as one part(1 pill as one part

for pills weighing 1.5g or more than 1.5g per pill; 10pills as one part for pills weighing

more than 0.015g per pill and with the largest number of pills in single dosage is above

10, or pills weighing 0.015g or less than 0.015g per pill and with the largest number of

pills in single dosage is not up to 10).Weigh separately 10 parts and compare with the

labelled total weight (labelled weight of each pill X the number of pills weighed)or labelled

single weight (if no labelled weight is stated, compare the weight of each pill with the

average weight calculated) According to the requirements stated in Table 1. Not more

than 2 parts exceed the limit of weight variation and none doubles the limit of weight

variation.

表1

标示总量或标示重量（或平均重量） 重量差异限度

0.05g及0.05g以下

0.05g以上至0.1g

0.1g以上至0.3g

0.3g以上至1.5g

1.5g以上至3g

3g以上至6g

6g以上至9g

9g以上

Table 1

Labelled total or single(average weight)

0.05g or less

more than 0.05g to 0.1g

more than 0.1g to 0.3g

more than 0.3g to 1.5g

more than 1.5g to 3g

more than 3g to 6g

more than 6g to 9g

士12%

士11%

士10%

士9%

士8%

士7%

士6%

士5%

weight variation limit

士12%

士11%

士10%

士9%

士8%

士7%

士6%

more than 9g

士5%

第二法 以供试品10丸为1份，取10份，分别称定重量,再与每份标示重量相比较（无标示重量的丸剂，与平均重量比较），按表2的规定，超出重量差异限度的不得多于2份，并不得有1份超出限度1倍。

Method 2 Take 10 pills as one part, weigh separately 10 Parts, compare with the

labelled weight of each part (if no labelled weight is stated, compart the weight of each

pill with the average weight calculated). According to the requirements stated in Table 2.

Not more than 2 parts exceed the weight variation limit and none doubles the limit.

表2

每份标示重量或平均重量

0.05g及0.05g以下

0.05g以上至0.1g

0.1g以上至0.3g

0.3g以上至1g

1g以上至2g

2g以上

Table 2

Labelled or Average weight of each part

0.5g or less

Weight variation limit

士12%

重量差异限度

士12%

士11%

士10%

士8%

士7%

士6%

more than 0.05g to 0.1g

more than 0.1g to 0.3g

more than 0.3g to 1g

more than 1g to 2g

more than 2g

士11%

士10%

士8%

士7%

士6%

包糖衣丸剂应检查丸芯的重量差异并符合规定，包糖衣后不再检查重量差异，其他包衣丸刘应在包农后检查重量差异并符合规定，凡进行装量差异检查的单剂量包装丸剂，不再进行重量差异检查。

Weight variation of sugar-coated pills should be examined before coating, pills are not to

be coated until the weight variation of the pill cores complies with the requirements. The

weight variation of pills is no longer examined after sugar-coating, other coated pills

should be examined the weight variation after coating and comply With the requirements;

The weight variation is no longer examined for the single dose packed pills, which have

been examined according to the filling variation standards.

【装量差异】 单剂量包装的丸剂，照下述方法检查应符合规定。

Filling variation The Filling variation of pills presented in single dose pack should

comply with the following requirements.

检查法 取供试品10袋（瓶〕，分别称定每袋（瓶）内容物 的重量，每袋（瓶）装量与标示装量相比较，按表3的规定，超出装量差异限度的不得多于2袋（瓶）并不得有1袋（瓶）超出限度1倍。

Procedure Take ten packs (or vials) of pills and weigh seperately the content of each

pack (or vial), compare with the labelled weight. According to the requirement stated in

Table more than 2 packs exceed the weight variation limit and none doubles the

limit.

表3

标示装量

0.5g及0.5g以下

0.5g以上至1g

1g以上至2g

2g以上至3g

3g以上至6g

6g以上至9g

9g以上

Table3

Labelled weight of each pack

0.5g or less

more than 0.5g to 1g

more than 1g to 2g

more than 2g to 3g

Weight variation limit

士12%

士11%

士10%

士8%

装量差异限度

士12%

士11%

士10%

士8%

士6%

士5%

士4%

more than 3g to 6g

more than 6g to 9g

more than 9g

士6%

士5%

士4%

【装量】装量以重量标示的多剂量包装丸剂，照最低装量检查法（附录Ⅻ C）检查，应符合规定。

Filling The Filling variation of multiple doses packed pills of which filling is labelled in

weight should comply with the test for Minimum Fill (Appendix Ⅻ C).

【溶散时限】除另有规定外，取供试品6丸，选择适当孔径筛网的吊篮（丸剂直径在2.5mm以下的用孔径约0.42mm的筛网；在2.5-3.5mm之间的用孔径约1.0mm的筛网；在3.5mm以上的用孔径约2.0mm的筛网），照崩解时限检查法〔附录Ⅻ A）片剂项下的方法加挡板进行检查。除另有规定外，小蜜丸、水蜜丸和水丸应在I小时内全部溶散；浓缩丸和糊丸应在2小时内全部溶散。操作过程中如供试品黏附挡板妨碍检查时，应另取供试品6丸，以不加挡板进行检查。

Disintegration test Unless specified other wise, Take 6 pills, select a basket with

proper porosity of sieve (for pills with the diameter of less than 2.5mm, 2.5-3.5mm or

more than 3.5mm,using sieves with pores of 0.42mm,1.0mm or 2.0mm in diameter

respectively). Carry out the test as described under the disintegration test (Appendix Ⅻ

A) for tablets, using disk. Unless specified otherwise, Small honeyed pills, water-honeyed

pills and watered pills should be completely disintegrated within 1 hour, concentrated pills

and pasted pills within 2 hours. During procedure, If pills adhere to the disk, thus

hindering the determination, take another 6 pills and carry out the determination as

described under the disintegration of tablets without disk, pills should be completely

disintegrated within the specified time.

上述检查，应在规定时间内全部通过筛网。如有细小颗粒状物未通过筛网，但己软化且无硬心者可按符合规定论。

In the determination mentioned above, all the pills should pass through the sieve within

the specified time. If there are minute granulated masses which cannot pass the sieve

but soften without hard core, should be considered to comply with the requirements.

蜡丸照崩解时限检查法（附录XⅫ A）片剂项下的肠溶衣片检查法检查，应符合规定。

Waxed pills should comply with the requirements stated in monograph for Determination

of Disintegration (Appendix Ⅻ A) for enteric-coated tablets.

大蜜丸不检查溶散时限。

No disintegration test is required for big honeyed pills.

【徽生物限度】 照微生物限度检查法（附录XIII C）检查，应符合规定

Microbial limit test Comply with the requirements stated under Microbial Limit Test

(Appendix XIII C).

（散剂）Ⅰ B Powders

散剂系指药材或药材提取物经粉碎、均匀混合制成的粉末状制剂，分为内服散剂和外用散剂。

Powders may be defined as mixtures of pulverized crude drugs or extract of crude drugs

which are used for oral administration or external application.

散剂在生产与贮藏期间应符合下列有关规定。

The production and storage of powders should comply with the following requirements.

一、供制散剂的药材、药材提取物均应粉碎。除另有规定外，内服散剂应为细粉；儿科用

及外用散剂应为最细粉。

crude drugs or extract of crude drugs for powders production should be

Comminuted. Unless specified otherwise, Powders of fine grade am employed for oral

administration, and powders of very fine grade, for pediatrics and external application.

二、散剂应干燥、疏松、混合均匀、色泽一致。制备含有毒性药、贵重药或药物剂量小的散剂时，应采用配研法混匀并过筛。

s Should be dry, loose, well mixed and uniform in appearance and colour.

When preparing powders containing poisonous, or precious drugs, they should be

prepared by a compounding and grinding method of isochoric increase by degrees,

mixed well and sieved.

三、多剂量包装的散剂应附分剂量的用具；含有毒性药的内服散剂应单剂量包装。

for separating dosage should be enclosed in powders presented in multiple

doses packs; Powders for oral administration containing poisonous drugs should be

packed in single dose.

四、除另有规定外，散剂应密闭贮存，含挥发性药物或易吸潮药物的散剂应密封贮存。

specified otherwise, Powders should be stored in well closed containers.

Powders containing volatile or moisture-absorbing drugs should be stored in tightly

closed containers.

散剂应进行以下相应检查。

Following relevant tests should be carried out for powders.

【粒度】用于烧伤或严重创伤的外用散剂，照下述方法检查应符合规定。

Particle size Powders used for burn or severe trauma should comply with the following

test.

检查法 照粒度测定法（附录Ⅺ B第二法，单筛分法）测定，除另有规定外，通过六号筛

的粉末重量，不得少于95％。

Procedure Carry out the method for the determination of particle size in general

(Appendix Ⅺ B, method 2, single particle size-sieve method),unless specified otherwise,

the weight of the powders passing through a sieve No.6 should not be less than that of 95

per cent of the powders examined.

【外观均匀度】 取供试品适量，置光滑纸上，平铺约5cm2,将其表面压平，在明亮处观察，应色泽均匀、无花纹与色斑。

Uniformity in appearance Spread evenly a sufficient quantity of powders in an area of

about 5 cm2 on a piece of smooth paper, press the surface to be even, observe the

powder under a bright light. It should be uniform in colouration without discolourations

and stains.

【水分】 照水分测定法（附录Ⅸ H）测定，除另有规定外，不得过9.0％。

Determination of water Carry out the method for the determination of water in general

(Appendix Ⅸ H). The powders contain not more than 9.0 per cent of water, unless

specified otherwise.

【装量差异】 单剂量包装的散剂，照下述方法检查应符合规定。

Filling variation Filling variation limit for powders presented in single dose should

comply with the requirements stated in the table below.

检查法 取供试品10袋（瓶），分别称定每袋（瓶）内容物的重量，每袋（瓶）装量与标示装量相比较，按表中的规定，超出装量差异限度的不得多于2袋（瓶），并不得有1袋（瓶）超出限度1倍。

Procedure Weigh accurately each of ten packs (or vials) of powders and compare the

weight of the content of each with the labelled weight. According to the requirements

stated in the table, not more than 2 packs should exceed the packing variation limit and

none should double the packing variation limit.

标示装量

0.1g及0.1g以下

0.1g以上至0.5g

0.5g以上至1.5g

1.5g以上至6g

6g以上

Labelled weight per pack

(or vial)

0.1 g to 0.1 g or less

more than 0.1 g to 0.5 g

more than 0.5 g to 1.5 g

more than 1.5 g to 6 g

more than 6 g

Weight variation limit

士15%

士10%

士8%

士7%

士5%

装量差异限度

士15%

士10%

士8%

士7%

士5%

【装量】 多剂量包装的散剂，照最低装量检查法（附录Ⅻ C)检查应符合规定。

Filling Filling variation for powders presented in multiple doses should comply with the

test for Minimum Fill (Appendix Ⅻ C).

【无菌】 用于烧伤或严重创伤的外用散剂，照无菌检查法（附录XIII B)检查，应符合规定。

Sterility Powders used for burn or severe trauma should comply with the Test for

Sterility (Appendix XIII B).

【微生物限度】 除另有规定外，照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Unless otherwise specified, Comply with the requirements stated

under Microbial Limit Test (Appendix XIII C).

（颗粒剂）Ⅰ C Granules

颗粒剂系指药材提取物与适宜的辅料或药材细粉制成具有一定拉度的颗粒状制剂，分为可溶颗粒、混悬颗粒和泡腾颗粒。

Granules are soluble, suspensible or effervescent preparations in granular form with

certain particle size made from drug extracts or finely powdered drug and suitable

excipients.

颗粒剂在生产与贮藏期间应符合下列有关规定。

The production and storage of medicinal granules should comply with the following

requirements.

一、除另有规定外，药材应按各品种项下规定的方法进行提取、纯化、浓缩成规定相对密度的清膏、采用适宜的方法干燥，并制成细粉，加适量辅料或药材细粉，混匀并制成颗粒；也可将清膏加适量辅料或药材细粉，混匀并制成颗粒。应控制辅料用量，一般前者不超过干膏量的2倍,后者不超过清膏量的5倍。

1. Unless specified otherwise, the crude drugs should be processed by extraction,

purification and concentration to form a thin extract with a required relative density as

described under individual monograph, dried by the appropriate methods, and pulverized

to fine powder particles, added with a quantity of excipients or finely powdered crude

drugs, well mixed and granulate. Also, a quantity of excipients or finely powdered crude

drugs may be added into the thin extracts, well mixed and granulated. The amount of

excipients added should be controlled, which is not more than 2 times of that of the dried

extracts, or not more than 5 times of that of the thin extracts in general.

二、除另有规定外，挥发油应均匀喷人干燥颗粒中，密闭至规定时间或用β环糊精包合后加人。

2. The volatile oil should be sprayed evenly upon dried granules, stored in well closed

containers for the required time, or be added after being wrapped in β-cyclodextrin,

unless specified otherwise.

三、制备颗粒剂时可加入矫味剂和劳香剂；为防潮、掩盖药物的不良气味也可包薄膜衣。必要时，包衣颗粒剂应检查残留溶剂。

3. Correctives and flavoring agents may be added in preparation of granules; Granules

may also be film-coated to prevent moisture absorption, or cover up unpleasant odour. If

necessary, solvent residues should be examined for film-coated granules.

四、颗粒剂应干燥、颗粒均匀、色泽一致，无吸潮、结块、潮解等现象。

4. Medicinal granules should be dry, uniform in appearance and colour, without moisture

absorption, agglomeration, deliquescence and so on.

五、除另有规定外，颗粒剂应密封，在干燥处贮存，防止受潮。

5. Medicinal granules should be stored in tightly closed containers, and in a dry place to

prevent moisture absorption, unless specified otherwise.

颗粒剂应进行以下相应检查。

Following relevant tests should be carried out for granules.

【粒度】 除另有规定外，照粒度测定法（附录Ⅺ B第二法，双筛分法）测定，不能通过一号筛与能通过五号筛的总和，不得过15%。

Particle size Unless specified otherwise. Carry out the method for the Determination of

Particle Size (Appendix Ⅺ B method 2, double particle size-sieve method), The total

which cannot pass through sieve No.1 and pass through sieve No.5 are not more than 15

per cent of granules examined.

【水分】照水分测定法（附录Ⅸ H)测定，除另有规定外，不得过6.0%.

Determination of water Carry out the method for the determination of water (Appendix

Ⅸ H). The medicinal granules contain not more than 6.0 per cent of water, unless

specified otherwise.

【溶化性】取供试品1袋（多剂里包装取10g），加热水200m1,搅拌5分钟，立即观察，应全部溶化或呈混悬状。可溶颗粒应全部溶化。允许有轻微浑浊，混悬颗粒应能混悬均匀。

Determination of dispersibility To 1 pack (10 g for granules in multiple doses pack) of

medicinal granules, add 200 ml of hot water, stir for 5 minutes, observe immediately,

granules should be completely dissolved or in suspension. Solube granules should be

dissolved completely and slight turbidity is allowed; suspensible granules should be

suspended uniformly.

泡腾颗粒 取供试品1袋，置盛有200ml水的烧杯中，水温为15-25℃，应能迅速产生气体而呈泡腾状，5分钟内颗粒应完全分散或溶解在水中。

Effervescent granules To 1 pack of effervescent granules, put in the beaker filled with

200 ml of water at the temperature between 15℃ and 25℃. Granules should produce

bubbles and be in effervescent state immediately, and be dispersed or dissolved in water

completely in 5 minutes.

颗粒剂按上述方法检查，均不得有焦屑等。

Examined by the methods above, granules should show no burned charrings etc.

【装量差异】 单剂量包装的颗粒剂，照下述方法检查应符合规定。

Filling variation The Filling variation limit of single dose package of medicinal granules

should comply with the following requirements.

检查法 取供试品10袋，分别称定每袋内容物的重量，每袋装量与标示装量相比较，按表中的规定，超出装量差异限度的不得多于2袋，并不得有1袋超出限度1倍。

Procedure Take 10 packs of medicinal granules, and weigh individual content of each

pack .Compare the calculated weight of each pack with the labelled amount, according to

the requirements stated in the table. Not more than 2 packs in filling variation exceed the

filling variation limit and none doubles the limit.

标示装量

1g及1g以下

1g以上至1.5g

1.5g以上至6g

装量差异限度

士10%

士8%

士7%

6g以上 士5%

Labelled weight per pack

1.0 g or less

more than 1 g to 1.5g

more than 1.5 g to 6 g

more than 6 g

Filling variation limit

士10%

士8%

士7%

士5%

【装量】 多剂量包装的颗粒剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。

Filling Granules presented in multiple doses should comply with the test for Minimum

Fill(Appendix Ⅻ C).

【微生物限度】 照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（片剂）Ⅰ D Tablets

片剂系指药材提取物、药材提取物加药材细粉或药材细粉与适宜辅料混匀压制或用其他适宜方法制成的国片状或异形片状的制剂有浸膏片、半浸膏片和全粉片。

Tablets are solid preparations of laminal or various shapes compressed to extracts of

crude drugs, extracts of crude drugs with finely powdered crude drugs, or finely

powdered crude drugs with suitable excipients, including extract tablets, semi-extract

tablets and powdered crude drug tablets.

片剂以口服普通片为主，另有含片、咀嚼片、泡腾片、阴道片、阴道泡腾片和肠溶片等。

Tablets are mainly ordinary tablets for oral administration, there are other tablets such as

buccal tablets, chewable tablets, effervescent tablets vaginal tablets, vaginal

effervescent tablets, enteric coated-tablets and so on.

含片 系指含于口腔中，药物缓慢溶出产生作用的片剂。

Buccal tablets are tablets staying in oral cavity, of which medicaments dissolve slowly

and take effects.

咀嚼片 系指于口腔中咀嚼或吮服使片溶化后吞服的片剂。

Chewable tablets are tablets swallowing down after being chewed or sucked to dissolve

in oral cavity.

泡腾片 系指含有碳酸氢钠和有机酸，遇水可产生气体而呈泡腾状的片剂。

Effervescent tablets are tablets containing sodium bicarbonate and organic acid, which

can produce bubbles and be in effervescent state once meet with water.

阴道片与阴道泡腾片 系指置于阴道内使用的片剂。

Vaginal tablets and vaginal effervescent tablets are tablets for vaginal cavity use.

肠溶片 系指用肠溶性包衣材料进行包衣的片剂。

Enteric-coated tablets are tablets coated with enteric coating Materials.

片剂在生产与贮藏期间应符合下列有关规定。

The production and storage of tablets should comply with the following requirements.

一、用于制片的药粉（膏）与辅料应混合均匀。含药量小的或含有毒性药的片剂，应根据

药物的性质用适宜的方法使药物分散均匀。

medicinal powders (extracts) for tableting should be mixed with the excipients

thoroughly. Tablets containing medicaments toxic in nature or those administered in

small dosage should be dispersed uniformly in a way appropriate for the substance

concerned.

二、凡属挥发性或遇热不稳定的药物在制片过程中应避免受热损失。

s containing volatile or thermolabile substances are processed in a way to avoid

loss on heating.

三、压片前的颗粒应控制水分，以适应制片工艺的需要，并防止成品在贮存期间发霉、变质。

moisture content of the granules should be controlled under the processing

requirement before tableting, thus to prevent mould contamination, deterioration during

storage.

四、片剂根据需要，可加人矫味剂、芳香剂和着色剂等附加剂。

necessary, additives such as correctauts, flavoring agents, colouring agents etc. May

be added in the preparation of tablets.

五、为增加稳定性、掩藏药物不良奥味或改善片剂外观等，可对制成的药片包糖衣或薄膜衣。对一些遇胃液易破坏、刺激胃黏膜或需要在肠道内释放的口服药片，可包肠溶衣。必要时，薄膜包衣片剂应检查残留溶剂。

order to increase the stability, cover up the unpleasant odour and taste or improve

the appearance etc., tablets may be coated with sugar or film. Tablets for oral

administration are enteric coated so as to avoid the gastric fluid's destroy, the irritation to

the gastric mucosa, thus to obtain a late release in the intestine. If necessary, solvent

residues should be examined for film-coated tablets.

六、片剂外观应完整光洁、色泽均匀，有适宜的硬度，以免在包装、贮运过程中发生磨损或破碎。

s should have a clean, smooth and uniformly coloured surface; they are

sufficiently hard to withstand handling without abrasion or cracking.

七、除另有规定外，片剂应密封贮存。

otherwise specified, tablets should be preserved in tightly closed containers.

片剂应进行以下相应检查

Following relevant tests should be carried out for tablets.

【重量差异】 片剂照下述方法检查，应符合规定。

Weight variation Tablets should comply with the following Requirements.

检查法 取供试品20片，精密称定总重量，求得平均片重后，再分别精密称定每片的重量，每片重量与标示片重相比较（无标示片重的片剂，与平均片重比较），按表中的规定，超出重量差异限度的不得多于2片，并不得有1片超出限度1倍。

Procedure Weigh accurately 20 tablets and calculate the average weight, then weigh

individually each of the 20 tablets. Compare the weight of each tablet with the labeled

tablet weight (if no labelled weight is stated, compare the weight of each tablet with the

average weight calculated).According to the requirements stated in the table, not more

than 2 of the individual weights exceed the weight variation limit and none doubles the

limit.

标示片重或平均片重

0.3g以下

重量差异限度

士7.5%

0.3g及0.3g以上

labelled or Average weight

Less than 0.3g

0.3g or more

±5%

Weight variation limit

士7.5%

±5%

糖衣片的片芯应检查重量差异并符合烧定，包糖衣后不再检查重量差异。除另有规定外，其他包衣片应在包衣后检查重量差异并符合规定。

Sugar coated tablets should be tested before sugar coating to show that the tablet cores

comply with the requirements. Tablets need not be tested again after sugar coating,

unless specified otherwise, other coated tablets should be tested after coating and

comply with the requirements.

【崩解时限】 除另有规定外，照崩解时限检查法（附录Ⅻ A）检查，应符合规定。

Disintegration Unless specified otherwise, Carry out the test as described under the

disintegration test (Appendix Ⅻ A).All the tablets should comply with the specified

requirements.

阴道片照融变时限检查法（附录Ⅻ B）检查，应符合规定。

Vaginal tablets should comply with the requiremeats under Disintegration Test for

Suppositories and Vaginal Tablets (Appendix Ⅻ B).

含片、咀嚼片不检查崩解时限。

No disintegration test is required for buccal tablets and chewable tablets.

【发泡量】 阴道泡腾片照下述方法检查，应符合规定。

Foaming capacity Vaginal effervescent tablets should Comply with the following test.

检查法 除另有规定外，取25m1具塞刻度试管（内径1.5cm)10支，各精密加水2ml，置37℃士1℃水浴中5分钟后，各管中分别投人供试品1片，密塞，20分钟内观察最大发泡量的体积，平均发泡体积应不少于6ml,且少于4ml的不得超过2片.

Assay Unless specified otherwise, take 10 25ml-graduated test tubes with piston, add

accurately 2 ml of water individually, put in the water bath with the temperature of 37℃士1℃ for 5 minutes. Put a piece of tablet in each tube, seal up with the piston. Observe the

volume of the largest amount of foam. Average volume should not be less than 6 ml, the

tablets less than 4 should not be more than 2.

【微生物限度】 照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（锭剂）ⅠE Troches

锭剂系指药材细粉与适宜黏合剂（或利用药材本身的黏性）制成不同形状的固体制剂。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).Troches are solid preparations of various shapes made from fine

powders of crude drugs and suitable binders (or using the binding property of crude

drugs themselves).

锭剂在生产与贮藏期间应符合下列有关规定。

The production and storage of troches should comply with the following requirements.

一、作为锭剂黏合剂使用的蜂蜜、糯米粉等应按规定方法进行处理。

honey, powder of glutinous rice etc. used for troches should be treated by the

specified methods.

二、制备时，应用各品种制法项下规定的黏合剂或利用药材本身的黏性合坨，以模制法或捏搓法成型，整修，阴干。也可用泛制法制备锭剂。

s should be prepared with binders or the binding property of crude drugs

themselves as described under individual monograph and formed by a moulding or a

kneading method, then renovated and dried in the shade. Torches may also be prepared

by water spray rotating Method.

三、需包衣或打光的锭剂，应用制法项下规定的包衣材料进行包衣或打光。

s may be coated or polished, if necessary, using the coating materials stated

under the individual monograph of the preparation.

四、锭剂应平整光滑、色泽一致，无皱缩、飞边、裂隙、变形及空心。

s should be neat, smooth, uniform in colour with no wrinkle, breach, gap, cavity

and change in form.

五、除另有规定外，锭剂应密闭，置阴凉干燥处贮存。

s should be preserved in well closed containers and stored in a cool and dry

place unless specified otherwise.

锭剂应进行以下相应检查。

Following relevant tests should be carried out for troches.

【重量差异】 除另有规定外，照丸剂重量差异项下方法检查，应符合规定。

Weight variation Unless specified otherwise, weight variation for troches complies with

the test for Weight variation stated under Pills.

【微生物限度】 照微生物限度检查法（附录XIII C）检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（煎膏剂）Ⅰ F Concentrated Decoctions

煎膏剂系指药材用水煎煮，取煎煮液浓缩，加炼蜜或糖（或转化糖）制成的半流体制剂。

Concentrated decoctions are semifluid preparations prepared by decoding the crude

drugs in water, concentrating the decoction and adding honey or sugar.(or invertsugar)

煎膏剂在生产与贮藏期间应符合下列有关规定。

The production and storage of concentrated decoctions should comply with the following

requirements.

一、药材按各品种项下规定的方法煎煮，滤过，滤液浓缩至规定的相对密度，即得清膏。

crude drugs should be decocted according to the appropriate methods for individual

species and filtered. The thin extract is obtained by concentrating the filtrate to a

specified relative density.

二、如需加入药粉，除另有规定外，一般应加入细粉。

specified otherwise, the fine powder of crude drugs should be added when the

powder is needed as required.

三、渭膏按规定量加入炼蜜或糖（或转化糖）收膏；若需加药材细粉，待冷却后加入，搅拌混匀。除另有规定外，加炼蜜或糖（或转化糖）的量，一般不超过清膏量的3倍。

thin extract is concentrated by adding specified quantity of processed honey or

sugar (or invert sugar). The fine powder of crude drugs should be added into a cold

concentrated decoction, stirred and mixed well. The quantity of honey or sugar (or invert

sugar )added is generally not more than 3 times of that of the thin extract, unless

specified otherwise.

四、煎膏剂应无焦臭、异味，无糖的结晶析出。

trated decoctions should have no burnt or other abnormal odour, and produce

no sugar crystal out.

五、除另有规定外，煎膏剂应密封，置阴凉处贮存。

trated decoctions should be preserved in tightly closed containers, stored in a

cool place, unless specified otherwise.

煎膏剂应进行以下相应检查。

Following relevent tests should be carried out for concentrated decoctions.

【相对密度】 除另有规定外，取供试品适量，精密称定，加水约2倍，精密称定，混匀，作为供试品溶液。照相对密度测定法（附录Ⅶ A)测定，按下式计算，应符合各品种项下的有关规定。

Relative density Unless specified otherwise, Weigh accurately a sufficient quantity of

concentrated decoction being examined, dilute with double quantities of water, weigh

accurately and mix well. Carry out the determination of relative density (Appendix Ⅶ

A),calculate by the following formula. Should comply with the requirements under

individual monograph.

供试品相对密度=W1W1f

W2W1fRelative density of-W1-W1×f

concentrated decoction-W2-W1×f

式中

W1为比重瓶内供试品溶液的重量，g；

Where W1 is the weight (g) of concentrated decoction in pycnometer;

W2为比重瓶内水的重量，g；

W2

is the weight (g) of water in pycnometer. weight of water added in

f

f加入供试品中的水重量

供试品重量加入供试品中的水重量

weight of water added in concentrated decoction

weight of concentrated decoction weight of water added in concentrated decoction凡加药材细粉的煎膏剂，不检查相对密度。

It is not necessary to examine the relative density when the concentrated decoctions

contain fine powder of crude drugs.

【不溶物】 取供试品5g,加热水200ml，搅拌使溶化，放置3分钟后观察，不得有焦屑等异物（微量细小纤维、颗粒不在此限）。

Insoluble materials To 5g of the concentrated decoction add 200 ml of hot water, stir

to dissolve, allow to stand for 3 minutes, and observe. No foreign matters such as

scorched masses, etc. should be observed (a small amount of fine fibres and particles

are not defined in this limit).

加药材细粉的煎膏剂，应在未加人药粉前检查，符合规定后方可加人药粉。加人药粉后不

再检查不溶物。

The concentrated decoction containing fine powder of crude drugs should be examined

before the powder is added. The powder is added if it complies with the requirements. It

is not necessary to examine the insoluble materials after the powder is added.

【装量】 照最低装量检查法（附录Ⅻ C)检查，应符合规定。

Filling Carry out the test for Minimum Fill (Appendix Ⅻ C),it should comply with the

specified requirement.

【微生物限度】 照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（胶剂）Ⅰ G Glues

胶剂系指动物皮、骨、甲或角用水煎取胶质，浓缩成稠胶状，经干燥后制成的固体块状内服制剂。

Glues are solid lump preparations intended for internal administration, prepared by

decocting animal skin, bone, shell or born with water, concentrating into thick gelatinous

mass and then drying.

胶剂在生产与贮藏期间应符合下列有关规定。

The production and storage of glues should comply with the following requirements.

一、胶剂所用原料应用水漂洗或浸漂，除去非药用部分，切成小块或锯成小段，再漂净。

and rinse the raw materials for the preparation of glues in water, remove foreign

matters or non medicinal parts, cut into small lumps or saw into small pieces, then wash

clean.

二、加水煎煮数次至煎煮液清淡为度，合并煎煮液，静置，滤过，浓缩。浓缩后的胶液在常温下应能凝固。

with water for several times until the decoction becomes light, combine the

decoctions, allow to stand, filter and concentrate the filtrate. The concentrated gelatinous

liquid should be able to coagulate under normal temperature.

三、胶凝前，可按各品种制法项下规定加入适量辅料（黄酒、冰糖、食用植物油等）。

the glues begin to coagulate, add a suitable amount of excipients (yellow rice

wine, crystal sugar, edible vegetable oil, etc.), according to the requirements for

processing specified in individual monograph.

四、胶凝后，按规定重量切成块状，阴干。

the glues coagulate, cut into lumps by weight as required and dry in the shade.

五、胶剂应为色泽均匀、无异常臭味的半透明固体。

should be translucent, uniform in appearance and colour, without abnormal

odour.

六、一般应检查总灰分、重金属、砷盐等。

general, total ash, heavy metals, arsenic salts etc. should be determined

七、胶剂应密闭贮存、防止受潮。

should be preserved in well closed containers and protected from moisture.

胶剂应进行以下相应检查。

Following relevant tests should be carried out for glues.

【水分】 取供试品lg，置扁形称量瓶中，精密称定，加水2ml,置水浴上加热使溶解后再干燥,使厚度不超过2mm,照水分测定法（附录Ⅸ H第一法）测定，不得过15.0％。

Determination of water Put 1g of gules into the flat weighing bottle, weigh accurately,

add 2ml of water, then heat it in the water bath to dissolve it, and then dry it. Make sure

the thickness is not more than 2 mm. carry out the method for the determination of water

(Appendix Ⅸ H, method 1),the glues contain not more than 15.0 per cent of water.

【微生物限度】 照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Test

(Appendix XIII C).

（糖浆剂）Ⅰ H Syrups

糖浆剂系指含有药材提取物的浓蔗糖水溶液。

Syrups are concentrated aqueous solutions of sucrose containing extracts of crude

drugs;

糖浆剂在生产与贮藏期间应符合下列有关规定。

The production and storage of syrups should comply with the following requirements.

一、含蔗糖量应不低于45％（g/ml）。

should contain not less than 45per cent (g/ml)of sucrose

二、药材应按各品种项下规定的方法提取、纯化、浓缩至一定体积，或将药物用新煮沸过的水溶解。加入单糖浆；如直接加入蔗糖配制，则需煮沸，必要时滤过，并自滤器上添加适量新煮沸过的水至处方规定量。

crude drugs should be extracted, purified and concentrated to a certain volume

using the appropriate methods specified under the individual monograph, or drugs are

dissolved with freshly boiled water, and then added with simple syrups are

prepared with solid sucrose, water is added and boiled and filtered, a suitable amount of

freshly boiled water may be added to the filtrate to comply with the labelled amount of

drugs described in individual monograph, then mixed well.

三、可加入适宜的附加剂。如需加入防腐剂，山梨酸和苯甲酸的用量不得超过0.3％(其钾盐、钠盐的用量分别按酸计），对羟基苯甲酸酯类的用最不得超过0.05％，如需加入其他附加剂，其品种与用量应符合国家标准的有关规定，不影响成品的稳定性，并应避免对检验产生干扰。必要时可加入适量的乙醇、甘油或其他多元醇。

le additives may be added to syrups. If preservatives are needed, the amount of

sorbic acid and benzoic acid should not be more than 0.3% (its potassium or sodium salt

should be taken by the acid amount),or the amount of p-hydroxybenzoic acid esters, not

more than 0.05%.

If other additives are added, the varieties and amount used should comply with the

requirements involved in national standards and do not interfere with stability and testing

of the preparation concerned. Suitable amount of ethanol, glycerin or other poly-alcohols

may be added if necessary.

四、除另有规定外，糖浆剂应澄清。在贮存期间不得有发霉、酸败、产生气体或其他变质现象，允许有少量摇之易散的沉淀。

should be clean, unless specified otherwise. No mold contamination, rancid,

gas or other deteriorations are allowed during storage. A small amount of dispersible

precipitates are allowed.

五、一般应检查相对密度、pH值等。

general, relative density, pH value etc. should be determined.

六、除另有规定外，糖浆剂应密封，置阴凉处贮存。

should be preserved in tightly closed containers. Stored in a cool place, unless

specified otherwise.

糖浆剂应进行以下相应检查。

Following relevant tests should be carried out for syrups.

【装量】 单剂量灌装的糖浆剂，照下述方法检查应符合规定。

Filling Syrups packed in a single doe should comply with the following test.

检查法 取供试品5支，将内容物分别倒人经校正的干燥量筒内，尽量倾净。在室温下检视，每支装量与标示装量相比较，少于标示装量的应不得多于1支，并不得少于标示装量的95%。

Procedure Take 5 bottles of syrup, pour the content separately to the calibrated dry

graduated cylinders, remove as completely as possible examine at room temperature.

Compare the filling volume of each pack with the labeled amount. Not more than 1 bottle

in volume is less than the labelled amount, none is less than 95 per cent of the labeled

amount.

多剂量灌装的糖浆剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。

Syrups packed in multiple doses comply with the requirements stated in Minimum

Fill(Appendix Ⅻ C)

【微生物限度】 照微生物限度检查法（附录XIII C）检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（贴膏剂）Ⅰ I Cataplasms

贴膏剂系指药材提取物、药材或和化学药物与适宜的基质和基材制成的供皮肤贴敷，可产生局部或全身性作用的一类片状外用制剂。包括橡胶膏剂、巴布膏剂和贴剂等。

Cataplasms are sheet preparations made of extract of crude drugs, crude drugs or (and)

chemical medicaments and appropriate bases, intended for application to skin, may

produce local or general effects, including adhesive plasters, babu plasters and sticking

plasters etc..

橡胶膏剂系指药材提取物或和化学药物与橡胶等基质混匀后，涂布于背衬材料上制成的贴膏剂。橡胶膏剂的制备方法常用的有溶剂法和热压法。常用溶剂为汽油、正已烷，常用基质有橡胶、热可塑性橡胶、松香、松香衍生物、凡土林、羊毛脂和氧化锌等。也可用其他

适宜溶剂和基质。

Adhesive plasters are cataplasms prepared by mixing the extract of crude drugs or (and)

chemical medicaments with bases to the backing materials. The preparation methods of

this agent consist of solvents method and hot-pressing method. The commonly used

solvents consist of gasoline, n-hexane, and commonly used bases consist of rubber,

hot-plastic rubber, rosin, rosin derivatives, vaselin, lanoline and zine oxide etc.. Other

appropriate solvents and bases are applicable. Consist of ethylene/vinyl acetate

copolymer, silicone rubber and polyethylene glycol etc.

巴布膏剂系指药材提取物、药材或和化学药物与适宜的亲水性基质混匀后，涂布于背衬材料上制成的贴膏剂。常用基质有聚丙烯酸钠、羧甲基纤维素钠、明胶、甘油和微粉硅胶等。

Babu plasters are cataplasms prepared by well mixing the extract of crude drugs, crude

drugs or (and) chemical medicaments with appropriate hydrophilic bases, then spreading

to the backing materials. The commonly used bases consist of sodium

carboxymethylcellcdose, gelatin, glyce-rine, microniting silica gel and so on.

贴剂系指药材提取物或和化学药物与适宜的高分子材科制成的一种薄片状贴膏剂。主要由背衬层、药物贮库层、粘胶层以及防粘层组成。常用基质有乙烯-醋酸乙烯共聚物、硅橡胶和聚乙二醇等。

Sticking plasters are lamellifom cataplasms made of extract of crude drags or (and )

chemical medicaments, and appropriate macromolecular materials mainly composed of

backing liner, drug-veserving liner, sticking liner and anti-sticking liner. The commonly

used bases consist of ethylene/vinyl acetate copolymer, silicone rubber, and

polyethylene glycol etc..

贴膏剂常用的背衬材料有棉布、无纺布、纸等；常用的盖衬材料有防粘纸、塑科薄膜、铝箔-聚乙烯复合膜、硬质纱布等。

The commonly used backing materials for cataplasms consist of calico, non-weaving

cloth, paper and so on; commonly used covering materials consist of anti-sticking paper,

plastic film, aluminum foil, polyethylene compound film, hard gauze and so on.

贴膏剂在生产与贮藏期间应符合下列有关规定。

Production and storage of cataplasms should comply with the following requirements.

一、药材提取物应按各品种项下规定的方法进行提取。除另有规定外，固体药物应预先粉碎成细粉或溶于适宜的溶剂中。

extracts of crude drugs are produced using the methods stated under individual

monographs. Unless specified otherwise, solid medicament should be finely powdered

previously or dissolved in a suitable solvent.

二、贴膏剂必要时可加入透皮促进剂、表面活性剂、保湿剂、防腐剂或抗氧剂等。

erme promoting agents, surfactants, stabiliyers, hygroscopic agents,

preservatives, antioxidants may be added in cataplasms, if necessary.

三、贴膏剂的膏料应涂布均匀，膏面应光洁，色泽一致，无脱膏、失黏现象；背衬面应平整、洁净、无漏膏现象。涂布中若使用有机溶剂的，必要时应检查残留溶剂。

plasters of cataplasms should be spreaded uniformly, the surface should be

smooth and clean, uniform in colour, not unglued and unviscous; Backing liner should be

smooth and clean, no plaster leaked. When organic solvents are used in spreading,

solvent residues should be examined if necessary.

四、贴膏剂每片的长度和宽度，按中线部位测量，均不得小于标示尺寸。

length and width of each piece of a cataplasm, measured by the mid-line, are not

less than those labeled.

五、除另有规定外，贴膏剂应密封贮存。

specified otherwise, Cataplasms should be preserved in tightly closed

containers.

贴膏剂应进行以下相应检查。

Following relevant tests should be carried out for cataplasms.

【含膏量】 橡胶膏剂照第一法检查，巴布膏剂照第二法检查。

Extractives in plaster mass Adhesive plasters are tested by Method 1, babu plasters

by method 2.

第一法 取供试品2片（每片面积大于35cm2的应切取35cm2),除去盖衬，精密称定，置于有盖玻璃容器中加适量有机溶剂（如三氯甲烷、乙醚等）浸渍，并时时振摇，待背衬与膏料分离后，将背衬取出，用上述溶剂洗涤至背衬无残附膏料，挥去溶剂，在105℃干燥30分钟，移置干燥器中，冷却30分钟。精密称定，减失重量即为膏重，按标示面积换算成100cm2的含膏量，应符合各品种项下的有关规定。

Method 1 Take 2 pieces of cataplasm (take 35cm2 for the cataplasms larger than

35cm2 in area),remove the covering liner, weigh accurately and put into a terrarium with

cover macerate in suitable quantity of organic solvent (chloroform, aether etc.) and shake

over and again until cataplasm separates from the cloth. Take out the cloth and wash

with above solvents until no cataplasm remains on it. Remove the solvent and dry the

cloth at the temperature of 105℃ for 30 minutes, transfer the cloth to the desiccator.

After cooling for 30 minutes, weigh accurately, the cloth. The difference between the

weightings is the weight of cataplasm. Calculate the weight per 100 cm2 of the cataplasm

by the labelled area. The result should comply with the requirement specified in individual

monograph.

第二法 取供试品1片，除去盖衬，精密称定，置烧杯中加适量水，加热煮沸至背衬与膏体分离后，将背衬取出，用水洗涤至背衬无残留膏体，晾干，在105℃干燥30分钟，移置

干燥器中，冷却30分钟，精密称定，减失重量即为膏重，按标示面积换算成100cm2的含膏量，应符合各品转项下的有关规定。

Method 2 Take one piece of cataplasm, remove the covering liner, weigh accurately

and put into a beaker, add suitable quantity of water and heat to boil until cataplasm

separates from the liner cloth. Take out the cloth, Wash the cloth with water until no

cataplasm remains on cloth. Allow to stand to dry, then put the cloth into an oven with a

temperature of 105℃ for 30 minutes, transfer the cloth to a desiccator. After cooling for

30 minutes, weigh accurately the cloth. The difference between the weightings is the

weight of cataplasm. Calculate the weight per 100 cm2 of the cataplasm by the labelled

area. The result should comply with the requirement specified in individual monograph.

【耐热性】 橡胶膏剂应做耐热性试验。

Heat-resistance Adhesive plasters should be tested for heat-resistance.

试脸方法 除另有规定外，取供试品2片，除去盖衬，在60℃加热2小时，放冷后，膏背面应无渗油现象；膏面应有光泽，用手指触试应仍有黏性。

Procedure Unless specified otherwise, take 2 pieces of cataplasm, remove the covering

liner, heat at the temperature of 60℃ for 2 hours, after cooling, the back of cataplasm

should be. no oily; the surface of the cataplasm Should have patina and still be viscous

when touch with finger.

【赋形性】 巴布膏剂应做赋形性试验。

Excipient property Excipient property should be tested for babu plasters.

试验方法 取供试品1片，置37℃、相对湿度64％的恒温恒湿箱中30分钟、取出，用夹子将供试品固定在一平整钢板上，钢板与水平面的倾斜角为600,放置24小时，膏面应无流淌现象。

Assay Place one piece of cataplasm into the constant T & H chamber with a

temperature of 37℃and a relative humidity of 64% for 30 minutes, then take out the piece

and fix it to a smooth steel plane using a clip, the steel plane is placed at an angle of

600with the horizontal plane, allow to stand for 24 hours. No moving of the adhesive side

occurs.

【黏附性】 除另有规定外，巴布膏剂照贴膏剂黏附力测定法（附录Ⅻ E第一法）、橡胶膏剂照贴膏剂黏附力测定法（附录Ⅻ E第二法）、贴剂照贴膏剂黏附力侧定法（附录Ⅻ E第二、三法）测定，均应符合各品种项下的有关规定。

Adhesive property Unless specified otherwise, babu plasters should comply with the

requirements stated under Determination of Cataplasms Adhesion (Appendix Ⅻ E,

method 1),adhesive plasters should comply with the requirements stated under

Determination of Cataplasms Adhesion (Appendix Ⅻ E, method 2),sticking plasters

should comply with the requirements stated under Determination of Cataplasms

Adhesion (Appendix Ⅻ E,method2,3).

【重量差异】 贴剂应做重量差异检查，并应符合规定。

Weight variation Cataplasm should be examined the weight variation and Comply with

the requirements.

检查法 除另有规定外，取供试品20片，精密称定总重量，求出平均重量，再分别称定每片的重量，每片重量与平均重量相比较、重量差异限度应在平均重量的±5％以内，超出重量差异限度的不得多于2片，并不得有1片超出限度1倍。

Assay Unless specified otherwise, weigh accurately 20 pieces of cataplasm, and

calculate the average weight, then weigh separately each piece of the cataplasm,

compare with the average weight. Not more than 2 of the indvidual weights exceed土5%

of the average weight and none doubles the limit.

【微生物限度】 除另有规定外，贴剂照微生物限度检查法（附录XIII C）检查，应符合规定。

Microbial limit test Unless specified otherwise, comply with the requirements stated

under Microbial Limit Test (Appendix XIII C).

（合剂）Ⅰ J Mixtures

合剂系指药材用水或其他溶剂，采用适宜方法提取制成的口服液体制剂（单剂量灌装者也可称“口服液”）。

Mixtures are liquid preparations intended for oral administration, prepared by extracting

the crude drugs with water or other solvents in suitable ways (package of a single dose is

also known as "oral liquids").

合剂在生产与贮藏期间应符合下列有关规定。

The production and storage of mixtures should comply with the following requirements.

一、药材应按各品种项下规定的方法提取、纯化、浓缩至一定体积。除另有规定外，含有挥发性成分的药材宜先提取挥发性成分，再与余药共同煎煮。

drugs should be extracted, purified and concentrated to a certain volume by the

methods as described under individual monograph. Unless specified otherwise The

volatile ingredients in crude drugs should be extracted at first, then the remaining crude

drugs decocted with the other drugs together.

二、可加人适宜的附加剂。如需加人防腐剂，山梨酸和苯甲酸的用量不得超过0.3％（其钾盐、钠盐的用量分别按酸计），对羟基苯甲酸酯类的用量不得超过0.05％，如需加入其他附加剂，其品种与用量应符合国家标准的有关规定，不影响成品的稳定性，并应避免对检验产生干扰。必要时可加入适量的乙醇.

le additives may by added to mixtures. If preservatives are needed, the amount

of sorbic acid and benzoic acid should not be more than 0.3%(its potassium or sodium

salt should be taken by the acid amount),or the amount of p-hydroxybenzoic acid esters,

not more than 0.05 per cent If another additives are added, The variety and quantity to be

used should comply with the requirements of the national standard, and not affect the

stability and interfere with the tests for mixtures. If necessary, mixtures could also contain

a proper quantity of alcohol

三、合剂若加蔗糖作为附加剂,除另有规定外,含蔗糖量应不高于20%（g/ml）。

sucrose is used as an additive in mixtures, unless specified otherwise the content of it

is not more than 20 percent (g/g).

四、除另有规定外，合剂应澄清。在贮存期间不得有发霉、酸败、异物、变色、产生气体或其他变质现象，允许有少量摇之易散的沉淀。

specified otherwise, mixtures should be clear, show no evidence of mold

contamination, rancidity, foreign matters, colour changing, gas or other deterioration

during storage, but a small amount of dispelsible precipitates are allowed.

五、一般应检查相对密度、pH值等。

general, relative density and pH value etc. should be determined.

六、除另有规定外，合剂应密封，置阴凉处贮存。

es should be preserved in tightly closed containers and stored in a cool place,

unless specified otherwise.

合剂应进行以下相应检查。

Following relevant test should be carried out for mixtures.

【装量】 单剂量灌装的合剂，照下述方法检查应符合规定。

Filling variation For mixtures packed in a single dose should comply with the following

test.

检查法 取供试品5支，将内容物分别倒入经校正的干燥量简内，在室温下检视，每支装

量与标示装量相比较，少于标示装量的不得多于1支，并不得少于标示装量的95%。

Assay Take 5 bottles of a mixture, pour the content separately to the calibrated dry

graduated cylinders, examine at room temperature. Compare the filling volume of each

pack with the labelled amount, not more than 1 bottle is less than the labelled amount,

none is less than 95 per cent of the labelled amount.

多剂量灌装的合剂，照最低装量检查法（附录Ⅻ C)检查，应符合规定。

Mixtures filled in multiple dose should comply with the requirements stated in Minimum

Fill(Appendix Ⅻ C).

【微生物限度】 照微生物限度检查法（附录XIII C）检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（滴丸剂）Ⅰ K Dripping Pills

滴丸剂系指药材经适宜的方法提取、纯化、浓缩并与适宜的基质加热熔融混匀后，滴入不相混溶的冷凝液中，收缩冷凝而制成的球形或类球形制剂。

Dripping pills are the preparations made by dripping a uniform, melted mixture of

medicaments prepared by purify and concentrating extract of crude drugs and

appropriate bases into an immiscible cooling liquid and congealing to a spherical or

sphare-like.

滴丸剂在生产与贮藏期间应符合下列有关规定。

The manufacture and storage of dripping pills should comply with the following

requirements.

一、根据不同品种可选用水溶性基质或非水溶性基质。常用基质有聚乙醇类、泊洛沙姆、硬脂酸聚烃氢（40)酯、明胶，硬脂酸、单硬脂酸甘油酯、氢化植物油等。

soluble or water-insoluble bases can be used to suit for different varieties of

dripping pills. Commonly used bases consist of polyethylene glycols poloxamer, polyoxy

[40] stearate, gelatin and stearic acid, glycerin monosterate, hydrogenated vegetable oils

and so on.

二、冷凝液必须安全无害，且与药物不发生作用。常用冷凝液有液状石蜡、植物油、甲基硅油和水等。

cooling liquid must be innocuous and should not interact with medicaments; liquid

paraffin. vegetable oil, methylsilicone oil and water are commonly used for this purpose.

三、滴丸应圈整均匀，色泽一致，无粘连现象，表面无冷凝液黏附。

ng pills should be round, integrate, uniform in colour and also well shaped without

adhesion. No cooling liquid remains on the surface of dripping pills.

四、根据药物的性质与使用、贮藏的要求，在滴制成丸后可包衣。

ng pills my be coated as required to suit for the properties of the medicaments

and for clinical usage and storage.

五、除另有规定外，滴丸剂应密封贮存。

specified otherwise, dripping pills should be kept in tightly closed containers.

滴丸剂应进行以下相应检查。

Following relevant test should be carried out for dripping pills.

【重量差异】 除另有规定外，滴丸剂照下述方法检查应符合规定。

Weight variation Unless specified otherwise, the limit of weight variation for dripping

pills complies with the following requirements.

检查法 取供试品20丸，精密称定总重量，求得平均丸重后，再分别精密称定每丸的重量。每丸重量与平均丸重相比较，按表中的规定，超出重量差异限度的不得多于2丸，并不得有1丸超出限度1倍。

procedure Weigh accurately the total weight Of 20 dripping pills, calculate the average

weight of each dripping weigh accurately each of the 20 dripping e

the weight of each pill with the average weight. According to the requirements stated in

the table, not more than 2 pills deviate outside the limit of weight variation,none deviates

outside 1 fold of the limit.

平均丸重

0.03g及0.03g以下

0.03g以上至0.1g

0.1g以上至0.3g

0.3g以上

Average weight

0.03g or less

more than 0.03g or 0.1g

Limit of weight variation

±15%

±12%

重量差异限度

±15%

±12%

±10%

±7.5%

mom than 0.1g to 3g

more than0.3g

±10%

±7.5%

包糖衣滴丸应检查丸芯的重量差异并符合规定，包糖衣后不再检查重量差异。包薄膜衣滴丸应在包衣后检查重量差异并符合规定。

The weight variation of sugar-coated dripping pills should be examined before coating.

Dripping pills are not to be coated until the weight variation of their cores complies with

the requirements. The test of weight variation is not required for dripping pills after

sugar-coating, but it is needed for dripping pills after film-coating and should comply with

the specified requirements.

【崩解时限】 照崩解时限检查法（附录Ⅻ A）检查，除另有规定外，应符合规定。

Disintegration test Carry out the test as described under disintegration test (Appendix

Ⅻ A),it should comply with the specified requirements, unless otherwise specified.

【微生物限度】 照微生物限度检查法（附录XIII C)检查，应符合规定。

Microbial limit test Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).