2024年3月30日发(作者：飞利浦6系列哪个好)

各国药典对溶解度的描述总结

我们在查文献时，对英文或日文中的溶解度描述常不知对应中国药典的准确翻译是什

么，下面汇总各国药典溶解度的对比，大家不会再迷惑：

一、快速对比检索

中文描述 英文描述 日文描述 溶解性质

极易溶解 Very soluble 極めて溶やすい ＜1

易溶 Freely soluble 溶けやすい 1to10

溶解 Soluble やや溶けやすい 10to30

略溶 Sparingly soluble やや溶けにくい 30to100

微溶 Slightly soluble 溶けにくい 100to1000

极微溶解 Very slightly soluble 極めて溶けにくい 1000to10,000

几乎不溶或不溶 Practically insoluble, or Insoluble ほとんど溶けない

≥10,000

二、中国药典2010版二部标准凡例中关于溶解度的规定:

溶解度是药品的一种物理性质。各正文品种项下选用的部分溶剂及其在该溶剂中的溶

解性能，可供精制或制备溶液时参考；对在特定溶剂中的溶解性能需作质量控制时，应在

该品种检查项下另作具体规定。药品的近似溶解度以下列名词表示：

极易溶解 系指溶质1g(ml)能在溶剂不到1ml中溶解；

易溶 系指溶质1g(ml)能在溶剂1～不到10ml中溶解；

溶解 系指溶质1g(ml)能在溶剂10～不到30ml中溶解；

略溶 系指溶质1g(ml)能在溶剂30～不到100ml中溶解；

微溶 系指溶质1g(ml)能在溶剂100～不到1000ml中溶解;

极微溶解 系指溶质1g(ml)能在溶剂1000～不到10000ml中溶解；

几乎不溶或不溶 系指溶质1g(ml)在溶剂10000ml中不能完全溶解。

试验法：除另有规定外，称取研成细粉的供试品或量取液体供试品，置于25℃±2℃

一定容量的溶剂中，每隔5分钟强力振摇30秒钟；观察30分钟内的溶解情况，如看不见

溶质颗粒或液滴时，即视为完全溶解。

三、EP中对溶解度试验方法和定义规定

European Pharmacopoeia7.0关于溶解度的规定:

SOLUBILITY

For this test a maximum of 111 mg of substance (for each solvent) and a

maximum of 30 ml of each solvent are necessary.

Dissolving procedure

Shake vigorously for 1 min and place in a constant temperature device,

maintained at a temperature of 25.0 ± 0.5 °C for 15 min. If the substance is not

completely dissolved, repeat the shaking for 1 min and place the tube in the

constant temperature device for 15 min.

Method

Weigh 100 mg of finely powdered substance (90) (2.9.12) in a stoppered tube

(16 mm in internal diameter and 160 mm long), add 0.1 ml of the solvent and

proceed as described under Dissolving Procedure. If the substance is completely

dissolved, it is very soluble.

If the substance is not completely dissolved, add 0.9 ml of the solvent and

proceed as described under Dissolving Procedure. If the substance is completely

dissolved, it is freely soluble.

If the substance is not completely dissolved, add 2.0 ml of the solvent and

proceed as described under Dissolving Procedure. If the substance is completely

dissolved, it is soluble.

If the substance is not completely dissolved, add 7.0 ml of the solvent and

proceed as described under Dissolving Procedure. If the substance is completely

dissolved, it is sparingly soluble.

If the substance is not completely dissolved, weigh 10 mg of finely powdered

substance (90) (2.9.12) in a stoppered tube, add 10.0 ml of the solvent and proceed

as described under Dissolving Procedure. If the substance is completely dissolved,

it is slightly soluble.

If the substance is not completely dissolved, weigh 1 mg of finely powdered

substance (90) (2.9.12) in a stoppered tube, add 10.0 ml of the solvent and proceed

as described under Dissolving Procedure. If the substance is completely dissolved,

it is very slightly soluble.

所以欧洲药典的溶解度与中国药典是等同，但又不完全等同中国药典，因为试验方法

略有不同O(∩_∩)O~

四、BP中对溶解度试验方法和定义规定

General Notices Part II

Solubility

The following table indicates the meanings of the terms used in statements of

approximate solubilities.

Descriptive term Approximate volume of solvent in millilitres per gram of

solute

very soluble less than 1

freely soluble from 1 to 10

soluble from 10 to 30

sparingly soluble from 30 to 100 对应Ch.P凡例，应该是“略溶”

slightly soluble from 100 to 1000

very slightly soluble from 1000 to 10 000

practically insoluble more than 10 000