2024年3月13日发(作者：电视机哪个牌子质量最好)

European Pharmacopoeia 6.0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 i

n the constant temperature device for 15 min.

Method

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

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

vent and proceed as described under Dissolving Procedure. If the substance i

s completely dissolved, it is very soluble.

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

nd proceed as described under Dissolving Procedure. If the substance is com

pletely dissolved, it is freely soluble.

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

nd proceed as described under Dissolving Procedure. If the substance is com

pletely dissolved, it is soluble.

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

d proceed as described under Dissolving Procedure. If the substance is comp

letely dissolved, it is sparingly soluble.

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

dered 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 co

mpletely dissolved, it is slightly soluble.

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

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

nd proceed as described under Dissolving Procedure. If the substance is com

pletely dissolved, it is very slightly soluble.

中国药典2005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。

所以欧洲药典sparingly soluble系指溶质100mg能在溶剂3.0ml～10ml中完全溶

解，属于中国药典“略溶”的范围，但不完全等同中国药典中的“略溶”（试验方法略有不

同）。

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