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1、European Pharmacopoeia 6.0关于溶解度的规定:SOLUBILITYFor this test a maximum of 111 mg of substance (for each solvent) and a maximum of 30 ml of each solvent are necessary.Dissolving procedureShake vigorously for 1 min and place in a constant temperaturedevice, maintained at a temperature of 25.0 0.5 C for
2、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.MethodWeigh 100 mg of finely powdered substance (90) (2.9.12) in a stopperedtube(16 mm in internal diameter and 160 mmlong), add 0.1 ml of the solvent a
3、nd proceed as described under Dissolving Procedure. If the substance is completely dissolved, it isverysoluble.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.I
4、f 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,add7.0 ml of the solvent and proceed as described under Dissolving Procedur
5、e. 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 completel
6、y 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 stopperedtube,add10.0 ml of the solvent and proceed as described under Dissolving Procedure. If the substance is completely dissolved, it isveryslightly solubl
7、e.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252一定容量的溶剂中，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3.0ml10ml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）。小眼董赟(站内联系TA)学习:victory:li_yeqing(站内联系TA)在水中难溶
