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本帖最后由 偶尔范范小糊涂 于 2021-3-22 11:39 编辑
我们在查药典时，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，或者说中文对应的专业术语是什么，下面主要在总结了各大主流药典供大家参考： 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 1~10 溶解 Soluble やや溶けやすい 10~30 略溶 Sparingly soluble やや溶けにくい 30~to100 微溶 Slightly soluble 溶けにくい 100~to1000 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2020版四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、USP对溶解度的定义（凡例5.30中） 5.30. Description and Solubility Only where a quantitative solubility test is given in a monograph and is designated as such is it a test for purity. A monograph may include information regarding the arti-cle’s description. Information about an article’s “description and solubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. The reference table merely denotes the properties of articles that comply with monograph standards. The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. Although the information pro-vided in monographs and the information in the reference table may indirectly assist in the preliminary evaluation of an article, it is not intended to serve as a standard or test for purity.The approximate solubility of a compendial substance i indicated by one of the following descriptive terms:
Descriptive Term Parts of Solvent Required for 1 Part of Solute Very soluble Less than 1 Freely soluble From 1 to 10 Soluble From 10 to 30 Sparingly soluble From 30 to 100 Slightly soluble From 100 to 1,000 Very slightly soluble From 1,000 to 10,000 Practically insoluble, Greater than or equal to 10,000 or Insoluble
四、EP中对溶解度试验方法和定义规定（5.11） European Pharmacopoeia10.0 GENERAL NOTICES中凡例有说明，（另外5.11 CHARACTERS SECTION IN MONOGRAPHS章节中关于溶解度的规定和检测方法）
CHARACTERS The statements under the heading Characters are not to be interpreted in a strict sense and are not requirements. Solubility. In statements of solubility in the Characters section, the terms used have the following significance, referred to a temperature between 15 °C and 25 °C. 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
5.11 CHARACTERS SECTION IN MONOGRAPHS 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. 基本上EP和BP描述都是一样的，
五、BP中对溶解度试验方法和定义规定 General Notices Part II Solubility Statements on solubility given under the heading Characteristics are intended as information on the approximate solubility at a temperature between 15° and 25°, unless otherwise stated, and are not to be considered as official requirements. Statements given under headings such as Solubility in ethanol express exact requirements and constitute part of the standards for the substances under which they occur. 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
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发表于 2021-3-22 11:32:36
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