溶出度检查法美国药典USP711.docx

1、溶出度检查法美国药典USP711溶出度检查法美国药典USP-711 DISSOLUTION溶出度(USP39-NF34 Page 540)General chapterDissolutionis being harmonized with the corresponding texts of theEuropean Pharmacopoeiaand/or theJapanese Pharmacopoeia. These pharmacopeias have undertaken to not make any unilateral change to this harmonized chapt

2、er.通则溶出度与欧盟药典和日本药典中的相应部分相统一。这三部药典承诺不做单方面的修改。Portions of the present general chapter text that are nationalUSPtext, and therefore not part of the harmonized text, are marked with symbols to specify this fact.本章中的部分文字为本国USP内容，并没有与其他药典统一。此部分以（）标注。This test is provided to determine compliance with the d

3、issolution requirementswhere stated in the individual monographfor dosage forms administered orally. In this general chapter, a dosage unit is defined as 1 tablet or 1 capsule or the amount specified.Of the types of apparatus designs described herein, use the one specified in the individual monograp

4、h. Where the label states that an article is enteric coated and a dissolution or disintegration test does not specifically state that it is to be applied todelayed-releasearticles and is included in the individual monograph, the procedure and interpretation given forDelayed-Release Dosage Formsare a

5、pplied, unless otherwise specified in the individual monograph.本测试用于检测药品口服制剂的溶出度是否符合各论中的规定。本章中，除另有规定外，单位制剂定义为1片或1粒胶囊。对于本章中所述多种仪器，使用各论中规定的种类。除各论中另有规定外，如果检品是肠溶衣片且各论中的溶出度或崩解时限检查项下没有特别指出适用迟释剂的，使用本章中适用于迟释剂的流程和解释。FOR DOSAGE FORMS CONTAINING OR COATED WITH GELATIN涂有或包含明胶的剂型If the dosage form containing gel

6、atin does not meet the criteria in the appropriateAcceptance Table(seeInterpretation,Immediate-Release Dosage Forms,Extended-Release Dosage Forms, orDelayed-Release Dosage Forms) because of evidence of the presence of cross-linking, the dissolution procedure should be repeated with the addition of e

7、nzymes to the medium, as described below, and the dissolution results should be evaluated starting at the first stage of the appropriateAcceptance Table. It is not necessary to continue testing through the last stage (up to 24 units) when criteria are not met during the first stage testing, and evid

8、ence of cross-linking is observed.如果剂型中含有明胶，其不符合验收表中的标准（见判断，速释制剂，延释制剂，缓释制剂），因为存在明胶交联结合作用，它的溶解过程与外加的媒介酶是重复的，见下面的描述，并且溶解结果可以通过适当的验收表的开始的第一阶段标准进行评估。如果溶出结果不满足第一阶段的测试标准，那么就没有必要继续测试到最后阶段，并且也证明了明胶交联结合作用的存在。Gelatin, in the presence of certain compounds and/or in certain storage conditions, including but not

9、 restricted to high humidity and temperature, may present cross-linking. A pellicle may form on the external and/or internal surface of the gelatin capsule shell or on the dosage form that prevents the drug from being released during dissolution testing (see more information inCapsulesDissolution Te

10、sting and Related Quality Attributes).明胶，存在于某一处方和/或某一储存条件下，如：高温高湿，可能存在明胶交联结合作用。在胶囊壳或其他剂型的外表面和/或内表面形成一层膜阻止溶出试验过程中药物的释放（见胶囊-溶出度检测和相关质量属性）。NoteAll references to a chapter aboveare for information purposes only, for use as a helpful resource. These chapters are not mandatory unless explicitly called out

11、 for this application.注-超过章节的所有引用应用的目的仅为提供参考信息。这些章节是非强制的，除非另有规定。Dissolution Medium with pH4.0 pH4.0的溶出介质Enzyme:Pepsin, activity determined by the procedure inpurified pepsin, in theReagent Specificationssection酶：胃蛋白酶，活性视试剂规格部分中的胃蛋白酶提纯过程而定。Amount:A quantity of pepsin that results in an activity of NM

12、T 750,000 Units/L of dissolution medium数量：一些胃蛋白酶对溶出介质提供NMT 750,000 单位/L的生物活性。Dissolution Medium with pH 4.0 and 4.0 和 6.8的溶出介质Enzyme:Papain, activity determined by theAssaytest in the monograph forPapain; or bromelain, activity determined by the procedure inbromelain, in theReagent Specificationssec

13、tion酶：木瓜蛋白酶，活性视木瓜蛋白酶专论中的分析测试而定；或菠萝蛋白酶，活性视试剂规格部分中的菠萝蛋白酶生产过程而定。Amount:A quantity of papain that results in an activity of NMT 550,000 Units/L of dissolution medium, or a quantity of bromelain that results in an activity of NMT 30 gelatin-digesting units (GDU)/L of dissolution medium数量：一些木瓜蛋白酶对溶出介质提供NM

14、T 550,000 单位/L的生物活性；一些菠萝蛋白酶对溶出介质提供NMT 30明胶消化单位/L的生物活性。Dissolution Medium with pH6.8 pH6.8的溶出介质Enzyme:Pancreatin, protease activity determined by the procedure inAssay for protease activity(Casein digestive power) in the monograph forPancreatin酶：胰液素，蛋白酶活性视胰液素专论中的蛋白酶活性（酪蛋白消化能力）分析中的生产过程而定。Amount:A quan

15、tity of pancreatin that results in a protease activity of NMT 2000 Units/L of dissolution medium数量：一些胰液素对溶出介质提供NMT 550,000 单位/L的蛋白酶活性。Dissolution Medium Containing Surfactant or Other Ingredients Known to Denature the Enzyme含有表面活性剂或其他已知成分变性酶的溶出介质If the dissolution medium contains surfactant or other

16、 ingredients that are known to denature the enzyme used, a pretreatment step in the dissolution testing of the dosage form may be applied. This pretreatment step is done using the specified dissolution medium without the surfactant or the ingredient and with the addition of the appropriate amount of enzyme a