复方甘草片溶出行为的研究与评价.PDF

复方甘草片溶出行为的研究与评价 郑淑凤，胡猛慎，杨红娟，黄剑英，李玲玲 厦门市药品检验所，福建 厦门 361012 摘 要：目的 建立复方甘草片溶出度试验方法，考察国内复方甘草片的溶出行为并评价其内在质量。方法 采用桨法，以 水为溶出介质，转速为75 r/min ，自身对照法，紫外-可见分光光度法测定，检测波长260 nm 。结果 复方甘草片在10%～ 100%的溶出量内呈良好的线性关系，回归方程Y＝1.098 19X ＋0.009 18，r ＝0.999 7，采用此法检测32 家生产企业76 批样 品溶出度，36.8%批次的溶出结果低于80%。结论 溶出试验方法在一定程度上反映本品的生物利用度，自身对照法能消除 干扰，重复性好、操作简便，对全国样品考察结果显示，方法能够有效控制产品的内在质量。 关键词：复方甘草片；溶出度；自身对照法；质量控制 中图分类号：R 文献标志码：A 文章编号：1674 - 6376 (20 14) 01 - 0 - 0 DOI: 10.7501/j.issn.1674-6376.2014.01. Analysis and evaluation of dissolution of Compound Liquorice Tablets ZHENG Shu-feng, HU Meng-shen, YANG Hong-juan , HUANG Jian-ying, LI Ling-ling Xiamen Institute for Drug Control, Xiamen 361012, China Abstract: Objective To establish a test method for the dissolution of Compound Liquorice Tablets (CLT), to inspect the dissolution of 76 batches of CLT made in China, and to evaluate their internal-quality. Methods Using paddle method, the medium was water, and rotated speed was 75 r/min. The detection wavelength was 260 nm, the values of dissolution were calculated by self-control method. Results The calibration curve was liner in the concentration range of 10%— 100% dissolution, r = 0.999 7; 76 batches of samples from 32 manufactories were detected using this method and the batches with the results below 80% were about 36.8% in total. Conclusion The dissolution test method shows the biological availability to some degree, and the self-control method is accurate, highly specific, and widely applicable. Through the investigation of the samples all over the country, it is shown that the method could be applicable to all the samples and effectively control the internal-quality of product. Key words: Compound Liquorice Tablets; dissolution; self-control method; quality control 药物的溶出不仅直接影响药物在体内的吸收和 成溶出行为差异的原因就是粒度、辅料和生产工艺； 利用，而且是研究固体制剂所含主药的晶形、粒度、 2 、消除误差，多组分中药由于生产工艺不同造成组 处方组成、辅料品种和性质、生产工艺等对制剂质 分比例差异，用某一特定组分比例的对照品测定