复方甘草片溶出行为的研究与评价  

Analysis and evaluation of dissolution of Compound Liquorice Tablets

作　　者：郑淑凤[1] 胡猛慎[1] 杨红娟[1] 黄剑英[1] 李玲玲[1] 

机构地区：[1]厦门市药品检验所,福建厦门361012

出　　处：《药物评价研究》2014年第2期130-134,共5页Drug Evaluation Research

基　　金：厦门市科技进步项目(Z20121035)

摘　　要：目的建立复方甘草片溶出度试验方法，考察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75r／min，自身对照法，紫外．可见分光光度法测定，检测波长260nm。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=1．09819X＋0．00918，r=O．9997，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，该方法能够有效控制产品的内在质量。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 15 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.

关 键 词：复方甘草片 溶出度 自身对照法 质量控制 

分 类 号：R974[医药卫生—药品]