两种条件下实时测定硝苯地平片溶出度研究

·制剂研究·

两种条件下实时测定硝苯地平片溶出度研究

林桂如1,2， 熊斌3

(1.广州中医药大学，广东 广州 510006；2.广州白云山拜迪生物医药有限公司，广东 广州 511495；

3.无限极(中国)有限公司，广东 江门 529156)

摘要：目的对比中国药典法与日本橙皮书法条件下硝苯地平片溶出度测定结果，为本品质量控制、溶出度评价提供依据。方法随机取6个市售不同厂家硝苯地平片，采用光纤药物溶出度实时测定仪进行溶出度测定，并将2种条件下测定的结果进行比较分析。结果6个厂家样品采用中国药典法条件测定的溶出度在60 min时均能达到75%以上，符合中国药典标准规定，但6个厂家样品溶出行为存在差异；采用日本橙皮书法条件测定的溶出度30 min时均小于70%，达不到日本橙皮书标准规定，且60 min时均未达到溶出平台。结论硝苯地平片溶出度在2种条件下检测的结果存在显著性差异，6厂家样品质量存在差异，且中国药典法溶出条件比日本橙皮书法宽松。

关键词：硝苯地平；溶出度；药典法；日本橙皮书；比较

作者简介：林桂如，女，研究方向：药物制剂，E-mail:714641491@qq.com

中图分类号：R927.1文献标识码：A

ComparisonontheprocessmonitoringofdissolutionofNifedipineTabletsintwoconditions

LIN Gui-ru1,2,XIONG Bin3

(1.Guangzhou University of Chinese Medicine,Guangzhou 510006,China;2.Guangzhou

Baiyunshan Baidi Biotechnology Co.,Ltd.,Guangzhou 511495,China;3.Infinitus (China)

Company Limited,Jiangmen 529156,China)

Abstract：ObjectiveTo compare the dissolution results of Nifedipine Tablets in the condition according to Chinese Pharmacopoeia and Japanese Orange Book respectively,and to provide a scientific basis for quality control and dissolution evaluation of the products.MethodsThe dissolution of 6 lots of commercial Nifedipine Tablets randomly selected from different manufacturers were determined with a fiber-optic medicine dissolution/release rate process monitoring system,and the results determined in the condition according to Chinese Pharmacopoeia and that according to Japanese Orange Book were comparatively analyzed.ResultsThe dissolution of samples from 6 manufacturers can all reach more than 75% in 60 min in Ch.P.condition,which met the requirements of Ch.P.,but there was difference in the dissolution behavior of them.When determined in condition according to Japanese Orange Book,the dissolution of these samples were less than 70% in 30 min,and can not reach dissolution platform in 60 min,which did not meet the requirements of Japanese standard.ConclusionThere was significant difference in the dissolution of Nifedipine Tablets determined in the two conditions.The quality of products from 6 manufacturers were uneven.The dissolution condition from Chinese Pharmacopoeia were more relaxed than that from Japanese Orange Book.

Keywords:Nifedipine;Dissolution;Pharmacopoeiamethod;Japanese Orange Book;Comparison

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