维脑路通片体外溶出度比较

Comparison the Dissolution Rates of Venoruton Tablets in vitro

目的 对国内 1 0个厂家生产的 1 2批维脑路通片进行体外溶出度比较 ,并分析各溶出参数 ,以评价产品的内在质量。方法 按中国药典 2 0 0 0年版溶出度测定方法 ,即以水为介质 ,采用转篮法 ,检测波长为 348nm ,用紫外分光光度法测定溶出液的含量。同时对片剂进行溶出度比较 ,计算各时间的累积溶出百分率 ,并提取溶出参数及方差分析。结果 根据威布尔(Weibull)分布模型 ,计算出 (T50 、Td、T80 、m)溶出参数 ,不同厂家产品的溶出参数具有极显著性差异 (P <0 .0 1 )。同一厂家 (SH)不同批号的溶出参数有显著性差异 (P<0 .0 5 ) ,而TJ的不同批号的溶出度参数没有显著性差异 (P >0 .0 5 )。结论 有必要增加对每批维脑路通片进行溶出度检查 ,以控制其质量 。

Aim To evalute the quality in vitro dissolution of venoruton tables from ten domestic plants (twelve different batches),and analyse their dissolution parameters and compare with each other.Methods According to the dissolution determination assay of Chinese Phamacopoeia(2000year),the distilled water was used as dissolution medium,rotating-basket method was adopted,the content of venoruton tablets was determined by UV Spectrophoto metry,detection wavelength was 348nm.The dissolution ratios of twelve different batches were compared,and the percents of cumulative dissolution were calculated.Parameters were collected and analyzed by pick-up.Results The dissolution parameters of T 50 、T d 、T 80 were obtained according to Weibull distribution.The results showed that parameters of these dissolution among the products from different manufactures have very significant difference(P<0.01).The parameters of different batches from the same factory (SH) have very significant difference (P<0.05),while TJ have no significant difference(P>0.05).Conclusion The dissolution of venoruton should be tested to control the quality and ensure clinical efficacy.