吉他霉素片溶出度检查的再研究样本

下载后可任意编辑吉她霉素片溶出度检查的再讨论刘金凤 1 康红钰 2 杨月华 1 李岩 1 ( 1.河南省漯河市食品药品检验所, 河南 漯河 46 ; 2.河南省漯河市医学高等专科学校, 河南 漯河 46 ) 摘要: 目的 改变吉她霉素片溶出度试验条件, 使溶出度检查和人的生理特点更接近, 更能区分不同厂家药品的质量高低。方法 采纳原法定方法和降低转速及改变溶出介质方法的比较。结果 质量好的药片二种方法的溶出度没有差别, 而质量差的药片的溶出度二种方法有明显的差别。结论 建议吉她霉素片溶出度检查条件改成第二法, 以盐酸溶液( 5.6→1000) 900ml 为溶出介质, 转速为每分钟 50 转; 溶出介质配制简单, 使用试剂少, 对环境的污染也少。关键词: 吉她霉素片 溶出度 转速 溶出介质Once More Study on the Examination at Dissolution ofKitasamycin TabletsLIU Jin-feng1 , KANG Hong-yu2 , YANG Yue-hua1, LI Yan1(1. Henan Luohe Institute for Food and Drug Control, 2. Henan Luohe Medical College, Luohe 46 ,China)Abstract: Objective: To change experimental condition of dissolution of kitasamycin tablets, make the human physiological characteristics more close,and distinguish different manufacturers the quality of the drugs. Method: Adopting schedule method to compare with reducing revolutions and changing dissolution medium. Result:There is no difference of the two methods in the dissolution of drugs of good qulity,but there is significant difference in the dissolution of drugs of bad qulity. Conclusion: The second method was proposed to determine the dissolution of kitasamycin tablets,taking the hydrochloric acid solution (5.6-1000)900ml as dissolution medium,rotating speed is 50rpm; dissolution medium is simple and fewer reagent consumption with lower pollution. keywords: Kitasamycin tablets; Dissolution; Rotationai speed; Dissolution 下载后可任意编辑medium中图分类号: 文献标识码: 文章编号: 吉她霉素片为临床常见药物, 质量的好坏直接关系着人民群众用药的安全性与有效...