摘要
目的：建立利福喷丁(Rifapentinum)胶囊的最佳溶出度方法。方法：通过考察利福喷丁原料在盐酸溶液(9→1000)、pH6.8磷酸盐缓冲液—异柄醇(9∶1)、1%十二烷基硫酸钠水溶液及0.5%十二烷基硫酸钠水溶液中的溶解性,选择出适当的溶出介质。在确定溶出介质后,通过对转速和取样时间的选择,确定了利福喷丁胶囊的溶出度方法。并对方法的回收率和线性进行了考察。结果：采用转篮法,以0.5%十二烷基硫酸钠水溶液为溶出介质,转速75r·min^(-1),溶出时间为30min。取样后采用紫外分光光度法,以供试品与利福喷丁对照品的吸收度比值,计算各粒的溶出量。结论：本方法符合溶出度方法的建立原则,可控制利福喷丁胶囊的内在质量。
Objective：To establish an optimal method to determine the dissolution of Rifapentinum Capsules. Methods：To establish the optimal dissolution medium by studying the solubility of Rifapentinum materials in different medium;hydrochloric acid solution （9→1000）, pH6. 8 phosphate buffer-isopropyl alcohol （9 ： 1）,distilled water with 1% Sodium Dodeeyl Sulphate and distilled water with0. 5% Sodium Dodeeyl Sulphate. To establish the dissolution condition by choosing rotational speed and taking solutions time. Its recovery and linear relationship have been tested. Results：The basket-stlrring method was used, Distilled water with 0. 5% Sodium Dodeeyl Sulphate was used as dissolution medium,and rotational speed was 75r · min^-1. After .30min the dissolution solution of capsule was taken. Use ultra-violet absorption spectrometry method. Measure the absorbance of the resulting solutions and Rifapentinum reference standard solutions. Calculate the dissolution from each capsule. Conclusion：The method accords with the establishing principle of dissolution. It can be used for internal quality control of Rifapentinum capsules.
出处
《中国药品标准》
CAS
2006年第1期53-55,共3页
Drug Standards of China
关键词
利福喷丁胶囊
溶出度
Rifapentinum capsules ,dissolution
