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牛磺酸颗粒的溶出度方法建立及国内产品质量现状考察
引用本文:张彤,陈思,山广志,任连杰,余立.牛磺酸颗粒的溶出度方法建立及国内产品质量现状考察[J].中国药品标准,2010,11(1):32-35.
作者姓名:张彤  陈思  山广志  任连杰  余立
作者单位:北京市药品检验所,北京,100035
摘    要:目的:建立牛磺酸颗粒的溶出度检查方法并对国内产品进行质量现状考察。方法:采用桨法50转,以水900mL为溶出介质,紫外.可见分光光度法测定,检测渡长333nm。结果:经方法学验证,牛磺酸检测浓度在80~400mg·L^-1范围内线性关系良好(r=0.9994),平均回收率为100.79%(RSD=1.32%)。且经用该法检验,国内5个厂家生产的牛磺酸颗粒在20min时,溶出度均不低于标示量的85%。结论:所建方法可行,准确灵敏,国内牛磺酸颗粒产品的溶出性能良好。

关 键 词:牛磺酸颗粒  溶出度  质量现状

Establishment for the Determination Method of Dissolution of Taurine Granules and Comparison of Dissolution for Domestic Manufactures
Authors:Zhang Tong  Chen Si  Shan Guang-zhi  Ren Lian-jie and Yu Li
Institution:( geijing Municipal Institute of Drug Control, Beijing 100035)
Abstract:Objective:The method for the determination of dissolution of Tanrine Granules was established and comparison of dissolution for domestic manufacture. Methods: The Apparatus 2 was used and water was used as dissolution medium; The absorbability was determined by ultraviolet Spectrophotometer with detection wavelength at 333 nm. Results: The method showed a good linear relationship in the range of 80 - 400 mg ·L ^- 1 ( r = 0. 999 4 ) with average recovery at 100. 79% ( RSD = 1.32% ), and the dissolution of Tanrine Granules had achieved 85% in 20 min. Conclusion:This method is simple, accurate and reliable, and it satisfied for the determination of dissolution of Taurine Granules ; and domestic manufactures taurine granules have no significant differences between each other.
Keywords:Taurine granules  Dissolution  Present condition of quality
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