牛磺酸颗粒的溶出度方法建立及国内产品质量现状考察 |
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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. |
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作者姓名: | 张彤 陈思 山广志 任连杰 余立 |
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作者单位: | 北京市药品检验所,北京,100035 |
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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。
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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 |
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Authors: | Zhang Tong Chen Si Shan Guang-zhi Ren Lian-jie and Yu Li |
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Institution: | ( geijing Municipal Institute of Drug Control, Beijing 100035) |
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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. |
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Keywords: | Taurine granules Dissolution Present condition of quality |
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