目的建立统一又能够区分不同厂家来源的双氯芬酸钠(diclofenacsodium)缓释片的释放度检查方法。方法采用流通池法,分别考察不同流速、不同介质条件下双氯芬酸钠缓释片的体外释放特性,并在最终选择的释放条件下,进行了释药曲线的相似性分析和威布尔参数的统计学分析。结果在所选流速范围内,流速对释放度无显著影响;f2因子和威布尔参数分析结果显示流速为4mL·min-1、流通池实验条件为0.1mol·L-1盐酸中释放1h后更换介质为水再释放7h对于市售双氯芬酸钠缓释片样品体外释放具有良好的区分力。结论本方法可用于实验样品的不同生产厂家的双氯芬酸钠缓释片的释放度检查,提示对于双氯芬酸钠缓释片释放度的全面考察以及仿制药质量的提高具有一定的科学实用意义。
Abstract
OBJECTIVE To develop a unified and discriminative method for the characterization of different diclofenac sodium extended release tablets. METHODS The flow-through cell method was employed to investigate the dissolution characteristics of all the samples at different flow rates and in different dissolution media. The dissolution data under the finally selected dissolution condition was also used to analyze the similarity of dissolution curves and statistical significance of Weibull parameters. RESULTS The dissolution behaviors of the samples were not significantly influenced by flow rates in the selected range. The dissolution at a flow rate of 4 mL穖in-1 and in hydrochloric acid (0.1 mol稬-1) for one hour followed by water for another seven hours was satisfactory to discriminate the samples,which was demonstrated by f2 and Weibull parameters analysis. CONCLUSION This method can be used for dissolution tests of diclofenac sodium extended release tablet samples from the manufacturers in this study with meanings in guiding both comprehensive investigation on the dissolution of diclofenac sodium extended release tablets and quality improvement of generic drugs.
关键词
双氯芬酸钠缓释片 /
流通池法 /
释放度 /
相似因子 /
威布尔参数
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Key words
diclofenac sodium extended release tablet /
flow-through cell method /
dissolution /
similarity factor /
Weibull parameter
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中图分类号:
R944
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参考文献
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脚注
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基金
国家“重大新药创制”科技重大专项资助项目(2011ZX09303-001)
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