15个厂家盐酸二甲双胍片溶出度的比较
Comparison of dissolution of metformin hydrochloride tablets in vitro from fifteen different pharmaceutical factories
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摘要: 目的 :比较15个厂家盐酸二甲双胍片的体外溶出度,为临床用药提供参考。 方法 :采用转篮法进行体外溶出度实验,以紫外分光光度法进行含量测定,计算累计溶出百分率。以成布尔方程拟合溶出参数,并用方差分析对组间溶出参数进行统计学分析。 结果 :15个厂家盐酸二甲双胍片的体外溶出度均符合《中国药典》2005年版的规定,但各厂家盐酸二甲双胍片的溶出参数m、T30、T50、Td和T80间存在显著性差异(P< 0.01)。 结论 :不同厂家盐酸二甲双胍片的溶出参数存在差异,临床用药时应加以注意。Abstract: Objective :To compare the dissolution of metformin hydrochloride tablets in vitro from fifteen different pharmaceutical factories and provide suggestions for clinical application. Methods :The dissolution tests were carried out with rotating basket.UV method was used to determine the concentration of metformin hydrochloride.The accumulative dissolution based on the labeled amount was calculated and the Weibull's equation was used to model the dissolution parameters.The difference between different groups was statistically evaluated by variance analysis. Results :The dissolution of metformin hydrochloride tablets in vitro from fifteen different pharmaceutical factories conformed to the requirements of Chinese Pharmacopoeia (2005).But significant difference was found among the metformin hydrochloride tablets from fifteen different pharmaceutical factories in dissolution parameter m,T30,T50,Td and T80 (P< 0.01). Conclusion :There was significant difference in dissolution parameters among the metformin hydrochloride tablets from fifteen different pharmaceutical factories.It was indicated that attention should be paid to their clinical application.
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Key words:
- metformin hydrochloride /
- tablets /
- dissolution
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