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目的:考察3个厂家罗格列酮片的溶出度,为临床合理有效用药提供依据。方法:以盐酸溶液(9→1000)为溶出介质,采用紫外分光光度法(中国药典2005年版二部附录IV A)测定溶出度,计算不同时间的累计溶出量。根据威布尔(weibul1)分布模型计算体外溶出参数Td、m,采用高效液相色谱法作为紫外分光光度法的平行对照实验。结果:3个厂家的罗格列酮片20min溶出均>80%,符合药典标准,但溶出参数有显著性差异(P<0.01)。结论:3厂家的罗格列酮片均符合质量标准,但不同厂家的产品之间有差异,紫外分光光度法与高效液相色谱法测定无差异。
OBJECTIVE: To investigate the dissolution of rosiglitazone tablets in three factories to provide a basis for clinical rational and effective drug use. Methods: The dissolution rate was determined by ultraviolet spectrophotometry (Chinese Pharmacopoeia 2005 edition two appendix IV A) with hydrochloric acid solution (9 → 1000) as dissolution medium, and the cumulative dissolution amount at different time was calculated. In vitro dissolution parameters Td, m were calculated according to the weibul1 distribution model, and high performance liquid chromatography (HPLC) was used as a parallel control for UV spectrophotometry. Results: The rosiglitazone tablets of three manufacturers were all eluted at 20% in 20 min, which was in accordance with Pharmacopoeia standard, but the dissolution parameters were significantly different (P <0.01). Conclusion: 3 manufacturers of rosiglitazone tablets are in line with quality standards, but there are differences between different manufacturers of products, UV spectrophotometry and high performance liquid chromatography no difference.