不同固体剂型盐酸吡格列酮制剂的溶出度考察

目的：比较3个厂家不同固体剂型吡格列酮片剂和胶囊剂的溶出度，为临床用药提供参考。方法：采用紫外分光光度法测定吡格列酮含量，桨法测定溶出度，并以威布尔分布模型拟合溶出参数，再对T50，Td，M进行统计分析。结果：3个厂家不同固体剂型中盐酸吡格列酮片剂和胶囊剂的溶出度均符合2005年版《中国药典》规定，其T50，Td，M值两两间均存在显著性差异（P〈0．05）。结论：该方法简便、快速、稳定性好、结果准确，可用于药品制剂的质量控制。

Studies on dissolution rates of pioglitazone hydrochloride preparation in different solid dosage forms

Objective： To compare the dissolution rates of pioglitazone hydrochloride in different solid dosage forms produced by three manufactures and offer reference to clinical medication. Methods： The drug concentration was measured by ultraviolet spectrophotometry;The dissolution was determined by paddles method, the parameters on stripping curves were fitted by Weibull distribution model, T50, Td and M were figured out,and on which statistical analysis was conducted. Results： All the dissolution rates of pioglitazone hydrochloride tablet and capsule preparations from these manufactures meet the standards specified in 2005 edition of China Pharmacopoeia, and significant differences were found in parameters of T50,Td and M （P〈0.05）. Conclusion：The method is simple, good stability, the results are accurate and could be used for quality control of pharmaceutical preparations.