氢氯噻嗪片质量分析

目的: 通过对市场上氢氯噻嗪片深入剖析,对产品质量进行评定。 方法: 按中国药典2010年版,检验所有样品;采用液质联用法,确证氢氯噻嗪的主要杂质,并对主要降解产物进行安全性评价;分别采用X射线粉末衍射技术和粒度分析仪,分析原料晶型类别和粒度及其分布情况;测定全部样品在不同pH的溶出介质中的溶出曲线。 结果: 明确了氢氯噻嗪的杂质种类及来源,主要降解杂质可引起试验动物肝细胞出现浊肿现象;氢噻嗪原料的晶型为同种;采用f₂因子和AV值进行溶出相似性比较,1家企业4条溶出曲线与参比产品一致。 结论: 2010年版药典能有效的控制药品质量,与原研制剂及国外上市制剂相比,国内产品的有效性上有较大差异,在处方及生产工艺方面需要提高。

Objective: Through to the market of hydrochlorothiazide thoroughly analyzed,each production enterprise of the quality evaluation. Methods: According to the ChP 2010,examine all the samples.The LC-MS methods was used,verifying the main impurities,and the main degradation products security is evaluated;Using the X-ray powder diffraction respectively technology and particle size analyzer,analysis raw material crystal category and particle size and distribution of;All the samples were in different pH value of dissolution dissolution medium curve. Results: Clear the hydrochlorothiazide impurities types and source,the main degradation impurities can cause experimental animal liver cells appear muddy swollen phenomenon;Hydrogen thiazide raw materials for the same type of crystal.The f₂ factor and AV value of dissolution,compared with only a similarity enterprise four dissolution curve and listed reference consensus. Conclusion: ChP 2010 can effectively control the quality of drugs,and the original research agents and foreign agents,the domestic product than listed on the effectiveness of have bigger difference,the prescription and production process needs to be improved.