10厂家替米沙坦片的体外溶出度考察

Study on the in vitro Dissolution Rate of Telmisartan Tablets From Ten Manufacturers

目的：考察国产替米沙坦片与原研样品在2种溶出介质中的体外溶出度,为全面评价药品质量提供依据。方法：分别以0.1 mol/L盐酸和磷酸盐缓冲溶液（PBS,p H 7.5）为溶出介质,用紫外分光光度法测定药物含量、桨法对10个厂家替米沙坦片进行体外溶出度试验,并与原研样品比较溶出度参数和相似因子（f2）值。结果：各样品含量均在90%~110%;在2种溶出介质中,国内产品溶出参数与原研样品比较均存在差异（P〈0.05）,与原研样品比较溶出曲线的f2值均小于50。结论：虽然国内各厂家产品含量均合格,但与原研样品比较,溶出行为不相似且不稳定。建议国内厂家应不断优化处方与工艺,并严格控制原辅料质量。

OBJECTIVE： To study the in vitro dissolution of domestic Telmisartan tablets and original sample in two dissolu- tion mediums, and provide the basis for a comprehensive evaluation of the quality of Telmisartan tablets. METHODS ： The drug con- tent was tested by ultraviolet （UV） spectrophotometric method and the in vitro dissolution rates of Telmisartan tablets from ten man- ufacturers was tested by paddle dissolving method, with the dissolution medium of hydrochloric acid 0.1 mol/L and PBS （pH 7.5）. Dissolution parameters and similarity factor J~ were compared with that of original sample. RESULTS： Contents of all samples were 90% to 110%. Domestic dissolution parameters of the sample and the original products were different （P〈0.05）, and dissolution curve f values were less than 50 when compared with original sample. CONCLUSIONS： The dissolution behavior of domestic sam- ple is not similar and unstable when it compared with original sample, though the content is qualified in domestic manufacturers. The domestic manufacturers should constantly optimize the formulation and technology and control materials＇ quality strictly.