甲磺酸多沙唑嗪片制剂处方工艺探讨

Prescription and technology research of mesylate doxazosin tablets

目的:筛选甲磺酸多沙唑嗪片的最佳处方组成。方法:通过全面考察市售品外观,崩解时限,溶出度,溶出曲线,含量测定等,了解该产品的特征;以市售品上述指标为依据,以片剂外观、可压性、崩解时限、溶出度为基本指标进行处方筛选。结果:最佳处方组成为每片含甲磺酸多沙唑嗪2.43mg(相当于多沙唑嗪2mg),乳糖75mg,微晶纤维素45mg,羧甲基淀粉钠7mg,10%PVPk30乙醇溶液(50%)100mg,吐温0.03g,硬脂酸镁1.2mg。结论:采用本处方及工艺制得的甲磺酸多沙唑嗪片溶出度符合中国药典要求,与市售甲磺酸多沙唑嗪片相似,且制备工艺简单,适于工业化生产。

Objective：To screen mesylate tablets doxazosin composed of the best prescription.Methods：Goods sold through the appearance of a comprehensive study,disintegration,dissolution,dissolution curve,determination and so on,to understand the characteristics of the product;to market products based on the above-mentioned indicators,the appearance of a tablet can be pressure,the collapse of time dissolution of the basic indicators for the screening prescription.Results：The best prescription for every film with the composition of mesylate doxazosin 2.43mg （equivalent to doxazosin 2mg）,lactose 75mg,microcrystalline cellulose 45mg,carboxymethyl starch sodium 7mg,10% PVPk30 ethanol solution （50%） 100mg,Twain 0.03 g,magnesium stearate 1.2mg.Conclusion：The use of the prescription and technology obtained mesylate doxazosin tablet dissolution requirements in line with the Chinese Pharmacopoeia,and the market mesylate doxazosin film similar to the preparation process is simple and suitable for industrial manufacture.