盐酸特拉唑嗪原料及其片剂晶型研究

Study on the Crystal Form of Terazosin Hydrochloride and Terazosin Hydrochloride Tablets

目的:考察盐酸特拉唑嗪原料及片剂中晶型。方法:采用粉末X射线衍射法检测国内上市的两家原料、参比制剂与自制盐酸特拉唑嗪片的晶型。结果:国内上市的两家原料与参比制剂的原料晶型一致,自制规格2mg的盐酸特拉唑嗪片与的参比制剂晶型一致。结论:采用粉末X射线衍射法检测原料及制剂中晶型,对制剂晶型检测方法进行优化,提高方法专属性,并对我国仿制药晶型研究提供思路。

Objective: To investigate the crystal of the active pharmaceutical ingredient and tables of terazosin hydrochloride. Methods: Crystal form analysis of active pharmaceutical ingredient from two sources, Reference Listed Drug and terazosin hydrochloride homemade generic tablets were carried out by powder X-ray diffraction. Results: The crystal forms of terazosin hydrochloride between its active pharmaceutical ingredient from two sources and Reference Listed Drug were consistent;they were also consistent between terazosin hydrochloride homemade generic tablets and the reference tablets(Hytrin). Conclusion: Powder X-ray diffraction method was used to detect the crystal form in active pharmaceutical ingredient and drugs, and the method was optimized to improve the specificity, and provide ideas for the study of the crystal type of generic drugs in China.