Dissolution Comparison of Terazosin Hydrochloride Tablets and Capsules from Different Manufacturers
- VernacularTitle:不同厂家盐酸特拉唑嗪片剂及胶囊剂溶出度的比较
- Author:
Bixin YI
;
Wen LAN
- Publication Type:Journal Article
- Keywords:
Terazosin hydrochloride;
Tablets;
Capsules;
Dissolution;
Similar factor
- From:
China Pharmacist
2015;18(10):1813-1817
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the dissolution of domestic terazosin hydrochloride tablets and capsules to provide reference for clinical use. Methods:The dissolution of the products from different manufacturers was investigated respectively in 4 kinds of media:pH 1. 0 hydrochloric acid solution,pH 4. 5 phosphate buffer solution,pH 6. 8 phosphate buffer solution and water. The dissolution tests were carried out by a paddle method at the stirring speed of 50 r·min-1 and an HPLC method was used to determine the dissolution rate. The dissolution behavior of the samples from different manufacturers was compared by a similar factor method. Results:The do-mestic tablets showed higher similarity with the reference formula, and the dissolution behavior of the capsules had significant differ-ence. Conclusion:The calculation method for the specification in some manufacturers is different from that of the reference prepara-tion, which leads to the difference between the testing preparation and the reference preparation, and should be paid attention in clini-cal use.