小杯法测定国产盐酸哌唑嗪片溶出度

Study on small glass dissolution rate of domestic prazosin hydrochloride tablets

目的:考察市售8批盐酸哌唑嗪片剂的溶出度。方法:采用小杯法,以含3%的十二烷基硫酸钠的0.1mol·L^(-1)盐酸溶液为溶出介质,检测波长为247nm,测定盐酸哌唑嗪片的溶出度。结果:8批盐酸哌唑嗪片的体外溶出度均符合2000年版中国药典的规定,但溶出参数(T_(50)、T_d、m)的差异有显著性(P<0.01)。结论:建议对盐酸哌唑嗪片进行溶出度检查以控制其质量,保证临床疗效。

Objective ：To determine the dissolution of comercial prazosin hydrochloride tablets from eight different batches. Methods：Small glass-method is adopted,the medium is 0. 1 mol ·L^-1 hydrochloric acid containing 3% sodium lauaryl sulfate 250 mL,the detective wavelength was 247 nm to determine the dissolution of prazosin hydrochloride tablets. Results： The dissolution of 8 different batches of prazosin hydrochloride tablets are satisfied with the request of ChP 2000, but the dissolution parameters （ T50, Td 、m） have significant difference （ P 〈 0. 01 ）. Conclusion：It is suggested that the dissolution should be tested to control the quanlity and ensure clinic efficacy.