摘要
评价了自制盐酸普萘洛尔氢氯噻嗪缓释胶囊与参比制剂体外释放曲线的相似性。用HPLC法测定受试与参比制剂在不同介质(水、pH 1.2人工胃液、pH 4.5和pH 6.8磷酸盐缓冲液)和不同转速(50、100 r/min)条件下的释放曲线,采用f_2相似因子法评价两者的相似性。结果受试制剂与参比制剂在不同介质、不同转速下的f_2值均大于50,两者体外释放行为相似。
The similarity of in vitro dissolution curves for the test and the reference propranolol hydrochloride and hydrochlorothiazide extended-release capsules was evalutated. The dissolution curves for the test and the reference preparations in four media（water, pH 1.2 artificial gastric juice, pH 4.5 and pH 6.8 phosphate buffer） and at different rotation speeds（50 and 100 r/min） were determined by HPLC. Their similarity was investigated according to the f_2 factor method. The results showed f_2 values of the test and the reference formulations under different conditions were all greater than 50, which indicated that their in vitro releasing behaviors were similar.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2016年第2期212-214,共3页
Chinese Journal of Pharmaceuticals
关键词
盐酸普萘洛尔氢氯噻嗪缓释胶囊
相似性
释放曲线
f_2因子
propranolol hydrochloride and hydrochlorothiazide extended-release capsule
similarity
release curve
f_2 factor
