氯沙坦钾片仿制药与原研药溶出曲线的相似性评价  

Similarity Evaluation of the Dissolution Curves of Generic and Original Preparation of Losartan Potassium Tablets

作　　者：史立川 蒲旭峰[1] 余永秀[2] 罗春颖 SHI Lichuan PU Xufeng YU Yongxiu LUO Chunying(School of Pharmacy, Chengdu University of TCM, Chengdu 610072, China Sichuan Heron Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group, Sich- uan Dujiangyan 611830, China)

机构地区：[1]成都中医药大学药学院,成都610072 [2]扬子江药业集团四川海蓉药业有限公司,四川都江堰611830

出　　处：《中国药房》2017年第30期4298-4301,共4页China Pharmacy

摘　　要：目的:考察氯沙坦钾片仿制药与原研药溶出曲线的相似性,为完善该制剂的质量评价提供参考。方法:采用桨法,以盐酸溶液(pH 3.0)、磷酸盐缓冲液(pH 4.5)、磷酸盐缓冲液(pH 6.8)、水为溶出介质,溶出介质体积为900 mL,转速为50 r/min,进行溶出试验,采用紫外-可见分光光度法,检测波长为256 nm,分别测定氯沙坦钾片仿制药与原研药的累积溶出度,并通过计算相似因子(f2)来评价其溶出曲线的相似性。结果:氯沙坦钾检测质量浓度线性范围为12.11~35.96μg/mL(r≥0.999 7);精密度、稳定性、重复性试验的RSD<5.0%;4种溶出介质中的回收率分别为98.66%~100.84%(RSD=0.77%,n=9)、98.91%~100.59%(RSD=0.49%,n=9)、98.33%~101.39%(RSD=0.85%,n=9)、99.46%~101.32%(RSD=0.55%,n=9)。在4种溶出介质中,3批氯沙坦钾片仿制药与原研药溶出曲线的f2均>70。结论:氯沙坦钾片仿制药与原研药的体外溶出曲线相似性较好。OBJECTIVE：To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation. METHODS：Using hydrochloric acid solution（pH 3.0）,phosphate buffer solution（pH 4.5）,phosphate buffer solution（pH 6.8）and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min. UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 nm. The similarity of dissolution curves were evaluated by calculating similarity factor（f2）. RESULTS：The linear range of losartan potassium was 12.11-35.96 μg/mL（r≥0.999 7）. RSDs of precision,stability and reproducibility tests were all lower than 5.0%. The recoveries of 4 dissolution media were 98.66%-100.84%（RSD=0.77%,n=9）,98.91%-100.59%（RSD=0.49%,n=9）,98.33%-101.39%（RSD=0.85%,n=9）,99.46%-101.32%（RSD=0.55%,n=9）. In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70. CONCLUSIONS：The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.

关 键 词：氯沙坦钾片 仿制药 原研药 溶出曲线 紫外-可见分光光度法 相似因子 评价 

分 类 号：R927[医药卫生—药学]