中国药房2016，Vol.27Issue(34)：4862-4863,4864,3.DOI:10.6039/j.issn.1001-0408.2016.34.34
12个厂家盐酸舍曲林片的溶出曲线相似性研究
Study on the Similarity of Dissolution Curves of Sertraline Hydrochloride Tablets from 12 Manufacturers
刘慧颖 1隋晓璠 1陈默1
作者信息
- 1. 辽宁省药品检验检测院，沈阳 110036
- 折叠
摘要
Abstract
OBJECTIVE:To compare the similarity of dissolution curves of Sertraline hydrochloride tablets from 12 manufactur-ers,and to evaluate the maturity and stability of technology. METHODS:The dissolution curves of Sertraline hydrochloride tablets from original manufacturer were investigated by using water,0.1 mol/L hydrochloric acid,acetic acid-natrium aceticum buffer solu-tion(pH 4.5)and phosphate buffer solution(pH 6.8)as medium respectively. The phosphate buffer solution(pH 6.8)900 ml was selected to determine the uniformity and dissolution curves of Sertraline hydrochloride tablets from different manufacturers because it was superior to other medium in identification capacity. The similarity of dissolution curves were evaluated by f2 factor method. RESULTS:The uniformity results of samples from 12 manufacturers were acceptable,all RSDs of each point dissolution were less than 10%(n=6);among 11 imitation manufacturers investigated,only one f2 value was more than 50,which was 9.1%of the to-tal. CONCLUSIONS:The stability of Sertraline hydrochloride tablets from 12 manufacturers were quite well,whereas,the quality of drugs from imitation manufacturers was greatly different from that of original drugs. It is suggested to intensively study the tech-nology,formula,raw material and excipients source so as to improve drug quality.关键词
盐酸舍曲林片/溶出度/溶出曲线/均一性/f2因子Key words
Sertraline hydrochloride tablets/Dissolution/Dissolution curve/Uniformity/f2 factor分类
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刘慧颖,隋晓璠,陈默..12个厂家盐酸舍曲林片的溶出曲线相似性研究[J].中国药房,2016,27(34):4862-4863,4864,3.
