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

目的:比较12个厂家盐酸舍曲林片的溶出曲线相似性,评价企业制剂工艺的成熟性和稳定性。方法:考察原研厂家盐酸舍曲林片分别以水、0.1 mol/L盐酸、醋酸-醋酸钠缓冲液(p H 4.5)和磷酸盐缓冲液(p H 6.8)为溶出介质的溶出曲线,最终确定以区分力最强的磷酸盐缓冲液(p H 6.8)900 ml来测定不同厂家盐酸舍曲林片的均一性和绘制溶出曲线;采用相似因子f_2法评价溶出曲线相似性。结果:12家生产企业的样品各点溶出度的RSD均小于10%(n=6),均一性均较好;11个仿制企业中,f_2值大于50的生产企业只有1家,占总数的9.1%。结论:12家生产企业制剂工艺的稳定性均较好,但多数仿制企业药品与原研药溶出性能比较存在较大差异。建议相关生产企业对工艺、处方和原、辅料来源等进行深入研究,以提高产品质量。

OBJECTIVE：To compare the similarity of dissolution curves of Sertraline hydrochloride tablets from 12 manufacturers,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 solution（p H 4.5）and phosphate buffer solution（p H 6.8）as medium respectively.The phosphate buffer solution（p H 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 total.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 technology,formula,raw material and excipients source so as to improve drug quality.