不同企业左炔诺孕酮片溶出曲线考察  

Study on Dissolution Curves of Levonorgestrel Tablets from Different Enterprises

作　　者：李秀焕 蔡伟 赵蕊蕊 井改革 闫培培 刘延娟 LI Xiu-huan;CAI Wei;ZHAO Rui-rui;JING Gai-ge;YAN Pei-pei;LIU Yan-juan(Heze Institute of Food and Drug Inspection and Testing)

机构地区：[1]菏泽市食品药品检验检测研究院

出　　处：《中国标准化》2022年第12期256-260,共5页China Standardization

摘　　要：目的:建立左炔诺孕酮片溶出曲线测定方法,比较6家生产企业左炔诺孕酮片和原研制剂在3种不同溶出介质中的体外溶出行为差异,为药品质量控制提供参考。方法:分别以0.1 mol/L盐酸溶液、水、pH6.8的磷酸盐缓冲液均加入0.1%SDS为溶出介质;采用HPLC法测定左炔诺孕酮片的溶出度,绘制溶出曲线,采用f2相似因子法评价溶出曲线的相似度。结果:在3种不同的溶出介质中,f2相似因子大于50%的企业分别占50%、17%和17%,说明国内仿制左炔诺孕酮片与原研溶出行为差异较大。在0.1 mol/L盐酸(0.1%SDS)介质中的溶出较好,但水(0.1%SDS)溶液对左炔诺孕酮片有较好的区分力。结论:本方法专属性强、灵敏度高、准确可靠,适用于左炔诺孕酮片仿制药的溶出曲线测定,可为左炔诺孕酮片的质量控制参考;不同企业的左炔诺孕酮片溶出曲线参差不齐,有待提高产品质量。Objective:To establish a method to determine the dissolution curve of levonorgestrel tablets,and to compare the difference in the dissolution behavior of levonorgestrel tablets and the original preparation in 3 different dissolution media from 6 manufacturers in vitro,so as to provide reference for drug quality control.Methods:0.1 mol/L hydrochloric acid solution,water and pH6.8 phosphate buffer were added into 0.1%SDS as dissolution medium.The dissolution of levonorgestrel tablets was determined by HPLC,the dissolution curve was drawn,and the similarity of the dissolution curve was evaluated by f;similarity factor method.Results:In the three different dissolution media,the enterprises with f;similarity factor greater than 50% accounted for 50%,17% and 17%,respectively,indicating that the dissolution behavior of domestic generic levonorgestrel tablets was significantly different from that of the original study.The solution in 0.1 mol/L hydrochloric acid(0.1%SDS) was better,but the solution in water(0.1%SDS) was better to distinguish levonorgestrel tablets.Conclusions:The method is specific,sensitive,accurate and reliable,and suitable for the dissolution curve determination of generic levonorgestrel tablets,which can be used as a reference for quality control of levonorgestrel tablets.The dissolution curves of levonorgestrel tablets from different enterprises are uneven,so the quality of products needs to be improved.

关 键 词：左炔诺孕酮 溶出曲线 HPLC 质量控制 

分 类 号：R927.1[医药卫生—药学]