自身对照法测定氨肽素片溶出度  

Determination of dissolution of Amino-polypeptide Tablets by self-control method

作　　者：刘晓菲 阚微娜 杨宏伟 王棘 LIU Xiaofei;KAN Weina;YANG Hongwei;WANG Ji(Liaoning Provincial Institute for Drug Control,Shenyang 110036,China)

机构地区：[1]辽宁省药品检验检测院,沈阳110036

出　　处：《中国药品标准》2020年第3期254-257,共4页Drug Standards of China

摘　　要：目的:建立自身对照法测定氨肽素片的溶出度,并应用该方法考察了国内各生产企业的溶出度,比较其溶出度的批间和批内均一性。方法:桨法,以0.1 mol•L-1盐酸溶液为溶出介质(900 mL),转速为50 r·min^-1,经60 min取样,滤过,取续滤液作为供试品溶液,照紫外可见分光光度测定法在272 nm的波长处测定吸光度,采用自身对照法计算溶出度。结果:氨肽素片溶出度测定自身对照法在0.09536~0.9536 mg·mL^-1范围内线性关系良好(R 2=0.9998,n=5),平均回收率为101.9%,RSD为1.7%(n=9),溶液4 h内的稳定性良好;A、B、C企业的27批氨肽素片60 min平均溶出度均达到85.0%;C企业3批在80%以下;D企业的1批在80%以上。4个企业的批内和批间均一性较差。结论:本法快速、简便,可行且具有区分力,能够控制氨肽素片的产品质量。Objective:To establish the self-control method for determination of dissolution of Amino-polypeptide Tablets and compare the intra and inter batch uniformity of dissolution of Amino-polypeptide Tablets from different manufactures.Methods:The paddle method was used with 0.1 mol•L-1(900 mL)hydrochloric acid as the dissolution medium.The rotation speed was 50 r·min^-1 and the sample as taken at 60 min.Then the sample was filtered and the filtrate was as the test solution.The absorbance of test solution was determined at 272 nm by UV spectrophotometry and the dissolution was calculated by self-control method.Results:The linear range of the method fell into 0.09536-0.9536 mg·mL^-1(R 2=0.9998,n=5).The average recovery was 101.9%with RSD as 1.7%(n=9),and the solution stability was good within 4 h.The average dissolution of 27 batches of Amino-polypeptide Tablets from enterprises A,B,C reached 85.0%,the dissolution of 3 batches from enterprise C was above 70%,and the dissolution of 1 batch from enterprise D was above 80%.The Amino-polypeptide Tablets from 4 enterprises had the poor inter-batch and inter-batch uniformity.Conclusion:This established method is simple,rapid,feasible and discriminating.It can be used for quality control of Amino-polypeptide Tablets.

关 键 词：氨肽素片 自身对照法 溶出度 

分 类 号：R921.2[医药卫生—药学]