吡拉西坦片溶出度的测定方法研究  

Determination of Dissolution of Piracetam Tablets

作　　者：聂延君 张乃斌 吴敏 陈真 徐玉文 NIE Yan-jun;ZHANG Nai-bin;WU Min;CHEN Zhen;XU Yu-wen(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Public Health Clinical Center,Jinan 250000,China)

机构地区：[1]山东省食品药品检验研究院,仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,山东济南250101 [2]山东省公共卫生临床中心,山东济南250000

出　　处：《食品与药品》2022年第2期106-110,共5页Food and Drug

基　　金：国家药品标准提高项目(编号:食药监办药化管[2017]139号)。

摘　　要：目的建立吡拉西坦片溶出度测定方法。方法采用高效液相色谱法(HPLC)测定溶出量:采用Kromasil C;色谱柱,流动相为0.1%磷酸氢二钾溶液(用磷酸调pH至6.0±0.05)-乙腈(95:5),检测波长为205 nm,流速为1.0 ml/min;并考察了不同溶出方法、转速、溶出介质和取样时间点等。结果采用桨法,以水900 ml为溶出介质,转速为50 r/min,取样时间为30 min,采用高效液相色谱法(HPLC)测定溶出量,限度为不低于标示量的85%。结论本法可用于吡拉西坦片溶出度的测定,能有效控制产品质量,可为吡拉西坦片质量标准提高提供依据。Objective To establish a method for the determination of dissolution of Piracetam Tablets.Methods The Kromasil 100-5 C;column was adopted.The mobile phase was 0.1%dipotassium hydrogen phosphate solution(adjust pH to 6.0 with phosphoric acid)-acetonitrile(95:5)at a flow rate of 1.0 ml/min,and the detection wavelength was 205 nm.Different dissolution methods,rotating speed,dissolution medium and sampling time were investigated.Results The paddle method was used.900 ml of water was used as the dissolution medium,the rotation speed was 50 r/min,and the sampling time was 30 min.The dissolution amount was determined by HPLC,and the limit was not less than 85%of the labeled amount.Conclusion This method can be used to determine the dissolution of Piracetam Tablets,effectively control the product quality,and provide a basis for improving the quality standard of Piracetam Tablets.

关 键 词：吡拉西坦 高效液相色谱法 溶出度 

分 类 号：R927.1[医药卫生—药学]