格列齐特片(Ⅱ)溶出曲线考察与有关物质测定  

Study on the Dissolution Profile of Gliclazide Tablets(Ⅱ)and Determination of Related Substances

作　　者：刘延娟 杨国宁 蔡伟 赵蕊蕊 李鹏战 LIU Yanjuan;YANG Guoning;CAI Wei;ZHAO Ruirui;LI Pengzhan(Heze Institute for Food and Drug Control,Heze,Shandong,China 274000)

机构地区：[1]山东省菏泽市食品药品检验检测研究院,山东菏泽274000

出　　处：《中国药业》2023年第20期113-116,共4页China Pharmaceuticals

基　　金：山东省药品质量风险监测项目[局函〔2022〕174号]。

摘　　要：目的评价山东省内流通的格列齐特片(Ⅱ)的质量。方法抽取国内8家企业生产并在山东省内流通的格列齐特片(Ⅱ)样品58批,按药物溶出曲线测定和相似性比较技术指导原则方法进行溶出曲线考察,并采用相似因子(f2)法比较。按2020年版《中国药典(二部)》格列齐特片(Ⅱ)有关物质测定方法测定制剂中杂质B含量,并建立杂质谱。结果各企业样品溶出曲线与参比制剂比较,f2范围在58.7~80.2之间,相似性良好。各企业样品均有杂质B检出,杂质B含量在0.00006%~0.00176%之间,其中G企业样品检出批数及含量高于其他企业;建立的杂质谱主要存在6种杂质,指认出其中4种分别为对甲苯磺酰脲、对甲苯磺酰胺、杂质B、杂质Ⅰ。结论不同企业间样品质量存在一定差异,主要表现在溶出度和杂质含量方面。山东省内流通的格列齐特片(Ⅱ)药品整体质量良好,为了进一步提高产品的安全性和有效性,建议对其有关物质进行控制。Objective To evaluate the quality of Gliclazide Tablets(Ⅱ)circulated in the Shandong province.Methods A total of 58 batches of Gliclazide Tablets(Ⅱ)produced by eight domestic manufacturing enterprises and circulated in the Shandong province were selected.The dissolution profile was investigated based on the technical guidelines of drug dissolution profile determination and similarity comparison,and the similarity factor(f2)method was used for comparison.The content of impurity B in the preparation was determined according to the determination method of related substances of Gliclazide Tablets(Ⅱ)in the Chinese Pharmacopoeia(2020 Edition,VolumeⅡ),and the impurity chromatogram was established.Results The f2 of dissolution profile of samples from various enterprises relative to the reference was in the range of 58.7 to 80.20,indicating the similarity was good.Impurity B was detected in all samples from various enterprises,with a content of 0.00006%-0.00176%,the enterprise G had the largest number of batches containing impurity B and the highest content of impurity B in the samples.Six impurities were obtained in the established impurity chromatogram,of which four were identified,namely p-toluenesulfonylurea,p-toluenesulfonamide,impurity B and impurityⅠ.Conclusion There are certain differences in the quality of samples among different enterprises,mainly dissolution and impurity content.The overall quality of Gliclazide Tablets(Ⅱ)circulated in Shandong province is good,and it is suggested we should control the related substances of this product to further improve the safety and effectiveness.

关 键 词：格列齐特片(Ⅱ) 溶出曲线 有关物质 杂质分析 

分 类 号：R927.11[医药卫生—药学]