摘要
目的:分析复方氨酚烷胺片的评价抽验结果,以期评价其质量现状。方法:依据法定标准对60批复方氨酚烷胺片溶出度与含量测定开展检验,采用高效液相色谱法(HPLC法)对对乙酰氨基酚溶出度、有关物质对氨基酚含量、咖啡因与马来酸氯苯那敏含量均匀度,以及对乙酰氨基酚、咖啡因、马来酸氯苯那敏含量等七项进行探索性研究,分析检验结果以评价复方氨酚烷胺片的质量。结果:60批复方氨酚烷胺片溶出度均符合标准规定;咖啡因的含量均匀度以咖啡因含1个结晶水计,有4批不符合规定,不合格率6.7%;咖啡因含量测定,按咖啡因含1个结晶水计,有3批不符合规定,不合格率5.0%;对乙酰氨基酚溶出度、有关物质对氨基酚含量、马来酸氯苯那敏含量均匀度,以及对乙酰氨基酚、马来酸氯苯那敏含量测定均符合规定标准。结论:目前市场上的复方氨酚烷胺片质量总体较好,个别生产企业的咖啡因含量均匀度和含量测定结果出现较大偏差。建议生产企业对原材料进行严格控制,对生产工艺进行优化,以保障产品质量安全有效。
Objective:To evaluate the quality status of compound paracetamol and amantadine hydrochloride tablets by analyzing the evaluation and sampling results.Methods:The dissolution and content determination items of 60 batches of compound paracetamol and amantadine hydrochloride tablets were tested according to legal standards,and then the dissolution of paracetamol,the content of related substances paracetamol,the uniformity of caffeine and chlorphenamine maleate,paracetamol,caffeine exploratory studies,including the determination of chlorphenamine maleate,analyzed the test results to evaluate the quality of compound paracetamol and amantadine hydrochloride tablets.Results:The dissolution of 60 batches of compound paracetamol and amantadine hydrochloride tablets met the standard requirements;the uniformity of caffeine content was calculated based on the fact that caffeine contains 1 crystal water,4 batches was not meet the requirements,and the unqualified rate was 6.7%;for the determination of caffeine content,according to the calculation that caffeine contains 1 crystal water,three batches didn’t not meet the requirements,and the unqualified rate was 5.0%;the dissolution of acetaminophen,the content of related substances,the content uniformity of chlorpheniramine maleate,and the content determination of acetaminophen and chlorpheniramine maleate all met the specified standards.Conclusion:At present,the quality of compound paracetamol and amantadine hydrochloride tablets on the market is generally good,and there are large deviations in the uniformity of caffeine content and content determination results of individual production enterprises.It is suggested that the production enterprises should strictly control the raw materials and optimize the production process,so as to ensure the safety and effectiveness of product quality.
作者
祝兴国
ZHU Xingguo(The Inspection and Testing Certification Center of Fuzhou,Fuzhou Jiangxi 344000,China)
出处
《药品评价》
CAS
2022年第17期1039-1042,共4页
Drug Evaluation
关键词
退热药
镇痛药
复方氨酚烷胺片
省级评价性抽验
药品质量分析
高效液相色谱法
Antipyretics
Analgesics
Compound paracetamol and amantadine hydrochloride tablets
Provincial evaluation sampling inspection
Drug quality analysis
High performance liquid chromatography
