甲钴胺胶囊评价性抽验的含量分析与比较研究

Content analysis and comparative study of Mecobalamin Capsules for evaluation sampling

目的通过对省内流通和生产环节甲钴胺胶囊评价性抽验的含量分析与比较,为进一步防范风险、完善其生产工艺提供参考,同时为监管部门提供技术支持。方法按照《中国药典》2015年版(二部)检验标准进行含量测定和含量均匀度检验。结果各个厂家的甲钴胺胶囊,其含量测定结果在92.4%~108.1%之间,平均值为99.8%;其含量均匀度结果A+2.20S的范围为4.4~14.0,平均数据8.2。结论各厂家生产的甲钴胺胶囊检验结果均符合规定,但各厂家结果有一定差异,且同一厂家不同批次的结果也存在较大差异。

Objective Through the analysis of the content of Mecobalamin Capsules in the provincial market and production enterprises,it provides reference for further risk prevention and improvement of its production process,and also provides technical support for regulatory authorities to ensure the safety and effectiveness of public medication.Methods According to the Pharmacopoeia of the People′s Republic of China 2015 edition of the second part of the inspection standards for content determination and content uniformity test.Results The content of mecobalamin capsules from various manufacturers was 92.4%~108.1%,with an average value of 99.8%.The content uniformity result A+2.20S ranges from 4.4 to 14.0,with an average of 8.2.Conclusion The test results of mecobalamin capsules produced by various manufacturers all conform to the regulations,but the results of various manufacturers are somewhat different,and the results of different batches of the same manufacturer are also quite different.