维酶素片的质量评价研究  

Quality Evaluation of Vitacoenzyme Tablets

作　　者：乔冲[1] 连莹[1] 仲平[1] QIAO Chong;LIAN Ying;ZHONG Ping(Henan Institute for Food and Drug Control,Henan Zhengzhou 450008,China)

机构地区：[1]河南省食品药品检验所,河南郑州450008

出　　处：《中国药物评价》2020年第6期442-447,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:评价维酶素片的质量,并对质量标准进行完善。方法:按法定标准检验与探索性研究相结合,对国家药品计划抽验的224批次样品与调研企业所得样品进行检验,通过对发酵菌种(阿氏假囊酵母菌)进行鉴定研究、特征图谱研究、黄曲霉毒素含量测定与维生素B 2含量等考察,对维酶素片的质量进行分析与评价。结果:法定标准检验结果显示224批维酶素片合格率99.1%。探索性研究结果显示,不同生产厂家生产的维酶素片性状有较大差异,分析原因为3个原料药生产厂家使用的发酵菌种和处方均有差异;共10批次样品检测出黄曲霉毒素B 1,存在用药安全性隐患。结论:综合法定标准检验与探索性研究实验,维酶素片质量总体一般。建议相关企业提高原料标准,增加黄曲霉毒素检查项,保证原料质量,提高产品安全性;建议相关企业考察并优化处方生产工艺,提高制剂质量。建议质量标准增加发酵菌种(阿氏假囊酵母菌)的鉴别项和特征图谱检查项,以确保标准可控,以及用药安全有效。Objective:To evaluate the quality of vitacoenzyme tablets,and improve the quality standards.Methods:According to the combination of legal standard tests and the exploratory research,224 batch samples from national drug plan and samples collected from survey enterprises were tested.The quality of vitacoenzyme tablets was analyzed and evaluated by the identification of fermentation strains(Eremothecium ashbyii guilliermond),the study of the characteristic map,the determination of aflatoxin content and the investigation of vitamin B 2 content.Results:The qualified rate of 224 batches of vitacoenzyme tablets was 99.1%.The exploratory study results showed that there were significant differences in the properties of vitacoenzyme tablets produced by different manufacturers.The reason was that there were differences in the fermentation strains and prescriptions used by the three API manufacturers.Aflatoxin B 1 was detected in a total of 10 batches of samples,indicating potential drug safety risks.Conclusion:The quality of vitacoenzyme tablets was generally general based on the examination of legal standards and exploratory experiments.It is suggested that relevant enterprises improve raw material standards,increase the identification of aflatoxin test.It is suggested that relevant enterprises investigate and optimize the prescription production process to improve the quality of the preparation.It is suggested that the quality standard should be updated to increase the identification of fermenting strains(Eremothecium ashbyii guilliermond)and the check item of characteristic chromatogram,so as to ensure that the standard is controllable and the drug is safe and effective.

关 键 词：维酶素片 质量评价 阿氏假囊酵母菌 黄曲霉毒素 

分 类 号：R927.1[医药卫生—药学]