甘露聚糖肽注射液的质量评价分析  

Quality Research of Mannatide Injection

作　　者：李炎 马晶 邹剑 林涛 王觉晓 秦力 陈婕 袁军 Li Yan;Ma Jing;Zou Jian;Lin Tao;Wang Juexiao;Qin Li;Chen Jie;Yuan Jun(Sichuan Institute for Food and Drug Control,Chengdu 610097,China)

机构地区：[1]四川省食品药品检验检测院,成都610097

出　　处：《中国药师》2021年第2期391-393,398,共4页China Pharmacist

摘　　要：目的:考察甘露聚糖肽注射液的质量现状及存在问题。方法:对国家药品监督管理局(NMPA)网站数据库中检索到的甘露聚糖肽原料和注射液生产企业进行问卷调查,对部分生产企业进行现场调研,对58批次甘露聚糖肽注射液依据法定标准进行检验,同时开展分子量与分子量分布、含量测定新方法的研究;对法定标准检验和探索性研究所得的结果进行统计分析,综合评价甘露聚糖肽注射液的质量现状。结果:58批次甘露聚糖肽注射液按法定标准检验,合格率为100%,结合探索性研究检验结果,合格率为100%。同时,探索性研究结果表明现有国家标准测得甘露聚糖肽注射液的分子量偏低,甘露聚糖肽的菌种管理、生产管理等较为粗放。结论:法定检验和探索性研究结果表明,甘露聚糖肽注射液整体质量较好,但是还有提升的空间,生产企业应该加强该品种的基础研究以及菌种管理、生产管理等。Objective: To research the quality status and existing problems in mannatide injection. Methods: After performing questionnaire survey and visiting the manufacturers of mannatide raw material and injection searched through the website database of National Medical Products Administration(NMPA),58 batches of mannatide injection were tested according to the approved specification. New methods for molecular weight,molecular weight distribution and content determination were studied. The results of approved specification test and exploratory research were statistically analyzed to comprehensively evaluate the quality status of mannatide injection. Results: Totally 58 batches of mannatide injection were tested according to the approved specification,and the qualified rate was100%,and combined with the results of exploratory research,the qualified rate was 100%. At the same time,the results of exploratory research showed that the molecular weight of mannatide injection measured by the approved specification couldn’t control the quality of mannatide injection strictly. The strain management and production management of mannatide were relatively superficial. Conclusion:The results of approved specification test and exploratory research show that there is still space to improve the quality of mannatide injection. Manufacturers should strengthen the basic research,strain management and production management of the product.

关 键 词：甘露聚糖肽注射液 质量评价 法定标准 探索性研究 

分 类 号：R927.1[医药卫生—药学]