注射用盐酸甲氯芬酯粒度分布与装量差异相关性研究  

Study on the correlation between the particle size distribution of meclofenoxate hydrochloride for injection and the weight variation

作　　者：王琳[1] 吴斌[1] 孙毅[1] 安京烨 吴兆伟[1] 吴科春[1] 张喆[1] 胡琴[1] 杨文良[1] 王铁松[1] WANG Lin;WU Bin;SUN Yi;AN Jing-ye;WU Zhao-wei;WU Ke-chun;ZHANG Zhe;HU Qin;YANG Wen-liang;WANG Tie-song(Beijing Institute for Drug Control,National Medical Products Administration,Key Laboratory for Research and Evaluation of Generic Drugs,Bejing 102206,China)

机构地区：[1]北京市药品检验所,国家药品监督管理局仿制药研究与评价重点实验室,北京102206

出　　处：《中国新药杂志》2021年第3期226-231,共6页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09101001)。

摘　　要：目的:考察注射用盐酸甲氯芬酯装量差异及其影响因素,建立基于激光衍射粒度分析技术的质控方法。方法:比较不同企业生产的注射用盐酸甲氯芬酯的原料药来源、分装设备类别和调试方法;采用粉末X射线衍射法测定晶型,采用激光衍射粒度分析法测定粒度和粒度分布,并计算径距。结果:装量差异较大以及装量过高或过低的注射用盐酸甲氯芬酯均为原料药直接分装工艺生产,其原料药粒度径距过大和分装设备调试方法不当是导致产品装量均一性较差的直接原因,且样品的径距与装量的相对标准偏差(RSD)值呈正相关,可通过径距值的大小判定产品的质量优劣。结论:本研究合理解释了注射用盐酸甲氯芬酯装量及含量不合格的原因,为企业生产工艺的改进提供了切实方法,并为分装使用的原料药提供了科学可行的控制验收方法,为提升药品质量及降低临床用药风险提供有力的技术支撑。Objective: To investigate the influencing factors of weight control level of meclofenoxate hydrochloride for injection,and establish the quality control method based on laser diffraction particle size analysis.Methods: The sources of APIs,types of packaging equipment and debugging methods of preparations from different companies were investigated by telephone survey. The crystal form was determined by powder X-ray diffraction.Laser diffraction particle size analysis was used to determine the particle size and particle size distribution,and the diameter was calculated. Results: For the meclofenoxate hydrochloride for injection produced by direct packing of API,the excessive spans of API and improper bugging methods of packaging equipment were the direct causes of product non-conformity. There was a positive correlation between the span and the RSD value of weight. Conclusion:This study reasonably explained the reasons for the unqualified weight and content of meclofenac hydrochloride injection and proposed a practical method for the improvement of the production process of the enterprise and a scientific and feasible control acceptance method for the bulk drug used in the packaging,which provides a strong technical support for improving the quality of medicines and reducing the risk of clinical medication.

关 键 词：注射用盐酸甲氯芬酯 激光衍射粒度分析 径距 装量差异 质量控制 

分 类 号：R917[医药卫生—药物分析学]