石膏煎煮入药方式对小儿麻甘颗粒钙含量影响的研究  

Investigation on the effect of decocting gypsum into medicineon calcium content of Xiao′er Magan granules

作　　者：费毅琴 姜涛 吕盼 杨萍 占方玲 徐玲 FEI Yiqin;JIANG Tao;L Pan;YANG Ping;ZHAN Fangling;XU Ling(Hubei Institute for Drug Control/NMPA key Laboratory of Quality Control of Chinese Medicine/Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院/国家药品监督管理局中药质量控制重点实验室/湖北省药品质量检测与控制工程技术研究中心,武汉430075

出　　处：《中国药品标准》2024年第2期187-194,共8页Drug Standards of China

摘　　要：目的:建立微波消解前处理结合电感耦合等离子体质谱法(ICP-MS)测定小儿麻甘颗粒钙含量,探讨石膏煎煮入药方式对小儿麻甘颗粒钙含量的影响。方法:建立微波消解前处理结合电感耦合等离子体质谱法(ICP-MS)对制剂中钙的含量进行测定,比较不同粉碎度石膏投料与不同醇沉工艺制备的小试制剂及小儿麻甘颗粒样品中钙含量差异。结果:不同企业间、同企业批间样品钙含量一致性较差;小试制剂结果显示颗粒越大,钙转移率越低;颗粒越小,钙转移率越高。结论:石膏煎煮入药钙的转移率与其粉碎度有关,为保证制剂质量一致性,建议对投料石膏的粉碎度进行统一。本法可为小儿麻甘颗粒生产工艺的优化提供指导意见。Objective:To establish a microwave digestion and inductively coupled plasma mass spectrometry(ICP-MS)for determination on calcium content of Xiao′er Magan granules and discuss the effect of decocting gypsum into medicine on calcium content.Methods:ICP-MS was adopted to determine the calcium content in the preparation,and the difference of calcium content in the small preparation and Xiao′er Magan granules prepared by different pulverization degree gypsum and different alcohol precipitation processes were compared.Results:The consistency of calcium content between different enterprises and batches of the same enterprise was poor.The results showed that the larger the particles,the lower the calcium transfer rate.The smaller the particles,the higher the calcium transfer rate.Conclusion:The transfer rate of gypsum decocted calcium is related to its degree of comminution to ensure consistency of preparation quality.It is suggested to unify the comminution degree of gypsum.The method can provide guidance for the optimization on preparation technology of Xiao′er Magan granules.

关 键 词：小儿麻甘颗粒 石膏 煎煮 钙含量 粉碎度 影响 

分 类 号：R921.2[医药卫生—药学]