三七总皂苷白蛋白微球注射剂的质量标准研究  

Study on the Quality Standards of Panax Notoginseng Saponin Albumin Microsphere Injection

作　　者：何梓瑶 陈汝玲 吴静澜 刘兴德 宋信莉 He Ziyao;Chen Ruling;Wu Jinglan;Liu Xingde;Song Xinli(School of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guiyang 550025;National Engineering Technology Research Center for Miao Medicine,Guiyang 550025;Guizhou Engineering Technology Research Center for Processing and Preparation of Traditional Chinese Medicine,Guiyang 550025;Luoding Hospital of Traditional Chinese Medicine,Luoding 527200,China)

机构地区：[1]贵州中医药大学药学院,贵州贵阳550025 [2]国家苗药工程技术研究中心,贵州贵阳550025 [3]贵州中药炮制与制剂工程技术研究中心,贵州贵阳550025 [4]罗定市中医院,广东罗定527200

出　　处：《广东化工》2022年第4期54-57,34,共5页Guangdong Chemical Industry

基　　金：贵州省药物新剂型新工艺科技创新人才团队项目(黔科合平台[2017]5655人才);贵州省国内一流建设学科项目(GNYL[2017]008号);贵州省一流专业(中药学)建设项目(黔高教发[2017]158号);贵州省特色功能食品与中药制剂开发攻关大平台黔教合KY字[2020]006;贵州中医药大学药用高分子材料研究中心(贵中医党办发[2019]70号)。

摘　　要：目的:建立三七总皂苷白蛋白微球注射剂(PNS-BSA-MS-inj)的质量标准。方法:对PNS-BSA-MS-inj进行性状、粒径、pH值、装量、沉降体积比、鞣质、树脂、细菌内毒素及可见异物进行检查;并采用高效液相色谱法,以三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1为指标进行含量测定。结果:PNS-BSA-MS-inj各项指标检查均符合药典规定,三批注射剂中微球的总载药量均为6.87%,三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1峰面积的RSD分别为0.21%、1.1%、0.30%,微球总载药量的RSD为0.50%。结论:该方法简便准确,为PNS-BSA-MS-inj质量可控提供了参考,初步建立PNS-BSA-MS-inj量化质控标准评价体系。objective: To establish the quality standard of panax notoginseng saponin albumin microsphere injection(PNS-BSA-MS-inj). Method: The properties, particle size, pH value, loading, sedimentation volume ratio, tannin, resin, bacterial endotoxin and the visible foreign body of PNS-BSA-MS injection was inspected;and the method for determining the content of PNS-BSA-MS injection was established by high performance liquid chromatography. Result:All indicators of PNS-BSA-MS-inj are in compliance with pharmacopoeia regulations. The total drug loading of the microspheres in the three batches of injection was 6.87 %. The RSD of the saponins R1, ginsenoside Rg1 and ginsenoside Rb1 peak area were 0.21 %, 1.1 %, 0.30 %, respectively. The RSD of the total drug loading of the microspheres was 0.50 %. Conclusion: The method is simple and accurate, and provides a reference for the equality control of PNS-BSA-MS-inj. And the quantitative quality standard evaluation system of PNS-BSA-MS-inj is initially established.

关 键 词：三七总皂苷 白蛋白微球 注射液 质量标准研究 含量测定 

分 类 号：R283.6[医药卫生—中药学]