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

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.