提高黄芩苷原料药质量标准的研究

Study on promotion of the quality standard of baicalin

目的提高黄芩苷原料(注射用)的质量标准。方法建立有关物质、重金属、乙醇溶液的澄清度和颜色等若干项质量指标。结果通过对我公司六批黄芩苷原料测定,所建立的各项质量指标均达到要求。结论建立的各项方法简便可行,结果可靠,可用于黄芩苷原料的生产质控。

OBJECTIVE To improve the quality stand of baicalin（for injection）. METHODS Established the detection criterions include the related substances of baicalin, heavy metals.the clarity and color of alcohol solution and so on. RESULTS All the methods we established meet the requirement through detection of six batch baicalin which come from our company. CONCLUSION Methods established were simple and reliable,and were suitable for the quality control of baicalin（for injection）.