注射剂用银杏叶提取物生产工艺监控研究

Study on Quality Control of the Production Process for the Ginkgo Biloba Extract Used For Injection

利用色谱指纹图谱技术建立注射剂用银杏叶提取物生产工艺监控方法。本文参照国家药典委员会颁布的舒血宁注射液质量公示标准,采用RP-HPLC-DAD方法及中药色谱指纹图谱相似度软件对贵州大学生化工程中心银杏叶生产链中注射剂用银杏叶提取物生产工艺中主要的四道工序进行了质量监控。色谱柱为InertsilRODS-3 C18(4.6 mm×250 mm,5μm);流动相为0.4%磷酸水(A)—乙腈(B)系统,梯度洗脱;柱温为30℃;流速为1.00 mL/min;检测波长为360nm.结果与对照品全峰匹配,四道工序相似度为0.949-0.888,表明该方法操作简便、稳定、重复性好,可为注射剂用银杏叶提取物的生产提供实践依据。

To establish the production process quality control method for the ginkgo biloba extract used for injection by chromatographic fingerprint. RP-HPLC-DAD method and the similarity evaluation system of Traditional Chinese medicine chromatographic fingerprint were used to analyze the qualities for the four mainly processes in the production of the ginkgo biloba extract used for injection in ginkgo industry chain of biochemical engineering center of Guizhou University with the public quality standard of Shuxuening injection as the reference. A InertsilR ODS-3 C18 （4.6mm×250mm,5μm） was used as analysis column and 0.4% phosphoric acid solution （A） / acetonitrile （B） as mobile phase at the flow rate of 1. 00 mL/min with gradient elution. The column temperature was 30 ℃ and detecting wavelength was 360 nm. Result compared with the reference substance, the similarities of the four processes are from 0. 949 to 0. 888, Showing the method was proved convenient, stable and repeatable, and can be provided practical basis for the production of the ginkgo biloba extract used for injection.