[关键词]
[摘要]
目的 通过正交试验优化黄芩粉的灭菌工艺条件。方法 以微生物(细菌、霉菌)数量和黄芩苷的量为评价指标,选取加热温度、加热时间、药粉厚度为考察因素,利用L9(34) 正交试验确定了黄芩粉的灭菌工艺。结果 黄芩粉最佳灭菌工艺条件:加热温度为100 ℃,加热时间为10 h,药粉厚度为2 cm。结论 此工艺条件经工艺验证试验和大生产验证,灭菌后黄芩粉的微生物指标可达到《中国药典》2010年版要求,重复性好,且灭菌前后黄芩苷的量无显著差异。
[Key word]
[Abstract]
Objective To illustrate the influences of various original processing techniques on chemical composition of Eucommiae Folium from different habitats by comparing HPLC fingerprint profiles, so as to select the suitable techniques for processing Eucommiae Folium. Methods To evaluate the quality of Eucommiae Folium with the various processing techniques by HPLC fingerprint. The analysis was performed on the Promosil C18 (250 mm × 4.6 mm, 5 μm) column. Acetonitrile-0.1% H3PO4 was used as the mobile phase with gradient elution. The scanned wavelength was from 200 to 400 nm, and the detection wavelength was at 208 nm. The flow rate was set at 0.8 mL/min. The column temperature was set at 25 ℃. Results The HPLC fingerprint profiles of Eucommiae Folium by the various processing techniques which were systematically researched were investigated. A total of main 22 common peaks were found, but the areas of the peaks were significantly different. The contents of chlorogenic acid and geniposidic acid obtained by the various processing techniques had the evident differences. Conclusion HPLC fingerprint technique with the application to the content determination of the active ingredients has the good reproducibility and maneuverability. It is one of the potential process analytical techniques to explore the ingredient differences in the processed Eucommiae Folium from different habitats.
[中图分类号]
[基金项目]
国家科技支撑计划课题(SQ2010BAJY1411-08)