Improvement of Production Process for Xiaoaiping Injection Based on Ultrafiltration Technology

Abstract:

Objective: To improve production process of Xiaoaiping injection by ultrafiltration technology. Method: Chlorogenic acid,total phenolic acids,content changes of bacterial endotoxin and passing rate of clarity were detected by HPLC,colorimetry,kenitic-turbidimetry and light blockage method before and after ultrafiltratin of Xiaoaiping injection;And compare effect of index ingredients,removal effect of bacterial endotoxin and improvement degree of clarity of Xiaoaiping injection between the original production process and ultrafiltration membrane technology. Result: In the original process,30 kDa-5 kDa and 30 kDa-10 kDa membranes combined technology,recoveries of chlorogenic acid were 51.6%,52.6% and 55.3%,recoveries of total phenolic acids were 75.3%,58.2% and 64.6%,removal rate of bacterial endotoxin were 84.2%,98.4% and 98.2%,qualified rate of clarity were 80.0%,95.6% and 93.3%,respectively. Conclusion: Compared with the original process,30 kDa-10 kDa membranes combined technology could eliminate bacterial endotoxin effectively,most of the content of index components were reserved and qualified rate of clarity was improved obviously,which was suitable for production of Xiaoaiping injection.