基于超滤技术的消癌平注射液工艺改进

Improvement of Production Process for Xiaoaiping Injection Based on Ultrafiltration Technology

摘要:

目的：采用超滤技术优化消癌平注射液的生产工艺。方法：采用HPLC、比色法、动态浊度法和光阻法分别检测消癌平注射液超滤前后绿原酸、总酚酸、细菌内毒素的含量变化及澄明度的合格率；比较原生产工艺和超滤膜联用技术对消癌平注射液中指标成分的影响、细菌内毒素的去除效果及澄明度的改善程度。结果：原生产工艺、30 kDa和5 kDa超滤膜联用、30 kDa和10 kDa超滤膜联用成品中绿原酸回收率分别为51.6%，52.6%，55.3%，总酚酸回收率分别为75.3%，58.2%，64.6%，细菌内毒素去除率分别为84.2%，98.4%，98.2%，成品澄明度合格率分别为80.0%，95.6%，93.3%。结论：与原工艺相比，采用截留相对分子质量30 kDa和5 kDa的超滤膜进行二级超滤时，指标性成分无明显损失，但可最大程度提高成品澄明度合格率，并能有效去除药液中细菌内毒素，保证注射剂的安全性及生产效率，适用于消癌平注射液的生产。

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.