超滤工艺对香丹注射液有效成分的影响分析  

Analysis of the Effect of Ultrafiltration Process on the Effective Components of Xiangdan Injection

作　　者：张小军 ZHANG Xiaojun(Guangdong Leiyunshang Pharmaceutical Co.,Ltd.,Yunfu 527300,China)

机构地区：[1]广东雷允上药业有限公司,广东云浮527300

出　　处：《中西医结合研究》2024年第4期221-224,共4页Research of Integrated Traditional Chinese and Western Medicine

摘　　要：目的 明确香丹注射液中有效成分在不同超滤条件下的差异,确定香丹注射液超滤工艺的最优条件。方法 采用正交试验设计,以超滤装置进出口压力差、药液温度、药液pH值和超滤膜的截留分子量为因素,以香丹注射液中丹参素与原儿茶醛平均透过率为指标,评估超滤工艺各试验条件下香丹注射液有效成分的差异。结果 正交试验结果显示,丹参素和原儿茶醛平均透过率最高的超滤工艺条件为超滤膜截留分子量30 KDa,超滤装置进出口压力差0.08 MPa,药液pH值9.0,药液温度20℃。丹参素及原儿茶醛平均透过率方差分析结果显示,除超滤膜截留分子量外,均P>0.05。结论 丹参素和原儿茶醛2种成分的超滤工艺影响因素基本一致,超滤膜的截留分子量对香丹注射液有效成分有显著的影响,其余因素的影响不显著。优化后超滤工艺对香丹注射液中有效成分影响较小,相对稳定,适用性强。Objective To clarify the differences in effective components of Xiangdan injection under different ultrafiltration conditions,and to determine the optimal conditions for the ultrafiltration process of Xiangdan injection.Methods The orthogonal experimental design was adopted,with the pressure difference between the inlet and outlet of the ultrafiltration device,the temperature of the medication,the pH value of the medication,and the molecular weight of the ultrafiltration membrane as factors.The average transmittance of Danshensu and Protocatechualdehyde in Xiangdan injection were used as the indicators,the differences in the effective components of Xiangdan injection under various experimental conditions of ultrafiltration process were evaluated.Results The results of the orthogonal experimental showed that the ultrafiltration process conditions with the highest average transmittance of Danshensu and Protocatechualdehyde were as follows:the molecular weight of the ultrafiltration membrane was 30 KDa,the pressure difference between the inlet and outlet of the ultrafiltration device was 0.08 MPa,the pH value of the medication was 9.0 and the temperature of the medication was 20℃.The results of variance analysis of the average transmittance of Danshensu and Protocatechualdehyde showed that except for the molecular weight of the ultrafiltration membrane,all P>0.05.Conclusion The factors affect the ultrafiltration process of Danshensu and Protocatechualdehyde were basically the same.The molecular weight of the ultrafiltration membrane has a significant influence on the effective components of Xiangdan injection,while the influence of other factors was not significant.The optimized ultrafiltration process has little effect on the effective components of Xiangdan injection,was relatively stable,and has strong applicability.

关 键 词：超滤 香丹注射液 丹参素 原儿茶醛 正交设计 透过率 

分 类 号：R284.1[医药卫生—中药学]