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超滤工艺对香丹注射液有效成分的影响分析

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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含量透过率为指标,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 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(P<0.05),其余因素的影响不显著(P>0.05).结论 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.
Analysis of the Effect of Ultrafiltration Process on the Effective Components of Xiangdan Injection
Objective To clarify the differences in effective components in Xiangdan injection under different ultrafiltration conditions,and to determine the optimal conditions for the ultrafiltration process of Xiangdan injec-tion.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 p H value of the medication,and the molecular weight of the ultrafiltration membrane as factors.The transmittance of Danshensu and Protocatechualde-hyde content in Xiangdan injection was used as the indicator,the differences in the effective components of Xiang-dan injection under various experimental conditions of ultrafiltration process were evaluated.Results 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(P<0.05),while the influence of other factors was not significant(P>0.05).Conclusion The optimized ultrafil-tration process has little effect on the effective components in Xiangdan injection,was relatively stable,and has strong applicability.

ultrafiltrationXiangdan injectionDanshensuProtocatechualdehydeorthogonal experimenttrans-mittance

张小军

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广东雷允上药业有限公司,广东云浮 527300

超滤 香丹注射液 丹参素 原儿茶醛 正交试验 透过率

2024

中西医结合研究
华中科技大学

中西医结合研究

影响因子:0.649
ISSN:1674-4616
年,卷(期):2024.16(4)