| 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 |
| DOI： |
| 中文关键词: 超滤 香丹注射液 丹参素 原儿茶醛 正交试验 透过率 |
| 英文关键词: Ultrafiltration Xiangdan Injection Danshensu Protocatechuic aldehyde Orthogonal experiment Transmittance |
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| 中文摘要: |
| 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，香丹注射液中丹参素钠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 丹参素和原儿茶醛两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影响具有显著性，其余因素影响无显著。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。 |
| 英文摘要: |
| Objective: To clarify the differences in effective ingredients in Xiangdan Injection under different ultrafiltration conditions and determine the optimal conditions for the ultrafiltration process of Xiangdan Injection. The method adopts an orthogonal experimental design, 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 transmittance of sodium danshensu and protocatechualdehyde content in Xiangdan injection is used as the indicator to evaluate the differences in the effective components of Xiangdan injection under various experimental conditions of the ultrafiltration process; The factors affecting the ultrafiltration process of danshensu and protocatechualdehyde were basically the same. The molecular weight of the ultrafiltration membrane had a significant impact on the effective ingredients of Xiangdan Injection, while the other factors had no significant impact. Conclusion: The optimized ultrafiltration process has little effect on the effective ingredients in Xiangdan Injection, is relatively stable, and has strong applicability. |
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