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| 基于星点设计-效应面法的雷公藤甲素脂质体处方的优化研究 |
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高榕波1,2, 孙精通3, 刘志东1,2, 唐海4
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1.天津中医药大学组分中药国家重点实验室, 天津 301617;2.天津中医药大学现代中药发现与制剂技术教育部工程研究中心, 天津 301617;3.天津中医药大学附属保康医院, 天津 300193;4.天士力医药集团股份有限公司, 天津 300410
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| 摘要: |
| [目的] 通过星点设计-效应面法优化雷公藤甲素脂质体（TP-Lip）处方。[方法] 以TP-Lip处方中的雷公藤甲素（TP）药物浓度、药脂比、胆脂比为影响因素，以TP-Lip包封率为响应值，采用星点设计-效应面法对TP-Lip处方进行优化。[结果] 通过星点设计-效应面法优化得到的TP-Lip最佳处方，TP药物浓度1.1 mg/mL，药脂比为1∶24，胆脂比为1∶4，最优处方下的脂质体包封率为91.57%±0.21 %。[结论] 通过星点设计-效应面法得到了TP-Lip处方的优化模型，实现了TP-Lip的制备，表明其制备工艺的稳定性，验证其预测结果的重复性良好。 |
| 关键词: 星点设计-效应面法 雷公藤甲素脂质体 包封率 |
| DOI：10.11656/j.issn.1672-1519.2025.07.13 |
| 分类号:R283 |
| 基金项目: |
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| Optimization of triptolide liposome formulation using central composite design-response surface methodology |
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GAO Rongbo1,2, SUN Jingtong3, LIU Zhidong1,2, TANG Hai4
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1.State Key Laboratory of Component Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Modern Traditional Chinese Medicine Discovery and Formulation Technology Engineering Research Center of the Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;3.Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;4.Tasly Pharmaceutical Group Co., LTD., Tianjin 300410, China
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| Abstract: |
| [Objective] To optimize the formulation of triptolide liposomes using central composite design response surface methodology. [Methods] The concentration of triptolide，the ratio of triptolide to egg yolk lecithin，and the ratio of egg yolk lecithin to cholesterol as influencing factors，and the encapsulation efficiency of triptolide liposomes as the response value，the formulation of triptolide liposomes was optimized using central composite design response surface methodology. [Results] The optimal preparation process for triptolide liposomes obtained through central composite design-response surface methodology optimization was as follows：triptolide drug concentration of 1.1 mg/mL，drug lipid ratio was 24∶1，bile lipid ratio was 4∶1，and liposome encapsulation efficiency of 91.57%±0.21%. [Conclusion] An optimized model for the formulation of triptolide liposomes was obtained through central composite design response surface methodology，and the preparation of triptolide liposomes was achieved. The stability of the preparation process was demonstrated，and the good repeatability of the predicted results was verified. |
| Key words: central composite design-response surface methodology triptolide liposomes entrapment efficiency |
