目的 采用星点设计-效应面法优化天山雪莲Saussureae Involucratae Herba提取物（SIHE）-磷脂复合物（PC）制备工艺，旨在提高SIHE的生物利用度。方法 考察反应溶剂、反应时间、SIHE反应物质量浓度、反应温度和投料比5个因素对复合率的影响，应用星点设计-效应面法设计实验，对指标与因素进行数学模型拟合，以效应面法预测优化并验证。利用红外光谱（IR）、X射线衍射（XRD）对SIHE-PC结构进行分析。结果 建立的多元二项式方程拟合度高，预测性好。最佳制备工艺条件为SIHE与大豆卵磷脂（SL）的投料比1：2.5、反应物质量浓度10 mg/mL及反应时间2 h，在此条件下绿原酸复合率可达到96%，芦丁复合率可达到93%。IR、XRD验证了SIHE-PC的形成。结论 采用星点设计-效应面法建立数学模型，预测性好，稳定可行。优化SIHE-PC制备工艺为中药制剂的进一步研究提供帮助。

Objective To optimize the preparation of Saussureae Involucratae Herba extract (SIHE) phospholipid complex (PC) by the central composite design-response surface method, and to increase the bioavailability of SIHE. Methods Five main factors including reaction solvent, reaction time, SIHE concentration, reaction temperature, and ratio of reactants on this reaction were investigated. On the basis of single factor test, central composite design was further adopted to arrange experiments in search of a curve fitting model between factors and effects. The optimal formulation was predicted by response surface method and was verified as well. The structure of SIHE-PC was analyzed by infrared spectroscopic (IR) analysis and X-ray diffraction (XRD). Results The correlation coefficient of second-order quadratic model was high. The optimal process conditions were as follows: The ratio of SIHE and soybean lecithin was 1:2.5, reaction concentration was 10 mg/mL, reaction time was 2 h, chologenic acid complex molar ratio was 96%, and rutin complex molar ratio was 93%. IR analysis and XRD proved the formation of SIHE-PC. Conclusion Central composite design-response surface method is successfully used for the optimization on preparation of SIHE-PC, with good predictability and stability.

国家自然科学基金资助项目（30960528）；新疆维吾尔自治区科技基础条件平台项目（PT1304）