星点设计-效应面法结合主成分分析法优选心脑苏颗粒醇提工艺

Optimization of Ethanol Extraction Technology of Xinnaosu Granules by Central Composite Design-response Surface Methodology and Principal Component Analysis

目的:优选心脑苏颗粒的醇提工艺条件,为该制剂的成型工艺研究提供参考。方法:在单因素试验基础上,选择乙醇体积分数、加液量、提取时间为自变量,以抗凝血酶效价、丹参酮Ⅱ_A和隐丹参酮提取量的总评"归一值"为因变量,通过星点设计-效应面法优选心脑苏颗粒醇提工艺,利用主成分分析法对优选的提取工艺进行分析与验证。采用HPLC测定丹参酮Ⅱ_A和隐丹参酮的含量,流动相甲醇-水(75∶25),检测波长270 nm。结果:最佳醇提工艺为加8倍量70%乙醇提取120 min,提取数1次。丹参酮Ⅱ_A和隐丹参酮的平均提取量分别为0.523,0.225 mg·g^(-1),抗凝效价平均值92.599 U·g^(-1),总评"归一值"预测值和实测值的偏差2.9%。结论:优选的提取工艺简单、稳定、可行,为心脑苏颗粒的成型工艺研究奠定基础。

Objective： To optimize ethanol extraction technology of Xinnaosu granules and provide a reference for molding technology of this preparation. Method： Based on single factor tests, taking overall desirability of extracting amounts of tanshinone ⅡA and cryptotanshinone, activity of anti-thrombin as index, ethanol concentration, the amount of ethanol and extraction time were selected by central composite design- response surface methodology, extraction technology was analyzed and verified by principal component analysis. HPLC was adopted to determine contents of tanshinone ⅡA and cryptotanshinone with isoeratic elution of methanol- water （75：25 ） and detection wavelength at 270 nm. Result： Optimum extraction process conditions was as follows： extracted 120 min with 8 times the amount of 70% ethanol. Extracting amounts of tanshinoneⅡA and cryptotanshinone were 0. 523, 0. 225 mg .g-1, activity of anti-thrombin was 92. 599 U .g-1 Overall desirability deviated 2.9% by comparing with the predictive value. Conclusion： This optimized process is simple and reliable with high predictability, which can lay foundation for molding technology of Xinnaosu granules.