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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 the alcohol extraction process conditions of Xinnaosu Granules, and to provide a reference for the study of the molding process of this preparation. Methods: On the basis of single factor test, the volume fraction of ethanol, the amount of liquid added and the extraction time were taken as independent variables. The antithrombin titer, tanshinone Ⅱ_A and the extraction of cryptotanshinone Variables, through the star point design - response surface method optimization of heart and brain Su particles alcohol extraction process, the use of principal component analysis of the preferred extraction process analysis and verification. The content of tanshinone Ⅱ_A and cryptotanshinone was determined by HPLC. The mobile phase was methanol-water (75:25) and the detection wavelength was 270 nm. Results: The optimum alcohol extraction process was extraction of 8 times 70% ethanol extraction for 120 min, the number of extraction 1 times. The average extraction rates of tanshinone Ⅱ_A and cryptotanshinone were 0.523 and 0.225 mg · g -1, respectively. The average value of anticoagulant titer was 92.599 U · g -1, the total value of “normalized value” and The measured value of the deviation of 2.9%. Conclusion: The optimal extraction process is simple, stable and feasible, which lays the foundation for the research of forming process of Xinnaosu granule.