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目的:优选“退热止痛散”解热镇痛活性部位β环糊精最佳包合工艺。方法:采用正交设计法进行工艺优选,比较不同方法的包合率、收得率,确定最佳包合方法及包合工艺。结果:饱和水溶液法优选的最佳包合工艺为:活性部位与β环糊精(β-CD)比例为1∶8(g/g),搅拌温度为40℃,搅拌时间2h,包合率为81.25%,收得率为78.13%。超声法优选的最佳包合工艺为:活性部位与β-CD比例为1∶6(g/g),β-CD与加水量比为1∶15(g/mL),超声时间为2h,包合率为56.60%,收得率为57.81%。研磨法优选的最佳包合工艺为:活性部位与β-CD比例为1∶8(g/g),β-CD与加水量比为1∶4(g/mL),研磨时间2h,包合率为86.38%,收得率为84.91%。结论:研磨法优选的最佳包合工艺较理想,包合率、收得率较高;饱和水溶液法优选的最佳包合工艺仅次于研磨法,工艺合理可行,更适宜投入大批量生产。
OBJECTIVE: To optimize the best inclusion process of β-cyclodextrin in antipyretic and analgesic active sites. Methods: Orthogonal design was used to optimize the technology. The inclusion rate and yield of different methods were compared to determine the best inclusion method and inclusion technology. Results: The best inclusion process of saturated aqueous solution was as follows: the ratio of active site to β-CD was 1: 8 (g / g), stirring temperature was 40 ℃, stirring time was 2h, inclusion rate 81.25%, the yield was 78.13%. The best inclusion process of ultrasonic method is as follows: the ratio of active site to β-CD is 1: 6 (g / g), the ratio of β-CD to water is 1:15 (g / mL) Inclusion rate was 56.60%, yield was 57.81%. The optimum inclusion process of grinding method is as follows: the ratio of active site to β-CD is 1: 8 (g / g), the ratio of β-CD to water is 1: 4 The rate was 86.38%, yield was 84.91%. Conclusion: The optimal inclusion process of the grinding method is better, the inclusion rate and the yield are higher. The optimal inclusion process of the saturated aqueous solution method is second only to the grinding method, the process is reasonable and feasible, and is more suitable for mass production .