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目的优选地龙活性组分的冻干工艺。方法采用单因素试验结合Box-Behnken响应面法,以冻干率为指标,考察1次升华温度、升华时间、解析干燥温度、解析干燥时间等因素对冻干工艺的影响,优化地龙活性组分的冻干工艺,采用HPLC法,测定优化后工艺样品的指纹图谱,并比较其与地龙药材指纹图谱相似度,确定最佳冻干工艺。结果确定地龙活性组分的最佳冻干工艺条件:预冻温度-26.5℃,预冻4 h,升华干燥温度-20℃、升华时间7 h、解析干燥温度30℃、解析干燥时间3.5 h,冻干率为96.55%,与对照药材的氨基酸指纹图谱相似度均大于0.9。结论 Box-Behnken响应面法用于地龙活性组分冻干工艺条件的优选是可行的,模型预测效果较好,优化工艺具备可行性。
Purpose The lyophilization process of the active ingredient is preferred. Methods The single factor experiment combined with Box-Behnken response surface method, the rate of freeze-drying as an index, investigated the sublimation temperature, sublimation time, analysis of drying temperature, analysis of drying time and other factors on the freeze-drying process, Min freeze-drying process, the use of HPLC method to determine the fingerprint of the optimized sample, and compared with the fingerprint similarity of Dilong herbs to determine the best freeze-drying process. The results showed that the optimal freeze-drying conditions for the active ingredient of Dilong were: pre-freezing temperature-26.5 ℃, pre-freezing 4 h, sublimation drying temperature -20 ℃, sublimation time 7 h, drying temperature 30 ℃, drying time 3.5 h , The lyophilization rate was 96.55%. The similarity of amino acid fingerprinting with the reference drug was greater than 0.9. Conclusion Box-Behnken response surface method is suitable for the optimization of freeze-drying process conditions of earthworm’s active components. The model predictive effect is good and the optimization process is feasible.