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目的:优选小儿止虚汗颗粒的制备工艺,为该制剂的临床应用提供参考。方法:采用UV测定总皂苷含量,检测波长541 nm。利用挤出制粒法制备小儿止虚汗颗粒,以总皂苷含量、溶散时间为综合评价指标,通过正交试验考察水提时间、醇沉浓度、浸膏与糊精用量比对制备工艺的影响并评价该制剂的质量。结果:最佳制备工艺条件为水提时间5 h,醇沉体积分数60%,清膏-糊精(1∶1.5);制备的3批颗粒大小均匀,呈黄褐色,略带甜味,色泽一致,无吸潮、结块、潮解现象,溶化时间194 s,含水量4.75%,总皂苷质量分数56.13 mg·g-1。结论:小儿止虚汗颗粒的制备工艺稳定可行、重复性好。
Objective: To optimize the preparation process of pediatric anti-perspiration granules and provide reference for the clinical application of this preparation. Methods: The total saponin content was determined by UV and the detection wavelength was 541 nm. The method of extrusion granulation was used to prepare the children’s only sweating granules. Taking total saponin content and dissolution time as the comprehensive evaluation indexes, the effects of water extraction time, alcohol concentration, extract and dextrin dosage ratio on the preparation process were investigated by orthogonal test And evaluated the quality of the preparation. Results: The optimal preparation conditions were as follows: water extraction time 5 h, alcohol precipitation volume 60%, clear paste - dextrin (1: 1.5); 3 batches of particles prepared were uniform in size, No hygroscopicity, agglomeration, deliquescence, melting time 194 s, water content 4.75%, total saponin mass fraction 56.13 mg · g-1. Conclusion: The preparation process of children only perspiration particles stable and feasible, good repeatability.