多指标综合评价法优化小儿止虚汗颗粒的制备工艺

Optimization of Preparation Technology of Children Anti-sweating Granules by Multi-index Comprehensive Evaluation Method

摘要:

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.

Abstract:

Objective: To optimize preparation process of children anti-sweating granules and provide a reference for clinical application of this preparation. Method: UV was adopted to determine the content of total saponins with detection wavelength of 541 nm.Children anti-sweating granules was prepared by extrusion granulation method,with total saponin content and dissolving time as comprehensive evaluation index,orthogonal test was adopted to optimize preparation process by taking water extraction time,alcohol precipitation concentration,ratio of dextrin-extract as factors,quality of this preparation was evaluated. Result: Optimal preparation process was as following:water extraction for 5 h,alcohol precipitation volume fraction of 60%,extract-dextrin(1:1.5);three batches of these granules had uniform particle size with brown,slightly sweet taste and consistent color,without moisture absorption,caking and deliquescence phenomenon.Dissolving time of these granules was 194 s,moisture content was 4.75%,the content of total saponins was 56.13 mg·g^-1. Conclusion: This preparation process is stable,repeatable and feasible for children anti-sweating granules.