温肾壮骨颗粒的干法制粒工艺研究

目的优选温肾壮骨颗粒(WZG)干法制粒的最佳工艺条件,提高生产效率,保证产品的质量和疗效。方法采用正交试验,以制粒的难易程度、颗粒的成型率和溶化性为评价指标确定辅料的种类及用量;通过单因素考察试验并结合Box-Behnken响应面法,以送料速度、轧轮转速、轧轮压力为自变量,颗粒一次成型率为因变量,优化干法制粒工艺参数。结果最佳辅料配比为加入与干膏粉用量比为1∶3的糊精,1∶15的羧甲基淀粉钠,1∶90的微粉硅胶;最佳制粒工艺为轧轮压力9.5 MPa、轧轮转速14.0 Hz、送料速度13.2 Hz。通过3批放大工艺验证,显示优化后的辅料及工艺参数制备出的WZG具有成型率高、溶化性好、吸湿率低等优点。结论所选工艺合理、可行,为今后该产品的产业化应用提供技术参考和依据。

Study on technology of dry granulation of Wenshen Zhuanggu Granule

Objective The optimum technological conditions of granule dry granulation of Wenshen Zhuanggu Granule (WZG) were optimized to improve production efficiency and ensure product quality and curative effect. Methods The difficulty degree of granulation was studied by orthogonal test. The molding rate and the dissolved property of the granule determined the type and dosage of excipients for the evaluation index. Through single factor investigation test and combined with Box-behnken response surface method, the feed speed, rolling speed and rolling pressure were the independent variables, and the particle forming rate was dependent variable, in order to optimize process parameters of dry granulation. Results The optimum proportion of excipients was the dextrin with 1:3 of the dosage of dry paste powder, 1:15 carboxymethy starch sodium, 1:90 of the micro-powder silica gel, the best granulation process for rolling wheel pressure 9.5 MPa, rolling speed 14.0 Hz, and feed speed 13.2 Hz. Through the amplification process validation of three batches, it showed that the WZG prepared by the optimized excipients and process parameters have the advantages of high molding rate, good melting and low moisture absorption rate. Conclusion The selected process is reasonable and feasible, and it provides technical reference and basis for the industrial application of the product.