栀灵复方颗粒的成型工艺优化及其对小鼠自主活动的影响

Optimization of molding process of Zhiling compound granules and its effect on spontaneous activity of mice

目的:筛选出栀灵复方颗粒的最佳成型工艺,并通过小鼠自主活动实验验证颗粒的疗效。方法:以栀灵复方提取获得的干浸膏为研究对象,分别对稀释剂、润湿剂、干浸膏与稀释剂比例、矫味剂进行单因素考察,并开展正交实验,以成型率、吸湿率、休止角、堆密度、溶化率、脆碎度为评价指标,采用总评归一值(overall desirablity, OD)法,优选出栀灵复方颗粒的最佳成型工艺。通过小鼠自主活动实验对优化验证后的栀灵复方颗粒进行疗效的二次验证。结果:最佳成型工艺如下:干浸膏与可溶性淀粉比例为1∶1.25,阿斯巴甜用量为1.5%,柠檬酸用量为0.2%,水为润湿剂(用量为0.087 4 mL·g^-1)制软材,14目筛制湿粒,60℃干燥,12目筛整粒即得。优选后的颗粒所测各项指标与正交实验结果基本一致,并且颗粒组小鼠的自主活动次数要少于空白组。结论:栀灵复方颗粒优化后的成型制备工艺简便可行,所得颗粒具有较好的镇静助眠作用,为进一步开展栀灵复方颗粒的研究与开发奠定基础。

Objective:To screen out the optimum molding process of Zhiling compound granules and verify the efficacy of the granules by spontaneous activity experiment in mice. Methods:Taking the dry extract from Zhiling compound as the research subject, single factor experi-ments were conducted on diluent, wetting agent, and the ratio of dry extract to diluent and flavoring agent. Subsequently orthogonal test was carried out and the method of overall desirablity(OD) was used to optimize the molding process of Zhiling compound granules by selecting molding rate, moisture absorption rate, angle of repose, bulk density, dissolution rate and friability as the evaluation indexes. After verification of the optimized preparation, the second verification of the efficacy of the compound granules was performed by sponta-neous activity experiments in mice. Results:The optimum molding process was as follows: the ratio of dry extract to soluble starch was 1 to 1.25, and the dosages of aspartame and citric acid were 1.5% and 0.2%, respectively. Water was used as wetting agent with an amount of 0.087 4 mL·g^-1 to make the soft material which was screened to prepare wet granules under 14 mesh size condition and dried at 60 ℃. Then 12 mesh screen was used to sort granules and final preparation was obtained. The individual indexes of the optimized granules were basically consistent with the results of orthogonal test, and the number of spontaneous activities of mice in the granule group was less than that of the blank group. Conclusion:The optimized molding and preparation process of Zhiling compound granules is simple and feasible, and the obtained granules have good sedative and sleep aiding effect. This research laid a foundation for further research and development of Zhiling compound granules.