| The purpose of this study was to investigate the preparation process of Qizhu Granules(Astragalus:Polygonatum:Cyperus tuber:APN=4:3:3:3),and evaluate its quality and stability.Firstly,taking the quality ratio of excipients and drug extracts,the quality ratio of excipients(lactose,soluble starch),the concentration of ethanol and drying temperature as factors,the qualified rate of particle size,solubility and moisture absorption rate of Qizhu Granules as indicators,orthogonal experiments were designed to select the best preparation technology.Secondly,the quality of the Qizhu Granules was evaluated according to the quality re-quirements of the granules in the Chinese Pharmacopoeia: the Qizhu Granules which were preferably prepared were placed under high temperature,high humidity and strong light for 10 days.On the 0th,5th,and 10 th day,the appearance,particle size,water content,solubility and flavonoid content were observed and recorded.and the thin layer chromatography was performed on the active ingredients in the bamboo granules on the 0th and 10 th days.Finally,different concentrations of Qizhu Granules solution were treated with mouse spleen lymphocytes.Under the stimulation of ConA and LPS,the OD value of each treatment group was detected by CCK-8 method;different concentrations of Qizhu Granules solution and mouse macrophage The cells were co-incubated and neutral erythr staining was used to detect the phagocytic ability of macrophages.Research results:(1)The best preparation process is lactose and soluble starch as auxiliary materials,the mass ratio of excipients to flow extract is 5:1,the mass ratio of soluble starch to lactose is 3:7,90% ethanol is humectant,dried at 60℃for 2 h.(2)Under the three test conditions of high temperature,high humidity and strong light,the appearance of Qizhu Granules particles did not change significantly.The results of thin layer chromatography of particle size,moisture,solubility and active ingredients were in compliance with the pharmacopoeia standards.The content of flavonoids in Qizhu granules did not change significantly.(3)Qizhu Granules solution can significantly promote the proliferation of mouse spleen T and B lymphocytes,and significantly promote the phagocytosis of mouse macrophages.In summary,the quality of the Qizhu Granules obtained by this preparation process is stable,the particles are uniform,the dissolution is good,and the weight loss is in accordance with the relevant provisions of the Chinese Pharmacopoeia(2015 edition)on Chinese granules,At the same time,Qizhu Granules has a positive regulatory effect on spleen lymphocyte and macrophage in mice,and has the potential to improve the cellular and humoral immune functions of animals. |