肺毒清颗粒制备工艺研究

为建立肺毒清颗粒的最佳制备工艺,并考察其可行性与稳定性,选用L9(34)正交试验优选苦参、木蝴蝶及栀子的提取工艺,通过多因素平行试验对醇沉浓度进行优选,确定栀子的纯化工艺,并采用单因素平行试验对辅料及其用量、干燥条件等进行成型工艺筛选.试验结果表明:优选的肺毒清颗粒最佳提取工艺为,苦参与木蝴蝶加10倍量75%乙醇提取3次,每次1.5 h;栀子加12倍量水提取3次,每次1 h;栀子提取液纯化工艺为,将栀子提取液浓缩为相对密度为1.20左右的清膏,加乙醇使含醇量达85%;成型工艺为,取纽甜3.75 g加入到12%投料量的20%乙醇中,混匀,备用,取苦参与木蝴蝶提取物150 g、栀子提取物75 g、可溶性淀粉660 g,麦芽糊精112 g,混匀,加入含纽甜的20%乙醇溶液,混匀,制粒、干燥、整粒、即得.本制备工艺合理、稳定,操作简单,适用于大规模生产.

Study on Preparation Technology of FDQ Granules

In order to establish the optimal preparation of FDQ granules and investigate the feasibility and stability, the research selects L9 （34 ） orthogonal test to achieve the optimum conditions of extraction process of Sophora flavescens, Oroxylum indicum and Gardenia jasminoides. The multi-factor parallel test is used to obtain the optimum ethanol concentration and determine purification process of Gardenia jasminoides. The single-factor parallel test is used to optimize the accessories and their dosage as well as drying conditions of forming process. The experimental results show that the best extraction technology conditions for the pref- erred FDQ granules include： Sophom flavescens and Oroxylum indicum are extracted 3 times with 10- fold amount of 75% ethanol,each for 1.5 h;Gardenia jasminoides is extracted 3 times with 12- fold amount of water, each for 1 h. The purification process of Gardenia jasminoides is that the Gardenia extract is concentrated to a clear paste with a relative density of about 1.20, and ethanol is added to make the amount of alcohol reach 85% .The forming process is that 3.75 g Neotame is added to 20% ethanol with 12% materi- als, mixed as standby solution; 150 g Sophora and wood butterfly extract,75 g Gardenia extract,660 g solu- ble starch and 112 g mahodextrin are taken,mixed as the mixture; the standby solution is added into the mixture, mixed, granulated, desiccated and straightened. We conclude that this preparation process is reasonable, stable, and has easy operation, which can be used for mass production.