糖网明目颗粒喷雾制粒工艺参数优选及其颗粒性状的研究.docVIP

糖网明目颗粒喷雾制粒工艺参数优选及其颗粒性状的研究 　　摘要：目的 优选糖网明目颗粒喷雾制粒最佳工艺，以提高成品率及成品质量。方法 分别采用单因素试验和正交试验对浸膏相对密度、辅料种类、浸膏与辅料比例、进风温度-物料温度、喷雾速率、雾化压力进行优选，确定最佳制备工艺，并进行3批样品验证，对颗粒流动性、吸湿性等制剂相关内容进行研究。结果 糖网明目颗粒的最佳喷雾制粒工艺为：浸膏相对密度（60 ℃测定）1.15～1.20，优选辅料为糊精，干浸膏与辅料比例为58∶42，进风温度-物料温度为90-75 ℃，雾化压力0.12 mPa，喷雾速率10 Hz。结论 本试验优选的工艺制得颗粒成型率高、流动性和吸湿性良好，可用于糖网明目颗粒的制备。 　　关键词：糖网明目颗粒；喷雾制粒；制粒工艺 　　DOI：10.3969/j.issn.1005-5304.2018.01.017 　　中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2018）01-0079-05 　　Optimization of Parameters of Granule Spray Process of Tangwang Mingmu Granules 　　and Study on Its Grain Properties 　　ZHANG Gui-jie1，2， CHEN Ming-xia2， SONG Xiao-li1，2， LIU Ye2， KANG Dong-zhou1， LIAN Zeng-lin3，4 　　1. College of Pharmacy， Yanbian University， Yanji 133000， China； 2. Beijing Handian Pharmaceutical Co.， LTD.， Handian Group， Beijing 102600， China； 3. Beijing Red Sun Pharmaceutical Co.， Ltd.， Handian Group， Beijing 100103， China； 4. Institute of Biological Chinese Medicine， Beijing Yichunag Industry Research Institute of Biological Technology， Beijing 100176， China 　　Abstract： Objective To select the optimum process of granule spray for Tangwang Mingmu Granules， To improve the yield and finished product quality. Methods The effects of the relative density， the type of excipients， the ratio of the extract and the excipient， the inlet temperature-the material temperature， the spray rate and the atomization pressure were selected by single factor and orthogonal test respectively to determine the optimum preparation process. Validation for three batch sample， particle flow， hygroscopicity and other related content of the preparation were studied. Results The optimum spray granulation process of Tangwang Mingmu Granules： the relative density of extract （60 ℃ determination） was 1.15?C1.20； the excipient was selected as dextrin； the ratio of dry extract and excipient was 58：42； inlet temperature - material temperature was 90-75 ℃； atomization pressure was 0.12 mPa； spray rate was 10 Hz. Conclusion The preparation technol