正交试验优化银翘败毒片的干法制粒工艺  

Optimization of Dry Granulation Technology for Yinqiao Baidu Tablet by Orthogonal Test

作　　者：刘永岭[1] 邵杰[2] 王永香[2] 张庆芬[2] 王振中[2] 

机构地区：[1]江苏联合职业技术学院连云港中医药分院,江苏连云港222007 [2]江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国药房》2017年第25期3553-3556,共4页China Pharmacy

基　　金：国家重大新药创制项目-现代中药创新集群与数字制药技术平台基金资助项目(No.2013ZX09402203)

摘　　要：目的:优化银翘败毒片干法制粒的工艺条件。方法:以制粒难易程度和崩解时限等为考察指标,对银翘败毒片中辅料微晶纤维素和可压性淀粉的配比、用量及喷干粉的含水量进行筛选;以颗粒得率和休止角为指标,采用L9(34)正交试验对干法制粒工艺中压轮压力、转速及送料速度等条件进行优化并进行验证试验。结果:微晶纤维素与可压性淀粉的比例为7∶3(m/m),二者与(喷干粉+包合物)的混合比例为1∶5;控制喷干粉含水量在1%~2%之间。干法制粒最优工艺参数为压轮压力3.5 MPa、压轮转速4 r/min、送料速度10 r/min。验证试验中颗粒平均得率为69.2%,平均休止角为31.5°,绿原酸转移率达92%以上,且各指标RSD均在2.53%以下(n=3)。结论:按优化辅料处方和工艺制备的颗粒各项指标均具有较好的重现性和可行性,且工艺稳定,适合工业生产。OBJECTIVE： To optimize the dry granulation technology conditions for Yinqiao baidu tablet. METHODS： Using granulating difficulty degree and disintegration time as investigation indexes, ratio and amount of accessories mierocrystalline cellu- lose and compressible starch in Yinqiao baidu tablet, moisture content of the sprayed powder were screened. Using yield of particle and angle of repose as indexes, L9（34） orthogonal test was used to optimize the wheel pressure, rotating speed and feeding speed in dry granulation technology, and verification test was conducted. RESULTS： The ratio of microcrystalline cellulose and compress- ible starch was 7 ： 3, and mixing ratio of the two with spray powder＋inclusion compound was 1 ： 5. The moisture content of spray powder was controlled in 1%-2%. The optimal technology was as follow as wheel pressure of 3.5 MPa, roller speed of 4 r/min and feeding speed of 10 r/min. In verification test, average yield of particle was 69.2% and angle of repose was 31.5 o. Transfer rate of chlorogenic acid had reached over 92 %, and RSD of each index was below 2.53 % （n = 3）. CONCLUSIONS： Each index of parti- cle prepared by optimized accessories formulation and technology shows good reproducibility and feasibility, and the technology is stable and suitable for production.

关 键 词：银翘败毒片 干法制粒 正交试验 颗粒得率 休止角 转移率 绿原酸 

分 类 号：R283[医药卫生—中药学]