正交试验优选复方痛风颗粒处方工艺  

Optimization of the Formulation Process of Compound Tongfeng Granules by the Orthogonal Test

作　　者：唐勇琛 张亚洲 吕建伟 TANG Yongchen;ZHANG Yazhou;LYU Jianwei(Liuzhou Traditional Chinese Medicine Hospital·Liuzhou Zhuang Medical Hospital,Liuzhou,Guangxi,China 545000;School of Pharmacy,Guizhou University of Chinese Medicine,Guiyang,Guizhou,China 550025;The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China 530000)

机构地区：[1]广西壮族自治区柳州市中医医院·柳州市壮医医院,广西柳州545000 [2]贵州中医药大学药学院,贵州贵阳550025 [3]广西中医药大学第一附属医院,广西南宁530000

出　　处：《中国药业》2022年第16期45-48,共4页China Pharmaceuticals

基　　金：广西中医药民族医药传承创新专项[GZZJ14-15]。

摘　　要：目的优选复方痛风颗粒处方工艺。方法在单因素试验基础上,以辅料用量(浸膏粉与辅料的质量比)、乙醇体积分数、料液比(浸膏粉∶乙醇,g/mL)为考察因素,以成型率、吸湿率、溶解性、流动性的综合得分为评价指标,采用L9(34)正交试验法优选复方痛风颗粒处方工艺并验证,测定样品临界相对湿度。结果复方痛风颗粒最佳处方工艺为,糖粉与糊精以及浸膏粉与辅料的质量比均为1∶1,以80%乙醇润湿,料液比为6∶1。验证试验结果显示,3批样品平均成型率为97.50%(RSD=0.56%),平均吸湿率为8.45%(RSD=1.56%),平均溶解时间为41.62 s(RSD=1.53%),休止角(α)均值为32.34°(RSD=1.42%),临界相对湿度为74.71%。结论该处方工艺科学合理、稳定可靠,可为复方痛风颗粒的中试及大生产提供理论依据。Objective To optimize the formulation process of Compound Tongfeng Granules.Methods Based on the single factor test,the formulation of Compound Tongfeng Granules was optimized and verified by the L9(34)orthogonal test with the dosage of excipients(mass ratio of extract powder to excipients),volume fraction of ethanol,material-liquid ratio(extract powder:ethanol,g/mL)as the investigation factors,and with the comprehensive score of molding rate,moisture absorption rate,dissolution time and fluidity as the evaluation indexes.The critical relative humidity(RH)of the sample was determined.Results The optimal formulation of Compound Tongfeng Granules was as follows:the mass ratio of powdered sugar to dextrin was 1∶1,the mass ratio of extract powder to excipients was 1∶1,80%ethanol was used as the wetting agent,and the material-liquid ratio was 6∶1.The validation test result showed that the average molding rate of the three batches of samples was 97.50%(RSD=0.56%),the average moisture absorption rate was 8.45%(RSD=1.56%),the average dissolution time was 41.62 s(RSD=1.53%),and the average angle of repose(α)was 32.34°(RSD=1.42%).The critical RH was 74.71%.Conclusion The formulation process is scientific,reasonable,stable and reliable,which can provide a theoretical basis for the pilot test and large-scale production of Compound Tongfeng Granules.

关 键 词：复方痛风颗粒 处方工艺 正交试验 临界相对湿度 

分 类 号：R943[医药卫生—药剂学] R932[医药卫生—药学] TQ461[化学工程—制药化工]