基于Box-Behnken设计-响应面法优化化湿败毒颗粒喷雾干燥工艺  

Optimization ofspray drying process of Huashi Baidu Granulesbased on Box-Behnken design-response surface method

作　　者：张志鹏 张兰兰 施文婷 王寿富 陈伟媚 汪梅 孙冬梅 ZHANG Zhi-peng;ZHANG Lan-lan;SHI Wen-ting;WANG Shou-fu;CHEN Wei-mei;WANG Mei;SUN Dong-mei(Guangdong Yifang Pharmaceutical Co.,Ltd.,Guangdong Key Laboratory of Traditional Chinese Medicine Formula Granule,Foshan 528244,China)

机构地区：[1]广东一方制药有限公司广东省中药配方颗粒企业重点实验实验室,广东佛山528244

出　　处：《中草药》2023年第22期7429-7435,共7页Chinese Traditional and Herbal Drugs

基　　金：国家工信部2022年产业技术基础公共服务平台项目——中药全产业链质量技术服务平台(2022-230-221)。

摘　　要：目的优选化湿败毒颗粒(Huashi Baidu Granules,HBG)的喷雾干燥工艺。方法利用Box-Behnken设计-响应面法(Box-Behnken design-response surface method,BBD-RSM)设计实验,以药液相对密度、进风温度及进料速率为考察因素,得粉率、芍药苷、甘草素、大黄酚-8-O-β-D-葡萄糖苷、甘草酸、和厚朴酚和厚朴酚的转移率的综合评分为评价指标,优选最佳喷雾干燥工艺。结果HBG的最佳喷雾干燥工艺为药液相对密度1.02,进风温度175℃,进料速率50%,验证试验的综合评分分别为92.57、92.50、91.96,各质量指标的RSD均小于3.0%。结论该方法优选的喷雾干燥工艺稳定可行,可为HBG的制剂工艺提供参考。Objective To optimize the spray drying process of Huashi Baidu Granules(HBG,化湿败毒颗粒).Methods Box-Behnken design-response surface design(BBD-RSM)was used to select the best spray drying process by taking the relative density of liquid medicine,air inlet temperature and feed rate as the investigation factors,and the comprehensive score of powder yield,paeoniflorin,liquiritigenin,chrysophanol-8-O-β-D-glucoside,glycyrrhizic acid,honokiol and magnololtransfer rate as the evaluation index.Results The optimal spray drying process of HBG was as follows:the relative density of liquid was 1.02,the inlet air temperature was 175℃,the feed rate was 50%,the comprehensive scores of validation test were 92.57,92.50,91.96,respectively,and the RSD of each quality index was less than 3.0%.Conclusion The spray drying process optimized by this method is stable and feasible,which can provide reference for the preparation process of HBG.

关 键 词：化湿败毒颗粒 Box-Behnken响应面法 熵权法 层次分析法 综合评分 喷雾干燥工艺 芍药苷 甘草素 大黄酚-8-O-β-D-葡萄糖苷 甘草酸 和厚朴酚 厚朴酚 

分 类 号：R283.6[医药卫生—中药学]