基于熵权法评价干燥方法对经典名方华盖散基准样品质量属性的影响  

Effect of drying method on quality attribute of benchmark samples of Huagai Powder Powder based on entropy weight method

作　　者：王冉[1] 杨凌宇 吴志峰 杨婧[2] 张爱玲[2] 罗晓健[1,2] 刘微[1,2] 饶小勇[1,2] WANG Ran;YANG Ling-yu;WU Zhi-feng;YANG Jing;ZHANG Ai-ling;LUO Xiao-jian;LIU Wei;RAO Xiao-yong(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;National Engineering Research Center for Manufacturing Technology of Solid Preparation of Traditional Chinese Medicine,Nanchang 330006,China;Jiangzhong Pharmaceutical Co.,Ltd.,Nanchang 330096,China)

机构地区：[1]江西中医药大学,江西南昌330004 [2]中药固体制剂制造技术国家工程研究中心,江西南昌330006 [3]江中药业股份有限公司,江西南昌330096

出　　处：《中草药》2023年第3期768-778,共11页Chinese Traditional and Herbal Drugs

基　　金：江西省主要学科和技术带头人培养计划—领军人才项目(20204BCJ22032);江西省中医药中青年骨干人才(第一批)培养计划项目(赣中医药科教字[2020]2号);江西省中药学一流学科专项科研基金(JXSYLXKZHYAO016)。

摘　　要：目的优选经典名方华盖散基准样品的干燥方法。方法采用真空干燥、真空带式干燥、喷雾干燥、冷冻干燥方法制备华盖散基准样品,应用扫描电子显微镜、差式扫描量热分析、HPLC等方法测定基准样品的质量属性,以得粉率、玻璃化转变温度及成分含量转移率等为评价指标,运用熵权法对各指标赋予权重进行综合评价。结果喷雾干燥基准样品粒子呈类球形、粒径最小,冷冻干燥基准样品不规则、蓬松、溶化性好。指标成分盐酸麻黄总碱、苦杏仁苷、橙皮苷、甘草苷、甘草酸转移率分别为85.66%~104.78%、90.81%~104.16%、91.42%~94.86%、83.98%~94.69%、87.85%~94.45%,指纹图谱相似度均大于0.9。结论经综合评价得出冷冻干燥方法最佳,3批验证工艺重复性、可行性较好,为经典名方基准样品质量属性研究提供了理论依据和实践价值。Objective To optimize the drying method of the classic popular prescription Huagai Powder (华盖散). Methods The benchmark samples of Huagai Powder were prepared by vacuum drying, belt vacuum drying, spray drying and freeze drying, using scanning electron microscopy, differential scanning calorimetry, high-performance liquid chromatography and other methods to determine the quality attributes of benchmark samples, taking powder yield, glass transition temperature and component content transfer rate as evaluation indexes, entropy weight method was used to give weight to each index for comprehensive evaluation. Results The particles of the spray-dried benchmark samples were spherical with the smallest particle size, while the freeze-dried benchmark samples are irregular, fluffy and had good solubility. The index components total ephedrine hydrochloride, amygdalin, hesperidin, liquiritin, and glycyrrhizic acid content transfer rate were 85.66%—104.78%, 90.81%—104.16%, 91.42%—94.86%, 83.98%—94.69%, 87.85%—94.45%, the similarity of fingerprints was greater than 0.9. Conclusion After comprehensive evaluation, it is concluded that the freeze-drying method was the best, and the three batches of verification processes have good repeatability and feasibility, which provides a theoretical basis and practical value for the study of the quality attributes of the benchmark samples of classic popular prescriptions.

关 键 词：经典名方 华盖散 干燥方法 基准样品 质量属性 熵权法 真空干燥 真空带式干燥 喷雾干燥 冷冻干燥 盐酸麻黄总碱 苦杏仁苷 橙皮苷 甘草苷 甘草酸 

分 类 号：R283.6[医药卫生—中药学]