基于特征图谱及指标成分优化新清毒饮颗粒的制备工艺  

Optimization of Preparation Technology of Xinqingduyin Granules Based on Characteristic Chromato⁃grams and Index Components

作　　者：陆小梦 古玉正 刘瑞媚 林银慧 周珊宇 何欣欣 肖飞[2] 张军[3] 黄新安 LU Xiaomeng;GU Yuzheng;LIU Ruimei;LIN Yinhui;ZHOU Shanyu;HE Xinxin;XIAO Fei;ZHANG Jun;HUANG Xin’an(Artemisinin Research Center of Guangzhou University of Chinese Medicine,Guangzhou 510405 Guangdong,China;Science and Technology Industry Park,Guangzhou University of Chinese Medicine,Guangzhou 510445 Guangdong,China;School of Pharmaceutical Sciences,Guangzhou University of Chinese Medicine,Guangzhou 510006 Guangdong,China)

机构地区：[1]广州中医药大学青蒿研究中心,广东广州510405 [2]广州中医药大学科技产业园有限公司,广东广州510445 [3]广州中医药大学中药学院,广东广州510006

出　　处：《中药新药与临床药理》2024年第2期263-273,共11页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家中医药管理局中医药合作专项资助项目(GZYYGJ2022026);广州市科技计划项目(202206010066)。

摘　　要：目的建立新清毒饮颗粒(蒲公英、金银花、野菊花等组成)的高效液相色谱(HPLC)特征图谱及菊苣酸、甘草酸的含量测定方法,优选新清毒饮颗粒的制备工艺。方法以新清毒饮特征图谱及菊苣酸、甘草酸保留率为评价指标,通过正交试验优选新清毒饮的提取工艺,开展浓缩工艺研究;通过筛选辅料的种类和用量,开展新清毒饮颗粒的成型工艺研究,并开展3批中试研究。结果建立新清毒饮颗粒的特征图谱及菊苣酸、甘草酸含量测定方法,优选的制备工艺为加水8倍量,煎煮3次,每次1 h;80℃下减压浓缩,浸膏加入乳糖和甜菊糖苷适量,一步制粒,分装。中试规模制备的3批新清毒饮颗粒中菊苣酸、甘草酸保留率分别为(54.56±1.63)%、(54.96±1.08)%,成品率为(87.47±0.49)%,质量均一,与同批饮片制得汤剂特征图谱相似度高。结论所优选的制备工艺合理可行、重现性好,可获得与新清毒饮汤剂物质基础相似的颗粒剂。Objective To establish high performance liquid chromatography(HPLC)characteristic chromatograms of Xinqingduyin Granules(composed of Taraxaci Herba,Lonicerae Japonicae Flos,Chrysanthemi Indici Flos,etc.)and content determination of chicory acid and glycyrrhizic acid,and to optimize the preparation process of Xinqingduyin Granules.Methods Using the characteristic chromatograms of Xinqingduyin and the retention rate of chicory acid and glycyrrhizic acid as indexes,we carried out orthogonal experiment to optimize the extraction process of Xinqingduyin,and studied the concentration process.The molding process of Xinqingduyin Granules was conducted by screening the types and dosage of auxiliary materials,then three batches of pilot experiments were carried out.Results HPLC characteristic chromatograms of Xinqingshuyin Granules and the determination methods of chicory acid and glycyrrhizic acid were established.The optimal preparation technology was as follows:8 times amount of water was added,the drug was decocted for 3 times,with 1 hour per time.After the extract was concentrated under reduced pressure at 80℃,the appropriate amount of steviol glycoside and lactose was added into the extract and mixed.One-step granulation and packaging were adopted.The retention rates of chicoric acid and glycyrrhizic acid in the 3 batches of Xinqingduyin Granules,which were prepared on the pilot scale,were(54.56±1.63)%and(54.96±1.08)%,and the rate of finished product was(87.47±0.49)%,respectively.The quality is uniform,and the characteristic map of Xinqingduyin Granules showed high similarity with that of decoction prepared from the same batch of slices.Conclusion The optimized preparation technology is reasonable,feasible and reproducible.This preparation can be used to obtain the granule with similar materials of Xinqingduyin decoction.

关 键 词：新清毒饮颗粒 含量测定 制备工艺 高效液相色谱法 特征图谱 菊苣酸 甘草酸 

分 类 号：R284.1[医药卫生—中药学]