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
陆小梦 1古玉正 2刘瑞媚 2林银慧 1周珊宇 2何欣欣 2肖飞 2张军 3黄新安1
作者信息
- 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
- 折叠
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.
Abstract
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Key words
Xinqingduyin Granules/content assay/preparation technology/HPLC/characteristic spectrum/chicoric acid/glycyrrhizic acid引用本文复制引用
基金项目
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)
出版年
2024
国家科技期刊平台
NSTL
万方数据