神经药理学报

神经药理学报 ›› 2025, Vol. 15 ›› Issue (5): 1-.DOI: 10.3969/j.issn.2095-1396.2025.05.001

• 研究论文 •    下一篇

备案制指导下院内制剂温阳化浊颗粒制备工艺研究

瞿晶田，何家琛，陈涛，李宇，王洋，吕明远，李连萍，宋纹，刘芳，柴士伟   

  1. 1. 天津中医药大学第一附属医院，天津，300193，中国 

    2. 国家中医针灸临床医学研究中心，天津，300193，中国 

    3. 天津宏仁堂药业有限公司，天津，300193，中国

  • 出版日期:2025-10-16 发布日期:2025-10-15
  • 通讯作者: 柴士伟，博士，主任药师；研究方向：中药制剂和质量标准；E-mail:：chaishiwei791109@sina.com
  • 作者简介:瞿晶田，硕士，副主任药师；研究方向：中药临床药学与中药制剂；E-mail：qvjingtian@sohu.com
  • 基金资助:
    中药创新能力提升项目（国家中医药管理局中医药科技研究专项）

Research on the Preparation Process of Wenyang Huazhuo- Pellet Under the Guidance of Intra-Hospital Preparation Filing System

QU Jing-tian, HE Jia-sheng, CHEN Tao, LI Yu, WANG Yang, LU Ming-yuan, LI Lian-ping, SONG Wen, LIU Fang, CHAI Shi-wei   

  1. 1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China 

    2. National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, 300193, China 

    3. Tianjin HongRenTang Pharmaceutical Co. Ltd, Tianjin, 300193, China

  • Online:2025-10-16 Published:2025-10-15

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摘要：

目的：依据备案制原则对温阳化浊颗粒的制备工艺进行探索研究。方法：使用单因素和正交实验法对温 阳化浊颗粒提取和制粒工艺进行探索，确定其最佳制备工艺，并进行三批工艺验证。结果：确定了温阳化浊颗粒 的最佳制备工艺。提取工艺：处方加入8 倍量水，提取3 次，每次1.5 h。制粒工艺：浸膏干燥温度为70 ℃，辅料 选择麦芽糊精，乙醇浓度为80%，用量为17.5 mL，制软材时干膏粉+ 辅料比为3:1，颗粒烘干条件为80℃真空干 燥3 h。结论：温阳化浊颗粒的制备工艺稳定可行。

关键词: 温阳化浊颗粒, 提取工艺, 制粒工艺

Abstract:

Objective: To investigate the preparation process of zhongyu-pellet. Methods: Single-factor and orthogonal experimental methods were used to explore the extraction and pelletizing processes. The optimal extraction and pelletizing processes were determined and validated through three pilot-scale batches. Results: The optimal preparation processes were determined. Extraction process: Take the prescribed medicinal materials, add water for extraction three times (1.5 hours each time), using 10 times the amount of water for the extractions. Pelletizing process: The extract is dried at 70℃ , and maltodextrin is used as the excipient. During granulation, a 3:1 ratio of dry extract powder to excipient is mixed, with the addition of 80% ethanol (17.5 mL). The resulting granules are then vacuum-dried at 80℃ for 3 hours. Conclusion: The optimal extractions for the zhongyu-pellet were successfully determined.

Key words: wenyang huazhuo-pellet, extraction process, pelletizing process

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