中国中药杂志

2021, v.46(15) 3746-3752

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中药临方颗粒剂的特点与发展设想
Characteristics and development assumptions of personalized traditional Chinese medicine granules

王优杰;李益萍;沈岚;吴飞;冯怡;林晓;洪燕龙;
WANG You-jie;LI Yi-ping;SHEN Lan;WU Fei;FENG Yi;LIN Xiao;HONG Yan-long;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine;College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine;Shanghai Traditional Chinese Medicine Health Service Collaborative Innovation Center, Shanghai University of Traditional Chinese Medicine;

摘要(Abstract):

临方颗粒剂是临方汤剂的固体形式,是适用性强、应用范围广的临方制剂剂型之一。临方颗粒剂采用共煎的方式提取药液,弥补了配方颗粒的短板,与处方无法灵活变动的中成药颗粒剂和经典名方颗粒剂形成良好的互补,具有显著的市场前景。但是由于基础研究不足,设备不匹配,工艺通用性差等因素,导致在临床上的应用比例较低。该文通过分析中药临方颗粒剂的特点以及生产现状,对制约临方颗粒剂发展的瓶颈问题进行梳理,指出开发具有通用性的临方颗粒剂制备工艺的意义及关键难点,提出制剂处方及工艺预测系统与在线检测技术对提高制粒生产效率的重要作用,并对解决临方颗粒剂特有问题的技术开发提出了一定的设想,为颗粒剂剂型在临方制剂中的应用和发展提供思路。
Personalized traditional Chinese medicine(TCM) granules are positioned as a solid dosage form of TCM decoctions, boasting strong applicability and wide application range. The market prospect of personalized TCM granules is promising in that their preparation by mixed decoction makes up for the shortcoming of formula granules like the Chinese patent medicine granules and classical TCM prescription granules whose components cannot be changed flexibly. However, such factors as insufficient basic research, equipment mismatch, and low process commonality have limited their clinical application. After analyzing the characteristics of perso-nalized TCM granules, their production status, and the bottlenecks restricting their development, this paper pointed out the meaning and key points of developing a generalized preparation process for personalized TCM granules and affirmed the vital roles of the preparation and process prediction system and the on-line detection technology in improving the productivity of granulation. Finally, some assumptions on technology development for solving the specific problems of personalized TCM granules were shared to provide some ideas for the application and development of personalized TCM granules in clinical practice.

关键词(KeyWords): 临方颗粒剂;处方适用性;制剂工艺通用性;制剂预测系统
personalized traditional Chinese medicine(TCM) granules;prescription applicability;preparation process commonality;preparation prediction system

Abstract:

Keywords:

基金项目(Foundation): 上海市自然科学基金项目(20ZR1458400,18ZR1439800,18ZR1436600,19ZR1457700);; 国家自然科学基金项目(81973490);; 上海市“科技创新行动计划”技术标准项目(20DZ2200900)

作者(Authors): 王优杰;李益萍;沈岚;吴飞;冯怡;林晓;洪燕龙;
WANG You-jie;LI Yi-ping;SHEN Lan;WU Fei;FENG Yi;LIN Xiao;HONG Yan-long;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine;College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine;Shanghai Traditional Chinese Medicine Health Service Collaborative Innovation Center, Shanghai University of Traditional Chinese Medicine;

DOI: 10.19540/j.cnki.cjcmm.20210422.302

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