中药浓缩丸的研究进展

Research Progress of Concentrated Pills of Traditional Chinese Medicine

关键词:  中药浓缩丸  制备工艺  质量控制  研究进展

Key words:  Chinese medicine concentrated pill  preparation process  quality control  research progress

摘要:

中药浓缩丸具有载药量大、顺应性好、服用和携带方便、适用人群范围广、易于贮存和运输等特点，改善了传统汤剂、蜜丸和煎膏剂等剂型的服用、贮存和运输不便等问题，从而引起了人们的广泛关注，具有深刻的研究意义。查阅了近年来发表的中药浓缩丸研究的相关文献，以国家药品监督管理局和中国药典2020年版收载的上市中药浓缩丸为研究对象，对其分类、数量和适应证等方面进行了梳理和分析，并对其制备工艺、干燥方法和质量标准等方面进行了综述，指出了中药浓缩丸研究中存在的问题，例如：质量评价缺乏统一标准等。中药浓缩丸既改善了传统剂型的缺点，顺应患者的生理和心理需求，又可以结合现代缓控释技术研制成具有缓控释功效的中药浓缩丸剂，尤其是在对胃肠道有刺激性、药效成分稳定性差和不良反应强的中药中发展前景广阔，符合中医药现代化发展要求。

Abstract:

Traditional Chinese medicine concentrated pills have the characteristics of large dosage, good compliance, easy to take and carry, wide range of suitable people, easy to store and transport, and improve the traditional decoction, honey pills and decoction dosage forms such as taking, storage and transportation inconvenience, thus causing widespread concern, has profound research significance. Based on the National Medical Products Administration and Chinese Pharmacopoeia 2020 edition, the classification, quantity and indication of the concentrated pills were reviewed, and the preparation process, drying methods and quality standards were summarized. The problems in the study of concentrated pills were pointed out, such as the lack of uniform standards for quality evaluation. Traditional Chinese medicine concentrated pills not only improve the shortcomings of traditional dosage forms, meet the physiological and psychological needs of patients, but also can be combined with modern slow controlled release technology to develop Chinese medicine concentrated pills with slow controlled release effect. Especially in the gastrointestinal tract irritation, poor stability of pharmacodynamic components and strong adverse reactions of Chinese medicine development prospects, in line with the requirements of modern development of traditional Chinese medicine.