药用辅料在中药制剂中的应用研究进展

缪妍; 胡丽琴; 张珂; 钱帅; 高缘; 张建军; 魏元锋

doi:10.11665/j.issn.1000-5048.2024082902

药用辅料在中药制剂中的应用研究进展

缪妍¹,
胡丽琴²,
张珂²,
钱帅¹,
高缘¹,
张建军²,
魏元锋^1, ,

1.
中国药科大学中药学院, 南京 211198
2.
中国药科大学药学院, 南京 211198

基金项目: 国家自然科学基金项目 (No.82274217, No.82373824, No.82474088)

详细信息

通讯作者:
魏元锋: Tel：15251756256　E-mail：weiyuanfengyuer@yeah.net

中图分类号: R944
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出版历程
- 收稿日期: 2024-08-28
- 刊出日期: 2024-12-24

Advances in research on the application of pharmaceutical excipients in traditional Chinese medicine preparations

1.
School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing 211198
2.
School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China

Funds: This study was supported by the National Natural Science Foundation of China (No.82274217, No.82373824, No.82474088)

摘要

摘要:
药用辅料作为制剂不可或缺的关键部分，扮演着充当药物载体、改善药物释放、保障药品稳定性及提高患者顺应性的重要角色。中医药在我国有着悠久的历史，随着科学技术的现代化发展，药学、化学与材料学深度交叉融合，为中药制剂的创新研发提供了更为广阔的空间，而与此同时制药行业对优质辅料的需求也日益凸显。本文旨在综述中药制剂辅料的研究进展，具体涵盖预混与共处理辅料、物理及化学改性辅料、“药辅合一”辅料包括矫味剂、填充剂、促透剂及在递送系统中的应用等，通过对现有研究的梳理与分析，探讨各类辅料在中药制剂中的具体应用现状，以期为中药制剂辅料的选择提供思路，并促进中药制剂辅料领域的创新活力，呼吁开发适合中药制剂的个性化辅料。
- 药用辅料 /
- 中药制剂 /
- 预混与共处理辅料 /
- 改性辅料 /
- 药辅合一
Abstract:
Pharmaceutical excipients, as an indispensable part of drug preparation, play crucial roles as drug carriers, improving drug release, ensuring drug stability, and enhancing patient compliance. Traditional Chinese Medicine (TCM) boasts a rich developmental history. With the modernization of technology, the deep integration of pharmacy, chemistry, and materials science has provided broader opportunities for innovative research in TCM. Simultaneously, the demand for high-quality excipients has become increasingly critical.This paper aims to review current research and applications of excipients in TCM preparations, including pre-mixed and co-processed excipients, modified excipients, and the unification of drugs and excipients, such as flavoring agents, fillers, penetration enhancers, and delivery systems. A meticulous synthesis and analysis of existing research aims to provide a reference for selecting excipients in TCM preparations, stimulate innovation in excipient development for TCM, and advocate for the development of personalized excipients.
- pharmaceutical excipients /
- traditional Chinese medicine preparations /
- pre-mixed and co-processed excipients /
- modified excipients /
- unification of drugs and excipients

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图 1 甘露醇-氯化钙共晶中形成的钙离子八配位结构（每个钙离子与相邻的3个甘露醇分子和2个水分子通过配位键相连）

下载: 全尺寸图片幻灯片

表 1 市售预混与共处理辅料的案例

分类	商品名	组成	制备工艺	功能特性	制造商	应用案例
预混辅料	Opadry^®	丙二醇、聚乙二醇、枸橼酸三乙酯、乙基纤维素等	物理混合	薄膜包衣	Colorcon	朱日很包衣滴丸^[4]
	Surelease^®	乙基纤维素、癸二酸二丁酯、油酸、氢氧化铵等	物理混合	缓释包衣	Colorcon	动物药材缓释颗粒^[5]
	薄膜包衣剂（胃溶型）	羟丙基纤维素、丙烯酸树脂、滑石粉、三醋酸甘油酯等	物理混合	胃溶包衣	北京英茂	连参通淋片^[6]
	薄膜包衣剂（肠溶型）	聚丙烯酸树脂、柠檬酸三乙酯、聚乙二醇、羟丙基甲基纤维素等	物理混合	肠溶包衣	江苏昕宇	大黄结肠靶向微丸^[7]
共处理辅料	Prosolv^®	微晶纤维素、胶体二氧化硅等	喷雾干燥	可压性、流动性好、可协同崩解	JRS Pharma	六味地黄分散片^[8]
	Starlac^®	一水乳糖、玉米淀粉等	喷雾干燥	流动性、可压性、崩解性能好、载药量高	Meggle Pharma	银杏叶提取物粉末直压口崩片^[9]
	Tomollose^®TM	微晶纤维素、羧甲基纤维素钠等	喷雾干燥	助悬剂、润滑口感好	珠海东辰	/
	乳糖粉状纤维素共处理物	一水乳糖、纤维素粉末等	喷雾干燥	流动性、直压性好	江苏道宁	/

下载: 导出CSV

表 2 “药辅合一”在中药制剂递药系统中的应用案例

成分分类	辅料	剂型/ 载体类型	药理作用	辅料功能	参考文献
挥发油	薄荷醇	微乳	抗菌抗炎	油相、促透剂	[38]
	辛夷油	亚微乳	抗炎抗过敏	油相、促透剂	[56]
	薄荷油	自微乳	消肿镇痛	油相、促透剂	[57]
天然多糖	白及多糖	凝胶	收敛止血	基质材料	[41]
	生姜多糖	凝胶	抗炎抑菌	基质材料	[42]
	甘草多糖	凝胶	抗炎抗氧化	基质材料	[43]
	香菇多糖	纳米粒	免疫调节	载体材料	[48]
	黄芪多糖	纳米粒	免疫调节	载体材料	[49]
脂肪油	薏苡仁油	微乳	抗肿瘤	油相	[39]
脂肪油	鸦胆子油	纳米脂肪乳	抗肿瘤	油相	[58]
其他	人参皂苷	脂质体	抗肿瘤	载体材料	[51−52]
	丹酚酸B	凝胶	抗炎、血管促成	基质材料	[44]
	葛根素	凝胶	抗菌抗炎	基质材料	[45]
	马铃薯生物碱	纳米粒	抗肿瘤	载体材料	[47]
	甘草酸	脂质体	免疫调节	载体材料	[50]
	小檗碱	纳米粒	抗菌	载体材料	[59]

下载: 导出CSV

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