Regulation and standardization of herbal drugs: Current status, limitation, challenge’s and future prospective

标准化 药典 质量(理念) 代理(哲学) 业务 风险分析(工程) 医学 协调 替代医学 政治学 病理 声学 认识论 物理 哲学 法学
作者
Gunawan Indrayanto
出处
期刊:Profiles of Drug Substances, Excipients and Related Methodology 卷期号:: 153-199
标识
DOI:10.1016/bs.podrm.2023.11.003
摘要

Herbal drugs (HD) or traditional drugs have been used worldwide for centuries, especially in the developing countries. Global market of HD reaches billion of USD annually and increases every year. For ensuring the safety and efficacy of HD, the Drug Agency/Authority issues regulations for the registration & application of new HD, their manufacturing processes, controlling and monitoring in the market. The efficacy and safety of HD depend on their whole chemical contents. Quality assessment of HD should be performed using standardization methods according to the current Pharmacopoeias or Materia Medica. Unfortunately, the official methods of the compendia cannot be applied for evaluation of mixed herbs and their preparations.; HD's producers should develop, validate, and standardize the method for the quality assessment of their own specific products. Therefore, assuring the safety and efficacy of HD remains a challenging task due to the complex nature of HD, that typically consist of many constituents of herbs/extracts whose quality may vary among different sources of materials. This present review will describe, compare, and discuss the regulations and standardization methods of HD from US, EU countries, Japan, Taiwan, Hong Kong and Indonesia. The official standardization methods of HD, their current criteria, limitations, challenge and future prospective will be described and discussed. Official methods for quality assessment of HD should be state of the art, fast, low-cost, accurate and precise, and could be used for evaluation of all kinds of HD.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
路瑶瑶完成签到,获得积分10
刚刚
米米莉完成签到,获得积分10
1秒前
C-3PO发布了新的文献求助10
1秒前
1秒前
2秒前
来了来了完成签到,获得积分10
2秒前
松鼠非鼠完成签到,获得积分10
2秒前
burn完成签到,获得积分20
3秒前
lizixiang发布了新的文献求助10
3秒前
少侠不是菜鸟完成签到,获得积分10
3秒前
Yultuz友发布了新的文献求助10
4秒前
Akim应助慢慢采纳,获得10
4秒前
ZY完成签到,获得积分10
4秒前
5秒前
8R60d8应助yao采纳,获得10
5秒前
xingcheng完成签到,获得积分10
6秒前
研友_VZG7GZ应助caihong采纳,获得10
6秒前
6秒前
6秒前
LabRat完成签到 ,获得积分10
6秒前
不能没有科研完成签到,获得积分10
7秒前
7秒前
7秒前
8秒前
在水一方应助微弱de胖头采纳,获得10
8秒前
星星完成签到,获得积分10
8秒前
鼠鼠完成签到 ,获得积分10
8秒前
蛋挞完成签到 ,获得积分10
9秒前
迫切完成签到,获得积分10
9秒前
康子的爹完成签到,获得积分10
9秒前
晓晓来了完成签到,获得积分10
10秒前
10秒前
小分队发布了新的文献求助10
11秒前
坦率的刺猬完成签到,获得积分10
11秒前
11秒前
11秒前
小丁完成签到,获得积分10
12秒前
lishuai发布了新的文献求助10
12秒前
12秒前
sunshine完成签到,获得积分10
13秒前
高分求助中
Sustainability in Tides Chemistry 1500
Handbook of the Mammals of the World – Volume 3: Primates 805
Gerard de Lairesse : an artist between stage and studio 500
Digging and Dealing in Eighteenth-Century Rome 500
Queer Politics in Times of New Authoritarianisms: Popular Culture in South Asia 500
Manual of Sewer Condition Classification 500
China's Relations With Japan 1945-83: The Role of Liao Chengzhi 400
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3068596
求助须知:如何正确求助?哪些是违规求助? 2722493
关于积分的说明 7477698
捐赠科研通 2369542
什么是DOI,文献DOI怎么找? 1256421
科研通“疑难数据库(出版商)”最低求助积分说明 609576
版权声明 596835