植物药品的黎明到黄昏
Ritu Tiwari1,2, Smita Mishra3, Aishwarya Chauhan1
1Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Raj Nagar, Ghaziabad 201002, India.
概括
植物药品为草药提供一种以科学为基础的方法,解决质量和疗效方面的挑战. 本综述探讨了它们的发展,监管地位,并将它们与草药和补充剂区分开来.
科学领域:
- 药理学和药物开发领域
- 植物学和植物化学.
- 监管科学 监管科学
背景情况:
- 草药产品因安全性和可负担性而受到全球的欢迎,但缺乏科学验证和监管,造成风险.
- 草药的传统使用在标准化,质量控制和科学证据方面面临挑战,这限制了它们与现代医疗保健的整合.
- 在全方位疗法和草药之间存在分歧,前者因特异性和精确性而受到青.
研究的目的:
- 引入以科学为基础的植物制药药物的概念,作为草药开发的现代方法.
- 讨论开发植物药物的优势和挑战,将其与草药和食补充剂区分开来.
- 提供关于植物药品监管和药典状况的综合信息,以""为案例研究.
主要方法:
- 审查有关草药和植物药品的现有文献和监管框架.
- 对1940年药品和化品法案和1945年关于植物的规则的修订草案的分析.
- 使用PRISMA方法进行植物选择,为*Aegle marmelos*开发植物制药产品信息 (PPI) 专著.
主要成果:
- 植物药品代表了科学验证的草药产品的监管途径,需要中央药品标准控制组织 (CDSCO) 等当局对质量,安全性和疗效进行评估.
- 植物制药的开发涉及克服与标准化,临床验证和监管合规性相关的挑战,与不受监管的草药和食补充剂不同.
- *海 (Aegle marmelos) *作为一个例子,说明了创建标准化植物药物专著的潜力和复杂性.
结论:
- 植物药品提供了一个有前途的途径,可以将传统的草药知识与现代科学严谨性相结合,提高安全性和有效性.
- 解决监管和科学挑战对于植物药物的成功开发和市场接受至关重要.
- 植物药品融入医疗保健系统需要有力的科学证据,标准化的制造工艺和明确的监管准则.
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