The main way of natural medicine validation study

Natural drug validation research main ways:

Investigation research (clinical investigation, drug resource species survey, processing, concoction method survey, literature review). Chemical composition system pre-test. Chemical composition extraction and separation. Active ingredient screening (combined with animal pharmacology experiments). Determination of the structure of single active ingredient (combined with instrumental analysis).

If you need to make a new drug dosage form, you must then proceed to the design of the drug dosage form, production process research, the declaration of new drug certificates and production approvals, as well as clinical research (clinical phase I-IV experiments), trial production of the new drug and the official production and so on.

Expanding Knowledge

Natural medicines are animal, plant and mineral medicines that have been proven to have certain pharmacological activities by modern pharmaceutical systems. Natural medicines are not the same as Chinese medicines or herbs.

With the development of society, people are more and more concerned about the negative impact of chemicals on human health and the living environment; returning to nature and protecting the environment has become a trend idea to deal with the relationship between human beings and the environment. The research and development of natural medicines, including plant medicines, animal medicines and marine medicines, has been vigorously developing, and the various artificial prohibitions on natural medicines have also tended to be loosened.

Development and Application

Natural medicines refer to natural medicinal substances and their preparations used under the guidance of modern medical theory. Their sources include plants, animals and minerals, generally excluding substances derived from genetically modified plants and animals, substances fermented by microorganisms or modified by chemistry, etc.

The research and development of natural medicines should focus on the following points: first, the design and evaluation of clinical trial protocols should be guided by modern pharmaceutical theories; second, there should be a sufficient basis for the determination of active ingredients; third, there should be sufficient test data to illustrate the rationality of the prescriptions, the non-clinical and clinical efficacy as well as the safety; and fourth, to ensure the sustainable utilization of resources.

1, so far the global use of natural medicines: has formed the application of systematic theory of Chinese medicine, Indian Buddhist medicine, Islamic medicine, European traditional herbal medicine, South American ethnomedicine and African ethnomedicine. Among them, Chinese medicine is considered to be the most developed natural medicine system in the world today.

2, from the scale of the use of natural medicines, China alone has reached a total of 12,772 kinds of natural medicines, of which 11,118 kinds of plant sources, animal sources of 1,574 kinds of mineral sources of 80 kinds of; and plant sources of natural medicines and the angiosperm dicotyledonous plants, accounting for the most, accounting for 8,598 kinds.

3, from the natural drug development and application of the technical level of analysis, there are the following cases: raw materials, which accounted for a large proportion of the market in China, that is, the traditional meaning of traditional Chinese medicine; preparations or extracts, through a number of simple processing, most of the proprietary Chinese medicines come from this; natural active chemical ingredients, the United States FDA, that is, so the requirements, but is also gradually deregulated.

4, the international hot natural drugs: anticancer drug paclitaxel and its derivatives; anti-malarial drug artemisinin; cardiovascular drug ginkgolides; anti-AIDS natural drugs although there are a lot of reports, but there is no drug can enter the clinic.