Raw material medicine refers to the raw material medicine used in the production of various preparations. It is an effective ingredient in the preparation. It is used as a medicinal powder, crystal, extract, etc., prepared by chemical synthesis, plant extraction or biotechnology. A substance that the patient cannot take directly.
Perfect definition of APIs in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of pharmaceuticals, and when used in pharmaceuticals, becomes an active ingredient of pharmaceuticals. Such substances may have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of the disease, or may affect the function or structure of the body.
The active ingredient of the medicament. Only raw materials can be processed into pharmaceutical preparations to become a medicine for clinical application.
According to its source, the drug substance is divided into two major categories: chemical synthetic drugs and natural chemical drugs.
Chemical synthetic drugs can be further divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (very few elements), such as aluminum hydroxide and magnesium trisilicate for the treatment of gastric and duodenal ulcers; organic synthetic drugs are mainly composed of basic organic chemical materials, through a series of organic Drugs produced by chemical reactions (such as aspirin, chloramphenicol, caffeine, etc.).
Natural chemical drugs can be divided into two major categories: biochemicals and phytochemicals. Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. A variety of semi-synthetic antibiotics that have emerged in recent years are products that combine biosynthesis and chemical synthesis. Among the raw materials, the proportion of organic synthetic drugs, the output and the output value account for the largest proportion, which is the main pillar of the chemical pharmaceutical industry. The quality of raw materials determines the quality of the preparations. Therefore, the quality standards are very strict. Countries around the world have established strict national pharmacopoeia standards and quality control methods for their widely used APIs.