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API(Active Pharmaceutical Ingredient)

Complete definition of an active substance in ICH Q7A: Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical product and, when used in a pharmaceutical product, to be an active ingredient in a pharmaceutical product. Such substances have pharmacological or other direct effects in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the body.

The active ingredient of a drug. Only when the bulk drug is processed into a pharmaceutical preparation can it become a medicine available for clinical application.

According to its origin, active substances are divided into two categories: chemical synthesis drugs and natural chemical drugs.

Chemical synthesis drugs can be divided into inorganic synthesis drugs and organic synthesis drugs. Inorganic compounds are inorganic compounds (very individual elements), such as aluminum hydroxide, magnesium trisilicate for the treatment of gastric and duodenal ulcers; Organic synthetic drugs are drugs (such as aspirin, chloramphenicol, caffeine, etc.) prepared from basic organic chemical raw materials through a series of organic chemical reactions.

Natural chemical drugs can also be divided into biochemical drugs and phytochemical drugs according to their sources. Antibiotics are generally produced by microbial fermentation and belong to the category of biochemistry. In recent years, many semisynthetics antibiotics are the combination of biosynthesis and chemical synthesis. As the main pillar of the chemical pharmaceutical industry, the variety, output and output value of organic synthetic drugs account for the largest proportion. The quality of the API determines the quality of the preparation, so the quality standards are very strict. Countries all over the world have formulated strict national pharmacopoeia standards and quality control methods for the API widely used.

Pharmaceutical preparation

Cicadae Periostracum Extract