Detailed definition and core characteristics
Basic definition
API is the active ingredient in a drug preparation, which refers to a medicinal substance prepared by chemical synthesis, plant extraction or biotechnology, but requires further processing (such as adding excipients) to make a drug that can be used directly. Its core characteristics include:
Pharmacological activity: It can diagnose, treat, alleviate or prevent diseases, or affect the functional structure of the body.
Indirect use: It is usually in the form of powder, crystals, etc., and patients cannot take it directly.
Comparison of authoritative definitions
Chinese definition: It emphasizes that it is an "active ingredient in a preparation" and needs to be processed to reflect its therapeutic effect.
WHO definition: It is extended to "a combination of substances that have a restorative or corrective effect on physiological functions", which has a wider range.
Distinction between API and related concepts Relationship with active pharmaceutical ingredients (API): The two are often used interchangeably, but strictly speaking, API emphasizes the "activity" attribute more, while API focuses on the role of "production raw materials".
Difference from preparations: APIs are the basic ingredients of preparations, which are used clinically by adding excipients and adjusting dosage forms (such as tablets and injections).
Additional notes
Quality control: APIs must undergo rigorous testing to ensure safety and effectiveness.
Role of the global supply chain: As the core of drug production, most pharmaceutical companies rely on external API suppliers, and only a few large companies can produce them themselves.
