Excipients for Injections are sterile solutions made for injection into the body and sterile powders or concentrated solutions prepared as solutions or suspensions prior to use. Aseptic preparation refers to a class of drug preparations prepared by aseptic operation or aseptic technique in a sterile environment without any live microorganisms. For heat-sensitive drugs, peptides, proteins and other large molecules are often prepared into sterile preparations by aseptic operation. Excipients are often added during the preparation of injections to increase the solubility of drugs and improve stability, etc. Therefore, pharmaceutical excipients have an important impact on the effectiveness, stability and safety of injections.
Injections directly into the body, fast absorption, rapid action, if the quality of excipients, it will quickly produce harm to the body, so there are more stringent requirements for injectable excipients. Excipients for injection should be strictly controlled from the source, production process, quality inspection and other aspects, in order to meet the quality requirements for injection.
1. Injections, eye drops and other sterile preparations with excipients should meet the requirements of injection grade or eye preparations, in addition to inspection, impurities and other requirements under more stringent, but also increased the sterility, bacterial endotoxin, microbial limits and control bacteria requirements.
2. No contraindications between the main drug and excipients, does not affect the efficacy of the drug, to avoid interference with the test.
3. Chemically stable, not easily affected by temperature, pH, etc.
4. The use of concentration shall not cause toxicity or obvious irritation, there should be no pharmacological effects.
5. Under the premise of meeting the requirements, try to reduce the type and amount of excipients for injection.
6. Commonly used excipients for injections should be used as much as possible.
When preparing injections, suitable additives can be added as needed. Commonly used excipients mainly include pH regulators, isotonic regulators, antibacterial agents, antioxidants, etc. Their main functions are to increase drug solubility, enhance drug stability, regulate osmotic pressure or pH, inhibit microbial growth, reduce pain or tissue irritation, etc.