Pyrogens, also known as endotoxins, are produced in the extracellular wall of Gram-negative bacteria, that is, fragments of bacterial corpses. It is a lipopolysaccharide substance with a relative molecular mass ranging from several thousand to several hundred thousand, depending on the species of bacteria that produces it. In aqueous solution, its relative molecular mass can vary from hundreds of thousands to millions
If a trace amount of pyrogen is mixed into the medicine and injected into the human blood system, it will cause severe fever and even death. Therefore, it is very necessary to reduce the pyrogen content in the medicinal liquid as much as possible, especially when the injection (such as large infusion) dosage is larger, the concentration requirement of the pyrogen should be more stringent.
Depyrogenation of the injection liquid (or water for injection) is a basic production link in the pharmaceutical industry to make it meet the testing regulations of the Pharmacopoeia. At present, the methods for depyrogenation are generally introduced in the following 3 categories:
1. Distillation method produces depyrogenated water, which is used as water for injection, washing water, etc., but its cost is high.
2. Depyrogenation by adsorption method. One of the ways is that the surface adsorbent adsorbs the pyrogenic substances and allows the product substances to pass through. The second way is that the adsorbent adsorbs the product material and allows the pyrogen to flow out.
3. Membrane separation method for pyrogen removal as a new process and new technology is being popularized and applied in the pharmaceutical industry. The principle of ultrafiltration to remove pyrogen is to use an ultrafiltration membrane smaller than the molecular weight of the pyrogen to intercept the pyrogen. This method has been certified. And has the advantages of low labor intensity, high product yield and good product quality.
Post time: Apr-20-2022