Injectable hydroxypropyl betacyclodextrin and its bacterial endotoxins

Bacterial endotoxin, also known as pyrogen, is a lipopolysaccharide in the cell wall of gram-negative bacteria. It is a pathogenic factor that poses a serious threat to human health, and a small dose can cause a wide range of biological and pathological effects. Injectable bacterial endotoxin content of up to 1μg/kg can cause adverse reactions, such as fever reaction, sometimes the body temperature can rise to more than 40 ℃, and in severe cases, even coma, collapse, if not rescued in time, can be life-threatening.

At present, in the production of injections, the removal of bacterial endotoxin often use activated carbon adsorption method. Generally, 0.03% to 0.50% of the volume of the liquid is added to remove bacterial endotoxin in the production of injections, but if the bacterial endotoxin of the liquid is too high, it is difficult to ensure that the content of pyrogen in the injections is within the safe range after the removal of pyrogen by activated carbon.

However, in the production process of injectable hydroxypropyl betacyclodextrin, the cleaning of nanofiltration machine, cation resin, filter cartridge and the storage of material in semi-closed condition are the main factors affecting the bacterial endotoxin of the product. In order to ensure that the bacterial endotoxin of the product is qualified, we should strictly control each key influencing factor to prevent the resin and cartridge, which are traditionally used for removing impurities, from becoming the source of bacterial endotoxin contamination of the product, and minimize the risk of contamination and cross-contamination in the process of the product according to the requirements of the Code of Practice for the Manufacture of Pharmaceuticals, so as to ensure that we can continuously and stably produce the product in accordance with the user's quality standards.