摘要
为减少青霉素类产品中的可见异物,提高产品质量。通过对目前产品中可见异物情况、生产工艺过程分析,结合热原性质及去除方法的理论知识,提出影响产品可见异物为产品中热原物质增加的假设。以此设计试验,通过增加生产过程中除热原能力,即活性炭用量,达到降低产品可见异物的目标。以活性炭用量为变量进行试验对比,活性炭的用量与试验成品可见异物情况呈现直接关系,随着活性炭用量增加,产品中可见异物数量逐渐减少,确定了活性炭最佳用量为≥27 g/十亿。通过工艺改进,降低了产品中的可见异物,提高了产品质量;并确认了生产过程中活性炭的最佳用量。
In order to reduce visible foreign matters in penicillin products and improve product quality, the hypothesis that the visible foreign matter in products is the increase of pyrogen in products was put forward based on the analysis of visible foreign matter in products and production process, combined with the theoretical knowledge of pyrogen properties and removal methods. Based on this design test, by increasing the pyrogen removal capacity in the production process, that is,the amount of activated carbon, the goal of reducing visible foreign substances in the product could be achieved. Taking the amount of activated carbon as a variable, the experimental comparison showed that the amount of activated carbon is directly related to the visible foreign bodies in the finished product. With the increase of the amount of activated carbon, the number of visible foreign bodies in the product gradually decreases, and the optimal amount of activated carbon is determined to be ≥27 g/billion. Through the process improvement, the visible foreign matter in the product is reduced, and the optimal dosage of activated carbon is confirmed.
作者
齐亚鹏
Qi Yapeng(North China Pharmaceutical Corporation Ltd.,Shijiazhuang 050015,China)
出处
《煤炭与化工》
CAS
2022年第7期133-135,共3页
Coal and Chemical Industry
关键词
可见异物
活性炭
热原
visible particles
activated carbon
pyrogen
