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| Process improvement of reducing visible particles in penicillin products |
| Qi Yapeng |
| North China Pharmaceutical Corporation Ltd., Shijiazhuang 050015, China |
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Abstract 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.
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| 1 ] 齐亚鹏. 青霉素钠原粉结晶终点取样方法的改进[ J ]. 煤炭与化工，2016，39（ 10 ）：144 - 145.
[ 2 ] 国家药典委员会. 中国药典[ S ]. 2020年.
[ 3 ] 吴旭国. 浅谈青霉素的生产工艺过程[ J ]. 民营科技，2012（ 2 ）：31 - 32.
[ 4 ] 王 聪，王永莉，李彦平. 青霉素钠成品中白点问题探析[ J ]. 河北化工，2007，30（ 2 ）：40 - 41.
[ 5 ] 邢 军. 可见异物检查法有关问题的探讨[ J ]. 中国药事，2008，22（ 6 ）：472 - 473.
[ 6 ] 郭 绮，陈 彪. 注射剂的热原及其控制方法简述[ J ]. 制剂技术，2008，17（ 20 ）：41 - 42.
[ 7 ] 张大为，陈国笋，杨金志，等. 活性炭在注射剂配制工艺中的应用与探讨[ J ]. 化工与医药工程，2017（ 3 ）：32 - 35.
[ 8 ] 张 金，张玉嘉，金 余，等. 应用活性炭去除破伤风抗毒素热原质的研究[ J ]. 兰州大学学报（医学版），2006，32（ 4 ）：50 - 51.
[ 9 ] 刘 枫. 发酵工艺中热原管理及改善措施分析[ J ]. 化工设计通讯，2019（ 9 ）：105 - 106.
[ 10 ] 黄健花，吕名蕊，宋志华，等. 活性炭吸附脱除大豆磷脂细菌内毒素的研究[ J ]. 中国油脂，2012，37（ 2 ）：55 - 57.
[ 11 ] 罗俊永，杨文智，张晓攀，等. 活性炭在注射剂生产中的潜在风险分析[ J ]. 中国新药杂志，2019（ 4 ）：24 - 27. |
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