眼用凝胶剂无菌生产工艺过程控制中的相关分析  

Correlation Analysis in the Process Control of Aseptic Production of Ophthalmic gel

作　　者：韦忠明 Wei Zhong-ming

机构地区：[1]桂林华诺威基因药业有限公司,广西桂林541004

出　　处：《化工设计通讯》2018年第4期166-166,228,共2页Chemical Engineering Design Communications

摘　　要：2015版《中华人民共和国药典》内有对眼用制剂的要求,要求各类眼用制剂必须保证无菌。眼用凝胶剂是直接作用在人们眼睛上的一种制剂,所以其安全性及可靠性是人们所关注的。主要对眼用凝胶剂的生产环境、生产设备、生产人员、生产操作等方面进行介绍,对生产中如何进行无菌控制进行探析,对相关方法进行讨论,提升眼用凝胶剂的生产数量及产品质量,让人们使用眼用凝胶剂时更放心,也有利于眼用凝胶剂制作水平的提升。In the 2015 edition of the Pharmacopoeia of the people＇ s Republic of China, there is a requirement for ophthalmic preparations, requiring all kinds of ophthalmic preparations to ensure its asepsis.Ophthalmic gel is a kind of preparation directly acting on people＇ s eyes, so its safety and reliability are the attention of people.This article mainly introduces the production environment, production equipment, production personnel, production operation and other aspects of ophthalmic gel, and discusses how to control aseptic control in production, and discusses the related methods to improve the production quantity and quality of ophthalmic gel.It is more reassuring for people to use ophthalmic gel, and it also helps to improve the level of eye gel.

关 键 词：眼用凝胶剂 无菌 生产工艺 过程控制 

分 类 号：R943[医药卫生—药剂学]