摘要
本文将胶囊用牛骨明胶生产企业从牛骨供应商选择和采购过程质量控制、生产过程控制、储存和销售环节质量控制,即全过程质量控制保证胶囊用牛骨明胶的质量,降低牛骨明胶可能存在疯牛病的风险。背景:最近10年,我国胶囊用明胶得到了长足的发展。特别是胶囊用牛骨明胶,产量持续在增长。胶囊用牛骨明胶生产过程所用的原料为牛骨。牛骨有潜在的疯牛病风险。疯牛病是-种人畜共患的疾病,且致死率100%。胶囊用牛骨明胶生产厂家及其客户都非常关注胶囊用明胶所用原料及其生产过程中疯牛病病毒的控制.确保胶囊用明胶的安全性。目的:为了给胶囊用明胶生产厂家提供疯牛病的控制指导,从胶囊用明胶定义、疯牛病定义以及动物来源药用辅料指导原则出发,结合国家牛海绵状脑病风险防范指导意见等文件阐述了胶囊用明胶生产过程的疯牛病控制揩施以及效果。意义:本文可为胶囊用明胶生产厂家控制疯牛病提供指导。
In this paper,the whole process quality control is used to ensure the quality of the bovine bone gelatin for capsules and reduce the risk of BSE in gelatin.The whole process quality control from the supplies select and purchase of the bovine bone control,the production process control,storage and sales quality control.Background:In recent 10 years,gelatin for capsule has been developed rapidly in China.In particular,the production of gelatin for bovine bone capsules has continued to increase.The raw material used in the production of gelatin for bovine bone capsule is bovine bone.Bovine bones are potentially at risk for BSE.BSE is a zoonotic disease with a 100%mortality rate.Manufacturers of gelatin for bovine bone capsules and their customers are very concerned about the raw materials used in gelatin for capsules and the control of BSE virus in the production process to ensure the safety of Gelatin for capsules.Objective:to provide guidance for the control of bovine spongiform encephalopathy(BSE)for the manufacturers of gelatin capsules,based on the definitions of gelatin capsules,BSE and animal-derived pharmaceutical excipients,the control measures and effects of BSE in the production of gelatin capsules were described in combination with the BSE and other documents.Meaning:This paper can provide guidance for the control of BSE in gelatin capsule manufacturers.
作者
陈世鹏
陈世会
Chen Shipeng;Chen Shihui(PB Gelatins(Heilongjiang)Co.,Itd,Nehe City,QiqiHar City,Heilongjiang Province 161000;Yueming Healh-center of Xipo Town,Zhengning County,Zhengning County,Qingyang City,Gansu Province 745301)
出处
《明胶科学与技术》
CAS
2022年第2期98-103,共6页
The Science and Technology of Gelatin
关键词
牛骨
胶囊用明胶
疯牛病
Bovine bone
Gelatin for capsules
BSE