中兽药前处理及提取车间布局设计的分析与建议

Analysis and Suggestion on the Layout Design for the Pretreatment and Extraction Manufacturing Units of Traditional Chinese Veterinary Drugs

关键词:  兽药  中药前处理  中药提取  车间设计

Key words:  Veterinary drugs  Pretreatment process of traditional Chinese drugs  Extraction of traditional Chinese drugs  Plant Design

摘要:

中兽药是兽医用药的重要组成部分，兽用中药制剂的质量与中药材前处理及中药提取工艺密切相关。文章从车间布局、设施设备和车间环境要求等方面详细分析了《兽药生产质量管理规范》对中药前处理车间和中药提取车间的要求，并结合生产实际提出中药前处理车间和中药提取车间的设计建议，给兽药企业中药前处理车间和提取车间GMP改造提供参考，以期在设计和建造中降低企业成本，满足兽用中药提取物及中药制剂达到安全、有效、稳定、可控的质量要求。

Abstract:

Traditional Chinese veterinary drugs are an integral part of veterinary medicine. The quality of traditional Chinese medicinal preparation for veterinary use is closely related to the pretreatment process and the extracting technique of traditional Chinese medicinal materials. This paper analyzes in detail the requirements of the "Good Manufacturing Practice For Animal Drugs (GMP)" for both pretreatment and extraction units of traditional Chinese drug manufacture in aspects of layout planning, facilities and equipment, environment criteria and etc. Furthermore, combined with production experience in practice, the paper offers design suggestions for both pretreatment and extraction units of traditional Chinese drug manufacture. It also provides references for veterinary drug companies to reconstruct and upgrade their manufacturing facilities to comply with GMP requirements, helping them to reduce the cost of design and construction and to meet the quality standards of traditional Chinese veterinary medicinal extracts and preparations to achieve safe, effective, stable and controllable.