中药前处理及提取车间药品GMP初步设计常见问题分析

The Problems Analysis of Preliminary Drug GMP Design of Traditional Chinese Medicine Pretreatment and Extraction Workplace

目前,从2010年版药品GMP的角度来看,部分中药制剂生产企业的中药前处理及提取车间的初步设计,存在着厂区布局不合理、车间工艺布局不合理、功能间(区)欠缺、生产设备选型与生产需求不适应、生产辅助设施不足、洁净区设计不合理、空调净化系统不完善等问题。文章通过分析这些常见问题,并提出解决建议,希望为中药制剂生产企业新建或改造中药前处理及提取车间提供参考。

At present, from the 2010 edition of pharmaceutical GMP＇s point of view, some designs of Chinese herbal medicine production enterprises＇ traditional Chinese medicine pretreatment and extraction workshop exist unreasonable factory, unreasonable workshop process, lack of function rooms（area）, lack of production equipment, lack of auxiliary facilities, unreasonable clean area, the imperfect HVAC system, and so on. By analyzing these common problems and proposing solutions, hopes for provide reference for Chinese herbal medicine manufacturer who would build or modify traditional Chinese medicine pretreatment and extraction workshop.