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中药制剂质量控制工作是中医药工作的根基,也是中医药服务体系中的关键环节。该文通过对2009年1月-2013年7月间影响丽水市中医院中药制剂质量的相关因素分析,发现处方审核不严格、原材料质量不良、生产工艺及设备落后、包装材料不合格以及现有的中药制剂质量标准不完善等5个方面是影响中药制剂质量的重要因素。针对上述因素制订了相应应对措施,采取严审处方、提高原材料质量、完善生产工艺、加强包装材料管理以及完善质量标准等来提高中药制剂的质量,避免中药制剂使用过程中不安全情况发生。
Chinese medicine preparation quality control work is the foundation of traditional Chinese medicine, but also the key link in Chinese medicine service system. Based on the analysis of the related factors influencing the quality of traditional Chinese medicine preparations in Lishui Traditional Chinese Medicine Hospital from January 2009 to July 2013, we found that the prescription examination is not strict, the quality of raw materials is poor, the production technology and equipment are outdated, the packaging materials are not qualified and the existing The quality of Chinese medicine preparation is imperfect, and other five aspects is an important factor affecting the quality of Chinese medicine preparations. According to the above factors, the corresponding countermeasures were formulated to improve the quality of Chinese medicine preparations by taking strict prescriptions, improving the quality of raw materials, improving the production process, strengthening the management of packaging materials and improving the quality standards so as to avoid the unsafe situations during the use of traditional Chinese medicine preparations.