日本汉方制剂协会根据汉方浸膏制剂的原料和生产特点,以GMP的精神为准则,制定了汉方浸膏制剂的生产管理和质量管理的自定标准(草案)。该标准对我国中成药行业在贯彻执行《中成药生产管理规范》时有一定的参考价值,现摘译如下。 Based on the raw materials and production characteristics of Hanfang extract preparations, the Japanese Kampo Formulation Association has adopted the spirit of GMP as the guideline to formulate a self-determined standard (draft) for the production management and quality management of Hanfang extract preparations. This standard has certain reference value for the Chinese patent medicine industry in the implementation of the “Chinese patent drug production management practices”, is now translated as follows.