论文部分内容阅读
多年来,日本医疗机构与研究单位对汉方浸膏制剂的质量提出了许多疑问,甚至公开例举了临床资料,证明汉方制剂的药效不如汤液。为解决这一问题,1982年由原来东京大学名誉教授野上寿负责,中药界名人组成了生药制剂恳谈会,专题研究汉方浸膏制剂的新对策。研究的课题有两个:一、确保汉方浸膏制剂的质置。二、关于临床上药效的研究。经过三年的努力,恳谈会通过对生药浸膏制剂厂的实际调查,举行了数次研究讨论,1985年在听取各界有关方面的意见后,向厚生省提出了《关于确保医疗用汉方浸膏制剂质量的研究》报告书。厚生省药物局根据此报告书,要求今后汉方浸膏制剂在申报时,必须附上与汉方标准汤液比较试验的详细资料,以确保汉方制剂的质量。
Over the years, Japanese medical institutions and research institutes have raised many questions about the quality of Chinese herbal extract preparations, and even publicly cited clinical data to prove that Kampo preparations are not as effective as decoction. In order to solve this problem, in 1982, Yeo Shou-Shou, Emeritus Professor of the University of Tokyo, was responsible for the establishment of a biopharmaceutical preparation seminar for celebrities in the Chinese medicine industry and a new strategy for the study of Chinese Herb extract preparations. There are two research topics: First, to ensure the quality of the preparation of Kampo extract. Second, on the clinical efficacy of the study. After three years of hard work, the Symposium held several investigations and discussions on the actual investigation of the crude drug extract preparation factory. After listening to opinions of relevant parties from various sectors in 1985, the “Sure to ensure medical use of Chinese herbal extract” was proposed to the Ministry of Health and Welfare. Study of Formulation Quality" report. According to the report of the Ministry of Health and Welfare of Japan, the Department of Medicine of the Ministry of Health and Welfare requires that during the application of Kampo extracts in the future, detailed information must be attached to the comparison test of the Chinese standard decoction to ensure the quality of Kampo preparations.