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日本厚生省在86年度,制定了55个特别研究课题,其中涉及药政管理的研究课题有6个。1.为确保汉方浸膏制剂的品质而进行的汤剂研究(由国立卫生试验所原田正敏主持研究)。到目前为止,已从不同研究途径进行了三年的工作,其成果已在去年以“标准汤剂”的形式提出(即完整的汉方制剂申请模式),其中规定每一种汉方制剂作定量分析的指标成分要在2种以上。现药务局正在受理申请。这次制定的研究课题是为了进一步确保汉方浸膏制剂质量,确立和充实指标成分的试验方法。但各企业的试验结果有明显的差异,需进一步明确试验方法。研究时间约为一年(原计划三年)。
The Ministry of Health and Welfare of Japan formulated 55 special research topics in fiscal year 86. Among them, there are six research topics involving drug administration. 1. Decoction study to ensure the quality of Kampo preparations (conducted by the National Institute of Sanitary Trial, Harada Harada). So far, three years of work have been carried out from different research approaches. The results have been presented in the form of “standard decoction” (ie, a complete Kampo preparation application model) last year, which stipulates that each Kampo preparation There are two or more types of indicators for quantitative analysis. The Pharmacy Bureau is accepting applications. The research project formulated this time is to further ensure the quality of Kampo preparations and to establish and enrich the test methods for index components. However, there are obvious differences in the test results of various companies, and the test methods need to be further clarified. The study period is approximately one year (three years originally planned).