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本报告的内容叙述了有关确保医疗用汉方浸膏制剂(以下简称为浸膏制剂)质量的基本观点和实施办法。1.作为药品的生药和汉方汤剂: 本研究是以稳定浸膏制剂的效价为目的的,但在进行此研究之前,首先要考虑生药和汉方汤剂的有效性,安全性和效价。(1)有效性及安全性:日本药局方中收载了很多生药,其中大部分也是浸膏制剂的原料。由于药局方中收载的都是国家法定药品,因此对药局方收载的生药应该评价其有效性,安全性,确保其效价。但是,有关生药这方面的内容,同阿司匹林等一般
The contents of this report describe the basic viewpoints and implementation methods for ensuring the quality of medical extracts of Chinese medicine (hereinafter referred to as extract preparations). 1. Herbal medicine and Chinese herbal decoction as medicines: This study is aimed at stabilizing the potency of extract preparations, but before conducting this study, it is necessary to consider the effectiveness and safety of raw herbs and Chinese herbal decoction. potency. (1) Effectiveness and safety: The Japanese Pharmacopoeia contains many crude drugs, most of which are also raw materials for extract preparations. Since all prescriptions contained in Pharmacopoeia are national statutory drugs, they should be evaluated on the effectiveness and safety of the crude drugs collected by Pharmacopoeia and ensure their potency. However, regarding the aspect of crude drugs, such as aspirin, etc.