中成药国家标准剂量单位计量形式的探索研究(一)

Exploratory Study on the Measurement Form of Dosage Unitsin National Standards of Traditional Chinese Medicines(一)

中成药服用剂量(饮片量)对患者的临床疗效至关重要,本研究着眼于剂量问题,通过系列品种标准比对分析,拟将国家标准中常用的制剂单位计量形式改为剂量单位计量形式,旨在弱化与药效无关的参数,真实地明示服用剂量,使中成药质量控制的表述更加直观、易溯源,且管理更加科学合理,并可解决目前中成药同品种标准和规格过多和中药涨料等的问题。本文对目前中成药国家标准的剂量相关内容的现状和存在问题进行了分析,提出剂量单位改革的总体思路,并拟在后续文章中以多个实例进行解析。

The dose of Traditional Chinese Medicine （TCM） （decoction pieces dose） is the key to clinical effect. Thisstudy pro- posed to change the common preparation unit as dosage unit for measurement form of TCM in national standards by standards com- parison analysis of the series of TCMs based on the dosage issue. That aimed at weakening the parameters not being related to clinical effect and expressing the used dose exactly. That would make the description of quality control of TCM simple, direct and traceable, and result in the morescientific and reasonable management for TCM. That would resolve the issue of overmuch strengths and standards for the same TCM. The current situation and issues related to the dosage in national standards of TCMs were analyzed and the idea on reform of dosage unit was provided in this paper. It is planned to share and analyze the more cases in the future.