基于国家药品标准的肺系病清热类中药注射剂含量测定相关问题概述

Summary of Research on Related Questions of Content Determination of Pulmonary Diseases with Heat-clearing Traditional Chinese Medicine Injection Based on National Drug Standard

关键词:  中药注射剂  含量测定  肺系病  有效成分  含量范围  指纹图谱

Key words:  traditional Chinese medicine injection  content determination  pulmonary disease  active ingredients  content range  fingerprint

摘要:

肺系病清热类中药注射剂目前广泛应用于临床，但其质量标准尚不完善的问题一直是医药界关注的焦点。受中药注射剂固有的特点和历史原因制约，部分肺系病清热类中药注射剂含量测定存在测定指标单一、检测方法专属性较低等问题，对产品质量控制实际意义不强。本文就肺系病清热类中药注射剂含量测定相关问题的现状和有待商榷的问题，从测定指标的选择、含量范围的规定、测定方法与技术以及指纹图谱应用等方面提出了国家药品标准含量测定存在的问题及解决思路，以期为药品标准提高工作提供参考。

Abstract:

Traditional Chinese medicine injection with clearing heat in pulmonary disease are widely used in clinical practice, but incomplete quality standards have been the focus of attention from medical professionals. Restricted by the inherent characteristics and historical reasons of traditional Chinese medicine injections, the content determination items of some varieties have problems such as single measurement index and low specificity of the detection method. The practical significance of content determination is not good for product quality control. This article analyze the selection of content measurement indicators, the content range specification, measurement methods and techniques, and the application of fingerprints, and presents the problems and solutions of content in order to provide a reference for the improvement of national drug standards.