[关键词]
[摘要]
中药注射剂作为中药现代化的重要代表,已成为中医药产业不可或缺的一部分。中药注射剂质量控制研究决定其安全性与有效性。针对中药注射剂成分复杂、药效物质基础不明确等问题,利用高效液相色谱法、气相色谱法等对其内在成分进行定量,从单一指标到多指标,结合指纹图谱、模式识别、谱效关系、质量标志物(Q-marker)的研究也取得很大的进展。从多指标定量测定、指纹图谱以及谱效关系和Q-marker等方面,对近年来中药注射剂质量控制研究成果进行综述。
[Key word]
[Abstract]
As an important representative of modern Chinese medicine, traditional Chinese medicine injections (TCMI) have become an indispensable part of the Chinese medicine industry. The quality standard researches of TCMI determine the safety and effectiveness of TCMI. In view of the complex ingredients of TCMI and unclear pharmacological material basis, modern pharmacy researches have made a lot of remarkable progress on the determination of intrinsic components by high performance liquid chromatography, gas chromatography and so on; From single-index to multi-index, combined with fingerprints, pattern recognition, spectrum-effect relationships, and quality markers, which bring new hope for the development of TCMI industry. In this paper, the progress on quality control of TCMI was summarized in aspect of the quantitative determination of multi-index, fingerprint spectrum, spectrum-effect relationship, Q-marker etc.
[中图分类号]
[基金项目]
“重大新药创制”科技重大专项(2013ZX09402202)