灯盏细辛注射液质量分析

Quality analysis of Injection Erigerontis Herba

灯盏细辛注射液为2009年国家药品评价性抽验品种之一,于1993年首获云南省卫生厅批准,先后经历由地方标准上升至部颁标准,再升至药典标准。本文通过对89批次59个批号的灯盏细辛注射液的质量进行评价,结果表明该品种的生产工艺较稳定,总体质量较好。同时本文建议需进一步研究灯盏细辛标准提取物及指纹图谱;重点关注患者长期使用灯盏细辛注射液前后的体内血铅水平;加强过敏试验和降压物质的控制,以提高本品临床使用的安全性;进一步研究本品酚酸类成分的含量测定方法,排除野黄芩苷等黄酮类成分的干扰,建立一种准确、可行的方法对某几种主要的咖啡酰奎宁酸或该大类成分进行定量分析。

Injection Erigerontis Herba is one of the variety of inspection for national drug evaluation in 2009,issued firstly by Yunnan Provincial Bureau of Health in 1993,embodied by Drug Specifications Promulgated by the Ministry of Public Health,P R China,and then embodied by Pharmacopoeia of the Peoples Republic of China.In this paper,the quality evaluation result of 89 samples involving 59 batches of Injection Erigerontis Herba,shows that the product has steadly process and good overall quality.As the same time,it is suggested that further study of the standard Erigerontis Herba extracts and fingerprint be mecessary.Focuses on blood lead levels in vivo of the long-term use patients before and after using Injection Erigerontis Herba and strengthen the allergic tests and the step-down material control,to improve the product safety of the clinical use.Further study an assay method of phenols,excluding the interference of flavonoids such as scutellarin,and build a precise and feasible method for determining the contents of caffeoyl quinic acid.