目的 监测和评价天麻素注射液的质量现状。方法 采用法定检验与探索性研究相结合的模式，按法定标准检验200批样品，统计分析pH值、有关物质和含量测定等检验结果，围绕安全性有效性开展了有关物质、渗透压摩尔浓度、依地酸二钠（EDTA-2Na）筛查及注射剂局部安全性4个方面的研究。结果 按法定标准检验结果均符合规定，合格率100%。通过探索性研究建立了杂质谱，渗透压摩尔浓度研究发现部分企业说明书中对“辅料”描述不完全，EDTA-2Na筛查与注射剂局部安全性研究结果均呈阴性反应或符合规定。结论 天麻素注射液总体质量状况好。
Objective To monitor and evaluate the quality status of gastrodin injection. Methods The mode of statutory testing method and exploratory research was adopted. 200 batches of the collected samples were tested according to the current quality standard, the tested results were statistically analyzed in terms of pH, related substances and assay. Several exploratory researches, including the study on related substances, measure osmotic pressure, screening EDTA-2Na and the study of safety of in situ injection, were carried out on the basis of security and effectiveness. Results Statutory test showed all the samples conform to the provisions, qualification rate is 100%. Impurity profile was established by exploratory research, the study of measuring osmotic pressure showed the incomplete description of medicine specification of partial company, screening EDTA-2Na and the study of safety of in situ injection showed the negative reaction or qualified results. Conclusions The overall quality status of gastrodin injection was good.