目的 監(jiān)測(cè)和評(píng)價(jià)天麻素注射液的質(zhì)量現(xiàn)狀。方法 采用法定檢驗(yàn)與探索性研究相結(jié)合的模式，按法定標(biāo)準(zhǔn)檢驗(yàn)200批樣品，統(tǒng)計(jì)分析pH值、有關(guān)物質(zhì)和含量測(cè)定等檢驗(yàn)結(jié)果，圍繞安全性有效性開(kāi)展了有關(guān)物質(zhì)、滲透壓摩爾濃度、依地酸二鈉（EDTA-2Na）篩查及注射劑局部安全性4個(gè)方面的研究。結(jié)果 按法定標(biāo)準(zhǔn)檢驗(yàn)結(jié)果均符合規(guī)定，合格率100%。通過(guò)探索性研究建立了雜質(zhì)譜，滲透壓摩爾濃度研究發(fā)現(xiàn)部分企業(yè)說(shuō)明書(shū)中對(duì)“輔料”描述不完全，EDTA-2Na篩查與注射劑局部安全性研究結(jié)果均呈陰性反應(yīng)或符合規(guī)定。結(jié)論 天麻素注射液總體質(zhì)量狀況好。

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.

R971