中药小通草质量控制的探索性研究

Exploratory Reaserch on the Quality Control of Stachyuri Medulla Helwingiae Medulla

关键词:  小通草  质量控制  探索性研究  薄层鉴别  总灰分测定  砷  汞

Key words:  Stachyuri Medulla Helwingiae Medulla  quality control  exploratory reaserch  TLC  determination of total ashes  As  Hg

摘要:

目的 通过对中药小通草现行质量标准检验及探索性研究，探索新的质量控制方法并提出相关建议。方法 在现行国家质量标准检验基础上，开展了薄层鉴别，总灰分测定和砷、汞含量测定3个探索性试验。结果 小通草薄层鉴别结果与2015版药典现行标准检验结果相一致；掺杂增重后的小通草总灰分（13.92%~28.42%）显著高于正品小通草的总灰分（1.72%~2.98%）；建立了原子荧光光谱法测定小通草中砷、汞含量的方法。该法对砷、汞的最低检出限分别为0.015 5 ng·mL^-1和0.009 4 ng·mL^-1，加样回收率（n=9） 分别为102.3%和103.7%。结论 薄层鉴别法适用于小通草正伪品的鉴别，可作为现行质量标准方法的补充之一；通过总灰分测定能够鉴别掺杂小通草；砷、汞含量测定方法的建立可为保障小通草安全性提供参考。

Abstract:

OBJECTIVE To investigate new control methods and offer some suggestions according to the current quality standards and the exploratory reaserches on Stachyuri Medulla Helwingiae Medulla. METHODS On the basis of current quality standards, the exploratory reaserches were performed including TLC, determination of toal ashes and determination of As, Hg. RESULTS The TLC results were consistent with the current quality standard results in Chinese Pharmacopoeia 2015 Edition; the toal ashes content(13.92%-28.42%) was significantly higher than that of certified products(1.72%-2.98%); the determination methods for As and Hg were established by AFS. The detection limit of As and Hg were 0.015 5 ng·mL^-1 and 0.009 4 ng·mL^-1, and their recoveries (n=9) were 102.3% and 103.7%. CONCLUCION TLC is applied to authenticity of the identification, and it can be used as a supplement of current quality standards. Determination of toal ashes can indentify the adulteration obviously; the determination methods for As and Hg can provide references for the security assurance of Stachyuri Medulla Helwingiae Medulla.