紫花高乌头药材的质量标准研究

Study on Quality Standard for Aconitum excelsum Reichb

目的建立紫花高乌头药材的质量标准,提高其质量控制水平。方法采用薄层色谱(TLC)对不同产地紫花高乌头药材进行定性鉴别;按《中国药典》方法测定其水分、灰分与浸出物;采用高效液相色谱-二极管阵列检测(HPLC-DAD)技术建立不同产地紫花高乌头药材指纹图谱并对其有效成分进行含量测定。结果不同产地紫花高乌头药材TLC斑点清晰,分离度好;暂定其药材水分、总灰分及酸不溶性灰分分别不得过10.0%、11.0%、4.5%,醇溶性浸出物应不少于24.0%;建立了紫花高乌头药材指纹图谱,标定共有峰14个,紫花高乌头药材中高乌甲素与冉乌头碱的含量应不少于0.126%、0.018%。结论该研究所建立的方法准确可靠、重复性好、特征性强,可用于紫花高乌头药材的质量评价。

Objective To improve the quality standard of Aconitum excelsum Reichb for its quality control. Methods The thin layer chromatography(TLC) were used for qualitative identification of Aconitum excelsum Reichb from different areas;and the pharmacopeia methods were used for the tests of moisture,ash and extractives. At the same time,HPLC-DAD method was developed to establish fingerprints for Aconitum excelsum Reichb from different areas and determination of the contents. Results The TLC showed the spots developed clearly and the separation was good. The moisture,total ash and acid insoluble ash of Aconitum excelsum Reichb should not be more than 10.0%,11.0%,4.5%,the alcohol soluble extractives should not be less than 24.0%,respectively. The common profile for Aconitum excelsum Reichb fingerprint was established, and 14 common fingerprint peaks were identified. The lappacontine and ranaconitine of Aconitum excelsum Reichb should not be less than 0.126% and 0.018%,respectively. Conclusion The methods developed were accurate,reproducible with high specificity,which can be used for quality control of Aconitum excelsum Reichb in the future.