蒙药材胡德日奈都日吉德的质量标准初步研究

目的:建立蒙药胡德日奈都日吉德的质量标准。方法:参照《中华人民共和国药典》(四部)2015年版相关方法,对胡德日奈都日吉德杂质、水分、灰分、浸出物进行检测;采用硅胶G薄层板,以大戟二烯醇为对照,以石油醚(60~90℃)-乙酸乙酯(10∶1)为展开剂,用10%硫酸乙醇溶液显色,对胡德日奈都日吉德进行鉴别;采用紫外分光光度法,以大戟二烯醇为对照,在545 nm波长下对胡德日奈都日吉德的活性成分萜类化合物进行定量分析。结果:胡德日奈都日吉德三批样品杂质在0.69%~0.75%之间,平均值为0.72%,RSD为4.26%;水分含量在7.68%~7.74%之间,平均值为7.72%,RSD为0.03%;总灰分0.20%~0.22%之间,平均值为0.21%,RSD为2.86%;酸不溶性灰分在0.21%~0.23%之间,平均值为0.22%,RSD为4.82%;浸出物1.24~1.35之间,平均值为1.31%,RSD为4.64%。在供试品的色谱中,与对照品色谱相应的位置上,显示相同颜色的斑点。总萜在0.6720~5.3790 mg/L呈良好的线性关系,该方法平均回收率为97.48%,RSD为0.478%,3批样品总萜含量在25.67~35.94 mg/g之间,均含量为31.03 mg/g。结论:根据实验结果,制定蒙药胡德日奈都日吉德药材(按干燥品计算)中杂质、水分、总灰分、酸不溶性灰分分别不得过1%,10.0%,0.4%、0.4%;水溶性浸出物不得少于1.0%;总萜含量不得少于20 mg/g。本办法可用于蒙药胡德日奈都日吉德药材的质量控制。

Primary Study on Quality Standard of Mongolian Crude Drug Huderinaidurijide

Objective:To establish quality standard of Mongolian crude drug Huderinaidurijide.Methods:According to relevant methods in Chinese Pharmacopoeia(2015 editionⅣ),impurity,moisture,ash and extract of Huderinaidurijide were tested.A silica gel G plate was used.Euphol was taken as a control.Petroleum ether(60~90℃)-ethyl acetate(10:1)was used as developing solvent and 10%sulfuric acid ethanol solution was used for color development.Huderinaidurijide was performed identification.UV spectrophotometry was applied.Taking euphol as a control,active ingredients-terpenoids of Huderinaidurijide were quantitatively analyzed at 545 nm wavelength.Results:The impurity of 3 batches of sample Huderinaidurijide was 0.69%~0.75%,with an average of 0.72%and a RSD of 4.26%.The moisture content ranged from 7.68%~7.74%,with an average of 7.72%and a RSD of 0.03%.The total ash was between 0.20%and 0.22%,with an average of 0.21%and a RSD of 2.86%.The acid-insoluble ash ranged from 0.21%~0.23%,with an average of 0.22%and a RSD of 4.82%.The extract ranged from 1.24 to 1.35,with an average of 1.31%and a RSD of 4.64%.In the chromatogram of the test product,spots of the same color were displayed at positions corresponding to the chromatogram of the control product.The total terpenoids showed a good linear relationship between 0.6720 and 5.3790 mg/L.The average recovery rate of this method was 97.48%and the RSD was 0.478%.The content of total terpenoids in the 3 batches of samples ranged from 25.67 to 35.94 mg/g,with an average of 31.03 mg/g.Conclusion:According to the results,it is formulated that impurity,moisture,total ash,and acid-insoluble ash in Mongolian crude drug Huderinaidurijide(calculated on dried products)can not exceed 1%,10.0%,0.4%and 0.4%,respectively.Water-soluble extract is not less than 1.0%.The content of total terpenoids is not less than 20 mg/g.This method can be used for quality control of Mongolian crude drug Huderinaidurijide.