目的 对余甘子药材质量标准进行改进和修订。方法 建立紫外-可见分光光度法测定余甘子果实和果肉中总鞣质含量的方法,建立HPLC测定果实和果肉中没食子酸和鞣花酸含量的方法;采用建立的方法对15批余甘子果实和果肉样品进行测定并建立相应质量标准。结果 总鞣质、没食子酸和鞣花酸分别在(0.001 023~0.010 23)mg·mL-1、(0.021 28~0.532 0)μg、(0.021 24~0.531 0)μg范围内线性良好,平均加样回收率在97.33%~99.29%范围内,方法学验证均符合要求。根据15批余甘子果实和果肉样品测定结果,建议修订药材含量测定项,按在干燥品计算,含鞣质不得少于6.0%,含没食子酸、鞣花酸的总量不得少于2.0%。增加余甘子去核饮片为冬季至次春果实成熟时采收,剖开除去果核,干燥,并规定饮片含量测定项,按在干燥品计算,含鞣质不得少于8.5%,含没食子酸、鞣花酸的总量不得少于2.7%。结论 本研究建立的标准具有较好的专属性和稳定性,可为余甘子标准的修订提供依据。
Abstract
OBJECTIVE To improve and revise the quality standard of Phyllanthus emblica L.. METHODS UV-vis spectrophotometry method was established to determine the contents of total tannins, and HPLC method was established to determine the contents of gallic acid and ellagic acid in the fruit and pulp. Fifteen batches of fruit and pulp samples of Phyllanthus emblica L. were determined by the established methods, and the corresponding quality standards were established. RESULTS There was good linearity in the ranges of 0.001 023-0.010 23 mg·mL-1, 0.021 28-0.532 0 μg, 0.021 24-0.531 0 μg for total tannins, gallic acid, and ellagic acid, respectively.The average recoveries of analytes were 97.33%-99.29%, and the methodology validation met the requirement. According to the results in 15 batches of fruit and pulp samples, it is recommended that the pulps were clinically used as prepared slices. And the amount of total tannins, the total amount of gallic acid and ellagic acid in the fruit were not less than 6.0% and 2.0%, respectively. The amount of total tannins, the total amount of gallic acid and ellagic acid in the pulp were not less than 8.5% and 2.7%, respectively. CONCLUSION The established standard has good specificity and stability, which can provide a basis for the standard revision of Phyllanthus emblica L..
关键词
余甘子 /
鞣质 /
鞣花酸 /
果肉 /
饮片
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Key words
Phyllanthus emblica L. /
total tannins /
gallic acid /
pulp /
prepared slice
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中图分类号：
R917
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参考文献
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基金
国家“重大新药创制”科技重大专项资助(2018ZX09711001-003-025);国家药典委员会标准制修订研究课题资助(2019Z096)
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