首页|小儿参术健脾丸的质量控制方法研究

小儿参术健脾丸的质量控制方法研究

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目的:提升小儿参术健脾丸质量控制标准。方法:建立麦芽的显微特征鉴别法;建立白术、陈皮、甘草的薄层色谱鉴别法;建立同时测定橙皮苷和甘草酸含量的高效液相色谱法。结果:麦芽显微特征鉴别专属性强,检视率高;白术、陈皮、甘草薄层色谱特征斑点清晰,专属性、耐用性好;橙皮苷、甘草酸铵分别在0。060 0~1。501 0 μg、0。020 1~0。502 2μg质量范围内与峰面积呈良好线性关系(r≥0。999 8),加样回收率分别为99%、96%,RSD分别为2。8%(n=9)、1。8%(n=9),两者精密度、稳定性、重复性的RSD均小于3。0%。结论:新建立的显微特征、薄层色谱鉴别及含量测定质量控制方法,准确可靠,操作简便快捷,耐用性好,可用于该制剂的质量评价和控制。
Invastigation on methods of quality control of Xiaoer Shenzhu Jianpi pills
Objective:To improve the quality standard of Xiaoer Shenzhu Jianpi Pills.Methods:The microscopic identification method was used to qualitatively identify Hordei Fructus Germinatus.TLC was used to qualitatively i-dentify of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium.HPLC was adopted to determine the contents of hesperidin and ammonium glycyrrhizinate.Results:The microscop-ic identification of Hordei Fructus Germinatus had strong specificity and high viewing rate.The TLC identification spots of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium were clear,with good separation and durability.The linear ranges of hesperidin and ammonium glycyrrhizinate were 0.060 0-1.501 0 μg and 0.020 1-0.502 2 μg,respectively(r≥0.999 8).The average recoveries(n=9)were 99%,96%and RSDs were 2.8%and 1.8%.The RSDs of precision,stability and repeatability of the two components were less than 3.0%.Conclusion:The newly established quality standard increases the quality control research of microscopic identification,thin layer chromatography and content determination.The experimental method is accurate and reliable,simple and fast,and has good applicability.It can be used for the quality control and evaluation of Xiaoer Shenzhu Jianpi Pills.

Xiaoer Shenzhu Jianpi pillsquality controlimprovement of standardAtractylodis Macrocephalae RhizomaGlycyrrhizae Radix Et RhizomaCitri Reticulatae Pericapium

杜娟、董超、史宪海、崔宇宏、王春芳

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山西省检验检测中心(山西省标准计量技术研究院),太原 030031

小儿参术健脾丸 质量控制 标准提高 白术 甘草 陈皮

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(3)