Establishment of Quality Control System for Aolanti Weikang Tablets with Multiple Indexes

WANG Zhang-wei; QIU Xiao-yan; WANG Zhen; LIU Fang-fang; LI Zhi-yong; ZHOU Peng; WEI Jin-ning; LYU Wu-qing; YANG Xiao-ling; XIE Ning

doi:10.13422/j.cnki.syfjx.20182411

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Establishment of Quality Control System for Aolanti Weikang Tablets with Multiple Indexes

更新时间：2024-09-23

- Establishment of Quality Control System for Aolanti Weikang Tablets with Multiple Indexes
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 24, Issue 23, Pages: 82-86(2018)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20182411
  CLC： R286.0
- Published：2018
- 稿件说明：
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WANG Zhang-wei, QIU Xiao-yan, WANG Zhen, et al. Establishment of Quality Control System for Aolanti Weikang Tablets with Multiple Indexes[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(23): 82-86.
DOI：

WANG Zhang-wei, QIU Xiao-yan, WANG Zhen, et al. Establishment of Quality Control System for Aolanti Weikang Tablets with Multiple Indexes[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(23): 82-86. DOI： 10.13422/j.cnki.syfjx.20182411.

摘要

目的：探索奥兰替胃康片的多指标质量控制方法，建立其HPLC特征图谱，并测定其主要黄酮苷类成分的含量。方法：选择新北美圣草苷、柚皮芸香苷、柚皮苷、橙皮苷、新橙皮苷为指标成分，采用YMC-Pack ODS-A色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.1%磷酸水溶液（18∶ 82）为流动相等度洗脱，检测波长283 nm，流速1.0 mL·min-1，柱温30℃。结果：建立了奥兰替胃康片的HPLC特征图谱，对10批次奥兰替胃康片中的5个特征峰进行含量测定，新北美圣草苷、柚皮芸香苷、柚皮苷、橙皮苷、新橙皮苷质量浓度分别在0.266 5~10.66 mg·L-1（r=0.999 9），1.055~42.20 mg·L-1（r=1.000 0），7.070~282.8 mg·L-1（r=1.000 0），0.797 8~31.91 mg·L-1（r=0.999 9），6.955~278.2 mg·L-1（r=1.000 0）与峰面积呈良好线性关系，平均加样回收率分别为99.4%（RSD 1.0%），100.5%（RSD 0.6%），97.8%（RSD 0.9%），96.7%（RSD 0.7%）和98.3%（RSD 0.8%）。奥兰替胃康片与原料枳实总黄酮苷提取物的特征图谱相似度1.000。结论：建立的特征图谱和指标成分含量测定方法稳定可行、专属性强，可作为奥兰替胃康片的多指标质量控制方法。

Abstract

Objective:To explore the method of multi-index quality control for Aolanti Weikang tablets

and establish its HPLC characteristic spectrum and determine the contents of main flavonoid glycosides in Aolanti Weikang tablets. Method:Neoeriocitrin

narirutin

naringin

hesperidin and neohesperidin were selected as index components

HPLC analysis was applied on an YMC-Pack ODS-A column(4.6 mm×250 mm

5 μm)

the mobile phase was acetonitrile-0.1% phosphoric acid aqueous solution(18:82)

the detection wavelength was set at 283 nm

the flow rate was 1.0 mL·min-1

and the column temperature was 30℃. Result:HPLC characteristic spectrum was established

and five characteristic peaks in ten batches of Aolanti Weikang tablets were simultaneously determined.Five components(neoeriocitrin

narirutin

naringin

hesperidin and neohesperidin) all showed good linear relationship within the ranges of 0.266 5-10.66 mg·L-1(r=0.999 9)

1.055-42.20 mg·L-1(r=1.000 0)

7.070-282.8 mg·L-1(r=1.000 0)

0.797 8-31.91 mg·L-1(r=0.999 9)

6.955-278.2 mg·L-1(r=1.000 0)

respectively.The average recoveries of these five components were 99.4%(RSD 1.0%)

100.5%(RSD 0.6%)

97.8%(RSD 0.9%)

96.7%(RSD 0.7%) and 98.3%(RSD 0.8%).The similarity of characteristic spectrum between Aolanti Weikang tablets and the total flavonoid glycosides extract of Aurantii Fructus Immaturus was 1.000. Conclusion:The proposed HPLC characteristic spectrum and determination method of five flavonoid glycosides can be used as the quality control method of Aolanti Weikang tablets with multitude indexes.

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