基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度

何艳梅; 林虓; 王雪; 李家春; 黄文哲; 萧伟

doi:10.13422/j.cnki.syfjx.2018010014

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基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度

药剂与炮制 | 更新时间：2024-01-04

- 基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度
- Determination of Dissolution of Eight Active Ingredients in Guizhi Fuling Capsules by UPLC
- 中国实验方剂学杂志 2018年24卷第1期页码：14-19
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家“重大新药创制”科技重大专项（2011ZX09101-403）
- DOI：10.13422/j.cnki.syfjx.2018010014
  中图分类号： O657.72;R286.0
- 纸质出版日期：2018
- 稿件说明：
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何艳梅, 林虓, 王雪, 等. 基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度[J]. 中国实验方剂学杂志, 2018,24(1):14-19.

HE Yan-mei, LIN Xiao, WANG Xue, et al. Determination of Dissolution of Eight Active Ingredients in Guizhi Fuling Capsules by UPLC[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(1): 14-19.
何艳梅, 林虓, 王雪, 等. 基于UPLC测定桂枝茯苓胶囊中8种活性成分的溶出度[J]. 中国实验方剂学杂志, 2018,24(1):14-19. DOI： 10.13422/j.cnki.syfjx.2018010014.

HE Yan-mei, LIN Xiao, WANG Xue, et al. Determination of Dissolution of Eight Active Ingredients in Guizhi Fuling Capsules by UPLC[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(1): 14-19. DOI： 10.13422/j.cnki.syfjx.2018010014.

摘要

目的：建立桂枝茯苓胶囊溶出度的测定方法，为该制剂的质量评价提供参考。方法：采用UPLC，没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛的流动相为0.02%三氟乙酸水溶液-乙腈梯度洗脱，检测波长分别为230 nm（没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚）和275 nm（肉桂酸、桂皮醛）。苦杏仁苷的流动相为水-甲醇（80：20），检测波长218 nm。结果：确定溶出介质为0.1 mol·L-1盐酸，转速50 r·min-1，采用转篮法测定溶出度。没食子酸、芍药苷、苯甲酸、苯甲酰芍药苷、丹皮酚、肉桂酸、桂皮醛、苦杏仁苷的线性范围分别为0.097 6~24.389 9，0.097 1~24.275 4，0.052 6~5.262，0.053~5.295 6，0.108 3~27.062 9，0.050 1~5.005，0.052 4~5.236 4，0.096 6~24.139 5 mg·L-1，平均加样回收率分别为102.3%，97.3%，99.3%，97.9%，97.8%，95.8%，97.0%，100.4%。样品溶出度均一性良好，45 min内各成分溶出度均能达到80%以上。结论：该方法操作简便、结果准确、重复性较好，可用于桂枝茯苓胶囊溶出度的测定，为中药复方制剂的质量标准评价提供了参考。

Abstract

Objective:To establish a method for the determination of dissolution of 8 active ingredients in Guizhi Fuling capsules. Method:UPLC was employed

mobile phase of gallic acid

paeoniflorin

benzoic acid

benzoylpaeoniflorin

paeonol

cinnamic acid and cinnamaldehyde was 0.02% trifluoroacetic acid aqueous solution-acetonitrile for gradient elution

their detection wavelengthes were 230 nm and 275 nm.The mobile phase of amygdalin was water-methanol(80:20) and its detection wavelength was 218 nm. Result:The soluble medium was determined to be 0.1 mol·L-1 hydrochloric acid

the rotation speed was 50 r·min-1

the solubility measurement was carried out by the basket method.The linear ranges of gallic acid

paeoniflorin

benzoic acid

benzoylpaeoniflorin

paeonol

cinnamic acid

cinnamaldehyde

amygdalin were 0.097 6-24.389 9

0.097 1-24.275 4

0.052 6-5.262

0.053-5.295 6

0.108 3-27.062 9

0.050 1-5.005

0.052 4-5.236 4

0.096 6-24.139 5 mg·L-1

their average recovery rates were 102.3%

97.3%

99.3%

97.9%

97.8%

95.8%

97.0% and 100.4%

respectively.The dissolution rate of samples was good

and the dissolution rate of each component in 45 min could reach >80%. Conclusion:This method is simple

accurate and reproducible

and it can be used for determination of dissolution of Guizhi Fuling capsules.

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