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1.湖南中医药大学 药学院,中药成药性与制剂制备湖南省重点实验室,中医药超分子机理与数理特征化实验室,长沙 410208;
2.湖南省中医药研究院,长沙 410006;
3.湖南中医药大学 附属常德医院,湖南 常德 415000
朱俊平,在读硕士,从事中药制剂研究,E-mail:302696724@qq.com
张喜利,高级工程师,从事中药制剂质量研究,E-mail:xiaoli610@126.com;
李龙,讲师,从事中药分析研究,E-mail:54496373@qq.com
收稿日期:2019-01-23,
网络出版日期:2019-05-08,
纸质出版日期:2019-11-05
移动端阅览
朱俊平, 魏佳明, 刘瑞连, 等. 养精种玉汤的“点-线-面”质量标准分析[J]. 中国实验方剂学杂志, 2019,25(21):12-18.
Jun-ping ZHU, Jia-ming WEI, Rui-lian LIU, et al. Analysis on " Point-line-surface" Quality Standard of Yangjing Zhongyu Tang[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(21): 12-18.
朱俊平, 魏佳明, 刘瑞连, 等. 养精种玉汤的“点-线-面”质量标准分析[J]. 中国实验方剂学杂志, 2019,25(21):12-18. DOI: 10.13422/j.cnki.syfjx.20191651.
Jun-ping ZHU, Jia-ming WEI, Rui-lian LIU, et al. Analysis on " Point-line-surface" Quality Standard of Yangjing Zhongyu Tang[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(21): 12-18. DOI: 10.13422/j.cnki.syfjx.20191651.
目的:
2
结合指纹图谱全成分分析及2015年版《中国药典》所载指标成分的含量测定方法,通过莫诺苷、马钱苷、芍药苷、阿魏酸、毛蕊花糖苷的每个单一成分“点”到多成分的“线”以及指纹图谱全成分的“面”建立养精种玉汤的“点-线-面”质量标准。
方法:
2
采用XB-C
18
色谱柱(4.6 mm×250 mm,5 μm),流动相0.1%磷酸水溶液-乙腈梯度洗脱,柱温30 ℃,进样量10 μL,流速1.0 mL·min
-1
,检测波长分别选择了240,316,230,334 nm。以3种一测多评校正方法以及外标法、回归方程法测定5种指标成分的含量,同时对指纹图谱进行全成分分析及相似度评价。
结果:
2
以阿魏酸为参照,莫诺苷、马钱苷、芍药苷、毛蕊花糖苷的相对校正因子(
f
)(多点校正法)分别为0.392 1,0.421 4,0.261 7,0.268 6,
f
(斜率校正法)分别为0.385 4,0.419 4,0.255 9,0.274 0;指纹图谱进行全成分分析了20个特征峰且相似度均≥0.999,采用一测多评校正方法以及外标法、回归方程法测得的5个指标成分含量之间无显著性差异。
结论:
2
建立的“点-线-面”质量标准体系在养精种玉汤中得到了验证,可为其他经典名方的定量测定和指纹图谱质量控制提供思路和方法。
Objective:
2
Based on the analysis of the total components of fingerprint and the determination methods of the existing components in the 2015 edition of
Chinese Pharmacopoeia
the " point-line-surface" quality standard of Yangjing Zhongyu Tang was established by the " point" of each single component (morroniside
loganin
paeoniflorin
ferulic acid and verbascoside) to the " line" of multicomponent and the " face" of fingerprint of the whole component.
Method:
2
XB-C
18
column (4.6 mm×250 mm
5 μm) was used for gradient elution of 0.1%phosphoric acid aqueous solution-acetonitrile. The column temperature was 30 ℃
the injection volume was 10 μL
the flow rate was 1.0 mL·min
-1
and the detection wavelengths were 240
316
230
334 nm. The contents of these five components in Yangjing Zhongyu Tang were determined by three correction methods
external standard method and regression equation method. At the same time
the fingerprint of Yangjing Zhongyu Tang were analyzed by total component analysis and similarity evaluation.
Result:
2
With ferulic acid as reference
the relative correction factor (
f
) of morroniside
loganin
paeoniflorin and verbascoside were 0.392 1
0.421 4
0.261 7
0.268 6 by multi-point correction method
and their
f
(slope correction method) were 0.385 4
0.419 4
0.255 9
0.274 0
respectively. Twenty characteristic peaks of fingerprint were analyzed and the similarity was ≥0.999.There was no significant difference in the contents of these five components from Yangjing Zhongyu Tang determined by the quantitative assay of multi-components by single-marker (QAMS) correction method
the external standard method and the regression equation method.
Conclusion:
2
The comprehensive quality standard established by the total component analysis of fingerprint combined with various determination methods of existing components in the 2015 edition of
Chinese Pharmacopoeia
has been validated in famous classical formula of Yangjing Zhongyu Tang
which can provide ideas and methods for the quality control with quantitative determination and fingerprint of other famous classical formulas.
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