[1]周大庆,胡俊光,徐波△.玫瑰糠疹合剂质量标准研究[J].西部中医药,2016,29(01):40-44.
　ZHOU Daqing,HU Junguang,XU Bo.Quality Standard of Gibert′s Disease Mixture[J].Western Journal of Traditional Chinese Medicine,2016,29(01):40-44.
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玫瑰糠疹合剂质量标准研究()
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
29
期数:
2016年01期
页码:
40-44
栏目:
出版日期:
2016-01-15

文章信息/Info

Title:
Quality Standard of Gibert′s Disease Mixture
文章编号:
1004-6852(2016)01-0040-05
作者:
周大庆1，胡俊光1，徐波2△
1 山东中医药大学，山东 济南 250355； 2 山东大学附属省立医院
Author(s):
ZHOU Daqing1, HU Jun′guang1, XU Bo2△
1 Shandong University of Traditional Chinese Medicine, Jinan 250355, China; 2 Shandong Provincial Hospital
关键词:
玫瑰糠疹合剂; 质量标准; 赤芍; 防风
Keywords:
gibert's disease mixture;  quality standard;  ChiShao;  FangFeng
分类号:
R283.61
文献标志码:
A
摘要:
目的：建立玫瑰糠疹合剂的质量标准。方法：采用薄层色谱法对玫瑰糠疹合剂中赤芍、防风进行定性鉴别；通过高效液相色谱法测定制剂中芍药苷、升麻素苷和5-O-甲基维斯阿米醇苷的含量。芍药苷的色谱条件为ZORBAX SB-C18色谱柱(4.6 mm×250 mm，5 μm)，流动相以乙腈-0.2%磷酸和0.04%三乙胺溶液(14∶86)，柱温30℃，流速1.0 mL/min，检测波长230 nm；升麻素苷和5-O-甲基维斯阿米醇苷色谱条件为ZORBAX SB-C18色谱柱(4.6 mm×250 mm，5 μm)，流动相以乙腈-0.1%磷酸水(40∶60)，柱温30℃，流速1.0 mL/min，检测波长为254 nm。结果：赤芍、防风薄层鉴别斑点清晰，分离度好，阴性对照无干扰。芍药苷在10～60 μg/mL范围内，芍药苷峰面积与质量浓度有良好的线性关系(r=1)，平均加样回收率为98.53%，RSD 为1.18%；升麻素苷在5.98～35.88 μg/mL范围内，升麻素苷峰面积与质量浓度有良好的线性关系(r=0.999 9)，平均加样回收率为98.3%，RSD 为1.77%； 5-O-甲基维斯阿米醇苷在2.86～17.1 6 μg/mL范围内，峰面积与质量浓度有良好的线性关系(r=1)，平均加样回收率为99.07%，RSD 为1.09%。结论：本实验方法可靠、准确，可以用于该制剂的质量控制。
Abstract:
Objective: To establish quality standard of gibert's disease mixture. Methods: ChiShao (Radix paeoniae rubra) and FangFeng(Radix Saposhnikoviae) in gibert's disease mixture were qualitatively identified by TLC; the contents of peoniflorin, prim-O-glucosylcimifugin and 4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol in the preparations were determined by HPLC. Chromatographic conditions of peoniflorin were ZORBAX SB-C18 chromatographic column (4.6 mm×250 mm, 5 μm), acetonitrile-0.2% phosphoric acid and 0.04% triethylamine solution as mobile phase, column temperature 30℃, flow rate 1.0mL/min, detection wavelength 230nm; chromatographic conditions of prim-O-glucosylcimifugin and 4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol were ZORBAX SB-C18 chromatographic column(4.6 mm×250 mm, 5 μm), acetonitrile-0.1% phosphoric acid(40:60) as mobile phase, column temperature 30℃, flow rate 1.0mL/min, detection wavelength 254 nm. Results: ChiShao and FangFeng showed clear spots, good separation and non-interference in negative control in TLC identification. Peoniflorin showed a good linear relationship in the range between 10 and 60μg/mL, its peak area and concentrations demonstrated better linear relationship (r=1), average recovery rate was 98.53%, RSD was 1.18%; prim-O-glucosylcimifugin showed a good linear relationship in the range between 5.98 and 35.88 μg/mL, its peak area and concentrations were in a good linear relationship (r=0.999 9), average recovery rate was 98.3%, RSD was 1.77%; 4'-O-beta-Glucopyranosyl-5-O-Methylvisamminol showed a good linear relationship in the range between 2.86 and 17.16 μg/mL, its peak area and concentrations demonstrated better linear relationship(r=1), average recovery rate was 99.07%, RSD was 1.09%. Conclusion: The method, reliable and accurate, could be used for quality control of the preparation.

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备注/Memo

备注/Memo:
作者简介：周大庆(1988—)，男，在读硕士研究生。研究方向：中药制剂及临床药学。△通讯作者：徐波(1964—)，女，硕士学位，副主任药师。研究方向：中药制剂及临床药学。
更新日期/Last Update: 2016-01-15