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[1]杨胜岩,赵国华,王仁久,等.红景天注射液HPLC指纹图谱研究[J].天津医科大学学报,2016,22(02):164-167.
　YANG Sheng-yan,ZHAO Guo-hua,WANG Ren-jiu,et al.Study on ingerprint of Hongjingtian injection by HPLC[J].Journal of Tianjin Medical University,2016,22(02):164-167.
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红景天注射液HPLC指纹图谱研究(PDF)
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
22卷
期数:
2016年02期
页码:
164-167
栏目:
技术与方法
出版日期:
2016-03-20

文章信息/Info

Title:
Study on ingerprint of Hongjingtian injection by HPLC
文章编号:
1006-8147（2016）02-0164-04
作者:
?杨胜岩1; 赵国华2; 王仁久2; 房宗宝2; 吴海波2; 刘 倩1; 唐 铖1; 3; 段宏泉1; 3

（1.天津医科大学药学院，天津市临床药物关键技术重点实验室，天津300070； 2. 通化玉圣药业有限公司， 通化134000； 3.天津医科大学基础医学研究中心，天津300070）

Author(s):
YANG Sheng-yan1;  ZHAO Guo-hua2;  WANG Ren-jiu2;  FANG Zong-bao2;  WU Hai-bo2;  LIU Qian1;  TANG Cheng1;  3;  DUAN Hong-quan1;  3
(1.Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics), School of Pharmacy, Tianjin Medical University, Tianjin 300070, China; 2.Tonghua Yu Sheng Pharmaceutical Co., Ltd., Tonghua 134000, China; 3. Research Center of Basic Medical Sciences, Tianjin Medical University,Tianjin 300070, China)
关键词:
红景天注射液; 高效液相色谱指纹图谱; 色谱峰鉴定; 相似度评价
Keywords:

line-height: 150%; " align="left">Hongjingtian injection;  HPLC fingerprint;  chromatograpic peak identification;  similarity evaluation

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分类号:
R9
DOI:
-
文献标志码:
A
摘要:
?目的：建立红景天注射液的色谱指纹图谱，为红景天注射液的质量控制提供依据。方法：采用高效液相色谱法进行检测，以Agilent XDB C18（150 mm×4.6 mm，5 μm）色谱柱为固定相，乙腈-水(0.07%磷酸)为流动相进行梯度洗脱，流速0.8 mL·min-1，检测波长278 nm，柱温30 ℃；并以中国药典指纹图谱相似度评价系统2004版对注射液进行指纹图谱数据分析。结果：所建立的色谱条件能够有效分离红景天注射液的主要成分，确定了6个共有峰，以化学对照品比对结合HPLC-MS鉴定了其中5个色谱峰，分别为没食子酸、对羟基苯甲酸、酪醇、红景天苷和对香豆酸。方法学考察结果表明，文中所建分析方法精密度RSD≤ 1.90 %、重现性RSD ≤ 0.32 %、稳定性RSD ≤ 1.63 %，均符合要求。对9个批次注射液进行的指纹图谱分析结果表明相似度均大于0.96。结论：文中所建立的指纹图谱分析方法准确可靠，可以用于红景天注射液的质量控制。
Abstract:

Objective: To improve the quality control of Hongjingtian Injection, and establish a HPLC fingerprint method. Methods: Agilent XDB C18 (150 mm× 4.6 mm，5 μm) column was used as stationary phase. And water containing 0.07 % phosphoric acid－acetonitrile system was utilized as a mobile phase, at the flow rate of 0.8 mL·min-1. The detection wavelength was 278 nm, and the column temperature was set at 30 ℃. All the data was analyzed by fingerprint evaluation system (2004). Results: Components of Hongjingtian injection were analyzed. Six common peaks were obtained for standard fingerprint chromatography and five of them such as gallic acid, p-hydroxybenzoic acid, Tyrosol, Salidroside, p-hydroxycinnamic acid were identified by HPLC-MS and standard compounds. The similarities of nine batches sample were above 0.96. Conclusion: Our HPLC fingerprint method is accurate and reliable, and could be used for the quality control of Hongjingtian injection.

参考文献/References:

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备注/Memo

备注/Memo:

作者简介 杨胜岩(1991-), 女, 硕士在读, 研究方向：中药现代质量控制与质量标准; 通信作者：段宏泉, Email:duanhq@tijmu.edu.cn。



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更新日期/Last Update: 2016-03-24