肾康注射液指纹图谱的研究

孙小萌; 笔雪艳; 曲范娜; 张清波; 杨会兵; 张雪; 周楠

doi:10.3969/j.issn.1006-0111.2019.06.014

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肾康注射液指纹图谱的研究

孙小萌, 笔雪艳, 曲范娜, 张清波, 杨会兵, 张雪, 周楠

文章导航 > 药学实践与服务 > 2019 > 37(6): 543-547,576

孙小萌, 笔雪艳, 曲范娜, 张清波, 杨会兵, 张雪, 周楠. 肾康注射液指纹图谱的研究[J]. 药学实践与服务, 2019, 37(6): 543-547,576. doi: 10.3969/j.issn.1006-0111.2019.06.014

引用本文:

SUN Xiaomeng, BI Xueyan, QU Fanna, ZHANG Qingbo, YANG Huibing, ZHANG Xue, ZHOU Nan. Studies on fingerprint of Shenkang injection[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(6): 543-547,576. doi: 10.3969/j.issn.1006-0111.2019.06.014

Citation:

SUN Xiaomeng, BI Xueyan, QU Fanna, ZHANG Qingbo, YANG Huibing, ZHANG Xue, ZHOU Nan. Studies on fingerprint of Shenkang injection[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(6): 543-547,576. doi: 10.3969/j.issn.1006-0111.2019.06.014

肾康注射液指纹图谱的研究

doi: 10.3969/j.issn.1006-0111.2019.06.014

1.
黑龙江中医药大学药学院, 黑龙江哈尔滨 150040
2.
黑龙江省食品药品检验检测所, 黑龙江哈尔滨 150088
3.
黑龙江省食品药品监督管理局, 黑龙江哈尔滨 150001
4.
西安世纪盛康药业有限公司, 陕西西安 710300

Studies on fingerprint of Shenkang injection

1.
Collage of Pharmacy, Heilongjiang University of Chinese Medicine, Haerbin 150040, China
2.
Heilongjiang Institute for Food and Drug Control, Haerbin 150088, China
3.
Heilongjiang Food and Drug Administration, Haerbin 150001, China
4.
Xi'an Shi Ji Sheng Kang Pharmaceutical Industry Co., Ltd, Xi'an 710300, China

摘要: 目的建立肾康注射液的超高效液相色谱（UPLC）指纹图谱，并对肾康注射液指纹图谱共有峰进行鉴定。方法采用超高效液相色谱条件法，色谱柱ACQUITY UPLC^® CSH-C₁₈（2.1mm×100mm，1.7μm），甲醇（A）-0.1%甲酸溶液（B）二元梯度洗脱，流速0.4 ml/min，检测波长280 nm，进样量2 μl，柱温30℃，使用飞行时间质谱仪，负离子模式扫描。结果建立了肾康注射液UPLC指纹图谱，采用UPLC/ESI-Q-TOF MS技术共鉴定了26个共有峰。采用《中药指纹图谱相似度评价系统（2012.130723版）》评价了20批肾康注射液，指纹图谱相似度均大于0.90。结论本方法所建立的肾康注射液指纹图谱灵敏度高，稳定可靠，为肾康注射液的质量控制提供了科学依据。
- 肾康注射液 /
- 指纹图谱 /
- 液相色谱-质谱联用技术
Abstract: Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint. Methods The UPLC method was established by employing ACQUITY UPLC^® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning. Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723). Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.
- Shenkang injection /
- fingerprint /
- UPLC/ESI-Q-TOF MS

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肾康注射液指纹图谱的研究

doi: 10.3969/j.issn.1006-0111.2019.06.014

1. 黑龙江中医药大学药学院, 黑龙江哈尔滨 150040

2. 黑龙江省食品药品检验检测所, 黑龙江哈尔滨 150088

3. 黑龙江省食品药品监督管理局, 黑龙江哈尔滨 150001

4. 西安世纪盛康药业有限公司, 陕西西安 710300

收稿日期: 2018-11-14
修回日期: 2019-11-05

关键词:

肾康注射液 /

指纹图谱 /

液相色谱-质谱联用技术

摘要: 目的建立肾康注射液的超高效液相色谱（UPLC）指纹图谱，并对肾康注射液指纹图谱共有峰进行鉴定。方法采用超高效液相色谱条件法，色谱柱ACQUITY UPLC^® CSH-C₁₈（2.1mm×100mm，1.7μm），甲醇（A）-0.1%甲酸溶液（B）二元梯度洗脱，流速0.4 ml/min，检测波长280 nm，进样量2 μl，柱温30℃，使用飞行时间质谱仪，负离子模式扫描。结果建立了肾康注射液UPLC指纹图谱，采用UPLC/ESI-Q-TOF MS技术共鉴定了26个共有峰。采用《中药指纹图谱相似度评价系统（2012.130723版）》评价了20批肾康注射液，指纹图谱相似度均大于0.90。结论本方法所建立的肾康注射液指纹图谱灵敏度高，稳定可靠，为肾康注射液的质量控制提供了科学依据。

English Abstract

Studies on fingerprint of Shenkang injection

1. Collage of Pharmacy, Heilongjiang University of Chinese Medicine, Haerbin 150040, China

2. Heilongjiang Institute for Food and Drug Control, Haerbin 150088, China

3. Heilongjiang Food and Drug Administration, Haerbin 150001, China

4. Xi'an Shi Ji Sheng Kang Pharmaceutical Industry Co., Ltd, Xi'an 710300, China

Received Date: 2018-11-14
Rev Recd Date: 2019-11-05

Keywords:

Abstract: Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint. Methods The UPLC method was established by employing ACQUITY UPLC^® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning. Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723). Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.