多黏菌素E甲磺酸钠的色谱指纹图谱与质量一致性研究

李宣; 黄敏文; 周杰; 袁耀佐; 杭太俊

doi:10.11665/j.issn.1000-5048.2023071903

多黏菌素E甲磺酸钠的色谱指纹图谱与质量一致性研究

李宣^1,2,3,
黄敏文^1,2,
周杰⁴,
袁耀佐^1,2,
杭太俊³

1.
江苏省食品药品监督检验研究院，南京 210019
2.
国家药品监督管理局化学药物杂质谱研究重点实验室，南京 210019
3.
中国药科大学药物分析教研室，南京 210009
4.
正大天晴药业集团股份有限公司，连云港 222062

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出版历程
- 收稿日期: 2023-07-18
- 修回日期: 2023-12-10
- 刊出日期: 2023-12-24

Chromatographic fingerprint and quality consistency of colistimethate sodium

1.
Jiangsu Institute for Food and Drug Control, Nanjing 210019
2.
NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210019
3.
Department of Pharmaceutical Analysis, China Pharmaceutical University,Nanjing 210009
4.
Chia Tai Tianqing Pharmaceutical Group Co Ltd, Lianyungang 222062, China

摘要

摘要: 建立了多黏菌素E甲磺酸钠的UPLC指纹图谱用于质量一致性研究，色谱柱为Acquity UPLC^? Peptide CSH C₁₈（2.1 mm × 150 mm，1.7 μm），以磷酸盐缓冲液-乙腈（19∶1）为流动相A，磷酸盐缓冲液-乙腈（1∶1）为流动相B，梯度洗脱，流速为0.3 mL/min，柱温为30 ℃，检测波长为210 nm；采用“中药色谱指纹图谱相似度评价系统（2012版）”进行相似度评价，结合多种指标性组分含量测定结果，对原研原料药和国产仿制原料药进行质量一致性评价。研究结果显示，原研原料药和仿制原料药指标性组分含量均满足欧洲药典标准的要求，二者的UPLC指纹图谱具有高度的相似性，表明两者质量基本一致。建立指纹图谱进行相似度评价，并与指标性组分含量测定结果相结合作为综合评价方法，用于复杂组分药物质量一致性的研究，具有快速、准确、全面的特点，有助于药品质量评价，为复杂组分抗生素质量一致性评价提供了思路。
- 多黏菌素E甲磺酸钠 /
- 指纹图谱 /
- 相似度评价 /
- 多种成分含量测定 /
- 质量评价方法
Abstract: The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC^? Peptide CSH C₁₈ (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.
- colistimethate sodium /
- fingerprint /
- similarity evaluation /
- multi-component content determination /
- quality evaluation method

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参考文献(18)

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