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SU Zhe, ZHOU Chaodong, MA Bing, ZHANG Jing, FU Shengqing, WANG Chong, SHUI Fengchun, HUANG Zhesu. Quality evaluation and specification research of Cervus and Cucumis polypeptide injection[J]. Journal of China Pharmaceutical University, 2020, 51(4): 479-487. DOI: 10.11665/j.issn.1000-5048.20200414
Citation: SU Zhe, ZHOU Chaodong, MA Bing, ZHANG Jing, FU Shengqing, WANG Chong, SHUI Fengchun, HUANG Zhesu. Quality evaluation and specification research of Cervus and Cucumis polypeptide injection[J]. Journal of China Pharmaceutical University, 2020, 51(4): 479-487. DOI: 10.11665/j.issn.1000-5048.20200414
shu

Quality evaluation and specification research of Cervus and Cucumis polypeptide injection

  • Tianjin Institute for Drug Control， Tianjin 300070， China

Funds: This study was supported by the National Natural Science Foundation of China (No.31970667) and the Chinese Pharmacopeia Commission-Enactment and Amendment of Standards (No.2019H03)
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  • Received Date: May 18, 2020
    Graphical Abstract
    • Abstract
  • To investigate the freshness, high molecular weight substances, the determination of polypeptide, haemolysis and agglomeration, biological activity of Cervus and Cucumis polypeptide injection; to provide the direction for improving the quality of products for enterprises; furthermore, to provide reference for the revision of the quality standards of Cervus and Cucumis polypeptide injection. Firstly, we investigated the factors affecting the freshness of the injection, including biogenic amines, aflatoxins, the acid value and peroxide value of the melon seeds. The method of dansyl chloride pre-column derivatization-HPLC was used to determine the content of 8 biogenic amines in Cervus and Cucumis polypeptide injection. The method validation results showed good specificity, precision, linearity and recovery rates, which was suitable for the determination of biogenic amines in Cervus and Cucumis polypeptide injection. The results of sample determination showed that relatively higher concentrations of cadaverine were detected in the products from company B. The results of aflatoxins, acid value and peroxide value showed that the melon seeds from some companies had rancidity, mildew and other problems, indicating that the quality standards of multi-component biochemical drugs containing animal- and plant-derived components should be controlled in terms of freshness. Secondly, the methods for the determination of high molecular weight substances and polypeptides in the quality standard were improved. Tricine-SDS-PAGE electrophoresis was used instead of gel chromatography to determine the high molecular weight substances, which improved the accuracy of determination. The kits were used instead of folin-phenol for the determination of peptide content, which is easy to operate, specific and suitable for high-throughput sample determination. Finally, the haemolysis, agglomeration, and biological activity of Cervus and Cucumis polypeptide injection were studied. The results showed that no haemolysis and agglomeration were found in all samples, and the inhibitory effect of samples on THP-1 proliferation in vitro from different companies was different to some extent. In conclusion, the optimized quality standard is more suitable for the detection of Cervus and Cucumis polypeptide injection, and can lay the foundation for improving the safety of multi-component biochemical drugs.
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    • References (17)
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