• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
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)
More Information
  • 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.
    • FullText(HTML)
    • References (17)
  • [1]
    Zhang XL. Clinical application research progress of luguapolypeptide [J]. Guide Chin Med（中国医药指南）, 2015, 13(13): 50-52.
    [2]
    Ruiz CC, Herrero AM. Impact of biogenic amines on food quality and safety [J]. Foods, 2019, 8(2): 62.
    [3]
    Hao AY, Zhao LY, Liu YH, et al. HPLC determination of aflatoxin residues in traditional Chinese medicine Yinpian with post column photochemical derivation and fluorescence detection [J]. Chin J Pharm Anal（药物分析杂志）, 2012, 32(12): 2203-2207.
    [4]
    Zhang L, Dou X, Kong W, et al. Assessment of critical points and development of a practical strategy to extend the applicable scope of immunoaffinity column cleanup for aflatoxin detection in medicinal herbs [J]. J Chromatogr A, 2017, 1483: 56-63.
    [5]
    Schagger H. Tricine-SDS-PAGE [J]. Nat Protoc, 2006, 1(1): 16-22.
    [6]
    Fan F, Tu M, Liu M, et al. Isolation and characterization of lactoferrin peptides with stimulatory effect on osteoblast proliferation [J]. J Agric Food Chem, 2017, 65(33): 7179-7185.
    [7]
    Zhang Q, Han SX, Chen Y, et al. Quality control of ossotide for injection in inhibiting proliferation of monocyte-macrophages [J]. Chin J Exp Tradit Med Form（中国实验方剂学杂志）, 2018, 24(13): 42-46.
    [8]
    Zhu P, Ding J, Zhou J, et al. Expression of CD147 on monocytes/macrophages in rheumatoid arthritis: its potential role in monocyte accumulation and matrix metalloproteinase production [J]. Arthritis Res Ther, 2005, 7(5): 1023-1033.
    [9]
    Maintz L, Novak N. Histamine and histamine intolerance [J]. Am J Clin Nutr, 2007, 85(5): 1185-1196.
    [10]
    Seki S, Misumi H, Tanaka T, et al. Effects of some polyamines, polyanions and antitumor drugs on replicative DNA synthesis and unscheduled DNA synthesis in vitro [J]. Acta Med Okayama, 1979, 33(3): 149-156.
    [11]
    Jellum E. Interaction of cystamine and cystamine derivatives with nucleic acids and nucleoproteins [J]. Int J Radiat Biol Relat Stud Phys Chem Med, 1965, 9(2): 185-200.
    [12]
    ICH. M7: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk [EB/OL]. 2014. [2020-04-28]. http: //www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf.
    [13]
    Del RB, Redruello B, Linares DM, et al. The biogenic amines putrescine and cadaverine show in vitro cytotoxicity at concentrations that can be found in foods[J].Sci Rep,2019,9(1): 120.
    [14]
    Gao MH, Wang M, Hou Z, et al. Determination of the composition and the contents of fatty acids in muskmelon seed by GC-MS and GC [J]. J Shenyang Pharm Univ（沈阳药科大学学报）, 2015, 32(7): 556-560.
    [15]
    Haman N, Romano A, Asaduzzaman M, et al. A microcalorimetry study on the oxidation of linoleic acid and the control of rancidity [J]. Talanta, 2017, 164: 407-412.
    [16]
    Xue QR, Liang WY, Chen YK. Determination of peptide contents of hepatocyte growth-promoting factor for injection by acid hydrolytic method [J]. J China Pharm Univ（中国药科大学学报）, 2011, 42(4): 333-336.
    [17]
    Wang C, Dong SS, Wang ZQ, et al. Research on the method for determining the in vitro activity of Cervus and Cucumis polypeptide [J]. Chin J Pharm Anal（药物分析杂志）, 2018, 38(7): 1196-1201.
    • Related Articles

  • Related Articles

    [1]HUANG Shuzhen, WANG Guangji, XIE Yuan. Advances in molecular mechanisms of organelle interaction and their role in disease development[J]. Journal of China Pharmaceutical University, 2019, 50(4): 389-396. DOI: 10.11665/j.issn.1000-5048.20190402
    [2]ZHENG Mei, LIU Fulei, XUE Jingwei, LIU Wenyuan. Investigation of herb-drug interaction between Liuwei Dihuang Pills and nifedipine based on rat liver microsomes and HPLC fingerprints[J]. Journal of China Pharmaceutical University, 2018, 49(2): 195-201. DOI: 10.11665/j.issn.1000-5048.20180209
    [3]ZHANG Tianxing, HUANG Wei, HUANG Xueyu, LIAO Anping. Interaction of oleanolic acid and its derivatives with bovine serum albumin by spectrofluorimetry[J]. Journal of China Pharmaceutical University, 2017, 48(5): 572-576. DOI: 10.11665/j.issn.1000-5048.20170511
    [4]WANG Yuhao, ZHANG Xue, ZHOU Xiaoting, HE Hua, LIU Xiaoquan. Pharmacokinetic interaction between sunitinib and ramipril in rats[J]. Journal of China Pharmaceutical University, 2017, 48(1): 60-65. DOI: 10.11665/j.issn.1000-5048.20170109
    [5]ZENG Yu, JI Yibing. Study of interaction between bovine serum albumin and nefopam enantiomers with affinity capillary monolith[J]. Journal of China Pharmaceutical University, 2016, 47(1): 66-72. DOI: 10.11665/j.issn.1000-5048.20160109
    [6]CHEN Lei, YANG Ping, JI Yibing. Chiral separation of esomeprazole and its enantiomer by affinity capillary electrophoresis[J]. Journal of China Pharmaceutical University, 2014, 45(4): 444-449. DOI: 10.11665/j.issn.1000-5048.20140411
    [7]CHENG Yu, HE Hua, CHEN Yuan-cheng, HUANG Li-hua, SI Qian, LIU Xiao-quan. Effects of content variation of water-soluble components in Dansheninjection on homocysteine metabolism in rats[J]. Journal of China Pharmaceutical University, 2011, 42(3): 255-261.
    [8]Interactions of folic acid and deoxycholic acid with bovine serum albumin as well as the effects of coexisting paclitaxel[J]. Journal of China Pharmaceutical University, 2010, 41(3): 253-258.
    [9]Metabolic Interaction of Cinildipine with Some Co-administrated Drugs in Human Liver Microsomes[J]. Journal of China Pharmaceutical University, 2004, (6): 43-46.
    [10]Studies on the Reaction Between Levofloxacin and Bovine Serum Albumin[J]. Journal of China Pharmaceutical University, 2004, (5): 70-73.

Catalog

    Get Citation
    PDF
    XML
    Article views (195) PDF downloads (366) Cited by()
    Turn off MathJax
    Article Contents
    Abstract
    References
    Related Articles

    Copyright © Journal of China Pharmaceutical University苏ICP备12050101号-2

    Address：24 Tongjia Lane, Nanjing City, Jiangsu Province （210009）Tel: 025-83271566E-mail: xuebao@cpu.edu.cn

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    Total visits：365747

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return