Quality evaluation and specification research of Cervus and Cucumis polypeptide injection

SU Zhe; ZHOU Chaodong; MA Bing; ZHANG Jing; FU Shengqing; WANG Chong; SHUI Fengchun; HUANG Zhesu

doi:10.11665/j.issn.1000-5048.20200414

Journal of China Pharmaceutical University > 2020 > 51(4): 479-487. > DOI: 10.11665/j.issn.1000-5048.20200414

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:

PDF (1166 KB)

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

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)

References

[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.

Cited By

Get Citation

PDF

XML

Article views (195) PDF downloads (367)

Turn off MathJax

Article Contents

Abstract

References

Quality evaluation and specification research of Cervus and Cucumis polypeptide injection

Abstract

References

Catalog

Export File

Citation

Format

Content