Relationship between the Chemical Composition of Polysorbate 80 and Its Solubilization Effect
ZHANG Rui1, WANG Yu2, GAO Zheng-song3, PENG Wen-yong3, ZHANG Hai-yan1, YANG Ming1
1. Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China; 2. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China; 3. Nanjing Well Chemical Co., Ltd., Nanjing 210009, China
Abstract��OBJECTIVE To determine the solubilization effects of the eight types of chemical components of polysorbate 80 to elucidate its material basis for solubilization, and provide a theoretical basis for the rational use of polysorbate 80. METHODS The shaking flask method and HPLC method were used to determine the concentrations of four types of water-insoluble drugs in the aqueous solution of the eight types of chemical components of polysorbate 80. RESULTS The solubilization effects of the eight types of chemical components of polysorbate 80 had significant difference. The polysorbate 80 with the best solubilization effect for different types of water-insoluble drugs differed in their chemical compositions. CONCLUSION The contents of the chemical components of commercially available polysorbate 80 vary significantly, which is considered to be the material basis for the differences in solubilization effect. The results of this study are valuable for the effective use and quality control of polysorbate 80.
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ZHANG Rui, WANG Yu, GAO Zheng-song, PENG Wen-yong, ZHANG Hai-yan, YANG Ming. Relationship between the Chemical Composition of Polysorbate 80 and Its Solubilization Effect. Chinese Pharmaceutical Journal, 2015, 50(10): 876-880.
ZHANG R,WANG Y,TAN L, et al. Analysis of the chemical composition of Polysorbate 80 . Chin Pharm J (�й�ҩѧ��־) , 2012, 47(2): 149-154.
[3]
ZHANG R, WANG Y, JI Y, et al. Quantitative analysis of oleic acid and three types of polyethers according to the number of hydroxy end groups in Polysorbate 80 by hydrophilic interaction chromatography at critical conditions . J Chromatogr A, 2013, 1272: 73-80.
[4]
CONG Y, ZHANG M L, SU T T, et al. Research on solubilization suitability of TCM injections excipients Tween 80 . Chin Trad Pat Med (�г�ҩ) , 2011, 33(3): 439-442.
[5]
ZHANG R, WANG Y, PENG W Y, et al. Preparation and purity determination of the chemical composition of Polysorbate 80 used for a reference standard . Chin Pharm J (�й�ҩѧ��־) , 2013, 48(9): 733-738.
[6]
STRICKLEY R G. Solubilizing excipients in oral and injectable formulations.Pharm Res,2004,21(2): 201-30.
[7]
CHEN F. The nature, structure, calculation and application of surfactant(������Լ����ʡ��ṹ��������Ӧ��).Beijing:China Science and Technology Press, 2004.
[8]
WS1-(X-129)-2005Z (��ҩת������������) . 2005.
[9]
Ch.P(2010) Vol ��(�й�ҩ��2010���.����) . 2010:1246-1247. WS1-XG-005-2000-2010(����ҩƷ����άԪ��Ƭ(21). 2010. XIAO J X, ZHAO Z G. The Application of the Principle of the Surfactant(������Լ�ʵ����������).Beijing:Chemical Industry Press,2003. ZHANG M L, ZHANG H Y, CONG Y, et al. Research on Tween-80 surfactant in aqueous solution . Chin Trad Pat Med (�г�ҩ), 2010, 32(1): 55-58. GB/T 21852-2008 (���ұ���ѧƷ.����ϵ��(������-ˮ). ��ЧҺ��ɫ������) . 2008. ZHANG R, WANG Y, DENG X L, et al. Study of degranulation induced by the chemical composition of polysorbate 80 in a rat mast(RBL-2H3) cell line . Chin Pharm J(�й�ҩѧ��־), 2014, 49(5): 371-376. ZHANG R, WANG Y, SHI B J, et al. HPLC/ELSD Determination of oleic acid, polyoxyethylene isosorbide, polyoxyethylene sorbitan and polyoxyethylene sorbitol in polysorbate 80.Chin J Pharm Anal(ҩ�������־),2013, 33(6): 994-998. ZHANG R, WANG Y, GAO Z S, et al. Investigation on determination of the content of Polysorbate 80 in traditional Chinese medicine injections. Chin Pharm J(�й�ҩѧ��־) , 2013, 48(11): 990-993.