Improving the Drug Quality in China Via the Development of the Standard System of Pharmaceutical Exicipent of the 2015 Edition of Chinese Pharmacopeia

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1 doi /cpj A Improving the Drug Quality in China Via the Development of the Standard System of Pharmaceutical Exicipent of the 2015 Edition of Chinese Pharmacopeia SUN Hui-min YANG Rui ZHANG Chao-yang YAN Zhong-tian SONG Xiao-song National Institutes for Food and Drug Control Beijing China ABSTRACT Pharmaceutical excipients are important ingredients of drugs and the quality of it directly related to the safety of drug. Compared to the 2010 edition one of the most significant improvement of the 2015 edition of Chinese pharmacopoeia is the monographs of pharmaceutical excipients will be available in an individual book Chinese Pharmacopoeia Book IV. And also some new features will be found in the new edition the doubled varieties of chronicled pharmaceutical excipients the application of new techniques the strict standards of the excipients for injection the establishment of functionality-related characteristics. This article will interpret the developing trend of the standards of pharmaceutical excipients and the effect of the trend on the entire pharmaceutical industry in the future via the improvement of Chinese Pharmacopoeia. KEY WORDS 2015 edition of Chinese pharmacopoeia pharmaceutical excipient drug safety excipients for injection Tel sunhm@ 126. com Chin Pharm J 2015 August Vol. 50 No

2 NECC ~ EU g mol L ml EU ml % PLGA 50 /50 4 PLGA 75 /25 5 PLGA 85 / PEG300 7 PEG PH Chin Pharm J 2015 August Vol. 50 No

3 2015 PLGA PLGA PLGA 50 / 50 PLGA 75 /25 PLGA 85 / Excipient Performance Chapter < 1059 > EP % HPMC % cps HPMC % ~ 10% 2% ~ 5% cps HPMC % % ~ 1. 0% % HPMC X X Chin Pharm J 2015 August Vol. 50 No

4 Ⅱ N β α L β DL Ⅱ Ⅲ dl-α- 44 Ⅳ 89 L Ⅰ Chin Pharm J 2015 August Vol. 50 No

5 % 80 REFERENCES 1 LUO M S GAO T H SONG MINXIAN. Chinese Pharmaceutical Necessities M. Beijing Chemical Industry Press VIKRANT S BHUPINDER S S. The regulation of Pharmaceutical Excipients. J. Agric Food Chem Ch. P 2010 Vol Ⅱ S Ch. P S ZHANG H Y QI Y LIAO Y H. Study on Safety and Solubilization of Solubitioning Excipients Used in Injections J. Chin J Exp Tradit Med Form SHEN F GAO W D. Look from the " qieffectively" strengthen the regulation of pharmaceutical excipients and the necessity of implementing GMP management J. Medical Innovation of China SHIREESH P A SYDNEY O U. A Review and Classification of Emerging Excipients in Parenteral Medications J. Pharm Technol CAI Q BEI J Z WANG S G et al. Study on the Biocompatibility and Degradation Behavior of Polyl l-lactide-co-glycolide in vitro and in vivo N. J Funct Polym USP 38 NF 36 S EP 8. 0 S DING C C TIAN H L LI G Y. Specific interaction in collagen / hydroxypropyl methylcellulose blends studied by vis ometry and two-dimensional infrared correlation spectroscopy J. J Funct Mater ZHU L WANG Y P ZHANG Z Y et al. Stduy The Weather Resistance of Dimethylpolysil Oxane Used in Liquid-Immersing Cpv Receivers J. Acta Energiae Solaris Sinica ZHANG H Y WU W K. Standard of Pharmaceutical Excipients in Chinese Pharmacopoeia 2010 Edition J. Chin J Exp Med Tradit Med Form ZHANG L T LIANG Y. The existing problems in the standards 2 for medica lsubsidiary substances in our country and the counter Chin Pharm J 2015 August Vol. 50 No

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