2015 100050 2015 2010 2015 2015 doi 10. 11669 /cpj. 2015. 15. 019 A 1001-2494 2015 15-1353 - 06 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 100050 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 2015 1-2 1 2015 2010 3 4 2015 1 2010 2015 2015 Tel 010 67095721 E-mail sunhm@ 126. com 2015 8 50 15 Chin Pharm J 2015 August Vol. 50 No. 15 1353
1 2005 5 2014 NECC 2015 8 2. 5 ~ 3. 3 2015 2015 2 EU g - 1 22015 2015 2015 3 2 2015 0. 05 mol L - 1 1. 4 ml 200 20 EU ml - 1 2 99% 6 2015 2010 2010 1 132 2015 270 2015 1 2 500 3 PLGA 50 /50 4 PLGA 75 /25 5 PLGA 85 /15 2015 6 PEG300 7 PEG400 2015 8 80 2010 31 9 2015 66 10 11 2010 12 13 PH 14 2015 15 188 16 2015 17 18 35 2 19 20 2015 21 2010 22 2 23 2015 23 1354 Chin Pharm J 2015 August Vol. 50 No. 15 2015 8 50 15
2015 PLGA 7 2015 PLGA PLGA 50 / 50 PLGA 75 /25 PLGA 85 /15 3 2015 34 Excipient Performance Chapter < 1059 > EP 7. 0 50 8-9 2015 2015 63% HPMC 10 2010 48% 5 15 50 cps HPMC 2015 2015 43 2% ~ 10% 2% ~ 5% 4 000 15 000 cps HPMC 2010 24 80% 2015 52 0. 45% ~ 1. 0% 2010 25 108% HPMC 2015 2015 X 5 2015 X 2015 2015 4 2010 2015 1 1 2015 174 4 72 2010 102 2 2010 2015 20 50 30 000 3 2015 10 2015 8 50 15 Chin Pharm J 2015 August Vol. 50 No. 15 1355
4 6 2012 2 11-13 2015 2 2015 1 46 Ⅱ 91 136 N- -2-2 47 92 137 3 48 93 138 4 49 94 139 3-5 50 95 140 6 51 96 141 7 52 97 142 8 53 98 143 9 54 99 144 10 1 4-55 100 145 11 56 101 146 12 57 102 147 2-13 58 103 148 14 59 104 149 4-15 60 105 150 16 61 106 151 17 4 62 107 152 18 5 63 108 153 19 6 64 109 154 20 6 65 110 155 21 8 66 111 156 22 12 67 112 157 23 32 68 113 β- 158 24 69 114 159 25 35 70 115 α- 160 26 71 116 161 27 40 72 117 162 1 3-28 7525 73 118 163 29 8515 74 119 164 30 75 120 165 31 76 121 166 32 77 L- 122 167 33 78 123 20 168 34 79 124 50 169 35 80 125 100 170 β - 36 81 126 200 171 37 5050 82 127 350 172 38 83 128 500 173 39 84 129 750 174 DL- 40 85 130 1000 41 86 131 12500 42 Ⅱ 87 132 30000 43 Ⅲ 88 133 dl-α- 44 Ⅳ 89 L- 134 45 Ⅰ 90 135 1356 Chin Pharm J 2015 August Vol. 50 No. 15 2015 8 50 15
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