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1 186 186 (1) - 192 (2) (ISAintrinsic sympathomimetic activity) 199 (3) ( MSAmembrane stabilizing activity) 2 (4) 21 (5) 212 (6) 216 (7) 219 (8) 224 (9) (ASL-8123) - 229 (1) d-esl l-esl - 231 2 235 235

日本化学療法学会雑誌第61巻第6号

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20mg CTD 2.4 2.4 2.4... 5 2.4.1... 5 2.4.2... 7 2.4.3... 10 2.4.4... 13 2.4.5... 18 2.4.6... 20 3 2.4 2.4 2.4.1 JNS002 ( HSPC) N-(Carbonyl-methoxypolyethylene glycol 2000)-1,2- distearoyl-sn-glycero-3-phosphoethanolamine

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,309 t 22,069 t 7,240 t µg/l µg/l < ,431-70, , , mg/l m

1 20019 1527 CAS 1317368 1230 PbO 223.20 1 99 1. 2 888 2 9.53 0.017 g/l 20 3 3 2 2. 10 29,309 t 22,069 t 7,240 t 4 1 3. 1 2 3.5 6 1 µg/l 9.1-24 2 µg/l < 43 6 27,431-70,000 4.5-1,300 13.4-17 31.7 0.48-3,459

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HydroxypropylcelluloseCellulose 2-hydroxypropyl ether CH 2 OR R=H H O O H CH H 3 OR H CH 2 CH O m H OR m1 n 30,000n 100 1,000,000n 2,500 13) 1 14 C 14

HPC 1), 2), 3) HPC 4) 5) 6), 7), 8) GMPGood Manufacturing Practice EU 9) 10), 11) GMP 9) FAO/WHO JECFA 1989 35 7 HPC ADI not specified 12) 14 7 JECFA EU 46 HPC 16 8 16 EU - 1 - HydroxypropylcelluloseCellulose

(1) (2) (1) (2) (1) Seg (2) Seg (3) Seg (4) Seg (1) (2) (3) ( ) (1) (PCA)...12

(1)...109 (2)...110 (1) 28...111 (2) 28...113 (1) Seg...115 (2) Seg...117 (3) Seg...119 (4) Seg...120 (1)...122 (2)...122 (3) ( )...126 (1) (PCA)...127 (2) Draize...128 (1) Ames...129 2 in vitro...132