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ŵ ŵGMP

ŵ®

˸ئ2bעҺ

2003Ʒҩ

ѡҩƵҪҩ

ˮ

ijЩԼ

  • ŵ

׼ڣ20070620

޶ڣ20101012015121


˸ئ2bעҺ˵

ϸĶ˵鲢ҽʦָʹ


ҩƷơ

ͨ˸ئ2bעҺ

Ʒŵ

ӢRecombinant Human Interferon 2b Injection

ƴChongzu Ren Ganraosu 2b Zhusheye

ɷݡ

Ҫɷݣ˸ئ2bת󳦸˾ʹЧ˸ئ2b߶ȴѪ׵ȶƳ

ϣѪ׵ɽ֬80EDTA¶λҺ(pH6.8)

״

ƷΪɫ͸ҺۿɼIJ

Ӧ֢

1.ijЩԼ缱ԲԸ״ʪ

2.ijЩëϸ԰Ѫϸ԰Ѫ෢ԹǺνܽܰԺɫϸͷ״ѳϸװ

100IU/ƿ300IU/ƿ

÷

ƷԼעƤעͲע

1.͸ףƤ»ע31066106IU/ܺΪ3/16

2.Ա͸ףƤ»ע31066106IU/ܺΪ3/16

3.͸ףƤ»ע41065106IU/ܺΪ3/16

4.״ע1106IU/6ͬʱڷ޻

5.ʪࣺɵӦע11063106IU/Ҳ뼤ƵȺһײע1106IU/

6.ëϸѪ21068106IU/m2/3

7.ϸѪ31065106IU/m2/ע뻯ҩǻAra-cȺ

8.෢ԹΪյά31065106IU/m2ע3/VMCPȻƷ

9.ǺνܽܰΪյά31065106IU/m2ע3/CHVPȻƷ

10.Ժɫ6106IUע3/뻯ҩ

11.ϸ6106IUע3/뻯ҩ

12.ͷ״3106IU/m2עƤעÿ3Σ1Σ

13.50106IU/m2/5ÿξע30ټ9ٽһ5

14.ϸ5106IUע3/3

15.ѳ51068106IUע3/뻯ҩ

Ӧ

ʹñƷзͷʹսʹؽʹ֢״ҩĵһӦע48СʱʧزӦ޸ƷֹͣҩһӦӦֹͣҩ˿ɳְϸѪСٵѪ쳣ͣҩ󼴿ɻָżʳкŻѷѪѹ߻򽵵ϵͳҵȲӦ

ɡ

1.˸ئ2bƼκγɷйʷ

2.༲

3.صĸ蹦ܲ

4.Pϵͳ

5.ؼܱƷʹ

ע

ƷΪɫ͸Һл쳣򲻵ʹװƿʧЧʹ

иڸŮҩ

иҩڰȫʹñƷķδиעڲʮҪٴҽϸúȷ

ֳԡ

ؿ鳤දой۲쵽ʹøصĶ¾ڳ쳣ݱʹ˰ϸؽƵĸŮѪƶͻͪŨȽ˳ҩڼȡЧıдʩŮԲӦʹñƷӦñƷ

ںӺо7.5MIU/kg15MIU/kg30MIU/kgĵ߼൱üעƤעƼ2MIU/M290180360ʱ׹̥Ȼм͸߼ͳѧĿǰδигּϸյٴоֻȷʵΪƷDZٴڶ̥DZΣиſʹñƷиܽбƷڸҩ

    ĿǰвƷǷԴ֭зڱƷܶԲӤӦӦDZƷĸ׵Ҫֹֹͣͣҩ

ͯҩ

ͯҩԴಡӦСȨ׺ҽҩ

껼ҩ

ಡ껼ߺ갩֢ڻڽҩǰжӦĵͼҽֹͣҩ

ҩ໥á

ؿܻıijЩøĻɼϸɫøP450Ļ涡ĵðҩлܵӰõҩϲʹʱ໥

ҩ

δҩıӦʱصƣ˥

ҩ

ҩãٴǰϸϵͳͶֲʾ˸ئ2bпֳԵߵо˸ئ2bƲ

ͨϸĤ϶оʾһϸĤһϵиӵϸڹаijЩøյΪһij̶ֳϵ˸صĸϸӦƲȾϸвĸϸֳһϵߵǿϸܰϸ԰ϸϸص漰ijֻȫû

⿹ؿ˸ϸϸϵHB611ҸβDNAߣΣάϸеļ׸θȾ

֪ؾ

ҩѧ

Ʒͨעڽ־ԸѪҩŨȴʱƽΪ2.7Сʱ˥ƽΪ13.3СʱֽлΪҪ;֭лҪ;עƤעճ80%

ء28ܹⱣ

װʹ2ml貣עƿҩöͿϸǷװ1ƿ/

Чڡ18

ִб׼

йҩ䡷2015

׼ĺš

ҩ׼S20030012(100IU/ƿ)ҩ׼S20030013(300IU/ƿ)

ҵ

Ϻ߼޹˾ַϺֶ·1150šʱࣺ201206绰021-58999090棺021-50312021ַwww.baileb.com