                           ˿µϣ20100504գ

10.05.03ûи
10.05.04, ƵڱŹ㲥̸Ԥ⣨أ25ӿʼ
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ƵڱŹ㲥̸Ԥ

أ25ӿʼ

http://res.audio.bjradio.com.cn/xwgb/bwtx/bwtx2010050321203461.wma

25ӿʼ

http://audio.rbc.cn/play.form?programId=401&start=20100503121000

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־ԣ̸Ǯѧɭ

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ѧѧԺĹͣʮ

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ƽãΪѧԺˡֵĵڣͻȻ䱱ҳϳ
˹ڹѧԺıдݶֵð棬͡Ҳ
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һƷԺҪ2015ˣʱҲһѧɵʱ̣
ƪһӭ쵼ͼ߼Ŭ

ԭļ
http://pkunews.pku.edu.cn/xwzh/2010-05/04/content_173708.htm

깤ѧ ⼫󵼣꡿ѧѧԺ
  

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ڣ 2010-05-04  ϢԴ:  Ž   

201052磬ѧѧԺؽӢܽľС
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(XYS20100504)

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谲ʯ䲩ʿ͵

ߣparadox

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ĸıƷеӪǰٷ֮գʳ


Ĺ۵㶼Ϊǿͨḻʳ㹻
Ӫʣֻĳ⻷ԭĳӪʵĲ㣬
Խв䣬ǲʳʯʿʳö԰
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ΪгϢ˵ԽôҪɲ
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оʯʿ˻кܴԻԵģΣԺܴ

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һٿĲ͡Ƶݣ֪Ļ
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ߣlw56102

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鼮ˣһǾԶ֮Ϳ滹治٣ԾȻ
ȫԶʵҿϵ鼮彡
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ߣLiu Yuan

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ԣҽѧܶȷʵ޷ֱģֻܿ鷢
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ˮƽ϶ȫԺЧԶõ̫ˡÿ϶
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ǰҾ˵ûкϷҽֻкϷļŮŮȡպϷӪ
ģֽϻ档˽мͬҩ꣬涼ǲҩûбٷ
϶ΪҩƷŵĶ˵ͬûʸʽҩƷ
ֽܰԼpharmacy  chemist  Ϊһ
ֶεǻһЩ˽ҽƱյĸĿУҲ˵ҽ
ϵͳƣЩ˽ҽƱֻҪǮʲôcoverģ
ϴɶģҽƲһ

֧ҽۣһֱûмɶ˵ݣϾ
͹ⰡɶģѹԶˡʵҽѾҹҽ
ϵʿ͹ԱǾǲϣӲ״еĽҽԺ
طҽİ취ƣҽԺܻҽƣܶ
ϲưɶģ֢˽һЩοҩҽ
ԺҲӦˣܻǱһЩϾ޹
ҪᲡˡԿ϶ҩҹҩҪҵĶ࣬ҽǱ
ҲĶ࣬ҩϾ൱ǱǱǱˡ

ܲϣҽڻֻ췹ԣһββ඼
ܺõĲһҲβõĲһЩʾõ
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ģΪϵУԲ⻹ϵˡȻ
˲žڲѧҽһ㶼ѧȡҽ
оʵְҵԾȡǱȽϲҽѧԺҵ
ϸҲҽԺʽ治֪ڻҽѧУѧ
ҵֺǰ;ҪôȥҩҪôͻ켣СƭӣҪôתб
ʵǻǰ;

һǶҲ˵⣬ڸû˲ҽ򡣻
˵ҽ򶼲˲ţٲصѧҵġ˵ѧУû
ţϿ϶ôһ˲ֵҽҽϵ
ҽ˲ˮƽ̫ԶͲҪȥǿ˰ɡ

 Ǯ ҽҩĻƭǮͲʤö˰ɡӡ
ǰ꿴̨˵һ£˵һҩ־ͽɭʮ
һУרɭۺ֢ʵǺܱ˵ļǮؽңöһ
ͼٿġЧȻǷǳЧȻҽȷʵɭ
ô޸˱簢ﰡ쵼˰ɶĶɭҲ
̫ˣ߸ϵĹ漰ҽҲ
ҽҩ˵µİɣҩû洫طôһ˵ġ

ȻⲻȫҽĴӦƭӸ˵Ҳ˵ȫû
ҽҩƭǮƣҽƭṩƽ̨Ȼҽḻ
ʺͷ׵Ķɡ

  о˵ˣҽΪ߰ɡ
˧Сbrad pitt ֮һˡ70ǰ80ɺԴϸڡbrad 
pitt benjamin button Ǹţ˵ԽԽᣬ˸˵İ
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ͻȻԼʵϰҽʱȲ缱ҵĹ£ERʱ
ʦһҹ֮ȫŴڲˣԼGeorge  
Clooney ǵӾ̫רҵˣһרҵʵϰѧƬ
ƵݶǳϽҲܺãѧܶණͬʱ
Ӿ署ҽƵרҵݻǺٳҵ10
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СѧѧҹŴѧźⷢ˵ضǣԤ𣬻˵ʧ
źǸԶܽԤ⡣
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Щͬѧǻʿҵˣô޶۵ǸͬѧԺĲʿˣ
˵ֻҪúüס˵ĻԼ˼Ҳܲʿġ

µĳÿGoogle/ baidu /bing ⣬
ѣİ˸ʵʵĽ顣ֻҪҽһϣȥҽ
ֻҪǱΣҩʵҩֻڷǧҪҩע
ϾڷȫĶ࣬յһЩҩעɱּѡ֡Ҫ
ҩǧҪڷãô˵ȫ޸ãԸ35˼
˼ˡ

۵γɵˣǰΪĹϵҶ˵Ӱбʱ˾
󣬸˿ʵνˣ˵ɶ˵ɶձͦţͳĻ
йѧģö෽汣ıйãִƼѧģö
չıȽ

ҽҩ˳ҽϵһ죬Ǻܶʶ˵
һ죬Ǽ־ؼҳԷһ졣Ϭˣƫ

(XYS20100504)

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ҽΪй˲ĥĹ

ߣgongxp

˵ûҽûйŴĻԻͣҽ
ЧйŵãΪʲôأ

1ҽ˹۹Ŵִġѭ֢ҽѧ
١ҽѧһţйǣʵֻ
ʹáʵ۾ӳݽ棬ٿԻĽ
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ԣһʹûˣΪ۹ƶȵ˾Ƕ731½
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֮ءǣҽ֮ȻЧҲëҽΪ
ص㣬Ч˵۹ƶȵı

(XYS20100504)

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˵Ժ

ߣֶ

ҵյһĿΪھѧԺϵл֮
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21಻ϼӿʱڷæŵĹѧϰ֮࣬
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λְ͹ͬѧԺ˼⡣
лҽѧԴԶཡƽ֪ʶֵѧϰ
ΪˣѧѧԺѧѧԺвᡢѧᣬͬ
㽭̳ҽԺҽרҡݻѧо°ҽѧС鸱鳤°ҽ
ԭʡɽ°ҽѧоϯҽʦԺٰ
͹ʦд迴5Ѯ
ΪǿԡЧԣλʦѯṩҪר
㽲ͽĹע㣬ֱʼ
ллϺ֧֣

ѧѧԺ
2010. 5. 4

һ䣬㽭ѧѧѧԺ˶ˡ

(XYS20100504)

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̵Ƶ

ߣ

йءۡڶϢۡ˵ѧҴԽ
ӱڶɺϢȫʧ˵ϢӦغġҾһֱΪʲô
ϢһغģѵˡӲ̸ˡϢҲغ

ǽgoogle һ¡Ϣغ㡱ļнָ
һй˵νϢغ㶨ɡҪǣһʼȫ
Ƶģйʽн˵ʽģкܶDENG'S̡Ϣ۵
һɡ˫ѭɡ

Ǻؿȿеϵͳغ㡱ʱе㲻Ծˣ
ȿЩʱʶTMĵˣ

Ϣغʽ.еPE, qE. 5ʽE=PE+qE
š,5ʽаֽΪֹȻʶһ
̶,

ϵΪеҳͬݣ硰ٶ֪
ٶȰٿơѰٿơٿơټ̳վȫ
ռ죬άٿҲСάٿϵĿ򿪺дšѱɾ
ԭǡơ

ǣһﾫĵذһͬۡڶϢۡ
Щٿ޷ƴšڶϢۡȻؾͶˡDENG'S
Ϣغ㶨ɡȻؾ֪иͬΰDENG

޺ߣһֱΪƴֻ
֣ˡҴˣ

(XYS20100504)

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ϵ̨Ҳαѧ



ą̃һٿȫ˵ĽĿʼͦģһЩ
ȥеı֪ʶܿ׵רҶˣһЩ
ʦˡһȵ̫ţ˵Ƶ֪Ƿ񽡿׵
ǴĴָܿǷ񽡿ʳָܿĸǷ񽡿ָܿ
񽡿Ҳ̫ˣ̨Ϊһڹ㷺һӰý壬
κĴʦȷʵҲһź顣

αѧ

(XYS20100504)

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𡰶FDA֤Ľ

ߣ첲׳
ԭأhttp://henzhai.com/watch/2010/04/hepalink-fda.html

һС𡱵ԭҩƾ衰A߷мۡ
ܶעй˵[1]УԼǡĿǰڸԭҩҵΨ
һͨ
FDA֤ҵͬʱҲýԺġFDA֤ԡʾ
[2]ԭҩҵҲѻáFDA֤֮£
һ⣺FDA֤ʲô

FDAȫǡʳƷҩƷ֡ΪеһܲţFDA
й˵ġȫ顱Ǯ̶֤߽
ĳְʾ֤ӦӢһǡCertificationFDAվ
ҩƷDrugs[3]УκιĳҩƷ̻
CertificationϢΨһصҩƷС׼Approval
ҩƷҵȡעᡱRegistrationҩƷСб
Listing)ġɼʱҲǡÿһƪ£ͽС
輫FDA֤ĲƷBe wary of products touting FDA 
certification[4]ǡѻFDA׼FDAעᡯĺ
ߵͨⲢһڸFDA֤һ֮ġFDA֤顱
2001
ҲFDAFDA ûν֤ӡ¡[5]

ȻΪҪͶߵӣġFDA֤
һƻʵϣֻһģ˵ȷкʵ
Ҫ

ںй˵FDA֤ΪFDA׼ʳƷҩƷ
гɳ򡱡ںġҩƷʵָԭҩ
гָԭҩгôɳʲôԴй˵


˾20057ȡFDA֤,֤ڹ˾ͨFDAֳ
ǰ³Ч˾һͨFDAֳʱΪ2008414
18ա414418գFDAļԱԹ˾ֳ飬
Ϊȱݡ

ɼƵġɳУؼھָFDAеֳ
鼰飬ȡFDAָ֤ͨFDAּ顣ֳ
InspectionFDAҩҵйԭҩҵмܵһҪ
ʩҪFDAйԭҩҵܳȥ˽[6-9]

1йԭҩҵȻFDAύһDMFҩļ
ԼĳֲƷ졢ӹͰװϸϢDMFֻҪϡʽ
Ҫ󡱣FDAͻʽǩոDMFDMFšҪǿ
һFDAԶDMF׼׼ĽۣA DMF IS 
NEVER APPROVED OR DISAPPROVEDҲ˵DMFǩղζDMFĳ
ˣHolderFDAġ׼̸ϡ֤ҲвƷFDA
עᡱڶFDAǩĳһDMFҲģReviewDMFڵϢ
ҩ루INDNDAȣDMFЩļ޶򲹳䣬
ȥãReferenceDMFʱFDAŻĸDMF

ҪЩDMFѱFDAǩգͨFDAվصExcelݱ[9]
Ҳͨվbetterchem.comHeparin sodium
ƣԿнʮйҵύصDMF
SubjectڡHEPARIN SODIUM AS MANUFACTURED IN xxx PROVINCE, 
CHINAйĳĳĸơЩҵȰں
HepalinkҲнǧ죨QianHongӱɽChangShanϾ
ѣKING-FRIENDýᵽҵ

2 ԭҩҵDMFҩΪFDAļʱſʼ
ĸDMFԱϤԭҩҵϸͬʱҪˣԭҩҵ
޸DMFڵȱݡDMFٴȱݣFDAͻᰲż٣Inspector
ԭҩҵ״cGMP̬ҩƷ淶ֳ顣üҪ
ĿǲҵǷΥcGMPԼֳʵDMF
Ƿһ¡

FDAйԭҩҵcGMPֳһ35졣죨
֮󣩣FDAٻcGMP֮ġֳȱݱ桱483
ҵ⣬Ҳ֪ҵǷֳͨ飬ԼǷ׼
ҵΪҩߵԭҩҵ֮ҵҪ30ڶԣ483
гĲ֮FDAظյظ󣬽FDAִа칫
ύһݡҵ鱨桱Establishment Inspection ReportEIRִ
칫EIR桢483ͣ483ҵظ󣬽ʽ
ҵǷͨcGMPֳ顣󣬲ǷͨFDA֪ᷢͨ
ҵ

3ʹԭҩҵͨ״cGMPֳ飬FDAҲԸҵ
ȼ飬顱һÿһΣΪFDAأ
Ҳӳڸз⣬FDAԸҵڣ483
Ļظе⣬ͻԸҵţWarning Letterҵû
вȡЧĸĽʩFDAȡһķƲãֹҵ
Ʒ

ںվϣԿFDA2005䷢ͨ״cGMPֳ
ź[10]д

Based on the corrections described in the response, we are 
classifying your facility as acceptable. The corrective actions will 
be further evaluated in the next routine inspection of this facility. 
It remains your responsibility to assure continued compliance with 
current good manufacturing practices.

ļڴĸʩѱڿɽܼ
ǽ´ζԹ󳧵мЩĽʩȷѭҩƷ
淶ǵΡ

ɼвû롰֤صֻ˵䡰ڿɽܼ
facility as acceptableΣ൱ͨFDAĴ˴ֳ
飻´θ֮ǰнԭҩгɡ⣬Ҳ
ȱݡͨ2008ĸ顣һƶȣ´θ2010
2011ꡣ

ˣġFDA֤ʲô壬ͻˡνΨһͨ
FDAָ֤ĿǰڹڵĸԭҩҵУֻкһ
ͨһεFDAֳ顣ҵҪ֤ԼҲͨν
FDA֤ҪʾFDAǵź֤Լͨ
һεFDAֳ顣˳һ£롰FDA֤صĴҵߣ
ԭҩҵĹƾЭύDMFЭͨFDAֳ֮Ĺ

ָ㣺1νġFDA֤һӵоͺǣ
´cGMPֳδͨصĺ޷
ԭҩ2ȻͨFDAcGMPֳҪŬ
FDA֤ڹԭҩҵҲǸ߲ʡع˾Ĺɼ
⣬гʿϸȥжˡ

ο
[1] кҩҵ׷й˵ http://www.p5w.net/stock/ssgsyj/zqgg/201001/t2771138.htm
[2] IPOС⡱http://www.21cbh.com/HTML/2010-4-28/yNMDAwMDE3NDcyNg_2.html
[3] FDAٷվġҩ http://www.fda.gov/Drugs/default.htm
[4] Be wary of products touting FDA certification
http://articles.latimes.com/2010/mar/01/health/la-he-0301-skeptic-20100301
[5] FDA֤顱 ٷ˵޹ϵ http://finance.sina.com.cn/g/75819.html
[6] Guideline for Drug Master Files (DMF)
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073164.htm
[7] ԭҩҩøϼ걨ϵݼʽҪ DMFPDFļ[5]ķ룩http://www.cde.org.cn/attachmentout.do?mothed=list&amp;id=705
[8] Compliance Program Guidance Manual for FDA Staff: Drug
Manufacturing Inspections Program 7356.002
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095598.htm
[9] PDACGMPֳ顷  йҽҩƼ 2007
[10] DMFб (Excelļ)
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/UCM073141.xls
[11] ״cGMPֳͨź http://www.hepalink.com/images/upload/FDA.jpg

(XYS20100504)

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Ůͯעҩ ҩ粹Ӧж

20100504й־

ҺزӦնСŮ5
ҩƷ8ʹã6вӦҩ鱨ǣҽ
Ժʹõҩ
/ ӱ

ѽεˣ迴㲻
ǰǸ˵ЦСˣ迴ȴһȥ
㣬ԶԶվ￴裬߽㿴СͱӻѪ
ΪȥѪһӵʹӣ
Ļĺúӣ𣿡һλĸڲдո
ȥ5ŮѪ֮ԣϣŮԸܵİ˼

źӸо

µС˹֣ľС2004ڡ

ңҪ20099˵𡣡治ôȥ˭֪
ܰҺӵߣʱգû뱯ʹţŮʿἰŮ
Ȼ

200996գв1¾Ҫ5յͻȻ˵ɤۡ
ŮеţŮʿţ̴Ů˽н߰ټֵ̫·
վվҽ쵱ʱΪ壺37.8棬
Ѫ״󡢳ѪΪϺȾףҩ


Ȼҩ3֢ȻûеõЧơ99磬
λص˸վƣȻȴǲҵĿʼĸ֣
վڸ˰ڵҩƷ󣬡ؼ10
ңӾ˵裬䡯ڸһˮ󣬾ͷص
վˡվֳսȵ֢״´ﵽ
41棬־ҽǵ֢״ҩƷӦ10mg 
ע䣬ͬʱ״Ż¡鴤״վҽ
ҳһ͵ҽԺҽԺʱ־ѣΪ 
39.3档

4ʱңҽԺҽҪ֣
Ͳͬ⣬תԺҽԺСơ

910գѪҽԺΪϺȾ
ϵͳȾЧѣֽת
ʡҽԺʡҽԺΣܾգֱת֣
ѧһҽԺICUƣȻûкת

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ƹУڱǶγѪжһ֣ݴѧһҽԺ
3ҽ֣ͽеһ˵ӿ϶ˣѾû壡
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أԷźҹ򳵸ϻؽʱӻ΢һ·
ҽܸоڱ䣡źӾ뿪ǣ
ĸȴûа취ʱĶУ33գ֣;Լ
䵱ʱʱԱߵ㣡

918գ12Ҫ5յֹ֣ͣ˺Զ
5ꡣ

ҩҺӵ

ҺزӦն5
һͥĲҡ

ҺӦ󣬽ҩڴգҲ20099
10գҩƷ顣

929գʡʳƷҩƷһݱΪ200903692ļ鱨棬
עôԴ鲻Ϲ涨ݡҩƷ49
ֹҩ6Ĺ涨ۺϺʡʳƷҩƷóļ
ۣʹõעáҩҩͲۡ

緢֣ͰĿۼҩ2009525գ
ձ㷢˹עҺԴӦĲ¼ıνԴ
ӦָҺԴµķȷ
ӦҪԴϸл(ڶ)ԴӦһ㷢Һ20 
ңҺУͻȻַ䡢սɫ԰ס֫
ָ֮ȣ¿ɴ40ϣʱɰжŻ¡ͷʹ֫ؽʹ
ƤҰɫѪѹ½ݿ˵Դϸ֢״
ϸŮ֢״һǣ֣ͰѱΪҩעô
ǵŮȱɵĶ

֣ڲ˴Ϻע⵽ʳƷҩƷල
200991շĵ23ҩƷӦϢͨгƣעҺҪ
ԷסϺȾƣҽƻҽԱҩƷ
ӪҵӦ贩עزӦرҪעͯҩ
գ֤ҩȫעٴҪڲԷ׺ͲϺ
ȾǴڰȫ⣬زӦҪȫΪ
ҪΪݿˡӦȡսȡ֣˵

200511£ʳƷҩƷܾ֪ͨҪ޸Ĵע
˵飬ӡĿǰ㹻ͯҩٴϡɾ÷С
üҽݡ֪ͨл飬ҽԱӦϸĶƷ˵飬
Ӧ֢ȫȨ⻼(Ƕͯ)ףҩ

Ҫһࡱ

˽⣬Ĵɶͨҩҵ޹˾(¼ơɶͨ¡)
ɽ̨ɽҩҵ޹˾

֣ìͷֱָĲϸ񡰴ƹг⣬
ͨڳ⣿ҩ֣ұķǷֱϵأ
ʳʱҾһӣһȭһˣ϶
ɺصӰ죬һȭϣǺ֪
ΪвͣǾͺܲ⣬һ
ˣ˭ҪȥҺأΪˣŻҺ躬˵


ܴܽûйϵĹ۵㣬ܽܵǳɶͨ
µ̬ȡ֣͸ймߣһɵЭټĵϣ
ҩ˵ǳ˵ԸǼԪǮǮ
ӦøģӦøжң

⳥ǮҲӵֻҪӣںûˣҩ
ǸûУǸܲˣ֣͸߼ߡ

ڵ֪йм߲ɷôº󣬳ɶͨ¸ߴˡڴ
ƷںϽʹõ˵

˵гϣ680֧У8ʹ14֧2δҺ
Ӧ֣ڵ6˳ҺӦ֣⣬5˾֢
״𽥻⡢

ںйزż⡰Դһ£ĴʡʳƷҩƷ
2009921ն090709עôȫ죬Ϲ涨ǰ9
18գҩಿŶԸԼβƷ¼Ʒ桢
ԭϹ롢洢ʹüȽϸ󣬵ó δ쳣
Ľۡ

˵󣬳ɶͨΪߵԭ(
)ϡҩʩȵȻڿܴڵĹµģ߼ҳ
߾ҽûƣҲֵ

ɶͨ¼ֱں˵˵ڳҵ˵֣˵Բ
ɡ߼ߣǲףҽԺֻȷϺȾ
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