Indasteri ea MIT-Ivy ke khoebo ea meriana le lik'hemik'hale e kopanyang tlhahiso, thekiso le lipatlisiso tsa mahlale. Ka lisebelisoa tse tsoetseng pele tsa tlhahiso le theknoloji ea tlhahiso, re boloka likamano tse ntle tsa tšebelisano-'moho le litsi tsa lipatlisiso tsa mahlale le liunivesithi tse kholo le tse mahareng. Re ameha haholo tlhahisong le thekisong ea letoto la meriana e mahareng, haholo-holo kalafong ea meriana e khahlanong le AIDS, meriana ea pelo le methapo ea mali, le ho tšehetsa meriana e mahareng ea meriana e khahlanong le ho ruruha. Lihlahisoa tsa sodium azide, triphenyl chloromethane, L-valine methyl ester hydrochloride li rekisoa lapeng le kantle ho naha.1. Kenyelletso ea meriana e mahareng. Meriana e mahareng e bua ka lihlahisoa tse mahareng tse kang lisebelisoa tse tala, lisebelisoa le lintho tse thusang tse sebelisoang tlhahisong ea lihlahisoa tsa meriana. Ha e le hantle, ke lisebelisoa tse ling tsa lik'hemik'hale kapa lihlahisoa tsa lik'hemik'hale ts'ebetsong ea ho kopanya lithethefatsi. Setšoantšo Bahlahisi ba meriana ea beng ba eona le lintho tse sebetsang tsa lithethefatsi ba hloka ho amohela setifikeiti sa GMP. Meriana e mahareng, leha e sebelisoa tlhahisong ea lithethefatsi, ha e le hantle ke tlhahiso le tlhahiso ea lisebelisoa tse tala tsa lik'hemik'hale feela. Ke dihlahiswa tsa motheo le tse tlase ka ho fetisisa ketaneng ya tlhahiso ya dithethefatsi mme di ke ke tsa bitswa dithethefatsi, kahoo setifikeiti sa GMP ha se hlokehe. Dihlahiswa tse mahareng tsa meriana di ka hlahiswa dimeleng tse tlwaelehileng tsa dikhemikhale mme di ka sebediswa ho kopanyeng dihlahiswa tsa meriana maemong a itseng. Sena se boetse se fokotsa moedi wa ho kena indastering bakeng sa bahlahisi ba mahareng. Setšoantšo sa 2. Sekala sa indasteri ea meriana e mahareng Ka ho lokisa sebopeho sa indasteri, phetisetso ea tlhahiso ea linaha tse ling le ntlafatso e eketsehileng ea karohano ea basebetsi ea machaba ea lik'hamphani tse kholo tsa meriana tsa machaba, Chaena e fetohile motheo oa bohlokoa oa tlhahiso ea mahareng karolong ea lefats'e ea basebetsi ea indasteri ea meriana. Ho ea ka Tlaleho ea Lipatlisiso mabapi le Ntšetso-pele ea Indasteri ea Meriana e Mahareng ea Chaena (2016), ho tloha ka 2011 ho isa ho 2015, indasteri ea meriana e mahareng ea Chaena le boleng ba eona bohle ba tlhahiso bo eketsehile selemo le selemo, ka sekhahla sa kholo ea selemo le selemo sa hoo e ka bang 13.5%. Har'a tsona, boleng bohle ba tlhahiso ea meriana e mahareng ea Chaena bo fihlile ho li-yuan tse limilione tse likete tse 422.56 ka 2015, keketseho ea 9.88% selemo le selemo. Tlhahiso ea indasteri e fihlile ho lithane tse limilione tse 17.2, e nyolohang ka liperesente tse 10.26 selemo le selemo. Boleng ba tlhahiso ea indasteri ea meriana e mahareng ea Chaena bo tla ba haufi le li-yuan tse libilione tse le 'ngoe ka 2020. Setšoantšo sa 3. Litšobotsi tsa indasteri tsa li-intermediate tsa merianaIndasteri e hloka ntlafatso le ntlafatso ka potlako: Boemo ba theknoloji ka kakaretso ba Chaena bo ntse bo le tlase haholo, 'me ho na le likhoebo tse fokolang tse hlahisang palo e kholo ea li-intermediate tse tsoetseng pele tsa meriana le li-intermediate tse tšehetsang meriana e mecha e nang le patente, e leng mohatong oa nts'etsopele ea ntlafatso le ntlafatso ea sebopeho sa sehlahisoa. Ke likhoebo tse ling feela tse nang le matla a matla a lipatlisiso le nts'etsopele, libaka tsa tlhahiso tse tsoetseng pele le boiphihlelo bo boholo ba tlhahiso tse ka fumanang phaello e kholo tlholisanong. Sekala se tsitsitseng sa khoebo: Bahlahisi ba baholo ba nka tlhahiso e ikhethileng e le mohlala oa bona oa mantlha oa khoebo. Tlas'a mohlala oa tlhahiso o ikhethileng, kamano ea tšebelisano-'moho pakeng tsa bareki ba baholo le bafepedi e tsitsitse hanyane, 'me ha tšebelisano-'moho e atamelana, tekanyo ea ts'epo e phahame, 'me mekhahlelo e mengata ea tšebelisano-'moho e fanoang ke bareki ba baholo e tla ba holimo. Ho nka nako e telele ho fetola bafepedi. Ka hona, jwalo ka kgwebo e kgomarelang haholo, dikgwebo tsa indasteri ya meriana di shebane haholo le dikgwebo tse tsebahalang tsa meriana tsa kantle ho naha mokgahlelong wa jwale. Hang ha khamphani e se e kene tsamaisong ya mantlha ya bafepedi ba dikhamphani tse kgolo tsa meriana, sekala sa tlhahiso le phaello e kgolo di ile tsa boloka boemo bo tsitsitseng. Ho romelwa kantle ho naha haholoholo: dibaka tse ka sehloohong tsa meriana e fapaneng ya meriana Chaena ke EU, Amerika Leboya, Botjhabela bo Hare, Asia Borwa-Botjhabela, jj. Ho romelwa kantle ho naha ya rona ho shebane haholo le vithamine C, penicillin, acetaminophen, citric acid le matswai le di-ester tsa yona, jwalo ka thepa, dibopeho tsa dihlahiswa ke tlhahiso ya dihlahiswa, dikgwebo tsa tlhahiso, tlholisano ya mmaraka e matla, theko ya dihlahiswa le boleng bo ekeditsweng di tlase, tlhahiso e kgolo ya tsona e bakile boemo ba phepelo e feteletseng ya mmaraka wa meriana e fapaneng ya lapeng. Dihlahiswa tsa theknoloji e hodimo di ntse di kenngwa haholo. Dikgwebo tse nyane le tse mahareng: dikgwebo tsa tlhahiso boholo ba tsona ke dikgwebo tsa poraefete, tshebetso e tenyetsehang, sekala sa matsete ha se seholo, ha e le hantle pakeng tsa dimilione ho isa ho dimilione tse leshome kapa mashome a mabedi tsa yuan. Kgatello ya dibaka: kabo ya dikgwebo tsa tlhahiso ya lebatowa e shebane haholo, ho potoloha difeme tse mmalwa tse kgolo tsa meriana, haholoholo tse ajwang Taizhou, Zhejiang le Jintan, Jiangsu e le setsi sa sebaka seo.Zhejiang Huangyan, Taizhou, Nanjing Jintan, Shijiazhuang, Jinan (ho kenyeletsoa le Zibo), leboea-bochabela (Siping, Fushun) le libaka tse ling tse nang le maemo a matle bakeng sa nts'etsopele ea li-intermediate tsa meriana li ntlafalitsoe ka potlako haholo.Ntlafatso e potlakileng ea sehlahisoa: sehlahisoa hangata se rekisoa lilemo tse 3 ho isa ho tse 5 hamorao, sekhahla sa sona sa phaello se tla theoha haholo, e leng se qobellang likhoebo ho nts'etsapele lihlahisoa tse ncha khafetsa kapa ho ntlafatsa ts'ebetso ea tlhahiso khafetsa, e le ho boloka phaello e phahameng ea tlhahiso.Tlholisano e matla: hobane phaello ea tlhahiso ea li-intermediate tsa meriana e phahame ho feta ea lihlahisoa tsa lik'hemik'hale, 'me ts'ebetso ea tlhahiso ea tse peli e tšoana hantle, likhoebo tse nyane tse ngata tsa lik'hemik'hale li ikopanya le tlhahiso ea li-intermediate tsa meriana, e leng se lebisang tlholisanong e matla e sa laoleheng indastering.4. Mefuta ea li-intermediate tsa merianaHo na le mefuta e mengata ea li-intermediate tsa meriana, ho kenyeletsoa li-intermediate tsa cephalosporin, letoto la li-protectant tsa amino acid, li-intermediate tsa vithamine, li-intermediate tsa quinolone, le mefuta e meng ea li-intermediate, joalo ka li-intermediate tsa meriana ea disinfectant, li-intermediate tsa meriana ea antiepileptic, li-intermediate tsa fluoropyridine, li-intermediate tsa meriana ea steroid, jj. Ho ea ka masimo a tsona a ts'ebeliso, li ka aroloa ka li-intermediate tsa meriana ea lithibela-mafu, li-intermediate tsa meriana ea antipyretic le ea analgesic, li-intermediate tsa meriana ea tsamaiso ea pelo le methapo, li-intermediate tsa meriana ea anti-cancer le tse ling. Hona joale, ho na le lihlahisoa tse ka bang makholo tsa li-intermediate tsa meriana, 'me li lula li qapa, li theha liindasteri tse ngata tse ntle tsa limolek'hule indastering ea li-intermediate tsa meriana. Ho na le mefuta e mengata ea li-intermediate tse khethehileng tsa meriana. Tse kang imidazole, furan, li-intermediate tsa phenolic, li-intermediate tse nkhang hamonate, pyrrole, pyridine, li-reagent tsa biochemical, sebabole, naetrojene, metsoako ea halogen, metsoako ea heterocyclic, microcrystalline cellulose, starch, mannitol, lactose, dextrin, ethylene glycol, tsoekere e phofshoana, letsoai le sa tloaelehang, li-intermediate tsa ethanol, stearic acid, amino acid le ethanol amine letsoai, sylvite, sodium letsoai le lintho tse ling tse mahareng le tse ling. Setšoantšo sa 5. Patent CliffHo tloha ka 2000, 'maraka oa lefats'e oa li-generic o ntse o tsoela pele ho hola ka potlako ho feta 'maraka o akaretsang oa meriana, o hola ka lebelo le fetang habeli ho feta meriana e nang le patent. 'Maraka oa lefats'e oa lithethefatsi tse tloaelehileng o lebelletsoe ho fihla ho $180 bilione ka 2013,' me CAGR ea 'maraka oa lefats'e oa lithethefatsi tse tloaelehileng ho tloha ka 2005 ho isa ho 2013 e lebelletsoe ho fihla ho 14.7%. 'Maraka oa lefats'e oa li-generic o lebelletsoe ho hola ka 10% ho isa ho 14% lilemong tse hlano tse tlang, ka potlako ho feta kholo e lebelletsoeng ea 4% ho isa ho 6% bakeng sa indasteri eohle ea meriana. Ho ka nahanoa hore nts'etsopele ea 'maraka oa lithethefatsi tse tloaelehileng e tla holisa nts'etsopele ea indasteri e mahareng ea meriana. Ho tloha ka 2010 ho isa ho 2020, 'maraka oa lefats'e oa meriana o tla tlisa leqhubu le phahameng la ho fela ha Patent, eo har'a eona, ho tloha ka 2013 ho isa ho 2020, mefuta ea lefats'e ea ho fela ha Patent e tla ba karolelano ea ho feta 200 selemo se seng le se seng, e tsejoang e le "Patent Cliff" lefatšeng. Ka 2014, ho tla ba le tlhōrō ea lithethefatsi tse nang le patent ho fela ha nako, moo ho tla ba le tlhoro ka 2014, ka kakaretso ea meriana ea patent e 326 e felang. 2010 le 2017 ke lilemo tse peli tse phahameng tse amanang, ka meriana ea patent e 205 le 242 e felang ka ho latellana. Meriana e feliloeng ke meriana e thibelang tšoaetso, ea endocrine, ea methapo le ea pelo, e nang le boholo bo boholo ba 'maraka. Ho fela ha nako e kholo ha meriana ea patent ea kantle ho naha ho tla tlisa li-catalyst tse ncha indastering ea meriana e mahareng Chaena. Hobane kamora ho fela ha meriana ea patent, tlhahiso ea meriana e tloaelehileng e amanang le eona e tla phatloha, e leng se tla khanna kholo e potlakileng ea tlhoko ea meriana e mahareng e amanang le eona. Setšoantšo sa 6. Khatello ea tikoloho Chaena e se e ntse e le morekisi e moholo oa li-API intermediates, hammoho le mosireletsi e moholo oa litšila. Bahlahisi ba meriana ba mahareng ke ba indasteri ea lik'hemik'hale tse ntle, ho tla ba le kotsi e tsamaellanang le tšilafalo. Ho ea ka lipalo-palo tse tsoang Lefapheng la Tšireletso ea Tikoloho, boleng bohle ba tlhahiso ea indasteri ea meriana ea malapeng bo ka tlase ho 3% ea GDP ea naha, empa kakaretso ea tšilafalo e hlahisoang e fihla ho 6%. Har'a mefuta eohle ea lithethefatsi, API e emeloang haholo ke livithamine le penicillin ke ea indasteri ea tšilafalo e phahameng le tšebeliso e phahameng ea matla, e silafatsang moea le metsi haholo-holo ka botebo. Ho ea ka ho romelloa ho kopaneng ha Lefapha la Tšireletso ea Tikoloho, ka la 15 Hlakola 2017, sehlopha se khethehileng sa tlhahlobo bakeng sa boleng ba moea kotara ea pele ea 2017 se phatlalalitse hore ho tsamaisoa ha khatello Shijiazhuang ho ne ho se teng, 'me mmuso oa boemo ba setereke o ne o ntse o thehiloe haholo-holo ho basebetsi ba Ofisi ea Tšireletso ea Tikoloho ho kenngoeng tšebetsong ha moralo oa tšohanyetso oa tšilafalo e matla ea boemo ba leholimo, ha mafapha a mang a ne a sa ameha ka tekanyo e phahameng. Tšilafalo ea likhoebo tse nyane le tse mahareng tse hlahisang li-intermediates tsa meriana Shijiazhuang e tebile. Likhoebo tsa meriana Ka theknoloji e saletseng morao e tla jara litšenyehelo tse phahameng tsa taolo ea tšilafalo le khatello ea taolo, 'me likhoebo tsa meriana tsa setso tse hlahisang tšilafalo e phahameng haholo, tšebeliso e phahameng ea matla le lihlahisoa tse nang le boleng bo tlase (joalo ka penicillin, livithamine, jj.) li tla tobana le ho felisoa ka potlako. Ho khomarela mekhoa e mecha le ho nts'etsapele theknoloji ea meriana e tala e fetohile tataiso ea nts'etsopele ea nakong e tlang ea indasteri ea meriana e mahareng. Setšoantšo
7. Baetapele ba indasteri
indasteri ea mit-ivy
Khamphani ea Zhejiang NHU Ltd.Plo Co., Ltd
Lianhe Chemical Technology Co., Ltd. Anhui Bayi Chemical Co. LtdZhejiang Huahai Pharmaceutical Co. LtdZhejiang Hisoar Pharmaceutical Co., Ltd. Jiangsu Jiujiu Technology Co., LtdFederal pharmaceutical (chengdu) co., LTDZhejiang Yongtai Technology Co., Ltd.Suzhou Tianma Specialty Chemicals Co., Ltd.