Standardization dongosolo
1 Miyezo ndi machitidwe okhazikika a mabotolo agalasi
ndime 52 ya Drug Administration Law of the People's Republic of China imati: “Zopakira ndi zotengera zomwe zakhudzana mwachindunji ndi mankhwala ziyenera kukwaniritsa zofunikira pakugwiritsa ntchito mankhwala ndi miyezo yachitetezo.”Ndime 44 ya Implementation Regulations of the Drug Administration Law of the People's Republic of China imati: Njira zoyendetsera, zolemba zazinthu, ndi zofunikira zamankhwala ndi miyezo yazinthu zopangira mankhwala ndi zotengera zidapangidwa ndikusindikizidwa ndi dipatimenti yoyang'anira mankhwala ku State Council. ."Malinga ndi zofunikira za malamulo ndi malamulo omwe tawatchulawa, State Drug Administration yakonza magulu kuyambira 2002. Anapanga ndikupereka miyezo ya 113 yazitsulo zopangira mankhwala (zida) (kuphatikizapo 2004 zomwe zinakonzedwa kumasulidwa), kuphatikizapo miyezo ya 43 ya botolo lagalasi lamankhwala. zotengera zonyamula (zida), ndipo kuchuluka kwa milingo kunafikira 38% ya miyeso yonse yamudzi.The muyezo kukula chimakwirira mankhwala galasi botolo ma CD muli zosiyanasiyana jekeseni jekeseni monga ufa jakisoni, jekeseni madzi, infusions, mapiritsi, mapiritsi, m`kamwa zakumwa ndi lyophilized, katemera, mankhwala magazi ndi mitundu ina mlingo.Dongosolo lokhazikika komanso lokhazikika la botolo lagalasi lachipatala lakhazikitsidwa.Kupanga ndi kutulutsidwa kwa miyezo imeneyi, kusinthidwa kwa mabotolo agalasi ndi zotengera zamankhwala, kuwongolera bwino kwazinthu, kutsimikizika kwamankhwala abwino, kuthamangitsa kuphatikizana ndi miyezo yapadziko lonse lapansi ndi msika wapadziko lonse lapansi, kukwezeleza ndi kuwongolera athanzi. , mwadongosolo, ndi chitukuko chachangu cha makampani Chinese mankhwala galasi , Ali ndi tanthauzo lalikulu ndi udindo.
Mabotolo agalasi amankhwala ndi zida zonyamula zomwe zimalumikizana mwachindunji ndi mankhwala.Amakhala ndi gawo lalikulu pakupanga zida zamankhwala, ndipo ali ndi zinthu zosasinthika komanso zabwino.Miyezo yawo imakhala ndi chiwopsezo chachikulu pakupanga kwamankhwala ndi chitukuko chamakampani.
Medicated dongosolo
2 Dongosolo lokhazikika la mabotolo agalasi azachipatala
Malinga ndi miyezo ya State Drug Administration yopangira zida zopangira mankhwala zogawidwa ndi zinthu, chinthu chimodzi (zosiyanasiyana) ndi muyezo umodzi, pali miyezo 43 yamabotolo agalasi azamankhwala omwe atulutsidwa ndipo akuyenera kutulutsidwa.Amagawidwa m'magulu atatu malinga ndi mtundu wamba.Pali miyezo 23 yazogulitsa m'gulu loyamba, pomwe 18 idatulutsidwa, ndipo 5 ikukonzekera kutulutsidwa mu 2004;Miyezo ya 17 ya mtundu wachiwiri woyesera njira, yomwe 10 yatulutsidwa, ndipo 7 ikukonzekera kumasulidwa mu 2004. Pali 3 mfundo zazikulu za gulu lachitatu, 1 yomwe yasindikizidwa, 2 idzatulutsidwa mu 2004. Pali mitundu ya 23 yamagulu azinthu zomwe zili m'gulu loyamba, zomwe zimagawidwa m'magulu a 8 molingana ndi mitundu ya mankhwala, kuphatikizapo "Mabotolo Ojambulira Opangidwa" 3 "Mabotolo Ajakisoni Oyendetsedwa" 3 "Mabotolo Olowetsera Magalasi" 3 "Mabotolo Opangira Mankhwala a Mold" 3 "Tube Mankhwala 3 a "Mabotolo", zinthu 3 za "Mabotolo Amadzimadzi Oyendetsedwa Pakamwa", 3 zinthu za "Ampoules" ndi zinthu zitatu za "Machubu Amankhwala Agalasi" (Zindikirani: Chida ichi ndi chinthu chomaliza chokonzekera mabotolo osiyanasiyana owongolera ndi ampoules).
Pali mitundu itatu ya zida zomangira, kuphatikiza zinthu 8 zagalasi la borosilicate.Galasi la Borosilicate limaphatikizapo α = (4 ～ 5) × 10 (-6) K (-1) (20 ～ 300 ℃) galasi lopanda ndale ndi α = (3. 2 ~ 3. 4) × 10 (-6) K (- 1) (20 ~ 300 ° C) 3.3 Borosilicate galasi.Galasi yamtunduwu imapangidwa ndi magalasi osalowerera ndale padziko lonse lapansi, omwe amadziwikanso kuti Class I glass kapena Class A material.Pali zinthu 8 za galasi la borosilicate, ndipo galasi la borosilicate lotsika ndi α = (6.2 mpaka 7. 5) × 10 (-6) K (-1) (20 mpaka 300 ℃).Magalasi amtundu uwu ndi galasi lapadera la China losalowerera ndale lomwe silingagwirizane ndi miyezo yapadziko lonse lapansi.Amatchulidwanso kuti zinthu za Class B.Soda-laimu galasi 7 zinthu, soda-laimu galasi α = (7.6 mpaka 9. 0) × 10 (-6) K (-1) (20 mpaka 300 ℃), mtundu wa zinthu galasi zinthu zambiri vulcanized, ndi pamwamba ndi madzi kusamva Magwiridwe kufika pa mlingo 2.
Pali miyezo 17 ya mtundu wachiwiri wa njira zoyendera.Njira zowunikirazi zimaphimba zinthu zosiyanasiyana zowunikira monga momwe zimagwirira ntchito komanso zisonyezo zamitundu yosiyanasiyana yamabotolo agalasi azamankhwala.Makamaka, kuyesa kwa zinthu zamagalasi zamagalasi kwawonjezera magwiridwe antchito atsopano amadzi molingana ndi miyezo ya ISO Kuzindikira kwa alkali ndi asidi kukana kumapereka njira zodziwikiratu, zowonjezereka komanso zasayansi zozindikiritsa kukhazikika kwamankhwala kuti agwirizane ndi zinthu zosiyanasiyana zamafuta. mankhwala galasi mabotolo mankhwala osiyanasiyana katundu ndi mlingo mitundu.Kuwonetsetsa kuti mabotolo agalasi azachipatala ndi abwino komanso momwe mankhwalawo amathandizira.Kuphatikiza apo, njira zodziwira kuchuluka kwa zinthu zovulaza zawonjezeredwa kuti zitsimikizire chitetezo cha mabotolo agalasi amankhwala.Njira zoyesera zamabotolo agalasi azachipatala ziyenera kuwonjezeredwa.Mwachitsanzo, njira yoyesera ya ma ampoules olimbana ndi alkali, njira yoyesera yothyola mphamvu, ndi njira yoyesera ya kukana kugwedezeka kwa kuzizira zonse zimakhudza kwambiri momwe mabotolo agalasi amapangidwira komanso kugwiritsa ntchito.
Pali 3 mfundo zofunika mu gulu lachitatu.Zina mwa izo, "Kugawa ndi Njira Zoyesera za Mabotolo Agalasi Achipatala" amatanthauza ISO 12775-1997 "Kugawa ndi Njira Zoyesera za Galasi mu Kupanga Kwachibadwa Kwambiri".Magulu a mabotolo ndi njira zoyesera ali ndi tanthauzo lomveka bwino losiyanitsa zida zamagalasi ndi mafakitale ena.Miyezo ina iwiri yofunikira imachepetsa zinthu zovulaza za zida zamagalasi, lead, cadmium, arsenic, ndi antimony, kuwonetsetsa kuti mitundu yosiyanasiyana yamankhwala imakhala yotetezeka komanso yogwira ntchito.
Makhalidwe a mabotolo amankhwala
3 Makhalidwe a muyezo wa botolo lagalasi lamankhwala
Muyezo wa botolo lagalasi lamankhwala ndi nthambi yofunikira yamakina okhazikika azinthu zopangira mankhwala.Popeza kuti mabotolo agalasi amankhwala amalumikizana mwachindunji ndi mankhwalawo, ndipo ena amafunikira kusungidwa kwa nthawi yayitali, mtundu wa mabotolo agalasi amankhwala umagwirizana mwachindunji ndi mankhwalawo ndipo umakhudza thanzi la munthu ndi chitetezo.Chifukwa chake, muyezo wamabotolo agalasi azachipatala uli ndi zofunikira zapadera komanso zokhwima, zomwe zimafotokozedwa mwachidule motere:
Mwadongosolo komanso mwathunthu, zomwe zimakulitsa kusankhika kwa miyezo yazinthu ndikugonjetsa kutsalira kwazinthu zomwe zimagulitsidwa.
Chomwecho chodziwika ndi muyezo watsopano chimachokera pa mfundo yopangira miyezo yosiyanasiyana yotengera zinthu zosiyanasiyana, zomwe zimakulitsa kwambiri kuchuluka kwa muyezo, kumawonjezera kugwiritsidwa ntchito ndi kusankha kwamankhwala osiyanasiyana atsopano ndi mankhwala apadera kuzinthu zosiyanasiyana zamagalasi ndi magwiridwe antchito osiyanasiyana. zogulitsa, ndi kusintha Miyezo pazambiri zogulitsa zimatsalira kumbuyo kwa chitukuko cha zinthu.
Mwachitsanzo, pakati pa mitundu 8 ya botolo lagalasi lamankhwala lomwe limakutidwa ndi muyezo watsopano, muyezo uliwonse wamankhwala umagawidwa m'magulu atatu molingana ndi zinthu ndi magwiridwe antchito, gulu loyamba ndi galasi la borosilicate, gulu lachiwiri ndi galasi lotsika la borosilicate, ndipo lachitatu. Kalasi ndi galasi la soda.Ngakhale kuti chinthu china chamtundu wina sichinapangidwebe, miyezo yamtunduwu yakhazikitsidwa, yomwe imathetsa vuto la kuchedwa pakupanga zinthu zokhazikika.Mitundu yosiyanasiyana ya mankhwala okhala ndi magiredi osiyanasiyana, katundu wosiyanasiyana, kugwiritsa ntchito mosiyanasiyana ndi mawonekedwe a mlingo amakhala ndi kusinthasintha komanso kusankha kwakukulu kwamitundu yosiyanasiyana yazinthu ndi miyezo.
Anafotokozera tanthauzo la galasi la borosilicate ndi galasi lotsika la borosilicate.Muyezo wapadziko lonse wa ISO 4802. 1-1988 “Kukaniza kwa Madzi kwa Glassware ndi Zotengera za Magalasi' Zamkati Zamkati.Gawo 1: Kutsimikiza ndi Kugawa ndi Titration.Galasi) imatanthauzidwa ngati galasi lomwe lili ndi 5 mpaka 13% (m / m) ya boron trioxide (B-2O-3), koma ISO 12775 "Magulu a magalasi ndi njira zoyesera zopangira misa wamba" idatulutsidwa mu 1997 Tanthauzo la borosilicate galasi (kuphatikiza magalasi osalowerera) lili ndi boron trioxide (B-2O-3) yoposa 8% (m / m).Malinga ndi muyezo wapadziko lonse wa 1997 wa mfundo zamagulu agalasi, zinthu zamagalasi pafupifupi 2% (m / m) za B-2O-3, zomwe zakhala zikugwiritsidwa ntchito kwambiri mumakampani opanga magalasi aku China kwazaka zambiri, sayenera kutchedwa. galasi la borosilicate kapena galasi lopanda ndale.Kuyesaku kumatsimikizira kuti magalasi ena amadzimadzi amadzimadzi amadzimadzi komanso kuyesa kwamkati kwamadzi amkati mwazinthu izi amalephera kufika pa Level 1 ndi HC1, kapena ali pakati pa mphepete mwa Level 1 ndi Level 2. Kuchita kwatsimikiziranso kuti ena mwa mitundu iyi Magalasi sakhala ndi vuto lolowerera kapena kusenda, koma galasi lamtunduwu lakhala likugwiritsidwa ntchito ku China kwa zaka zambiri.Muyezo watsopano umasunga galasi lamtunduwu ndipo umatchula B-2O- Zomwe zili mu 3 ziyenera kukwaniritsa zofunikira za 5-8% (m / m).Zimatanthauzidwa momveka bwino kuti galasi lamtundu uwu silingatchulidwe galasi la borosilicate (kapena galasi lopanda ndale), ndipo limatchedwa galasi la borosilicate.
Tsatirani mfundo za ISO mwachangu.Miyezo yatsopanoyi ikugwirizana ndi miyezo yapadziko lonse lapansi.Miyezo yatsopanoyi imatchulanso miyezo ya ISO ndi miyezo ya mafakitale ndi pharmacopoeia ya United States, Germany, Japan ndi mayiko ena otsogola, ndikuphatikiza mikhalidwe yeniyeni yamakampani aku China opanga mabotolo agalasi kuchokera kuzinthu ziwiri zamitundu yamagalasi ndi zida zamagalasi. Kufikira pamiyezo yapadziko lonse lapansi.
Mitundu ya magalasi a galasi: Pali mitundu ya 4 ya galasi muyeso yatsopano, kuphatikizapo 2 mitundu ya galasi la borosilicate, kuphatikizapo galasi la 3.3 la borosilicate [α = (3. 3 ± 0. 1) × 10 (-6) K (-1) ] Ndipo 5.0 0 magalasi osalowerera ndale [α = (4 mpaka 5) × 10 (-6) K (-1)], galasi la borosilicate lochepa [α = (6.2 mpaka 7. 5) × 10 (-6) K (-1) ] Mtundu wa 1, galasi la soda-laimu [α = (7.6 ~ 9. 0) × 10 (-6) K (-1)] 1 mtundu, kotero pali mitundu 4 ya galasi ndi zinthu.
Chifukwa galasi laimu la soda limaphatikizapo mankhwala ambiri osasunthika pakupanga ndi kugwiritsa ntchito, amagawidwa m'mitundu 5 malinga ndi mankhwala.Mitundu 4 ya magalasi yomwe ili pamwambapa ndi mitundu 5 ya zinthu zamagalasi imaphatikizapo miyezo yapadziko lonse lapansi, US Pharmacopoeia ndi mabotolo agalasi apadera azachipatala aku China.Kuphatikiza apo, mwa zinthu zisanu ndi zitatu zomwe zidapangidwa ndi muyezo, ma ampoule okha ndi omwe adapanga miyezo iwiri, "ma ampoules agalasi a borosilicate" ndi "magalasi otsika agalasi a borosilicate," ndi mtundu umodzi wokha wa α = (4 mpaka 5) × 10 (-6) K (-1) ya 5.0 galasi la borosilicate popanda α = (3. 3 ± 0. 1) × 10 (-6) K (-1) ya 3. 3 galasi la borosilicate Ndi makamaka chifukwa palibe mankhwala otere padziko lapansi. , ndi kufewetsa kwa galasi la 3.3 borosilicate ndipamwamba, zomwe zimapangitsa kuti zikhale zovuta kusindikiza ampoule.M'malo mwake, muyezo wapadziko lonse lapansi uli ndi ampoule yagalasi ya 5.0 ya borosilicate, ndipo palibe 3.3 borosilicate galasi ampoule ndi soda-laimu galasi ampoule.Ponena za China wapadera otsika magalasi ampoules borosilicate galasi, 5.0 borosilicate galasi ampoules sanapangebe nthawi yeniyeni ya kupanga yaikulu khola China chifukwa cha zifukwa zosiyanasiyana, ndipo angagwiritsidwe ntchito ngati mankhwala kusintha.Pamapeto pake, galasi lotsika la borosilicate likadali lochepa.Ampoule, pangani 5.0 borosilicate galasi ampoule kuti mukwaniritse kusakanikirana kwathunthu ndi miyezo yapadziko lonse lapansi ndi mankhwala posachedwa.
Magwiridwe a zinthu zamagalasi: Thermal coefficient α yotchulidwa mu muyezo watsopano, galasi 3.3 borosilicate ndi galasi 5.0 borosilicate zimagwirizana kwathunthu ndi miyezo yapadziko lonse lapansi.Magalasi otsika a borosilicate ndi apadera ku China, ndipo palibe zipangizo zoterezi m'mayiko osiyanasiyana.Soda-laimu galasi ISO ikunena α = (8 ～ 10) × 10 (-6) K (-1), ndipo muyezo watsopano umanena α = (7.6–9. 0) × 10 (-6) K (-1) , Zizindikiro ndi zokhwima pang'ono kusiyana ndi mayiko.Mu muyezo watsopano, mankhwala katundu wa 3.3 borosilicate galasi, 5.0 borosilicate galasi ndi soda-laimu galasi pa 121 ° C zimagwirizana ndi mfundo mayiko.Kuphatikiza apo, zofunikira pakupanga mankhwala a boron oxide (B-2O-3) mumitundu itatu yamagalasi zimagwirizana kwathunthu ndi miyezo yapadziko lonse lapansi.
Magwiridwe azinthu zamagalasi: Magwiridwe azinthu zomwe zafotokozedwa mu muyezo watsopano, kukana kwamadzi pamwamba pamadzi, kukana kugwedezeka kwamafuta, komanso zisonyezo za kukakamiza kwamkati zimagwirizana ndi miyezo yapadziko lonse lapansi.Mlozera wamkati wamkati wa ISO umanena kuti ampoule ndi 50nm / mm, zinthu zina ndi 40nm / mm, ndipo mulingo watsopano umanena kuti ampoule ndi 40nm / mm, kotero index yamkati yamkati ya ampoule ndiyokwera pang'ono kuposa ISO muyezo.
Kugwiritsa ntchito botolo lachipatala
Kugwiritsa ntchito miyezo ya botolo lagalasi lamankhwala
Zogulitsa zosiyanasiyana ndi zida zosiyanasiyana zimapanga njira yokhazikika yolumikizirana, yomwe imapereka maziko okwanira ndi zikhalidwe zamagalasi asayansi, oyenera komanso oyenera amitundu yosiyanasiyana yamankhwala.Kusankhidwa ndi kugwiritsa ntchito mankhwala osiyanasiyana m'mitundu yosiyanasiyana ya mlingo, katundu wosiyanasiyana ndi magiredi osiyanasiyana a mabotolo agalasi azamankhwala ayenera kutsatira mfundo izi:
Kukhazikika kwamankhwala
Mfundo Zabwino Zokhazikika Zokhazikika za Chemical
Chidebe cha galasi chomwe chimagwiritsidwa ntchito kusunga mitundu yonse ya mankhwala chiyenera kukhala chogwirizana bwino ndi mankhwala, kutanthauza kuti, kupanga, kusunga ndi kugwiritsa ntchito mankhwala, mankhwala a chidebe cha galasi sayenera kukhala osakhazikika, ndi zinthu zina pakati pawo. siziyenera kuchitika.Kusiyanasiyana kapena kusagwira ntchito kwa mankhwala chifukwa cha kusintha kwa mankhwala.Mwachitsanzo, zotengera zamagalasi zopangidwa ndi galasi la borosilicate ziyenera kusankhidwa pamankhwala apamwamba monga kukonzekera kwa magazi ndi katemera, komanso mitundu yosiyanasiyana yamankhwala amphamvu a asidi ndi madzi amchere, makamaka kukonzekera jekeseni wamadzi amchere, ayeneranso kupangidwa ndi galasi la borosilicate. .Magalasi otsika a borosilicate omwe amagwiritsidwa ntchito kwambiri ku China sali oyenera kukhala ndi kukonzekera kwa jekeseni wa madzi.Zida zamagalasi zoterezi ziyenera kusintha pang'onopang'ono ku zipangizo zamagalasi 5.0 kuti zigwirizane ndi miyezo yapadziko lonse mwamsanga kuti zitsimikizire kuti mankhwala omwe ali nawo sakugwiritsidwa ntchito.Off-chip, osati chipwirikiti, ndipo sichiwonongeka.
Pakuti ambiri ufa jakisoni, kukonzekera m`kamwa ndi infusions lalikulu, ntchito otsika galasi borosilicate kapena neutralized soda-laimu galasi akhoza akadali kukumana ake mankhwala bata.Kuchuluka kwa dzimbiri kwa mankhwala pagalasi nthawi zambiri kumakhala kwamadzimadzi kuposa zolimba komanso zamchere ndi zazikulu kuposa acidity, makamaka jakisoni wamadzi amchere amphamvu amakhala ndi zofunikira zambiri pamabotolo agalasi amankhwala.
Kugonjetsedwa ndi kuwonongeka kwa kutentha
Kukaniza bwino kutentha kwachangu
Popanga mitundu yosiyanasiyana ya mankhwala, kuyanika kwapamwamba kwambiri, kutsekereza kapena kuumitsa kutentha kwapang'onopang'ono kumafunika popanga, zomwe zimafuna kuti chidebe cha galasi chili ndi luso labwino komanso loyenera kukana kusintha kwadzidzidzi kwa kutentha popanda kuphulika. .Kukaniza kwa galasi ku kusintha kwachangu kutentha kumakhudzana makamaka ndi coefficient of thermal expansion.Kutsika kwa coefficient ya kukula kwa matenthedwe, kumapangitsanso kukana kwake kusintha kwa kutentha.Mwachitsanzo, ambiri mkulu-mapeto kukonzekera katemera, kwachilengedwenso kukonzekera ndi lyophilized kukonzekera ayenera zambiri ntchito 3.3 borosilicate galasi kapena 5.0 borosilicate galasi.Pamene magalasi otsika kwambiri a borosilicate opangidwa ku China amasintha mofulumira kusiyana kwa kutentha, nthawi zambiri amaphulika ndikuponya mabotolo.China 3.3 borosilicate galasi ali ndi chitukuko chachikulu, galasi makamaka oyenera lyophilized Kukonzekera, chifukwa kukana kwake mwadzidzidzi kusintha kutentha ndi bwino kuposa 5.0 borosilicate galasi.
Mphamvu zamakina
Zabwino ndi zoyenera makina mphamvu
Mankhwala amitundu yosiyanasiyana amayenera kupirira kukana kwamakina panthawi yopanga ndi kunyamula.Mphamvu zamakina zamabotolo agalasi azamankhwala ndi zida sizimangokhudzana ndi mawonekedwe a botolo, kukula kwa geometric, kukonza kwamafuta, ndi zina zambiri, komanso mphamvu yamakina azinthu zamagalasi.Pamlingo wina, mphamvu yamakina ya galasi la borosilicate ndi yabwino kuposa galasi la soda-laimu.
Kutulutsidwa ndi kukhazikitsidwa kwa miyezo yatsopano ya mabotolo agalasi amankhwala ndikofunikira kuti pakhale njira yabwino komanso yasayansi yokhazikika, kufulumizitsa mayendedwe ophatikizika ndi miyezo yapadziko lonse lapansi ndi misika yapadziko lonse lapansi, ndikuwongolera zida zonyamula mankhwala, kuonetsetsa kuti mankhwala ali abwino, kulimbikitsa chitukuko cha mafakitale ndi malonda apadziko lonse.Adzagwira ntchito yabwino.Zachidziwikire, monga dongosolo lonse lazinthu zopangira mankhwala, pali zinthu zambiri zomwe zikuyenera kukonzedwanso, kuwongolera, komanso kukonzedwa bwino pamakina oyambira a mabotolo agalasi azamankhwala, makamaka kuti agwirizane ndi kukula mwachangu kwamakampani opanga mankhwala. ndi kuphatikiza msika wapadziko lonse lapansi.Funsani.Kupanga, zomwe zili ndi zizindikiro za miyezo, ndi momwe miyezo yapadziko lonse imagwiritsidwira ntchito komanso mogwirizana ndi msika wapadziko lonse lapansi zimafuna kusintha koyenera ndi kuwonjezereka panthawi yokonzanso.
Miyezo yoyezetsa botolo lagalasi ndi thanki:
Njira yoyesera ya kupsinjika kwa mitsuko yamagalasi: ASTM C 148-2000 (2006).
Nthawi yotumiza: Dec-06-2019