Standardization system
1 Mayero uye akamisikidzwa masisitimu emabhodhoro egirazi
chikamu 52 cheDrug Administration Law yePeople's Republic of China chinoti: “Midziyo yekurongedzerwa nemidziyo inosangana zvakananga nemishonga inofanira kuzadzisa zvinodiwa pakushandiswa kwemishonga uye mwero yekuchengetedza. Chisungo chechina 44 cheImplementation Regulations yeDrug Administration Law yePeople's Republic of China inoti: Matanho ekutungamira, zvinyorwa zvechigadzirwa, uye zvinodiwa zvemishonga uye zviyero zvemidziyo yekurongedza yemishonga uye midziyo inogadzirwa uye yakaburitswa nedhipatimendi rekutonga zvinodhaka reHurumende Council. . "Maererano nezvinodiwa zvemitemo nemirairo yambotaurwa, State Drug Administration yakaronga mumabheji kubvira 2002. Yakagadzira uye yakapa zviyero 113 zvemidziyo yekurongedza yemishonga (zvinhu) (kusanganisira 2004 yakarongwa kuburitswa zviyero), kusanganisira 43 miyero yemishonga yegirazi bhodhoro. midziyo yekurongedza (zvishandiso), uye huwandu hwemazinga akaverengera 38% yehuwandu hwemishonga yekurongedza misha miyero. Iyo yakajairwa chiyero inovhara mishonga yegirazi bhodhoro midziyo yekurongedza yemhando dzakasiyana dzejekiseni senge majekiseni ehupfu, jekiseni remvura, infusions, mapiritsi, mapiritsi, zvinwiwa zvemukanwa uye lyophilized, vaccin, zvigadzirwa zveropa uye mamwe mafomu emushonga. Iyo yakakwana uye yakamisikidzwa yekurapa girazi bhodhoro standardization system yakatanga kuumbwa. Kugadzirwa uye kuburitswa kwemayero aya, kutsiviwa kwemabhodhoro egirazi emishonga uye midziyo, kuvandudzwa kwemhando yechigadzirwa, kuvimbiswa kwemhando yemishonga, kukurumidza kwekubatanidzwa nemitemo yepasirese uye musika wepasi rose, kusimudzirwa uye kudzora vane hutano. , kurongeka, uye kukurumidza kukura kweChinese mishonga yegirazi indasitiri , Iine chirevo chakakosha uye basa.
Mishonga yegirazi mabhodhoro zvinhu zvekurongedza izvo zvinosangana zvakananga nemishonga. Ivo vanotora chikamu chikuru mumunda wemishonga yekurongedza zvinhu, uye vane zvisingadzoreki zvivakwa uye zvakanakira. Zviyero zvavo zvine simba rakakosha pamhando yekurongedza kwemishonga uye kusimudzira indasitiri.
Medicated system
2 Yakamisikidzwa sisitimu yemabhodhoro egirazi emishonga
Zvinoenderana neiyo State Drug Administration's zviyero zvekugadzira mishonga yekurongedza zvinhu zvakakamurwa nezvinhu, chimwe chinhu (yakasiyana) uye imwe chiyero, kune makumi mana nematatu mazinga emabhodhoro egirazi emishonga akapihwa uye anofanira kuburitswa. Yakakamurwa muzvikamu zvitatu zvichienderana nemhando yemhando. Pane 23 zvigadzirwa zviyero muchikamu chekutanga, izvo gumi nemasere zvakaburitswa, uye 5 zvakarongwa kuburitswa muna 2004; 17 miyero yemhando yechipiri nzira yekuedza, iyo gumi yakaburitswa, uye 7 yakarongwa kuburitswa muna 2004. Pane 3 yakakosha zviyero zvechikamu chechitatu, 1 yacho yakadhindwa, 2 ichaburitswa mu2004. Kune marudzi makumi maviri nematatu emhando yezvigadzirwa muchikamu chekutanga, ayo akakamurwa kuva 8 mhando maererano nemhando dzechigadzirwa, kusanganisira "Mabhodhoro Ejekiseni Akaumbwa" 3 "Mabhodhoro Ejekiseni Anodzorwa" 3 "Mabhodhoro eGlass Infusion" 3 "Mold Pharmaceutical Bottles" 3 "Tube Pharmaceutical 3 zvinhu zve "Mabhodhoro", 3 zvinhu zve "Controlled Oral Liquid Bottles", 3 zvinhu zve "Ampoules" uye 3 zvinhu zve "Glass Medicinal Tubes" (Cherechedza: Ichi chigadzirwa chigadzirwa chehafu-chakapedzwa chekugadzirisa akasiyana mabhodhoro ekudzora uye ampoules).
Kune marudzi matatu ekubatanidza zvinhu, kusanganisira 8 zvinhu zve borosilicate girazi. Borosilicate girazi rinosanganisira α = (4 ～ 5) × 10 (-6) K (-1) (20 ～ 300 ℃) girazi risina kwariri uye α = (3. 2 ~ 3. 4) × 10 (-6) K (- 1) (20 ~ 300 ° C) 3.3 Borosilicate girazi. Rudzi rwegirazi urwu rwakagadzirwa negirazi repasi rose rakarerekera, iro rinowanzo kunzi Class I girazi kana Class A zvinhu. Pane 8 zvinhu zvepasi borosilicate girazi, uye yakaderera borosilicate girazi iri α = (6.2 kusvika 7. 5) × 10 (-6) K (-1) (20 kusvika 300 ℃). Rudzi urwu rwegirazi zvinhu ndeye China yakasarudzika quasi-neutral girazi risingakwanise kuenderana nezviyero zvepasirese. Iyo inowanzonziwo Class B zvinhu. Soda-lime girazi 7 zvinhu, soda-lime girazi iri α = (7.6 kusvika 9. 0) × 10 (-6) K (-1) (20 kusvika 300 ℃), rudzi urwu rwegirazi zvinhu runowanzo vulcanized, uye iyo pamusoro pemvura inodzivirira Kuita kunosvika padanho 2.
Kune 17 zviyero zvemhando yechipiri yekuongorora nzira. Aya maitiro ekuongorora maitiro anonyanya kuvhara zvinhu zvakasiyana-siyana zvekuongorora zvakaita sekuita uye zviratidzo zvemhando dzakasiyana dzemabhodhoro egirazi emishonga. Kunyanya, kuyedzwa kwegirazi kemikari zvivakwa kwakawedzera mashandiro matsva ekuramba kwemvura zvinoenderana neISO zviyero Kuonekwa kwealkali uye asidi kuramba kunopa yakawanda, yakazara uye nesainzi nzira dzekuona dzekuziva kugadzikana kwemakemikari kuitira kugadzirisa zvakasiyana zvigadzirwa zve. mishonga yegirazi mabhodhoro kune zvinodhaka zvezvakasiyana zvivakwa uye dosage mafomu. Kuve nechokwadi chemhando yemabhodhoro egirazi emishonga uye nekudaro mhando yemishonga ichaita basa rakakosha. Uye zvakare, nzira dzekuona dzehuwandu hwekuleaching hwezvinhu zvinokuvadza dzakawedzerwa kuve nechokwadi chekuchengetedzwa kwemabhodhoro egirazi emishonga. Iyo yekuyedza nzira zviyero zvemabhodhoro egirazi emishonga inoda kuwedzerwa kuwedzerwa. Semuyenzaniso, nzira yekuyedza ye alkali-resistant kubviswa kwekupokana kweampoules, nzira yekuyedza yekupwanya simba, uye nzira yekuyedza yekudzivirira kuvhunduka kwechando zvese zvine simba rakakosha pamhando nekushandiswa kwemabhodhoro egirazi emishonga.
Pane 3 basic standards muchikamu chechitatu. Pakati pavo, "Kuronga uye Kuedza Nzira dzeMedical Glass Bottles" inoreva ISO 12775-1997 "Kuronga uye Kuedza Nzira dzeGlass muNormal Large-Scale Production". Mabhodhoro ekuumbwa kwechikamu uye bvunzo nzira zviyero zvine tsananguro yakajeka yekusiyanisa magirazi zvinhu kubva kune mamwe maindasitiri. Mimwe miviri miviri miyero inodzikamisa zvinhu zvinokuvadza zvegirazi zvinhu, lead, cadmium, arsenic, uye antimony, kuve nechokwadi chekuchengetedza uye kushanda kwemhando dzakasiyana dzemishonga.
Hunhu hwemabhodhoro emishonga
3 Hunhu hweiyo yekurapa girazi bhodhoro chiyero
Iyo mishonga yegirazi bhodhoro chiyero ibazi rakakosha reiyo yakajairwa sisitimu yemishonga yekurongedza zvinhu. Sezvo mabhodhoro egirazi emishonga ari kusangana zvakananga nemishonga, uye mamwe acho anoda kuchengetwa kwenguva yakareba, mhando yemabhodhoro egirazi yemishonga inobatana zvakananga nemhando yemishonga uye inosanganisira hutano hwevanhu uye chengetedzo. Naizvozvo, chiyero chemishonga yegirazi mabhodhoro ane zvakakosha uye zvakasimba zvinodiwa, izvo zvinopfupikiswa sezvizvi:
Yakawedzera kurongeka uye yakazara, iyo inosimudzira kusarudzwa kwezviyero zvechigadzirwa uye inokunda iyo lag yemazinga kune zvigadzirwa.
Chigadzirwa chimwe chete chakacherechedzwa nechiyero chitsva chakavakirwa pamusimboti wekugadzira zviyero zvakasiyana zvichibva pane zvakasiyana zvinhu, izvo zvinowedzera zvakanyanya kuwanda kweiyo chiyero, inowedzera kushanda uye kusarudzwa kwemishonga mitsva yakasiyana-siyana uye mishonga yakakosha kune akasiyana girazi zvinhu uye kushanda kwakasiyana. zvigadzirwa, uye shanduko Mitemo mune zvakajairika zvigadzirwa zviyero zvinosara kumashure kwekugadzirwa kwechigadzirwa.
Semuyenzaniso, pakati pemhando 8 dzemishonga yemabhodhoro emabhodhoro emishonga yakafukidzwa nechiyero chitsva, chiyero chega chega chechigadzirwa chakakamurwa muzvikamu zvitatu zvinoenderana nechinhu uye kuita, chikamu chekutanga girazi reborosilicate, chikamu chechipiri chakaderera borosilicate girazi, uye chechitatu. Kirasi ndeye soda lime girazi. Kunyangwe chimwe chigadzirwa cheimwe mhando yezvinhu chisati chagadzirwa, zviyero zverudzi urwu rwechigadzirwa zvakaunzwa, izvo zvinogadzirisa dambudziko rekunonoka mukugadzirwa kwezvakajairwa zvigadzirwa. Mhando dzakasiyana dzemishonga ine magiredhi akasiyana, zvivakwa zvakasiyana, kushandiswa kwakasiyana uye mafomu ekuyeresa ane zvakawanda kushanduka uye sarudzo huru yemhando dzakasiyana dzezvigadzirwa uye zviyero.
Yakajekesa tsananguro yegirazi yeborosilicate uye yakaderera borosilicate girazi. Chiyero chepasi rose ISO 4802. 1-1988 “Kuramba Mvura kweGlassware neMagirazi eMagirazi emukati. Chikamu 1: Kutsunga uye Kurongeka neTitration. Girazi) rinotsanangurwa segirazi rine 5 kusvika 13% (m / m) ye boron trioxide (B-2O-3), asi ISO 12775 "Kukamurwa kwegirazi kuumbwa uye nzira dzekuyedza dzeyakajairwa kugadzirwa kwemazhinji" yakapihwa muna 1997 Tsananguro ye borosilicate. girazi (kusanganisira neutral girazi) ine boron trioxide (B-2O-3) yakakura kupfuura 8% (m / m). Zvinoenderana neyakajairwa 1997 chiyero chepasi rose chemisimboti yegirazi, iyo girazi zvinhu zvingangoita 2% (m / m) yeB-2O-3, iyo yakashandiswa zvakanyanya muChinese mishonga yegirazi bhodhoro indasitiri kwemakore mazhinji, haifanirwe kudaidzwa. girazi re borosilicate kana girazi risina kwariri. Muedzo uyu unoratidza kuti mamwe egirazi diki rekudzivirira mvura uye bvunzo yemukati memvura yekuramba yemidziyo iyi inotadza kusvika paNhamba 1 neHC1, kana kuti iri pakati pemipendero yeNhamba 1 neNhamba 2. Kudzidzira kwakaratidzawo kuti mamwe emhando idzi. yegirazi ichange iine kutadza kwayakarerekera kana kupepeta mukushandiswa, asi rudzi urwu rwegirazi rwakashandiswa muChina kwemakore mazhinji. Muyero mutsva unochengeta rudzi urwu rwegirazi uye unotsanangura B-2O- Zviri mukati me3 zvinofanirwa kusangana nezvinodiwa zve5-8% (m / m). Zvinonyatsotsanangurwa kuti rudzi urwu rwegirazi harugoni kunzi borosilicate girasi (kana kuti girasi risina zvematongerwo enyika), uye inonzi yakaderera borosilicate girazi.
Shingairira kutora ISO zviyero. Miyero mitsva inoenderana nezviyero zvepasi rose. Miyero mitsva inoreva zvizere kune ISO zviyero uye maindasitiri zviyero uye pharmacopoeia yeUnited States, Germany, Japan nedzimwe nyika dzepamusoro, uye inosanganisa iwo chaiwo mamiriro eiyo Chinese mishonga yegirazi bhodhoro indasitiri kubva kune maviri maficha emhando dzegirazi uye zvigadzirwa zvegirazi. Yakasvika pasi rose.
Girazi zvinhu mhando: Kune 4 mhando dzegirazi muyero mutsva, kusanganisira 2 mhando dzegirazi reborosilicate, kusanganisira 3.3 borosilicate girazi [α = (3. 3 ± 0. 1) × 10 (-6) K (-1) ] Uye 5.0 0 girazi risina kwaakarerekera [α = (4 kusvika 5) × 10 (-6) K (-1)], pasi borosilicate girazi [α = (6.2 kusvika 7. 5) × 10 (-6) K (-1) ] 1 mhando, soda-lime girazi [α = (7.6 ~ 9. 0) × 10 (-6) K (-1)] 1 mhando, saka kune 4 marudzi egirazi nezvinhu.
Nekuti soda lime girazi rinosanganisira huwandu hukuru hwekunatira kwepasi pekurapa mukugadzirwa chaiko uye kushandiswa, inokamurwa kuita 5 mhando zvichienderana nechigadzirwa. Idzo dziri pamusoro 4 mhando dzegirazi uye 5 mhando dzezvigadzirwa zvegirazi dzinosanganisira zviyero zvepasi rose, US Pharmacopoeia uye China-chaiyo mabhodhoro egirazi ekurapa. Pamusoro pezvo, pazvigadzirwa zvisere zvakafukidzwa nechiyero, maampoules chete akagadzira 2 zviyero, "borosilicate glass ampoules" uye "low borosilicate glass ampoules," uye mhando imwe chete ye α = (4 kusvika 5) × 10 (-6) K (-1) ye5.0 borosilicate girazi isina α = (3. 3 ± 0. 1) × 10 (-6) K (-1) ye 3. 3 borosilicate girazi Inonyanya nokuti hapana chigadzirwa chakadaro munyika. , uye iyo yakapfava yegirazi ye3.3 borosilicate yakakwirira, izvo zvinoita kuti zvive zvakaoma kuvhara ampoule. Muchokwadi, chiyero chepasi rose chine 5.0 borosilicate girazi ampoule, uye hapana 3.3 borosilicate girazi ampoule uye soda-lime girazi ampoule. Nezve China yakasarudzika yakaderera borosilicate girazi ampoules, 5.0 borosilicate girazi ampoules haisati yagadzira yakatarwa nguva yeyakakura-yakagadzikana kugadzirwa muChina nekuda kwezvikonzero zvakasiyana, uye inogona chete kushandiswa sechigadzirwa chekuchinja. Pakupedzisira, pasi borosilicate girazi ichiri shoma. Ampoule, gadzira 5.0 borosilicate girazi ampoule kuti uwane kubatanidzwa kwakazara nemaitiro epasi rose uye zvigadzirwa nekukurumidza sezvinobvira.
Kuita zvemagirazi egirazi: Iyo yekupisa yekuwedzera coefficient α inotsanangurwa muyero nyowani, 3.3 borosilicate girazi uye 5.0 borosilicate girazi zvinonyatsoenderana nezviyero zvepasirese. Yakaderera borosilicate girazi yakasarudzika kuChina, uye hapana zvinhu zvakadaro mune zvepasirese zviyero. Soda-lime girazi ISO inotara α = (8 ～ 10) × 10 (-6) K (-1), uye mwero mutsva unotaura α = (7.6–9. 0) × 10 (-6) K (-1) , The zviratidzo zvishoma kuomarara kupfuura mitemo yenyika. Muchiyero chitsva, makemikari e3.3 borosilicate girazi, 5.0 borosilicate girazi uye soda-lime girazi pa 121 ° C inopindirana nemitemo yenyika. Mukuwedzera, zvinodiwa zvemakemikari e boron oxide (B-2O-3) mumhando nhatu dzegirazi zvinonyatsoenderana nemitemo yenyika.
Kuita kwechigadzirwa chegirazi: Kuita kwechigadzirwa kwakatarwa muyero nyowani, iyo yemukati pamusoro pemvura kuramba, kupisa kwekuvhunduka, uye yemukati kudzvinyirira zviratidzo zvinopindirana nezviyero zvepasirese. Iyo yemukati yekushushikana index ye ISO standard inotaura kuti ampoule i50nm / mm, zvimwe zvigadzirwa 40nm / mm, uye chiyero chitsva chinoti iyo ampoule i40nm / mm, saka iyo yemukati yekushushikana index yeampoule yakakwira zvishoma pane iyo. ISO standard.
Medical bottle application
Kushandiswa kwemishonga yegirazi bhodhoro zviyero
Zvigadzirwa zvakasiyana-siyana uye zvinhu zvakasiyana zvinoumba yakamisikidzwa sisitimu yekuchinjika, iyo inopa hwaro hwakakwana uye mamiriro esainzi, anonzwisisika uye akakodzera magirazi emidziyo yemhando dzakasiyana dzemishonga. Kusarudzwa uye kushandiswa kwemishonga yakasiyana-siyana mumhando dzakasiyana dzedosi, zvivakwa zvakasiyana uye mamakisi akasiyana emabhodhoro egirazi emishonga anofanira kutevedzera zvinotevera misimboti:
Kugadzikana kwemakemikari
Yakanaka uye Yakakodzera Kemikari Yakagadzikana Mitemo
Chigadziko chegirazi chinoshandiswa kubata marudzi ese emishonga chinofanirwa kuenderana nemushonga, kureva, mukugadzira, kuchengetedza uye kushandiswa kwemushonga, makemikari emugaba regirazi haafanire kunge asina kugadzikana, uye zvimwe zvinhu pakati. havafaniri kuitika. Kusiyana kana kusashanda kwemishonga kunokonzerwa nekuchinja kwemakemikari. Semuenzaniso, midziyo yegirazi yakagadzirwa negirazi yeborosilicate inofanira kusarudzwa kumishonga yepamusoro-soro yakadai sekugadzirira ropa uye majekiseni, uye marudzi akasiyana-siyana emvura yakasimba uye alkali majekiseni emvura, kunyanya majekiseni emvura ane alkaline, anofanirawo kugadzirwa negirazi re borosilicate. . Iyo yakaderera-borosilicate magirasi ampules ayo anoshandiswa zvakanyanya muChina haana kukodzera kune ine mvura jekiseni gadziriro. Zvigadzirwa zvegirazi zvakadaro zvinofanirwa kuchinjika zvishoma nezvishoma kuenda ku5.0 magirazi zvinhu kuitira kuti zvienderane nezviyero zvepasi rose nekukurumidza kuti zvive nechokwadi chekuti mishonga yainayo haisi kushandiswa. Off-chip, kwete turbid, uye haina kuipa.
Kune majekiseni ehupfu, kugadzirira nemuromo uye infusions yakakura, kushandiswa kwegirazi reborosilicate rakaderera kana kuti neutralized soda-lime girazi rinogona kuramba richizadzisa zvido zvayo zvekugadzikana kwemakemikari. Dhigirii rekuora kwemishonga kune girazi kazhinji mvura yakakura kupfuura yakaoma uye alkalinity yakakura kupfuura acidity, kunyanya majekiseni akasimba ealkaline emvura ane akakwira makemikari ekuita zvinodiwa kumabhodhoro egirazi emishonga.
Kudzivirira kuderera kwekupisa
Kupikisa kwakanaka kwekukurumidza kuchinja kwekushisa
Mukugadzirwa kwemhando dzakasiyana-siyana dzemishonga, kuomeswa kwepamusoro-tembiricha, sterilization kana kutonhora-kuomesa-kuomesa kunodiwa mukugadzira, izvo zvinoda kuti chigadziko chegirazi chine simba rakanaka uye rakakodzera rekudzivisa kushanduka kamwe kamwe kwekushisa pasina kuputika. . Kupokana kwegirazi kukurumidza kushanduka kwekushisa kunonyanya kuenderana neiyo coefficient yekuwedzera kwekupisa. Iyo yakaderera iyo coefficient yekuwedzera kwekupisa, iyo yakasimba kuramba kwayo kushanduka kwekushisa. Semuyenzaniso, akawanda emhando yepamusoro-ekupedzisira majekiseni ekugadzirira, biological gadziriro uye lyophilized gadziriro vanofanira kazhinji kushandisa 3.3 borosilicate girazi kana 5.0 borosilicate girazi. Kana huwandu hukuru hwegirazi-yakaderera-borosilicate girazi inogadzirwa muChina inoiswa nekukurumidza shanduko mukusiyana kwetembiricha, inowanzoita kuputika nekudonhedza mabhodhoro. China's 3.3 borosilicate girazi ine kukura kukuru, girazi iri rinonyanya kukodzera kugadzirira lyophilized, nokuti kuramba kwayo kushanduka kamwe kamwe kwekushisa kuri nani kupfuura 5.0 borosilicate girazi.
Mechanical simba
Yakanaka uye yakakodzera mechanical simba
Mishonga iri mumhando dzakasiyana dzedosi inoda kumira imwe dhigirii remechani kuramba panguva yekugadzira uye yekufambisa. Simba remagetsi remishonga yegirazi mabhodhoro uye midziyo haina kungoenderana chete nechimiro chebhodhoro, saizi yejometri, kugadzirwa kwemafuta, nezvimwewo, asiwo simba remagetsi rezvinhu zvegirazi. Kune imwe nhanho, iyo mechanical simba ye borosilicate girazi iri nani pane iyo soda-lime girazi.
Kuburitswa nekuitwa kwezviyero zvitsva zvemabhodhoro egirazi emishonga zvinodikanwa kumisikidza yakakwana uye yesainzi yekumisikidza sisitimu, kumhanyisa kumhanya kwekubatanidzwa nemazinga epasi rose nemisika yepasirese, nekuvandudza mhando yemishonga yekurongedza zvinhu, kuve nechokwadi chemhando yemishonga, kukurudzira kusimukira kweindasitiri nekutengeserana kwenyika. Ichaita basa rakanaka. Ehe, seyakajairwa sisitimu yemishonga yekurongedza zvinhu, kuchine nyaya dzakawanda dzinoda kuvandudzwa, kuvandudzwa, uye kukwenenzverwa mune yekutanga standard system yemabhodhoro egirazi emishonga, kunyanya kugadzirisa kukurumidza kusimudzira kweindasitiri yemishonga. uye kubatanidzwa kwemusika wepasi rose. Claim. Iko kuumbwa, zvinyorwa uye zviratidzo zvezviyero, uye kusvika kune iyo mitemo yenyika yose inogamuchirwa uye maererano nemusika wepasi rose zvinoda kugadziriswa kwakakodzera uye kuwedzerwa panguva yekudzokorora.
Girazi bhodhoro uye tangi yekuyedza zviyero:
Nzira yekuedza yekushushikana kwezvirongo zvegirazi: ASTM C 148-2000 (2006).
Nguva yekutumira: Zvita-06-2019