Tsarin daidaitawa
1 Standards da daidaitattun tsarin don kwalabe gilashi
sashi na 52 na dokar kula da magunguna ta Jamhuriyar Jama'ar kasar Sin ya tanadi cewa: "Kayan marufi da kwantena da ke hulda da magunguna dole ne su cika ka'idojin amfani da magunguna da ka'idojin aminci."Sashe na 44 na aiwatar da ka'idojin hukumar kula da magunguna ta kasar Sin ya bayyana cewa: Ma'aikatar kula da magunguna ta majalisar gudanarwar kasar Sin ce ta tsara da kuma buga matakan gudanarwa, da kasidun kayayyakin da ake bukata, da ka'idojin harhada magunguna da kayyakin magunguna da kwantena. .“Bisa ga buƙatun dokokin da aka ambata a baya, Hukumar Kula da Magunguna ta Jiha ta shirya a batches tun 2002. Ƙirƙira kuma ta ba da ka'idoji 113 don kwantena na marufi (kayan) (ciki har da ka'idodin sakin 2004 da aka tsara), gami da ka'idoji 43 na kwalban gilashin magani. kwantena marufi (kayan), kuma adadin ma'auni ya kai kashi 38% na jimillar marufi na ƙauyen.Matsakaicin iyaka ya ƙunshi kwantena na kwalban gilashin magunguna don nau'ikan allura daban-daban kamar allurar foda, allurar ruwa, infusions, allunan, kwaya, ruwa na baka da lyophilized, alluran rigakafi, samfuran jini da sauran nau'ikan sashi.An fara kafa tsarin daidaita ma'aunin gilashin likitanci cikakke kuma daidaitacce.Ƙirƙirar da sakin waɗannan ka'idodi, maye gurbin kwalabe na gilashin magani da kwantena, haɓaka ingancin samfur, tabbatar da ingancin magunguna, haɓaka haɓakar haɗin gwiwa tare da ka'idodin duniya da kasuwannin duniya, haɓakawa da ƙa'idodi na lafiya. , bisa tsari, da saurin bunkasuwar masana'antar gilashin magunguna ta kasar Sin, tana da ma'ana da rawar da take takawa.
kwalaben gilashin magani kayan tattarawa ne waɗanda ke cikin hulɗa kai tsaye tare da magunguna.Suna mamaye babban kaso a fagen kayan tattara magunguna, kuma suna da kaddarorin da ba za a iya maye gurbinsu ba.Matsayin su yana da tasiri mai mahimmanci akan ingancin marufi da ci gaban masana'antu.
Tsarin magani
2 Daidaitaccen tsarin don kwalaben gilashin magani
Dangane da ka’idojin Hukumar Kula da Magunguna ta Jiha na samar da kayan tattara magunguna da aka raba da kayan, abu daya ( iri-iri) da ma’auni daya, akwai ka’idoji 43 na kwalaben magani da aka fitar kuma za a sake su.An kasu kashi uku bisa ga ma'auni.Akwai ka'idodin samfura guda 23 a rukuni na farko, waɗanda aka fitar da 18 daga cikinsu, kuma an shirya fitar da 5 a cikin 2004;Ma'auni 17 na hanyar gwajin nau'i na biyu, wanda 10 aka saki, kuma 7 an shirya fitar da su a shekara ta 2004. Akwai ma'auni na asali guda 3 na rukuni na uku, 1 daga cikinsu an buga, 2 za a sake shi a shekara ta 2004. Akwai nau'ikan ma'auni guda 23 a rukunin farko, waɗanda aka raba su zuwa nau'ikan nau'ikan nau'ikan samfura guda 8, gami da "Klulaban allurar da aka ƙera" 3 "Klulaban allurar da aka sarrafa" 3 "Glass ɗin Jikin Gilashin" 3 "Kwalayen Magunguna" 3 "Tube". Pharmaceutical 3 abubuwa na "Klulabai", 3 abubuwa na "Controlled Oral Liquid Bottles", 3 abubuwa na "Ampoules" da 3 abubuwa na "Glass Magani Tubes" (Lura: Wannan samfurin ne Semi-kare samfurin don sarrafa daban-daban iko kwalabe da kuma ampoules).
Akwai nau'ikan kayan haɗin gwiwa iri uku, gami da abubuwa 8 na gilashin borosilicate.Gilashin Borosilicate ya haɗa da α = (4 ～ 5) × 10 (-6) K (-1) (20 ～ 300 ℃) gilashin tsaka tsaki da α = (3. 2 ~ 3. 4) × 10 (-6) K (- 1) (20 ~ 300 ° C) 3.3 Borosilicate gilashin.Irin wannan gilashin an yi shi da gilashin tsaka-tsakin duniya, wanda kuma ana kiransa gilashin Class I ko kayan Aji.Akwai abubuwa 8 na ƙaramin gilashin borosilicate, kuma ƙaramin gilashin borosilicate shine α = (6.2 zuwa 7. 5) × 10 (-6) K (-1) (20 zuwa 300 ℃).Irin wannan nau'in gilashin gilashin gilas ne na musamman na kasar Sin wanda ba zai iya yin daidai da ka'idojin kasa da kasa ba.Hakanan ana kiranta da kayan Class B.Soda-lemun tsami gilashin 7 abubuwa, soda-lemun tsami gilashin ne α = (7.6 to 9. 0) × 10 (-6) K (-1) (20 zuwa 300 ℃), irin wannan gilashin abu ne kullum vulcanized, da kuma surface ne ruwa resistant Aiki ya kai matakin 2.
Akwai ma'auni 17 don nau'ikan hanyoyin dubawa na biyu.Waɗannan ƙa'idodin hanyar dubawa suna rufe abubuwa daban-daban na dubawa kamar aiki da alamun nau'ikan kwalabe na gilashin magunguna daban-daban.Musamman ma, gwajin kaddarorin sinadarai na gilashi ya kara sabon aikin juriya na ruwa daidai da ka'idodin ISO Binciken alkali da juriya na acid yana ba da ƙarin, ƙarin cikakkun bayanai da hanyoyin gano kimiyya don gano kwanciyar hankali na sinadarai don daidaita samfuran samfuran daban-daban. kwalabe gilashin magani zuwa kwayoyi na kaddarorin daban-daban da nau'ikan sashi.Tabbatar da ingancin kwalabe na magunguna don haka ingancin magunguna zai taka muhimmiyar rawa.Bugu da ƙari, an ƙara hanyoyin gano adadin leaching na abubuwa masu cutarwa don tabbatar da amincin kwalabe na gilashin magunguna.Hanyar gwajin gwajin kwalabe na magani yana buƙatar ƙarin ƙari.Misali, hanyar gwaji don jure juriyar alkali juriya na ampoules, hanyar gwaji don karya ƙarfi, da kuma hanyar gwajin juriya ga daskarewa duk suna da tasiri mai mahimmanci akan inganci da aikace-aikacen kwalabe na gilashin magunguna.
Akwai ma'auni na asali guda 3 a cikin rukuni na uku.Daga cikin su, "Rabawa da Hanyoyin Gwaji na Gilashin Gilashin Likita" yana nufin ISO 12775-1997 "Rarraba da Hanyoyin Gwajin Gilashin a cikin Samar da Babban Sikeli na Al'ada".Rarraba abun da ke ciki na kwalba da ka'idodin hanyar gwaji suna da bayyananniyar ma'ana don bambanta kayan gilashi daga sauran masana'antu.Sauran matakan asali guda biyu suna iyakance abubuwan cutarwa na kayan gilashi, gubar, cadmium, arsenic, da antimony, don tabbatar da aminci da ingancin nau'ikan magunguna daban-daban.
Halayen kwalabe na magani
3 Halayen ma'auni na gilashin magani
Ma'auni na kwalban gilashin magunguna wani muhimmin reshe ne na tsarin daidaitaccen tsarin don kayan marufi na magunguna.Tunda kwalaben gilashin magani suna da alaƙa kai tsaye da magungunan, kuma wasu daga cikinsu suna buƙatar adana su na dogon lokaci, ingancin kwalaben magani yana da alaƙa kai tsaye da ingancin magungunan kuma ya shafi lafiyar ɗan adam da aminci.Don haka, ma'aunin kwalabe na magani yana da buƙatu na musamman kuma masu tsauri, waɗanda aka taƙaita kamar haka:
Ƙarin tsari da cikakke, wanda ke haɓaka zaɓin ƙa'idodin samfuri kuma ya shawo kan rashin daidaituwa ga samfurori.
Samfurin guda da aka gano ta sabon ma'auni ya dogara ne akan ka'idar samar da ma'auni daban-daban dangane da kayan aiki daban-daban, wanda ke fadada girman ma'auni, yana haɓaka aiki da zaɓin sababbin magunguna da magunguna na musamman ga kayan gilashi daban-daban da kuma ayyuka daban-daban. samfura, da canje-canjen Ma'auni a cikin ƙa'idodin samfur gabaɗaya baya bayan haɓaka samfuri.
Misali, a cikin nau'ikan nau'ikan samfuran kwalabe na magani guda 8 wanda sabon ma'auni ya rufe, kowane ma'aunin samfurin ya kasu kashi 3 bisa ga kayan aiki da aiki, nau'in farko shine gilashin borosilicate, nau'in na biyu shine ƙaramin gilashin borosilicate, na uku kuma. Class shine gilashin soda lemun tsami.Duk da cewa har yanzu ba a samar da wani samfur na wani nau'i na kayan aiki ba, amma an gabatar da ka'idoji na irin wannan samfurin, wanda ke magance matsalar koma baya wajen samar da daidaitattun kayayyaki.Daban-daban na kwayoyi tare da maki daban-daban, kaddarorin daban-daban, amfani daban-daban da nau'ikan sashi suna da ƙarin sassauci da zaɓi mafi girma don nau'ikan samfura da ƙa'idodi daban-daban.
Ya fayyace ma'anar gilashin borosilicate da ƙaramin gilashin borosilicate.Matsayin kasa da kasa ISO 4802. 1-1988 “Tsarin Ruwa na Gilashin Gilashi da Filayen Ciki na Gilashin.Sashe na 1: Ƙaddara da Rarraba ta Titration."Gilashi) an bayyana shi azaman gilashin da ke ɗauke da 5 zuwa 13% (m / m) na boron trioxide (B-2O-3), amma ISO 12775 "Rarraba abun da ke cikin gilashi da hanyoyin gwaji don samar da taro na al'ada" da aka bayar a cikin 1997 Ma'anar borosilicate. gilashin (ciki har da gilashin tsaka tsaki) ya ƙunshi boron trioxide (B-2O-3) fiye da 8% (m / m).Bisa ga ka'idojin rarraba gilashin na kasa da kasa na 1997, gilashin abu mai kimanin 2% (m / m) na B-2O-3, wanda aka yi amfani da shi sosai a masana'antar gilashin kwalba na kasar Sin shekaru da yawa, bai kamata a kira shi ba. gilashin borosilicate ko gilashin tsaka tsaki.Gwajin ya tabbatar da cewa wasu daga cikin juriya na ruwan gilashin da gwajin juriya na ruwa na ciki na waɗannan kayan sun kasa kaiwa matakin 1 da HC1, ko kuma suna tsakanin gefuna na Level 1 da Level 2. Hakazalika ya tabbatar da cewa wasu daga cikin waɗannan nau'ikan. Gilashin gilashi zai sami gazawar tsaka-tsaki ko kwasfa a cikin amfani, amma ana amfani da irin wannan gilashin a China shekaru da yawa.Sabon ma'auni yana riƙe da irin wannan gilashin kuma ya ƙayyade B-2O- Abubuwan da ke cikin 3 ya kamata ya dace da bukatun 5-8% (m / m).An bayyana a sarari cewa irin wannan gilashin ba za a iya kiransa gilashin borosilicate (ko gilashin tsaka-tsakin ba), kuma ana kiransa ƙaramin gilashin borosilicate.
Yi amfani da ƙa'idodin ISO da gaske.Sabbin ka'idojin sun yi daidai da ka'idojin kasa da kasa.Sabbin ka'idodin sun yi la'akari da ka'idodin ISO da ka'idojin masana'antu da magunguna na Amurka, Jamus, Japan da sauran ƙasashe masu ci gaba, kuma sun haɗu da ainihin yanayin masana'antar kwalban gilashin magunguna na kasar Sin daga bangarorin biyu na nau'ikan gilashi da kayan gilashi. Ya kai matsayin duniya.
Nau'in kayan gilashi: Akwai nau'ikan gilashin 4 a cikin sabon ma'auni, gami da nau'ikan gilashin borosilicate guda 2, gami da gilashin borosilicate na 3.3 [α = (3. 3 ± 0. 1) × 10 (-6) K (-1)] Kuma 5.0 0 gilashin tsaka tsaki [α = (4 zuwa 5) × 10 (-6) K (-1)], ƙananan gilashin borosilicate [α = (6.2 zuwa 7. 5) × 10 (-6) K (-1) ] nau'in 1, gilashin soda-lime [α = (7.6 ~ 9. 0) × 10 (-6) K (-1)] nau'in 1, don haka akwai nau'in gilashin 4 ta kayan aiki.
Saboda gilashin soda lemun tsami ya haɗa da adadi mai yawa na jiyya na ƙasa a cikin ainihin samarwa da aikace-aikacen, an raba shi zuwa nau'ikan 5 bisa ga samfurin.Nau'o'in gilashin 4 da ke sama da nau'ikan samfuran gilashin 5 sun haɗa da ka'idodin ƙasashen duniya, Pharmacopoeia na Amurka da kwalaben gilashin likitanci na musamman na China.Bugu da ƙari, daga cikin samfurori na 8 da aka rufe da ma'auni, kawai ampoules sun haɓaka matakan 2, "ampoules gilashin borosilicate" da "ƙananan gilashin gilashin borosilicate," kuma nau'i ɗaya kawai na α = (4 zuwa 5) × 10 (-6). K (-1) na gilashin borosilicate na 5.0 ba tare da α = (3. 3 ± 0. 1) × 10 (-6) K (-1) na 3. 3 gilashin borosilicate Shi ne yafi saboda babu irin wannan samfurin a duniya. , kuma wurin laushi na gilashin borosilicate 3.3 yana da girma, wanda ya sa ya zama da wuya a rufe ampoule.A gaskiya ma, ƙa'idar ƙasa da ƙasa tana da ampoule gilashin borosilicate 5.0 kawai, kuma babu gilashin gilashin borosilicate 3.3 da ampoule gilashin soda-lime.Dangane da nau'in ampoules na gilashin borosilicate na musamman na kasar Sin, nau'in gilashin borosilicate guda 5.0 har yanzu ba su samar da wani takamaiman lokaci na samar da kwanciyar hankali mai girma a kasar Sin ba saboda dalilai daban-daban, kuma ana iya amfani da su a matsayin samfurin mika mulki kawai.A ƙarshe, ƙananan gilashin borosilicate har yanzu yana iyakance.Ampoule, haɓaka ampoule gilashin borosilicate 5.0 don cimma cikakkiyar haɗin kai tare da ka'idoji da samfuran duniya da wuri-wuri.
Ayyukan kayan aikin gilashi: Ƙirar haɓakar haɓakar thermal α da aka ƙayyade a cikin sabon ma'auni, gilashin borosilicate 3.3 da gilashin borosilicate 5.0 sun yi daidai da ƙa'idodin duniya.Ƙananan gilashin borosilicate na musamman ne ga kasar Sin, kuma babu irin waɗannan kayan a cikin matakan duniya.Gilashin Soda-Lime ISO ya kayyade α = (8 ～ 10) × 10 (-6) K (-1), kuma sabon ma'auni yana α = (7.6-9. 0) × 10 (-6) K (-1) , Alamun sun ɗan tsana fiye da ƙa'idodin ƙasashen duniya.A cikin sabon ma'auni, sinadarai na gilashin borosilicate 3.3, gilashin borosilicate 5.0 da gilashin soda-lime a 121 ° C sun yi daidai da ka'idodin duniya.Bugu da ƙari, abubuwan da ake buƙata don tsarin sinadarai na boron oxide (B-2O-3) a cikin nau'in gilashin guda uku sun cika daidai da ka'idodin duniya.
Ayyukan samfurin gilashi: Ayyukan samfurin da aka ƙayyade a cikin sabon ma'auni, juriya na ruwa na ciki, juriya na zafi, da alamun juriya na ciki sun dace da ƙa'idodi na duniya.Indexididdigar damuwa na cikin ma'aunin ISO ya nuna cewa ampoule shine 50nm / mm, sauran samfuran sune 40nm / mm, kuma sabon ma'aunin ya nuna cewa ampoule shine 40nm / mm, don haka ma'aunin damuwa na ciki na ampoule ya ɗan fi girma fiye da ISO Standard.
Aikace-aikacen kwalban likita
Aikace-aikacen ma'auni na gilashin magunguna
Kayayyaki daban-daban da kayan daban-daban suna samar da daidaitaccen tsarin ƙetare, wanda ke ba da isasshiyar tushe da yanayi don kwantena gilashin da suka dace da ma'ana don nau'ikan magunguna daban-daban.Zabi da aikace-aikacen magunguna daban-daban a cikin siffofin sashi daban daban daban daban daban, daban-daban kaddarorin da maki daban-daban don kwalabe masu zuwa ya kamata bi wadannan ka'idodi:
Tsabar sinadarai
Kyawawan Ka'idodin Tabbatar da Sinadarai masu dacewa
Akwatin gilashin da aka yi amfani da shi don ɗaukar kowane nau'in magunguna ya kamata ya dace da maganin, wato, a cikin samarwa, adanawa da kuma amfani da miyagun ƙwayoyi, abubuwan sinadarai na gilashin gilashin ba dole ba ne su kasance m, kuma wasu abubuwa a tsakanin su. kada su faru.Bambance-bambance ko rashin tasiri na magunguna sakamakon halayen sinadaran.Misali, dole ne a zabi kwantena gilashin da aka yi da gilashin borosilicate don samun magunguna masu mahimmanci kamar shirye-shiryen jini da alluran rigakafi, da nau'ikan shirye-shiryen allurar ruwa mai ƙarfi na acid da alkali iri-iri, musamman ma shirye-shiryen allurar ruwa mai ƙarfi na alkaline, suma yakamata a yi su da gilashin borosilicate. .Ƙananan gilashin gilashin borosilicate da aka yi amfani da su sosai a kasar Sin ba su dace da dauke da shirye-shiryen allurar ruwa ba.Irin waɗannan kayan gilashi ya kamata a hankali su canza zuwa kayan gilashin 5.0 domin su kasance daidai da ƙa'idodin ƙasashen duniya da wuri-wuri don tabbatar da cewa ba a amfani da magungunan da ke cikin su.Kashe guntu, ba turbid ba, kuma baya lalacewa.
Don allurar foda na gabaɗaya, shirye-shiryen baka da manyan infusions, yin amfani da ƙaramin gilashin borosilicate ko gilashin soda-lemun tsami na iya cika buƙatun kwanciyar hankali na sinadarai.Matsayin lalata magunguna zuwa gilashin shine gabaɗaya ruwa ya fi daskararru kuma alkalinity ya fi acidity girma, musamman ƙaƙƙarfan allurar ruwa na alkaline suna da buƙatun aikin sinadarai don kwalabe na gilashin magunguna.
Resistance zuwa thermal degeneration
Kyakkyawan juriya ga saurin canjin zafin jiki
A cikin samar da nau'i-nau'i daban-daban na kwayoyi, ana buƙatar bushewa mai zafi, sterilization ko ƙananan zafin jiki daskarewa-bushewa a cikin tsarin samarwa, wanda ke buƙatar cewa gilashin gilashi yana da kyakkyawar damar da ya dace don tsayayya da canje-canje na zafin jiki ba tare da fashewa ba. .Juriya na gilashi zuwa saurin canjin zafin jiki yana da alaƙa da ƙimar haɓakar haɓakar thermal.Ƙarƙashin ƙayyadaddun ƙayyadaddun haɓakar haɓakar thermal, ƙarfin juriya ga canje-canjen zafin jiki.Alal misali, yawancin shirye-shiryen rigakafi na ƙarshe, shirye-shiryen nazarin halittu da shirye-shiryen lyophilized ya kamata a yi amfani da gilashin borosilicate 3.3 ko gilashin borosilicate 5.0.Lokacin da ƙananan gilashin borosilicate masu yawa da aka samar a kasar Sin suna fuskantar saurin sauye-sauye na bambance-bambancen yanayin zafi, sukan yi fashewa da sauke kwalabe.Gilashin borosilicate na kasar Sin mai nauyin 3.3 yana da babban ci gaba, wannan gilashin ya dace da shirye-shiryen lyophilized, saboda juriya da canjin zafin jiki ba zato ba tsammani ya fi gilashin borosilicate 5.0.
Ƙarfin injina
Kyakkyawan ƙarfin injin da ya dace
Magunguna daban daban bisa ga siffofin daban daban suna buƙatar yin tsayayya da wani matakin juriya na injin na inji yayin samarwa da sufuri.Ƙarfin injiniya na kwalabe na gilashin magani da kwantena ba kawai suna da alaƙa da siffar kwalban, girman geometric, sarrafa zafi, da dai sauransu, amma har ma da ƙarfin injin kayan gilashi.Har zuwa wani lokaci, ƙarfin injiniya na gilashin borosilicate ya fi na gilashin soda-lemun tsami.
Bayarwa da aiwatar da sabbin ka'idoji don kwalaben gilashin magani ya zama dole don kafa ingantaccen tsarin daidaitaccen tsarin kimiyya, haɓaka saurin haɗin kai tare da ka'idodin duniya da kasuwannin duniya, da haɓaka ingancin kayan marufi na magunguna, tabbatar da ingancin magunguna. inganta ci gaban masana'antu da cinikayyar kasa da kasa.Zai taka rawa mai kyau.Tabbas, kamar duk tsarin daidaitaccen tsarin kayan marufi na magunguna, har yanzu akwai batutuwa da yawa waɗanda ke buƙatar ƙarin haɓakawa, haɓakawa, da kuma daidaita su a cikin tsarin ƙa'idar farko don kwalaben gilashin magani, musamman don daidaitawa da saurin haɓaka masana'antar harhada magunguna. da kuma hadewar kasuwannin duniya.Da'awar.Ƙirƙirar, abun ciki da alamomi na ma'auni, da kuma iyakar abin da ake ɗauka na kasa da kasa da kuma dacewa da kasuwannin duniya duk suna buƙatar gyare-gyare masu dacewa da ƙari yayin bita.
Matsayin gwajin kwalban gilashi da tanki:
Hanyar gwaji don damuwa na gilashin gilashi: ASTM C 148-2000 (2006).
Lokacin aikawa: Dec-06-2019