A cikin gwaji da kuma samar da ƙwayoyin nifedipine masu dorewa, ƙwayoyin hana ɗaukar ciki, ƙwayoyin ciki masu kama da na ciki, ƙwayoyin ferrous fumarate, ƙwayoyin buflomedil hydrochloride, da sauransu, muna amfani da su.hydroxypropyl methylcellulose (HPMC)ruwa, Hydroxypropyl methylcellulose da polyacrylic acid resin liquid, Opadry (wanda Colorcon, UK ta bayar), da sauransu ruwa ne na rufe fim, waɗanda suka yi nasarar amfani da fasahar rufe fim, amma sun fuskanci matsaloli a cikin samarwa da samarwa. Bayan wasu matsalolin fasaha, yanzu muna sadarwa da abokan aiki game da matsaloli da mafita na gama gari a cikin tsarin rufe fim.
A cikin 'yan shekarun nan, fasahar rufe fim ta yi amfani sosai a cikin shirye-shiryen da suka dace. Rufin fim ɗin zai iya kare maganin daga haske, danshi da iska don ƙara kwanciyar hankali na maganin; ɓoye mummunan ɗanɗanon maganin kuma ya sauƙaƙa wa majiyyaci ya sha shi; sarrafa wurin da aka saki da saurin sakin maganin; hana canjin daidaito na maganin; inganta bayyanar kwamfutar. Haka kuma yana da fa'idodin ƙarancin tsari, ɗan gajeren lokaci, ƙarancin amfani da kuzari, da ƙarancin nauyin kwamfutar. Ingancin allunan da aka rufe fim ya dogara ne akan abun da ke ciki da ingancin ƙwayar kwamfutar, umarnin ruwan rufewa, yanayin aikin rufewa, yanayin marufi da ajiya, da sauransu. Abun da ke ciki da ingancin ƙwayar kwamfutar an fi nuna su a cikin sinadaran aiki na ƙwayar kwamfutar, abubuwan taimako daban-daban da bayyanar, tauri, guntu masu rauni, da siffar kwamfutar kwamfutar hannu. Tsarin ruwan rufewa yawanci yana ɗauke da manyan polymers na ƙwayoyin halitta, masu amfani da filastik, rini, abubuwan narkewa, da sauransu, kuma yanayin aiki na murfin shine daidaiton feshi da bushewa da kayan aikin rufewa.
1. Abrasion mai gefe ɗaya, fashewar gefen fim da kuma barewar
Taurin saman saman ƙwayayen shine mafi ƙanƙanta, kuma yana iya fuskantar gogayya mai ƙarfi da damuwa yayin aikin shafa, kuma foda ko barbashi mai gefe ɗaya suna faɗuwa, wanda ke haifar da alamun fata ko ramuka a saman ƙwayayen, wanda ke lalacewa ta gefe ɗaya, musamman tare da fim ɗin da aka sassaka mai alama. Mafi raunin ɓangaren fim ɗin a cikin ƙwayayen da aka shafa mai fim shine kusurwoyi. Idan mannewa ko ƙarfin fim ɗin bai isa ba, akwai yiwuwar fashewa da barewar gefunan fim ɗin. Wannan saboda raguwar sinadarin da ke narkewa yana sa fim ɗin ya ragu, kuma faɗaɗawa da yawa na fim ɗin da ke rufe da ƙwaya yana ƙara damuwa ta ciki na fim ɗin, wanda ya wuce ƙarfin juriya na fim ɗin.
1.1 Binciken manyan dalilai
Dangane da tushen guntu, babban dalilin shine ingancin tushen guntu ba shi da kyau, kuma taurin da karyewarsu ƙanana ne. A lokacin aikin shafa, tushen kwamfutar yana fuskantar gogayya mai ƙarfi lokacin birgima a cikin kwanon rufi, kuma yana da wuya a jure irin wannan ƙarfin ba tare da isasshen tauri ba, wanda ke da alaƙa da tsari da hanyar shirya ƙwayar kwamfutar. Lokacin da muka naɗe ƙwayoyin nifedipine masu jurewar saki, saboda ƙaramin tauri na ƙwayar kwamfutar, foda ya bayyana a gefe ɗaya, wanda ke haifar da ramuka, kuma fim ɗin kwamfutar da aka rufe da fim bai yi santsi ba kuma yana da mummunan kama. Bugu da ƙari, wannan lahani na shafa yana da alaƙa da nau'in kwamfutar hannu. Idan fim ɗin bai da daɗi, musamman idan fim ɗin yana da tambari a kan kambi, yana da saurin lalacewa ta gefe ɗaya.
A cikin aikin shafa, saurin feshi mai jinkiri da yawan shan iska ko yawan zafin iska mai shigowa zai haifar da saurin bushewa da sauri, samar da fim a hankali na ƙwayoyin cuta, tsawon lokacin aiki na ƙwayoyin cuta a cikin kwanon rufi, da kuma tsawon lokacin lalacewa. Na biyu, matsin lamba na atomization yana da girma, danko na ruwan shafa yana da ƙasa, digo-digo a cikin cibiyar atomization suna tarawa, kuma sinadarin narkewa yana canzawa bayan digo-digo ya bazu, wanda ke haifar da babban damuwa na ciki; a lokaci guda, gogayya tsakanin saman gefe ɗaya kuma yana ƙara damuwa na ciki na fim ɗin kuma yana hanzarta fim ɗin. Gefen da suka fashe.
Bugu da ƙari, idan saurin juyawar kwanon rufi ya yi sauri sosai ko kuma saitin baffle bai dace ba, ƙarfin gogayya a kan kwamfutar zai yi yawa, ta yadda ruwan murfin ba zai yaɗu sosai ba, kuma samuwar fim ɗin zai yi jinkiri, wanda zai haifar da lalacewa ta gefe ɗaya.
Daga ruwan shafa, yawanci saboda zaɓin polymer a cikin tsari da ƙarancin danko (mafi yawa) na ruwan shafa, da kuma rashin mannewa tsakanin fim ɗin shafa da ƙwaya.
1.2 Magani
Ɗaya shine a daidaita tsarin rubuta magani ko samar da kwamfutar hannu don inganta taurin zuciyar kwamfutar hannu. HPMC wani abu ne da aka saba amfani da shi. Mannewar sinadaran kwamfutar hannu yana da alaƙa da ƙungiyoyin hydroxyl akan ƙwayoyin da ke cikinta, kuma ƙungiyoyin hydroxyl suna samar da haɗin hydrogen tare da ƙungiyoyin da suka dace na HPMC don samar da ƙarin mannewa; Mannewar tana raguwa, kuma fim ɗin gefe ɗaya da murfin suna rabuwa. Adadin ƙungiyoyin hydroxyl akan sarkar ƙwayoyin microcrystalline yana da yawa, kuma yana da ƙarfin mannewa mai yawa, kuma ƙwayoyin da aka shirya daga lactose da sauran sukari suna da matsakaicin ƙarfin mannewa. Amfani da man shafawa, musamman man shafawa masu kama da hydrophobic kamar stearic acid, magnesium stearate, da glyceryl stearate, zai rage haɗin hydrogen tsakanin tsakiyar kwamfutar hannu da polymer a cikin maganin rufewa, yana sa mannewa ya ragu, kuma tare da ƙaruwar man shafawa, ƙarfin mannewa yana raguwa a hankali. Gabaɗaya, yawan man shafawa, ƙarin mannewa yana raguwa. Bugu da ƙari, a cikin zaɓin nau'in kwamfutar hannu, ya kamata a yi amfani da nau'in kwamfutar hannu mai zagaye biconvex gwargwadon iyawa don shafa, wanda zai iya rage faruwar lahani na shafa.
Na biyu shine a daidaita yadda ruwan shafa yake aiki, a ƙara yawan danshi a cikin ruwan shafa ko kuma ɗanko na ruwan shafa, sannan a inganta ƙarfi da mannewar fim ɗin shafa, wanda hanya ce mai sauƙi don magance matsalar. Gabaɗaya, yawan danshi a cikin tsarin shafa ruwa shine kashi 12%, kuma yawan danshi a cikin tsarin shafawa na halitta shine kashi 5% zuwa 8%.
Bambancin danko na ruwan shafa yana shafar saurin da matakin shigar ruwan shafa a cikin tsakiyar kwamfutar hannu. Idan babu ko babu shigar, mannewa yana da ƙasa sosai. Danko na ruwan shafa da halayen fim ɗin shafa suna da alaƙa da matsakaicin nauyin kwayar polymer a cikin tsarin. Mafi girman matsakaicin nauyin kwayar halitta, mafi girman taurin fim ɗin shafa, ƙarancin sassauci da juriyar lalacewa. Misali, HPMC da ake samu a kasuwa yana da matakan danko daban-daban don zaɓi saboda bambancin matsakaicin nauyin kwayar halitta. Baya ga tasirin polymer, ƙara masu filastik ko ƙara abun ciki na talc na iya rage yawan fashewar gefen fim, amma ƙarin masu launi na iron oxide da titanium dioxide suma na iya shafar ƙarfin fim ɗin shafa, don haka ya kamata a yi amfani da shi a matsakaici.
Na uku, a cikin aikin shafa, ya zama dole a ƙara saurin fesawa, musamman lokacin da aka fara shafa, saurin fesawa ya kamata ya ɗan yi sauri, ta yadda za a rufe tsakiyar kwamfutar da wani Layer na fim cikin ɗan gajeren lokaci, wanda ke taka rawa wajen kare tsakiyar kwamfutar. Ƙara yawan fesawa na iya rage zafin gado, ƙimar ƙafewa da zafin fim, rage damuwa ta ciki, da kuma rage yawan fashewar fim ɗin. A lokaci guda, a daidaita saurin juyawa na kwanon rufi zuwa mafi kyawun yanayi, kuma a saita baffle daidai don rage gogayya da lalacewa.
2. Mannewa da ƙuraje
A cikin tsarin shafa, lokacin da haɗin haɗin tsakanin yanka biyu ya fi ƙarfin rabuwar kwayoyin halitta, yanka da yawa (ƙwayoyi da yawa) za su ɗan haɗu kaɗan sannan su rabu. Lokacin da daidaito tsakanin feshi da bushewa bai yi kyau ba, fim ɗin ya yi danshi sosai, fim ɗin zai manne a bangon tukunya ko kuma ya manne da juna, amma kuma yana haifar da karyewar fim ɗin a wurin mannewa; A cikin feshi, lokacin da ɗigon bai bushe gaba ɗaya ba, ɗigon da ba su karye ba za su zauna a cikin fim ɗin rufewa na gida, akwai ƙananan kumfa, suna samar da layin murfin kumfa, don haka takardar murfin ta bayyana kumfa.
2.1 Binciken manyan dalilai
Girman da kuma yawan wannan lahani na shafa fuska ya faru ne galibi saboda yanayin aikin shafa fuska, rashin daidaito tsakanin feshi da bushewa. Saurin feshi yana da sauri sosai ko kuma yawan iskar gas mai narkewa ya yi yawa. Saurin bushewa yana da jinkiri sosai saboda ƙarancin shigar iska ko ƙarancin zafin shiga iska da kuma ƙarancin zafin gadon zanen. Ba a busar da zanen ta hanyar Layer ba kuma mannewa ko kumfa suna faruwa. Bugu da ƙari, saboda kuskuren kusurwa ko nisa na feshi, mazubin da feshi ya samar ƙarami ne, kuma ruwan shafa fuska yana taruwa a wani yanki, wanda ke haifar da danshi na gida, wanda ke haifar da mannewa. Akwai tukunya mai laushi a hankali, ƙarfin centrifugal ya yi ƙanƙanta, birgima a fim ba shi da kyau kuma zai haifar da mannewa.
Dankowar ruwa mai rufewa ya yi yawa, shi ma yana ɗaya daga cikin dalilan. Dankowar ruwa mai rufewa yana da girma, yana da sauƙin samar da manyan faɗuwar hazo, ikonsa na shiga cikin zuciyar ba shi da kyau, tarin gefe ɗaya da mannewa sun fi yawa, a lokaci guda, yawan fim ɗin ba shi da kyau, ƙarin kumfa. Amma wannan ba shi da tasiri sosai ga mannewa na ɗan lokaci.
Bugu da ƙari, nau'in fim ɗin da bai dace ba zai bayyana mannewa. Idan fim ɗin da ke cikin tukunyar rufi bai yi kyau ba, zai haɗu tare, yana da sauƙi ya haifar da fim mai layuka biyu ko da yawa. A cikin gwajinmu na samar da allunan buflomedil hydrochloride, an ga guntu da yawa da suka haɗu a cikin tukunyar rufi ta ruwan chestnut saboda rufin lebur.
2.2 Mafita
Babban abu shine a daidaita saurin feshi da bushewa don cimma daidaito mai ƙarfi. Rage saurin feshi, ƙara yawan iskar shiga da zafin iska, ƙara zafin gado da saurin bushewa. Ƙara yankin rufewar feshi, rage matsakaicin girman barbashi na digo ko daidaita tazara tsakanin bindigar feshi da gadon takarda, ta yadda yawan mannewa na ɗan lokaci zai ragu idan aka daidaita tazara tsakanin bindigar feshi da gadon takarda.
Daidaita umarnin maganin shafawa, ƙara yawan sinadarin da ke cikin maganin shafawa, rage yawan sinadarin da ke cikin maganin ko ƙara yawan sinadarin ethanol yadda ya kamata a cikin kewayon danko; Haka kuma ana iya ƙara sinadarin hana mannewa yadda ya kamata, kamar foda talcum, magnesium stearate, foda silica gel ko oxide peptide. Zai iya inganta saurin tukunyar shafawa yadda ya kamata, ƙara ƙarfin centrifugal na gadon.
Zaɓi shafa takardar da ta dace. Duk da haka, ga zanen gado mai faɗi, kamar allunan buflomedil hydrochloride, an yi nasarar shafa murfin daga baya ta hanyar amfani da kaskon shafa mai inganci ko kuma ta hanyar sanya baffle a cikin kaskon shafa na yau da kullun don haɓaka birgima na takardar.
3. Fatar da ke da kauri da kuma wrinkles mai gefe ɗaya
A yayin aikin shafa, saboda ruwan shafa ba ya yaɗu sosai, busasshen polymer ɗin ba ya warwatsewa, ba ya mannewa daidai gwargwado ko mannewa a saman fim ɗin, wanda ke haifar da rashin launi da kuma rashin daidaituwar saman. Fatar da ta kumbura wani nau'in saman da ba ta da ƙarfi ne, kuma ana iya ganinta da kyau sosai.
3.1 Binciken manyan dalilai
Na farko yana da alaƙa da tsakiyar guntu. Girman farkon ƙaiƙayin saman core ɗin, haka nan girman ƙaiƙayin saman samfurin da aka shafa zai yi.
Na biyu, yana da kyakkyawar alaƙa da maganin maganin shafawa. Gabaɗaya ana kyautata zaton cewa nauyin ƙwayoyin halitta, yawansu da ƙari na polymer a cikin maganin shafawa suna da alaƙa da ƙaiƙayin saman murfin fim ɗin. Suna aiki ta hanyar shafar ƙaiƙayin maganin shafawa, kuma ƙaiƙayin murfin fim ɗin kusan layi ɗaya ne da ƙaiƙayin maganin shafawa, yana ƙaruwa tare da ƙaruwar ƙaiƙayin. Yawan abubuwan da ke cikin maganin shafawa na iya haifar da ƙaiƙayi na gefe ɗaya cikin sauƙi.
A ƙarshe, yana da alaƙa da aikin shafa. Saurin atomization yana da ƙasa ko kuma ya yi yawa (tasirin atomization bai yi kyau ba), wanda bai isa ya yaɗa ɗigon hazo da kuma samar da fata mai lanƙwasa gefe ɗaya ba. Kuma yawan busasshiyar iska (iskar shaye-shaye ta yi yawa) ko kuma yawan zafin jiki mai yawa, ƙafewa da sauri, musamman kwararar iska ta yi yawa, samar da kwararar iska, kuma hakan yana sa yaduwar ɗigon ba ta da kyau.
3.2 Mafita
Na farko shine inganta ingancin core. Dangane da tabbatar da ingancin core, daidaita umarnin maganin shafawa kuma rage danko (mafi yawa) ko abun da ke cikin maganin shafawa. Ana iya zaɓar maganin shafawa mai narkewar barasa ko barasa-2-ruwa. Sannan a daidaita yanayin aiki, a inganta saurin tukunyar shafawa yadda ya kamata, a sa fim ɗin ya yi birgima daidai, a ƙara gogayya, a haɓaka yaɗuwar ruwan shafawa. Idan zafin gado yana da yawa, a rage yawan iskar da ake sha da zafin iskar da ake sha. Idan akwai dalilan feshi, ya kamata a ƙara matsin lamba don hanzarta saurin feshi, kuma ya kamata a inganta matakin atomization da girman feshi don sa digogin hazo su bazu da ƙarfi a saman takardar, don samar da digogin hazo tare da ƙaramin diamita na matsakaici da hana faruwar manyan digogin hazo, musamman don rufe ruwa mai babban danko. Hakanan za'a iya daidaita nisan da ke tsakanin bindigar feshi da gadon takarda. An zaɓi bindigar feshi mai ƙaramin diamita na bututun ƙarfe (015 mm ~ 1.2 mm) da kuma yawan kwararar iskar gas mai narkewa. An daidaita siffar feshi zuwa nau'ikan mazugi mai faɗi iri-iri na kwararar hazo mai kusurwa, ta yadda ɗigon ruwan zai bazu a babban yanki na tsakiya.
4. Gano gada
4.1 Binciken manyan dalilai
Wannan yana faruwa ne lokacin da aka yiwa saman fim ɗin alama ko aka yiwa alama. Saboda membrane ɗin tufafi yana da ma'auni masu ma'ana, kamar babban ƙarfin lanƙwasa, ƙarfin fim ɗin ba shi da kyau, rashin mannewa mai kyau, da sauransu, yayin da ake busar da membrane ɗin tufafi, ana samun babban ja, daga buga saman membrane na tufafi, ja da baya da kuma gadoji, yana sa a ɓace ko kuma tambarin ba a bayyana ba, dalilan wannan lamari sun ta'allaka ne a cikin takardar maganin ruwa mai rufewa.
4.2 Magani
Daidaita yadda ake amfani da maganin rufewa. Yi amfani da ƙananan polymers masu nauyin ƙwayoyin halitta ko kayan ƙirƙirar fim mai mannewa masu yawa; Ƙara yawan mai narkewa, rage ɗanko na maganin rufewa; Ƙara adadin mai sanya filastik, rage damuwa ta ciki. Tasirin mai sanya filastik daban-daban ya bambanta, polyethylene glycol 200 ya fi propylene glycol, glycerin kyau. Hakanan yana iya rage saurin fesawa. Ƙara zafin shiga iska, ƙara zafin gadon takarda, don murfin da aka samar ya yi ƙarfi, amma don hana fashewa a gefen. Bugu da ƙari, a cikin ƙirar manne mai alama, ya kamata mu kula da faɗin kusurwar yankewa da sauran ƙananan maki, gwargwadon iyawa don hana faruwar abin da ya faru na gada.
5. Tsarin membrane na tufafi
5.1 Binciken manyan dalilai
A cikin mafi yawan maganin shafawa, akwai launuka ko rini waɗanda aka rataye a cikin maganin shafawa, kuma saboda rashin aikin shafa mai kyau, rarraba launi ba iri ɗaya ba ne kuma bambancin launi yana faruwa tsakanin yanka ko a sassa daban-daban na yanka. Babban dalili shine saurin tukunyar shafawa yana da jinkiri sosai ko kuma ingancin haɗawa ba shi da kyau, kuma ba za a iya cimma tasirin shafa mai iri ɗaya tsakanin guda a lokacin shafa ba; Yawan launi ko rini a cikin ruwan shafa mai launi ya yi yawa ko kuma yawan danshi ya yi yawa, ko saurin fesa ruwan shafa mai sauri, zafin gado ya yi yawa, don haka ba a mirgina ruwan shafa mai launi akan lokaci ba; Ana iya haifar da mannewa na fim ɗin; Siffar yanki bai dace ba, kamar dogon yanki, yanki mai siffar kapsul, saboda birgima a matsayin yanki mai zagaye, shi ma zai haifar da bambancin launi.
5.2 Magani
Ƙara saurin kwanon rufi ko adadin baffle, daidaita zuwa yanayin da ya dace, don zanen da ke cikin kwanon rufi ya yi birgima daidai gwargwado. Rage saurin fesa ruwa na rufi, rage zafin gado. A cikin tsarin maganin shafawa mai launi, ya kamata a rage yawan ko abun da ke cikin launi ko rini, kuma a zaɓi launin da ke da ƙarfi. Ya kamata launin ko rini ya zama mai laushi kuma barbashi ya zama ƙanana. Rini mara narkewa na ruwa ya fi rini mai narkewa na ruwa kyau, rini mara narkewa na ruwa ba ya ƙaura da ruwa cikin sauƙi kamar rini mai narkewa na ruwa, da inuwa, kwanciyar hankali da rage tururin ruwa, iskar shaka a kan iskar shaka a cikin fim ɗin ya fi rini mai narkewa na ruwa kyau. Hakanan zaɓi nau'in yanki da ya dace. A cikin tsarin rufe fim, sau da yawa akwai matsaloli daban-daban, amma komai irin matsaloli, abubuwan suna da yawa, ana iya magance su ta hanyar inganta ingancin tsakiya, daidaita takardar izinin rufi da aiki, don cimma aikace-aikacen sassauƙa da aikin dialectical. Tare da ƙwarewar fasahar rufi, haɓakawa da amfani da sabbin injunan rufi da kayan rufin fim, fasahar rufi za ta inganta sosai, rufin fim kuma zai sami ci gaba cikin sauri wajen samar da shirye-shirye masu ƙarfi.
Lokacin Saƙo: Afrilu-25-2024