Abubuwan gama gari na gama gari na nau'ikan nau'ikan sashi na baka

Shirye-shirye masu ƙarfi a halin yanzu sune mafi yadu da kuma mafi yawan amfani da nau'ikan sashi a kasuwa, kuma yawanci sun ƙunshi manyan abubuwa biyu da abubuwan haɓakawa.Excipients, wanda kuma aka sani da excipients, koma zuwa gaba ɗaya kalma don duk ƙarin kayan a cikin shirye-shirye masu ƙarfi sai dai babban magani.Dangane da kaddarorin da ayyuka daban-daban na abubuwan haɓakawa, ana rarraba abubuwan haɓakar shirye-shirye masu ƙarfi zuwa: filler, binders, disintegrants, lubricants, masu sarrafa sakin, da kuma wasu lokuta ana iya ƙara wakilai masu canza launi da abubuwan dandano bisa ga buƙatun shirye-shiryen. don inganta Ko daidaita bayyanar da dandano na tsari.
Abubuwan da ke tattare da shirye-shirye masu ƙarfi ya kamata su dace da buƙatun don amfani da magani, kuma suna da halaye masu zuwa: ①Ya kamata ya sami kwanciyar hankali mai ƙarfi kuma ba shi da halayen jiki da sinadarai tare da babban magani;②Kada ya shafi tasirin warkewa da ƙayyadaddun abun ciki na babban magani;③Babu cutarwa ga jikin mutum mai cutarwa, dafi guda biyar, babu illa.
1. Filler (mai bakin ciki)
Saboda ƙarancin maganin babban magani, adadin wasu magunguna wani lokaci yakan zama 'yan milligrams kaɗan ko ƙasa da haka, waɗanda ba su da amfani ga ƙirƙirar kwamfutar hannu ko gudanarwar asibiti.Sabili da haka, lokacin da babban abun ciki na miyagun ƙwayoyi bai wuce 50mg ba, ana buƙatar ƙara wani nau'i na filler, wanda kuma aka sani da diluent.
Madaidaicin filler yakamata ya kasance cikin ilimin kimiya da sinadarai kuma baya tasiri bioavailability na kayan aikin magani.Filayen da aka fi amfani da su sun haɗa da: ① Sitaci, gami da sitacin alkama, sitacin masara, da sitacin dankalin turawa, daga cikinsu sitacin masara ne aka fi amfani da su;barga a cikin yanayi, low a hygroscopicity, amma matalauta a compressibility;② Lactose, mai kyau a cikin kaddarorin da matsawa, mai kyau ruwa;③ sucrose, yana da ƙarfi hygroscopicity;④ pregelatinized sitaci, wanda kuma aka sani da sitaci mai matsewa, yana da kyau mai ƙarfi, ruwa da lubricanci;⑤ microcrystalline cellulose, wanda ake magana a kai a matsayin MCC, yana da ƙarfin ɗauri mai ƙarfi da mai kyau matsawa;da aka sani da "bushe mai ɗaure";⑥ Mannitol, idan aka kwatanta da abubuwan da ke sama, ya ɗan fi tsada, kuma galibi ana amfani da shi a cikin allunan da za a iya taunawa, wanda kuma yana da ɗanɗano mai ɗanɗano;⑦Inorganic salts, yafi ciki har da calcium sulfate, calcium phosphate, calcium carbonate, da dai sauransu, tare da ingantacciyar barga jiki da sinadarai Properties.
2. Wakilin jika da m
Ma'aikatan jika da masu ɗaure su ne abubuwan da aka ƙara yayin matakin granulation.Wakilin wetting da kansa ba danko bane, amma ruwa ne wanda ke haifar da danko na kayan ta hanyar jika kayan.Abubuwan da ake amfani da su na jika galibi sun haɗa da ruwa mai daskarewa da ethanol, daga cikinsu akwai ruwa mai tsafta shine zaɓi na farko.
Adhesives suna nufin kayan taimako waɗanda suka dogara da ɗankowar kansu don ba da kayan da ba su da ɗanɗano ko ƙarancin ɗanƙoƙi tare da ɗanko mai dacewa.Adhesives da aka fi amfani da su sun haɗa da: ① Starch slurry, wanda shine ɗayan abubuwan da aka fi amfani da su, yana da arha , kuma yana da kyakkyawan aiki, kuma yawan abin da ake amfani da shi shine 8% -15%;② Methylcellulose, wanda ake kira MC, yana da kyau mai narkewa;③Hydroxypropylcellulose, da ake magana a kai a matsayin HPC, za a iya amfani da shi azaman foda kai tsaye mai ɗaukar hoto;④Hydroxypropylmethylcellulose, wanda ake magana a kai a matsayin HPMC, kayan yana narkewa a cikin ruwan sanyi;⑤ Carboxymethylcellulose sodium, wanda ake magana a kai a matsayin CMC-Na, wanda ya dace da kwayoyi tare da rashin ƙarfi;⑥Ethylcellulose, da ake magana a kai a matsayin EC, kayan da ba a iya narkewa a cikin ruwa, amma mai narkewa a cikin ethanol;⑦Povidone, wanda ake magana a kai a matsayin PVP, kayan abu yana da matukar hygroscopic, mai narkewa a cikin ruwa da ethanol;⑧ Bugu da ƙari, akwai polyethylene glycol (wanda ake kira PEG), Kayan aiki irin su gelatin.
3. Rarrabewa
Masu tarwatsawa suna nufin abubuwan haɓakawa waɗanda ke haɓaka saurin rushewar allunan zuwa ɓangarorin lafiya a cikin ruwan ciki.Ban da allunan baka masu buƙatu na musamman kamar allunan da aka ɗorewa, da allunan da ake sarrafawa, da allunan da za a iya taunawa, gabaɗaya ana buƙatar ƙara masu tarwatsewa.Abubuwan da aka saba amfani da su sune: ① busasshen sitaci, dace da magungunan da ba za a iya narkewa ko kaɗan ba;② carboxymethyl sitaci sodium, ake magana a kai a matsayin CMS-Na, wannan abu ne mai high-inganci disintegrant;③ ƙananan maye gurbin hydroxypropyl cellulose, wanda ake kira L-HPC, wanda zai iya kumbura da sauri bayan sha ruwa;④Cross-linked methyl cellulose sodium, ake magana a kai a matsayin CCMC-Na;abu ya fara kumbura a cikin ruwa sannan ya narke, kuma ba ya narkewa a cikin ethanol;Rashin hasara shi ne cewa yana da ƙarfi hygroscopicity kuma ana amfani dashi a cikin granulation na allunan effervescent ko allunan da za a iya taunawa;⑥Effervescent disintegrants yafi hada da cakuda sodium bicarbonate da citric acid, da citric acid, fumaric acid, da sodium carbonate kuma za a iya amfani da, Potassium Carbonate da Potassium Bicarbonate da dai sauransu.
4. Man shafawa
Ana iya raba man shafawa gabaɗaya zuwa nau'i uku, gami da glidants, magungunan hana ɗorawa, da man shafawa a cikin kunkuntar hankali.① Glidant: babban aikinsa shi ne don rage juzu'i tsakanin barbashi, inganta ruwa na foda, da kuma taimakawa wajen rage bambancin nauyin kwamfutar hannu;② anti-sticking wakili: babban aikinsa shi ne hana danko yayin damfara kwamfutar hannu, Don tabbatar da aiki mai sauƙi na matsi na kwamfutar hannu, yana iya inganta bayyanar allunan;③ chivalrous man shafawa: rage gogayya tsakanin abu da mold bango, don tabbatar da santsi aiki na kwamfutar hannu matsawa da turawa.Abubuwan da aka saba amfani da su (a cikin ma'ana mai faɗi) sun haɗa da talc foda, magnesium stearate (MS), micronized silica gel, polyethylene glycols, sodium lauryl sulfate, hydrogenated kayan lambu mai, da sauransu.
5. Saki mai daidaitawa
Masu kula da sakewa a cikin allunan baka sun dace don sarrafa saurin da matakin sakin miyagun ƙwayoyi a cikin shirye-shiryen ci gaba da ci gaba na baka, don tabbatar da cewa an isar da maganin zuwa wurin mara lafiya a wani ɗan gudun hijira kuma yana kula da wani yanki a cikin kyallen takarda ko ruwan jiki. , Ta haka Samun sakamako na warkewa da ake tsammani da kuma rage mai guba da sakamako masu illa.Matsakaicin sakin da aka saba amfani da su an raba su zuwa nau'in matrix, polymer mai ɗaukar jinkirin sakin fim da mai kauri.
(1) Matrix-nau'in fitarwa mai daidaitawa
①Hydrophilic gel kwarangwal abu: yana kumbura lokacin da aka fallasa shi zuwa ruwa don samar da shingen gel don sarrafa sakin miyagun ƙwayoyi, yawanci ana amfani da su ne methyl cellulose, carboxymethyl cellulose, hydroxypropyl cellulose, povidone, carbomer, alginic acid Salt, chitosan, da dai sauransu.
② Kayan kwarangwal mara narkewa: Kayan kwarangwal wanda ba a iya narkewa yana nufin babban polymer kwayoyin halitta wanda ba ya narkewa a cikin ruwa ko kuma yana da ƙarancin narkewar ruwa.Mafi yawan amfani da su ne ethyl cellulose, polyethylene, polyethylene mai guba biyar, polymethacrylic acid, ethylene-vinyl acetate copolymer, silicone roba, da dai sauransu.
③ Kayayyakin Tsarin Halittu: Abubuwan da aka fi amfani da su na bioerodible galibi sun haɗa da kitsen dabba, man kayan lambu mai hydrogenated, beeswax, barasa stearyl, carnauba kakin zuma, glyceryl monostearate, da dai sauransu. Yana iya jinkirta rushewa da sakin magungunan ruwa mai narkewa.
(2) Mai gyara saki mai rufi
① Abubuwan polymer marasa narkewa: kayan kwarangwal na gama gari kamar EC.
②Enteric polymer kayan: na kowa enteric polymer kayan yafi hada da acrylic guduro, L-type da S-type, hydroxypropylmethylcellulose acetate succinate (HPMCAS), cellulose acetate phthalate (CAP), hydroxypropylmethylcellulose phthalate (HPMCP), da dai sauransu Yana amfani da disoluzes da disoluses sama kayan a cikin ruwan 'ya'yan itace na hanji, kuma yana narkewa a cikin takamaiman sassa don taka rawa.
6. Sauran kayan haɗi
Baya ga abubuwan da aka saba amfani da su na sama, ana ƙara wasu abubuwan da ake amfani da su a wasu lokuta domin a fi dacewa da biyan buƙatun sarrafa magunguna, inganta sanin magunguna ko inganta bin doka.Misali, canza launi, dandano da abubuwan zaki.
①Mai sanya launi: Babban manufar ƙara wannan kayan shine don inganta bayyanar kwamfutar hannu kuma ya sauƙaƙe ganewa da bambanta.Alamomin da aka saba amfani da su yakamata su dace da ƙayyadaddun magunguna, kuma adadin da aka ƙara bai kamata ya wuce 0.05%.
②Aromatics and sweeteners: Babban manufar kayan kamshi da kayan zaki shine inganta dandanon magunguna, kamar allunan da ake taunawa da allunan da ke wargaza baki.Kamshin da aka fi amfani da su sun haɗa da essences, mai daban-daban na kamshi, da sauransu;Abubuwan da aka saba amfani da su sun hada da sucrose, aspartame, da sauransu.