A cikin tarihin shekara ɗari na capsules, gelatin koyaushe yana kiyaye matsayin kayan capsule na yau da kullun saboda faɗuwar tushen sa, barga na zahiri da sinadarai da kyawawan kaddarorin sarrafawa.Tare da karuwar fifikon mutane na capsules, ana amfani da capsules mara kyau a cikin fagagen abinci, magunguna da kayayyakin kiwon lafiya.
Duk da haka, faruwa da yaduwar cutar hauka ta saniya da cutar ƙafa da baki na sa mutane su fara damuwa game da kayan da aka samu daga dabbobi.Danyen gelatin da aka saba amfani da su shine kashi da fatar shanu da aladu, kuma hadarinsa ya jawo hankalin mutane a hankali.Don rage haɗarin aminci na albarkatun kafsule mara kyau, ƙwararrun masana'antu suna ci gaba da bincike da haɓaka kayan kafsul ɗin da suka dace.
Bugu da ƙari, tare da haɓaka nau'in capsules iri-iri, bambancin abubuwan da ke cikin su a hankali yana sa mutane su gane cewa akwai matsalolin daidaitawa tsakanin gelatin hollow capsules da wasu abubuwan ciki tare da kaddarorin musamman.Misali, abubuwan da ke dauke da kungiyoyin aldehyde ko amsawa don samar da kungiyoyin aldehyde karkashin wasu sharudda na iya haifar da giciye na gelatin;Abubuwan da ke ciki tare da raguwa mai ƙarfi na iya samun amsawar Maillard tare da gelatin;Abun ciki tare da ƙaƙƙarfan hygroscopicity zai sa harsashi na capsule Ming ya rasa ruwa kuma ya rasa ainihin taurinsa.Zaman lafiyar capsule na gelatin yana sa haɓaka sabbin kayan capsule ya jawo hankali sosai.
Abin da shuka samu kayan ne dace da samar da m wuya capsules?Mutane sun yi kokari da yawa.Aikace-aikacen takaddun shaida na kasar Sin No.: 200810061238 X da aka yi amfani da shi don shan cellulose sodium sulfate a matsayin babban kayan capsule;200510013285.3 an yi amfani da shi don ɗaukar sitaci ko abun da ke cikin sitaci azaman babban kayan capsule;Wang GM [1] ya ba da rahoton cewa an yi su ne daga capsules na chitosan;Zhang Xiaoju et al.[2] an ruwaito samfuran tare da furotin waken soya na Konjac a matsayin babban kayan capsule.Tabbas, kayan da aka fi nazari sune kayan cellulose.Daga cikin su, ƙananan capsules da aka yi da hydroxypropyl methylcellulose (HPMC) sun samar da babban sikelin samarwa.
Ana amfani da HPMC sosai a fannin abinci da magunguna.Kayayyakin magunguna ne da aka saba amfani da shi, wanda ke cikin Pharmacopoeia na ƙasashe daban-daban;FDA da EU sun amince da HPMC azaman ƙari na abinci kai tsaye ko kaikaice;Gras abu ne mai aminci, A'a. GRN 000213;Dangane da bayanan JECFA, INS no.464, babu iyaka akan matsakaicin adadin yau da kullun na HPMC;A cikin 1997, Ma'aikatar Lafiya ta kasar Sin ta amince da ita a matsayin kayan abinci da kauri (Lamba 20), wanda ya dace da kowane nau'in abinci kuma an kara shi bisa ga bukatun samarwa [2-9].Saboda bambancin kaddarorin da ke tsakanin HPMC da Gelatin, takardar sayan magani na HPMC hollow capsule ya fi rikitarwa, kuma ana buƙatar ƙara wasu magungunan gelling, irin su ɗanɗano na Larabci, carrageenan (danko ruwan teku), sitaci, da sauransu.
HPMC m capsule samfuri ne mai ra'ayi na halitta.Ƙungiyoyin Yahudawa, Musulunci da masu cin ganyayyaki sun san kayan sa da fasahar samarwa.Yana iya biyan bukatun mutanen da ke da addinai daban-daban da halaye na cin abinci, kuma yana da karbuwa sosai.Bugu da kari, HPMC m capsules suna da wadannan musamman kaddarorin:
1.Low ruwa abun ciki - game da 60% kasa da gelatin m capsule
Abubuwan da ke cikin ruwa na gelatin m capsules shine gabaɗaya 12.5% - 17.5% [10].Ya kamata a sarrafa zafin jiki da zafi na mahalli a cikin kewayon da ya dace yayin samarwa, sufuri, amfani da adana magudanar ruwa.Matsakaicin zafin jiki mai dacewa shine 15-25 ℃ kuma dangi zafi shine 35% - 65%, don haka ana iya kiyaye aikin samfurin na dogon lokaci.Abubuwan da ke cikin ruwa na membrane HPMC yana da ƙasa sosai, gabaɗaya 4% - 5%, wanda shine kusan 60% ƙasa da na gelatin hollow capsule (Fig. 1).Musayar ruwa tare da mahalli yayin ajiyar dogon lokaci zai ƙara yawan ruwa na HPMC hollow capsule a cikin takamaiman marufi, amma ba zai wuce 9% cikin shekaru 5 ba.
Hoto 1.LOD kwatankwacin HMPC da bawoyin Gelatin a ƙarƙashin RH daban-daban
Siffar ƙarancin abun ciki na ruwa yana sa HPMC ƙwanƙwasa kwandon ya dace da cike hygroscopic ko abubuwan da ke cikin ruwa don tsawaita rayuwar samfurin.
2. High tauri, babu brittleness
Kamar yadda aka ambata a sama, fim din gelatin yana da ƙayyadadden abun ciki na danshi.Idan ya kasance ƙasa da wannan iyaka, fim ɗin gelatin zai kasance da ƙarfi sosai.Casules na gelatin na yau da kullun ba tare da wani ƙari ba suna da haɗarin ɓarna fiye da 10% lokacin da abun ciki na danshi shine 10%;Lokacin da abun cikin ruwa ya ci gaba da raguwa zuwa 5%, 100% brittleness zai faru.Sabanin haka, da tauri na HPMC m capsules ne mafi alhẽri, kuma suna kula da kyau yi ko da muhalli zafi ne low (Fig. 3).Hakika, da embrittlement kudi na HPMC m capsules tare da daban-daban prescriptions karkashin low zafi zai nuna babban bambance-bambance.
Akasin haka, capsules na gelatin da aka sanya a cikin yanayin zafi mai zafi zai yi laushi, lalacewa ko ma rushewa bayan sha ruwa.HPMC m capsule iya kula da kyau siffar da kuma yi ko da a karkashin yanayin high zafi.Saboda haka, HPMC m capsule yana da ƙarfi karbuwa ga muhalli.Lokacin da yankin tallace-tallace na samfurin ya ƙunshi wurare daban-daban na yanayin yanayi ko yanayin ajiya ba su da ɗanɗano, wannan fa'idar HMPC ƙwalƙwalwar kwandon yana da mahimmanci musamman.
3.Karfafa sinadarai
Halin haɗin kai na capsules na gelatin matsala ce mai ƙaya da shirye-shiryen capsule ke fuskanta.Saboda rukunin aldehyde na abun ciki yana amsawa tare da rukunin amino acid na amino acid a cikin gelatin don samar da tsarin hanyar sadarwa, harsashi na capsule yana da wahalar narkewa a ƙarƙashin yanayin rushewar in vitro, wanda ke shafar sakin magunguna.Hydroxypropyl methylcellulose wani nau'in cellulose ne, wanda ba shi da sinadarai kuma yana da kyakkyawar dacewa da yawancin abubuwa.Saboda haka, HPMC m capsule ba shi da wani hadarin giciye-linked dauki da high sinadaran kwanciyar hankali
4.Good shafi yi
Ana amfani da capsules masu rufi na ciki don magungunan da ke da sauƙin lalacewa ta hanyar acid na ciki, mai ban sha'awa ga mucosa na ciki ko buƙatar gudanarwa mai niyya.Fasahar da aka yarda da ita ta duniya ta capsules masu rufin ciki ita ce gabaɗayan rufin pellets masu rufi da capsules.HPMC m capsule yana nuna fa'idodi na musamman a cikin babban shafi na capsule.
Binciken ya nuna cewa saboda m surface na HPMC m capsule, da dangantaka da mafi enteric shafi kayan ne muhimmanci mafi girma fiye da gelatin, da kuma mannewa gudun da uniformity na shafi kayan ne muhimmanci fiye da gelatin, musamman shafi AMINCI na jiki hula junction. an inganta sosai.Gwajin narkar da in vitro ya nuna cewa iyawar capsule na HPMC a cikin ciki ya ragu kuma an sami saki mai kyau a cikin hanji.
Kammalawa
Halayen capsule na HPMC sun haɓaka filin aikace-aikacen sa.Daga duk samfurori na halitta zuwa danshi mai mahimmanci ko abun ciki na hygroscopic, yana da aikace-aikace na musamman a fagen busassun foda da kuma suturar ciki.Ya kamata a lura da cewa HPMC m capsules a halin yanzu a kasuwa a gida da kuma waje suna da in mun gwada da high oxygen permeability da dan kadan tarwatsewa fiye da gelatin m capsules, amma su bioavailability a vivo shi ne kama [11], wanda ya kamata a yi la'akari a cikin bincike da ci gaba.
Kamar yadda muka sani, akwai hanya mai nisa daga binciken dakin gwaje-gwaje, gwaji mai girma, samar da masana'antu zuwa haɓaka kasuwa.Wannan shine dalilin da ya sa, bayan shekaru na bincike da haɓakawa, ƙananan samfuran capsule kaɗan ne kawai aka yi nasarar jera abubuwan da aka samo daga shuka.A cikin 1997, capsugel ya ɗauki jagora a cikin jera HPMC hollow capsule vcapstm a Amurka, yana ba da sabon zaɓi na capsule na baka.A halin yanzu, adadin tallace-tallace na shekara-shekara na capsules na HPMC a cikin duniya ya zarce biliyan 20, kuma yana haɓaka da ƙimar 25% a kowace shekara.
Lokacin aikawa: Mayu-06-2022