Ingxoxo ngemakethe ye-capsule yomhlaba wonke engenalutho
Umbhali: I-Jianhua Lv icashunwe kokuthi: "Medicine&Packaging"
Umthombo:http://www.capsugel.com.cn/aboutjlshow.asp?id=7
I-Capsule ingenye yezinhlobo zasendulo zomthamo wezidakamizwa, ezavela eGibhithe lasendulo [1]. UDe Pauli, usokhemisi eVienna, wakhuluma encwadini yakhe yezokuvakasha ngo-1730 ukuthi amaphilisi e-Oval asetshenziselwa ukuvala iphunga elibi lezidakamizwa ukunciphisa ubuhlungu beziguli [2]. Eminyakeni engaphezu kweyi-100 kamuva, osokhemisi uJoseph Gerard Auguste dublanc kanye noFrancois Achille Barnabe motors bathola ilungelo lobunikazi be-gelatin capsule yokuqala emhlabeni ngo-1843 futhi ngokuqhubekayo balithuthukisa ukuze livumelane nokukhiqizwa kwezimboni [3,4]; Kusukela lapho, amalungelo obunikazi amaningi kuma-capsules angenalutho asezelwe. Ngo-1931, u-Arthur Colton wenkampani i-Parke Davis waklama ngempumelelo futhi wakhiqiza okokusebenza okuzenzakalelayo kwe-capsule engenalutho futhi wakhiqiza i-capsule engenalutho yokuqala emhlabeni eyenziwe ngomshini. Kuyathakazelisa ukuthi kuze kube manje, umugqa wokukhiqiza we-capsule ongenalutho uthuthukiswe ngokuqhubekayo kuphela ngesisekelo somklamo ka-Arthur wokuthuthukisa ikhwalithi yomkhiqizo nokusebenza kahle kokukhiqiza.
Njengamanje, i-capsule yenze intuthuko enkulu futhi esheshayo emkhakheni wezokunakekelwa kwempilo kanye nekhemisi, futhi isibe enye yezindlela eziyinhloko zomthamo wamalungiselelo aqinile omlomo. Kusukela ngo-1982 kuya ku-2000, phakathi kwemithi emisha egunyazwe emhlabeni wonke, amafomu omthamo we-capsule eqinile abonisa ukuthambekela okukhuphukayo.
Umfanekiso 1 Kusukela ngo-1982, imithi emisha yamangqamuzana iye yaqhathaniswa phakathi kwamaphilisi namaphilisi
Ngokuthuthuka kokukhiqizwa kwemithi kanye nemboni ye-R & D, izinzuzo zamaphilisi ziye zaqashelwa kakhulu, ikakhulukazi kulezi zici ezilandelayo:
1. Izintandokazi zesiguli
Uma kuqhathaniswa namanye amafomu omthamo, ama-capsules aqinile angakwazi ukuvala ngokuphumelelayo iphunga elibi lezidakamizwa futhi kulula ukugwinya. Imibala eyahlukene kanye nemiklamo yokuphrinta yenza izidakamizwa zibonakale kakhudlwana, ukuze kuthuthukiswe ngempumelelo ukuthobela izidakamizwa. Ngo-1983, ucwaningo olwenziwe yiziphathimandla zaseYurophu naseMelika lubonise ukuthi phakathi kweziguli eziyi-1000 ezikhethiwe, i-54% ikhetha ama-capsules aqinile, i-29% ikhetha ama-pellets afakwe ushukela, i-13% kuphela ikhetha amaphilisi, kanti enye i-4% ayizange ikhethe ngokucacile.
2. Ukusebenza Okuphezulu Kwe-R&D
Umbiko we-tufts ka-2003 waveza ukuthi izindleko zocwaningo nokuthuthukiswa kwezidakamizwa zenyuka ngamaphesenti angama-55 kusukela ngo-1995 kuya ku-2000, futhi izindleko ezijwayelekile zomhlaba zocwaningo nokuthuthukiswa kwezidakamizwa sezifinyelele ku-897 million US dollar. Njengoba sazi sonke, imishanguzo yangaphambili ibaliwe, isikhathi sokudla kwemakethe yemithi enelungelo lobunikazi sizoba side kakhulu, futhi inzuzo yemithi emisha yezinkampani ezithaka imithi izokhula kakhulu. Isilinganiso senani le-excipients elisetshenziswe kuma-capsules laliyi-4, eyancishiswa kakhulu uma iqhathaniswa ne-8-9 kumaphilisi; Izinto zokuhlola amaphilisi nazo zincane, futhi izindleko zokusungulwa kwendlela, ukuqinisekiswa nokuhlaziya cishe ziyingxenye yamaphilisi. Ngakho-ke, uma kuqhathaniswa namaphilisi, isikhathi sokuthuthukiswa kwama-capsules okungenani isigamu sonyaka sifushane kuneso samaphilisi.
Ngokuvamile, ama-22% ezinkampani ezintsha ezihlanganisiwe ocwaningweni nasekuthuthukisweni kwezidakamizwa zingangena ezivivinyweni zomtholampilo zesigaba I, lapho okungaphansi kuka-1/4 kungaphumelela ezivivinyweni zomtholampilo zesigaba sesi-III. Ukuhlolwa kwezinhlanganisela ezintsha kunganciphisa ngempumelelo izindleko zocwaningo lwezidakamizwa ezintsha nezikhungo zokuthuthukisa ngokushesha okukhulu. Ngakho-ke, imboni yokukhiqiza i-capsule yomhlaba wonke ithuthukise amaphilisi e-preclinical (pccaps) afanele ukuhlolwa kwamagundane ®）; Imishini yokugcwalisa enembile encane (i-xcelodose) elungele ukukhiqizwa kwamasampula e-capsule yomtholampilo ®)）， Futhi amaphilisi ayimpumputhe kabili omtholampilo (dbcaps) afanele ukuhlolwa kwemitholampilo emikhulu & nokwehliswa kwemikhiqizo ye-R kanye nokwehliswa okuphelele kwe-D yemikhiqizo.
Ngaphezu kwalokho, kunezinhlobo ezingaphezu kwezingu-9 zamaphilisi ngobukhulu obuhlukahlukene, okunikeza izinketho eziningi zokuklama umthamo wezidakamizwa. Ukuthuthukiswa kobuchwepheshe bokulungiselela kanye nemishini ehlobene nakho kwenza i-capsule ifanele izinhlanganisela eziningi ezinezakhiwo ezikhethekile, njengezinhlanganisela ezingancibiliki emanzini. Ukuhlaziywa kukhombisa ukuthi amaphesenti angama-50 wezinto ezintsha ezihlanganisiwe ezitholwe ngokuhlolwa okuphezulu kanye namakhemikhali ahlanganisiwe awancibiliki emanzini (20%) μ G / ml), womabili amaphilisi agcwele uketshezi kanye namaphilisi athambile angahlangabezana nezidingo zalokhu kulungiswa kwenhlanganisela.
3. Izindleko zokukhiqiza eziphansi
Uma kuqhathaniswa namaphilisi, i-workshop yokukhiqiza ye-GMP yama-capsules aqinile inezinzuzo zemishini yenqubo encane, ukusetshenziswa kwendawo ephezulu, ukuhlelwa okunengqondo, izikhathi ezimbalwa zokuhlola ohlelweni lokukhiqiza, imingcele yokulawula ikhwalithi encane, ama-opharetha amancane, ingozi ephansi yokungcoliswa kwesiphambano, inqubo yokulungiselela elula, izinqubo zokukhiqiza ezincane, izinto eziwusizo ezilula kanye nezindleko eziphansi. Ngokusho kokulinganisa kochwepheshe abagunyaziwe, izindleko eziphelele zamaphilisi aqinile ziphansi ngo-25-30% kunalezo zamaphilisi [5].
Ngokuthuthuka okunamandla kwama-capsules, ama-capsules angenalutho, njengenye yezinto ezisiza kakhulu, nawo asebenza kahle. Ngo-2007, inani eliphelele lokuthengiswa kwamaphilisi angenalutho emhlabeni lidlule izigidigidi ezingama-310, lapho ama-94% awo amaphilisi angenalutho e-gelatin, kanti amanye amaphesenti angu-6 avela kumaphilisi angewona asuselwa ezilwaneni, izinga lokukhula kwawo lonyaka lamaphilisi angenalutho e-hydroxypropyl methylcellulose (HPMC) lingaphezu kuka-25%.
Ukwenyuka okukhulu ekuthengisweni kwamaphilisi angenalutho okungezona ezilwane kukhombisa inkambiso yokusetshenziswa kokukhangisa imikhiqizo yemvelo emhlabeni. E-United States iyodwa, isibonelo, kunabantu abayizigidi ezingu-70 “abangakaze badle imikhiqizo ephuma ezilwaneni”, futhi amaphesenti angu-20 engqikithi yabantu “abayimifino”. Ngaphezu komqondo wemvelo, amaphilisi angenalutho angewona awesilwane nawo anezici zawo zobuchwepheshe ezihlukile. Isibonelo, ama-capsules angenalutho e-HPMC anokuqukethwe kwamanzi aphansi kakhulu kanye nokuqina okuhle, futhi afanele okuqukethwe nge-hygroscopicity kanye nokuzwela kwamanzi; I-pullulan hollow capsule ihlakazeka ngokushesha futhi inomoya-mpilo ophansi kakhulu. Ifanele izinto ezinciphisa amandla. Izici ezihlukile zenza imikhiqizo ehlukahlukene yama-capsule angenalutho iphumelele ezimakethe ezithile nezigaba zomkhiqizo.
IZIKHOMBISI
[1] La Wall, CH, 4000 iminyaka ekhemisi, umlando uhlaka ekhemisi kanye nesayensi ehlangene, JB Lippincott Comp., Philadelphia/London/Montreal, 1940
[2] Feldhaus, FM: Emlandweni Wekhephuseli Lokwelapha. I-Dtsch. U-Apoth.-Ztg, 94 (16), 321 (1954)
[3] I-French Patent No. 5648, Inikezwe ngoMashi 25, 1834
[4] Planche und Gueneau de Mussy, Bulletin of the Royal Academy of Medicine, 442-443 (1837)
[5] U-Graham Cole, Uhlola Izindleko Zokuthuthukiswa Nezokukhiqiza : Amathebulethi Ngokuphikisana Nama-Capsugel. I-Capsugel Library