Zokambirana pa msika wapadziko lonse wa makapisozi opanda kanthu

Wolemba: Jianhua Lv adachokera ku: "Medicine&Packaging"
Kuchokera: http://www.capsugel.com.cn/aboutjlshow.asp?id=7

Kapisozi ndi imodzi mwamitundu yakale yamankhwala, yomwe idachokera ku Egypt wakale [1]. De Pauli, wamankhwala ku Vienna, adatchula m'buku lake laulendo mu 1730 kuti makapisozi a Oval adagwiritsidwa ntchito kubisa fungo loipa la mankhwala kuti achepetse ululu wa odwala [2]. Zaka zoposa 100 pambuyo pake, akatswiri azamankhwala a Joseph Gerard Auguste dublanc ndi Francois Achille Barnabe motors adalandira chilolezo cha kapisozi woyamba wa gelatin padziko lapansi mu 1843 ndipo mosalekeza adawongolera kuti agwirizane ndi kupanga mafakitale [3,4]; Kuyambira nthawi imeneyo, ma Patent ambiri pa makapisozi opanda kanthu adabadwa. Mu 1931, Arthur Colton wa kampani ya Parke Davis adapanga bwino ndikupanga zida zopangira zokha za kapisozi wopanda pake ndikupanga kapisozi woyamba padziko lonse lapansi wopangidwa ndi makina. Chosangalatsa ndichakuti, mpaka pano, mzere wopangira kapisozi wopanda kanthu wakhala ukungokonzedwa mosalekeza pamaziko a mapangidwe a Arthur kuti apititse patsogolo luso lazogulitsa komanso kupanga bwino.

Pakali pano, kapisozi wapanga lalikulu ndi mofulumira chitukuko m'munda wa chisamaliro chaumoyo ndi mankhwala, ndipo wakhala mmodzi wa waukulu mlingo mitundu ya m'kamwa olimba kukonzekera. Kuyambira 1982 mpaka 2000, pakati pa mankhwala atsopano ovomerezeka padziko lonse lapansi, mawonekedwe a kapisozi olimba akuwonetsa kukwera.
Chithunzi 1 Kuyambira 1982, mankhwala atsopano a maselo akhala akuyerekezedwa pakati pa makapisozi ndi mapiritsi

Ndi chitukuko cha kupanga mankhwala ndi mafakitale a R & D, ubwino wa makapisozi wadziwika kwambiri, makamaka muzinthu izi:

1. Zokonda za odwala

Poyerekeza ndi mitundu ina ya mlingo, makapisozi olimba amatha kubisa fungo loipa la mankhwala ndipo ndi osavuta kumeza. Mitundu yosiyanasiyana ndi mapangidwe osindikizira amapangitsa kuti mankhwala azidziwika bwino, kuti apititse patsogolo kutsata kwamankhwala. Mu 1983, kafukufuku wopangidwa ndi akuluakulu a ku Ulaya ndi ku America anasonyeza kuti mwa odwala 1000 omwe anasankhidwa, 54% ankakonda makapisozi olimba, 29% anasankha mapepala opangidwa ndi shuga, 13% okha anasankha mapiritsi, ndipo ena 4% sanasankhe bwino.

2. Kuchita bwino kwa R&D

Lipoti la 2003 tufts linanena kuti mtengo wa kafukufuku wa mankhwala ndi chitukuko unakula ndi 55% kuchokera ku 1995 mpaka 2000, ndipo pafupifupi mtengo wapadziko lonse wa kafukufuku wa mankhwala ndi chitukuko wafika pa madola 897 miliyoni a US. Monga tonse tikudziwira, mankhwala oyambilira adalembedwa, nthawi yayitali pamsika yamankhwala ovomerezeka ikhala yayitali, ndipo phindu lamankhwala lamakampani azamankhwala lidzakwera kwambiri. Pafupifupi chiwerengero cha othandizira omwe amagwiritsidwa ntchito mu makapisozi anali 4, omwe adachepetsedwa kwambiri poyerekeza ndi 8-9 m'mapiritsi; Zinthu zoyezera makapisozi ndizochepa, ndipo mtengo wa kukhazikitsa njira, kutsimikizira ndi kusanthula ndi pafupifupi theka la mapiritsi. Choncho, poyerekeza ndi mapiritsi, nthawi ya chitukuko cha makapisozi ndi osachepera theka la chaka wamfupi kuposa mapiritsi.
Nthawi zambiri, 22% yazinthu zatsopano zofufuza zamankhwala ndi chitukuko zitha kulowa m'mayesero azachipatala a gawo I, pomwe osakwana 1/4 amatha kudutsa gawo lachitatu la mayeso azachipatala. Kuwunika kwa mankhwala atsopano kungachepetse bwino mtengo wa kafukufuku watsopano wa mankhwala ndi mabungwe a chitukuko mwamsanga. Chifukwa chake, makampani opanga makapisozi padziko lonse lapansi apanga makapisozi opangira makoswe (pccaps) oyenera kuyesa makoswe ®）; Chida chokhazikika chapang'onopang'ono (xcelodose) choyenera kupanga zitsanzo zamakapisozi azachipatala ®）， Ndipo makapisozi akhungu awiri (dbcaps) oyenera kuyeserera kwakukulu kwachipatala ® & kuwongolera mtengo wa R & D kuti athandizire kuwongolera kwanthawi zonse kwa R & D kuti athandizire kuwongolera mtengo wazinthu zonse.
Kuphatikiza apo, pali mitundu yopitilira 9 ya makapisozi amitundu yosiyanasiyana, omwe amapereka zosankha zingapo pamapangidwe a mlingo wamankhwala. Kupititsa patsogolo ukadaulo wokonzekera ndi zida zofananira kumapangitsanso kapisozi kukhala yoyenera kuphatikizika ndi zinthu zapadera, monga mankhwala osasungunuka m'madzi. Kusanthula kukuwonetsa kuti 50% yazinthu zatsopano zomwe zimapezedwa kudzera pakuwunika kwambiri komanso chemistry yophatikizika sizisungunuka m'madzi (20%) μ G / ml), makapisozi odzaza madzi ndi makapisozi ofewa amatha kukwaniritsa zofunikira za kukonzekera kwapawiri.

3. Mtengo wotsika mtengo

Poyerekeza ndi mapiritsi, GMP kupanga msonkhano wa makapisozi olimba ali ndi ubwino wa zida zochepa ndondomeko, mkulu danga magwiritsidwe, masanjidwe wololera, nthawi zochepa kuyendera mu ndondomeko kupanga, zochepa khalidwe kulamulira magawo, opareshoni zochepa, chiopsezo chochepa cha kuipitsidwa kwa mtanda, njira yosavuta kukonzekera, njira zochepetsera kupanga, zipangizo zosavuta zothandizira ndi mtengo wotsika. Malinga ndi kuyerekezera kwa akatswiri ovomerezeka, mtengo wokwanira wa makapisozi olimba ndi 25-30% kutsika kuposa mapiritsi [5].
Ndi kukula kwakukulu kwa makapisozi, makapisozi opanda kanthu, monga chimodzi mwazothandizira zazikulu, amakhalanso ndi ntchito yabwino. Mu 2007, kuchuluka kwa malonda a makapisozi opanda kanthu padziko lonse lapansi kudaposa 310 biliyoni, pomwe 94% ndi makapisozi opanda kanthu a gelatin, pomwe ena 6% adachokera ku makapisozi omwe sianyama, omwe kukula kwapachaka kwa makapisozi a hydroxypropyl methylcellulose (HPMC) ndi oposa 25%.
Kuwonjezeka kwakukulu kwa malonda a makapisozi osapangidwa ndi nyama kukuwonetsa momwe anthu amagwiritsidwira ntchito polimbikitsa zinthu zachilengedwe padziko lapansi. Ku United States kokha, mwachitsanzo, pali anthu 70 miliyoni omwe "sanadyepo zinthu zochokera ku nyama", ndipo 20% ya anthu onse ndi "odya zamasamba". Kuphatikiza pamalingaliro achilengedwe, makapisozi opanda zinyama opangidwa ndi dzenje alinso ndi mawonekedwe awoawo apadera. Mwachitsanzo, makapisozi opanda kanthu a HPMC ali ndi madzi otsika kwambiri komanso olimba bwino, ndipo ndi oyenera zomwe zili ndi hygroscopicity ndi kumva kwamadzi; Pullulan hollow capsule imasweka mwachangu ndipo imakhala ndi mpweya wochepa kwambiri. Ndi oyenera kuchepetsa zinthu zamphamvu. Makhalidwe osiyanasiyana amapangitsa kuti zinthu zosiyanasiyana za kapisozi zikhale zopambana m'misika inayake komanso magulu azogulitsa.

MALONJE

[1] La Wall, CH, zaka 4000 za pharmacy, mbiri yakale ya pharmacy ndi allied sciences, JB Lippincott Comp., Philadelphia / London / Montreal, 1940
[2] Feldhaus, FM: Pa Mbiri Yamankhwala Kapsule. Dtsch. Apoth.-Ztg, 94 (16), 321 (1954)
[3] French Patent No. 5648, Yoperekedwa pa Marichi 25, 1834
[4] Planche und Gueneau de Mussy, Bulletin wa Royal Academy of Medicine, 442-443 (1837)
[5] Graham Cole, Kuwunika Mtengo Wotukuka ndi Kupanga : Mapiritsi Otsutsana ndi Capsugels. Laibulale ya Capsugel