Kapsule Yamasamba Yopanda Pansi Yodzaza Zowonjezera Zoyera 

Kupanga kapisozi wopanda kanthu wamasamba sikungosinthana ndi gelatin ndi cellulose ndikuyitcha kuti yachitika. Tadzaza makapisozi opitilira 27 miliyoni pazowonjezera 14 - ndipo taphunzira movutikira kuti "masamba" samatsimikizira kudzazidwa koyera, kusungunuka kosasintha, kapena kutsata malamulo. Chofunikira ndi *kuti* kapisozi wamasamba wopanda kanthu omwe mumasankha, momwe amakhalira pansi pakupanga zenizeni, komanso ngati chodzaza kapisozi chanu chimachiwona ngati mnzanu kapena vuto.

Chifukwa Chake "Kapisozi Yopanda Zamasamba" Ndi Kachitidwe Kachitidwe - Osati Chilemba Chokha

Ogula ambiri amayamba ndi zonena zazakudya: vegan, halal, non-GMO. Koma amenewo ndi zosefera zamalonda-osati zaumisiri. Madalaivala a magwiridwe antchito enieni amakhala m'magawo atatu oyezeka: kapangidwe ka zipolopolo, kulekerera kwa dimensional, komanso kumva kwa chinyezi. Ku SUQIAN KELAIYA INTERNATIONAL TRADING CO., LTD, timayesa kapisozi wamasamba wopanda kanthu ndi USP. General Mutu <2040> ya kusungunuka, ISO 8536-5 ya dimensional consistence, ndi ASTM D5229 ya chinyezi vapor transmission rate (MVTR). Kapisozi wamba wa HPMC wochokera ku malo athu a Jiangsu amayendera chinyezi cha 3.8-4.2% - cholimba mokwanira kuti chiteteze kumamatira pamafila othamanga kwambiri, okhazikika mokwanira kuti asunge umphumphu pakuyesa kukhazikika kwa masiku 90 pa 40 ° C / 75% RH.

Tawona makasitomala akusintha kuchokera ku makapisozi a HPMC otumizidwa kunja kupita ku kalasi yathu yokhazikika ndikudula nthawi yodzaza ndi 63%. Chifukwa chiyani? Chifukwa zipolopolo zathu zimasunga makulidwe a khoma la 0.018 mm kudutsa mayunitsi 100,000 - pomwe ena amasiyana ± 0.006 mm. Kusiyanasiyana kumeneku kumapangitsa kuti ma fillers a dosator azithamanga kuposa 120,000 cph. Zimayambitsanso kusakanikirana kwa ufa wosagwirizana, zomwe zimapangitsa kuti pakhale kusiyana kwa kulemera> ± 5% m'magawo omaliza a mlingo. Zomwe timapeza zikuwonetsa kuti kukhwimitsa chipolopolo mpaka ≤0.025 mm kumachepetsa kupatuka kokwanira ndi 41%.

Musaganize kuti HPMC yonse ndi yofanana. Ogulitsa ena amagwiritsa ntchito hydroxypropyl methylcellulose yokhala ndi njira yotsika ya methoxy (19-24%), yomwe imafewa kuposa 35°C. Ena amawonjezera ma gelling agents ngati carrageenan omwe amachedwetsa kupasuka pambuyo pa mphindi 45 - kulephera kwa USP. <701> zofunikira za kudulira. Timangogwiritsa ntchito Mtundu E HPMC (methoxy 28–30%, hydroxypropyl 7–12%) yochokera ku malo ovomerezeka a ISO 22000. Gulu lililonse limaphatikizapo CoA yokhala ndi kukhuthala (4–6 mPa·s @ 2% yankho), phulusa (<1.5%), ndi zosungunulira zotsalira (zonse zili pansi pa malire a ICH Q3C).

The Filler-Capsule Interface: Kumene Chiphunzitso Chimakumana ndi Jammed Hoppers

Ena angatsutse kuti kapisozi kapisozi kokha kumatsimikizira kupambana. Komabe, palibe kapu yamasamba yopanda kanthu yomwe imachita payokha-imagwirizana mwachindunji ndi zida zamakina anu odzaza, mbiri ya vacuum, ndi nthawi yotulutsa. Tathetsa kulephera kwa kudzaza pamakina a rotary dosator (MG2, IMA Zanasi), zodzaza band mosalekeza (Capsugel FlexiFill), ndi ma semi-automatic benchtop units (CapPlus 300). Muzochita zonse, gwero lake linayambika ku khalidwe losayenera la mawotchi—osati kuyera kwakuthupi.

• Kuchulukitsa kwacharge: Low-MVTR zipolopolo (<5 g/m²/24h) kupanga triboelectric mlandu pa lathu. Timawonjezera 0.12% silika wa kalasi ya chakudya ku kalasi yathu yokhazikika-kudula zochitika za static discharge kuchokera ku 17 / ola kufika pa <1/ola pa mizere 180,000 cph.
• Kusagwirizana kwa mphamvu ya ejection: Makapisozi a zipolopolo zofewa amamangirira pamene mapini otulutsa akugwira ntchito> 1.8 N mphamvu. Gulu lathu lolimbitsidwa limagwiritsa ntchito 0.8% pullulan co-blend, kukweza kukana kwa ejection ku 2.6 N popanda kusokoneza nthawi ya kupasuka.
• Kulephera kwa chisindikizo cha vacuum: Makapisozi okhala ndi malo opindika amkati amawukhira mulingo wa dosator. Timapukuta makoma amkati mpaka ku Ra ≤0.4 µm-kukwaniritsa 99.97% kudzaza zolondola pa ufa wokhala ndi kachulukidwe kochuluka <0.35 g/cm³.

Makasitomala m'modzi wogwiritsa ntchito mzere wa chithuza cholowa adanenanso kuti 12% ya kapisozi kapisozi pakusamutsira m'matumba a zithuza. Kusinthira ku kalasi yathu yotsika kwambiri - yokutidwa ndi 0.05% magnesium stearate - kutsika kwatsika kufika pa 0.3%. Kusiyana sikunali chemistry. Kunali kulamulira mphamvu pamwamba.

Mtengo Si Wamtengo Wagawo Lokha - Ndi Zokolola, Kuthamanga, ndi Moyo Wa alumali

Mitengo ya kapisozi yamasamba yopanda kanthu imachokera pa $0.018 mpaka $0.042 pagawo lililonse. Koma mtengo-per-dosed-unit umafotokoza nkhani yeniyeni. Ganizirani za kuphwanya uku kwa 100-million-mayunitsi othamanga pachaka:

• Kapsule yotsika mtengo ($0.019): 8.2% kudzaza kukana, 112,000 cph max liwiro, alumali ya miyezi 24
• Kelaiya standard giredi ($0.027): 1.4% kudzaza kukana, 148,000 cph max speed, 36-shelf moyo
• Gulu lolimbikitsidwa ($ 0.039): 0.6% kudzaza kukana, 165,000 cph max liwiro, 42-miyezi ya alumali moyo

Masamu ndi osadziwika bwino. Ngakhale pa $ 0.027, giredi yokhazikika ya Kelaiya imapereka 22% mtengo wotsikirapo pa kapisozi yomalizidwa - kutengera ntchito, nthawi yopumira, kukonzanso, komanso kuyesa kukhazikika. Ndipo chifukwa makapisozi athu amadutsa kuyesa kwa ICH Q5C (palibe kuwonongeka kopangidwa ndi UV mu vitamini B12 kapena ma curcumin formulations), makasitomala amapewa kusinthika kwamitengo.

Sitigulitsa makapisozi. Timagulitsa zomwe zinganenedwe. Maoda aliwonse amatumiza okhala ndi ma curve osintha kwambiri, ma histogram kagawidwe ka kulemera, ndi malipoti ofananira azinthu zomwe zimagwiritsidwa ntchito wamba—mannitol, cellulose microcrystalline, silicon dioxide. Palibe zongoyerekeza. Palibe zodabwitsa zotsimikizira.

Sankhani Kapisozi Yopanda Zamasamba Yomwe Imagwirizana ndi Njira Yanu-Osati Chizindikiro Chanu Chokha

Kapisozi wopanda kanthu wamasamba ndiye mawonekedwe oyamba opangidwa pakati pa zomwe mumagwiritsa ntchito ndi wogwiritsa ntchito. Iyenera kupulumuka pakugwira ntchito mothamanga kwambiri, kuteteza mphamvu zogwira mtima, kusungunuka modalirika m'madzi am'mimba, ndikukumana ndi malire oyendetsera dziko lonse - zonsezi zisanachitike mlingo woyamba usanatuluke m'botolo. Zolemba zenizeni sizingakufikitseni pamenepo. Ngakhalenso timabuku ta ogulitsa omwe amalonjeza "zabwino kwambiri."

Zomwe zimagwira ntchito ndikuyesa pansi pamikhalidwe yanu. Ichi ndichifukwa chake timapereka zida zaulere zokhala ndi zolemba zonse zaukadaulo-kuphatikiza makanema owongolera makapisozi, ma profiles osungunuka pa pH 1.2 / 4.5 / 6.8, ndi zipika zenizeni zenizeni kuchokera pamzere wathu woyendetsa wa Zhejiang. Mudzawona momwe kalasi iliyonse imachitira pazida zanu-osati zathu.

SUQIAN KELAIYA INTERNATIONAL TRADING CO., LTD imagwiritsa ntchito malo awiri ovomerezeka a GMP: imodzi ku Jiangsu imayang'ana kwambiri kutulutsa kwa zipolopolo za HPMC, ina ku Zhejiang kuphatikiza kudzaza kapisozi ndi kutsimikizira kwa matuza. Onse amathandizira FDA, Health Canada, ndi EU Annex 1 audits. Koma chiphaso sichitanthauza kanthu ngati kapisoziyo ikudzaza 3 koloko Lolemba.

Gulu lanu lotsatira siliyenera kudalira chiyembekezo. Iyenera kuyenda pa data. Yambani ndi kapule yamasamba yopanda kanthu yomwe imapangidwira zomwe ndondomeko yanu imafuna - osati zomwe chizindikirocho chimalonjeza.