
2026-04-05
Umusaruro wimboga capsule wubusa ntabwo ari uguhindura gelatine ya selile no kuyita byakozwe. Twujuje capsules zirenga miliyoni 27 mubirango 14 byiyongera-kandi twize uburyo bukomeye "bushingiye ku mboga" butemeza ko buzuye neza, busenyuka buri gihe, cyangwa kubahiriza amabwiriza. Icyangombwa ni * iyo * capsule yubusa yubusa wahisemo, uko yitwara mubihe byinganda zikora, kandi niba uwuzuza capsule abibona nkumufatanyabikorwa cyangwa ikibazo.
Abaguzi benshi batangirana nibisabwa nimirire: ibikomoka ku bimera, halale, bitari GMO. Ariko ibyo nibicuruzwa byungurura-ntabwo ari ibintu byubuhanga. Imikorere nyayo abashoferi bicaye mubice bitatu byapimwe: ibishishwa, kwihanganira ibipimo, hamwe nubushuhe. Muri SUQIAN KELAIYA INTERNATIONAL TRADING CO., LTD, turagerageza buri capsule yimboga zubusa zirimo USP. Umutwe rusange <2040> yo guseswa, ISO 8536-5 yo guhuza ibipimo, na ASTM D5229 kubipimo byo kwanduza imyuka (MVTR). Ubusanzwe capsule ya HPMC iva mu kigo cyacu cya Jiangsu ikora kuri 3.8-4.2% yubushuhe - bikabije bihagije kugirango wirinde kwihagararaho kwuzuza umuvuduko mwinshi, bihamye bihagije kugirango ube inyangamugayo mugihe cyiminsi 90 yo gupima umutekano kuri 40 ° C / 75% RH.
Twabonye abakiriya bahindura kuva muri capsules ya HPMC yatumijwe mucyiciro cyacu gisanzwe kandi bagabanya kuzuza amasaha 63%. Kubera iki? Kuberako ibishishwa byacu bigumana uburebure bwa mm 0,018 mm kurugero rwa 100.000-aho izindi zitandukanye ± 0.006 mm. Itandukaniro ritera guhuzagurika muri dosiye zuzuza hejuru ya 120.000 cph. Itera kandi guhuza ifu idahuye, biganisha ku guhinduka kw ibiro> ± 5% mubice bya dosiye yanyuma. Amakuru yacu yerekana ko gukomera shell ovality kuri ≤0.025 mm bigabanya gutandukana-uburemere busanzwe bwa 41%.
Ntukibwire ko HPMC yose ingana. Bamwe mubatanga isoko bakoresha hydroxypropyl methylcellulose hamwe no gusimbuza mikorobe nkeya (19-24%), yoroshye hejuru ya 35 ° C. Abandi bongeramo ibintu bya gelling nka carrageenan itinda gusenyuka muminota 45 ishize - kunanirwa USP <701> ibisabwa. Dukoresha Ubwoko E HPMC gusa (mikorobe 28-30%, hydroxypropyl 7-12%) biva mubikoresho byemewe ISO 22000. Buri cyiciro kirimo CoA ifite ubukonje (4-6 mPa · s @ 2% igisubizo), ibirimo ivu (<1.5%), hamwe nibisigara bisigaye (byose biri munsi yumupaka wa ICH Q3C).
Bamwe bashobora kuvuga ko formulaire ya capsule yonyine igena intsinzi. Nyamara, nta capsule yimboga irimo ubusa ikora mu bwigunge-ikorana neza nibikoresho bya mashini yawe yuzuza ibikoresho, umwirondoro wa vacuum, nigihe cyo gusohora. Twakemuye kunanirwa kuzuza muri sisitemu ya rotateur ya rotateur (MG2, IMA Zanasi), kuzuza bande ikomeza (Capsugel FlexiFill), hamwe na bintike ya bomatike (CapPlus 300). Muri buri kintu cyose, intandaro yaturutse ku myitwarire idahwitse - ntabwo ari ibintu byiza.
Umukiriya umwe akoresha umurage wa blister kumurongo yatangaje 12% ya capsule deformasiyo mugihe cyoherejwe mumifuka ya blister. Guhindukira kurwego rwacu rwo hasi-rushyizweho na 0,05% ya magnesium stearate - yagabanutse guhindura 0.3%. Itandukaniro ntabwo ryari chimie. Byari kugenzura ingufu zo hejuru.

Ubusa imboga za capsule zirimo ibiciro kuva $ 0.018 kugeza $ 0.042 kuri buri gice. Ariko ikiguzi-kuri-buri-gice kivuga amateka nyayo. Tekereza uku gusenyuka kwa miliyoni 100-yumwaka ukoreshwa:
Imibare ntisobanutse. Ndetse no ku $ 0.027, icyiciro gisanzwe cya Kelaiya gitanga 22% munsi yikiguzi cyose kuri capsule yarangiye-gushingira kumurimo, kumasaha, gukora, no gupima ituze. Kandi kubera ko capsules zacu zatsinze ICH Q5C kwipimisha (nta kwangirika kwa UV guterwa na vitamine B12 cyangwa curcumin), abakiriya birinda inzitizi zivugurura.
Ntabwo tugurisha capsules. Tugurisha umusaruro uteganijwe. Ibicuruzwa byose byoherejwe hamwe nibisobanuro byihariye byo gusesa, gukwirakwiza ibiro byerekana amateka, hamwe na raporo yo guhuza ibicuruzwa bisanzwe - mannitol, microcrystalline selile, dioxyde de silicon. Nta gukeka. Nta kwemeza gutunguranye.

Imboga zifite imboga zirimo ubusa nubwa mbere bwakozwe hagati yimikorere yawe nu mukoresha wa nyuma. Igomba kurokoka umuvuduko mwinshi, kurinda ibikorwa byoroshye, gushonga neza mumazi ya gastric, kandi ikuzuza ibipimo ngenderwaho byisi - byose mbere yuko ikinini cya mbere kiva mumacupa. Ibisobanuro rusange ntibizakugeza aho. Nta nubwo udutabo tw’abacuruzi dusezeranya “ubuziranenge buhebuje.”
Igikora nukugerageza mubihe byawe. Niyo mpamvu dutanga ibikoresho byintangarugero kubuntu hamwe na dosiye yuzuye ya tekiniki-harimo videwo yerekana capsule, imyirondoro yo gusesa kuri pH 1.2 / 4.5 / 6.8, hamwe n’ibihe byuzuye-byuzuye byuzuye uhereye kumurongo wa pilote wa Zhejiang. Uzabona neza uko buri cyiciro cyitwara kubikoresho byawe-ntabwo ari ibyacu.
SUQIAN KELAIYA INTERNATIONAL TRADING CO., LTD ikora imbuga ebyiri zemewe na GMP: imwe muri Jiangsu yibanze ku gusohora ibicuruzwa bya HPMC byuzuye, ikindi muri Zhejiang gihuza capsule yuzuza no kwemeza ibipfunyika. Byombi bishyigikira FDA, Ubuzima bwa Canada, hamwe na EU Umugereka wa 1. Ariko icyemezo ntacyo bivuze niba capsule ihinduye uwuzuza saa tatu za mugitondo.
Icyiciro cyawe gikurikira ntigikwiye gushingira kumizero. Igomba gukora ku makuru. Tangira hamwe na capsule yubusa yubusa yubatswe kubyo inzira yawe isaba-ntabwo aribyo label isezeranya.