Ubungakanani be-2 yeGelatin Capsules

Ubungakanani be-2 ye-Gelatin Capsules zezamachiza{1}}ii-capsules zebakala eziyilelwe ukugquma umgubo okanye izithako ezingamanzi, eziqhele ukusetyenziselwa izongezo zemifuno, iivithamin, okanye amayeza afuna ngokuthe ngqo, iidosi ezincinci, ukulinganisa ukusebenza kunye nokulula kwesigulana.

1. 100% i-gelatin ye-capsule ethathwe kwi-bovine ekrwada, idigri ye-capsule yamayeza.

 

2. Umenzi ongenanto wee-capsules ezinzima ongenanto iminyaka eyi-13 enesibonelelo esiphezulu.

 

3. Ukulawula umgangatho ongqongqo.

 

4. Inkonzo ekhawulezayo kunye{1}}nokuhanjiswa kwexesha.

 

5. Yamkela iodolo yesiko, ekhoyo ngemibala, ukuprintwa kwelogo.

 

6. Ixabiso lasefektri.

• Ukuze kuveliswe{0}umgangatho ophezulu, ukhuselekile, iicapsules ezingenanto ezisempilweni, inyathelo ngalinye lemveliso linemigaqo yokusebenza engqongqo kunye nolawulo lomgangatho.

 

• Ukususela ekukhethweni kwezinto eziluhlaza, kugxininiso kwinkqubo yokuvelisa kunye nokuhlolwa kwee-capsules ezigqityiweyo, zonke ngokungqongqo ngokuhambelana nemigangatho.

Ulawulo

 

Landela i-cGMP ukuququzelela imveliso kunye nolawulo lomgangatho, ukuseka inkqubo yokuqinisekisa umgangatho, kwaye ilabhoratri iya kuqhuba isiqinisekiso se-CNAS.

Iinjongo zomgangatho: ireyithi yesampulu yentengiso yemveliso ye-100% yereyithi yokupasa, umgangatho obalulekileyo kunye neengozi zokhuseleko ukuya kuthi ga kwi-zero, iimveliso eziphambili kunye nemigangatho yoshishino lweenkonzo.

Imveliso yethu ihambelana nemigangatho ye-Pharmacopoeia yaseTshayina kwaye iphumelele iziqinisekiso zamazwe ngamazwe ezifana ne-HALAL, i-Kosher, i-FDA, i-ISO9001 kunye ne-ISO22000.

Iinkonzo zoThutho

Emva kokuhlolwa kwemveliso, siya kucwangcisa ngokukhawuleza izithuthi ezikhethekileyo, izithuthi ezifakwe efrijini, imithwalo yomoya, i-express kunye nezinye iinkonzo ngokweemfuno zabathengi ukuhlangabezana ngokufanelekileyo neemfuno zokubonelela abathengi abahlukeneyo.

• Ibhegi ye-PE+Ibhegi yeAluminiyam yefoyile+Ibhodi yogwebu emithandathu engaphezulu +5 Ikhathoni etyatyiweyo

 

• Ubungakanani bekhathoni 60x73x40cm, umthamo 0.18 cubic metres, ubunzima bumalunga ne-15kgs ngebhokisi

 

• Imeko yoGcino: Ubushushu: 15℃~ 25℃, Ukufuma: 35% ~ 65%

 

• I-20 'Isikhongozelo sefriji: Iibhokisi ze-140 ze-capsules ezingenanto.

 

• I-40 'Isikhongozelo sefriji: Iibhokisi ze-345 ze-capsules ezingenanto.

 

Iyafumaneka ukulungiselela ngokweemfuno zomthengi.

1. Iimeko zoThutho zobukhulu be-2 yeGelatin Capsules
Ubungakanani be-2 ye-gelatin capsules, njengezinye ii-capsules ze-gelatin ezinzima, zinovakalelo kwiimeko zokusingqongileyo ezifana nobushushu, ukufuma kunye nokukhanya. Ngexesha lokuthutha, ukugcina ingqibelelo yomzimba kunye nokuzinza kweekhemikhali ze-capsules kubalulekile ukuqinisekisa umgangatho wemveliso.

Izikhokelo zezothutho eziphambili ziquka:

Ukulawula ubushushu: Ngokufanelekileyo, i-gelatin capsules kufuneka ihanjiswe kwi-15-25 degree. Ukuvezwa kumaqondo obushushu aphezulu kunokubangela ukuthamba, ukuncamathela, okanye ukuguquka, ngelixa amaqondo obushushu aphantsi anokubenza babe brittle.

Ulawulo lokufuma: Ukufuma okunxulumeneyo (RH) kufuneka kugcinwe phakathi kwe-35% -65%. Ukufuma okugqithisileyo kunokubangela ukuba ii-capsules zidumbe okanye zincamathele, ngelixa iimeko ezomileyo kakhulu zinokukhokelela ekuqhekekeni.

Ukupakishwa: Iicapsules zivalwa ngokufuma -ziyaxhathisa, ezichasene{1}}neengxowa ze-PE ezingatshintshiyo kwaye zipakishwe-kwiibhokisi zesithintelo okanye imigqomo yefayibha. Ukupakishwa kufuneka kukhusele ii-capsules ekukhanyeni, ukufuma, kunye nomonakalo womzimba.

Imo yezothutho:{0}}Iilori ezinomoya opholileyo okanye izikhongozeli ziyakhethwa, ngakumbi kwimozulu egqithisileyo. Ukothuka kunye nokungcangcazela kufuneka kuncitshiswe ukunqanda ukophuka okanye ukuvuza komgubo ukuba -kuzaliswe ngaphambili.

Ukuphatha: Ngexesha lokulayisha kunye nokukhupha, ii-capsules kufuneka ziphathwe ngokucophelela ukuphepha uxinzelelo okanye ukutyumza.

2. Iimeko zokuGcina
Ukugcina i-gelatin capsules' iipropathi zoomatshini kunye neekhemikhali kubomi bazo beshelufa, ukugcinwa ngokufanelekileyo kubalulekile.

Iimeko zokugcina ezicetyiswayo:

Ubushushu: 15-25 degree

Ukufuma okuhambelanayo: 35% -65% RH

Indawo yokungenisa umoya: Iindawo zogcino kufuneka{0}zingene kakuhle kwaye zibe kude nevumba elinamandla, imichiza, okanye izinto eziguquguqukayo ezinokuchaphazela igelatin.

Ukukhanya: Gcina kude nelanga elithe ngqo ukunqanda ukujika kombala okanye ukonakala.

Ukupakisha: Kuphephe ukupakisha izinto ezinzima phezu kweebhokisi ze-capsule ukuthintela ukuguquka.

Okokuqala-Phakathi{1}}Kuqala{2}}Ngaphandle (FIFO): Iibhetshi zeCapsule kufuneka zisetyenziswe ngokolandelelwano lwemveliso ukuqinisekisa ukutsha.

Ukuba igcinwe phantsi kwezi meko zicetyiswayo, ubukhulu be-2 i-gelatin capsules buhlala buhlala kwiinyanga ezingama-24.

3. Izinto zoVavanyo lwePhysicochemical
Ukuqinisekisa umgangatho, ukhuseleko, kunye nokuhambelana, isethi ebanzi yovavanyo lwe-physicochemical lwenziwa kwii-capsules ze-gelatin. Ezi mvavanyo zihambelana nemigangatho ye-pharmacopeial efana ne-USP, i-EP, okanye i-ChP.

Izinto eziphambili zovavanyo ziquka:

Imbonakalo

Iicapsules kufuneka zibe cylindrical kunye nomphezulu ogudileyo, ezingenazo iintanda, izibonda, okanye ukuguqulwa.

Umbala kufuneka ufane kwaye ungabi namabala okanye amabala.

Ubungakanani kunye nemilinganiselo

Umzimba we-Capsule kunye ne-cap kufuneka ihlangabezane nedayimitha ethile kunye nemilinganiselo yobude bobukhulu be-2.

Ukunyamezela kujongwa ngokungqongqo ukuqinisekisa ukuhambelana noomatshini bokuzalisa.

Umxholo wokufuma

Ngokuqhelekileyo kulawulwa ngaphakathi kwe-13.0% -16.0% ukugcina i-elasticity kunye nokukhusela i-brittleness.

Ukulinganisa usebenzisa i-Karl Fischer titration okanye iindlela ze-thermogravimetric.

Ixesha lokuchithakala

Iipilisi kufuneka zidibanise ngokupheleleyo kwi-0.5% ye-hydrochloric acid (i-simulating gastric fluid) ngaphakathi kwemizuzu eyi-10, ngaphandle kokuba iguqulwe ngenye indlela.

Imida yeMicrobial

Iyonke i-aerobic microbial count (TAMC): Ngaphantsi okanye ilingana ne-1000 CFU/g

Iyonke igwele kunye nesibalo sokungunda (TYMC): Ngaphantsi okanye ilingana ne-100 CFU/g

Ukungabikho kwe-pathogens: i-E. coli, i-Salmonella, i-S. aureus kufuneka ingabonwa

Ilahleko ekomisweni

Isetyenziselwa ukulinganisa amanzi kunye neziqulatho eziguquguqukayo; inceda ukuvavanya ukuzinza kokufuma.

Iintsimbi ezinzima kunye nezinyibilikisi ezishiyekileyo

Kufuneka ihambelane nemida ye-pharmacopeial ukuqinisekisa ukhuseleko.

Amandla eGel (Ixabiso leBloom)

Ibonisa amandla e-gelling ye-gelatin; Ngokwesiqhelo malunga ne 150–250 Bloom ye capsule -yegrade gelatin.

Viscosity

Kubalulekile kwinkqubo yokufakwa kwe-encapsulation; iqinisekisa ukwakheka okufanelekileyo kweqokobhe.

Umbala kunye nesiqulatho esongezelelweyo

Ukuba ii-colorants okanye ii-opacifiers (umz., i-titanium dioxide okanye i-iron oxide) zisetyenzisiwe, ugxininiso lwazo kufuneka luhlangabezane nemigangatho yokulawula.

Ukuqukumbela
Ukuthuthwa ngokufanelekileyo kunye nokugcinwa kwe-2 ye-gelatin capsules kubalulekile ukugcina ukusebenza kunye nokhuseleko lwabo. Ngeli xesha, uvavanyo olungqongqo lwephysicochemicals luqinisekisa ukuba iicapsules ziyahlangabezana nepharmacopeial kunye nomthengi{2}}imigangatho ethile yobulunga. Ezi zenzo zibalulekile ekuqinisekiseni ukusebenza kwe-capsule engaguqukiyo kwizicelo zamachiza kunye nezondlo.

Iifayile ezishisayo: Ubungakanani be-2 ye-gelatin capsules, ubukhulu baseTshayina i-2 ye-gelatin capsules abavelisi, ababoneleli, umzi-mveliso