Imigangatho yoMgangatho wePharmacopoeial kwiGelatin yePharmaceutical - grade

Amayeza - inqanaba i-gelatin (I-Gelatin yamayeza) ifumaneka ngokufaka ulwelo lwezilwanyana olufana nolweenkomo. Sisithako esiqhelekileyo samayeza, esisetyenziswa kakhulu kwi imboni yamayezangenxa Iigobolondo zeCapsule, ukugqunywa kwee-granules zamayeza, kunye nezinto ezizinzisayo zamayeza, njl. I-gelatin yezinga lezemithi kufuneka ihlangabezane nemigangatho engqongqo yomgangatho ukuqinisekisa ukhuseleko kunye nokusebenza kwayo xa isetyenziswa kumayeza. Ezi zilandelayo ziimfuno zomgangatho womgangatho we-gelatin yezinga lezemithi ngokwemigaqoI-Chinese Pharmacopoeia:

1. Inkangeleko kunye neempawu

Amayeza - inqanaba i-gelatin yimthubi okanye ityheli ekhanyayo, ecacileyo ukuya kweyona nto ifana nejeli okanye izinto ezirhabaxa ezinekhazimla elithile. Imveliso akufuneki ibe nezinto ezingabonakaliyo okanye ukungcola, kwaye akufuneki ibe nevumba elicaphukisayo. Ukucoceka kunye nokucaca kwembonakalo yenye yezona zinto zibalulekileyo zolawulo lomgangatho, ezichaphazela ukusetyenziswa kwayo kumayeza.

2.Ukunyibilika

I-gelatin yodidi lwezamayeza inokunyibilika ngokupheleleyo emanzini afudumeleyo ukuze yenze isisombululo esicacileyo nesiqinileyo. Ukunyibilika kwe-gelatin kumisela ukusebenza kwayo kwiigobolondo ze-capsule kunye nezinye iindlela zamayeza. Ukunyibilika okulungileyo kunceda ukuphucula isiphumo sokukhululwa kweyeza.

3.Indawo yokuQokelela iGelatin

I-coagulation point ye-gelatin yenye yezona zinto zibalulekileyo ezibonisa umgangatho wayo, kwaye idla ngokuba phakathi kwama-35°C nama-38°C. Ulawulo lwe-coagulation point lubalulekile ekuzinzeni nasekusebenziseni amayeza, ingakumbi kwiindawo ezinotshintsho olukhulu kubushushu.

4. Umxholo wobumanzi

Umthamo wokufuma we-gelatin yamayeza ngokubanzi kufuneka ube phakathi kwe-10% kunye ne-15%. Umthamo wokufuma ophezulu kakhulu okanye ophantsi kakhulu unokuchaphazela ukuzinza kwe-gelatin kunye nefuthe lokusetyenziswa kwayo kumayeza. Umthamo wokufuma ophezulu uya kukhokelela ekuwohlokeni okanye ekuwohlokeni komgangatho we-gelatin, ngelixa ukufuma okunganelanga kunokuchaphazela ukuguquguquka kwayo kunye nokusebenza kwayo.

5. Umxholo wothuthu

Umxholo wothuthu lwegelatin udla ngokufuneka ungabi ngaphezu kwe-2% (kubalwa ngokwesiseko esomileyo). Umxholo wothuthu ophezulu kakhulu unokubonisa ukuba igelatin inezinto ezingcolileyo, nto leyo echaphazela umgangatho wayo. Ulawulo lomxholo wothuthu lubalulekile ukuqinisekisa ukuba igelatin icocekile kwaye ayinangcoliseko.

6. Umda weMicrobial

Njengomxumi wamayeza, i-gelatin yodidi lwamayeza kufuneka ihlangabezane neemfuno ezingqongqo zomda weentsholongwane. I-pharmacopoeia ichaza imida yayo yeentsholongwane, kwaye iimveliso ze-gelatin akufuneki zibe neentsholongwane eziyingozi ukuqinisekisa ukuba aziyi kuchaphazela ukhuseleko lwamayeza.

7. Umxholo weChloride

Njengomnye wemigangatho ebalulekileyo yomgangatho, umxholo we-chloride kwi-gelatin yamayeza akufanele udlule kwi-0.05%. I-chloride egqithisileyo inokuba nefuthe elibi ekuzinzeni nasekufumanekeni kwamayeza.