Izindinganiso Zekhwalithi Ye-Pharmacopoeial ze-Gelatin Yezinga Lemithi

Ibanga lezemithi i-gelatin (I-Gelatin Yemithi) itholakala ngokufaka izikhumba zezilwane emanzini njengesikhumba sezinkomo. Kuyisithako esivamile semithi, esisetshenziswa kabanzi imboni yezemithingoba Amagobolondo e-Capsule, ukumbozwa kwama-granule emithi, kanye neziqinisi zemithi, njll. I-gelatin yezinga lemithi kumele ihlangabezane nezindinganiso zekhwalithi eziqinile ukuqinisekisa ukuphepha kwayo kanye nokusebenza kwayo uma isetshenziswa emithini. Nazi izidingo zezinga lekhwalithi ye-gelatin yezinga lemithi ngokusho kwe-I-Chinese Pharmacopoeia:

1. Ukubukeka Nezakhiwo

Ibanga lezemithi i-gelatin iphuzi eliphuzi noma elikhanyayo, elifana nejeli noma elifana ne-granular elinombala okhanyayo. Umkhiqizo akufanele uqukathe izinto ezingaphandle noma ukungcola okusobala, futhi akufanele ube nephunga elicasulayo. Ukuhlanzeka kanye nokubonakala kokubukeka kungenye yezinkomba ezibalulekile zokulawulwa kwekhwalithi, ezithinta ukusebenza kwayo emithini.

2.Ukuncibilika

I-gelatin yezinga lemithi ingancibilikiswa ngokuphelele emanzini afudumele ukuze kwakheke isixazululo esibonakalayo nesiqinile. Ukuncibilika kwe-gelatin kunquma ukusebenza kwayo kumagobolondo e-capsule kanye neminye imithi. Ukuncibilika okuhle kusiza ukuthuthukisa umphumela wokukhishwa kwemithi.

3. Iphuzu Lokujiya Kwe-Gelatin

Iphuzu lokujiya kwe-gelatin lingenye yezinkomba ezibalulekile zokuhlola ikhwalithi yayo, futhi ngokuvamile kudingeka libe phakathi kuka-35°C no-38°C. Ukulawulwa kwephuzu lokujiya kubalulekile ekuzinzeni nasekusetshenzisweni kwemithi, ikakhulukazi ezindaweni ezinezinguquko ezinkulu zokushisa.

4. Okuqukethwe komswakama

Umswakama we-gelatin yezinga lemithi ngokuvamile kudingeka ube phakathi kuka-10% no-15%. Umswakama ophezulu noma ophansi kakhulu ungathinta ukuzinza kwe-gelatin kanye nomphumela wokusetshenziswa kwayo emithini. Umswakama owedlulele uzoholela ekuwohlokeni noma ekuwohlokeni kwekhwalithi ye-gelatin, kanti umswakama onganele ungathinta ukuguquguquka nokusebenza kwayo.

5. Okuqukethwe komlotha

Okuqukethwe komlotha we-gelatin ngokuvamile kudingeka kungabi ngaphezu kuka-2% (kubalwa ngokwesisekelo esomile). Okuqukethwe komlotha okuphezulu kakhulu kungabonisa ukuthi i-gelatin iqukethe izinto ezingcolile, okuthinta ikhwalithi yayo. Ukulawulwa kokuqukethwe komlotha kubalulekile ukuqinisekisa ukuthi i-gelatin ihlanzekile futhi ayinakho ukungcola.

6. Umkhawulo We-Microbial

Njengomphelelisi wemithi, i-gelatin yezinga lemithi kumele ihlangabezane nezidingo eziqinile zomkhawulo wamagciwane. I-pharmacopoeia icacisa imikhawulo yayo yamagciwane, futhi imikhiqizo ye-gelatin akumele iqukathe amagciwane ayingozi ukuqinisekisa ukuthi ngeke ithinte ukuphepha kwemithi.

7. Okuqukethwe kwe-Chloride

Njengenye yezindinganiso ezibalulekile zekhwalithi, okuqukethwe kwe-chloride ku-gelatin yemithi akufanele kudlule u-0.05%. I-chloride eningi ingaba nomthelela omubi ekuzinzeni nasekutholakaleni kwemithi.