Dab tsi yuav tsum tau txiav txim siab thaum siv tshuaj Gelatin Hollow Capsules?

Raws li kev siv tshuaj ntau ntxiv, cov tshuaj gelatin hollow capsules yuav tsum sib npaug ntawm kev nyab xeeb, kev ua haujlwm, kev ruaj ntseg, thiab kev ua raws cai. Cov kev txhawj xeeb tseem ceeb yog raws li nram no:

1, Kev Nyab Xeeb: nruj me ntsis tswj cov kev pheej hmoo ntawm cov khoom siv raw thiab cov pa phem

Kev ua raws li cov khoom siv raw: Qhia meej meej qhov chaw ntawm cov pob txha / daim tawv nqaij gelatin, xyuas kom meej tias cov khoom siv raw yog los ntawm cov chaw tua tsiaj raws li txoj cai, thiab muab pov thawj tias tsis muaj kab mob nyuj vwm rau bovine gelatin kom tsis txhob muaj kab mob sib kis los yog kev txhaum cai.

Kev tswj cov pa phem: Cov hlau hnyav (lead, arsenic, thiab lwm yam) Tsawg dua los yog sib npaug li 10ppm, tag nrho cov microbial suav Tsawg dua lossis sib npaug li 1000CFU / g, sulfur dioxide residue Tsawg dua lossis sib npaug li 50ppm (Suav Pharmacopoeia), cov tshuaj tua kab mob (xws li cov tshuaj tiv thaiv kab mob sib kis, parabensid residue) Tsawg dua lossis sib npaug li 0.1ppm.

Allergen labeling: Gelatin yog tsiaj muab los ntawm cov protein thiab yuav tsum tau sau npe nrog kev pheej hmoo ua xua kom tsis txhob kis kab mob sib kis nrog lwm cov tsiaj protein.

2, Kev Ua Haujlwm: Sib piv cov yam ntxwv ntawm cov tshuaj thiab cov kev xav tau siv

Kev hloov tshuaj: Rau cov tshuaj tso tawm tam sim, xaiv cov tshuaj ntsiav zoo tib yam (kev sib cais tsawg dua lossis sib npaug li 30 feeb), thiab rau kev txhawb nqa - tso tawm / nkag mus rau cov tshuaj, xaiv cov tshuaj ntsiav tshwj xeeb (acid resistant, cov hnyuv me tso tawm); Cov tshuaj nqus dej noo xav tau cov tshuaj tsis muaj dej noo permeable, thaum cov tshuaj alkaline xav tau kev txheeb xyuas kev sib raug zoo.

Cov khoom siv kho tshuab: Lub brittleness ntawm cov tshuaj ntsiav yog tsawg dua los yog sib npaug li 10%, thiab cov tshuaj ntsiav muag yuav tsum tau dhau los ntawm -10℃qis-kub ntsuas nrog rau qhov ntev ntawm qhov ntev ntawm tsawg dua los yog sib npaug rau ± 0.3mm kom hloov mus rau cov khoom ntim.

Cov xwm txheej tshwj xeeb: Lub teeb pom kev zoo nrog lub teeb thaiv cov tshuaj ntsiav (ntxiv nrog titanium dioxide), cov tshuaj me me me (xws li loj 5) lossis yooj yim rau nqos tsim.

3, Stability: Standardized cia thiab txee lub neej tswj

Environmental control: Cia kub 15-25 degree, txheeb ze av noo tsawg dua los yog sib npaug li 60%, ntim tsaus (aluminium foil hnab / lub raj mis xim av), tsis txhob kub adhesion los yog tsis kub brittleness.

Kev pov thawj muaj tseeb: Los ntawm kev ntsuas nrawm ntawm 40℃/ 75% RH (3 lub hlis) thiab ntev- lub sijhawm kuaj ntawm 25℃/ 60% RH (Ntau dua lossis sib npaug rau 24 lub hlis), qhov sib xyaw ntawm cov tshuaj thiab cov tshuaj ntsiav (tsis muaj adsorption, degradation) yog ib txhij ua pov thawj.

4, Kev Ua Raws Cai thiab Kev Siv Khoom Siv: Sib npaug ua raws li cov kev cai thiab cov nqi

Kev ua raws cai: Ua raws li Suav Pharmacopoeia / USP / EP cov qauv, nrog rau cov lus qhia tshwj xeeb, cov lej batch, thiab daim ntawv lo "medicinal". Enteric coated capsules yuav tsum tau sau kom meej meej; DMF cov ntaub ntawv yuav tsum tau muab thaum lub sijhawm tshuaj xyuas, thiab txhua qhov kev hloov pauv yuav tsum tau rov siv dua.

Tus nqi thiab cov saw hlau: Pob txha gelatin muaj tus nqi qis dua li daim tawv nqaij gelatin, thiab GMP cov neeg muab ntawv pov thawj yog nyiam. Tsim kom muaj tsawg kawg yog 2 lwm tus neeg muab khoom; Kev thauj kub tswj tsheb kom tsis txhob muaj kev hloov pauv ib puag ncig cuam tshuam rau qhov zoo.