Gelatin rau Hard Capsules
Nrog rau txoj kev loj hlob ntawm kev lag luam tshuaj, complex thiab nruj multi-functional yuav tsum tau muab tso rau pem hauv ntej rau kev ua tau zoo ntawm cov ntaub ntawv, uas yog ib qho nyuaj rau ua tau raws li feem ntau cov ntaub ntawv hlau thiab inorganic cov ntaub ntawv.
Gelatin yog cov khoom siv ntuj tsim, uas muaj cov qauv zoo sib xws rau lub cev.Nws muaj cov khoom zoo ntawm lub cev thiab tshuaj lom neeg, biocompatibility, biodegradability, nrog rau kev tsim khoom yooj yim, kev ua thiab molding yam ntxwv, ua rau nws muaj txiaj ntsig zoo hauv kev lag luam biomedicine.
Thaum cov tshuaj gelatin yog siv los tsim cov hollow nyuaj capsules, nws muaj cov yam ntxwv tseem ceeb xws li viscosity kom zoo ntawm qhov siab concentration, siab mechanical zog, thermal invertibility, qis qis / tsim nyog lub freezing point, txaus lub zog, siab transparency thiab gloss ntawm cov gelatin uas tsim. phab ntsa capsule.
Yog vim li cas vim li cas kev kho mob gelatin muaj keeb kwm ntev yog tias thawj gelatin soft capsule yug hauv xyoo 1833. Txij thaum ntawd los, gelatin tau siv dav hauv kev lag luam kws tshuaj thiab dhau los ua ib feem tseem ceeb ntawm nws.
| Test Criterion: Tuam Tshoj Pharmacopoeia 2015 edition 2 | Rau Hard Capsule |
| Cov khoom siv lub cev thiab tshuaj lom neeg | |
| 1. Jelly Strength (6.67%) | 200-260 hli |
| 2. Viscosity (6.67% 60 ℃) | 40-50 mps |
| 3 Mesh | 4-60 mesh |
| 4. Cov dej noo | ≤ 12% |
| 5. Tshauv (650 ℃) | ≤ 2.0% |
| 6. Pob tshab (5%, 40 ° C) mm | ≥500mm |
| 7. PH (1%) 35 ℃ | 5.0-6.5 |
| ≤0.5mS/cm |
| Tsis zoo |
| 10. Transmittance 450nm | ≥70% |
| 11. Transmittance 620nm | ≥90% |
| 12. Arsenic | ≤ 0.0001% |
| 13. Chrome | ≤ 2 ppm |
| 14. Heavy Hlau | ≤30ppm |
| 15. TSO2 | ≤30ppm |
| 16. Insoluble tshuaj nyob rau hauv dej | ≤0.1% |
| 17 .Tag nrho cov kab mob suav | ≤ 10 cfu / g |
| 18. Escherichia coli | Tsis zoo / 25g |
| Salmonella | Tsis zoo / 25g |
