Dab tsi yog cov khoom siv los ua HPMC hollow capsules?

HPMC hollow capsules yog ua los ntawm hydroxypropyl methylcellulose (HPMC) nrog cov khoom tsim nyog, thiab lawv cov ntaub ntawv tseem ceeb thiab cov yam ntxwv ntawm cov txheej txheem yog raws li nram no:

1, Cov ntaub ntawv tseem ceeb

Hydroxypropyl methylcellulose (HPMC)

Qhov chaw: Ua los ntawm cov nroj tsuag ntuj fibers (xws li paj rwb luv thiab ntoo pulp) los ntawm kev hloov kho etherification, nws belongs rau cellulose derivatives.

Yam ntxwv:

Chemical inertness: tsis raug hla -txuas los yog Maillard cov tshuaj tiv thaiv nrog tshuaj, zam cov tshuaj lwj.

Kev ruaj ntseg siab: Nyob rau hauv ib txwm muaj mob, nws yuav tsis decompose los yog deteriorate tom qab khaws cia rau lub sij hawm ntev. Nws muaj qhov xav tau noo noo tsawg rau cov khoom ntim thiab tsim nyog rau kev sau cov tshuaj uas muaj zog noo noo.

Zoo biocompatibility: Sau npe raws li cov khoom siv nyab xeeb (GRAS tau lees paub) los ntawm FDA, EU, thiab Suav Pharmocopoeia, tsis muaj kev txwv txhua hnub, haum rau cov neeg tsis noj nqaij thiab cov neeg muaj kev ntseeg tshwj xeeb.

accessories

Plasticizers xws li glycerol thiab polyethylene glycol 400 txhim khu kev yooj yim ntawm cov tshuaj ntsiav thiab tiv thaiv nkig tawg.

Sunscreen tus neeg saib xyuas: xws li titanium dioxide (0.5% -2%), txhim khu lub capsule tiv thaiv cov tshuaj photosensitive.

Pigments: Ntuj los yog hluavtaws pigments (ua raws li cov qauv zaub mov) siv los paub qhov txawv tshwj xeeb lossis hom.

Lubricant: xws li magnesium stearate (0.1% -0.5%), txo pwm kev sib txhuam thiab ua kom zoo molding.

2, Cov khoom sib piv thiab cov txheej txheem tswj

Basic formula

HPMC suav rau 85% -95%, plasticizer 3% -10%, thiab qhov sib npaug yog dej.

Dissolve los ntawm siab -ceev shearing emulsifier los yog colloid zeb, nrog kub tswj ntawm 60-80℃thiab lub sij hawm ntawm 2-4 teev, los xyuas kom meej lub pob tshab thiab tsis muaj hais nyob rau hauv cov tshuaj gel.

Lub hom phiaj viscosity yog 5000-15000mPa · s (25 degree), saib xyuas los ntawm Brookfield viscometer.

txheej txheem txheej txheem

Dip molding: Preheat lub pwm mus rau 40-50 degree, raus nws hauv cov kua nplaum thiab maj mam tshem nws los ua cov kua nplaum zoo ib yam.

Rotary drying: Qhuav hauv huab cua kub ntawm 30-40℃rau 10-15 feeb, rov ua 2-3 zaug los tswj cov phab ntsa thickness (0.08-0.15mm) thiab qhov hnyav (xws li . 0 # capsule txog 0.12g/capsule).

Demoulding thiab txiav: Demoulding yog ua los ntawm siab - cov pa roj los yog cov cuab yeej siv tshuab, thiab txiav rau hauv cov qauv ntev (xws li 23.3mm ± 0.3mm).

tseem ceeb tswj point

Gel kub: siab dhau tuaj yeem ua rau cov dej tsis zoo, thaum qis dhau tuaj yeem tsim cov npuas yooj yim.

Ib puag ncig qhuav: Cov av noo yuav tsum tau tswj ntawm 30% -40% kom tsis txhob muaj dej nqus thiab deformation ntawm cov tshuaj ntsiav.

Impurity residue: qhuav poob qis dua los yog sib npaug li 8%, pob tshab residue ntawm ignition Tsawg dua los yog sib npaug rau 3%, semi pob tshab residue Tsawg dua los yog sib npaug li 5%, opaque residue Tsawg dua los yog sib npaug li 9%, cov ntsiab lus hnyav hlau tsawg dua los yog sib npaug rau 20ppm.

3, Khoom zoo

kev nyab xeeb

Tsis muaj cov khoom xyaw los ntawm cov tsiaj, zam kev pheej hmoo ntawm cov kab mob tsiaj xws li kab mob nyuj vwm, thiab ua raws li cov neeg tsis noj nqaij, halal, thiab cov neeg Yudais noj zaub mov.

nruj microbial txwv (tag nrho cov kab mob aerobic Tsawg dua lossis sib npaug li 10 ³ CFU / g, pwm / poov xab Tsawg dua lossis sib npaug li 10 ² CFU / g) xyuas kom huv thiab zoo ntawm cov tshuaj.

kev ua haujlwm

Tsis tshua muaj av noo stability: ya raws- pov thawj thiab pwm pov thawj, txo qhov kev pheej hmoo ntawm cov tshuaj pwm thiab kev puas tsuaj.

Kev tswj cov tshuaj tso tawm kev ua tau zoo: ntxhib nto, siab affinity nrog enteric txheej cov ntaub ntawv, zoo txheej uniformity tshaj gelatin capsules, qis gastric permeability, thiab ntau precise plab hnyuv tso tawm.

Strong adaptability: Nws tuaj yeem ntim nrog cov tshuaj ntub dej, hygroscopic hmoov lossis kua dej kom tsis txhob muaj cov tshuaj capsule rupture lossis tshuaj degradation.

ib puag ncig phooj ywg

Cov ntaub ntawv raw yog rov ua dua tshiab, thiab tsis muaj cov organic hnyav emissions thaum lub sij hawm tsim khoom, uas yog nyob rau hauv txoj kab nrog cov qauv ntawm ntsuab manufacturing.

Qee cov khoom siv biodegradable HPMC derivatives los txhim kho lawv cov kev ua haujlwm ib puag ncig.