Disintegrant

Dab tsi yog Disintegrant

Lub disintegrant yog ib qho ntxiv uas txhawb kev tawg, uas yog kev tawg ntawm cov ntsiav tshuaj mus rau hauv cov khoom me me thaum sib cuag nrog cov kua nruab nrab. Disintegrants thiab superdisintegrant excipients yog cov khoom siv tseem ceeb siv hauv kev lag luam kws tshuaj los txhim kho kev sib cais thiab bioavailability ntawm cov khoom xyaw tshuaj nquag (APIs). Cov excipients no pab txhawb kev tawg thiab tawg sai ntawm cov ntsiav tshuaj lossis tshuaj ntsiav, uas thaum kawg ua rau lawv qhov kev nqus ntawm lub cev.

Qhov zoo ntawm Disintegrant

Capillary kev ua
Hom disintegrant no tuaj yeem tswj xyuas qhov pore qauv ntawm cov ntsiav tshuaj compressed hauv cov ntsiav tshuaj, tsim cov kab capillary uas yooj yim rau ntub thiab nthuav tawm qhov qis ntawm qhov sib txuam hauv qhov nruab nrab aqueous. Thaum cov ntsiav tshuaj muab tso rau hauv dej, dej tuaj yeem nkag mus rau hauv cov ntsiav tshuaj sai sai nrog lub raj capillary, kom tag nrho cov ntsiav tshuaj ntub thiab tawg. Cov hmoov txhuv nplej siab thiab nws cov derivatives, thiab cellulose derivatives tag nrho yog cov hom disintegrant.
Hom disintegrant no feem ntau ntxiv ob qho tib si sab hauv thiab sab nraud. Txoj kev sib ntxiv sab nraud yog qhov tsim nyog rau kev tawg sai ntawm cov ntsiav tshuaj mus rau hauv cov khoom, thaum txoj kev sib ntxiv sab hauv yog qhov tsim nyog rau cov khoom tawg yooj yim ntawm cov khoom thiab tuaj yeem txhim kho qhov hardness ntawm tus neeg sawv cev.

Cov nyhuv o
Ntxiv nrog rau qhov kev txiav txim ntawm capillary, qee cov disintegrants lawv tus kheej tuaj yeem swell nrog dej ua rau cov ntsiav tshuaj tawg. Piv txwv li, cov hmoov txhuv nplej siab derivative sodium carboxymethyl hmoov txhuv nplej siab tuaj yeem o hauv dej txias, thiab cov nyhuv o ntawm nws cov granules tseem ceeb heev, ua rau cov ntsiav tshuaj tawg sai heev.

Gas ntau lawm
Disintegrants uas tsim cov roj yog tsuas yog siv rau cov ntsiav tshuaj uas yuav tsum tau disintegrate los yog yaj sai sai, xws li effervescent ntsiav tshuaj, ua npuas ncauj ntsiav tshuaj, thiab lwm yam. Nyob rau hauv lub effervescent disintegrant, citric acid los yog tartaric acid ntxiv rau sodium carbonate los yog sodium bicarbonate feem ntau yog siv. Thaum nws ntsib dej, cov pa roj carbon dioxide tsim tawm, thiab cov ntsiav tshuaj disintegrates nrog kev pab ntawm cov pa nthuav dav.

Enzymatic hydrolysis
Qee cov enzymes muaj kev cuam tshuam rau qee cov tshuaj ntxiv hauv cov ntsiav tshuaj. Thaum lawv tau tsim nyob rau hauv tib lub ntsiav tshuaj, lawv tuaj yeem tawg sai sai hauv kev sib cuag nrog dej. Piv txwv li, thaum cov hmoov txhuv nplej siab slurry yog siv los ua ib daim ntawv khi, amylase tuaj yeem muab ntxiv rau cov granules qhuav, thiab cov ntsiav tshuaj compressed tsim los ntawm txoj kev no tuaj yeem tawg sai sai thaum sib cuag nrog dej. Feem ntau siv cov nplaum thiab lawv cov enzymes sib xws yog cov hmoov txhuv nplej siab thiab amylase, cellulose thiab cellulose, pos hniav thiab hemicellulose, gelatin thiab protease, sucrose thiab invertase, alginates thiab carrageenase, thiab lwm yam.

Vim li cas thiaj xaiv US

Peb lub Hoobkas:Hangzhou Weitong Nanomaterials Co., Ltd. yog ib lub lag luam tshiab tsom rau ntawm thaj chaw ntawm nanomaterials, nrhiav tau nyob rau hauv 2015. Peb lub Hoobkas muaj peev xwm ua tau zoo thiab muaj peev xwm tsim tau ntau yam khoom zoo.

Peb cov khoom:Peb ntau yam ntawm NVP-raws li cov khoom lag luam npog ntau yam kev ua haujlwm raws li kev lag luam sib txawv. Qhov no suav nrog homopolymer series (K15-K120), copolymer series (VA64 hmoov, V64E, VA64W, 73W, 37E, 37W), thiab kab sib txuas (PVPP XL-10, PVPP{11 }}, povidone-iodine pvpI). Cov khoom no pom cov ntawv thov thoob plaws ntau qhov chaw, ua haujlwm ruaj khov, dispersants, coatings, inks, thiab adhesives.

Kev tswj kom zoo:Peb muaj daim ntawv pov thawj ISO9001, thiab peb nruj me ntsis ua raws li GMP cov qauv tsim khoom.

Kev pabcuam zoo tom qab muag:Peb muaj cov kev pab cuam tom qab muag zoo, yog li txawm tias koj muaj kev tsis ntseeg txog cov khoom, koj tuaj yeem tiv tauj peb, peb yuav muab cov phiaj xwm txaus siab rau koj.

Excipients siv los ua Disintegrants thiab Superdisintegrants

Muaj ntau ntau yam khoom siv los ua disintegrants thiab superdisintegrants hauv kev lag luam kws tshuaj, suav nrog:

Starches

Qhov no yog qhov feem ntau siv disintegrant hauv kev lag luam. Nws suav nrog cov hmoov txhuv nplej siab, qos yaj ywm starch, thiab hloov cov hmoov txhuv nplej siab xws li pregelatinized starch, sodium starch glycolate, thiab starch 1500.

Cellulose-based excipients

Cov no suav nrog microcrystalline cellulose, croscarmellose sodium, sodium carboxymethyl cellulose, thiab hydroxypropyl methylcellulose.

Ntuj cov pos hniav

Cov no muaj xws li guar gum, xanthan gum, thiab locust taum gum.

Ion pauv resins

Cov no suav nrog polacrilin potassium thiab Amberlite IRP69.

Calcium silicates

Cov no suav nrog dicalcium phosphate thiab tricalcium phosphate.

Lwm tus

Cov no suav nrog sodium alginate, cross-linked polyvinylpyrrolidone, thiab chitosan.

Cov ntaub ntawv keeb kwm ntawm Disintegrants thiab Superdisintegrants

Cov qauv tshuaj ntawm disintegrants thiab superdisintegrants sib txawv nyob ntawm seb tus excipient siv. Starches, piv txwv li, yog polysaccharides ua los ntawm cov piam thaj molecules txuas ua ke los ntawm alpha 1-4 glycosidic bonds. Hloov cov hmoov txhuv nplej siab tau raug hloov kho los txhim kho lawv txoj haujlwm. Sodium starch glycolate, piv txwv li, yog cross-linked sodium carboxymethyl ether ntawm starch, thaum starch 1500 yog pre-gelatinized pob kws starch uas tau hloov kho nrog sodium sulfate.

Cellulose-based excipients kuj yog polysaccharides, tab sis lawv yog tsim los ntawm cov piam thaj molecules txuas ua ke los ntawm beta 1-4 glycosidic bonds. Microcrystalline cellulose, piv txwv li, yog ib feem ntawm depolymerized cellulose uas tau ua tiav los ua cov khoom me me, crystalline. Croscarmellose sodium, ntawm qhov tod tes, yog cross-linked sodium carboxymethyl cellulose.

Cov pos hniav ntuj, xws li guar gum, xanthan gum, thiab locust taum gum, yog polysaccharides uas tau los ntawm cov nroj tsuag. Lawv yog cov chains ntev ntawm cov piam thaj molecules txuas ua ke los ntawm glycosidic bonds. Cov pos hniav no muaj peev xwm nqus tau dej thiab o, uas pab txhawb kev tawg ntawm cov ntsiav tshuaj lossis tshuaj ntsiav.

Ion txauv resins, xws li polacrilin potassium thiab Amberlite IRP69, yog cov khoom siv hluavtaws uas muaj cov pab pawg ua haujlwm uas tuaj yeem pauv ions. Lawv ua hauj lwm los ntawm absorbing dej thiab o, uas cuam tshuam cov ntsiav tshuaj los yog capsule qauv thiab txhawb kom sai disintegration.

Calcium silicates, xws li dicalcium phosphate thiab tricalcium phosphate, yog inorganic compounds uas feem ntau siv los ua excipients hauv kev lag luam kws tshuaj. Lawv muaj peev xwm nqus tau dej thiab o, uas pab txhawb kev tawg.

Sodium alginate yog lub ntuj polysaccharide tau los ntawm cov xim av algae uas tau hloov kho nrog sodium ions. Hla-txuas polyvinylpyrrolidone yog ib qho hluavtaws polymer uas tau hla kev sib txuas los ua kom nws cov haujlwm ua haujlwm tau zoo, thaum chitosan yog cov khoom siv ntuj tsim los ntawm chitin.

Disintegrants thiab superdisintegrant excipients yog cov khoom siv tseem ceeb siv hauv kev lag luam kws kho mob txhawm rau txhim kho kev sib cais thiab bioavailability ntawm APIs. Muaj ntau yam excipients siv los ua disintegrants thiab superdisintegrants, xws li starches, cellulose-based excipients, natural pos hniav, ion exchange resins, calcium silicates, thiab lwm yam. Cov excipients no muaj cov qauv tshuaj sib txawv thiab cov txheej txheem ntawm kev ua haujlwm, tab sis lawv txhua tus ua haujlwm los pab txhawb kev tawg sai ntawm cov ntsiav tshuaj lossis tshuaj ntsiav. Kev siv cov tshuaj disintegrants thiab superdisintegrants hauv cov tshuaj formulations yog ib qho tseem ceeb hauv kev txhim kho kev ua tau zoo ntawm cov tshuaj thiab ua kom cov neeg mob muaj kev nyab xeeb.

Ib qho yooj yim Tableting nrog Natural Disintegrants

Khoom siv
Porous tribasic calcium phosphate (TCP 500) thiab DC qib anhydrous dibasic calcium phosphate (DCPA 150), DC qib microcrystalline cellulose (MCC 200); Magnesiumstearate (Mg-St); affeine (Caff); ntxhib crystalline saccharose (Sacc); gellan cov pos hniav; qos yaj ywm fiber thiab cellulose hmoov nrog ib tug D50 ntawm 70μm (CP_2) /; cellulose nplua hmoov nrog D50 ntawm 30 μm (CP_1); qos yaj ywm starch; pregelatinized pob kws starch.

Hmoov Characterization
Cov ntaub ntawv tau qhia txog lawv qhov loj me me (tsis muaj nyob ntawm no) dej uptake speed (WUS), dej uptake (WU) thiab o muaj peev xwm (SC) siv lub teeb uas muaj ib lub khob iav nrog lub khob-sinter qab.
Cov cuab yeej tau npaj los ntawm kev tso dej kom txog thaum lub khob sinter tau wetted tusyees. Ib qho piv txwv hmoov ntawm qhov nruab nrab ntawm 5.0 g tau muab tso rau hauv lub nkoj nyob rau sab saum toj ntawm lub khob sinter ua raws li kev qhia me ntsis qib thiab compression kom tau txais ib lub txaj txawm hmoov. Kev sib txuas rau cov dej xa dej tau qhib thiab cov ntaub ntawv kaw tau pib ib txhij. Qhov siab ntawm lub txaj ntub thiab o ntawm cov hmoov av tau txiav txim siab nrog rau qhov siab ntawm lub txaj tsis ntub dej tom qab lub sijhawm khiav ntawm 30 min. Lub peev xwm swell yog xam los ntawm qhov ntim ntawm cov hmoov qhuav qhuav thiab qhov ntim ntawm cov hmoov ntub dej.

Tablet Formulations thiab Tablet Test
Cov ntsiav tshuaj sib tov tau npaj los ntawm kev sib xyaw cov khoom hauv Turbula blender rau tsib feeb (tsis muaj Mg-St) thiab peb feeb ntxiv tom qab ntxiv Mg-St. Cov khoom sib xyaw tau muab tso rau ntawm RoTab T teb xovxwm siv lub ntsej muag tiaj tus 11.28-mm punches. Rau F1 lub ntsiab compression quab yuam (MCF) yog 18.5 kN. Cov ntsiav tshuaj tau raug kuaj txog lawv qhov kev sib tsoo, qhov ntev thiab qhov loj ntawm P5 ntsiav tshuaj ntsuam xyuas qhov system (Charles Ischi AG). Kev puas tsuaj raug ntsuas los ntawm kev siv lub cuab yeej nrog kev txiav txim siab kawg ntawm DISI-EVO (CHARLES ISCHI AG - OSD Testing Technology).

Lub peev xwm nqus dej thiab qhov o muaj peev xwm ntawm qhov sib tov tshiab disintegrant yog ntau dua li ntawm cov khoom siv cellulose thiab hmoov txhuv nplej siab. Nyob rau hauv sib piv rau tias tus nqi ntawm cov dej uptake yog sai npaum li cas rau cellulose hmoov dua starches los yog cov tshiab DIS sib tov. Nws tuaj yeem pom tau tias cov khoom me me ntawm cov cellulose cuam tshuam sai dua.

Disintegrant siv nyob rau hauv Disintegration Test

Disintegrants xa mus rau excipients uas txhawb kev tawg sai ntawm cov ntsiav tshuaj mus rau hauv cov khoom me me hauv plab hnyuv. Txij li thaum cov tshuaj yog compressed rau hauv ib ntsiav tshuaj los ntawm ib tug loj siab, lub porosity yog me me thiab lub binding quab yuam muaj zog heev. Txawm tias cov tshuaj compressed rau hauv ib ntsiav tshuaj uas yooj yim soluble hauv dej, nws yuav siv sij hawm ib tug npaum li cas ntawm lub sij hawm kom tau yaj los yog disintegrated. Lub disintegration ntawm cov ntsiav tshuaj feem ntau yog thawj kauj ruam nyob rau hauv lub dissolution ntawm cov tshuaj. Txhawm rau kom cov ntsiav tshuaj kom sai sai rau lawv cov tshuaj, cov tshuaj disintegrants feem ntau yuav tsum tau ntxiv tshwj tsis yog cov ntsiav tshuaj buccal, ntsiav tshuaj sublingual, cov ntsiav tshuaj cog lus, thiab cov ntsiav tshuaj ua haujlwm ntev uas yuav tsum tau tso tshuaj qeeb.

Disintegrants thiab txheej txheem rau lawv cov Manufacture

1. Cov txheej txheem rau kev npaj cov disintegrant, haum rau siv nyob rau hauv ib tug muaj pes tsawg leeg nyob rau hauv daim ntawv ntawm ib tug molded lub cev, uas yog tsim los ntawm ib tug qhuav granulation txheej txheem granular muaj pes tsawg leeg muaj ib tug o ntawm av nplaum thiab ib tug dej insoluble inorganic khoom.
2. Cov txheej txheem rau kev npaj cov disintegrant, haum rau siv nyob rau hauv ib tug muaj pes tsawg leeg nyob rau hauv daim ntawv ntawm ib tug molded lub cev, uas yog tsim los ntawm ib tug qhuav granulation txheej txheem granular muaj pes tsawg leeg muaj xws li ib tug swelling av nplaum, ib tug dej insoluble inorganic khoom thiab ib tug water-swellable. Tus neeg sawv cev uas, nyob rau hauv nws lub xeev tsis muaj dej, suav nrog tsis pub ntau tshaj 20 feem pua ntawm qhov hnyav ua ke ntawm cov av nplaum hais tias o, hais tias cov khoom siv dej tsis sib haum thiab hais tias cov dej swellable.
3. Ib txheej txheem raws li daim ntawv thov 1 lossis 2 tus cwj pwm hauv cov txheej txheem granulation qhuav muaj cov khoom xyaw ntawm cov granular muaj pes tsawg leeg nyob rau hauv ib tug tov khoom raws li cov menyuam compaction ntawm cov sib tov thiaj li tsim.
4. Tias cov menyuam siab thaum lub sij hawm cov menyuam compacting yog nyob rau hauv qhov ntau ntawm 8 mus rau 25 MPa.
5. Tias cov granules raug soj ntsuam rau qhov loj me hauv thaj tsam ntawm 500 txog 3000 μm.
6. Ib tug muaj pes tsawg leeg tsim nyog rau siv raws li ib tug disintegrant nyob rau hauv ib tug muaj pes tsawg leeg nyob rau hauv daim ntawv ntawm ib tug molded lub cev, hais tias muaj pes tsawg leeg nyob rau hauv daim ntawv ntawm granules muaj xws li ib tug swelling av nplaum, ib tug dej insoluble inorganic khoom thiab ib tug dej-swellable neeg sawv cev uas, nyob rau hauv nws cov anhydrous. lub xeev, suav nrog tsis pub ntau tshaj 20 feem pua ntawm qhov hnyav ua ke ntawm cov av nplaum o, hais tias dej insoluble inorganic khoom thiab hais tias dej-swellable neeg sawv cev.
7. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 6 tus cwj pwm nyob rau hauv hais tias cov dej-swellable neeg sawv cev yog tam sim no nyob rau hauv ib tug npaum li cas uas tsis muaj ntau tshaj li 7.5 feem pua ntawm tag nrho cov hnyav ntawm hais tias o av nplaum, hais tias dej insoluble inorganic khoom thiab hais tias dej-swellable neeg sawv cev.
8. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 6 los yog 7 tus cwj pwm nyob rau hauv hais tias cov dej-swellable neeg sawv cev yog tam sim no nyob rau hauv ib tug npaum li cas muaj tsawg kawg yog 1 feem pua ntawm cov hnyav ua ke ntawm hais tias o av nplaum, hais tias dej insoluble khoom thiab hais tias dej-swellable neeg sawv cev.
9. Ib qho kev sib xyaw ua ke raws li ib qho ntawm cov lus thov 6 txog 8 tus yam ntxwv uas cov av nplaum o yog smectite av nplaum.
10. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 9 characterized nyob rau hauv hais tias cov smectite av nplaum yog ib tug bentonite av nplaum.
11. Ib qho kev sib xyaw ua ke raws li ib qho ntawm 6 mus rau 10 tus yam ntxwv hauv cov khoom siv dej insoluble inorganic yog silica, cov khoom uas muaj tsawg kawg yog 70 feem pua silica los ntawm qhov hnyav lossis aluminosilicate.
12. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 11 characterized nyob rau hauv hais tias cov dej insoluble inorganic cov ntaub ntawv yog ib tug crystalline aluminosilicate uas yog ib tug zeolite muaj cov empirical formula.
Mz/nO ■ Al203 • xSi02 • yH20 nyob rau hauv M sawv cev rau ib tug hlau cation muaj ib tug valency ntawm n, x qhia qhov ratio ntawm atoms ntawm silica rau atoms ntawm txhuas thiab y qhia qhov ratio ntawm molecules dej rau atoms ntawm txhuas.
13. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 12 tus cwj pwm nyob rau hauv hais tias lub zeolite yog ib tug zeolite P, a zeolite A los yog zeolite X.
14. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 12 los yog 13 tus cwj pwm nyob rau hauv hais tias lub zeolite yog ib tug zeolite P nyob rau hauv uas M yog ib tug alkali hlau thiab x muaj ib tug nqi nyob rau hauv lub cheeb tsam ntawm 1.8 mus rau 2.66.
15. Ib tug muaj pes tsawg leeg raws li daim ntawv thov 12, 13 los yog 14 tus yam ntxwv nyob rau hauv uas zeolite yog ib tug zeolite P muaj ib tug dej ntsiab lus nyob rau hauv thaj tsam ntawm 9 mus rau 12 ib xees los ntawm qhov hnyav ntawm zeolite.
16. Ib tug muaj pes tsawg leeg raws li ib tug ntawm cov neeg pab leg ntaubntawv 6 mus rau 15 characterized nyob rau hauv hais tias tus txheeb ze npaum li cas ntawm o ntawm av nplaum thiab crystalline aluminosilicate nyob rau hauv granular disintegrant yog nyob rau hauv qhov ratio ntawm 9: 1 mus rau 1: 9 los ntawm hnyav av nplaum: aluminosilicate.
17. Ib qho kev sib xyaw ua ke raws li ib qho ntawm 6 mus rau 16 tus yam ntxwv ntawm cov av nplaum o yog muaj nyob rau hauv granular disintegrant nyob rau hauv ib tug npaum li ntawm 20 mus rau tsawg tshaj li 50 ib xees los ntawm qhov hnyav thiab cov dej insoluble khoom yog tam sim no nyob rau hauv granular. disintegrant nyob rau hauv ib tug npaum li ntawm 35 mus rau 70 feem pua ntawm qhov hnyav.
18. Ib qho kev sib xyaw ua ke raws li ib qho ntawm cov lus foob 6 txog 17 tus yam ntxwv ntawm cov dej-swellable tus neeg sawv cev muaj qhov nruab nrab qhov loj me me txog li 600 μm.
19. Ib qho kev sib xyaw ua ke raws li ib qho ntawm cov lus thov 6 txog 18 tus yam ntxwv hauv cov dej-swellable tus neeg sawv cev muaj cov dej-swelling peev tsawg kawg yog 5 cm3 / g.
20. Ib tug muaj pes tsawg leeg raws li ib qho ntawm cov lus foob 6 txog 19 tus cwj pwm nyob rau hauv cov dej-swellable tus neeg sawv cev yog natural cellulose, cross-linked cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, cross-linked sodium carboxymethyl cellulose, pre-gelatinised starch, cross. linked starch, los yog cross linked polyvinyl pyrrolidone.

Kev Tshawb Fawb Txog Kev Siv Dej los ntawm Kev Xaiv Superdisintegrants los ntawm Sub-Molecular mus rau Particulate Level

Dej diffusion los ntawm matrix ntawm peb superdisintegrants, uas yog sodium starch glycolate (SSG), croscarmellose sodium (cCMC-Na) thiab crospovidone (cPVP), tau kawm nyob rau hauv sub-molecular theem siv Attenuated Total Reflectance (ATR)-FTIR spectroscopy thiab molecular dynamics simulations, thiab cov txiaj ntsig tau cuam tshuam nrog cov kev tshawb fawb txog dej uptake ua nyob rau hauv cov particulate theem siv Parallel Exponential Kinetics (PEK) qauv hauv dynamic noo noo sorption kev tshawb fawb thiab kho qhov muag microscopy. Cov kev tshawb fawb ATR-FTIR tau qhia tias cov dej diffuses hauv cPVP los ntawm ib qho kev ua yeeb yam sai sai, thaum nyob rau hauv SSG thiab cCMC-Na, cov txheej txheem qeeb thiab ceev ua ib txhij, tau txheeb xyuas. Cov qauv tib yam hais txog tus nqi ntawm cov dej uptake rau tag nrho cov superdisintegrants kuj pom nyob rau ntawm cov particulate theem los ntawm PEK qauv. Ntxiv mus, molecular dynamics simulation pab elucidate hydrogen bonding qauv tsim ntawm dej-SSG thiab dej-cCMC-Na, feem ntau ntawm lawv carboxylic oxygen atoms thiab thib ob ntawm lawv hydroxyl pawg, thaum cPVP tsim hydrogen bonds tsuas yog los ntawm carbonyl oxygen. Thaum kawg, cPVP chains tau pom qhov hloov pauv tseem ceeb thaum lub sij hawm hydration, thaum cCMC-Na thiab SSG chains khaws lawv cov kev sib haum xeeb rau qee qhov, piav qhia txog qhov o uas tau pom nyob rau hauv cov ntsiab lus los ntawm optical microscopy hydration kev tshawb fawb.

FAQ

Q: Dab tsi yog Disintegrants nrog piv txwv?

A: Muaj ob chav disintegrants: ib txwm disintegrants, xws li starch, thiab super disintegrants, uas muaj xws li croscarmellose sodium, crospovidone, thiab sodium starch glycolate. Tam sim no, peb lub rooj noj mov no yog cov disintegrants nrov tshaj plaws.

Q: Lub ntsiav tshuaj disintegrant yog dab tsi?

A: Disintegrants yog cov neeg ua hauj lwm ntxiv rau cov ntsiav tshuaj formulations los txhawb kev tawg ntawm cov ntsiav tshuaj mus rau hauv me me fragments nyob rau hauv ib tug aqueous ib puag ncig, yog li ua kom muaj nyob rau saum npoo av thiab txhawb kev tso tawm sai dua ntawm cov tshuaj.

Q: Dab tsi yog natural disintegrant?

A: Ntuj polymers suav nrog starches, pos hniav, mucilage, & qhuav txiv hmab txiv ntoo yog siv raws li ib tug binder, diluent, & disintegrants kom ceev lub disintegration ntawm cov tshuaj uas tsis heev dej-soluble, boost zaub mov supplementation, thiab nce lub solubility ntawm cov tshuaj. tshuaj kho mob.

Q: Dab tsi yog disintegration hauv lub tsev muag tshuaj?

A: Disintegration yog hais txog cov neeg kho tshuab tawg ntawm cov ntsiav tshuaj compressed rau hauv me me granules thaum noj thiab yog li nws yog tus cwj pwm los ntawm kev tawg ntawm cov ntawv cog lus interparticulate, uas tau forged thaum lub sij hawm compaction ntawm cov ntsiav tshuaj.

Q: Dab tsi yog qhov zoo disintegrant?

A: Starch muaj ob lub zog; nws tuaj yeem ua raws li diluent thiab zoo dua disintegrant vim nws qhov o thiab hydrophilicity. Ib yam li ntawd, microcrystalline cellulose ua raws li ib qho zoo heev disintegrant thiab qeeb dissolution tus nqi impressively.

Q: Dab tsi yog cov ntsiav tshuaj disintegrants?

A: Starches: Qhov no yog qhov feem ntau siv disintegrant hauv kev lag luam. Nws suav nrog cov hmoov txhuv nplej siab, qos yaj ywm starch, thiab hloov cov hmoov txhuv nplej siab xws li pregelatinized starch, sodium starch glycolate, thiab starch 1500.

Q: Cov piv txwv ntawm Disintegrants hauv khw muag tshuaj yog dab tsi?

A: Piv txwv ntawm cov disintegrant muaj xws li Crosslinked polymers, nrog rau crosslinked polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl cellulose (croscarmellose sodium), thiab hloov cov hmoov txhuv nplej siab sodium starch glycolate.

Q: Yuav ua li cas disintegrating ntsiav tshuaj ua haujlwm?

A: ODT yog cov ntsiav tshuaj uas tawg hauv lub qhov ncauj tsis pub dhau ob peb feeb yam tsis xav tau cov kua ntxiv. Daim ntawv koob tshuaj no yog thawj zaug tsim los txhim kho kev ua raws li cov neeg mob uas muaj teeb meem nqos cov ntsiav tshuaj, xws li menyuam yaus, cov neeg laus thiab cov neeg mob hauv txaj.

Q: Puas yog txiv tsawb starch yog disintegrant?

A: Xaus: Los ntawm cov kev tshawb fawb saum toj no, nws tuaj yeem txiav txim siab tias cov hmoov txhuv nplej siab tau los ntawm cov txiv tsawb qhia tau hais tias muaj txiaj ntsig zoo thiab muaj txiaj ntsig zoo cuam tshuam piv rau cov hmoov txhuv nplej siab. Cov ntsiav tshuaj no kuj tau lees paub qhov tseem ceeb ntawm kev tawg raws li cov qauv.

Q: Dab tsi yog lub ntsiav tshuaj yaj sai sai?

A: Kev tawg sai sai lossis tawg: FDTs muaj peev xwm ua kom yaj lossis tawg hauv ob peb feeb thaum muab tso rau hauv lub qhov ncauj, obviating qhov xav tau dej. 28. Cov Tshuaj Muaj Peev Xwm Muaj Peev Xwm: Cov ntsiav tshuaj no tso cai rau kev thauj tshuaj siab, ua kom yooj yim rau kev xa cov koob tshuaj zoo.

Q: Vim li cas kev tsis sib haum xeeb tseem ceeb?

A: Disintegrant yog ib qho ntawm cov khoom tseem ceeb tshaj plaws nyob rau hauv daim ntawv tshuaj ntsiav tshuaj. Nws yog lub luag haujlwm los xyuas kom meej qhov tawg ntawm cov ntsiav tshuaj matrix thaum noj. Disintegrants ua los ntawm cov txheej txheem sib txawv, thiab ntau yam yuav cuam tshuam rau lawv qhov kev ua tau zoo.

Q: Dab tsi yog super disintegrant?

A: Modified Starch (Sodium starch glycolate, Primojel) Sodium starch glycolate yog sodium ntsev ntawm carboxymethyl ether ntawm starch. Cov no yog hloov cov starches ua los ntawm crosslinking ntawm qos starch raws li nws muab cov khoom uas zoo tshaj plaws disintegrating zog.

Q: Dab tsi yog qhov sib txawv ntawm kev tawg thiab tawg?

A: Dissolution tuaj yeem yog ib hom kev tawg vim nws kuj ua rau cov khoom tawg mus rau hauv cov khoom me me. Tab sis, feem ntau, cov kev daws teeb meem los ntawm kev sib cais yog qhov sib xws thiab cov khoom tsis tuaj yeem pom ntawm qhov muag liab qab. Disintegration tej zaum yuav xav tau los rhuav tshem cov khoom tawv uas tsis yooj yim yaj hauv cov kuab tshuaj.

Q: Muaj pes tsawg ntsiav tshuaj siv rau kev tawg?

A: Yuav kom ua tiav qhov kev ntsuam xyuas kev puas tsuaj rau cov ntsiav tshuaj, peb siv lub pob tawb uas tuav 1 txog 6 ntsiav tshuaj. Qhov no yog ces tsa thiab txo mus rau hauv lub beaker ntawm dej, uas yog siv los simulate tej yam kev mob nyob rau hauv lub plab ntawm 37 degree.

Q: Puas yog crospovidone yog qhov tsis sib xws?

A: Feem ntau siv disintegrants nyob rau hauv ntub granulation yog crospovidone, CCS, thiab SSG, uas ua rau kom lub hydrostatic siab nyob rau hauv lub formulation thaum nws los txog rau hauv kev sib cuag nrog dej. Lub siab yog nce los ntawm dej wicking (rau crospovidone) los yog o (CCS thiab SSG) phenomena.

Q: Yuav ua li cas yog starch yog disintegrant?

A: Cornstarch tau ntev lawm tus qauv disintegrant rau compressed ntsiav tshuaj. Lub tshuab uas cov hmoov txhuv nplej siab ua haujlwm raws li cov ntsiav tshuaj disintegrant tau suav tias yog cov hmoov txhuv nplej siab swell thaum sib cuag nrog cov dej noo, ua rau cov ntsiav tshuaj tawg.

Q: Vim li cas ib lub ntsiav tshuaj siv sijhawm ntev dua kom tawg?

A: Lub sijhawm tawg tuaj yeem cuam tshuam los ntawm lwm cov yam ntxwv zoo, xws li lub zog tensile (hardness) thiab porosity ntawm cov ntsiav tshuaj. Feem ntau, ib qho kev nce hauv hardness ntawm ib ntsiav tshuaj txo nws cov porosity, ua rau lub sij hawm qeeb qeeb.

Q: Qhov feem pua ntawm disintegrant hauv cov ntsiav tshuaj yog dab tsi?

A: Qhov concentration ntawm 0.5-2% yog txaus raws li disintegrant nyob rau hauv cov pa ntsiav tshuaj. Txawm li cas los xij, hauv ODTs, cov nyiaj ntau dua qhov no tuaj yeem raug ntxiv kom ua tiav kev tawg sai dua.

Q: Yuav ua li cas txo lub sij hawm disintegration ntawm cov ntsiav tshuaj?

A: Kev txo qis ntawm cov ntsiav tshuaj disintegration lub sij hawm tau txais los ntawm kev nce ntawm granulation noo noo; los ntawm kev nce ntawm cov feem zoo; los yog los ntawm kev txo cov roj nplua nyeem concentration lossis compression quab yuam.

Q: Puas yog disintegrants siv nyob rau hauv cov ntsiav tshuaj chewable?

A: Muaj ntau cov khoom uas chewable ntsiav tshuaj tsis muaj disintegrants los yog super-disintegrants, uas tej zaum yuav ua rau kom lub sij hawm dissolution yog hais tias lawv tsis chewed. Txawm li cas los xij, kev tawg lossis tawg sai yog qhov tseem ceeb los daws cov teeb meem uas tus neeg tsis tuaj yeem nqos ntsiav tshuaj yam tsis tau zom nws.

Raws li ib qho ntawm cov kws tshaj lij disintegrant manufacturers thiab lwm tus neeg nyob hauv Suav teb, peb tau tshwj xeeb los ntawm cov khoom zoo thiab cov kev pabcuam zoo. Thov so assured mus yuav bulk disintegrant ntawm tus nqi qis los ntawm peb lub hoobkas. Tiv tauj peb rau kev hais lus thiab qauv dawb.