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Ọgwụ Polyvinyl Alcohol (PVA) maka mkpuchi mbadamba | Ihe nkiri dị ọcha nke ukwuu, nke dabara na GMP, edenyere aha na CDE

Polyvinyl Alcohol nke Ọgwụ anyị (PVA) bụ polima sịntetik dị ọcha nke ukwuu, nke a na-agbaze mmiri nke ukwuu, nke a na-ejikarị eme ihe dị ka ihe na-enye ọgwụ. Ọ dabara na nnukwu ọgwụ dịka USP-NF, EP, JP, na ChP, yana ndebanye aha CDE (F20209990114). PVA na-eje ozi dị ka ihe na-emepụta ihe nkiri dị mma maka mkpuchi mbadamba, ihe na-ejikọ maka granulation mmiri, ihe na-eme ka ọ sie ike maka ngwọta anya, na ihe na-eme ka ọ dị nro/ihe na-eme ka ọ kwụsie ike n'ụdị dị iche iche. Ọ na-enye ihe mgbochi mmiri dị elu, ike nrapado dị elu, na nkwụsi ike kemịkalụ dị mma. Dị na ọkwa hydrolyzed nke akụkụ (85-89 mol%) yana viscosity a na-achịkwa (4.6-6.0 mPa·s maka ngwọta 4%)A na-emepụta ya n'okpuru ebe GMP kwadoro ya, ọ dabara adaba maka iji ọgwụ ọnụ, ọgwụ dị n'ahụ, na ọgwụ anya.

    Mmanya Polyvinyl (PVA) nke ọkwa ọgwụ

    Nchịkọta Ngwaahịa

    Polyvinyl Alcohol (PVA) bụ polymer sịntetik nke a maara nke ọma dịka ihe na-enye aka dị iche iche na nke dị mkpa na ụlọ ọrụ ọgwụ.A na-emepụta PVA nke ọkwa ọgwụ anyị n'okpuru ntuziaka GMP siri ike, na-ahụ na ọ dị ọcha nke ukwuu, na-agbanwe agbanwe, ma na-agbaso ụkpụrụ ọgwụ mba ụwa.

    Njirimara Ngwaahịa:

    • Aha Kemịkalụ:Mmanya Polyvinyl

    • Nọmba CAS:9002-89-5

    • Nọmba Ndebanye Aha CDE:F20209990114

    • Nrubeisi nke Pharmacopoeia:ChP, USP-NF, EP, JP

    • Ọkwa:Ejiri obere mmiri mee ka ọ dị ọcha (85-89 mol%)

    • Viscosity (ngwọta 4%, 20°C):4.6-6.0 mPa·s

    Atụmatụ na Uru Ndị Dị Mkpa

    1. Njirimara Ịmepụta Ihe Nkiri Dị Mma

    • Na-emepụta ihe nkiri siri ike, siri ike, ma na-agbanwe agbanwe nke ọma maka mkpuchi mbadamba

    • Na-enye nchebe dị elu nke mmiri na ihe mgbochi ikuku oxygen, na-eme ka ngwaahịa kwụsie ike ma na-adịgide ndụ

    • Ike ikpuchi isi dị mma

    2. Ike Njiko Dị Elu

    • Ihe njide dị irè maka granulation mmiri mmiri na obere njupụta (2-5%)

    • Na-emepụta mbadamba nwere ike siri ike na obere friability

    • Na-egbochi mkpọchi, ọkachasị n'ụdị ọgwụ dị elu

    3. Ọrụ dị iche iche

    • Ihe na-eme ka ihe sie ike/na-eme ka ihe sie ikemaka ngwọta anya na anya mmiri e ji aka mee

    • Emulsifiamaka emulsions na usoro dị n'elu

    • Ihe isi ihemaka ntụpọ gel na sistemụ nnyefe transdermal

    • Matrix mbụmaka ụdị ọgwụ ọnụ na-ewepụta mgbe niile

    • polima na-eme ka mgbaze dịkwuo mmamaka mgbasa siri ike amorphous (nke teknụzụ nhazi dị elu nyeere)

    4. Àgwà Anụ Ahụ Kachasị Elu

    • Polima na-abụghị ionic nwere mmiri na-anaghị agbaze na pH - na-ahụ na arụmọrụ na-aga n'ihu n'ofe eriri afọ

    • Ihe na-adịgide adịgide na kemịkalụ, ọ naghịkwa egbu egbu

    • Ọbara dị ala na-eme ka ọdịnaya siri ike dị elu na nkwusioru mkpuchi na mmiri granulation, na-eme ka arụmọrụ nhazi dịkwuo mma

    • Enweghị peroxides - ọ dị mma maka API ndị nwere mmetụta dị nro

    5. Nrubeisi na Nkwanyesi Ike n'Ịdị Mma

    • Nrubeisi zuru oke na mkpụrụ akwụkwọ USP-NF, EP, JP, na ChP

    • Edenyere aha CDE (F20209990114) maka ahịa China

    • Emepụtara ya n'okpuru ụlọ ọrụ ndị kwekọrọ na GMP

    • Asambodo Nyocha zuru oke (COA) enyere na ogbe ọ bụla

    • Dị na nkwado Drug Master File (DMF) maka ntinye akwụkwọ iwu.

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