Ho netefatsa bohloeki ba hydroxypropypropyLe methylcelllulose (HPMC) e sebelisitsoeng ho li-pharmacEutas le lijo ke tsa bohlokoa bakeng sa ho boloka polokeho, katleho le litekanyetso tsa boleng. HPMC e sebelisoa haholo joalo ka moemeli oa Binder, ea Khanyang, ea Khanyang le Moemeli oa Thuso e Sebetsa, ea Stabil, le Emolifier Lihlahisoang tsa Lijo. Mona ke lintlha tsa bohlokoa ho netefatsa bohloeki ba bona:
1. Boleng ba thepa
1.1 Mohloli oa cellulose:
Peaty ea HPMC e qala ka boleng ba Cellulose e sebelisitsoeng. Clloulose e lokela ho tsoa ho se seng sa GMO Cotton kapa pulp ea lehong e sa lefelloeng ka litloholoana tse kang mafu a linoko, litloaelo tse ling.
1.2 Chain ea phepelo:
Ho netefatsa mohloli o tšepahalang le o sa fetoheng oa cellulose ea boleng bo holimo e bohlokoa. Li-Chaneders li lokela ho phuthoa hantle, 'me liketane li lokela ho ba pepeneneng ebile li lokela ho ba bonolo ho qoba ho feptjoa kapa ho se sebetse hantle.
2. Ts'ebetso ea Tlhahiso
2.1 Setereke se laoloang:
Ts'ebetso ea tlhahiso e tlameha ho etsoa tikolohong e laoloang e isang tloaelo e ntle ea tlhahiso (GMP). Sena se kenyelletsa ho boloka lits'oants'o le ho sebelisa lisebelisoa tse fokotsang kotsi ea tšilafalo.
2.2 Tšebeliso ea lik'hemik'hale tsa meroho:
Lik'hemik'hale tse sebelisoang ho feto-fetoha ha cellulose ho hlahisa HPMC, joalo ka Methyl Chmc, joalo ka sehlopha sa phapanyetsano kapa sa lijo ho thibela ho hlahisoa ha litšila tse kotsi.
2.3 Netefatso ea Ts'ebetso:
Mohato o mong le o mong oa ts'ebetso ea tlhahiso o lokela ho netefatsoa ho netefatsa hore hangata e hlahisa HPMC ea bohloeki le boleng bo batlang. Sena se kenyelletsa ho laola maemo a karabelo, joalo ka mocheso, PH le karabelo ea boikutlo.
3. Mehato ea ho hloekisa
3.1 ho hlatsoa le ho fifala:
Boikemisetso, bo hlahang hantle le mehato ea ho fana ka ho hlakisoa hoa hlokahala ho tlosa lik'hemik'hale tse sa tsejoeng, lihlahisoa le litšila tse ling. Lipotoloho tse ngata tsa ho tšela ka metsi a hloekisitsoeng a ka ntlafatsa ho tlosa litšila tsa qubu ea qubu.
3.2 Solvention Atction:
Maemong a mang, mekhoa ea ho khella e sebelisetsoa ho felisa likopo tse qhibilihang tsa metsi. Khetho ea Solvent le ts'ebetso ea ho theoloa e lokela ho laoloa ka hloko ho qoba ho tlisa litloholo tse ncha.
4. Teko ea tlhahlobo
4.1 ho se bue ka phaello:
Teko e Phethahetseng Bakeng sa Tlhaselo, ho kenyelletsa le li-solt tse sa feleng, litloaelo tse boima, tšilafalo ea melamula, le mabenkele a bohlokoa. Mekhoa e kang chromatography (GC), Li-chromatograph tsa metsi tse phahameng tsa chromatography (HPLC)
4.2 Ho lumellana ha litaba:
HPMC e tlameha ho fihlela litekanyetso tse itseng tsa pharmakopeal (joalo ka USP, EP, JP) Ke meeli efe e lumellang litšila. Teko ea Batch ea Kamehla Batch e tiisa hore sehlahisoa se lumellana le litlhaloso tsena.
4.3 Checkscy disconcy:
Ho lumellana ha Viscosity, ho aka degree, le kabo ea limolek'hule e lokela ho hlahlojoa khafetsa ho netefatsa li-batch-to-e sa tsoakoang. Ho kheloha leha e le bofe bo ka bontša tšilafalo kapa litaba tsa ts'ebetso.
5. Ho paka le ho boloka
Lifehelo tsa mahala tsa 5.1:
HPMC e lokela ho kenngoa litšila - lijana tsa ho jella tse sireletsang linthong tsa tikoloho e kang mongobo, e leng moea, e ka nyenyefatsang boleng ba eona.
5.2 Maemo a Pholositsoeng ea polokelo:
Maemo a nepahetseng a polokelo, ho kenyelletsa le taolo ea mocheso le mongobo, e bohlokoa ho thibela ho nyollo kapa ho litšila tsa HPMC. Libaka tsa polokelo li lokela ho hloeka, ho omella le tse bolokiloeng maemong a loketseng.
6. Ho latela tumellano
6.1 Ho latela melao:
Ho latela melao ea machabeng (FDA, Ema, Ema, Ema, Ema, ETC.) e etsa bonnete ba hore HPMC e etsoa ho latela litekanyetso tsa boleng bo holimo.
6.2 Litokomane le ho hlonama:
Ho boloka lingoliloeng tse qaqileng le ho hloka botsitso bakeng sa sehlopha ka seng sa HPMC ke sa bohlokoa. Sena se kenyelletsa litlaleho tsa mekhatlo ea lintho tse bonahalang, mekhoa ea ho etsa liteko, litholoana tsa liteko le ho ajoa.
7. TLHALOSO EA MOTSOALLE
7.1 Litefiso tse thata tsa barekisi:
Ho etsa tlhahlobo ea mafutsana ho netefatsa hore ba latela melao ea boleng le ea GPP. Sena se kenyelletsa ho hlakisa lits'ebetso tsa bona tsa boleng ba boleng, lits'ebetso tsa thepa le boima ba lintho tse tahang.
7.2 Ho lekola ts'ebetso ea ts'ebetso:
Ho beha leihlo le tsoelang pele ha motho ea tsamaeang le thepa, ho kenyelletsa le litlamo le lits'ebetso tsa khalemelo, li thusa ho boloka botšepehi ba litulo tsa phepelo.
8. Taolo ea boleng le tiiso ea boleng
8.1 Taolo ea Boleng ba Ntlo:
Ho thelwa ke mahlahahlaha ka polokeho ho ntlo ea thepa ea thepa ea thepa ea ka tlung ho tiisa hore o tla lekola khafetsa le tlhahlobo ea HPMC.
8.2 TLHOKOMELISO EA BOPHELO:
Ho etsa li-laboratories tse ikemetseng tsa karolo ea boraro bakeng sa tlhahlobo ea nako ea nako ho ka fana ka karolo e 'ngoe e tiisitsoeng bakeng sa bohloeki le boleng ba HPMC.
8.3 Tlholisano e tsoelang pele:
Ho kenya tšebetsong lenaneo le tsoelang pele le likhakanyo tse fanang ka maikutlo khafetsa le lits'ebetso tsa boleng ba boleng bo thusa ho boloka litabeng life kapa life tse tsoang ka mokhoa o hlakileng.
9. Koetliso ea mohiruoa
9.1 mananeo a khopisitseng a koetliso:
Ho koetlisa basebeletsi ho GMP, Ts'ebetso e Sebetsa ea Ts'ebetso ea Ts'ebetso ea Tsamaiso (Sops), le bohlokoa ba bohloeki ho lisebelisoa tsa pharmaconetic, lijo-kholo li bohlokoa. Basebetsi ba koetlisitsoeng hantle ha ba na monyetla oa ho etsa liphoso tse ka sekisang bohloeki.
9.2 Tlhokomeliso le Boikarabello:
Ho khothaletsa semelo sa boleng le boikarabello bona ba nang le basebetsi ba tiisa hore motho e mong le e mong o hlokomela hore motho e mong le e mong o hlokomela hore ba lule ba hloekile hpmc.
10. Tsamaiso ea kotsi
10.1 Tlhahlobo ea Kotsi:
Ho etsa tlhahlobo ea mafutsana ea kotsi ho khetholla le likotsi lits'ebetsong tsa lenyalo le li phepelo tsa chankaneng ke tsa bohlokoa. Sena se kenyelletsa ho lekola lintlha tse ka bakang tšilafalo le ho nka mehato ea thibelo ea thibelo.
10.2 PUSELETSO EA TLHOKOMELISO:
Ho ba le moralo oa karabelo ea ketsahalo ea ketsahalo ea ho sebetsana le tšitiso kapa litaba tsa boleng hang-hang li etsa hore tšusumetso e nyane ho sehlahisoa sa ho qetela.
Ha ba tsepamisa maikutlo linthong tsena tsa bohlokoa, bahlahisi ba ka netefatsa bohloeki bo phahameng ba HPMC e sebelisitsoeng ho phela le ho boloka bophelo bo botle ba bareki ba ho boloka le ho boloka melao e tiileng. Boiteko bo potlakileng, tlhahlobo e matla le ho khomarela litloaelo tse ntle ho theosa le liketane le ho boloka maemo a hloekileng a HPMC.
Poso: Feb-18-2025