Zvinhu zvinoshandiswa mumishonga zvinhu zvinoshandiswa mukugadzira mishonga nekugadzira mishonga, uye chikamu chakakosha chemishonga. Sezvinhu zvakasikwa zvinobva mupolymer, cellulose ether ine hunhu hwekuora, kusakuvadza, uye mutengo wakaderera, senge sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Cellulose etherszvakaita sehydroxyethyl cellulose uye ethyl cellulose zvine kukosha kwakakosha muzvinhu zvinobatsira mumishonga. Parizvino, zvigadzirwa zvemakambani mazhinji emumba e cellulose ether zvinonyanya kushandiswa munzvimbo dzepakati nepasi dzeindasitiri, uye kukosha kwakawedzerwa hakusi kwakakwira. Indasitiri iyi inoda nekukurumidza kushandura nekuvandudza uye kuvandudza mashandisirwo ezvigadzirwa zvepamusoro.
Zvinhu zvinosanganisa mishonga zvine basa guru mukugadzirwa nekugadzirwa kwemishonga. Semuenzaniso, mukugadzirira kwenguva refu, zvinhu zvepolymer zvakaita se cellulose ethers zvinoshandiswa sezvinhu zvinosanganisa mishonga mumapellets anosunungurwa kwenguva refu, maformula akasiyana-siyana e matrix anosunungurwa kwenguva refu, maformula anosunungurwa kwenguva refu, macapsules anosunungurwa kwenguva refu, mafirimi emishonga anosunungurwa kwenguva refu, uye mishonga ye resin inosunungurwa kwenguva refu. Kugadzirira uye mishonga inosunungurwa kwenguva refu zvave zvichishandiswa zvakanyanya. Muchirongwa ichi, mapolymers akadai se cellulose ethers anowanzo shandiswa sekutakura mishonga kudzora huwandu hwekusunungurwa kwemishonga mumuviri wemunhu, kureva kuti, inofanirwa kuburitswa zvishoma nezvishoma mumuviri nechiyero chakatarwa mukati menguva yakatarwa kuti iwane chinangwa chekurapa kunobudirira.
Zvichienderana nenhamba dzeDhipatimendi reConsulting and Research, kune mhando dzinosvika mazana mashanu dzezvinhu zvinobatsira pamusika munyika yangu, asi kana tichienzanisa neUnited States (mhando dzinopfuura 1500) neEuropean Union (mhando dzinopfuura 3000), pane musiyano mukuru, uye mhando dzacho dzichiri diki. Zvinhu zvinobatsira pamishonga munyika yangu. Kugona kwemusika kukura kwakakura. Zvinonzwisisika kuti zvinhu gumi zvepamusoro zvemishonga mumusika wenyika yangu imishonga yegelatin capsules, sucrose, starch, film coating powder, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), uye microcrystalline fibers. Vegetarian, HPC, lactose.
"Natural cellulose ether izwi rekuti "seroluse ether" inogadzirwa ne "reaction" ye "alkali cellulose" uye "etherifying agent" pasi pemamwe mamiriro ezvinhu, uye chigadzirwa umo mapoka ehydroxyl ari mu "cellulose macromolecule" anotsiviwa zvishoma kana zvachose nemapoka e "ether". Cellulose ethers anoshandiswa zvakanyanya muminda yepetroleum, zvinhu zvekuvaka, machira, chikafu, mishonga uye makemikari ezuva nezuva. Muminda yese, zvigadzirwa zve "pharmaceutical-grade" zviri munzvimbo dzepakati nedzepamusoro dzeindasitiri uye zvine kukosha kwakanyanya. Nekuda kwezvinodiwa zvemhando yepamusoro, kugadzirwa kwe "pharmaceutical-grade cellulose ethers" kwakaomawo. Zvinogona kutaurwa kuti mhando yezvigadzirwa zve "pharmaceutical-grade" zvinogona kumiririra simba rehunyanzvi remabhizinesi e "cellulose ether". Cellulose ether inowanzo kuwedzerwa sechinhu chinoretarder, matrix material uye thickener kugadzira mapiritsi e "sustained-release matrix", zvinhu zvekufukidza zvinonyunguduka mudumbu, zvinhu zvekurongedza zve "sustained-release microcapsule", zvinhu zve "sustained-release drug film", nezvimwewo.
Sodium carboxymethyl cellulose (CMC-Na) ndiyo cellulose ether ine simba guru rekubudisa nekushandisa zvinhu zvakawanda mumba nekune dzimwe nyika. I ionic cellulose ether yakagadzirwa nedonje nehuni kuburikidza ne alkalization uye etherification ne chloroacetic acid. CMC-Na imushonga unoshandiswa zvakanyanya mumishonga. Inowanzo shandiswa se binder yekugadzirira zvakasimba uye semushonga unoomesa, unokora uye unomisa kugadzirira kwemvura. Inogona zvakare kushandiswa se matrix inonyungudika mumvura uye inoita firimu. Inowanzo shandiswa semushonga unoburitsa mushonga unochengetedza uye piritsi rinoburitsa matrix rinochengetedza mumafomu ekuburitsa anochengetedza (anodzorwa).
Pamusoro pe sodium carboxymethyl cellulose sezvinhu zvinosanganisa mishonga, croscarmellose sodium inogonawo kushandiswa sezvinhu zvinosanganisa mishonga. Cross-linked carboxymethyl cellulose sodium (CCMC-Na) chinhu chisinganyungudike mumvura icho carboxymethyl cellulose inopindirana ne cross-linking agent patembiricha yakati (40-80°C) pasi pesimba re inorganic acid catalyst uye inocheneswa. Chinhu chinosanganisa chinogona kuva propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, nezvimwewo. Croscarmellose sodium inoshandiswa se disintegrant yemapiritsi, makapisiri uye granules mukugadzirira kwemuromo. Inovimba ne capillary uye kuzvimba mhedzisiro kuti iparare. Ine kumanikidzwa kwakanaka uye kuparara kwakasimba. Zvidzidzo zvakaratidza kuti mwero wekuzvimba kwe croscarmellose sodium mumvura wakakura kupfuura we common disintegrants dzakadai se low-substituted sodium carboxymethyl cellulose uye hydrated microcrystalline cellulose.
Methyl cellulose (MC) imhando yemonoether isina ionic cellulose yakagadzirwa nedonje nehuni kuburikidza ne alkalization uye methyl chloride etherification. Methyl cellulose ine mvura inonyungudika zvakanaka uye yakagadzikana mu pH range ye2.0 kusvika 13.0. Inoshandiswa zvakanyanya mumishonga inobatsira, uye inoshandiswa mumapiritsi e sublingual, majekiseni emutsinga, magadzirirwo emaziso, makapisiyuru emuromo, ma suspension emuromo, mapiritsi emuromo uye magadzirirwo epamusoro. Pamusoro pezvo, mumafomula anoburitswa kwenguva refu, MC inogona kushandiswa se hydrophilic gel matrix sustainable-release formulation, gastric-soluble coating material, sustainable-release microcapsule packaging material, sustainable-release drug film material, nezvimwewo.
Hydroxypropyl methylcellulose (HPMC) imhando ye ether yakasanganiswa isina ionic cellulose yakagadzirwa nedonje nehuni kuburikidza ne alkalization uye etherification ye propylene oxide ne methyl chloride. Hainhuhwi, haina kunaka, haina chepfu, inonyungudika mumvura inotonhora, uye ma gels mumvura inopisa. Hydroxypropyl methylcellulose imhando ye ether yakasanganiswa ne cellulose yave ichiwedzera nekukurumidza mukugadzirwa, kushandiswa uye kunaka mumakore gumi nemashanu apfuura. Ndiyo imwe yemishonga mikuru inoshandiswa kumba nekune dzimwe nyika. Yave ichishandiswa semushonga wemishonga kwemakore anoda kusvika makumi mashanu. Makore enhoroondo. Parizvino, kushandiswa kweHPMC kunonyanya kuratidzwa muzvinhu zvishanu zvinotevera:
Imwe yacho inosunga uye inopwanyika. HPMC sechinobatanidza inogona kuita kuti mushonga uve nyore kunyorovesa, uye inogona kuwedzera kazana mushure mekunwa mvura, saka inogona kuvandudza zvakanyanya kunyungudika kana kuburitswa kwepiritsi. HPMC ine viscosity yakasimba, uye inogona kuwedzera viscosity yezvikamu uye kugadzirisa kudzvanywa kwezvinhu zvakagadzirwa nemavara akaomarara kana akaomarara. HPMC ine viscosity yakaderera inogona kushandiswa sechinobatanidza uye chinopwanyika, uye HPMC ine viscosity yakawanda inogona chete kushandiswa sechinobatanidza.
Chechipiri, inoshandiswa sechinhu chinosunungura chinogara kwenguva refu uye chinodzorwa pakugadzirira nemuromo. HPMC chinhu chinowanzo shandiswa mukugadzira hydrogel matrix mukugadzirira kutsungirira. HPMC yemhando yakaderera ye viscosity (5 ~ 50mPa·s) inogona kushandiswa sechinobatanidza, chinosimudzira viscosity uye chinomisa, uye HPMC yemhando yepamusoro ye viscosity (4000 ~ 100000mPa·s) inogona kushandiswa kugadzira mapiritsi akasanganiswa e matrix sustainable-release uye sustainable-release Blocker yemacapsules uye hydrophilic gel matrix sustainable-release tablets. HPMC inonyungudika mumvura yemudumbu, ine mabhenefiti ekumanikidzwa kwakanaka, kuyerera kwakanaka, kugona kwakasimba kwemushonga uye hunhu hwekuburitsa mushonga husina kukanganiswa ne pH. Chinhu chakakosha zvikuru che hydrophilic carrier muzvirongwa zvekugadzirira kutsungirira uye chinowanzo shandiswa se hydrophilic gel matrix uye coating materials ekugadzirira kutsungirira, uye inoshandiswa mukugadzirira kutakura kwemudumbu uye sustainable-release drug membrane assistant materials.
Chechitatu chinoshandiswa semushonga wekugadzira firimu.HPMCine hunhu hwakanaka hwekugadzira firimu. Firimu rinogadzirwa naro rakafanana, rinoonekera, uye rakaoma, uye harisi nyore kunamira panguva yekugadzira. Kunyanya kune mishonga iri nyore kunwisa hunyoro uye isina kugadzikana, kuishandisa sechikamu chekuzviparadzanisa kunogona kuvandudza kugadzikana kwemushonga uye kudzivirira. Firimu rinochinja ruvara. HPMC ine mhando dzakasiyana dzehunhu hwe viscosity. Kana ikasarudzwa nemazvo, mhando uye chitarisiko chemapiritsi akafukidzwa zviri nani pane zvimwe zvinhu, uye huwandu hwayo hwakajairika i2% kusvika 10%.
Four inoshandiswa sechigadzirwa chekapisi. Mumakore achangopfuura, nekupararira kwezvirwere zvemhuka pasi rose, zvichienzaniswa nemakapisi egelatin, makapisi emiti ave chinhu chitsva chinodiwa neindasitiri yemishonga neyekudya. Pfizer yakabudirira kubvisa HPMC kubva muzvirimwa zvechisikigo uye kugadzira makapisi emiriwo eVcapTM. Kana ichienzaniswa nemakapisi egelatin asina chinhu, makapisi emiriwo ane mabhenefiti ekuti anogona kuchinjika zvakanyanya, hapana njodzi yekubatana, uye kugadzikana kwakanyanya. Mwero wekuburitswa kwemishonga wakadzikama, uye musiyano wemunhu wega wega mudiki. Mushure mekuparara mumuviri wemunhu, haunyudzwe uye unogona kuburitswa. Inoburitswa mumuviri. Panyaya yemamiriro ekuchengetedza, mushure mekuedzwa kwakawanda, inenge isina kupwanyika mumamiriro ekunze asina hunyoro, uye hunhu hwekapisi huchiri kugadzikana pasi pehunyoro hwakawanda, uye ma indexes akasiyana emakapupisi emiti pasi pemamiriro ekuchengetedza akanyanya haakanganisike. Nekunzwisisa kwevanhu makapisi emiti uye shanduko yepfungwa dzemishonga yeruzhinji kumba nekune dzimwe nyika, kudiwa kwemusika kwemakapupisi emiti kuchakura nekukurumidza.
Yechishanu inoshandiswa semushonga unomisa. Kugadzirira kwemvura yemhando yesuspension imhando yemushonga unoshandiswa zvakanyanya mukiriniki, inova sisitimu yekupararira yakasiyana-siyana umo mishonga yakasimba isinganyunguduke inoparadzirwa munzvimbo inopararira mvura. Kugadzikana kwesisitimu kunosarudza mhando yemishonga inomisa. HPMC colloidal solution inogona kuderedza kushushikana kwemvura yakasimba, kuderedza simba rezvinhu zvakasimba, uye kudzikamisa sisitimu yekupararira yakasiyana-siyana. Imushonga unomisa wakanakisa. HPMC inoshandiswa semushonga unosimbisa madonhwe emaziso, ane huwandu hwe0.45% kusvika 1.0%.
Hydroxypropyl cellulose (HPC) imhando yemonoether isina ionic cellulose yakagadzirwa nedonje nehuni kuburikidza ne alkalization uye propylene oxide etherification. HPC inowanzo nyungudika mumvura iri pasi pe40°C uye yakawanda ye polar solvents, uye mashandiro ayo ane chekuita nehuwandu hwehydroxypropyl uye mwero we polymerization. HPC inogona kushanda nemishonga yakasiyana-siyana uye ine kusagadzikana kwakanaka.
Hydroxypropyl cellulose isingatsiviwe zvakanyanya(L-HPC)Inonyanya kushandiswa sepiritsi rinopwanyika uye rinosunga. Hunhu hwaro ndehwekuti: nyore kudzvanya nekugadzira, kushanda kwakasimba, kunyanya kuoma kugadzira, mapiritsi epurasitiki uye anopwanyika, kuwedzera L -HPC kunogona kuvandudza kuoma kwepiritsi uye kupenya kwechitarisiko, uye kunogonawo kuita kuti piritsi riparare nekukurumidza, kuvandudza kunaka kwemukati mepiritsi, uye kuvandudza mhedzisiro yekurapa.
Hydroxypropyl cellulose (H-HPC) inoshandiswa zvakanyanya inogona kushandiswa semushonga unosunga mapiritsi, magranules uye magranules akanaka mumunda wemishonga. H-HPC ine hunhu hwakanaka hwekugadzira firimu, uye firimu rinobuda rakasimba uye rinonamira, izvo zvinogona kuenzaniswa nepurasitiki. Nekusanganisa nezvimwe zvinodzivirira kunyorova, mashandiro efirimu anogona kuvandudzwa, uye rinowanzo shandiswa semushonga wepurasitiki wemapiritsi. H-HPC inogona zvakare kushandiswa semushonga we matrix kugadzira mapiritsi e matrix, mapellets e matrix uye mapiritsi e matrix.
Hydroxyethyl cellulose (HEC) imhando yemonoether isina ionic cellulose inogadzirwa nedonje nehuni kuburikidza ne alkalization uye ethylene oxide etherification. HEC inonyanya kushandiswa se thickener, colloidal protective agent, adhesive, dispersant, stabilizer, suspending agent, film-forming agent uye slow-release material mumunda wekurapa. Inogona kushandiswa pa emulsions, ointments, uye eyedrops yemishonga ye topical. Mvura inonwiwa, mapiritsi akaoma, makapisi uye mamwe marudzi e dosage. Hydroxyethyl cellulose yakabatanidzwa muUS Pharmacopoeia/US National Formulary neEuropean Pharmacopoeia.
Ethyl cellulose (EC) ndeimwe yemidziyo inoshandiswa zvakanyanya mu cellulose isinganyunguduke mumvura. EC haina chepfu, yakasimba, hainyunguduke mumvura, acid kana alkaline solutions, uye inonyunguduka mu organic solvents dzakadai se ethanol ne methanol. Iyo solvent inowanzoshandiswa isanganiswa ye toluene/ethanol 4/1 (huremu). EC ine mashandisirwo akawanda mukugadzirira mishonga inosunungurwa kwenguva refu, uye inoshandiswa zvakanyanya semutakuri uye microcapsules, coating film-forming materials, nezvimwewo zvekugadzirira zvinosunungurwa kwenguva refu, zvakaita semapiritsi anodzoreredza, adhesives, firimu coating materials, nezvimwewo. Inoshandiswa sematrix material film kugadzira mhando dzakasiyana dzematrix sustainable-release tablets, semusanganiswa wekugadzira coated sustainable-release preparations uye sustainable-release pellets, se encapsulation assistant material kugadzirira sustainable-release microcapsules; inogonawo kushandiswa zvakanyanya se carrier material. Inoshandiswa kugadzira solid dispersions; inogona kushandiswa zvakanyanya mu pharmaceutical technology se film-forming substance uye protective coating, uye inogonawo kushandiswa se binder and filler. Sechidziviriro chekudzivirira mapiritsi, chinogona kuderedza kukanganiswa kwemapiritsi nehunyoro uye kudzivirira mishonga kuti isashanduke ruvara uye isaora nehunyoro; chinogonawo kugadzira glue layer inoburitsa zvishoma nezvishoma uye kuisa polymer mu microcapsulate kuti irambe ichiburitsa mushonga.
Muchidimbu, sodium carboxymethyl cellulose inonyungudika mumvura, methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose uye ethyl cellulose inonyungudika mumafuta zvese zvinoenderana nezvavari. Hunhu hwechigadzirwa ichi hunoshandiswa muzvinhu zvinosanganisa mishonga sezvinamathelisi, zvinoparadza, zvinhu zvinosunungura zvinogara kwenguva refu uye zvinodzorwa zvekugadzirira nemuromo, zvinogadzira mafirimu, zvinhu zvecapsule uye zvinomisa. Tichitarisa pasi rose, makambani akati wandei ekunze kwenyika (Shin-Etsu Japan, Dow Wolff naAshland) akaona musika mukuru we cellulose yemishonga muChina mune ramangwana, uye kungave kuwedzera kugadzirwa kana kubatanidzwa, vakawedzera kuvapo kwavo mundima iyi. Kudyara mari mukati mekushandisa. Dow Wolff yakazivisa kuti ichawedzera kutarisisa kwayo pakuumbwa, zvinhu uye zvinodiwa nemusika wekugadzirira mishonga wekuChina, uye tsvakiridzo yayo yekushandisa ichaedzawo kuswedera pedyo nemusika. Wolff Cellulose Division yeDow Chemical and Colorcon Corporation yeUnited States yakagadzira mubatanidzwa wekugadzirira kuburitsa wakasimba uye unodzorwa pasi rose. Ine vashandi vanopfuura 1,200 mumaguta mapfumbamwe, masangano emidziyo gumi nemashanu uye makambani matanhatu eGMP. Nyanzvi dzekutsvaga dzinoshanda dzinopa masevhisi kune vatengi munyika dzinosvika 160. Ashland ine nzvimbo dzekugadzira muBeijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan neJiangmen, uye yakaisa mari munzvimbo nhatu dzekutsvagisa tekinoroji muShanghai neNanjing.
Zvichienderana nehuwandu hwewebsite yeChina Cellulose Association, muna 2017, kugadzirwa kwe cellulose ether yemuno kwaive matani 373,000 uye huwandu hwekutengesa hwaive matani 360,000. Muna 2017, huwandu hwekutengesa chaihwo hwe ionicCMCyaive matani 234,000, kuwedzera kwe18.61% gore negore, uye huwandu hwekutengesa hwe non-ionic CMC hwaive matani 126,000, kuwedzera kwe8.2% gore negore. Pamusoro peHPMC (mhando yezvinhu zvekuvaka) zvigadzirwa zvisiri zveionic,HPMC(giredhi remishonga), HPMC (giredhi rechikafu), HEC, HPC, MC, HEMC, nezvimwewo zvese zvakakwira zvichipesana nezviri kuitika, uye kugadzirwa nekutengesa kwakaramba kuchikwira. Ma ether e cellulose emumba anga achikura nekukurumidza kwemakore anopfuura gumi, uye kubuda kwacho kwave kwekutanga pasi rose. Zvisinei, zvigadzirwa zvakawanda zvemakambani e ether e cellulose zvinonyanya kushandiswa pakati nepakati peindasitiri, uye kukosha kwakawedzerwa hakuna kukwira.
Parizvino, makambani mazhinji emuno e-cellulose ether ari munguva yakakosha yekuchinja nekusimudzira. Anofanira kuramba achiwedzera kutsvagisa nekuvandudza zvigadzirwa, kuramba achivandudza mhando dzezvigadzirwa, kushandisa zvizere China, musika mukuru pasi rose, uye kuwedzera kuedza kusimudzira misika yekunze kuitira kuti mabhizinesi akwanise kukura nekukurumidza. Pedzisa shanduko nekusimudzira, pinda pakati nepakati peindasitiri, uye uwane budiriro yakanaka uye yakasvibirira.
Nguva yekutumira: Kubvumbi-25-2024