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### SystemsTuas Kev Ntsuas Xyuas thiab cov kev tsom xam ntawm kev ua kom pom kev loj hlob ntawm tib neeg txoj kev loj hlob hormone (HGH 191AA)

Kev nthuav qhia tib neeg txoj kev loj hlob hormone (HGH 191AA) yog cov protein protein tsim ntawm 191 amino acids. Nws yog tsim los ntawm cov caj ces engineering Technology thiab yog siv dav hauv kev kho mob, kev tshawb fawb thiab los tiv thaiv kev laus. Kab lus no yuav pom zoo nws cov peev txheej thiab tshuaj lom neeg thiab cov qauv tshuaj ntsuab, thiab daim ntawv thov cov qauv, thiab muab cov kws tshawb xyuas kev paub zoo.

### 1. Kev faib tawm raws cov qauv molecular hloov kho

#### 1. ** Tsis muaj zais HGH (Retgh) **

- ** Cov qauv thiab cov yam ntxwv **: muaj raws li cov qauv ntawm tib neeg txoj kev loj hlob muaj, kev hloov kho kev loj hlob ntawm 22 KDA, ISOELECTIC PARCH (PI) 5.3.

- **Advantages**: High biological activity (>3. {{0 iu / mg), ze rau 100% khi kev ua tau zoo nrog cov hormone hormone receptors.

- ** Lub cev thiab tshuaj lom neeg **:

- ** Solubility **: Yooj yim soluble hauv pH 7.4 ntas, lub lyophilized hmoov yog kua tsis muaj xim thiab pob tshab tom qab kho dua tshiab.

- ** STABLY **: Lub xeev lyophilized tuaj yeem khaws cia rau 2 xyoo ntawm 2-8 degree; Kev npaj ua kua yuav tsum yuav tsum tau muab tso rau hauv tub yees thiab ntxim nyiam los sib sau ua ke vim qhov kub hloov pauv lossis kev ntxhov siab.

- ** Cov yam ntxwv xim ": Lub lyophilized hmoov dawb yog dawb lossis dawb (nrog mankitol lossis glycine ntxiv raws li qhov kev daws teeb meem), thiab kev daws teeb meem yog qhov tseeb thiab tsis muaj xim.

- ** Cov khoom sawv cev ": Genotropin (Pfizer), Norditropin (NOVO NORNISK).

### 2. ** Pegylated HGH (Peg-RHGH) **

- ** Kev hloov kho qauv qauv **: Polyethylene glycoles tau txuas los ntawm kev sib txuas lus sib txuas los ntawm kev sib txuas lus sib txuas lus kom txuas ntxiv lub neej (los ntawm {teev rau 48 teev).

- ** PIB **: {{1-2 kev txhaj tshuaj ib lim piam, txhim kho kev ua raws li tus neeg mob ua raws.

- ** Lub cev thiab tshuaj lom neeg **:

- ** Molecular hnyav **: Txawv nyob ntawm qhov ntev ntawm PEG saw (feem ntau nce ntxiv los ntawm 10-40 kda).

- ** Solubility **: qis dua me ntsis dua li hom tsis muaj kev tsis tau pom, xav tau ib qho kev ua haujlwm tsis zoo (xws li phosphate tsis).

- ** STABLY **: PEG txheej txo cov Enzymatic degradation thiab immunogenicity, thiab cov kua muaj ruaj khov nyob rau hauv chav tsev kub.

- ** Cov yam ntxwv xim **: Lub lyophilized hmoov yog daj me ntsis (Peg oxidation yuav ua rau muaj kev sib txawv me ntsis), thiab kev daws teeb meem yog lub teeb milky dawb.

- ** Cov khoom sawv cev ": pegervisomant (tsis tshua muaj siv rau acromegaly, tsis yog-txheem kev kho mob kho kom zoo).

### 3. ** FATHYF MEDFifified HGH (xws li Albutropin) **

- ** Kev hloov kho qauv qauv **: Kev sib khi ua ke los ntawm fatty acid chains (xws li c {1}} C18) los ua tus qauv uas raug xa tawm.

- ** "Zoo **: Lub neej ib nrab-lub neej yog txuas ntxiv rau 7 hnub, haum rau kev kho ncua ntev hauv kev kho mob.

- ** Lub cev thiab tshuaj lom neeg **:

- ** Txhim kho hydrophobicity **: surfactants (xws li polysorbate 80) yuav tsum tau txhim kho kev txhim kho solubility.

- **Thermal stability**: freeze-dried state is resistant to high temperature (activity retention >95% Tom qab 3 hlis ntawm 25 degree).

- ** Cov yam ntxwv xim ** ** Cov hmoov xim xim ** ** Cov hmoov nplej qhuav yog cov dawb huv dawb, thiab kev daws teeb meem yuav yog turfactants me ntsis vim surfactants.

### 2. Kev faib tawm raws li Kev Hais Qhia

### 1. ** Escherichia coli qhia tawm cov txheej txheem **

- ** Txheej txheem ntau lawm **: Los ntawm cov kev suav hauv lub cev hais tawm, cov kauj ruam rov ua dua, thiab tus nqi qis.

- **Advantages**: high yield (>1 g / l), haum rau kev tsim khoom loj.

- ** Kev sib txawv ntawm lub cev thiab tshuaj lom neeg **:

- ** Tsis muaj glycosylation **: piv nrog ntuj HGH, nws yuav cuam tshuam rau Vivo tshem tawm tus nqi.

- ** PURIity tswj **: Cov tswv lag luam Protein yuav tsum muaj<0.1% (detected by HPLC).

- ** Cov yam ntxwv xim **: Cov khoom lag luam muaj xim dawb yog xim khov-qhuav hmoov, cov nyom roj av muaj kua qaub).

#### 2. ** Mam Mam Mam Tes Cell Qhia Tawm (xws li xov tooj ntawm tes) **

- ** Txheej txheem ntau lawm **: Cov Lus Qhia zais, tsis muaj kev lees paub, khaws cov kev sib txuas lus ntuj.

- ** "Zoo *: Glycosylation Hloov kho yog ze rau tib neeg lub cev thiab tau qis dua immunogenicity.

- ** Kev sib txawv ntawm lub cev thiab tshuaj lom neeg **:

- ** Cov chaw glycosylation **: txawm hais tias HGH yog ib txwm tsis yog-glycosylated, lub kaw lus yuav qhia tau cov kab ntawv hloov kho.

- ** Qhab **: Npaj ua kua yog tived ntau dua rov qab ua kom khov thiab yaj.

- ** Cov qauv xim ** ** Cov kev daws teeb meem muaj qhov pom ntau dua thiab cov hmoov kom qhuav-qhuav muaj cov xoob xoob.

### 3. Kev faib tawm raws li daim foos npaj

#### 1. ** Lyophilized hmoov txhaj **

- ** Consula composition **: HGH, MANNITOL, sodium phosphate mosphate muffer system.

- ** Qhov zoo **: Lub sijhawm ntev ntev ruaj khov thiab kev thauj mus los yooj yim.

- ** Lub cev thiab tshuaj tsis raws cai **:

- ** Lub sijhawm Reconstov **:<1 minute (related to the crystallinity of the excipient).

- ** POS tus nqi **: 6. {8-7. 8, ze rau lub cev ib puag ncig.

- ** Pib xim **: yog khaws cia tsis raug (qhov kub thiab txias / lub teeb), nws yuav tig lub teeb liab vim oxidation.

### 2. ** Daim ntawv ua ntej ua kua noj **

- ** Cov qauv kev tsim tawm tshiab **: Ntxiv cov tsis muaj ionic surfactants (xws li poloxamier 188) txhawm rau inhibit sib cav.

- ** "Zoo **: Npaj siv thiab yooj yim, txo txoj kev pheej hmoo ua haujlwm.

- ** Lub cev thiab tshuaj tsis raws cai **:

- ** Viscosity **: 1. 2-1. 5 CP, ze rau dej.

- ** Cia tej yam khoom cia **: 18 lub hlis ntawm 2-8 degree, qee hom lag luam txhawb nqa luv luv luv luv luv luv ntawm 25 degree.

- ** Cov yam ntxwv xim **: pob tshab thiab tsis muaj kob, yog tias cov nplaim taws, yog tias cov nplaim dej tshwm sim, nws qhia tau protein denaturation.

### 4. Kev faib tawm raws li cov chaw thov

### 1. ** Cov Kho Mob Qib HGH **

- ** Qhia txog **: Kev Loj Hlob Nrig Tsis Txaus (GHD) rau cov menyuam yaus, tus tub sab tub rog, Choj Syndrome, Chronic Renal tsis muaj peev xwm.

- ** QIB TSWJ ZOO **: Ntsib USP / EP qauv, endotoxin<5 EU/mg, host DNA <10 ng/dose

- ** Sau cov lus qhia tshwj xeeb ": Ntau cov tshuaj muaj roj ntau (xws li Norditropin FlexPro®), Txhawb Dose hloov kho.

### 2. ** Kev Tshawb Fawb-Qib HGH **

- ** NTA **: Purity> 95% (SDS-Page PERFICTION), muaj LDace tshuaj lom (xws li Phenol).

- ** Kev kho mob ntawm tes kuaj xyuas **: Kev sim ntawm tes ua haujlwm ntawm tes, cov kev tshawb fawb no (xws li siv Radiolabeled HGH).

#### 3. ** Kev tawm tsam kev laus / kev ua si ua kis las txhim kho khoom **

- ** Kev sib cav sib ceg **: Tsis muaj kev tswj hwm siv, feem ntau pom hauv kev ua lag luam grey.

- ** Kev pheej hmoo **: Tsis muaj kev coj dawb huv (qee cov khoom ntes tau <70% purity), tej zaum yuav muaj cov kab mob protein zoo.

### 5. Kev ua tau zoo sib piv thiab yav tom ntej sib piv

|------------------|------------|--------------|------------|--------------|-----------------------|

| Unmodififififififififwm Hgh|4-6} teev|Niaj Hnub|Nruab nrab|Tsawg|Cov neeg mob pediaric |

** Kev qhia rau yav tom ntej **:

- ** QAUV LUB CEV ": NANOLIPSILIOMIOMIOMIOMIOME PROXAPPSula Technology txhawm rau txhim kho Bioavailability.

- ** Ntse tswj kev tso tawm **: Microedle thaj uas teb rau ib puag ncig p lossis enzyme.

- ** QE Kev Kho Mob **: Nruam kev nthuav dav ntawm Envogenous Hgh los ntawm Aav Vectors.

### xaus

Ntau ntau yam kev kawm ntawm HGH 191AA qhia txog kev nce qib ntawm cov thev naus laus zis thev naus laus zis. Cov tshuaj xyuas cov kev kho mob raug tswj hwm raws li kev coj dawb huv thiab kev nyab xeeb, thiab kev ua yeeb yam ntev txhim kho lub neej zoo ntawm cov neeg mob. Nyob rau yav tom ntej, nrog kev txhim kho cov qauv tsim kho tshiab thiab kho cov thev naus laus zis, hgh kev kho mob yuav evolve hauv kev coj ua tau zoo thiab yooj yim.