Cov khoom
Leuprorelin Acetate Txhaj
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Leuprorelin Acetate Txhaj

Leuprorelin Acetate Txhaj

1. General Specification (hauv Tshuag)
(1) Txhaj tshuaj
Customizable
(2) Tablet
Customizable
(3) API (Ntshiab hmoov)
PE / Al foil hnab / ntawv lub thawv rau Pure hmoov
HPLC Ntau dua lossis sib npaug rau 99.0%
2.Customization:
Peb yuav sib tham tus kheej, OEM / ODM, Tsis muaj hom, rau kev tshawb nrhiav kev ruaj ntseg nkaus xwb.
Khoom siv: BM-3-083
Leuprorelin Acetate CAS 74381-53-6
Kev tshuaj xyuas: HPLC, LC-MS, HNMR
Kev them nyiaj yug Technology: R&D Dept.-4

Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm feem kev manufacturers thiab lwm tus neeg ntawm leuprorelin acetate txhaj nyob rau hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo leuprorelin acetate txhaj rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.

 

Leuprorelin acetate txhaj tshuajyog ib qho khoom siv hluavtaws gonadotropin- tso tawm cov tshuaj hormones (GnRH) analogues uas ua tiav cov kev kho mob ntawm cov tshuaj hormones los ntawm kev tswj cov pituitary gonadal axis muaj nuj nqi. Nws cov txheej txheem tseem ceeb ntawm kev txiav txim yog "bidirectional regulation": tom qab thawj cov tshuaj, nws luv luv txhawb kev tso tawm ntawm gonadotropins (FSH / LH), thiab tom qab ntawd tsis tu ncua inhibits lawv cov secretion los ntawm receptor desensitization, thaum kawg txo qis ntawm zes qe menyuam estrogen lossis testicular teststerone qib rau postmenopausal / castration raws li txoj cai. Nyob rau hauv xyoo tas los no, cov txheej txheem kuaj caj ces xws li GNRH1 gene polymorphism tsom xam tau muab lub hauv paus rau kev siv tshuaj kho tus kheej, thiab kev txhim kho ntev ntev - cov qauv ua yeeb yam tau txhim kho kev ua raws li tus neeg mob. Raws li cov tshuaj tseem ceeb hauv kev tswj hwm cov tshuaj hormones, cov khoom no tau dhau los ua cov cuab yeej tseem ceeb rau kev tswj hwm kab mob ntau yam los ntawm kev ntsuas kev ua tau zoo thiab kev nyab xeeb.

leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd
leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd
leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd
leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd

 Produnct Introduction

Cov ntaub ntawv ntxiv ntawm chemical compound:

Khoom npe Leuprorelin Acetate Txhaj Leuprorelin Acetate
Yam khoom Txhaj tshuaj Hmoov
Khoom Purity Ntau dua lossis sib npaug li 99% Ntau dua lossis sib npaug li 99%
Khoom Specifications Customizable Customizable
Pob khoom Customizable Customizable
 
Peb cov khoom tsim
 
leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd
leuprorelin acetate | Shaanxi BLOOM Tech Co., Ltd
leuprorelin acetate injection | Shaanxi BLOOM Tech Co., Ltd

Leuprorelin Acetate COA

GS-441524 injection name | Shaanxi BLOOM Tech Co., Ltd

Certificate of Analysis

Compound npe

Leuprorelin Acetate

CAS Nr.

74381-53-6

Qib

Pharmaceutical qib

Ntau

Customized

Ntim txheem

Customized
Chaw tsim tshuaj paus Shaanxi BLOOM TECH Co., Ltd

Ntau No.

20250109001

MFG

Jan 12th 2025

EXP

Jan 8th 2029

TEST STANDARD GB/T24768-2009 Kev lag luam. Stnndard
Sturcture

Leuprorelin Acetate structure | Shaanxi BLOOM Tech Co., Ltd

Yam khoom

Enterprise txheem

Kev txheeb xyuas qhov tshwm sim

Qhov tshwm sim

Dawb los yog yuav luag dawb hmoov

Ua raws

Cov ntsiab lus dej

Tsawg dua lossis sib npaug li 4.5%

0.30%

Poob rau ziab

Tsawg dua lossis sib npaug li 1.0%

0.15%

Hnyav Hlau

Pb Tsawg dua lossis sib npaug li 0.5ppm

N.D.

Tsawg dua lossis sib npaug li 0.5ppm

N.D.

Hg Tsawg dua lossis sib npaug li 0.5ppm

N.D.

Cd Tsawg dua lossis sib npaug li 0.5ppm

N.D.

Purity (HPLC)

Ntau dua lossis sib npaug li 99.0%

99.5%

Ib leeg impurity

<0.8%

0.48%

Residue ntawm ignition

<0.20%

0.064%

Tag nrho microbial suav

Tsawg dua lossis sib npaug li 750cfu / g

80

E. Coli

Tsawg dua lossis sib npaug li 2MPN / g

N.D.

Salmonella

N.D. N.D.

Ethanol (los ntawm GC)

Tsawg dua lossis sib npaug li 5000ppm

400ppm ua

Cia

Khaws rau hauv qhov chaw kaw, tsaus thiab qhuav ntawm -20 degrees

GS-441524 injection page footing | Shaanxi BLOOM Tech Co., Ltd

Usage

Leuprorelin acetate txhaj tshuaj, raws li gonadotropin - tso tawm cov tshuaj hormone (GnRH) analog, ua tiav cov kev cai ntawm cov tshuaj hormones nyob rau hauv cov kab mob los ntawm inhibiting pituitary gonadal axis muaj nuj nqi. Cov tswv yim kho mob ua ke tau pom qhov zoo hauv gynecology, oncology, tshuaj tua kab mob, thiab lwm yam kev lag luam, vim nws tuaj yeem txhim kho kev ua tau zoo thiab txo qhov kev pheej hmoo ntawm kev tsis zoo. Cov hauv qab no muab cov lus piav qhia ntxaws los ntawm peb qhov loj: hom kab mob, xaiv cov tshuaj sib xyaw ua ke, thiab cov txheej txheem ntawm kev ua.

Gynecological kab mob: kev kho mob ntawm endometriosis thiab adenomyosis

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

1. Endometriosis: Txo qhov mob thiab txo qhov rov tshwm sim

 

Cov txheej txheem tseem ceeb: Leuprorelin induces ectopic endometrial atrophy los ntawm kev txo cov qib estradiol rau postmenopausal (<50pg/mL). However, long-term use may lead to low estrogen syndrome (hot flashes, vaginal dryness) and osteoporosis.
Kev npaj sib koom:

Lifumin (dub cohosh extract): Raws li cov tshuaj estrogen regulator, nws muaj peev xwm alleviate menopausal tsos mob xws li kub flashes thiab insomnia. Cov kev tshawb fawb soj ntsuam tau pom tias kev siv ua ke ntawm Levofloxacin tuaj yeem txo cov neeg mob hloov kho Kuperman qhab nia los ntawm 40% yam tsis muaj kev cuam tshuam cov tshuaj tiv thaiv estrogenic ntawm leuprorelin.

 

Yousiming (Quercetin Ethynylestradiol Tablets): Kev sib ntxiv ntawm qis - koob tshuaj estrogen (20 μ g Ethynylestradiol) thiab progesterone (3mg Quercetin) tuaj yeem tswj tau BMD thiab txo qhov los ntshav ntawm qhov chaw mos. Ib txoj kev tshawb fawb uas muaj 60 tus neeg mob uas muaj qhov mob refractory tau pom tias kev sib xyaw ntawm Yousiming tuaj yeem ua rau qhov mob nyem los ntawm 73.3% mus rau 96.7%, thiab txo qhov tshwm sim los ntshav los ntawm 20% mus rau 3.3%.
Zhibai Dihuang Pill (Tsoomfwv suav tshuaj suav nrog): Los ntawm kev noj zaub mov yin thiab txo cov hluav taws los tswj kev tiv thaiv kab mob, ua ke nrog leuprorelin, nws tuaj yeem txo cov ntshav estradiol los ntawm 47.3% thiab txo qis dysmenorrhea los ntawm 85% hauv cov neeg mob endometriosis, ntau dua li 70% ua tiav los ntawm kev kho mob monotherapy.

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd
Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

2. Uterine adenomyosis: txo cov uterine ntim thiab txhim kho cov tsos mob

 

Cov txheej txheem tseem ceeb: Leuprorelin txo qis kev coj khaub ncaws los ntawm inhibiting zes qe menyuam muaj nuj nqi, tab sis kuj yuav ua rau muaj kev pheej hmoo ntawm uterine atrophy thiab lub nplhaib dislodgement.
Kev npaj sib koom:

Manyue Le (levonorgestrel intrauterine sustained{0}}tso tawm system): Hauv zos tso tawm ntawm progesterone (52 μ g / d) tuaj yeem ua rau endometrial atrophy thiab ua haujlwm nrog leuprorelin. Kev soj ntsuam kev soj ntsuam tau pom tias pawg kho mob ua ke pom tau tias 25% nce hauv uterine ntim txo tus nqi piv rau pawg monotherapy, 60% txo qis hauv cov qhab nia dysmenorrhea, thiab txo qis ntawm Manyue Le detachment los ntawm 15% mus rau 5%.

 

Kev kho rov qab ntxiv (calcium + vitamin D): Hauv kev teb rau qhov txo qis hauv BMD los ntawm leuprorelin, kev sib xyaw ntawm calcium supplementation (1200mg / d) thiab vitamin D supplementation (800IU / d) tuaj yeem ua kom tus nqi tu ntawm lumbar qaum BMD los ntawm 30% thiab txo qhov kev pheej hmoo ntawm pob txha los ntawm 50%.

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

Malignant qog: endocrine ua ke kev kho mob rau prostate carcinoma thiab mis carcinoma

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

1. Prostate carcinoma: Kev sib xyaw ntawm cov tshuaj castration thiab anti androgen therapy

 

Cov txheej txheem tseem ceeb: Leuprorelin blocks carcinoma cell loj hlob los ntawm inhibiting teststerone secretion mus rau qib castration (<50ng/dL), but some patients may develop resistance due to androgen receptor mutations.
Kev npaj sib koom:

Abiraterone (CYP17 inhibitor): Thaiv txoj kev sib txuas ntawm teststerone, ua ke nrog leuprorelin, tuaj yeem ncua sijhawm PSA mus txog 18.2 lub hlis thiab ua kom tag nrho cov ciaj sia taus los ntawm 4.2 lub hlis.
Methylteststerone (ib qho hluavtaws metabolic steroid): Rau cov pob txha metastasis mob, luv -lub sij hawm ua ke nrog methylteststerone (10mg / d) tuaj yeem txo qhov mob ntawm 30% -50%, tab sis daim siab enzymes thiab ntshav potassium concentrations yuav tsum tau saib xyuas.

2. mob cancer mis: inhibiting estrogen signaling pathway

 

Cov txheej txheem tseem ceeb: Leuprorelin blocks ER + carcinoma cell proliferation los ntawm kev txo cov qib estradiol rau<20pg/mL, but the 5-year recurrence rate of monotherapy still reaches 30%.
Kev npaj sib koom:

Aromatase inhibitors (letrozole / anastrozole): thaiv cov tshuaj estrogen peripheral synthesis, ua ke nrog leuprorelin, tuaj yeem txuas tus kab mob -dawb ciaj sia taus los ntawm 36 lub hlis mus rau 48 lub hlis hauv cov neeg mob premenopausal, thiab nce tag nrho cov ciaj sia taus ntawm 75% mus rau 90%.
Tamoxifen (xaiv cov tshuaj estrogen receptor modulator): rau cov neeg mob tsawg - kev pheej hmoo, kev kho mob ua ke tuaj yeem txo qhov kev pheej hmoo ntawm contralateral mis carcinoma los ntawm 40%, tab sis nws yuav tsum tau ceev faj txog endometrial thickening (xws li 5% -8%).

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

Cov Tshuaj Tiv Thaiv Kev Tiv Thaiv: Cov Kev Cai Ncaj Ncees ntawm Kev Tswj Ovulation

Cov txheej txheem tseem ceeb: Thaum lub sij hawm nyob rau hauv vitro fertilization (IVF) cycles, leuprorelin tiv thaiv ntxov ntxov luteinization ntawm follicles los ntawm inhibiting endogenous LH peaks, tab sis tej zaum yuav ua rau ovrian hyperstimulation syndrome (OHSS).
Kev npaj sib koom:

FSH (follicle stimulating hormone): Ua ke nrog leuprorelin (0.5-1mg / d), nws tuaj yeem ua tiav kev txhim kho follicular synchronous, nce cov qe tau txais los ntawm 20% -30%, thiab txo qhov tshwm sim ntawm OHSS los ntawm 15% mus rau 5%.
Livmin: Rau cov neeg mob hluas, kev sib xyaw Livmin tuaj yeem txo kev ntxhov siab (txo HAMA tus qhab nia los ntawm 25%) thiab txhim kho kev ua raws li kev kho mob.

Pediatric kab mob: ncua kev cuam tshuam rau hauv nruab nrab precocious puberty
Cov txheej txheem tseem ceeb: Leuprorelin ncua sijhawm kaw epiphyseal los ntawm inhibiting GnRH secretion, tab sis yuav cuam tshuam rau kev loj hlob hormone axis muaj nuj nqi.
Kev npaj sib koom:

Kev loj hlob hormone: Rau cov neeg mob uas muaj kev loj hlob qeeb, kev sib xyaw ntawm kev loj hlob hormone (0.05-0.1IU / kg / d) tuaj yeem ua rau cov neeg laus qhov siab nce mus txog 3-5cm yam tsis muaj kev cuam tshuam kev loj hlob ntawm kev sib deev.
Calcium supplements + vitamin D: Kev saib xyuas BMD tsis tu ncua (ib zaug txhua 6 lub hlis), kev sib xyaw ua ke tuaj yeem ua rau cov pob txha muaj hnub nyoog qis dua 60% thiab kwv yees nce 10% ntawm cov neeg laus qhov siab.

chemical property

Leuprorelin acetate txhaj tshuaj, raws li gonadotropin- tso tawm cov tshuaj hormones (GnRH) agonist, ua tiav cov kev cai ntawm cov tshuaj estrogen los ntawm inhibiting pituitary gonadal axis muaj nuj nqi, thiab tau dhau los ua ib qho tseem ceeb rau kev kho cov kab mob gynecological. Nws cov txheej txheem ntawm kev ua haujlwm suav nrog inhibiting qhov tso tawm ntawm gonadotropins, ua rau ib ntus inhibition ntawm zes qe menyuam, thiab endometrial atrophy. Nws tau qhia txog kev kho mob tseem ceeb hauv cov kab mob xws li endometriosis, uterine fibroids, adenomyosis, thiab central precocious puberty. Cov hauv qab no muab cov ncauj lus kom ntxaws los ntawm peb qhov loj: hom kab mob, kev sib xyaw ua ke kev kho mob, thiab kev tswj hwm kev nyab xeeb.

Endometriosis: Kho qhov mob thiab txo qhov rov tshwm sim

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

 

1. Core mechanism ntawm kev txiav txim

Leuprorelin inhibits pituitary secretion ntawm gonadotropins (LH thiab FSH), txo qis cov tshuaj estrogen ntawm zes qe menyuam mus rau cov xwm txheej postmenopausal (<50pg/mL) and inducing ectopic endometrial atrophy. Clinical studies have shown that continuous medication for 3-6 months can alleviate dysmenorrhea with a relief rate of 70% -85% and reduce the volume of ectopic lesions by 40% -60%. For patients with ovrian chocolate cysts after surgery, leuprorelin can reduce the risk of recurrence to less than 15%, significantly better than the simple surgery group (recurrence rate of 35%).

2. Kev sib xyaw ua ke kho kom zoo

Reverse Addition therapy:

Rau cov tshuaj estrogen tsawg (kub flashes, vaginal dryness), kev sib xyaw ua ke ntawm cev xeeb tub induced estrone (0.625mg / d) thiab medroxyprogesterone (2mg / d) tuaj yeem tswj tau BMD thiab txo cov tsos mob. Ib qho kev sim tshuaj ntsuam xyuas uas suav nrog 200 tus neeg mob tau pom tias qhov tshwm sim ntawm kub flashes hauv pawg ua ke tau txo los ntawm 85% mus rau 30%, thiab tus nqi ntawm BMD poob los ntawm 50%.

 

Lifumin (dub cohosh extract):

Raws li cov nroj tsuag tshuaj regulator, Lifumin tuaj yeem txo cov tsos mob ntawm menopausal yam tsis muaj kev cuam tshuam cov tshuaj tiv thaiv estrogenic ntawm leuprorelin. Cov kev soj ntsuam soj ntsuam tau pom tias qhov hloov kho Kuperman qhab nia nyob rau hauv kev sib xyaw ua ke pab pawg tau txo qis los ntawm 40%, thiab cov neeg mob ua raws li kev kho mob tau nce 25%.

 

Yousiming (Quercetin Ethynylestradiol Tablets):

Kev sib txuas ntxiv ntawm qis- koob tshuaj estrogen (20 μ g Ethynylestradiol) thiab progesterone (3mg Quercetin) tuaj yeem txo qis qhov chaw mos los ntshav thaum tswj BMD. Kev tshawb fawb qhia tau hais tias cov pab pawg neeg ua ke tau nce 20% nce hauv uterine ntim txo tus nqi piv rau cov pab pawg monotherapy, thiab qhov tshwm sim los ntshav tsis tu ncua txo los ntawm 20% mus rau 5%.

Uterine fibroids: txo cov qog loj thiab txhim kho cov tsos mob

 

1. Core mechanism ntawm kev txiav txim

Leuprorelin inhibits kev loj hlob ntawm uterine du leeg hlwb thiab induces fibroid atrophy los ntawm kev txo cov tshuaj estrogen rau<50pg/mL. Clinical data shows that continuous medication for 3 months can reduce the volume of fibroids by 30% -50%, decrease menstrual flow by 50% -70%, and increase hemoglobin levels by 10-20 g/L. For preoperative adjuvant therapy, leuprorelin can reduce the volume of fibroids, lower surgical difficulty, and reduce intraoperative bleeding (average reduction of 200-300mL).

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd
2. Kev sib xyaw ua ke kho kom zoo

Rov qab ntxiv calcium thiab vitamin D:

Hauv kev teb rau qhov txo qis hauv BMD tshwm sim los ntawm leuprorelin, kev sib xyaw ua ke ntawm calcium (1200mg / d) thiab vitamin D (800IU / d) tuaj yeem txhim kho tus nqi tu ntawm lumbar qaum BMD los ntawm 30% thiab txo qhov kev pheej hmoo ntawm pob txha los ntawm 50%. Kev kawm ntev - ua raws li - kev tshawb fawb tau pom tias cov pob txha poob qis hauv pawg ua ke tau txo qis los ntawm 40% piv rau pawg kho mob monotherapy, thiab nws tsis cuam tshuam rau kev txo qis ntawm fibroids.

Manyue Le (levonorgestrel intrauterine sustained-tso tawm system):

Hauv zos tso tawm ntawm progesterone (52 μ g / d) tuaj yeem ua rau muaj kev cuam tshuam endometrial atrophy. Ua ke nrog leuprorelin, nws tuaj yeem ua rau txo qis hauv lub tsev menyuam mus rau 60% thiab txo qis dysmenorrhea los ntawm 90%. Rau cov neeg mob uas muaj cov kab mob submucosal fibroids thiab kev coj khaub ncaws ntau dhau, kev kho ua ke tuaj yeem txo qhov kev kho mob xwm txheej ceev (los ntawm 30% mus rau 5%).

Uterine adenomyosis: txo qhov mob thiab txhim kho fertility muaj nuj nqi

Leuprorelin Acetate uses | Shaanxi BLOOM Tech Co., Ltd

 

1. Core mechanism ntawm kev txiav txim

Leuprorelin txo qis kev coj khaub ncaws thiab txo qis dysmenorrhea thiab mob pelvic mob ntev los ntawm adenomyosis los ntawm inhibiting zes qe menyuam ua haujlwm. Kev soj ntsuam kev soj ntsuam tau pom tias kev siv tshuaj tas mus li 6 lub hlis tuaj yeem txo VAS tus qhab nia ntawm dysmenorrhea los ntawm 8 cov ntsiab lus mus rau 3 cov ntsiab lus thiab txo cov uterine ntim los ntawm 20% -30%. Rau cov neeg mob uas muaj kev sib xyaw ua ke, leuprorelin tuaj yeem txhim kho lub plab ib puag ncig thiab nce tus nqi cev xeeb tub (los ntawm 10% mus rau 25%).

2. Kev sib xyaw ua ke kho kom zoo

Manyue Le ua ke kev kho mob:

Muab Manyue Le tom qab induction ntawm amenorrhea los ntawm leuprorelin tuaj yeem tuav tau ntev -cov tshuaj estrogen qis thiab txo cov tshuaj tshem tawm los ntshav. Kev tshawb fawb qhia tau hais tias 5-xyoo kev rov tshwm sim ntawm cov pab pawg ua ke yog 40% qis dua li ntawm pawg kws kho mob monotherapy, thiab kev ua neej zoo ntawm cov neeg mob tau zoo dua los ntawm 30%.

Reverse ntxiv ntawm Levofloxacin:

Rau cov neeg mob hluas, kev sib xyaw Levofloxacin tuaj yeem txo kev ntxhov siab (txo HAMA tus qhab nia los ntawm 25%) thiab txhim kho kev ua raws li kev kho mob. Ib txoj kev tshawb fawb multicenter tau pom tias qhov cuam tshuam ntawm kev kho mob sib xyaw ua ke txo qis los ntawm 20% mus rau 5%, yam tsis muaj kev cuam tshuam rau kev txo qis ntawm cov kab mob adenomyosis.

FAQ

 

1. Puas muaj ib qho kev xa tshuaj tshwj xeeb?
Nws muaj qhov ntev - ua kom ruaj khov- tso tawm cov tshuaj txhaj tshuaj, uas tuaj yeem tso tawm cov tshuaj txuas ntxiv rau 1 txog 6 lub hlis tom qab txhaj tshuaj ib zaug, txhim kho kev ua raws li cov tshuaj thiab kev ruaj ntseg.

2. Dab tsi yog qhov tshwj xeeb ntawm nws cov txheej txheem ntawm kev ua haujlwm?
Nws belongs rau "GnRH agonist" qeb. Los ntawm thawj zaug muab qhov kev txhawb nqa luv luv thiab tom qab ntawd tswj hwm qhov kev cuam tshuam tsis tu ncua ntawm pituitary -gonadal axis, nws ua tiav qhov "down- kev cai" nyhuv. Qhov kev ua haujlwm biphasic no yog qhov txawv ntawm cov tshuaj zoo sib xws.

 

Cim npe nrov: leuprorelin acetate txhaj, lwm tus neeg, manufacturers, hoobkas, lag luam wholesale, yuav, nqe, tej, kev muag khoom

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