Tsis ntev los no, hlau succinate active tshuaj ingredient (API) thiab empagliflozin API ntawm Xuancheng Minnohua Pharmaceutical Co., Ltd. (tom qab no hu ua "Xuancheng Minnohua"), ib tug tag nrho -tus tswv subsidiary ntawm Ningbo Minnohua Pharmaceutical Co., Ltd. kev tshuaj xyuas los ntawm Lub Chaw Rau Tshuaj Ntsuam Xyuas Tshuaj ntawm National Medical Products Administration (tom qab no hu ua "CDE"). Lub tuam txhab tau txais covDaim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Siv Tshuajtso tawm los ntawm National Medical Products Administration (NMPA). Cov lej sau npe ntawm ob APIs tau hloov kho rauxwm txheej Araws li tau pom nyob rau ntawm CDE Publicity Platform rau Kev Sau Npe Cov Ntaub Ntawv ntawm APIs, Pharmaceutical Excipients thiab Pharmaceutical Packaging Materials. Peb tshaj tawm cov ntaub ntawv tseem ceeb raws li hauv qab no:
I. Cov ntsiab lus tseem ceeb ntawm cov ntaub ntawv sau npe
(I) Ferrous Succinate
Tus Naj Npawb: Y20220000178Product Name: Ferrous SuccinateManufacturer: Xuancheng Minnohua Pharmaceutical Co., Ltd. Chaw tsim tshuaj paus: Tsis yog. 9 Meizigang Road, Xuancheng High-tech Industrial Development Zone, Anhui ProvinceProduct Origin: 5 kgs Specifications 10kg / hnab, 15kg / hnab, 20kg / hnab, 25kg / hnab Kev tshuaj xyuas thiab kev pom zoo: A (API pom zoo rau kev siv hauv khw muag tshuaj npaj)
(II) Empagliflozin
Tus lej Sau Npe: Y20220000587Product Name: EmpagliflozinManufacturer: Xuancheng Minnohua Pharmaceutical Co., Ltd. Chaw tsim tshuaj paus: Tsis yog. 9 Meizigang Road, Xuancheng High-tech Industrial Development Zone, Anhui ProvinceProduct Origin: 5 kgs Specifications 10kg / hnab, 15kg / hnab, 20kg / hnab, 25kg / hnab Kev tshuaj xyuas thiab kev pom zoo: A (API pom zoo rau kev siv hauv khw muag tshuaj npaj)
II. Indications, Pharmacological Effects thiab Mechanism of Action
Ferrous Succinate ntsiav tshuaj
Cov lus qhia: Rau kev tiv thaiv thiab kho cov hlau deficiency anemia.Pharmacological Effects thiab Mechanism of Action: Hlau yog ib qho tseem ceeb ntawm hemoglobin hauv cov qe ntshav liab. Hauv cov xwm txheej ntawm cov hlau tsis muaj peev xwm, cov synthesis ntawm hemoglobin hauv cov qe ntshav liab raug txo, ua rau microcytosis thiab tsis muaj oxygen - nqa lub peev xwm, uas ua rau muaj hlau tsis txaus ntshav ntshav. Kev tswj qhov ncauj ntawm cov khoom no ntxiv cov hlau thiab kho cov hlau deficiency anemia.
Empagliflozin ntsiav tshuaj
Cov lus qhia: Rau kev kho mob ntawm hom 2 mob ntshav qab zib mellitus.Pharmacological Effects thiab Mechanism of Action: Sodium-glucose cotransporter 2 (SGLT-2) yog lub luag haujlwm thauj khoom loj rau kev rov nqus cov piam thaj los ntawm glomerular filtrate rau hauv lub cev. Empagliflozin, raws li SGLT-2 inhibitor, txo lub raum qabzib reabsorption, txo qis lub raum cov ntshav qabzib, thiab txhawb kev tso zis tso zis. Tsis tas li ntawd, empagliflozin txo sodium reabsorption thiab nce sodium xa mus rau lub distal tubule, uas yuav ua rau muaj kev cuam tshuam rau ntau lub cev lub cev, tab sis tsis txwv rau, txhim kho tubuloglomerular tawm tswv yim, txo intraglomerular siab, txo qis plawv preload thiab afterload, thiab down-regulating sympathetic hlab ntsha.
