Igama leMveliso: I-Tranexamic Acid 98% yi-HPLC
Inombolo yeCAS:1197-18-8
Ifomula yemolekyuli: C₈H₁₅NO₂
Ubunzima beMolekyuli: 157.21 g / mol
Ubunyulu: ≥98% (HPLC)
Imbonakalo: Umgubo omhlophe wekristale
Ukugcinwa: +4°C (ixesha elifutshane), -20°C (ixesha elide)
Isicelo: I-Pharmaceutical, Cosmetics, Research
1. Isishwankathelo seMveliso
I-Tranexamic Acid (TXA), i-synthetic lysine analog, isetyenziswa ngokubanzi njenge-agent ye-antifibrinolytic ukunciphisa ukopha kwimimiselo yotyando kunye ne-trauma. Le mveliso yenziwe phantsi kolawulo olungqongqo lwekhwalithi, iqinisekisa ukucoceka kwe-≥98% njengoko kuqinisekiswe yi-High-Performance Liquid Chromatography (HPLC). Ubume bayo beekhemikhali (i-trans-4- (aminomethyl) i-cyclohexanecarboxylic acid) kunye nokuzinza okuphezulu kwenza ukuba ifaneleke kwizicelo ezahlukeneyo, kuquka:
- Ukusetyenziswa kwezonyango: Ukulawulwa kokuphuma kwegazi, unyango lokulimala kwengqondo (TBI).
- Izithambiso: Iikhrimu eziqaqambisa ulusu ezijolise kwi-hyperpigmentation.
- Uphando: Uphuhliso lwendlela yohlalutyo kunye nezifundo ze-pharmacokinetic.
2. IiPropati zeMichiza kunye nezoMzimba
- Igama le-IUPAC: 4-(Aminomethyl) cyclohexane-1-carboxylic acid
- Uncumo: NC[C@@H]1CCC@HC(=O)O
- I-InChI Key: InChI=1S/C8H15NO2/c9-5-6-1-3-7(4-2-6)8(10)11/h6-7H,1-5,9H2,(H,10,11)/t6-,7
- Indawo yokunyibilika: 386°C (ngoDisemba)
- Ukunyibilika: Inyibilika emanzini (1N HCl, i-pH-adjusted buffers), i-methanol, kunye ne-acetonitrile.
3. Ukuqinisekiswa koMgangatho
3.1 Uhlalutyo lwe-HPLC
Indlela yethu ye-HPLC iqinisekisa ubungakanani obuchanekileyo kunye neprofayili yokungacoceki:
- Ikholamu: XBridge C18 (4.6 mm × 250 mm, 5 μm) okanye ilingana.
- ISigaba seMobile: I-Methanol:i-acetate buffer (20 mM, pH 4) (75:25 v/v).
- Inqanaba lokuhamba: 0.8-0.9 mL / min.
- Ukufumanisa: UV kwi-220 nm okanye i-570 nm (i-post-derivatization kunye ne-1% ninhydrin).
- Ukufaneleka kweNkqubo:
- Ukuchaneka: ≤2% iCV yendawo ephezulu (i-6 replicates).
- Ukubuyiswa: 98-102% (80%, 100%, 120% amanqanaba e-spiked).
3.2 Iprofayile yokungcola
- Ukungcola A: ≤0.1%.
- Ukungcola B: ≤0.2%.
- Ukungcola okupheleleyo: ≤0.2%.
- IiHalides (njenge-Cl⁻): ≤140 ppm.
3.3 Uzinzo
- pH Ukuzinza: Ihambelana ne-buffers (pH 2-7.4) kunye nezisombululo eziqhelekileyo ze-IV (umzekelo, i-fructose, i-sodium chloride).
- Ukuzinza kweThermal: Ukuzinza kwi-37 ° C kwiiyure ze-24 kwiimatriki zebhayoloji.
4. Izicelo
4.1 Ukusetyenziswa kwezonyango
- Ukhathalelo lwe-Trauma: Ukunciphisa ukusweleka kwizigulane ze-TBI nge-20% (ulingo lwe-CRASH-3).
- Utyando: Lunciphisa ukulahleka kwegazi ngeperioperative (utyando lwamathambo, utyando lwentliziyo).
4.2 Izithambiso
- I-Mechanism: Inqanda i-plasmin-induced melanogenesis ngokuvala iindawo ezibopha i-lysine.
- Ukuqulunqwa: I-3% ye-TXA creams ye-melasma kunye ne-hyperpigmentation.
- Ukhuseleko: Ukusetyenziswa okusentloko kuthintela imingcipheko yenkqubo (umzekelo, i-thrombosis).
4.3 UPhando noPhuhliso
- Iindlela zokuhlalutya: Ukwenziwa: izifundo zokuguqulwa kwemveliso phantsi kweemeko ze-acidic.
- I-UPLC-MS/MS: Uhlalutyo lweplasma (LOD: 0.1 ppm).
- I-Fluorimetry: I-Derivatization kunye ne-NDA / CN (i-5-minute reaction).
5. Ukupakishwa kunye noGcino
- Ukupakishwa okuPhambili: Iingxowa ze-aluminium ezitywiniweyo ezine-desiccant.
- Ubomi beShelf: iinyanga ezingama-24 ku-20°C.
- Ukuthumela: Ubushushu be-Ambient (ivunywe iiyure ezingama-72).
6. Ukhuseleko kunye nokuthotyelwa
- Ukuphatha: Sebenzisa iPPE (iiglavu, iiglasi) ukunqanda ukuphefumla/ukudibana.
- Isimo soLawulo: Ihambelana ne-USP, i-EP, kunye ne-JP pharmacopeias.
- Ubuthi: LD₅₀ (ngomlomo, irat)>5,000 mg/kg; non-carcinogenic.
7. Iireferensi
- Ukuqinisekiswa kokufaneleka kwenkqubo ye-HPLC.
- Ulungelelwaniso lwegophe kunye neeprothokholi zokuphuma.
- UPLC-MS/MS indlela yokuthelekisa.
- Iindleko-ukusebenza kukhathalelo lokwenzakala.
- Uzinzo lokuqulunqa izithambiso.
Amagama angundoqo: Tranexamic Acid 98% HPLC, Agent Antifibrinolytic, Skin Whitening, Care Trauma, UPLC-MS/MS, CRASH-3 Trial, Melasma Treatment
Inkcazo yeMeta: I-High-purity Tranexamic Acid (≥98% yi-HPLC) yonyango, i-cosmetic, kunye nokusetyenziswa kophando. Iindlela eziqinisekisiweyo ze-HPLC, ukhathalelo lwe-trauma olungabizi kakhulu, kunye ne-topical formulations ekhuselekileyo. I-CAS 1197-18-8.
