Akalabrutinib ntụ ntụ bụ ọgwụ na-anwale ọrịa cancer nke bụ onye na-emechi emechi nke Bruton's tyrosine kinase (BTK). Kinase a na-ebunye akara sitere na onye na-anabata mkpụrụ ndụ B (BCR), yabụ ngbanwe ọ bụla BTK ketara ga-eduga na immunodeficiency B cell. Ya mere, ndị na-egbochi BTK na-elekwasị anya na akara B cell egosiwo nnukwu nkwa n'ịgwọ ọrịa leukemia lymphocytic na-adịghị ala ala (CLL).
Acamprosate bụ ọgwụ a na-eji agwọ ịdabere na mmanya.
Nke a bụ usoro nkwadebe nke acalabrutinib:
1. Isi akụrụngwa maka synthesizing acalabrutinib bụ alanine (L-proline) na acetamide.
(acetic anhydride).
2. Nke mbụ, meghachi omume acetyl-L-prolinc na acetamide na ihe mgbaze iji mepụta N-acetylactine (N-acctyl-L-prolinc).
3. Meghachi omume N-acetylalanine na amonia iji mepụta acetylalanine (acetyl-L-proline).
4. Meghachi omume acetylalanine na butyl isocyanate n'okpuru ọnọdụ alkaline iji mepụta acetylalanine isocyanate butyl ester (acetyl-L-proline-4-butyl ester).
5. Meghachi omume acetylalanine isocyanate butyl ester na n-butanol n'okpuru ọnọdụ alkaline iji mepụta acalabrutinib.
6. Acalabrutinib nwere ike nweta n'ụdị dị ọcha site na nzọụkwụ dị ka crystallization na ọcha.
Acalabrutinib bụ obere ihe mgbochi tyrosine kinase Bruton nke ọgbọ nke abụọ. Acalabrutinib na metabolite ya ACP-5862 na-etolite njikọ njikọ na 481st cysteine residue na BTK nọ n'ọrụ saịtị, na-egbochi ọrụ nke BTK enzyme; na BTK bụ ihe nrịbama molekul maka B cell antigen receptor na cytokine ọwa nnabata. Na mkpụrụ ndụ B, ịgbalite akara ngosi BTK bụ akara ọwa dị mkpa iji kwalite mmụba cell B, njem, chemotaxis na adhesion. Acalabrutinib na metabolites ya na-ahọrọ igbochi ụzọ BTK na-emebighị ụzọ mkpụrụ ndụ ihe ndị ọzọ dị mkpa maka platelet na ọrụ mgbochi, si otú a na-ezere ma ọ bụ ibelata mmeghachi omume ọjọọ metụtara ọgwụgwọ ọrịa kansa.
1. Usoro a na-ahụkarị maka lymphoma okenye: 100 mg ọnụ kwa awa 12 ruo mgbe ọrịa na-aga n'ihu ma ọ bụ nsị na-adịghị anabata.
2. Usoro a na-ejikarị maka ọrịa leukemia okenye:
3. Monotherapy: 100 mg ọnụ kwa awa 12 ruo mgbe ọrịa na-aga n'ihu ma ọ bụ nsị na-adịghị anabata.
4. Ngwakọta na obinutuzumab:
1) 100 mg ọnụ kwa awa 12 ruo mgbe ọrịa na-aga n'ihu ma ọ bụ nsị na-adịghị anabata;
2) Malite iji ọgwụ ahụ na usoro nke mbụ (usoro nke ọ bụla bụ ụbọchị 28);
3) Malite iji obinutuzumab na okirikiri nke abụọ maka ngụkọta nke okirikiri isii, ma rụtụ aka na dose akwadoro na ozi ndenye nke obinutuzumab, ma nyekwa acalabrutinib tupu ị were obinutuzumab n'otu ụbọchị ahụ.
Salispharm kwụpụrụ iche dị ka onye nwere ntụkwasị obi nye onye na-eweta akụrụngwa emechabeghị ọgwụ n'ihi ihe ole na ole doro anya:
Otu nyocha na mmepe nwere ahụmahụ: Nzukọ anyị na-egosipụta otu ọrụ ọhụrụ toro eto zuru oke na-agba mbọ na-ekwe nkwa atụmanya kacha mma nke ịdị mma na mmepe ihe.
Osisi na-arụ ọrụ GMP: Anyị na-arụ ọrụ ọfịs na-emepụta ihe nke na-arapara n'ihe omume nnukwu mgbakọ (GMP), na-agba mbọ na-agbanwe agbanwe na ịdị mma nke ihe anyị.
Nnukwu ngwaahịa: Site na ngwaahịa dị mkpa nke akụrụngwa anaghị arụcha, anyị nwere ike meju arịrịọ nke nha ọ bụla ọsọ ọsọ, na-enye ndị ahịa anyị ngbanwe na nkwekọ n'ime.
Agba zuru oke: nkwado niile dị mkpa jikọtara ihe anyị gụnyere FDA-Salis,HALAL, ISO, CCRE5, USDA eke, na EU Natural nzere, na-egosipụta ọrụ anyị na nguzobe nhazi na nkwenye ịdị mma.
Nlekọta OEM: Anyị na-enye nchịkwa OEM nke na-erute, na-ahapụ ndị ahịa ka ha gbanwee nhazi nha na nchịkọta dị ka ihe dị ha mkpa. Ọzọkwa, anyị nwere ike ịrụ ọrụ na inye ihe ndị emechara maka ndị na-achọ nhazi ntụgharị.
Nnweta ngwa ngwa: Anyị ghọtara mkpa mbufe dị mma ma na-agba mbọ mee ka usoro njem dị ngwa, na-ekwe nkwa na ndị ahịa anyị na-anabata iwu ha ozugbo na nke ọma.
Mkpokọta echekwara: A na-eju ihe niile ngwa ngwa iji gbochie mmetọ wee kwe nkwa ntụkwasị obi ihe n'oge njem.
Ọ bụrụ n'ịchọrọ ịzụta Akalabrutinib ntụ ntụ biko kpọtụrụ anyị maka nkọwa ndị ọzọ iceyqiang@aliyun.com