Esikwenzayo
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Ukuhlolwa kwezithako ezisebenzayo zezitshalo
Izitshalo zemvelo ziqukethe inani elikhulu lezithako ezisebenzayo, njenge-alkaloids, i-polysaccharides, i-saponins, njll Lezi zinto ezisebenzayo zingasetshenziswa kwezokwelapha, ukunakekelwa kwezempilo, izimonyo kanye nezibulala-zinambuzane eziphilayo kanye neminye imikhiqizo. Uma ikhasimende lifuna isithako semvelo sohlelo oluthile lokusebenza, singase sinikeze usizo. Ngokusekelwe ekuqoqweni kwethu okubanzi kwedatha namandla okuhlaziya aqinile, singasiza ikhasimende lethu ukuthi lihlole futhi lihlonze ukuthi iziphi izinto ezisebenza kangcono ekuzuzeni umthelela othile nokuthi yiziphi izitshalo eziqukethe isithako esifiselekayo esiqondisiwe ngobuningi obukhulu, ukuze sinikeze isixazululo ngakho kokubili kucatshangelwa umnotho kanye nobungane bemvelo.
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Ukufunda nokuhlola amandla esithako esisebenzayo sebhotani kusukela ezinkathini zonyaka ezahlukene kanye nemvelaphi ehlukene.
Izitshalo ezifanayo ezikhula ezindaweni ezahlukene zingaba nomehluko omkhulu emandleni ezithako ezisebenzayo. Ngisho noma izitshalo ezikhula endaweni eyodwa zizoba nomehluko emandleni ezithako ezisebenzayo ezivela ezinkathini ezahlukene zonyaka. Ngakolunye uhlangothi, ukuma okuhlukile kwezitshalo kuhlukile kumandla wezithako ezisebenzayo. Umsebenzi wethu wenza amakhasimende ethu akwazi ukuhlonza indawo engcono kakhulu adabuka kuyo, inkathi yokuvuna efaneleke kakhulu kanye nezingxenye ezisebenza kahle kakhulu zezinto ezingavuthiwe futhi ngaleyo ndlela usize amakhasimende ethu akhe isixazululo sokuthola umthombo esisebenza kahle kakhulu nesingabizi kakhulu.
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Ukusungulwa kwezindlela zokuhlaziya zezithako ezisebenzayo
Indlela yokuhlola eqinisekisiwe iyisici esibalulekile ukuze kuqinisekiswe into esebenzayo. Izindlela zokuhlaziya esizenzele ikhasimende lethu zingaqinisekisa ukuthi amakhasimende ethu anamathuluzi athembekile okulawula ikhwalithi futhi ngaleyo ndlela athole ukwethenjwa emakethe. Kuye ngomkhiqizo, izindlela zokuhlaziya ezihilelekile zizofaka konke noma okunye kwalokhu okulandelayo: i-chromatography yongqimba oluncane esebenza kahle kakhulu (HPTLC), i-high-performance liquid chromatography (HPLC), i-gas chromatography (GC), i-chromatography yokuphrinta iminwe, njll.
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Ucwaningo lwenqubo yokukhiqiza yesithako esisebenzayo
Uma isithako esisebenzayo sikhiyiwe, kubaluleke kakhulu ukusebenzela ukuthi singasikhiqiza kanjani ngezindleko ezingcono kakhulu. Ithimba lethu lingasungula inqubo yokukhiqiza ephumelela kakhulu kumakhasimende ethu ukuze kuthuthukiswe ukuncintisana nokunciphisa ingcindezi emvelweni. Isevisi yethu ihlanganisa ukunakekelwa kwangaphambili kwempahla eluhlaza, indlela yokucubungula eyengeziwe (njengokuhlanza, ukukhipha, ukomisa, njll.). Imingcele ebalulekile njengoba ibalwe ngenhla ingaba bucayi kakhulu ekunqumeni impumelelo yokukhiqiza.
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Ucwaningo lwenqubo yokukhiqiza lwemikhiqizo eqediwe
Kungase kube nezinye izinselele ngenkathi kuguqulwa izithako ezisebenzayo zibe imikhiqizo ezosetshenziswa. Isibonelo, inqubo engalungile ingase yehlise okuqukethwe kwezithako ezisebenzayo, noma ingase ibe nokushoda ekuncibilikeni noma ekunambithekeni. Ithimba lethu lingahlinzeka ngezinsizakalo zocwaningo ukuze lixazulule izinkinga ezingenhla kumakhasimende ethu.
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Izifundo Zobuthi (LD50, Acute, Chronic, Geno)
Ukuphepha kufanele kuqinisekiswe ngaphambi kokuba umkhiqizo wethulwe emakethe. Senza izifundo zobuthi emikhiqizweni yamakhasimende ethu, ukuze sikhulule izinkathazo, futhi sithole imikhiqizo esebenzayo nephephile ukuze imakethwe. Le nsizakalo ihlanganisa ucwaningo lwe-LD50 yobuthi obuyingozi, isifundo sobuthi obungapheli, ucwaningo lobuthi bofuzo, njll.
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Isifundo ngezilwane
Sihlinzeka ngenkonzo yokufunda ngezilwane kumakhasimende ethu. Ukuhlolwa kobuthi kanye nokuhlola ukusebenza kahle kumamodeli ocwaningo lwezilwane, isikhathi esiningi, kungaba ireferensi enengqondo emikhiqizweni yamakhasimende ethu, ikakhulukazi izithasiselo zokudla nezimonyo. Ngokuhlukile ocwaningweni lwasemtholampilo, ukufunda ngezilwane kuyindlela yokuhlola esheshayo nethengekayo yokuqinisekisa ukuthi umkhiqizo uzosebenza ngempumelelo futhi ungabi nangozi.
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In Vitro Test / Research Service
Ukuhlolwa kwe-in vitro kunganikeza ukusabela kweseli nezitho kusithako/izithako ezisebenzayo ukuze kunikezwe izinkomba ekuhloleni ukuthi ingabe ucwaningo kufanele luqhutshwe. Nakuba ukuhlolwa kwe-in vitro kungafanele kuso sonke isifundo sezithako ezisebenzayo, ngokungangabazeki kuyisici esibalulekile esingasekela ikhasimende lethu ukwenza isinqumo ngezindleko ezincane kakhulu ngoba isikhathi esiningi ukuhlolwa kwe-vitro kunokusetshenziswa okuphansi kakhulu ngezindleko nesikhathi. Isibonelo, uma kwenziwa izithako ezisebenzayo zokulawula ushukela wegazi, noma imikhiqizo elwa namagciwane, idatha etholwe ekuhlolweni kwe-in vitro isho lukhulu.
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Ucwaningo lomtholampilo (Isigaba1 - Isigaba 4)
Ngaphansi kocwaningo lwenkontileka yesithako esisha esisebenzayo noma ifomula entsha, singahlela ucwaningo lwasemtholampilo, ngokwemfuneko, okuhlanganisa umkhondo womuntu eqenjini elincane ukuze uthole izithasiselo zokudla, kanye nocwaningo lomtholampilo lwesigaba I, isigaba II, isigaba III kanye nesigaba IV esidingwa yizidingo ezintsha zokusetshenziswa kwezidakamizwa, ukusekela amakhasimende ethu ukuze athole idatha edingekayo futhi afanelekele isicelo esisha somuthi (NDA).
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Isevisi Yocwaningo Lokwakhiwa Kwemvelo
Ngokusekelwe ekuqongeleleni kwethu emkhakheni wocwaningo Lwemithi Yendabuko YamaShayina (TCM), sisebenza ngokukhethekile ekwenziweni kwemvelo, ukuthuthukisa ukusebenza kahle kwezithako zokudla kanye noma ukuthuthukisa imithi emisha. Isevisi ingaba inqubo egcwele ehlanganisa ukwakheka, ukusungulwa kwamazinga ezinto ezingavuthiwe, ukusungulwa kwezindlela zokuhlaziya, ukuthuthukiswa kwenqubo yokukhiqiza, ukucwaninga ngokusebenza kahle kanye nokucwaninga ngobuthi, njll. Khonamanjalo, umsebenzi ngamunye oshiwo ngenhla ungenziwa futhi uma ucelwa.
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Ukwakhiwa kwenkontileka (i-OEM) yesithako esisebenzayo
Singahlela ukukhiqizwa kwempahla eluhlaza ethile efiswa yikhasimende lethu. Sinefekthri yethu yokuhlola kanye nezimboni ezisebenzisanayo ngaphansi kokuphathwa okuqondile kwethimba lethu lezobuchwepheshe, yonke imiphumela yocwaningo ingashintshwa ngokushelelayo ibe yimikhiqizo futhi siqinisekise ukuthi amakhasimende ethu angathola umkhiqizo awufisayo wekhwalithi ephezulu ngesikhathi. Ifomu lesithako esisebenzayo kungaba uketshezi olugxilile, amandla, okunamathiselwe, uwoyela oguquguqukayo, njll.
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Ukwakhiwa kwenkontileka (i-OEM) yemikhiqizo eqediwe
Ngesikhungo sethu sokuhlola kanye nezimboni ezisebenzisanayo, singahlinzeka ngokuthuthukiswa kwenkontileka kanye nensizakalo yokukhiqiza izinkontileka (i-CDMO) kumakhasimende ethu. Imikhiqizo yethu ingaba utshwala, amaphilisi, ama-softgels, amaphilisi, izimpushana ezincibilikayo, ama-granules, njll. Ngokusekelwe kusizinda sethu esikhethekile sobuchwepheshe kanye nemodeli yethu yebhizinisi lokukhiqiza izinkontileka, siyakwazi ukuqinisekisa ukulethwa okufika ngesikhathi, ikhwalithi ethembekile kanye nokungavezwa kolwazi.
