ʻO ka pauka Meloxicam

Pauka Meloxicam Maʻemaʻe Kiʻekiʻe no ka Hana ʻana i nā lāʻau lapaʻau | 99% COX-2 Selective NSAID API me nā Hoʻonā Bioavailability Kiʻekiʻe

Ma ke ʻano he mea hana hilinaʻi a me ka mea hoʻolako i nā mea hana ikaika o ka papa lāʻau lapaʻau, loea ʻo Shaanxi Hongda Phytochemistry Co., Ltd. i ka hana ʻana i ka Meloxicam Powder premium me ka maʻemaʻe 99%, e hoʻokō ana i nā kūlana honua koʻikoʻi no ka hana ʻana o ka NSAID API. Loaʻa i kā mākou ʻano micronised ka pane i ka pilikia bioavailability no nā mea BCS Class II, e hāʻawi ana i kahi hoʻolaha like ʻana o ka nui o nā ʻāpana (D90 < 10 microns) e pono ai no nā helu hoʻoheheʻe kūpono o nā ʻano dosage hope loa. Me ka hale hana i hōʻoia ʻia e 20,000-sqm cGMP, nā lako hoʻāʻo HPLC kiʻekiʻe loa a me ka ʻoi aku o 20 mau makahiki o ka ʻike i ka hana ʻana i nā lāʻau lapaʻau, hiki iā mākou ke hāʻawi iā ʻoe i nā mea paʻa i kāohi ʻia e ka polymorph e hōʻoiaʻiʻo ana i ka hana therapeutic wānana no kāu papa, capsule a me nā ʻano injectable.

Product Introduction

ʻO ka Meloxicam bulk kahi lāʻau anti-inflammatory non-steroidal o ka hui enolic acid (oxicam), me ka hana pale COX-2 kikoʻī ma o kahi ʻano hana enzyme i makemake ʻia. ʻO ka pauka crystalline melemele māmā ʻo Meloxicam he amphoteric me ʻelua mau waiwai pKa o 1.1 a me 4.2. ʻAneʻane hiki ʻole ke hoʻoheheʻe ʻia ka Meloxicam a Shaanxi hongda i ka wai akā naʻe he maʻalahi i ke kaiapuni hoʻohui me ka kaohi ʻana i ka pH. ʻO ka mea waiwai ka API koʻikoʻi no ka hana ʻana i nā dosis paʻa waha no ka osteoarthritis a me ka rheumatoid arthritis a me nā hoʻonā hoʻokele ʻeha holoholona. Ua hoʻopaʻa paʻa ʻia kā mākou pauka nui Meloxicam lāʻau lapaʻau no ka polymorph e hōʻoia i ke ʻano enolic paʻa (Polymorph I), he mea nui ia i nā ʻano hoʻoheheʻe like ʻole ma waena o ka hana ʻana o ka batch.

Nāʻikepili huahana

Nā Pōmaikaʻi o ka Pauka Meloxicam

Ka Mana Polymorph Papa Lapaʻau: Hoʻokumu kā mākou ʻenehana hana i ka Polymorph I paʻa thermodynamically (enolic tautomer), e pale ana i ka pōʻino o ka hoʻololi ʻana o ke ʻano kristal i ka wā e mālama ai e hoʻoweliweli paha i ka kinetics dissolution a me ka bioequivalence i kāu mau ʻano.

ʻEnehana Micronization Kiʻekiʻe: Hāʻawi ka ʻenehana Micronization i kahi hoʻolaha nui o nā ʻāpana i hoʻoponopono pono ʻia me nā waiwai D50 hiki ke hana hou ʻia ma kahi o 5 microns, kahi e hoʻoponopono ai i ka pilikia solubility wai maikaʻi ʻole o nā API BCS Class II a ʻae i nā ʻano hoʻokuʻu lāʻau wikiwiki.

ʻIkepili Maʻemaʻe Kiʻekiʻe: Hāʻawi nā ʻenehana synthesis hana kiʻekiʻe i ka maʻemaʻe assay >99% me ka kaohi paʻa i nā haumia e pili ana i ke kaʻina hana, ʻoiai ka huahana hōʻino amide i nā pae ma lalo loa o nā palena pharmacopeial, no laila e hoʻohaʻahaʻa ana i ka pilikia i ka wā o nā haʻawina paʻa.

Nā ʻano Flowability Hoʻomaikaʻi: Manaʻo ʻia nā ʻano hoʻololi ʻili e hoʻonui i ka pauka flowability a me nā ʻōkuhi compressibility e ʻae i ka hoʻopili pololei a me nā kaʻina hana granulation pulu ma nā laina hana papa wikiwiki me ka ʻole o nā pilikia hoʻokaʻawale.

Ka Hoʻohana ʻana o ka Meloxicam Powder

Hana ʻana i nā lāʻau lapaʻau no nā kānaka: Hoʻohana ʻia kā mākou pauka ma ke ʻano he mea hana nui no ka hana ʻana i nā papa waha a me nā capsules 7.5mg a me 15mg e mālama i ka osteoarthritis a me ka rheumatoid arthritis. ʻO kona hoʻolaha mau ʻana i nā ʻāpana e hōʻoiaʻiʻo ana i ka hoʻokō ʻana me nā koi like ʻana o ka ʻike ma nā ʻāpana hana nui.

Nā ʻAno Lapaʻau Holoholona: Hoʻohana pinepine ʻia no ka hoʻomākaukau ʻana i nā hopena injectable a me nā hoʻokuʻu waha i ka hoʻokele ʻeha no nā holoholona hoa a me nā holoholona. Pono nā ʻano hana solubilisation kikoʻī, e like me ka tromethamine complexation a i ʻole ka hoʻokomo ʻana o cyclodextrin, no kēia mau ʻano hana e hana i nā ʻano hana wai paʻa.

Nā Hoʻohana Hoʻohuihui Kūikawā: ʻAe i nā hale kūʻai lāʻau lapaʻau hoʻohuihui e hana i nā gels transdermal i hana kūikawā ʻia a me nā kirīmi topical. ʻO ka kaohi ʻana i ka nui o nā ʻāpana e ʻae i ke komo ʻana o ka stratum corneum no ka hopena anti-inflammatory kūloko me ka emi ʻana o ka ʻike ʻōnaehana.

Nā Papahana Noiʻi a me ka Hoʻomohala: Kākoʻo i ka hana hou ʻana o nā lāʻau lapaʻau i nā ʻōnaehana hou no ka hoʻokele lāʻau me ka hoʻohana ʻana iā Meloxicam Powder e komo pū ana me nā hoʻokuʻu nanoparticle, nā dispersions lipid paʻa, a me nā ʻōnaehana emulsifying ponoʻī no ka lawe ʻana i nā lāʻau e hoʻomaikaʻi hou aku i nā ʻano bioavailability.

Ka Hana Hana

KaʻAnuʻu Hana 1 - Hana ʻia nā mea maka a me ka hoʻomaʻemaʻe ʻana: Hoʻopilikia nā precursors papa lāʻau lapaʻau i nā hopena condensation i kāohi ʻia ma lalo o ka lewa nitrogen me ka nānā mau ʻana i nā palena hopena, e loaʻa ai ka Meloxicam maka i hoʻopili ʻia ma hope mai nā ʻōnaehana solvent i kāohi ʻia e hoʻokō i nā pahuhopu maʻemaʻe mua.

KaʻAnuʻu Hana 2 - Ka Hoʻohālikelike ʻana o ka Polymorph a me ka Crystallization: Hoʻomaʻamaʻa ʻia ka mea maka i ka recrystallization i kāohi ʻia e ka mahana me ka hoʻohana ʻana i nā lakio solvent i hōʻoia ʻia, e hana wale ana i ka ʻano kristal Polymorph I paʻa, i hōʻoia ʻia ma o ka differential scanning calorimetry a me ka nānā ʻana o ka diffraction pauka X-ray.

KaʻAnuʻu Hana 3 - Micronization a me ka ʻenekinia ʻāpana: Hele nā ​​kristal Meloxicam maloʻo ma o nā lako wili jet ma lalo o nā kūlana cryogenic, e hoʻokō ana i ka hoʻolaha nui o ka ʻāpana i manaʻo ʻia me ka pale ʻana i ka hōʻino wela, a ukali ʻia e ka hoʻokaʻawale ʻana o ka ea e wehe i nā ʻāpana nui loa.

KaʻAnuʻu Hana 4 - Ka Hoʻāʻo ʻana i ka Maikaʻi a me ka Hoʻopili Sterile : ʻO ka pauka hope loa e hele ana i ka hōʻoia piha ʻana o ka HPLC assay, ka profiling haumia, ka nānā ʻana i nā solvent koena, a me ka hoʻāʻo ʻana i ka microbial ma kā mākou keʻena hoʻokolohua SGS-standard ma mua o ka hoʻopiha ʻana i ka aseptic i loko o nā ʻeke PE pālua i loko o nā pahu fiber ma lalo o nā kūlana lumi maʻemaʻe ISO Class 7.

Hōʻike Hoʻāʻo mai ka ʻAoʻao ʻEkolu

Nā Kūlana Hōʻoia Kūʻokoʻa: Hoʻokomo mākou i kā mākou waiwai i nā hoʻāʻo nui ʻana mai nā ʻaoʻao ʻekolu ma nā keʻena hoʻokolohua SGS a me Eurofins no ka mālama piha ʻana i nā lula a me ka palekana lāʻau lapaʻau.

Ka Nānā ʻana i nā Metala Kaumaha: Hōʻike ka hoʻāʻo ʻana o ICP-MS aia nā metala kaumaha āpau (ke kēpau, arsenic, cadmium, mercury) i loko o nā kūlana USP <232> a me EP 2.4.27. ʻO ka huina o nā metala kaumaha he <5ppm.

Nānā ʻana i nā mea hoʻoheheʻe koena: Hōʻoia ʻana o ka chromatography kinoea e like me nā ʻōlelo aʻoaʻo a ICH Q3C e hōʻoia i ka noho ʻana o nā mea hoʻoheheʻe synthesis (methanol, xylene, THF) i loko o nā palena o ka papa 2 a me ka papa 3 no ka palekana o ka mea maʻi i nā ʻano hana hope loa.

Palekana Microbiological: ʻOi aku ka nui o ka helu microbial aerobic a me ka helu ʻana o ka hū/ʻōpala ma mua o nā kūlana o ka papa lāʻau lapaʻau no nā noi API non-sterile me TAMC <1000 CFU/g a me TYMC <100 CFU/g.

No ke aha e koho ai iā mākou

ʻOi aku ma mua o 20 mau makahiki o ka ʻike o Shaanxi Hongda Phytochemistry i ka hana lāʻau lapaʻau me 20,000 mika kuea o ke kahua hana cGMP, 10 mau laina hana o kēia wā a me ka hale hana hoʻomaʻemaʻe pae 100,000. ʻO kā mākou ʻōnaehana maikaʻi he keʻena hoʻokolohua SGS-standardized me HPLC, GC, nā lako hana analytical spectrophotometric a me nā loea pae polopeka e hōʻoia i kēlā me kēia pūʻulu e hoʻokō i nā kūlana pharmacopeial honua.

ʻO kā mākou mau Palapala Hōʻoia e komo pū me HALAL, KOSHER, FSSC22000, ISO22000, ISO9001 a hāʻawi mākou i nā kemika pae lāʻau lapaʻau i hilinaʻi ʻia e nā ʻoihana ma ʻEulopa, ʻAmelika ʻĀkau a me ʻAsia.

Loaʻa iā mākou kahi hale kūʻai he 3,000 mika kuea me ka waihona mākaukau no ka lawe ʻana i 3-7 mau lā. Hāʻawi kā mākou limahana mālama mea kūʻai aku i ke kōkua loea ma o ke ola holoʻokoʻa o kāu huahana.

Kākoʻo OEM / ODM

Ka Hoʻomohala ʻana i ka Hoʻohuihui Maʻamau: Hana pū kā mākou hui o 20+ mau loea lāʻau lapaʻau me kāu hui loea e hana i nā hoʻohuihui i hoʻomaikaʻi ʻia e hoʻoponopono i nā pilikia kikoʻī no kāu ʻano dosage i manaʻo ʻia me nā pono hoʻoheheʻe, ka hoʻohālikelike ʻana o nā excipient a me ke kūpaʻa.

Ka Nui o nā ʻĀpana Maʻamau: Hoʻololi mākou i nā hoʻonohonoho micronization e hāʻawi i nā hoʻolaha nui o nā ʻāpana maʻamau e kūlike me kāu mau hiki hana hana a me nā ʻano hoʻokuʻu i makemake ʻia no nā papa hoʻokuʻu koke a i ʻole nā ​​​​ʻōnaehana matrix hoʻokuʻu mau.

Kākoʻo Palapala Hoʻoponopono ʻO ke kākoʻo hoʻomākaukau piha no ka Drug Master File (DMF) e komo pū me nā wehewehe ʻana o ke kaʻina hana, ka ʻikepili hōʻoia ʻana i ke ʻano loiloi, nā haʻawina kūpaʻa a me nā palapala hoʻokō GMP e hoʻolalelale i nā lā palena hoʻopaʻa inoa huahana.

Nā Hoʻonā Pūʻolo Maʻalahi Loaʻa iā mākou nā ʻōnaehana pale makū kūikawā no nā hoʻonohonoho mālama koʻikoʻi. Hiki iā mākou ke hāʻawi i nā hoʻonohonoho pūʻolo i hana kūikawā ʻia mai nā laʻana nui o ka lab 100g a i nā pahu nui 500kg, me nā pahu fiber 25kg maʻamau.

Nīnau Hoʻoholo Pine

Q: He aha ka mea e hoʻokaʻawale ai i kāu mea lāʻau lapaʻau mai ke ʻano maʻamau o ka ʻoihana?

A: Loaʻa iā mākou ka hōʻoia polymorph koʻikoʻi e hōʻoia i nā kristal Form I paʻa wale nō, ka kaohi haumia papa lāʻau lapaʻau me ka amide <0.1% a me ka micronization i hōʻoia ʻia no ka hoʻolaha like ʻana o ka nui o nā ʻāpana D90 <10μm.

Q: Hiki iā ʻoe ke hāʻawi i ke kākoʻo hoʻoponopono no nā noi lāʻau lapaʻau hou?

A: ʻAe, hāʻawi mākou i nā palapala ākea e pili ana i nā Palapala Hōʻoia o ka Nānā ʻana, ʻikepili kūpaʻa, nā kikoʻī o ke kaʻina hana, a hiki ke hana i nā faila Master Drug Type III e kākoʻo i nā waihona ANDA a me NDA.

Q: He aha kāu ʻano hoʻokele maikaʻi no ke kūlike o ka batch-to-batch?

A: Aia ma mua o 15 mau wahi nānā maikaʻi no kēlā me kēia pūʻulu hana, me ka HPLC pureness assay, ka diffraction laser size particle, ka nānā ʻana o ke koena solvent GC a me ka hoʻāʻo microbiological, ma mua o ka hoʻokuʻu ʻia ʻana o kahi pūʻulu. Mālama ʻia nā laʻana mālama no ʻelua mau makahiki.

Q: Ke hāʻawi nei ʻoe i ke kōkua loea no nā pilikia hoʻokumu ʻana?

A: ʻAe, ʻoiaʻiʻo loa. Hāʻawi kā mākou hui hoʻomohala lāʻau lapaʻau i ka ʻōlelo aʻoaʻo manuahi e pili ana i nā koho hoʻomaikaʻi solubility, ka hoʻohālikelike ʻana o nā excipient a me ka hoʻonui ʻana i ka hoʻoheheʻe ʻana i kūpono i kāu mau pono hana.

Q: He aha kāu nui kauoha liʻiliʻi loa no nā ʻāpana hoʻokolokolo?

A: Hoʻokō mākou i nā pono noiʻi e hoʻomaka ana mai ka nui o ka laʻana 100g, me nā hiki ke hana ʻoihana piha e hoʻonui ana i nā ʻaelike hoʻolako makahiki he nui-tona i kākoʻo ʻia e nā ʻano kumukūʻai paʻa.

Kāhea iā mā˚ou

Ua mākaukau ʻoe e hoʻomaikaʻi i kāu mau ʻano lāʻau lapaʻau me ka Meloxicam Powder premium i kākoʻo ʻia e ka hōʻoia maikaʻi koʻikoʻi a me ka ʻike loea? E leka uila pololei mai iā mākou ma duke@hongdaherb.com a ʻike pehea e hana ai ʻo Shaanxi Hongda Phytochemistry i ka maikaʻi loa.