Haina Pancreatin o Deebio me te Hanga o te paura, Granule me te wheketere Pellet me nga kaihanga |Deebiotech

Pancreatin o Deebio me te Hanganga o te Paura, Granule me te Pellet Whakaahua Whakaatu

Pancreatin o Deebio me te hanga o te paura, te kirikiri me te pellet

Tau CAS:8049-47-6

Waehere HS:3507.9090.90

Ratonga Kōnae:Hainamana-GMP/EU-GMP/DMF/EU-DMF

Paerewa Pharmacopoeia:EP/USP/CP

Tukuna he imeera ki a matou tauira kore utu

Taipitopito Hua

Tohu Hua

Taipitopito

1. Nga Tohu: Ko te Pancreatin he paku parauri, he paura amorphous, he paku parauri ranei ki te kirikiri kirikiri.Ko te amylase, te lipase me te protease.

2. Puna Tangohanga: Porcine pancreas.

3. te tukanga: Ka tangohia te Pancreatin mai i te pancreas poaka hauora e to tatou hangarau whakahohe-tangohanga motuhake.

4 .Nga tohu me nga whakamahinga: Ko te Pancreatin he ranunga o te maha o nga whākōkī kūnatu i mahia e te pancreas o te porcine.Ka taea te whakamahi i roto i te ahumahi rongoa, te tukatuka kai, te tanning, te horoi me etahi atu mara, me te maha o nga tono.

He aha tatou?

·I hangaia i roto i te awheawhe GMP

· 27 nga tau o te hitori R&D o te enzyme koiora

· Ka kitea nga rauemi mata

· Kia rite ki nga paerewa a nga kaihoko

· Kaweake ki runga i te 30 whenua me nga rohe

· He kaha ki te whakahaere punaha kounga penei i te US FDA, Japan PMDA, South Korea MFDS, etc.

Whakatakotoranga

Nga Tuemi Whakamatau		Whakatakotoranga Kamupene
Nga Tuemi Whakamatau		CP	EP	USP
Ngā Pūāhua	Paura	He paura paku parauri, amorphous	He paura paku parauri, amorphous	He paura paku parauri, amorphous
Ngā Pūāhua	Granule	He kirikiri paku parauri ki te kirikiri-tae	He kirikiri paku parauri ki te kirikiri-tae	He kirikiri paku parauri ki te kirikiri-tae
Tautuhinga		————	Ka rite	————
Nga whakamatautau	Ngako ngako	≤20mg/g	≤ 5.0%	≤3.0%(<3USP)；≤ 6.0%(≥3USP)
	Ngaronga i te whakamaroke	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60 ℃, 4h	≤ 5.0%Maroke i roto i te korehau 60 ℃, 4h
	Te toenga whakarewa	————	≤ 0.5%E ai ki te EP(5.4)	≤ 0.5%E ai ki te USP(467)
	Te rahi o te matūriki	————	E ai ki te EP(2.1.4&2.9.12)	E ai ki te USP(811)
Te whakamatautau	Protease	≥600U/g	1.0～5.2Ph.Eur.U/mg	100～450USP.U/mg
	Amylase	≥7000U/g	12.0～80.0Ph.Eur.U/mg	100～500USP.U/mg
	Lipase	≥4000U/g	15.0～130Ph.Eur.U/mg	10～90USP.U/mg
Nga poke moroiti	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ka rite	Ka rite	Ka rite
	Haramona	Ka rite	Ka rite	Ka rite