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Inotengeswa Nepamusoro-soro China Yemhando yepamusoro Kallidinogenase (CAS: 9001-01-8)

CAS NO.:9001-01-8

HS CODE:3507.9090.90

Faira Service:Chinese-GMP, DMF

Pharmacopoeia standard:JP/CP

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Iyo ine maitiro akanaka uye anofambira mberi kune kufarira kwemutengi, bhizinesi redu rinogara richivandudza zvigadzirwa zvedu zvemhando yepamusoro kuti zvizadzise zvinodiwa nevatengi uye zvakare kutarisa nezve kuchengetedzeka, kuvimbika, zvinodiwa kwezvakatipoteredza, uye hunyanzvi hweKutengesa-Kutengesa China Yemhando yepamusoro.Kallidinogenase(CAS: 9001-01-8), Kazhinji kune ruzhinji rwevashandisi vebhizinesi nevatengesi kuti vape zvemhando yepamusoro zvinhu uye yakanakisa kambani.Tikugashirei noushamwari kuti tibatane nesu, ngatiite hutsva pamwe chete, kuhope dzekubhururuka.
Iyo ine maitiro akanaka uye anofambira mberi kune kufarira kwemutengi, bhizinesi redu rinogara richivandudza zvigadzirwa zvedu zvemhando yepamusoro kuti zvizadzise zvinodiwa nevatengi uye zvakare kutarisa nezve kuchengeteka, kuvimbika, zvinodiwa kwezvakatipoteredza, uye hunyanzvi hwekuvandudza.Kallidinogenase, Isu tinovavarira kuve bhizinesi remazuva ano rine kutengeserana kwakanaka kwe "Kuvimbika uye kuvimba" uye nechinangwa che "Kupa vatengi masevhisi akatendeseka uye zvigadzirwa zvemhando yepamusoro".Isu tinokumbira nemoyo wese rutsigiro rwenyu rusina kuchinjika uye tinoonga zano renyu remutsa uye kutungamira.

Detail

1. Hunhu: Hupfu huchena kana hunenge huchena, husina hwema.

2. Kubvisa Kunobva: Porcine pancreas.

3. Maitiro:Kallidinogenaseinotorwa kubva kune ine hutano porcine pancreas.

4. Zviratidzo uye kushandiswa: Ichi chigadzirwa chinogona kushandiswa kune zvakasiyana-siyana zvemwoyo uye cerebovascular chirwere, zvakadai sechirwere chemwoyo, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders uye peripheral vascular disease.Iva nekurapa kurinani patsvagurudzo dzichangobva kuitika dzekudzivirira kwekutanga diabetesic microangiopathy uye diabetic nephropathy, inogona kuderedza kubuda kwealbumin.Clinical data kumba nekune dzimwe nyika inoratidza kuti inogona kuwedzera sperm chiitiko uye kuwanda kwekugadzirwa, uye ine imwe nzira yekurapa mukurapa kweimwe sterility yemurume.

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Sei isu?

· Yakagadzirwa muGMP musangano

· Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo

·Maraw materials anotarisika

·Kutevedzera mwero wevatengi

·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu

·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.

Tsanangudzo

Test Items		Kutsanangurwa kwekambani
Test Items		CP	JP
Vanhu		Muchena kana hupfu hwakachena, husina hwema	Hupfu hwakachena kusvika kushava shoma, husina hwema kana kuti husina kufenda
Identification		R (hydrolysis rate): 0.12 ~ 0.17	R (hydrolysis rate): 0.12 ~ 0.16
Identification		Liquid Chromatography: Inopindirana	Ini : ≤ 0.2
Miedzo	pH	5.5 - 7.5 (300unit/ml)	5.5 - 7.5 (1g/300ml)
	Kujeka kwemhinduro	Zvakajeka (2mg/ml)	————
	Mafuta	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Kukosha:≥ 0.8
	Trypsin-yakafanana nezvinhu	————	T Kukosha: ≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Kurasikirwa pakuomeswa	≤ 5.0% (60 ℃ Dry in Vacuum, 4h)	≤ 2.0% (60 ℃ Dry in Vacuum, 4h)
	Residue pakubatidza	≤ 3.0%	≤ 3.0%
	Kinin-kusunungura basa	————	≥ 500ng bradykinin yakaenzana / min / chikamu pachikamu
	Kuchena	≥ 75% (yemuromo)	————
	Kuchena	≥ 90% (yejekiseni)	————
	Bacterial endotoxin	≤ 2.5 EU/yuniti (yejekiseni)	————
Assay	Enzyme chiitiko	————	≥ 25 unit/mg
	Chiitiko chakananga	≥ 300 unit/mg protein (yemuromo)	≥ 100 unit / mg protein
	Chiitiko chakananga	≥ 600 unit/mg protein (yejekiseni)	≥ 100 unit / mg protein
Kusvibiswa kweMicrobial	TAMC	≤ 1000cfu/g (yemuromo)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (yejekiseni)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Conforms	Conforms
	Salmonella	Conforms	Conforms

Izvo zvine maitiro akanaka uye anofambira mberi kune kufarira kwemutengi, bhizinesi redu rinogara richivandudza zvigadzirwa zvedu zvemhando yepamusoro kuti zvizadzise zvinodiwa nevatengi uye zvakare kutarisa nezve kuchengetedzeka, kuvimbika, zvinodiwa zvezvakatipoteredza, uye hunyanzvi hweKutengesa Kwakanyanya Kutengesa China Yemhando yepamusoro Cp Kallidinogenase (CAS: 9001-01-8), Kazhinji kune ruzhinji rwevashandisi vebhizinesi nevatengesi kuti vape zvemhando yepamusoro zvinhu uye yakanakisa kambani.Tikugashirei noushamwari kuti tibatane nesu, ngatiite hutsva pamwe chete, kuhope dzekubhururuka.
Yakatengesa-Yakanyanya Kutengesa China Pharmaceutical Yepakati, Antibiotic, Isu tinovavarira kuve bhizinesi remazuva ano rine bhizimusi rekutengesa re "Kuvimbika uye chivimbo" uye nechinangwa che "Kupa vatengi masevhisi akatendeseka uye zvigadzirwa zvemhando yepamusoro".Isu tinokumbira nemoyo wese rutsigiro rwenyu rusina kuchinjika uye tinoonga zano renyu remutsa uye kutungamira.

Zvakapfuura: Inotengeswa Nepamusoro-soro China Yemhando yepamusoro Kallidinogenase (CAS: 9001-01-8)

Zvinotevera: Inotengeswa Nepamusoro-soro China Yemhando yepamusoro Kallidinogenase (CAS: 9001-01-8)

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