Pharmaceutical Industry Standard of the People's Republic of China-Medical Absorbent Thonje (YY/T0330-2015)

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Pharmaceutical Industry Standard of the People's Republic of China-Medical Absorbent Thonje (YY/T0330-2015)

Ku China, monga mtundu wamankhwala, thonje loyamwitsa zamankhwala lomwe limayendetsedwa ndi boma, wopanga thonje woyamwa mankhwala ayenera kupitilira kuyesa kwamankhwala aku China ngati ali ndi chikhalidwe chopanga ndi zida, zinthuzo zimayenera kuyesedwa kuchipatala ndikuwunikanso akatswiri. ndi mayiko satifiketi yolembetsa thonje yamankhwala, Kuti aloledwe kugulitsidwa.
Mumsika waku China, thonje loyamwa mankhwala liyenera kutsata Pharmaceutical Industry Standard of the People's Republic of China—Medical Absorbent Cotton (YY/T0330-2015), muyezo waukulu motere, ndikuyembekeza kukuthandizani kumvetsetsa mankhwala a thonje.
1/ Malinga ndi kuwonera, thonje loyamwa mankhwala liyenera kukhala loyera kapena loyera, lopangidwa ndi ulusi wokhala ndi utali wosachepera 10 mm, wopanda masamba, peel, zotsalira za malaya kapena zonyansa zina.Pali kukana kwina potambasula, ndipo palibe fumbi lomwe liyenera kugwa pogwedezeka pang'onopang'ono.
2/ Malinga ndi kuwonera, thonje loyamwa mankhwala liyenera kukhala loyera kapena loyera, lopangidwa ndi ulusi wokhala ndi ulusi wosachepera 10 mm, wopanda masamba, peel, zotsalira za malaya kapena zonyansa zina.Pali kukana kwina potambasula, ndipo palibe fumbi lomwe liyenera kugwa pogwedezeka pang'onopang'ono.
Reagent - Zinc chloride iodide solution: gwiritsani ntchito 10 5mL kuphatikiza kapena kuchotsera 0.1 ml madzi, sungunulani 20 g ± 0.5 g zinki kolorayidi, ndi 6 5g ± 0.5 g potaziyamu iodide, onjezerani 0,5 g ± 0.5 g kutulutsa mutagwedeza mphindi 15, fyuluta. zofunika, kupewa kuteteza kuwala.Zinc chloride-formic acid solution: Sungunulani 20 g chloride-0.5 g paundi mu njira ya 8 50 g/L anhydrous formic acid ndi 80 g kuphatikiza kapena kuchotsera 1g.
Chizindikiritso A: Mukayang'ana pansi pa maikulosikopu, ulusi uliwonse wowoneka uyenera kukhala ndi selo imodzi mpaka 4cm m'litali ndi 40μm m'lifupi, yokhala ndi chubu lathyathyathya, lozungulira lozungulira, lomwe nthawi zambiri limapindika.
Chizindikiritso B: Mukakumana ndi njira yopumira ya chlorine, ulusi uyenera kukhala wofiirira.
Chizindikiritso C: Onjezani 10 ml ya chlorinated pot-formic acid solution ku 0.1g, tenthetsani mpaka 4 00C, ikani kwa maola 2.5 ndikugwedezani mosalekeza, sayenera kusungunuka.
3/ Ulusi Wachilendo: Akaunikiridwa ndi maikulosikopu, uyenera kukhala ndi ulusi wa thonje wokhazikika, womwe umalola kuti nthawi zina ulusi ung'ono wakunja ukhale wokha.
4/ thonje mfundo: pafupifupi 1g mankhwala kuyamwa thonje anali wogawana kufalikira mu 2 colorless mbale mandala lathyathyathya, mbale iliyonse ndi dera 10 cmX10cm, chiwerengero cha neps mu chitsanzo sayenera kupitirira wa nep muyezo (RM) pamene kufufuzidwa. ndi kuwala kofalitsidwa.
5/ Kusungunuka m'madzi: tenga 5. 0g thonje woyamwa, ikani m'madzi 500 mL ndikuwiritsa kwa mphindi 30, gwedezani nthawi ndi nthawi ndikuwonjezera mpweya.
Kuchuluka kwa madzi otayika.Thirani mosamala madziwo.Finyani madzi otsala mu chitsanzo ndi ndodo yagalasi ndikusakaniza ndi madzi otsanulidwa pamene akusefa.400 mL ya filtrate idasungunuka (yogwirizana ndi 4/5 ya misa yachitsanzo) ndikuumitsa pa 100 ℃ ~ 105 ℃ mpaka kulemera kosalekeza.Werengani kuchuluka kwa zotsalira ku misa yeniyeni yeniyeni.Kuchuluka kwa zinthu zosungunuka m'madzi sikuyenera kupitirira 0.50%.
6/ Ph: Reagent - phenolphthalein solution: Sungunulani 0.1 g ± 0.01g phenolphthalein mu 80 ml ya ethanol solution (voliyumu kachigawo 96%) ndi kuchepetsa mpaka 100 ml ndi madzi.Methyl lalanje yankho: 0.1g ± 0.1g methyl lalanje anali kusungunuka mu 80 mL madzi ndi kuchepetsedwa 100 mL ndi 96% Mowa njira.
Mayeso: 0,1 ml ya phenolphthalein yankho anawonjezera 25 ml mayeso njira S, 0,05 anawonjezera zina 25 ml mayeso njira SML methyl lalanje njira, kuona ngati njira zikuoneka pinki.Yankho sayenera kuwoneka pinki.
7/ Nthawi yomira: nthawi yomira isapitirire 10 s.
8/ Mayamwidwe amadzi: kuyamwa kwamadzi kwa galamu iliyonse ya thonje yoyamwa mankhwala sikuyenera kukhala kuchepera 23.0g.
9/ Suluble matter mu ether: kuchuluka kwa zinthu zosungunuka mu ether sikuyenera kupitilira 0.50%.
10/ Fluorescence: thonje loyamwa mankhwala liyenera kukhala losawoneka bwino komanso lofiirira fulorosisi ndi tinthu tating'ono tachikasu.Kupatula ulusi wochepa wodzipatula, palibe kuyenera kuwonetsa fluorescence yolimba ya buluu.
11 / Kuyanika kuwonda: kuwonda sikuyenera kukhala kwakukulu kuposa 8.0%.
12/ Phulusa la Sulfate: Phulusa la sulphate siliyenera kupitirira 0. 40%.
13/ Pamwamba yogwira: thovu la zinthu zogwira ntchito sayenera kuphimba madzi onse.
14/ Zinthu zopangira utoto: Mtundu wa zomwe mwapeza usakhale wakuda kuposa yankho la Y5 ndi GY6 lofotokozedwa mu Zowonjezera A kapena njira yowongolera yokonzedwa powonjezera 7. 0mL hydrochloric acid solution (concentrated mass) mpaka 3. 0mL primary blue yankho
Ndipo chepetsani 0,5 ml ya njira yomwe ili pamwambapa 100 ml ndi hydrochloric acid solution (kuchuluka kwa 10 g/L).
15/ Ethylene oxide zotsalira: ngati mankhwala thonje mankhwala chosawilitsidwa ndi ethylene okusayidi, zotsalira ethylene okusayidi sayenera kupitirira 10 mg/kg.
16/ Bioload: kwa thonje wosabala wa thonje woyamwa mankhwala, wopanga adzalemba kuchuluka kwa bioload pa gramu imodzi ya mankhwala ena mwa chiwerengero cha tizilombo.


Nthawi yotumiza: Mar-12-2022