蛋黃卵磷脂（EPC)
蛋黃卵磷脂是以蛋黃粉末磷脂為原料，經(jīng)乙醇萃取等工序，采用獨創(chuàng)的專利設(shè)備（ZL20...
蛋黃卵磷脂（供注射用）是以蛋黃粉末磷脂為原料，經(jīng)乙醇萃取等工序，采用獨創(chuàng)的專利設(shè)備（ZL2017.2 0049599.7；ZL2010.2 0147413.X）精制、純化而成的黃色或淡黃色蠟狀產(chǎn)品。由于較強的抗氧化能力及其獨特的表面活性能力和生理學(xué)特性，被廣泛應(yīng)用于醫(yī)藥、營養(yǎng)學(xué)領(lǐng)域及化妝品行業(yè)。
產(chǎn)品規(guī)格：Product Specifications
理化指標Physical and chemical indicators | ||
EPC-80 | EPC-98 | |
性狀 Appearance | 本品為淡黃色粉末或蠟狀固體light yellow powder or waxy solid | |
磷 P | 3.5～4.1% | 3.5～4.1% |
氮 N | 1.75～1.95% | 1.75～1.95% |
磷脂酰膽堿 PC | ≥80% | ≥98% |
磷脂酰乙醇胺 PE | ≤20% | ≤20% |
磷脂酰膽堿和磷脂酰乙醇胺PC+PE | ≥80% | ≥98% |
磷脂酰肌醇 PI | ≤5.0% | ≤5.0% |
溶血磷脂酰膽堿 LPC | ≤3.5% | ≤3.5% |
溶血磷脂酰乙醇胺 LPE | ≤1% | ≤1% |
溶血磷脂酰膽堿和溶血磷脂酰乙醇胺 LPC+LPE | ≤4.0% | ≤4.0% |
鞘磷脂 Sphingolipids | ≤3.0% | ≤3.0% |
總有關(guān)物質(zhì) Total related substances | ≤8.0% | ≤8.0% |
皂化值 Saponification value | 195～212 | 195～212 |
酸值 Acid value | ≤20.0 | ≤20.0 |
碘值Iodine value | 60～73 | 60～73 |
過氧化值 Peroxide value | ≤3.0 | ≤3.0 |
游離脂肪酸 Free fatty acids | ≤1% | ≤1% |
甘油三酸脂 Triglyceride | ≤3% | ≤3% |
膽固醇 cholesterol | ≤2% | ≤2% |
棕櫚酸 Palmitic acid | ≤0.2% | ≤0.2% |
總殘留溶劑 Total residual solvents | ≤0.5% | ≤0.5% |
水分 Moisture | ≤3% | ≤3% |
蛋白質(zhì) Protein | 不得檢出 | 不得檢出 |
微生物、細菌內(nèi)毒素Microorganismss, bacterial endotoxins | ||
EPC-80 | EPC-98 | |
細菌內(nèi)毒素 Bacterial endotoxin | ＜2.0Eu/g | ＜2.0Eu/g |
需氧菌總數(shù)TAMC | ≤100cfu/g | ≤100cfu/g |
霉菌和酵母菌總數(shù) TYMC | ≤100cfu/g | ≤100cfu/g |
大腸埃希菌 E.coli | 每1g不得檢出 Not detectable/1g | 每1g不得檢出 Not detectable/1g |
沙門菌 Salmonella | 每10g不得檢not detectable/10g | 每10g不得檢出not detectable/10g |
重金屬Heavy metals | ||
EPC-80 | EPC-98 | |
重金屬 Heavy metals | ≤5ppm | ≤5ppm |
砷鹽 Arsenic | ≤2ppm | ≤2ppm |
其他規(guī)格蛋黃卵磷脂（供注射用）可根據(jù)客戶要求提供。Other specifications of Egg yolk Lecithin(for injection) will be available upon requestt.
應(yīng)用范圍：Scope of application
醫(yī)藥制品Medical products | 注射用乳劑的乳化劑 emulsifier for injection |
包裝規(guī)格：Packing Specifications
凈重：10Kg/箱，分1Kg×10袋及2.5Kg×2袋兩種規(guī)格；
Net weight: 10 Kg/box, divided into 1 Kg × 10 bags and 2.5 Kg × 2 bags;
內(nèi)包裝采用雙層包裝：內(nèi)層為藥用低密度聚乙烯袋，外層為鋁箔袋；
The inner packaging adopts double-layer packaging: the inner layer is a medicinal low-density polyethylene bag, and the outer layer is an aluminum foil bag;
外包裝采用雙層包裝：內(nèi)層為泡沫箱內(nèi)置冰盒，外層為紙箱；
The outer packaging adopts double-layer packaging: the inner layer is a foam box with a built-in ice box and the outer layer is a carton;
外包裝尺寸：610x460x315mm
Packing size: 610 X 460 X 315mm
儲存條件及保質(zhì)期:Storage conditions and shelf life
密封，避光，低溫（-18℃以下）保存；保質(zhì)期24個月
Sealed, avoiding light, store at low temperatures(below -18℃); Shelf life :12 months.
執(zhí)行標準standard of execution
《中國藥典》2020年版蛋黃卵磷脂（供注射用）標準
Chinese Pharmacopoeia 2020 Standard for Egg Yolk lecithin(for injection)
