大豆磷脂（供注射用PC）
大豆磷脂（供注射用）是以粉末磷脂為原料，經(jīng)乙醇萃取等工序，采用獨(dú)創(chuàng)的專利設(shè)備（Z...
大豆磷脂（供注射用）是以粉末磷脂為原料，經(jīng)乙醇萃取等工序，采用獨(dú)創(chuàng)的專利設(shè)備（ZL2017.2 0049599.7；ZL2010.2 0147413.X）精制、純化而成的淡黃色蠟狀產(chǎn)品。具有良好的乳化性、潤(rùn)濕性、粘度調(diào)整性、分散性、抗氧化性等及本身所特有的生理活性，廣泛應(yīng)用于注射用乳劑、脂質(zhì)體的原料及碳氟乳劑等領(lǐng)域。
產(chǎn)品規(guī)格：Product Specifications
理化指標(biāo)Physical and chemical indicators | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
性狀 Appearance | 黃色蠟狀 Yellow waxy | |||
磷 P | ≥2.7% | ≥2.7% | ≥2.7% | ≥2.7% |
氮 N | 1.5～2.0% | 1.5～2.0% | 1.5～2.0% | 1.5～2.0% |
磷脂酰膽堿 PC | ≥80% | ≥90% | ≥95% | ≥98% |
磷脂酰乙醇胺 PE | ≤30% | ≤30% | ≤30% | ≤30% |
磷脂酰膽堿和磷脂酰乙醇胺PC+PE | ≥80% | ≥90% | ≥95% | ≥98% |
丙酮不溶物 Acetone insolubles | ≥90% | ≥90% | ≥90% | ≥90% |
溶血磷脂酰乙醇胺 LPE | ≤1% | ≤1% | ≤1% | ≤1% |
溶血磷脂酰膽堿 LPC | ≤3.5% | ≤3.5% | ≤3.5% | ≤3.5% |
溶血磷脂酰乙醇胺和溶血磷脂酰膽堿 LPE+LPC | ≤4.0% | ≤4.0% | ≤4.0% | ≤4.0% |
磷脂酰肌醇 PI | ≤5.0% | ≤5.0% | ≤5.0% | ≤5.0% |
總有關(guān)物質(zhì) Total related substances | ≤8.0% | ≤8.0% | ≤8.0% | ≤8.0% |
己烷不溶物 Hexane insolubles | ≤0.3% | ≤0.3% | ≤0.3% | ≤0.3% |
水分 Moisture | ≤1.5% | ≤1.5% | ≤1.5% | ≤1.5% |
總殘留溶劑 Total residual solvents | ≤0.5% | ≤0.5% | ≤0.5% | ≤0.5% |
蛋白質(zhì) Protein | 不得檢出 | 不得檢出 | 不得檢出 | 不得檢出 |
酸值 Acid value | ≤30 | ≤30 | ≤30 | ≤30 |
碘值Iodine value | ≥75 | ≥75 | ≥75 | ≥75 |
過(guò)氧化值 Peroxide value | ≤3.0 | ≤3.0 | ≤3.0 | ≤3.0 |
微生物、細(xì)菌內(nèi)毒素Microorganismss, bacterial endotoxins | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
需氧菌總數(shù) TAMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g |
霉菌和酵母菌總數(shù) TYMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g |
大腸埃細(xì)菌 E. coli | 每1g不得檢出 not detectable/1g | 每1g不得檢出not detectable/1g | 每1g不得檢出 not detectable/1g | 每1g不得檢出not detectable/1g |
沙門(mén)菌 Salmonella
| 每10g不得檢出not detectable/10g | 每10g不得檢出not detectable/10g | 每10g不得檢出not detectable/10g | 每10g不得檢出not detectable/10g |
細(xì)菌內(nèi)毒素 Endotoxins | ＜2.0Eu/g | ＜2.0Eu/g | ＜2.0Eu/g | ＜2.0Eu/g |
重金屬heavy metals | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
重金屬 Heavy metals | ≤5ppm | ≤5ppm | ≤5ppm | ≤5ppm |
砷 Arsenic | ≤2ppm | ≤2ppm | ≤2ppm | ≤2ppm |
鉛 Lead | ≤2ppm | ≤2ppm | ≤2ppm | ≤2ppm |
其他規(guī)格大豆磷脂（供注射用）可根據(jù)客戶要求提供。
Other specifications of soya lecithin (for injection) will be available upon requestt.
應(yīng)用范圍：Scope of application
醫(yī)藥制品 Medical products | 廣泛應(yīng)用于注射用制劑、脂質(zhì)體的原料及碳氟乳劑等領(lǐng)域。 The emulsifier of injection emulsion, the material of Liposome medicine and the carbon fluoride emulsions. |
化妝品 Cosmetics | 乳化劑、助乳化劑、膚感柔順劑、潤(rùn)濕劑、保濕、抗衰老 Emulsifier, co-emulsifier, skin softener, moisturizer, moisturizing, , anti-aging |
包裝規(guī)格：Packing Specifications
凈重：10Kg/箱，分1Kg×10袋及5Kg×2袋兩種規(guī)格；
Net weight: 10 Kg/box, divided into 1 Kg × 10 bags and 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(chǔ)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12個(gè)月
Sealed, avoiding light,store at low temperature(below -18℃)Shelf life:12months.
執(zhí)行標(biāo)準(zhǔn)standard of execution
《中國(guó)藥典》2020年版大豆磷脂（供注射用）標(biāo)準(zhǔn)
Chinese Pharmacopoeia 2020 Standard for Soya lecithin(for injection)
