大豆磷脂（供注射用PC）
大豆磷脂（供注射用）是以粉末磷脂为原料，经乙醇萃取等工序，采用独创的专利设备（Z...
大豆磷脂（磷脂酰胆碱，简称PC）是以大豆粉末磷脂为原料，经乙醇萃取等工序，采用独创的专利设备（ZL2017.2 0049599.7；ZL2010.2 0147413.X）精制而成的黄色蜡状产品。在医药制品、保健食品、化妆品行业中广泛应用。
产品规格：Product Specifications
理化指标Physical and chemical indicators | ||
PC-50 | PC-70 | |
性状 Appearance | 黄色蜡状 Yellow waxy | |
磷 P | ≥2.7% | ≥2.7% |
氮 N | 1.5～2.0% | 1.5～2.0% |
磷脂酰胆碱 PC | ≥45.0% | ≥70.0% |
磷脂酰乙醇胺 PE | ≤30.0% | ≤30.0% |
磷脂酰胆碱和磷脂酰乙醇胺PC+PE | ≥70% | ≥70% |
丙酮不溶物 Acetone insolubles | ≥90.0% | ≥90.0% |
己烷不溶物 Hexane insolubles | ≤0.3% | ≤0.3% |
水分 Moisture | ≤1.5% | ≤1.5% |
总残留溶剂 Total residual solvents | ≤0.5% | ≤0.5% |
酸值 Acid value | ≤30 | ≤30 |
碘值Iodine value | ≥75 | ≥75 |
过氧化值 Peroxide value | ≤3.0 | ≤3.0 |
微生物 Microorganisms | ||
PC-50 | PC-70 | |
需氧菌总数 TAMC | ≤100cfu/g | ≤100cfu/g |
霉菌和酵母菌总数 TYMC | ≤100cfu/g | ≤100cfu/g |
大肠埃细菌 E.coli | 每1g不得检出 Negative/1g
| 每1g不得检出 Negative/1g |
沙门菌 Salmonella | 每10g不得检出Negative/10g | 每10g不得检出Negative/10g |
重金属 heavy metals | ||
PC-50 | PC-70 | |
重金属 Heavy metals | ≤20ppm | ≤5ppm |
砷 Arsenic | ≤2ppm | ≤2ppm |
铅 Lead | ≤2ppm | ≤2ppm |
其他规格大豆磷脂可根据客户要求提供Other specifications of lecithin will be available upon request
应用范围：Scope of application:
医药制品 Medical products | 广泛用作口服制剂的乳化剂、增溶剂、分散剂，以及口服药物的生物利用度增强剂和局部渗透增强剂。 Widely used as emulsifiers, solubilizers, dispersants , and bioavailability enhancers and local penetration enhancers for oral drugs |
保健食品 Health foods | 磷脂本身促细胞生长、调节血脂、防止脂肪肝、健脑益智、延缓衰老等生理功能Phospholipid itself promotes cell growth, regulates blood lipids, prevents fatty liver, enhances brain intelligence, and delays aging. |
化妆品Cosmetics | 乳化剂、助乳化剂、肤感柔顺剂、润湿剂、保湿、抗衰老 Emulsifier,co-emulsifier, skin softener, moisturizer, moisturizing, anti-aging |
包装规格：Packing Specifications
净重：10Kg/箱，分1Kg×10袋及5Kg×2袋两种规格；
Net weight: 10 Kg/box, divided into 1 Kg × 10 bags and 5 Kg × 2 bags;
内包装采用双层包装：内层为药用低密度聚乙烯袋，外层为铝箔袋；
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;
外包装采用双层包装：内层为泡沫箱内置冰盒，外层为纸箱；
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;
外包装尺寸：610x460x315mm
Packing size: 610 X 460 X 315mm
储存条件及保质期:Storage conditions and shelf life
密封，避光，低温（-18℃以下）保存；保质期12个月
Sealed ,avoiding light ,store at low temperature(below -18℃)Shelf life:12months.
执行标准standard of execution
《中国药典》2020年版大豆磷脂标准
Chinese Pharmacopoeia 2020 Standard for Soya lecithin
GB28401-2012食品添加剂 磷脂标准
GB28401-2012 Food additive phospholipid standard
