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（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（ZL2017.2 0049599.7；ZL2010.2 0147413.X）精制、纯化而成的淡黄色蜡状产品。具有良好的乳化性、润湿性、粘度调整性、分散性、抗氧化性等及本身所特有的生理活性，广泛应用于注射用乳剂、脂质体的原料及碳氟乳剂等领域。
产品规格：Product Specifications
理化指标Physical and chemical indicators | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
性状 Appearance | 黄色蜡状 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% |
磷脂酰胆碱 PC | ≥80% | ≥90% | ≥95% | ≥98% |
磷脂酰乙醇胺 PE | ≤30% | ≤30% | ≤30% | ≤30% |
磷脂酰胆碱和磷脂酰乙醇胺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% |
溶血磷脂酰胆碱 LPC | ≤3.5% | ≤3.5% | ≤3.5% | ≤3.5% |
溶血磷脂酰乙醇胺和溶血磷脂酰胆碱 LPE+LPC | ≤4.0% | ≤4.0% | ≤4.0% | ≤4.0% |
磷脂酰肌醇 PI | ≤5.0% | ≤5.0% | ≤5.0% | ≤5.0% |
总有关物质 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% |
总残留溶剂 Total residual solvents | ≤0.5% | ≤0.5% | ≤0.5% | ≤0.5% |
蛋白质 Protein | 不得检出 | 不得检出 | 不得检出 | 不得检出 |
酸值 Acid value | ≤30 | ≤30 | ≤30 | ≤30 |
碘值Iodine value | ≥75 | ≥75 | ≥75 | ≥75 |
过氧化值 Peroxide value | ≤3.0 | ≤3.0 | ≤3.0 | ≤3.0 |
微生物、细菌内毒素Microorganismss, bacterial endotoxins | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
需氧菌总数 TAMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g |
霉菌和酵母菌总数 TYMC | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g | ≤100cfu/g |
大肠埃细菌 E. coli | 每1g不得检出 not detectable/1g | 每1g不得检出not detectable/1g | 每1g不得检出 not detectable/1g | 每1g不得检出not detectable/1g |
沙门菌 Salmonella
| 每10g不得检出not detectable/10g | 每10g不得检出not detectable/10g | 每10g不得检出not detectable/10g | 每10g不得检出not detectable/10g |
细菌内毒素 Endotoxins | ＜2.0Eu/g | ＜2.0Eu/g | ＜2.0Eu/g | ＜2.0Eu/g |
重金属heavy metals | ||||
PC-80 | PC-90 | PC-95 | PC-98 | |
重金属 Heavy metals | ≤5ppm | ≤5ppm | ≤5ppm | ≤5ppm |
砷 Arsenic | ≤2ppm | ≤2ppm | ≤2ppm | ≤2ppm |
铅 Lead | ≤2ppm | ≤2ppm | ≤2ppm | ≤2ppm |
其他规格大豆磷脂（供注射用）可根据客户要求提供。
Other specifications of soya lecithin (for injection) will be available upon requestt.
应用范围：Scope of application
医药制品 Medical products | 广泛应用于注射用制剂、脂质体的原料及碳氟乳剂等领域。 The emulsifier of injection emulsion, the material of Liposome medicine and the carbon fluoride emulsions. |
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（供注射用）标准
Chinese Pharmacopoeia 2020 Standard for Soya lecithin(for injection)
