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目的探索人血高密度脂蛋白 (HDL)注射液的制备方法 ,并对该产品进行质量研究和初步稳定性试验 ,为预防和治疗动脉粥样硬化提供一种新药。方法采用低温乙醇法从经乙肝疫苗免疫的健康人血浆中分离、纯化并采取病毒灭活技术制成HDL注射液 ,同时拟订质量标准并进行检验。结果HDL注射液生产工艺路线合理 ,质量达到拟定标准要求。结论此法可制备出合格的HDL注射液 ,且适合于规模化生产
Objective To explore the preparation method of human blood high-density lipoprotein (HDL) injection and to conduct quality research and preliminary stability test of this product to provide a new drug for the prevention and treatment of atherosclerosis. Methods Low-temperature ethanol was isolated from healthy human plasma immunized with Hepatitis B vaccine and purified by virus inactivation technique to produce HDL injection. At the same time, quality standards were formulated and tested. Results HDL injection production process is reasonable, the quality of the proposed standard requirements. Conclusion This method can produce qualified HDL injection, and is suitable for large-scale production