脂肪乳注射液生产工艺对乳粒的影响因素研究

Studying Influencing Factors in Production Process of Fat Emulsion Injection

目的研究脂肪乳注射液生产工艺对乳粒的影响因素。方法以脂肪乳注射液生产工艺中的均质温度、均质压力、均质次数、为影响因素,采用正交试验设计方法进行筛选,通过考察其平均粒径确定了最终工艺参数;以>5μm乳粒为检验指标,并对脂肪乳制备后使用滤芯孔径进行了筛选;对筛选后的参数进行了确认。最后对不同厂家提供卵磷脂制备的脂肪乳进行了考察。结果均质温度和均质压力是平均粒径的主要影响因素,确定了脂肪乳的最优制备工艺,即均质温度为50℃;均质压力为6×10 7Pa;均质次数7次;选择3μm聚丙烯和1μm聚丙烯两道滤芯用于脂肪乳的过滤;3批样品乳粒结果符合规定,且重现性良好;德国lipoid GMBH、韩国斗山Doosan Corporation和广州白云山汉方现代药业有限公司提供卵磷脂制备脂肪乳的>5μm乳粒测定结果均远远小于0.05%,且无明显差异。结论优化了脂肪乳的制备工艺;选择德国lipoid GMBH、韩国斗山Doosan Corporation和广州白云山汉方现代药业有限公司作为卵磷脂的供应商。

OBJECTIVE To study the influencing factors in the production process of fat emulsion injection. METHODS The homogenization temperature,homogenization pressure,and times of homogenization cycle in the production process of fat emulsion injection were selected as the influencing factors.The orthogonal test design method was used for screening.The final process parameters were determined by examining the average particle size.Then the fat emulsion whose particle size greater than 5μm was used as a test indicator to evaluate the pore size of the filter.Finally,lecithin provided by different manufacturers was used to prepare fat emulsions. RESULTS The homogenization temperature and pressure were the main influencing factors of the average particle size.The preparation process of the fat emulsion was optimized,the homogenization temperature was 50℃;pressure was 6×10 7 Pa;times of homogenization cycle was 7.Polypropylene filters of 3μm and 1μm were used for the filtrating fat emulsions.The results of the 3 batches of samples of fat emulsions were in compliance with the regulations,and the reproducibility was good.Particles,whose size was greater than 5μm,in fat emulsions prepared from different lethicins were all far less than 0.05%.And there was no significant difference between different lethicin providers. CONCLUSION The preparation process of fat emulsion was optimized;the German lipoid GMBH,Doosan Corporation,and GuangzhouHanfang Modern Pharmaceutical Co.,Ltd.were selected as the suppliers of lecithin.