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醒脑静脂肪乳注射液处方工艺研究

Formulation and Technology Study on Xingnaojing Fat Emulsion Injection

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【作者】 张来芳晏彩霞蔡紫阳

【Author】 ZHANG Lai-fang,YAN Cai-xia,CAI Zi-yang(Jiangsu Chia-tai Tianqing Pharmaceutical Co.Ltd,Nanjing 210023,China)

【机构】 江苏正大天晴药业股份有限公司

【摘要】 目的:对醒脑静脂肪乳注射液的处方工艺进行了筛选研究,以确定稳定的处方工艺。方法:按照脂肪乳注射液的研制要求并结合各味药物的成分特点对处方工艺进行研究。结果:确定用5%大豆油作为油相并将冰片及药物中提取的挥发油成分溶于油相,2.25%甘油水溶液作为水相并将药物中提取的水溶性成分溶于水相,1.2%蛋黄卵磷脂作为乳化剂制备该乳剂,并对大豆油用量、乳化剂用量及pH、灭菌工艺等进行了筛选,确定了各辅料最佳用量及工艺,经影响因素试验,证明按照拟定的处方工艺制备的样品在凉暗处稳定良好。

【Abstract】 Objective:A study on the Formulation and Technology of Xingnaojing Fat Emulsion injection carried on to establish a steady prescription process.Methods:According to the basic requirement of fat emulsion and the characteristic of content,the formulation and technology was investigated.Results:Oil phase was 5% soybean oil,in which resolved the volatile oil extracted from borneol and other drugs.Water phase was 2.25% glycerine solution,in which resolved the water soluble constituents extracted from drugs.emulsifier was 1.2% egg yolk lecithin.The optimum dosage and technology selected from the factors of the amount of soybean oil and emulsifier,pH,and the sterilization processes.Through influence factor experiments,samples prepared using confirmed formulation and technology proved good stability under cool and dark.

  • 【文献出处】 中国现代中药 ,Modern Chinese Medicine , 编辑部邮箱 ,2012年12期
  • 【分类号】R286.0
  • 【被引频次】3
  • 【下载频次】227
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