| 张媛,纳涛,吴彦霖,高华.药用辅料中不同来源溶血磷脂酰胆碱含量限值的合理性分析[J].中国药事,2019,33(5):582-585 |
| 药用辅料中不同来源溶血磷脂酰胆碱含量限值的合理性分析 |
| Rationality Analysis of Limits on Lysophosphatidylcholine Content in Different Sources of Pharmaceutical Excipients |
| 投稿时间：2018-11-23 |
| DOI：10.16153/j.1002-7777.2019.05.014 |
| 中文关键词: 溶血磷脂酰胆碱 红细胞 溶血 渗透脆性 |
| 英文关键词: lysophosphatidycholine erythrocyte hemolysis osmotic fragility |
| 基金项目: |
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| 摘要点击次数: 1223 |
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| 中文摘要: |
| 目的：通过比较蛋黄来源及大豆来源溶血磷脂酰胆碱对红细胞影响的差异来评价目前药用辅料中不同来源溶血磷脂酰胆碱含量限值的合理性。方法：采用体外红细胞溶血试验及红细胞渗透脆性试验考察两种不同来源溶血磷脂酰胆碱对红细胞的影响。结果：蛋黄来源及大豆来源溶血磷脂酰胆碱红细胞溶血IC50分别为0.0427mg·mL-1、0.0801mg·mL-1；二者在0.65%、0.60%、0.55% NaCl低渗盐溶液中引起的溶血率亦具有显著性差异，蛋黄来源溶血磷脂酰胆碱的溶血率明显高于大豆来源溶血磷脂酰胆碱。但红细胞凝聚试验结果表明，二者均未见引起红细胞凝聚。结论：两种不同来源的溶血磷脂酰胆碱致溶血能力具有显著性差异，建议应分别制定不同来源磷脂类产品中溶血磷脂酰胆碱的含量限值，以保证临床用药安全。 |
| 英文摘要: |
| Objective:To evaluate the rationality of the limits on lysophosphatidylcholine content in different sources of pharmaceutical excipients by comparing the different effects of lysophosphatidycholine from egg yolk and soybean on erythrocyte. Methods:Erythrocyte hemolysis tests and erythrocyte osmotic fragility tests in vitro were conducted to investigate the effect of two different sources of lysophosphatidycholine on erythrocyte. Results:The IC50 of hemolysis of lysophosphatidycholines from egg yolk and soybean was 0.0427mg/ml and 0.0801mg/ml respectively. There was significant difference in the hemolysis rates between the two kinds of lysophosphatidycholine in 0.65%, 0.60% and 0.55% low osmotic pressure sodium chloride solution. The hemolysis rate of lysophosphatidylcholines from egg yolk was significantly higher than that from soybean. However, the results of erythrocyte coagulation test showed that neither of them caused red blood cell condensation. Conclusion:There are significant differences in the hemolysis ability of lysophosphatidylcholines from soybean and egg yolk. It is suggested that the content of lysophosphatidylcholine in phospholipid products from different sources should be separately determined to ensure the safety of clinical medication. |
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