三七总皂苷注射剂除热原方法的效果及对有效成分的影响研究  

Study on the Effect of Depyrogenation Method of Panax Notoginsenosides Injection and Its Influence on Active Ingredients

作　　者：杨妹妹 梁咏梅 招丽君 梁云飞 兰星 

机构地区：[1]广西梧州制药集团(股份)有限公司,广西梧州543002 [2]广西三七综合利用技术重点实验室,广西梧州543002

出　　处：《大众科技》2023年第9期26-29,共4页Popular Science & Technology

基　　金：中央引导地方科技发展资金项目(桂科ZY22096004);广西科技基地和人才专项(桂科AD20297068);梧州市科技计划项目(202202022)。

摘　　要：目的:考察三七总皂苷注射剂除热原方法的效果及其对三七总皂苷有效成分的影响。方法:外加细菌内毒素模拟热原污染,采用动态浊度法和高效液相色谱法检测药用炭吸附及无菌滤膜过滤前后三七总皂苷药液中细菌内毒素及有效成分含量,分别计算内毒素去除率和三七总皂苷回收率。结果:细菌内毒素标准曲线r值为0.9982,符合要求;三七总皂苷供试品最小无干扰稀释倍数为128倍;以水为溶质时,药用炭对细菌内毒素最小饱和吸附浓度为0.1%;以三七总皂苷为溶质时,细菌内毒素最小饱和吸附浓度为0.5%;药用炭吸附后再通过过滤手段能进一步提高细菌内毒素去除率;药用炭对不同浓度的药液存在不同吸附影响。结论:同时采取药用炭吸附与过滤两种手段能有效除去细菌内毒素,但对于突发大污染情况,常规药用炭用量可能不能完全控制细菌内毒素的清除。Objective:To investigate the effect of depyrogenation method of Panax notoginsenosides injection and its influence on active ingredient of Panax notoginsenosides.Methods:The bacterial endotoxin was added to simulate pyrogen pollution,and the content of bacterial endotoxin and active ingredient in Panax notoginsenosides solution before and after medicinal charcoal adsorption and sterile membrane filtration were detected by dynamic turbidimetry and high-performance liquid chromatography.The endotoxin removal rate and recovery rate of Panax notoginsenosides were calculated respectively.Results:The r value of the bacterial endotoxin standard curve is 0.9982,which meets the requirements;the minimum non-interference dilution ratio of Panax notoginsenosides for the test sample is 128 times;when water is used as the solute,the minimum saturated adsorption concentration of bacterial endotoxins on medicinal charcoal is 0.1%;when using Panax notoginsenosides as solute,the minimum saturated adsorption concentration of bacterial endotoxin is 0.5%;the adsorption of medicinal charcoal and subsequent filtration can further improve the removal rate of bacterial endotoxins;medicinal charcoal has different adsorption effects on different concentrations of medicinal solutions.Conclusion:Both medical carbon adsorption and membrane filtration can effectively remove bacterial endotoxins,but for sudden large pollution situations,conventional dosage of medicinal charcoal may not fully control the clearance of bacterial endotoxins.

关 键 词：三七总皂苷 动态浊度法 细菌内毒素 药用炭 

分 类 号：R282[医药卫生—中药学]