活血通络注射剂活性炭法与超滤法工艺比较

Comparison of Activated Carbon and Ultrafiltration Technique in the Production Process of Huoxue Tongluo Injection

目的:研究活性炭及超滤工艺对活血通络注射剂的适用性。方法:以鲎试剂动态浊度法定量活血通络药液中内毒素的含量,并用纳米粒径仪测定不同浓度活性炭及不同分子量超滤膜使用前后活血通络注射液中微粒的粒径变化。结果:将活血通络注射剂中外加内毒素后作为供试品溶液,测得0.05%、0.10%、0.3%3种浓度活性炭的内毒素去除率为65.2%、77.5%、80.4%。5、10 kDa截留分子量超滤膜的内毒素去除率均大于95%。纳米粒径仪测定结果表明10 kDa截留分子量超滤膜超滤后滤液中粒径比不同浓度活性炭使用后药液中微粒粒径小得多。结论:超滤法更适用于活血通络注射剂去热原工艺,同时能提高溶液的澄明度,去除溶液中的大颗粒,为注射剂生产工艺提供依据。

Objective：To research the applicability of activated carbon and ultrafiltration technique in the production process of Huoxue Tongluo Injection.Methods：The kinetic-turbidimetric method was used to determine the content of bacterial endotoxins in Huoxue Tongluo solution.Particle size change in Huoxue Tongluo solution was determined by nanometer particle size instrument before and after the use of different concentration activated carbon and different molecular weight ultrafiltration membrane.Results：The removal efficacy of bacterial endotoxins was 65.2%,77.5%,80.4% by using three concentrations of active carbon at 0.05%,0.10%,0.30% in Huoxue Tongluo Injection,respectively.It was above 95% by using cutoff molecular weight both 5 kDa and 10 kDa ultrafiltration membrane.Measure results by nanometer particle size instrument showed that particle size of filter liquor by 10 kDa cutoff molecular weight ultrafiltration membrane was much smaller than that of by use of different concentration activated carbon.Conclusion：Ultrafiltration method is more suitable to the removal of bacterial endotoxins.The solution is more clear after using ultrafiltration method,and large particles of solution is removed.The ultrafiltration method provides the basis for injection production.