柴胡注射液制备工艺研究

Study on the Preparative Process of Bupleurum Injection

目的:优选柴胡注射液的制备工艺。方法:通过正交试验对煎煮水的PH值,加水量,浸泡温度,浸泡时间,聚山梨酯-80的溶解温度,弱碱调PH值,冲高纯氮气抗氧化等进行因素考察,验证工艺路线的可行性。结果:采用水蒸汽蒸馏法,条件为加水11倍量、煎煮水的PH值1、浸泡温度为70℃、浸泡时间为8h、用10%枸橼酸钠调PH值、冲高纯氮气防止氧化等,使含量及澄明度都得到提高,保证质量。结论:新工艺充分考虑经济性、可操作性,达到提高含量及澄明度的目的,适用于柴胡注射液的大生产。

Objective： To optimize the preparation technology of Bupleurum Injection.Methods： The PH value of decocting-water,the volume of water,the temperature of marination,soak period,the temperature that dissolve Polysorbate-80 in water,proper PH of alkalilye and avoid the oxygen effect by using pure N2 were studied to verify the possibility of craft route by orthogonal design.Results： Using steam distillation to extract,11 times water.The PH value of decocting-water is one,70℃ is the temperature of marination,eight-hour is soak period.Adjust the number of PH by 10% of sodium citrate,avoid the oxygen effect by using pure N2 and so on.The contents and clarity were all raised,the quality was been guaranteed.Conclusion： This craft is considered on the economy and operation.Attain to the contents and clarity was all raised.This experimental method is suitable to the productive preparation of Bupleurum Injection.