Abstract: Objective Through the special pharmacodynamics tracking test to determine the optimum extraction process.Methods The effect on mice hypnosis of pentobarbital sodium of subthreshold dosage and the hypnotic time experiment on mice by pentobarbital sodium in threshold dosage were used to evaluate the optimum process.Result The results showed that Anmian preparation No.4 drug group could enhance the number of asleep mice of pentobarbital sodium in subthreshold hypnotic dosage.Compared with the blank control group there was significant difference(P <0.05).Anmian preparation No.4 drug group also could shorten substantially the rats' sleep latent period and prolong obviously the rats' sleep time which induced by pentobarbital sodium at threshold dosage.Compared with the blank control group there was significant difference(P <0.05).Conclusion Through the observations of the 2 experiments,Anmian preparation No.4 drug group and the blank control group have significant difference.The optimum extraction process was as follows:The volatile oil of one of the drugs was extracted firstly,the residue with the other 2 drugs refluxing and extracting with water,filtering.The combined filtrate was concentrated to about 200 mL and then added the volatile oil.The Preparation made by this process could enhance the number of asleep mice.The Preparation also could shorten substantially the rats' sleep latent period and prolong the rats' sleeping time,suggesting that the process was the optimal process.

Key words: Anmian preparation, Procedure selection, Pharmacodynamics tracking test

摘要： 目的通过采用特异的药效学跟踪实验,确定最佳提取工艺。方法采用对小白鼠戊巴比妥钠阈下催眠剂量作用的实验及对小白鼠延长戊巴比妥钠催眠时间的实验来确定最佳工艺。结果安眠制剂4组对小白鼠戊巴比妥钠阈下催眠剂量作用实验表明,该药能使小鼠入睡鼠数增加,与空白对照组比较有明显差异(P<0.05);对小白鼠延长戊巴比妥钠催眠时间的实验结果表明,该药使小鼠入睡潜伏期缩短,并能延长小鼠的睡眠时间。与空白对照组比较有明显差异(P<0.05)。结论通过2个实验的观测,安眠制剂4组与空白对照组比较有明显差异,即按照将其中1味中药先提取挥发油后,残渣同其余2味中药加水回流提取,过滤,滤液合并,浓缩至约200mL,再加入已提取的挥发油的工艺研制的制剂能使小鼠入睡鼠数增加,使小鼠入睡潜伏期缩短,并能延长小鼠的睡眠时间,提示此工艺为最佳工艺。

关键词: 安眠制剂, 工艺筛选, 药效学跟踪