正交试验法优选小儿解感颗粒中柴胡挥发油的包合工艺

Inclusion Process Optimization of Bupleurum Volatile Oil in Xiao'er Jiegan Particle by Orthogonal Test

目的:优选小儿解感颗粒中挥发油的最佳包合工艺。方法:以β-环糊精(β-CD)为包合载体,采用正交试验以挥发油包合物的得率和包合率为指标综合考察包结温度、包结时间、β-环糊精与挥发油比例对包合工艺的影响。将β-CD-挥发油包合物制备成小儿解感颗粒,并进行稳定性考察。结果:β-CD-挥发油包合物的最佳包合工艺为:包合温度为40℃、包合时间3 h及β-CD与挥发油的比例为8∶1(g∶ml)。按照挥发油直接喷入法制备的小儿解感颗粒在室温放置6个月后,挥发油损失51.27%;按照包结法制备的小儿解感颗粒在室温放置24个月后,挥发油损失仅为3.13%。结论:优选的挥发油包合工艺合理可行,制备的小儿解感颗粒稳定性良好。

Objective ： To optimize the inclusion process of volatile oil in Xiao＇ er Jiegan particle. Methods： β-Cyclodextrin was used as the inclusion material. Orthogonal experiments were performed, and the yield of volatile oil inclusion complex and the inclusion rate of volatile oil were taken as the indices to study the influence of inclusion temperature, inclusion time and the ratio of β-cyclodex- trin to volatile oil （ g · ml） on the inclusion process. The β-CD-volatile oil inclusion complex was added to Xiao＇ er Jiegan particle and the stability studies were conducted as well. Results： The optimum volatile oils inclusion process of Xiao＇ er Jiegan particle was as fol- lows： the inclusion temperature was 40℃, the inclusion time was 3 h , and the ratio of β-cyclodextrin to volatile oil （g ： ml） was 8 ： 1. The loss4of volatile oil prepared by direct injection method was 51.27% after 6-month storage at room temperature, while that pre- pared by the inclusion method was only 3, 13% after 24-month storage at room temperature. Conclusion： The optimized inclusion process of volatile oil is reasonable and feasible, and the stability of the prepared particle is also promising.