冠心康胶囊挥发油β-环糊精包合物的制备工艺优选

Optimization of Preparation Technology of β-Cyclodextrin Inclusion Complexes for Volatile Oil in Guanxinkang Capsule

目的:优选β-环糊精包合冠心康胶囊挥发油的制备工艺,提高挥发油的稳定性。方法:采用饱和水溶液超声法制备包合物,以挥发油包合率、包合物收得率及包合物含油率为综合评价指标,采用星点设计考察β-CD与挥发油的用量比、包合温度及超声时间等因素对包合工艺的影响,对结果进行多元线性回归和二项式拟合,用效应面法确定最佳工艺条件,并进行预测分析。结果:冠心康胶囊挥发油的β-CD最佳包合工艺条件为β-CD与挥发油的用量比7∶1,包合温度45℃,超声时间40 min,预测值与理论值偏差<3%。结论:通过β-CD包合后可使挥发油粉末化,提高其稳定性。优选的包合工艺方法简便、预测性良好,为冠心康胶囊的工业生产提供试验依据。

Objective： To grope preparation technology of β-cyclodextrin （β-CD） inclusion compound of volatile oil in Guanxinkang capsule, in order to improve stability of volatile oil. Method： Inclusion complexes was prepared by saturated aqueous solution ultrasonic method, with inclusion rate of volatile oil, inclusion oil content and inclusion yield as comprehensive evaluation index, influence of ratio ofβ-CD and volatile oil, inclusion temperature and ultrasonic time on inclusion technology was investigated by central composite design, test data was fitted by multi-linear regression and binomial equation, inclusion technology conditions were optimized by response surface method, and to predictive analysis. Result： Optimum inclusion process conditions were as follows ： ratio ofβ-CD and volatile oil of 7 ： 1, inclusion temperature at 45 ℃ and ultrasonic time of 40 min, deviation between observed and predicted values was less than 3%. Conclusion： Volatile oil was powdered and its stability had been increased after being included byβ-CD. This optimized inclusion process was simple with high predictability, it could provide test basis for industrial production of Guanxinkang capsule.