摘要
采用星点设计制备不同处方的组分中药芳冰鼻吸剂,通过一种模拟人鼻子呼吸的测试装置开展体外释放度实验,利用气相色谱仪测定芳樟醇、冰片和薄荷脑的累积释放率,再通过效应面法进行多元线性回归和二项式拟合,选择最佳制备工艺,进行预测分析,比较预测值与实验值的偏差。结果二项式拟合方程相关系数较高,r分别为0.999 3、0.998 0、0.944 9。最佳制备工艺:乙醇浓度为84.39%,淀粉为1.45 g,羧甲基纤维素钠(CMC-Na)为1.22 g,3个指标实验值与模型预测值相比偏差分别是0.36%、1.52%和2.40%。表明实验中建立的模型预测性良好,可较好地描述芳冰鼻吸剂制备工艺中因素与指标的关系,同时采用优化的芳冰鼻吸剂对睡眠剥夺模型的大鼠进行吸入实验,具有良好的镇静助眠效果,这为组分中药吸入制剂的研究提供思路。
To obtain the optimal preparation technology of Fang-bing nasal inhalant from components of traditional Chinese medicine by central composite design, with an apparatus containing nasal inhalant that simulated the expiration and inspiration of nose, the dissolution in vitro of different optimized inhalant samples designed through central composite design were investigated. The accumulative release of linalool, borneol, menthol was detected with GC. Response surface methodology was used to optimize the conditions of preparation technology by establishing multiple linear regression and second-order quadratic models. Then, deviation was carried out through comparing the observed and predicted values. It was showed that the coefficient of correlation of second-order quadratic model was high. The related coefficient reached 0.999 3, 0.998 0, 0.944 9, separately. The optimum conditions of preparation technology were as following： 84.39% of alcohol concentration, the weight of starch 1.45 g and the weight of carmellose sodium （CMC-Na for short） 1.22 g. The deviations between observed and predicated values showed -0.36%, 1.52%, 2.40%, separately. In this experiment, the established model can describe the good relation between factors and indexes from preparation technology of Fang-bing nasal inhalant and the outcome of prediction is well. This optimal Fang-bing nasal inhalant was used to study its in vivo effect on model rats deprived from sleep and showed sedative and sleep aiding, which will bring an instruction on inhalants of components from traditional Chinese medicine.
出处
《药学学报》
CAS
CSCD
北大核心
2013年第4期573-579,共7页
Acta Pharmaceutica Sinica
基金
福建省科技厅资助课题(2012Y0043)
关键词
鼻吸剂
星点设计-效应面法
体外释放
气相色谱
镇静助眠
nasal inhalant
central composite design-response surface method
in vitro dissolution
gaschromatography
sedative sleep
