时域反射法测定香砂养胃丸水分的应用研究

Application of time domain reflectometry for determination of wate content in Xiangsha Yangwei pills

以香砂养胃丸为模型药物,采用时域反射法测定药丸的含水量。考察了药丸铺展层数、药丸装填密度、环境湿度、温度和药丸配方等因素对药丸水分测定结果的影响。结果表明,药丸铺展的层数、环境温度2个因素对药丸水分测试的影响显著,而药丸装填密度、环境湿度以及药丸配方比例对药丸水分测试的影响不显著。当药丸铺展6层时,反射值较为稳定,在气候箱内环境温度25℃、湿度45%时,含水量在4.01%~22.38%,香砂养胃丸水分与反射值线形关系良好,方程式为Y=0.279X-21.670（R^2=0.997 0）。通过验证实验证明,该预测模型准确,该方法精密度达到方法学标准,用时域反射法来测定香砂养胃丸的含水量是可行的。该方法具有快速,高效等优势,为制药过程中的快速水分测定提供了新途径,在中药浓缩丸水分测定中具有推广价值。

Xiangsha Yangwei pill was selected as a model drug in this research, and time domain reflectometry （TDR） was used to determine the water content in the pill. The effects of five factors including the number of pill layers, pill packing density, atmospheric moisture, ambient temperature and the ratio of pill formula were investigated on water content. The results showed that the number of pill layers and ambient temperature had significant effects on water content of pills, while the pill packing density, atmospheric mois- ture and pill formula ratio had little effect on the determination of water content in pills. The reflection value was stable when 6 layers of pills were used. Under the condition of 25 ℃ and 45 % relative humidity, the water content of pills ranged from 4. 01% to 22. 38%, showing good linear relationship between water content and reflection value, and the model equation was as follows ： Y = 0. 279X - 21. 670 （R^2 = 0. 997 0）. Verification experiment was used to explain the feasibility of this prediction model. The precision of the meth- od complied with the methodology standard. It is concluded that TDR can be used in determination of water content in Xiangsha Yang- wei pills. Additionally, TDR, as a new way to quickly and efficiently determine the water content, has a prospect application in the processing of traditional Chinese medicine pharmacy, especially for concentrated pill.