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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(R2=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。
Xiangshayangwei pills as a model drug, using time domain reflectometry of water content of pills. The effects of factors such as spreading layer of pills, packing density of pellets, ambient humidity, temperature and pellet formulation on the determination of pellet moisture were investigated. The results showed that two factors affecting the test of water content of pellets, such as the number of spreading layers and ambient temperature, had significant effects on the pellet moisture test. However, the pellet packing density, ambient humidity and pellet proportion had no significant effect on pellet moisture test. When the six layers of the pill spread, the reflection value is stable. The water content is between 4.01% and 22.38% when the ambient temperature is 25 ℃ and the humidity is 45%. The linear relationship between the water content and the reflection value of Xiangsha Yangwei Wan is good Y = 0.279X-21.670 (R2 = 0.997 0). The results of the verification experiments show that the prediction model is accurate and the precision of the method meets the methodological standards. It is feasible to determine the moisture content of Xiangshayangwei pills by time-domain reflectometry. The method has the advantages of fastness and high efficiency, provides a new way for the rapid determination of moisture in the pharmaceutical process, and has the promotion value in the determination of the moisture content of the Chinese medicine concentrated pill.