漫反射光谱法定量考察宣肺清热颗粒剂的颜色变化

Investigation on the Quantity of Xuanfeiqingre Granules by Diffuse Reflectance Spectroscopy

目的宣肺清热颗粒剂表面颜色变化为指标,采用漫反射光谱法定量考察颜色变化,预测有效期。结果与含量为考察指标时预测的有效期进行比较,对清热解毒颗粒剂的制剂稳定性进行多指标综合评价。为漫反射光谱法在中药稳定性考察中的应用提供实验依据。方法采用加速实验法对颗粒剂热稳定性进行试验研究,用漫反射光谱法测定不同温度、不同时间段颜色变化。根据Remission函数值θ求相应的浓度C并用Arrhenius公式处理数据。结果与含量变化为指标时的结果进行比较。结果环境温度越高颜色变化越明显。颜色变化为指标预测颗粒剂25℃室温下的有效期为0.5年。在不同温度、不同时间段的颜色变化指标比含量变化指标更明显。结论尝试用多指标评价中药颗粒剂的稳定性,颜色变化为指标定量考察稳定性,预测有效期比含量变化为指标预测有效期短。在样品处理中无需进行破坏。

OBJECTIVES To estimate the shelf life of Xuanfeiqingre granules by diffuse reflectance spectroscopy （DRS） and compare the result with quantity control of other varieties of indexes ephedrine, hesperidins and glycyrrhizic acid in this granule as determined by RP-HPLC. To give a base for predicting the granule＇s shelf life and optimize the usage of DRS in Chinese medicine stability research. METHODS The dosage form was deposited at different temperatures and the colors of Xuanfeiqingre were determined by the DRS method at different times to obtain a quantitative color measurement. The converse result of the obtained remission function θ, was applied to the content of this granule according to each condition and then the Arrhenius formula was used to acquire the shelf life by the contents of the above. The result was compared with the result obtained by the quantity control of other varieties of indexes ephedrine, hesperidins and glycyrrhizic acid in this granule determined by RP-HPLC. RESULTS The color of these granules changed significantly according to the temperature condition. The activating energies of different indexes was calculated based on the Arrhinius formula and the shelf-life determined by DRS was predicted as 0.5 year. The results of color index at different times and temperatures are more significant than the quantity control of other varieties of indexes. CONCLUSION By using a variety of indexes to estimate the stability of Xuanfeiqingre granules, the shelf life obtained with DRS was found to be shorter than with other quantity control results. DRS is a non-destructive analysis method.