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目的:以枸杞多糖含量的变化及颗粒表面颜色的变化为指标,采用双波长等吸收法测定枸杞多糖含量,漫反射光谱法测定颜色变化,对七子茶冲剂的制剂稳定性进行了考察。方法:①对颗粒进行了模拟夏季环境试验及光照试验(30℃,3000纳克斯,10日)。②考察了湿度对制剂稳定性的影响(相对湿度92.5%,1月)。③采用多元线性模型法预测七子颗粒剂的有效期,并以经典恒温法为对照。④采用正交试验法考察湿度及温度对颗粒剂稳定性的影响。结果:①分别在高湿度强光照射条件下颗粒剂含量未发生明显变化。②环境湿度愈高,含量下降及颜色变化愈明显,且湿度对颜色变化的影响更大。③七子颗粒剂的有效期为2.87年。④湿度与温度对含量下降均有显著影响。结论:尝试用双指标来评价中药颗粒剂的稳定性,加速试验表明该颗粒剂稳定性较好,可初步认为符合中药稳定性要求。
OBJECTIVE: To determine the polysaccharide content of alfalfa by dual-wavelength absorptiometry and the change of color by diffuse reflectance spectroscopy with the change of alfalfa polysaccharide content and the change of surface color of pellets. The stability of Qizicha granules was investigated. Methods: A simulated summer environmental test and illumination experiment were performed on the particles (30 °C, 3000 NX, 10 days). 2 The effect of humidity on the stability of the formulation was examined (relative humidity 92.5%, January). 3 The multivariate linear model method was used to predict the effective period of Qizi granules, and the classic constant temperature method was used as a control. 4 The orthogonal test was used to investigate the effect of humidity and temperature on the stability of granules. Results: 1 There was no significant change in granule content under high humidity and strong light conditions. 2 The higher the ambient humidity, the lower the content and the more obvious the color change, and the greater the influence of humidity on the color change. The period of validity of Sanqizi Granules is 2.87 years. 4 Humidity and temperature have a significant effect on the content reduction. Conclusion: Two indicators were used to evaluate the stability of traditional Chinese medicine granules. Accelerated tests showed that the granules have good stability and can be initially considered to meet the stability requirements of traditional Chinese medicine.