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目的:研究鲜鹿茸全成分口腔崩解片的稳定性并测定其临界相对湿度。方法:考察该制剂在高温、高湿、光照和加速实验及长期实验条件下的外观性状、崩解时限、含水量和生物活性等变化,并采用减重法测定其临界相对湿度。结果:影响因素实验结果表明,本制剂在光照条件下性质稳定;高湿显著影响本制剂的外观性状、含水量和崩解时限;高温显著降低其生物活性(P<0.01);加速长期实验条件下制剂的外观性状、含水量和崩解时限与0月相比均发生显著变化,超出了质量标准的要求;减重法测得其临界相对湿度为72.59%。结论:湿度和高温是影响鲜鹿茸全成分口腔崩解片稳定性的关键因素,该制剂应采用防潮包装材料,密封置于相对湿度低于72.59%的阴凉干燥环境下储存,以保证制剂的稳定性和有效性。
Objective: To study the stability of orally disintegrating tablets of fresh antler and to determine its critical relative humidity. Methods: The appearance, disintegration time, water content and bioactivity of the preparation under the conditions of high temperature, high humidity, light and acceleration and long-term experiment were investigated. The critical relative humidity of the preparation was determined by weight loss method. Results: The experimental results of the influencing factors showed that the preparation was stable under light conditions. High humidity significantly affected the appearance, water content and disintegration time of the preparation. High temperature significantly reduced the biological activity (P <0.01). Accelerated long-term experimental conditions The appearance, water content and disintegration time of under formulation all changed significantly compared with that of 0, which was beyond the requirements of quality standard. The critical relative humidity measured by weight loss method was 72.59%. Conclusion: Humidity and high temperature are the key factors affecting the stability of orally disintegrating tablets. The preparation should be packed in moisture-proof packaging material and stored in a cool and dry environment with the relative humidity less than 72.59%, so as to ensure the stability of the preparation Sexuality and effectiveness.