黄芪发酵散剂稳定性的研究

为黄芪发酵散剂的储存条件及有效期的制订提供参考。依据发酵黄芪制剂的性状、粒度、外观均匀度检查、黄芪发酵散剂活菌数、黄芪甲苷含量为检测指标评价不同条件对药剂的影响程度,通过影响因素试验,高温试验,高湿度试验,强光照射试验等方法探究影响该制剂的因素,运用加速试验、长期试验为制订药物有效期做初步预定。经稳定性影响因素试验,发现黄芪散剂易受温度、湿度、光照等条件的影响,且以湿度和温度影响较大,考察项中以粒度、黄芪甲苷含量及活菌数变化明显,粒度易受到湿度的影响,黄芪甲苷及活菌数可受三种因素的影响,为了减少温度、湿度、光线因素对该药剂稳定性的影响,选用铝箔+PE复合包装袋密闭包装为市售包装,并对其进行了加速试验及长期试验,经包装处理后的黄芪发酵散剂稳定性显著提高,粒度均合格,黄芪甲苷含量、活菌数有所下降,但均高于最低限度值。湿度、温度、光线三种因素对黄芪甲苷含量及活菌数均影响较大,在工业生产中应选择隔湿包装,在包装过程中也应控制环境湿度、温度,建议可将黄芪发酵散剂的有效期暂定为2年,使用铝箔+PE复合包装袋密闭包装,室温保存。

Study on The Stability of Astragalus Fermentation Powder

Objective It provides a reference for the formulation of storage conditions and validity period of Astragalus fermentation powder. Method According to the character, particle size, appearance uniformity of fermented Astragalus preparation, the number of live bacteria of Astragalus fermentation powder and the content of astragaloside IV, the influence degree of different conditions on the preparation was evaluated. The factors affecting the preparation were explored through influencing factor test, high temperature test, high humidity test, strong light irradiation test and other methods. Use accelerated test and long-term test to make preliminary reservation for the formulation of drug validity. Result Through the stability influencing factor test, it is found that Huangqi powder is easy to be affected by temperature, humidity, light and other conditions, humidity and temperature have a great influence, In the investigation items, the particle size, astragaloside IV content and viable bacteria number change obviously, and the particle size is easily affected by humidity, Astragaloside IV and viable bacteria count can be affected by three factors, Astragaloside IV and viable bacteria count can be affected by three factors. In order to reduce the influence of temperature, humidity and light on the stability of the drug, aluminum foil + PE composite packaging bag is selected as the commercial packaging, The accelerated test and long-term test were carried out. After packaging, the stability of Astragalus fermentation powder was significantly improved, the particle size was qualified, and the content of astragaloside IV and the number of live bacteria decreased, but they were higher than the minimum value. Conclusion Humidity, temperature and light have a great impact on the content of astragaloside IV and the number of viable bacteria. Moisture proof packaging should be selected in industrial production, and the environmental humidity and temperature should also be controlled in the packaging process. It is suggested that the validity period of Astragalus fermentation powder can be temporarily set as 2 years, sealed packaging with aluminum foil + PE composite packaging bag and stored at room temperature.