速康解毒口服溶液的稳定性研究

Study on the stability of Sukang detoxification oral liquid

为了对速康解毒口服溶液整体稳定性进行评价以及计算速康解毒口服溶液贮存的有效期,试验采用温度湿度加速试验、光加速试验和长期稳定性试验对3批中试生产的速康解毒口服溶液中的4种药物成分硫酸镁、正磷酸钠、酵母甘露聚糖、L-鼠李糖的含量变化进行测定,并考察了速康解毒口服溶液形状、色泽、pH值、澄清度和各组分含量的变化。结果表明:3批供试品性状、微生物限度、相对密度、pH值和4种药物成分含量均未见明显变化,并最终根据鼠李糖的稳定性数据确定速康解毒口服溶液贮存有效期为15.67个月。说明速康解毒口服溶液在避光、密封、阴凉的环境中稳定性良好。

To evaluate the overall stability of Sukang detoxification oral liquid and to calculate the stored validity period of Sukang detoxification oral liquid, temperature humidity accelerated test, light accelerated test and long - term stability test were used to determined the changes in the contents of four drugs including magnesium sulfate, sodium orthophosphate, yeast mannose and L - rhamnose in three batches of Sukang detoxification oral liquid produced by pilot test. The shape, color, pH value, clarity and the contents of each component of the oral liquid were also investigated. The results showed that there were no significant changes in the traits, microbiological limit, relative density, pH value and the contents of the four drug components in the three batches of test materials, and the validity period of Sukang detoxification oral liquid was determined as 15.67 months for storage according to the stability data of L - rhamnose. The results indicate that Sukang detoxification has good stability in the dark, sealed, cool environment.