摘要
目的考察吐温-80对阿司匹林干混悬剂质量稳定性的影响,为药物贮存和使用提供合理依据。方法参考《中国药典》2015版(二部),采用加速试验对阿司匹林干混悬剂进行稳定性考察,重点考察项目是性状、含量、沉降体积比、有关物质和再分散性。结果阿司匹林干混悬剂在40±2℃、75±5%相对湿度的条件下,3个月内稳定性较好,半年内稳定性不佳。与空白组(不加吐温-80)相比,制剂百分含量、有关物质含量和沉降体积比的差别均无统计学意义。结论吐温-80对阿司匹林干混悬剂稳定性的影响不显著。
Objective To investigate the influence of Twain-80 on the stability of aspirin for suspension, and provide reasonable basis for its storage and application. Metfiods Referring to the “Chinese pharmacopoeia” 2015 edition （Section 2）, accelerated test was used to study the stability of aspirin for suspension, including its character, content, sedimentation volume, relative substances and dispersion. Results Aspirin for suspension showed good stability in the first 3 months, but poor in 6 months at 40±20C and RH75±5%. Compared with the blank group （without Twain -80） , there was no significant difference in the content of the preparation, the content of the substance and the volume ratio of sedimentation. Condusion Twain-80 had almost no influence on stability of aspirin for suspension.
出处
《佛山科学技术学院学报（自然科学版）》
CAS
2017年第2期84-88,共5页
Journal of Foshan University(Natural Science Edition)
基金
佛山科学技术学院2015年度省级大学生创新创业训练计划(201511847023)
