摘要
以ODPs为原料,采用正交试验确定口服液中关键成分的配比及制备工艺条件,并采用强光照射、高温、Rogers加温加速试验对口服液的稳定性进行研究.得出ODPs口服液的最佳灭菌条件为灭菌功率700W、灭菌时间9min;最佳处方(以1L口服液计)为ODPs 10g,甜菊糖0.64g,尼泊金混合酯0.025 6g,各项主要质量指标符合口服液制剂法定质量标准.ODPs口服液对光照不敏感,无需避光保存;高温试验、Rogers法测得ODPs口服液的t0.9为5.4h,说明在高温条件下,其稳定性较差,应低温储存.
To prepare the ODPs oral solution and to provide a reference for the industrialization of ODPs.The key components and the preparation process of the ODPs oral solution were determined by orthogonal test.The strong light,high temperature and Rogers nonisothermal accelerative test were employed to study the stability of the ODPs oral solution.The optimal sterilization conditions using a microwave were 700 W（power）,9 min（time）;the optimal prescription was 10 g·L-1 of ODPs,0.64 g·L-1 of the stevioside,0.025 6 g·L-1 of the mixed parabens.the main indexes meet the statutory quality standards of the oral solution.The illumination did not affect the quality of ODPs oral solution.The expiry of the ODPs oral solution tested by Rogers method was 4.5 h,so it should be stored under a low temperature condition.
出处
《湛江师范学院学报》
2011年第6期125-131,共7页
Journal of Zhanjiang Normal College
基金
广东省自然科学基金资助项目(8152404801000011)
湛江市科技计划项目(2011D032)
关键词
仙人掌多糖
正交试验
口服液
Opuntia dillenii Haw.polysaccharides
orthogonal test
oral solution
