摘要
为了确定巢脾多糖片的处方工艺,采用硫酸—苯酚法处理多种辅料,筛选出对含量测定无影响的无水磷酸氢钙、交联聚维酮、PVPK30分别作为填充剂、崩解剂、黏合剂。以上述辅料用量及压片压力为考查因素设计L_9(3~4)正交试验,采用综合评分法得出最佳处方工艺:巢脾多糖22%,无水磷酸氢钙52%,交联聚维酮10%,15%PVPK30-90%乙醇15%,硬脂酸镁1%,压片压力4.2 N。在最佳处方工艺条件下制备3批样品,其脆碎度、崩解时限、重量差异均合格,平均含量达到97%以上,10 min累积溶出度达90%以上。表明该处方条件制备工艺合理可行。
In order to determine the prescription process of honeycomb polysaccharide tablets, a method of sulfuric acid - phenol was used to treat a variety of pharmaceutic adjuvants, and the CaHPO4, PPVP and PVPK30 which had no interferences on determination of honeycomb polysaccharide content were screened to serve as diluent agent, disintegrating agent and binder, respectively. Furthermore, using the doses of pharmaceutic adjuvants and the tableting pressure as indices, the prescription was screened by L9 （34） orthogonal test combined with comprehensive scoring method. The results showed that the optimized prescription process was 22% of honeycomb polysaccharide, 52% of CaHPO4, 10% of PPVP, 15% of PVPK30 （15%） - ethanol （90%）, 1% of magnesium stearate, and 4.2 N of tableting pressure. Under this condition, three batches of samples were successfully prepared, and the friability, disintegration time limit and weight variation of them were all qualified. In addition, the average content of honeycomb polysaccharide was all above 97% and the ten-minute accumulative dissolution reached up to 90%. In conclusion, the optimized process was demonstrated to be reasonable and feasible.
作者
时菲菲
陈倩
殷玲
SHI Fei-fei,CHEN Qian,YIN Ling(Jliangsu Agri-animal Husbandry Vocational College,Taizhou 225300,China)
出处
《畜牧与饲料科学》
2018年第6期8-12,共5页
Animal Husbandry and Feed Science
基金
国家自然科学基金青年基金项目(31502020)
江苏农牧科技职业技术学院重点科研课题(NSFRC1401)
江苏农牧科技职业技术学院科研课题(NSFPT201719)
企业横向合作课题(00010115004)
关键词
巢脾多糖
正交试验
处方工艺
质量控制
honeycomb polysaccharide
orthogonal test
prescription process
quality control
