摘要
目的对刺五加总苷片制备工艺进行优选并建立片剂的测定方法。方法采用L9（3^4）正交试验法考察影响片剂制备工艺的各因素（A：淀粉用量;B：糊精用量;C：蔗糖用量）,以多指标综合评分法进行直观分析及方差分析,筛选出符合片剂成型质量要求的处方,并运用高效液相色谱法测定刺五加总苷片中丁香苷的量,对制剂的质量标准进行研究。结果最佳处方为A2B3C1,即刺五加总苷浸膏粉末20 g、淀粉10 g、糊精15 g、蔗糖2 g;以HPLC法测定该片剂中丁香苷的量,方法精密度、稳定性、重现性良好,回收率为98.8%,RSD为0.69%（n=6）。结论此工艺简单易行,稳定可行,适于工业化生产;拟定的质量标准稳定、可靠。
Objective To study the best composition of total eleutheroside tablet and to establish an analysis method of measuring the content of it. Methods The L9 （34） orthogonal table and the multitarget grading method was applied were employed to select the best formulation by means of starch, dextrin, and sucrose as the three main factors in which all factors been selected of three levels. HPLC method was used to determine the content of syringin in total eleutheroside tablet. Results The tablets were successfully prepared in which the drug, starch, dextrin, and sucrose were 20, 10, 15, 2 g, respectively. The analysis method of syringin by HPLC has been established with sufficient accuracy, stability and reappearance. The recovery rate is 98. 80/00, RSD is 0. 69%0（n =6）. Conclusion The preparation technology is simple and repeatable and can be used in industrial production. The quantitative analytic methods are stable and reliable.
出处
《现代药物与临床》
CAS
2008年第3期100-103,共4页
Drugs & Clinic
关键词
刺五加总苷片
正交试验
质量标准
total eleutheroside tablets
orthogonal design
quality control standard
