论文部分内容阅读
目的:建立复方白头翁汤结肠缓释片的质量标准。方法:采用TLC对制剂中的白头翁、黄连和黄柏、秦皮进行定性鉴别;采用HPLC测定制剂中白头翁皂苷B4和盐酸小檗碱的含量。结果:白头翁、黄连和黄柏、秦皮薄层图谱斑点清晰,分离效果好,专属性强,限性对照无干扰;白头翁皂苷B4在0.60～6.00μg呈良好的线性关系,r=0.999 9,平均加样回收率100.08%,RSD 0.19%;盐酸小檗碱在0.135～1.350μg呈良好的线性关系(r=0.999 9),平均加样回收率为99.25%,RSD0.58%。结论:建立的定性、定量方法简单、重复性好,结果准确可靠,可作为复方白头翁汤结肠缓释片的质量控制方法。
Objective: To establish the quality standard of Pulsatilla Compound Colon Sustained Release Tablets. Methods: TLC, Pulsantum, Coptis chinensis and Cortex Phellodendri, Qin skin were identified qualitatively by HPLC. The content of Pulsatilla saponin B4 and berberine hydrochloride in the preparation was determined by HPLC. Results: The spots of Pulsatilla, Coptis chinensis and Phellodendron chinense were significantly clear spots with good separation effect and specificity, and no interference was found in the control. Pulsatilla saponin B4 showed a good linear relationship at 0.60 ~ 6.00μg, r = 0.999 9, The recovery rate was 100.08% with RSD 0.19%. Berberine hydrochloride showed a good linearity (r = 0.999 9) at 0.135-1.350 μg with an average recovery of 99.25% and RSD 0.58%. Conclusion: The established qualitative and quantitative methods are simple, reproducible, and the results are accurate and reliable, which can be used as a quality control method for Pulsatilla Decoction sustained-release tablets.