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目的针对糖尿病视网膜病变的发病机制,对有效治疗糖尿病视网膜病变的正元芸生滴丸的成分含量和稳定性进行实验研究。方法采用薄层色谱法高效液和相色谱法对滴丸成分进行定性鉴别和定量测定,并通过对质量标准中关键项目检测确定滴丸稳定性。结果薄层色谱法对制剂中的当归、川芎、桃仁、红花、牛膝、桔梗、生地黄定性鉴别薄层色谱斑点显示清晰,阴性对照无干扰;高效液相色谱法对制剂中的芍药苷定量分析显示芍药苷在0.05～0.25μg之间呈良好的线性关系。平均回收率为98.96%,RSD为0.8%(n=5)。结论正元芸生滴丸的成分含量明确,滴丸稳定性符合临床要求及药典规定。
Objective To investigate the pathogenesis of diabetic retinopathy and to study the composition and stability of Zhengyuan Yunsheng pills effectively treating diabetic retinopathy. Methods The components of dropping pills were identified and quantified by TLC and HPLC. The stability of dropping pills was determined by the detection of key items in the quality standard. Results TLC showed that TLC spots of Angelica sinensis, Rhizoma chuanxiong, Peach kernel, Safflower, Achyranthes bidentata, Campanulaceae and Radix Rehmanniae showed TLC clearly and negative control had no interference. HPLC assay showed that Paeoniflorin Quantitative analysis showed that paeoniflorin showed a good linear relationship between 0.05 ~ 0.25μg. The average recovery was 98.96% with a RSD of 0.8% (n = 5). Conclusion ZhengYuanYunSheng dripping pill has clear ingredients, dripping pill stability accords with clinical requirement and pharmacopoeia regulation.