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目的建立银丁灌肠剂的质量标准。方法采用TLC法鉴别紫花地丁、黄柏;采用HPLC法测定样品中大黄酚、大黄素的含量。结果薄层色谱图斑点清晰,阴性无干扰;大黄素在0.042~1.246μg范围内呈良好的线性关系(r=0.9999),平均回收率为98.93%,RSD为0.85%(n=9);大黄酚在0.244~2.440μg范围内呈良好的线性关系(r=0.9998),平均回收率为98.26%,RSD为0.40%(n=9)。结论测定方法操作简便、结果准确、重复性好,可用于该制剂的质量控制。
Objective To establish the quality standard of Yin Ding enema. Methods The method of TLC was used to identify Viola yedoensis and Phellodendron amurense. The contents of chrysophanol and emodin in the samples were determined by HPLC. Results The echocardiography showed clear spot and no negative interference. The emodin showed good linearity (r = 0.9999) in the range of 0.042-1.246 μg with an average recovery of 98.93% and a RSD of 0.85% (n = 9) Phenol showed a good linear relationship (r = 0.9998) in the range of 0.244 ~ 2.440μg with an average recovery of 98.26% and a RSD of 0.40% (n = 9). Conclusion The determination method is simple, accurate, reproducible and can be used for the quality control of the preparation.