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目的建立菊冰鼻腔喷雾剂的质量标准。方法采用薄层色谱(TLC)法对制剂中川芎、冰片、菊花3味中药进行定性鉴别,采用高效液相色谱(HPLC)法对制剂中阿魏酸含量进行测定。结果 TLC法能检出川芎、冰片、菊花,斑点清晰,且阴性对照无干扰;HPLC法测定阿魏酸在0.02458～0.36870μg之间呈现良好的线性关系,r=0.9999;平均加样回收率为100.75%,RSD=0.91%。结论所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,能有效地控制菊冰鼻腔喷雾剂的质量。
Objective To establish the quality standard of chrysanthemum nasal spray. Methods Chuanxiong, borneol and chrysanthemum were identified by thin layer chromatography (TLC). The contents of ferulic acid in the preparations were determined by high performance liquid chromatography (HPLC). Results Chuanxiong, borneol and chrysanthemum could be detected by TLC method. The spots were clear and there was no interference in the negative control. The HPLC method showed a good linear relationship between ferulic acid and 0.02458 ~ 0.36870μg, r = 0.9999. The average recoveries were 100.75%, RSD = 0.91%. Conclusion The established qualitative and quantitative detection methods are simple, accurate and reliable, reproducible, and can effectively control the quality of daisy nasal spray.