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目的分析并建立苍辛滴鼻液的质量检测控制标准。方法采用TLC法对方中苍耳子、盐酸麻黄碱进行定性鉴别。用HPLC法测定方中盐酸麻黄碱含量,采用Shim-Pack CLC ODS柱(150×4.6mm,5μm),以乙睛-0.1%磷酸溶液(10∶90)为流动相,柱温25℃,流速为1.0ml/min,检测波长为207nm。结果薄层鉴别的色谱斑点清晰,特征斑点对应性强,阴性对照无干扰。盐酸麻黄碱在36.26μg/ml～181.30μg/ml范围内呈良好的线形关系(r=0.9996,n=5),平均回收率为98.89%,RSD 0.27%。结论本研究建立的TLC和HPLC法专属性强、灵敏度高、重现性好,可用于苍辛滴鼻液的质量控制。
Objective To analyze and establish the quality control standard of Cingxin nasal drops. Methods TLC method for the other side Xanthium, ephedrine hydrochloride qualitative identification. The HPLC method was used to determine the content of ephedrine hydrochloride. The mobile phase was acetonitrile-0.1% phosphoric acid solution (10:90) with a Shim-Pack CLC ODS column (150 × 4.6 mm, 5 μm) 1.0ml / min, detection wavelength of 207nm. Results TLC identification of clear spots, characteristic spot correspondence strong, negative control without interference. Ephedrine hydrochloride showed a good linear relationship (r = 0.9996, n = 5) in the range of 36.26μg / ml ~ 181.30μg / ml with the average recovery of 98.89% and RSD 0.27%. Conclusion The TLC and HPLC methods established in this study are of high specificity, high sensitivity and good reproducibility and can be used for the quality control of Cingxin nasal drops.