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目的建立玳玳黄酮滴丸质量评价方法。方法采用薄层色谱法鉴别玳玳黄酮滴丸,并对玳玳黄酮滴丸进行重金属及砷盐的检查;建立高效液相色谱法同时测定玳玳黄酮滴丸主要药效成分柚皮苷和新橙皮苷含量的方法。结果薄层色谱主要成分斑点清晰可见,阴性对照无干扰;玳玳黄酮滴丸重金属及砷盐的限量均小于百万分之十;新橙皮苷在4.088~16.352μg·mL-1内呈良好线性关系,柚皮苷在4.084~16.336μg·mL-1内呈良好线性关系,3批玳玳黄酮滴丸新橙皮苷平均含量分别为75.32,74.82,73.76 mg·g-1,柚皮苷平均含量分别为63.05,63.21,62.07 mg·g-1。结论所建立的鉴别、检查、含量测定方法稳定简便,可有效控制玳玳黄酮滴丸质量。
Objective To establish the quality evaluation method of tortoise shell flavone dropping pills. Methods Thin layer chromatography was used to identify Daitai flavonoids dropping pills, and the test of heavy metals and arsenic salts was carried out on Daitai flavone dropping pills. A HPLC method was established for the simultaneous determination of naringin and naringin Hesperidin content of the method. Results The main components of TLC were clearly visible and the negative control had no interference. The limits of heavy metals and arsenic salts were less than 10 parts per million for toadstool flavonoids dropping pills. Neohesperidin was good in 4.088-16.352μg · mL-1 Linear relationship, naringin in the range of 4.084 ~ 16.336μg · mL-1 showed a good linear relationship, three batches of Daidai Bei flavone pills new hesperidin average content were 75.32,74.82,73.76 mg · g-1, naringin The average contents were 63.05, 63.21 and 62.07 mg · g-1, respectively. Conclusion The established identification, examination, determination of content method is stable and easy, which can effectively control the quality of tortoise shell flavone pills.