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目的建立海生素冻干粉的质量控制方法及其高效液相指纹图谱。方法用茚三酮反应和双缩脲反应对海生素冻干粉进行鉴别;用氮测定法测定海生素冻干粉中的氮含量,并用高效液相色谱法建立海生素冻干粉的高效液相指纹图谱。结果茚三酮反应和双缩脲反应呈阳性,海生素冻干粉中氮含量不低于6.0%,且各批次间样品的指纹图谱一致,冻干粉质量稳定。结论建立的方法分析快速、准确,可用于该制剂的质量控制。
Objective To establish a method for the quality control of marine frozen lyophilized powder and its HPLC fingerprint. Methods The lyophilized powder of sea sapogenin was identified by ninhydrin reaction and biuret reaction. The nitrogen content in freeze-dried sea melanin powder was determined by nitrogen determination method. The lyophilized powder of marine lycopene was established by high performance liquid chromatography. HPLC fingerprints. Results The ninhydrin reaction and the biuret reaction were positive. The nitrogen content of freeze-dried sea melanin powder was not less than 6.0%. The fingerprints of the batches were the same, and the freeze-dried powder was stable. Conclusion The established method is rapid, accurate and can be used for quality control of the preparation.