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目的建立中药复方制剂陈皮姜软胶囊的质量标准。方法采用TLC法鉴别陈皮姜软胶囊中干姜;用高效液相色谱法对制剂中6-姜酚进行定量分析。结果定性鉴别分离度好,专属性强;6-姜酚的含量测定线性范围为42.08~420.8μg·m L-1(r=0.9998,n=6),平均回收率为100.80%(RSD=1.33,n=6)。结论所建立之方法准确可靠、灵敏度高、专属性强,可有效控制陈皮姜软胶囊的质量。
Objective To establish the quality standard of traditional Chinese medicine compound Chenpi ginger soft capsule. Methods TLC method was used to identify dried ginger in Chenpi Ginger soft capsule. Quantitative analysis of 6-Gingerol in the preparation was performed by high performance liquid chromatography. The results showed that the method of qualitative identification was good and the specificity was good. The linear range of determination of 6-gingerol was 42.08-420.8μg · m L-1 (r = 0.9998, n = 6) with an average recovery of 100.80% (RSD = 1.33 , n = 6). Conclusion The established method is accurate, reliable, sensitive and specific, which can effectively control the quality of Chenpi ginger soft capsule.