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目的建立积贝消肿胶囊指纹图谱及其含量测定的方法。方法样品经过甲醇超声提取后,过滤、进液相色谱仪测定,采用Alltech C18色谱柱分离;梯度洗脱;流速:1.0 m L·min-1;检测波长:205 nm;柱温:30℃。结果在指纹图谱中标示了15个共有峰,以5号峰为参照峰,2、3、6号峰面积接近或大于总峰面积的10%。并对色谱峰中主要的皂苷类成分进行了含量测定,在0.160~0.800 mg·L-1浓度范围内,线性相关系数r>0.9996,回收率均>98%,方法学考察结果符合建立指纹图谱的技术要求及含量测定要求。结论应用HPLC指纹图谱结合主要皂苷类成分含量测定可以更好地控制积贝消肿胶囊制剂的质量。
Objective To establish the method of measuring the fingerprint of Jibei Qiaozhong Capsule and its content determination. Methods After the sample was extracted by methanol, it was filtrated and measured by liquid chromatography. Alltech C18 column was used for gradient elution. The flow rate was 1.0 m L · min-1. The detection wavelength was 205 nm. The column temperature was 30 ℃. Results Fifteen common peaks were identified in the fingerprints. Peaks 5, 6 were close to or greater than 10% of the total peak area. The main saponins in the chromatographic peaks were determined. The linear correlation coefficient (r) was 0.9996 and the recoveries were both> 98% in the range of 0.160-0.800 mg · L-1. The methodological results were in line with the established fingerprint The technical requirements and content determination requirements. Conclusion The application of HPLC fingerprinting combined with the determination of the main components of saponins can better control the quality of Jibei Qiaozhong Capsule preparation.