纯阳正气胶囊挥发油的质量标准研究

目的 建立纯阳正气胶囊挥发油的质控方法。方法 采用GC法建立挥发油的特征图谱，并测定桂皮醛与丁香酚的含量。结果 15批样品中确定了19个共有峰，指认了峰的归属，选取了9个特征峰建立了特征图谱。桂皮醛与丁香酚分别在0.522～1.565 mg/ml(r=0.999 4)和3.038～9.115 mg/ml(r=0.999 7)范围内线性良好，平均回收率分别为97.1%和97.3%,RSD分别为1.5%、1.4%。结论 所建立的GC特征图谱及含量测定方法可从定性和定量两方面控制纯阳正气胶囊挥发油的质量，方法准确、可行，可作为纯阳正气胶囊挥发油的质量控制方法。

Study on quality standards of volatile oil of Chunyang Zhengqi capsules

Objective To establish a quality control system of volatile oil of Chunyang Zhengqi capsules. Methods The chromatogram of volatile oil was established by GC method, and the contents of cinnamaldehyde and eugenol were determined. Results In 15 batches of samples, 19 common peaks were identified, and 9 characteristic peaks were selected to establish the characteristic spectrum. The linear ranges of cinnamaldehyde and eugenol were 0.522 - 1.565 mg/ml (r=0.9994) and 3.038 - 9.115 mg/ml (r=0.9997), respectively. The average recoveries were 97.1% and 97.3%, with RSD of 1.5% and 1.4%, respectively. Conclusion The established GC characteristic map and content determination method could control the quality of essential oil in Chunyang Zhengqi capsules qualitatively and quantitatively. The method is accurate and feasible which could be used as the quality control method of essential oil in Chunyang Zhengqi capsules.