维药肉桂子含量测定方法的建立

Establishment of content determination methods of Uygur medicine Fructus cinnamomi cassiae immaturi

目的建立HPLC测定维药肉桂子中桂皮醛含量的方法,并定性定量测定肉桂子中的挥发油,合理制定肉桂子的含量测定方法。方法采用依利特C_(18)柱(250mm×4.6mm,5μm);以甲醇-水(45∶55)为流动相;流速:1mL·min^(-1);柱温:35℃;检测波长:285nm。肉桂子挥发油定性定量测定参照2010年版《中国药典》和日本药典(JP16)。结果桂皮醛质量浓度在2.45~34.24μg·mL^(-1)范围内(r=0.999 9)线性关系良好,平均加样回收率为104.10%(RSD=1.44%)。肉桂子挥发油含量(mL·g^(-1))为1.00%~2.88%,平均含量为1.62%;肉桂子挥发油的折光率(20℃)为1.50~1.55。肉桂子挥发油的鉴别实验和纯度实验结果均符合日本药典规定。结论建立的HPLC方法简便易行,准确性、重复性好,可作为测定肉桂子中桂皮醛的定量测定方法。肉桂子挥发油含量可纳入肉桂子质量标准含量测定起草项。

Objective To determine the content of cinnamic aldehyde in Fructus cinnamomi cassiae immaturi by HPLC,to qualitatively and quantitatively test the volatile oil of Fructus cinnamomi cassiae immaturi,and to establish a quality standard of Fructus cinnamomi cassiae immaturi.Methods An Elite Hypersil C18column（250mm×4.6mm,5μm）with methanol-water（45∶55）solution as mobile phase was applied for isocratic elution in a flow rate of 1mL·min-1.The detection wavelength was 285 nm and the column temperature was 35℃.The volatile oil was determined according to the methods of Chinese Pharmacopoeia（2010version）and Japanese Pharmacopoeia（16version）.Results The linear relationship was good in the sample concentration range of2.45-34.24μg·mL-1（r=0.999 9）and the average recovery rate was 104.10%（RSD=1.44%）.The content of volatile oil of Fructus cinnamomi cassiae immaturi was 1.00%-2.88%（mL·g-1）with an average of 1.62%.The refractive index of the volatile oil was 1.50-1.55（20 ℃）.Both of the identification test and purity test of volatile oil were complied with the regulations of Japanese Pharmacopoeia.Conclusion This method is simple,accurate and reproducible and can be used to measure the content of cinnamic aldehyde in Fructus cinnamomi cassiae immaturi.The content of volatile oil should be included in the quality standard of Fructus cinnamomi cassiae immaturi under the content determination item.