小儿消积丸定性定量检测方法研究

Study on quality and quanlitative specification of Xiao’er Xiaoji pills

目的:研究小儿消积丸定性定量检测方法。方法:采用 TLC 法对处方中的大黄、香附、牵牛子、槟榔4种药材进行定性鉴别;采用 HPLC 法对处方中大黄的大黄素和大黄酚进行了含量测定。保护柱:Symmetry-C_(18)(4.6mm×20mm,5μm);分析柱:Kromasil-C_(18)(4.6mm×150mm,5μm);流动相:甲醇-0.1%磷酸溶液(85:15);流速:1mL·min^(-1);检测波长:254nm;柱温:室温。结果:大黄素在2.06～65.92μg·mL^(-1)范围内线性关系良好,r=0.9995,平均回收率为98.6%,RSD 为1.7%;大黄酚在2.14～68.48μg·mL^(-1)范围内线性关系良好,r=0.9993,平均回收率为98.1%,RSD 为1.4%。结论:本法准确、可靠地进行定性、定量检测,能有效控制小儿消积丸的质量。

Objective：To develop qualitative and quantilitative methods for the quality control of Xiao＇er Xiaoji pills. Methods： Radix et Rhizoma Rhei, Rhizoma Cyperi, Semen Pharbitidis and Semen Arecae in the pills were identified by TLC. The content of emodin and chrysophanol was determined by HPLC. A Kromasil C is column（4. 6 mm ×150 nm,5 μm） was used with mobile phase of CH3OH-0. 1% H3PO4（85： 15） and flow rate of 1 mL ·min^-1 The detection wavelength was set at 254 nm and the column temperature at room temperature. Results： The spots of samples on TLC showed well separated patterns. The linear ranges for emodin and chrysophanol were 2. 06 -65.92 μg · mL^-1 and 2. 14 -68.48 μg · mL^-1 respectively. The average recovery of emodin was 98.6% and RSD was 1.7% ;The average recovery of chrysophanol was 98.1% and RSD was 1.4%. Conclusion： The methods are simple, specific and accurate. They can be used for qualitative control of Xiao＇er Xiaoji pills.