摘要
目的:建立小儿清热速崩片的质量标准。方法:采用 TLC 法对处方中的甘草、黄芩进行定性鉴别,甘草 TLC 法鉴别以乙酸乙酯-甲酸-乙酸-水(15:1:1:1)为展开剂;黄芩 TLC 法鉴别以醋酸乙酯-丁酮-甲酸-水(5:3:1:1)为展开剂;用HPLC 法定量分析麻黄碱的含量,色谱柱为 C_(18)(4.6 mm×150 mm,5 μm),以0.1%磷酸溶液(100 mL 中加三乙胺0.1 mL)-乙腈(99:3)为流动相,检测波长205 nm,流速0.8 mL·min^(-1)。结果:用 TLC 法能检出甘草、黄芩;HPLC 法测定中,盐酸麻黄碱在0.06～2.8 μg的范围内呈良好的线性关系,线性回归方程为 Y=2.99×10~3X-15.9,r=0.9999;平均回收率为99.8%,RSD=0.56%。结论:方法简便、准确,重复性好,能有效控制该制剂质量。
Objective： Set up the quality standard of Xiao＇er Qingre rapidly disintegrating tablets. Method： Qualitative analysis to Radix Glycyrrhizae and Radix Scutellariae of prescription by TLC, the chromatographic conditions for Radix Glycyrrhizae were：a developer of ethyl acetate -formic acid -acetic acid -water（ 15： 1：1：1 ） ;and the chromatographic conditions for Radix Scutellariae were： a developer of ethyl acetate - methyl ethyl ketone - formic acid -water（5： 3： 1：1 ）. Quantitative analysis to the content of ephedrine by HPLC. The chromatographic conditions a- dopted were：C,s column（4. 6 mm × 150 mm,5 μm） ;a mobile phase of 0. 1% phosphoric acid（ add 0. 1 mL triethylamine to 100 mL phosphoric acid） - acetonitrile（99：3 ） and the detection wavelength was 205 nm with a flow rate of 0. 8 mL · min^-1. Results：Radix Glycyrrhizae and Radix Scutellariae could be detected by TLC;The calibration curve of ephedrine hydrochloride was linear over the range of 0. 06 - 2.8μg, and the equation of linear regression is Y=2. 99 × 10^3X - 15.9（r =0. 9999）. The average recovery rate was 99. 8% （ RSD =0. 56% ）. Conclusion：The method is convenient, accurate and have a good reappearance. The preparation＇s quality can be controlled effectively.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第4期516-518,共3页
Chinese Journal of Pharmaceutical Analysis
