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目的:建立小儿清肺分散片的质量标准。方法:采用TLC法对制剂中的百部、地龙、麦冬进行定性鉴别研究;采用HPLC-ELSD法测定制剂中桔梗皂苷D的含量;采用HPLC-UV法,测定制剂中黄芩苷的含量。结果:TLC法可鉴别出百部、地龙、麦冬的特征斑点,专属性强,重复性好;桔梗皂苷D浓度在43~430μg·m L﹣1范围内与峰面积呈良好的线性关系(r=0.999 6),平均回收率为100.72%(n=6),RSD=0.99%;黄芩苷浓度在0.02~0.1 mg·m L-1范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为100.90%(n=6),RSD=2.91%。结论:本方法操作简便,结果准确,重复性好,可作为小儿清肺分散片的质量控制标准。
Objective: To establish the quality standard of Qingfei dispersible tablets. Methods: TLC method was used to determine the content of platycodin D in Radix Angelicae Sinensis, Rhizoma Anemarrhenae and Radix Ophiopogonis. HPLC-ELSD was used to determine the content of Platycodin D. The content of baicalin in the preparations was determined by HPLC-UV method. Results: TLC method could identify the characteristic spots of Radix Bupleuri, Radix Rehmanniae and Radix Ophiopogonis, with strong specificity and good repeatability. Platycodin D had a good linear relationship with the peak area in the range of 43-430 μg · m L-1 (r = 0.999 6). The average recovery was 100.72% (n = 6) and RSD was 0.99%. The concentration of baicalin showed a good linear relationship with the peak area in the range of 0.02-0.1 mg · m L-1 (r = 0.999 9) with an average recovery of 100.90% (n = 6) and RSD = 2.91%. Conclusion: The method is simple, accurate, reproducible and can be used as a quality control standard for children Qingfei dispersible tablets.