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目的探讨消炎止咳片的质量控制标准。方法采用薄层色谱法鉴别方中百部、桔梗,采用高效液相色谱法测定穿心莲内酯和脱水穿心莲内酯的含量。结果百部、桔梗薄层鉴别效果好;穿心莲内酯9.021~108.250μg,具有良好的线性关系(r=0.9997),脱水穿心莲内酯10.070~120.840μg,具有良好的线性关系(r=0.9999);穿心莲内酯平均回收率为97.9%,RSD为2.4%,脱水穿心莲内酯平均回收率为98.0%,RSD为2.0%。结论该方法简单、快速、准确、重现性好,能够较好地控制该制剂的质量。
Objective To investigate the quality control standard of anti-inflammatory cough tablet. Methods TLC and HPLC were used to identify Radix Bupleuri and Platycodon, and the contents of andrographolide and dehydroandrographolide were determined by high performance liquid chromatography. Results There was a good linear relationship between the concentrations of andrographolide (9.021 ~ 108.250μg, r = 0.9997) and dehydroandrographolide 10.070 ~ 120.840μg (r = 0.9999). The average recovery of andrographolide was 97.9% with RSD of 2.4%. The average recovery of dehydroandrographolide was 98.0% and the RSD was 2.0%. Conclusion The method is simple, rapid, accurate and reproducible, which can control the quality of the preparation better.