消炎止咳片质量标准的研究

Quality Standard of Xiaoyanzhike Tablets

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 establish the quality standard of Xiaoyanzhike Tables.Methods TLC method was used in the prescription of stemona root, Platycodon grandiflorum,content by high performance liquid chromatography determination of andrographolide and dehydroandrographolide.Results Stemona root,Platycodon grandiflorum TLC identification effect is good;andrographolide has good linear relationship in the range of 9.021 - 108.250 μg （r=0.9997）;dehydroandrographolide have good linear relation in the range of 10.070-120.840 μg（r=0.9999）; andrographolide the average recovery was 97.9%,RSD was 2.4%,dehydroandrographolide,the average recovery was 98%,RSD was 2%.Conclusion The method is simple,rapid,accurate and reproducible,and can better control the quality of this preparation.