复方苦参泡腾片的质量标准研究

Study on Quality Control Standard of Compound Kushen Effervescent Tablets

目的建立复方苦参泡腾片的质量标准。方法用薄层色谱法对苦参、冰片、蛇床子进行鉴别,并用高效液相色谱法测定苦参碱的含量。结果薄层鉴别色谱斑点清晰,阴性对照无干扰;苦参碱进样量在0.16928～8.464μg范围内与峰面积积分值呈良好线性关系(r=0.9997),平均加样回收率为99.12%,RSD为1.13%(n=6)。结论该方法简单、易行、重现性好,可用于复方苦参泡腾片的质量控制。

Objective To establish the quality standard for Compound Kushen Effervescent Tablets. Methods Radix Sophorae Flavescentis, Bomeol and Fructus Cnidii in Compound Kushen Effervescent Tablets were identified by TLC. The content of matrine was determined by HPLC. Results The specificity and the reappearance of the qualitative identifications were good and the blank experiments had no inter- ference. The linear quantity range of the calibration curve for matrine was 0. 169 28-8.464 μg （r=0. 999 7）.The average recovery was 99. 12% and RSD was 1.13% （ n = 6）. Conclusion The precision and reproducibility of the method are good. The method can be used for the quality control of Compound Kushen Effervescent Tablets.