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目的:建立润肠丸(水蜜丸)的质量标准。方法:采用TLC法对处方中的羌活、大黄、当归进行了定性鉴别;用RPHPLC法测定了大黄素、大黄酚的含量。结果:在TLC图谱中可检出羌活、大黄、当归的特征斑点;大黄素在0.011～0.110μg范围内呈良好的线性关系,r=0.999 6;大黄酚在0.020～0.204μg范围内呈良好的线性关系,r=0.999 5。结论:所建立的方法可行、重复性好,能有效的控制该制剂的质量。
Objective: To establish the Runchang pill (water pill) quality standards. Methods: The prescriptions of Notopterygii, Rhubarb and Angelica were identified by TLC. The contents of emodin and chrysophanol were determined by RPHPLC. Results: The characteristic spots of Notopterygii, Rhubarb and Angelica were found in TLC. Emodin showed a good linear relationship in the range of 0.011 ~ 0.110 μg, r = 0.999 6. The results showed that the content of chrysophanol in the range of 0.020 ~ 0.204 μg was good Linear relationship, r = 0.999 5. Conclusion: The established method is feasible, reproducible, and can effectively control the quality of the preparation.