肾宁片质量标准研究

Study on Quality Standard for Shenning Tablet

目的:建立肾宁片的质量标准。方法:采用薄层色谱(TLC)法对肾宁片中益母草、大黄、栀子、黄柏进行定性鉴别;采用高效液相色谱法测定栀子苷、芍药苷的含量。结果:TLC可鉴别出益母草、大黄、栀子、黄柏相对应的斑点。栀子苷、芍药苷的进样量分别在0.032 2～0.386 4μg(r=0.999 9)、0.041～0.492μg(r=0.999 9)范围内与各自峰面积积分值呈良好的线性关系;二者平均回收率分别为101.09%、100.08%,RSD分别为0.54%(n=6)、1.28%(n=6)。结论:所建标准可用于肾宁片的质量控制。

OBJECTIVE： To establish a quality standard for Shenning tablet.METHODS： Leonurus japonicus, Radix et Rhizoma Rhei, Gardenia jasminoides, Phellodendron chinense in Shenning tablet was identified by TLC.The contents of Jasminoidin and Peoniflorin in Shenning tablet were determined by HPLC.RESULTS：The relevant spots in Leonurus japonicus, Radix et Rhizoma Rhei, Gardenia jasminoides, Phellodendron chinense were identified by TLC.The linear ranges of Jasminoidin and Peoniflorin were 0.032 2-0. 386 4 μg（ r = 0. 999 9） and 0.041-0.492μg（ r = 0.999 9）, respecctively, with average recovery rates at 101.09 % and 100.08 %, respectively and RSD at 0.54% and 1.28%, respectively （ n = 6） . CONCLUSION ： The established quality standard is suitable for the quality control of Shenning tablet.