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目的:建立乳核分散片质量标准,以更好地控制其质量。方法:采用薄层色谱法鉴别处方中三棱、香附、当归、郁金、蒲公英等药味,运用高效液相色谱法测定制剂中芍药苷、橙皮苷含量。结果:TLC色谱斑点清晰。芍药苷在0.098~0.343 mg·ml~(-1)范围内呈良好线性关系(r=0.999 3),平均回收率98.48%,RSD=1.80%(n=6);橙皮苷在0.032~0.112 mg·ml~(-1)范围内线性关系良好(r=0.999 0),平均回收率98.15%,RSD=1.70%(n=6)。结论:该方法准确、可靠,可用于乳核分散片的质量控制。
OBJECTIVE: To establish a quality standard for dispersible tablets of latex to better control its quality. Methods: TLC, HPLC, HPLC, HPLC method was used to determine the content of paeoniflorin and hesperidin in prescription. Results: TLC chromatogram spots clear. Paeoniflorin showed a good linearity (r = 0.999 3) in the range of 0.098-0.343 mg · ml -1 with an average recovery of 98.48% and a RSD of 1.80% (n = 6) The linear relationship was good (r = 0.999 0) with an average recovery of 98.15% and RSD = 1.70% (n = 6) in the range of mg · ml -1. Conclusion: This method is accurate and reliable and can be used for the quality control of dispersible tablets.