祛腐再生膏的质量标准研究

Study on quality standard of Qufuzaisheng ointment

目的：提高祛腐再生膏的质量标准,更好地控制产品质量.方法：采用薄层色谱法（TLC）对该制剂中当归和白芷药材进行定性鉴别;采用高效液相色谱法（HPLC）测定制剂中藁本内酯的含量,色谱条件：色谱柱为Diamonsil C18柱（200 mm ×4.6 mm,5μm）;流动相为甲醇-0.05%三氟乙酸水（58∶42）;流速为1.0 mL·min-1;检测波长为328 nm;柱温为30℃.结果：薄层色谱法可检出当归和白芷,斑点清晰,分离度好,阴性无干扰;藁本内酯在0.0406~2.03μg范围内与峰面积呈良好的线性关系（r=0.9998）,藁本内酯的平均回收率为98.26%,RSD=2.48%（n=9）.结论：本文方法简便、专属性好、准确,可作为祛腐再生膏的质量控制标准.

Objective： To establish the quality standard of Qufuzaisheng ointment for scientific evaluation and effective control quality. Methods： Radix Angelicae Sinensis and Radix Angelicae Dahuricae were identified by TLC. The content of ligustilid was determined by HPLC. Diamonsil C18 column （200 mm × 4.6 mm, 5μm） was used and the mobile phase was a mixture of methanol-0.05% trifluoroacetic acid solution （58 ： 42）, with column temperature at 30 %. The flow rate was 1.0 mL.min-~ and the detection wavelength was 328 nm. Results： Radix Angelicae Sinensis and Radix Angelicae Dahuricae could be detected by TLC and the spots were clear and distinguished well. The linear curve of ligustilid was shown in the range of 0.040 6 - 2.03μg （r = 0.999 8）. The average recovery of ligustilid was 98.26%, RSD = 2.48% （ n = 9）. Conclusion： This method is simple, specific and accurate, it can be used for the qulity control of Qufuzaisheng ointment.