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目的:建立不同基质制备复方南星止痛膏中丁香酚、欧前胡素的含量测定方法,比较制备过程中丁香酚、欧前胡素损失。方法:C18色谱柱(4.6 mm×250 mm,5μm),以甲醇-1%乙酸水溶液进行梯度洗脱(0～30 min,46%A;30～32 min,46%～61%A;32～34 min,61%A;34～42 min,61%～47%A;42～60 min,47%A),检测波长280,300 nm,柱温30℃。以丁香酚、欧前胡素的损失率为指标,比较不同基质制备的3种贴膏剂的优劣。结果:丁香酚和欧前胡素进样量分别在0.018 31～3.662 7,0.013 22～0.528 6μg与峰面积线性关系良好(r=0.999 9)。3种贴膏剂制备过程中欧前胡素损失均较小,丁香酚损失均较大,其中凝胶膏剂制备过程中丁香酚损失最少。结论:建立的含量测定方法准确、稳定、分离效果好,可用于测定3种复方南星止痛贴膏中丁香酚、欧前胡素的含量;复方南星止痛凝胶膏剂优于其他2种基质制备的复方南星止痛贴剂。
OBJECTIVE: To establish a method for the determination of eugenol and imperatorin in compound Nanxin Zhitong cream with different matrixes, and to compare the loss of eugenol and imperatorin during the preparation. METHODS: C18 column (4.6 mm × 250 mm, 5 μm) was eluted with a gradient of methanol-1% acetic acid (0-30 min, 46% A; 30-32 min, 46% -61% 34 min, 42 min, 61% -47% A; 42-60 min, 47% A). The detection wavelength was 280 and 300 nm and the column temperature was 30 ℃. The eugenol and imperatorin loss rate as an index to compare the advantages and disadvantages of three kinds of patch prepared by different matrix. Results: The elution volume of eugenol and imperatorin were 0.018 31 ~ 3.662 7,0.013 22 ~ 0.528 6μg, respectively, and the peak area was linear (r = 0.999 9). In the process of preparation of the three kinds of plasters, the loss of imperatorin was small and the loss of eugenol was larger, and the loss of eugenol was the least during the preparation of the gel plaster. Conclusion: The established method is accurate, stable and can be used for the determination of eugenol and imperatorin in three kinds of compound natal analgesic patches. The preparation of compound ningxing analgesic gel ointment is superior to other two kinds of matrix Auxiliary analgesic compound patch.