不同基质制备复方南星止痛贴膏剂的过程中指标成分损失对比  

Comparison on Index Components Loss During Preparation Process of Compound Nanxing Pain Paste Formed with Different Stroma

作　　者：黎迎[1] 杜守颖[1] 刑煜舒[1] 尚可心[1] 萧伟[2,3] 

机构地区：[1]北京中医药大学,北京100102 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室(筹),江苏连云港222001

出　　处：《中国实验方剂学杂志》2013年第7期17-19,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中药制药过程新技术国家重点实验室开放基金课题(SKL2010M0302);北京中医药大学复方中药制药研究创新团队项目(2011-CXTD-13)

摘　　要：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 determining the content of eugenol and imperatorin in compound Nanxing pain paste formed with different stroma, and compare the loss rate of these two components during preparation process. Method： HPLC was adopted performing on a Cls column （4.6 mm x 250 mm, 5 p.m） with a mobile phase of methanol （A） -1% acetic acid （B）, the gradient elution program was as follows： 0-30 rain, 46% A; 30-32 min, 46%-61% A; 32-34 min, 61% A; 34-42 min, 61%-47% A; 42-60 min, 47% A; The detection wavelength was set at 280 and 300 nm, the column temperature was at 30 qC. Quality of these prepared three kinds of paste were comprehensively compared with the loss rate of index components during preparation process as indexes. Result： Eugenol was linear in the range of 0. 018 31-3. 662 7 Ixg （r = 0. 999 9）, imperatorin was linear in the range of 0. 013 22-0. 528 6 μg （r =0. 999 9）. The loss rate of eugenol in compound Nanxing pain paste formed with different stroma were all large, however the loss rates of imperatorin were all small. Then the loss rates of eugenol in gel ointment of compound Nanxing pain paste were all smaller than solvent and emulsion transdermal patch of compound Nanxing pain paste. Conclusion： This established determination method was accurate and had satisfactory efficacy, it could determine the content of eugenol and imperatorin in these three kinds of compound Nanxing pain paste, and compound Nanxing pain gel ointment was more superior to be prepared as patch.

关 键 词：复方南星止痛膏 凝胶膏剂 溶剂型压敏胶贴剂 乳液型压敏胶贴剂 丁香酚 欧前胡素 HPLC 

分 类 号：R283.6[医药卫生—中药学]