复方银杏叶胶囊质量控制方法研究

目的建立复方银杏叶胶囊的质量控制方法。方法供试品经盐酸水解法前处理，采用高效液相色谱法测定银杏总黄酮醇苷含量。结果槲皮素、山柰素、异鼠李素色谱峰分离良好（R〉1．5），供试品其他组分对其均无干扰，线性回归方程分别为Y1=43．75X1-34．30（r1=0．9998），Y2=43．96X2—18．66（r2=0．9998），Y3=41．67X3-35．72（r3=0．9999）；峰面积RSD分别为1．54％，1．85％，1．63％（n=5），平均回收率分别为99．21％，99．38％，99．24％。结论该方法重现性好，灵敏度高，可以作为复方银杏叶胶囊的质量控制方法。

Study on Method of Quality Control for Compound Ginkgo Biloba Capsules

Objective To establish a method for quality control of compound ginkgo biloba capsules.Methods After precondition of the tested products by hydrochloric acid hydrolysis,the total flavonoids glycosides was determined by HPLC.Results Quercatin (Q),kaempferide(K),isorhamnetin (I) had good chromatographic peak separation (R > 1.5).Other components of the test materials for Q,K,I did not interfere. The linear regressive equations were as follows:Y1=43.75X1-34.30(r1=0.999 8),Y2=43.96X2-18.66(r2=0.999 8),Y3=41.67X3-35.72(r3=0.999 9);peak area relative standard deviations (RSD,n=5) were 1.54% ,1.85% ,1.63% ; the average recovery rates were 99.21% ,99.38% ,99.24% ,respectively.Conclusion The method is reproducible,sensitive:it can be used for the quality control of compound ginkgo biloba capsules.