目的:以麦冬、五味子等药材为主药的冬奇子口服液,对其进行质量标准和稳定性的研究。方法:采用紫外分光光度法对冬奇子口服液中的成分——黄酮进行含量测定;建立了该制剂中黄酮的含量测定方法。对冬奇子口服液做影响因素实验,测定其在高温、高湿和光照条件下的稳定性。结果:用紫外分光光度计测定黄酮的含量,结果:黄酮的线性范围6~32μg/m L,相关系数r=0.9993,加样平均回收率98.35%(n=5),RSD=1.35%,样品中黄酮的平均含量为20.95%;稳定性实验结果表明,口服液在高温、高湿和光照下稳定。结论:冬奇子口服液质量标准科学可控,制剂稳定。
Objective:Based primarily medicine to Ophiopogon japonicus and Schisandra of DongqiziOral Liquid,carries on the quality specification and stability to it. Methods:Adopted UV spectrophotometry to determine the content of flavonoids,established the method for determination flavonoids of Dongqizi Oral Liquid,and determined its stability at high temperatures,high humidity and light conditions. Results:The result is:the flavanone linear scope is 6~32 μg/m L,correlation coefficient is r=0.9993,adds the type returnsratio is 98.35%(n=5),RSD=1.35%,the flavanone quality score is 20.95% in sample;Experimental results show it is stable under high temperature,humidity and illumination. Conclusion:The quality specification science of Dongqizi Oral Liquid is controllable,and the preparation is stable.