复方桑菊清热口服液的质量控制研究

目的 建立复方桑菊清热口服液的质量控制方法并考察其稳定性.方法 采用高效液相色谱法测定绿原酸和连翘苷的含量,色谱柱为YMC- Pack ODS-AQ L1 (250 mm× 4.6 mm,5 μm),流动相为乙腈-水(25 ∶ 75),柱温为25℃,检测波长为220 nm,流速为1.0 mL·min-1.采用留样观察法进行初步稳定性试验.结果 绿原酸、连翘苷分别在0.011～0.22、0.02～0.4 μg线性关系良好,Y=6.211×103X+98.70(r=0.999 98,n=7),Y=4.357×103X+12.30(r=0.999 98,n=-7)；平均回收率分别为99.7％和98.8％,RSD为1.7％、2.0％(n=6)；与放置0d时比较,该制剂放置6个月,3批样品的各项指标均无明显变化.结论 所用测定方法简单可行,可作为建立该药品质量标准的参考依据,且制剂在考察期内质量稳定.

Quality control of Fufang Sangju Qingre Koufuye

Objective To establish a quality control method for Fufang Sangju Qingre Koufuye and inspect its stability. Methods HPLC was used to determine the content of chlorogenic acid and phillyrin.The YMC-Pack ODS-AQ L1(250 mm×4.6 mm,5 μm) column was used,the mobile phase was acetonitribe-water(75∶25),the temperature was 25 ℃,and the detection wavelength was 220 nm.The flow rate was 1.0 mL·min-1.Storage observation method was used to determine its stability. Results The linear ranges of chlorogenic acid and phillyrin were 0.011-0.22 and 0.02-0.4 μg;Y=6.21×103X+98.70(r=0.999 98,n=7)and Y=4.357×103X+12.30(r=0.999 98,n=7).The average recoveries of chlorogenic acid and phillyrin were 99.7% and 98.8% with RSDs of 1.7% and 2.0%(n=6).Comparing the preparation placed for 6 months to d 0,we found the indexes of the 3 samples had no obvious change. Conclusion The method is simple,reliable,and can be used as a reference for the quality standard.The preparation is stable during the inspected time.