CAJ | 학술논문

目的：考察金茵清热口服液的稳定性。方法依据《药物制剂稳定性实验指导原则》，观察金茵清热口服液的性状、pH、相对密度，采用高效液相色谱（ HPLC）法测定样品中栀子苷、绿原酸、丹酚酸B在实验条件下的含量变化，色谱条件：AtlantisT3色谱柱（150 mm×4.6 mm，3μm），流动相A：0.05%磷酸溶液，流动相 B：乙腈，梯度洗脱，流速：0.8 mL·min-1，柱温：35℃，检测波长：254 nm。结果影响因素实验和加速实验中口服液的性状、pH和相对密度均未发生明显变化，而药效成分栀子苷、绿原酸、丹酚酸B的平均含量随存放时间的延长出现不同程度的降低。结论光照和高温对金茵清热口服液的稳定性有一定影响。
목적：고찰금인청열구복액적은정성。방법의거《약물제제은정성실험지도원칙》，관찰금인청열구복액적성상、pH、상대밀도，채용고효액상색보（ HPLC）법측정양품중치자감、록원산、단분산B재실험조건하적함량변화，색보조건：AtlantisT3색보주（150 mm×4.6 mm，3μm），류동상A：0.05%린산용액，류동상 B：을정，제도세탈，류속：0.8 mL·min-1，주온：35℃，검측파장：254 nm。결과영향인소실험화가속실험중구복액적성상、pH화상대밀도균미발생명현변화，이약효성분치자감、록원산、단분산B적평균함량수존방시간적연장출현불동정도적강저。결론광조화고온대금인청열구복액적은정성유일정영향。
Objective To investigate the stability of jinyin qingre oral liquid. Methods According to the stability test guidelines for pharmaceutical preparations,the appearance,pH and relative density of jinyin qingre oral liquid were detected, the contents of geniposide,chlorogenic acid and salvia acid B were determined by HPLC. The chromatographic conditions were as follows:AtlantisT3 column(150 mm×4. 6 mm,3 μm),mobile phase A:0. 05% phosphoric acid,mobile phase B:acetonitrle, gradient elution at the flow rate of 0. 8 mL · min-1 ,and column temperature at 35 ℃. The detection wavelength was set at 254 nm. Results The appearance,pH,and relative density of jinyin qingre oral liquid did not change significantly with the acceleration test,but the contents of geniposide,chlorogenic acid and salvia acid B decreased time dependently. Conclusion Light and high temperature could decrease the stability of the jinyin qingre oral liquid.