CAJ | 학술논문

目的：考察红花口服液的稳定性。方法：利用加速试验、长期试验对红花口服液的稳定性进行考察，采用高效液相色谱法测定红花口服液中羟基红花黄色素A的含量，色谱条件：Hypersil ODS C18（250mm×4.6mm，5μm）色谱柱，流动相∶甲醇∶乙腈∶0.02%磷酸水溶液（14∶2∶84）；流速：1.0mL·min-1；柱温：25℃，检测波长：402nm。结果：加速试验、长期试验稳定性良好，产品外观、pH值、吸收度及有效成分含量等项目没有显著变化，结果均符合要求。结论：红花口服液在室温条件下贮存，24个月内各项指标可符合质量标准要求。
목적：고찰홍화구복액적은정성。방법：이용가속시험、장기시험대홍화구복액적은정성진행고찰，채용고효액상색보법측정홍화구복액중간기홍화황색소A적함량，색보조건：Hypersil ODS C18（250mm×4.6mm，5μm）색보주，류동상∶갑순∶을정∶0.02%린산수용액（14∶2∶84）；류속：1.0mL·min-1；주온：25℃，검측파장：402nm。결과：가속시험、장기시험은정성량호，산품외관、pH치、흡수도급유효성분함량등항목몰유현저변화，결과균부합요구。결론：홍화구복액재실온조건하저존，24개월내각항지표가부합질량표준요구。
Objective to research the stability of honghua oral liquid. Methods: Determining the effect of accelerating experiment, long-term experiment. Change trends of HSYA were determined by HPLC. The Agilent Hypersil ODS C 18 column was used with gradient elution, taking methanol∶acetonitrile∶0.02% phosphoric acid solution (14∶2∶84) as mobile phase. The flow rate was 1.0mL·min-1.The column temperature was 25℃.The wavelength of detector was 402nm. Results: Honghua Oral liquid was stable to accelerating experiment, long-term experiment. The Appearance ,pH, absorbance and the HYSA have no notable changes. Conclusions:Honghua Oral liquid was stored at room temperature for 24 months, The test items were consistent with the satandard.