抗病毒口服液的质量标准改进研究

Research on Quality Improvement of Antiviral Oral Liquid

目的:提高抗病毒口服液的质量标准。方法:采用高效液相色谱法测定抗病毒口服液中(R,S)-告依春、连翘酯苷A和连翘苷的含量,并同时建立抗病毒口服液的指纹图谱。色谱柱为Waters CORTECS C_(18)柱(150 mm×4.6 mm,2.7μm);流动相为甲醇-0.1%磷酸溶液,梯度洗脱;检测波长为236 nm;柱温为29℃。结果:(R,S)-告依春、连翘酯苷A及连翘苷分别在16.86~527.00、156.43~4 888.50及122.97~3 842.85 ng范围内与相应峰面积呈良好的线性关系。(R,S)-告依春、连翘酯苷A及连翘苷的平均加样回收率分别为89.9%(RSD=2.9%)、93.5%(RSD=3.6%)及95.1%(RSD=0.8%)。建立了抗病毒口服液的高效液相指纹图谱共有模式,标定了其中9个共有峰,40批抗病毒口服液的相似度均>0.9。结论:该含量测定方法简便、准确,专属性强,结合特征性强的高效液相指纹图谱可更好地控制抗病毒口服液的质量。

OBJECTIVE： To improve the quality standard of antiviral oral liquid. METHODS： High performance liquid chromatography（ HPLC） was adopted to determine the content of（ R,S）-epigoitrin,forsythoside A and forsythin,in the meantime,finger-print of antiviral oral liquid was also established. With the chromatographic column was Waters CORTECS C_（18）（ 150 mm × 4. 6 mm,2. 7 μm）; the mobile phase was methyl alcohol -0. 1% of phosphoric acid solution,with gradient elute; the detected wave length was 236 nm; and the column temperature was 29 ℃.RESULTS：（ R,S）-epigoitrin,forsythoside A and forsythin presented well linear relation with their corresponding peak areas in respective ranges of 16. 86-527. 00 ng,156. 43-4 888. 50 ng and 122. 97-3 842. 85 ng. The average sampleadding recovery rates of（ R,S）-epigoitrin,forsythoside A and forsythin were respectively 89. 9%（ RSD = 2. 9%）,93. 5%（ RSD = 3. 6%） and 95. 1%（ RSD = 0. 8%）. Under the establishment of mutual model of HPLC finger-print of antiviral oral liquid,a total of 9 mutual peaks were marked,the similarity of 40 batches of antiviral oral liquid was 〉0. 9. CONCLUSIONS： This content-determination method is convenient and accurate,with strong specificity,which can preferably control the quality of antiviral oral liquid with the combination of HPLC finger-print.