CAJ | 학술논문

目的：通过对比研究维C银翘片糖衣片和薄膜衣片中化药成分维生素C体外溶出度曲线，以建立确定产品一致性的方法。方法采用浆法，以0.5％亚硫酸氢钠（用磷酸调节pH＝1.5）为溶出介质，温度控制在37℃±0.5℃，转速75r· min －1，以包衣层脱落作为取样时间起点，考察两种规格的产品在90min内各相同取样点的累积溶出度。色谱柱为氨基硅烷键合硅胶柱（250mm ×4mm，5μm）；以乙腈-0.01mol· L －1磷酸二氢钾（用磷酸调节pH值至2.4）（70∶30）为流动相；检测波长246nm；柱温为25℃；流速为1mL· min －1；进样量10μL。结果维生素 C在2.10～210.40μg· mL－1范围内呈现良好的线性关系，糖衣片、薄膜衣片加样回收率平均值分别为101.75％、100.46％。通过相似因子进行比较，薄膜衣片和糖衣片中维生素C的体外溶出曲线相似。结论该方法可行性、重现性均良好。且可推断二者溶出时间有所差异的原因是包衣材料的不同，这为后期即将进行的生物等效性试验奠定理论数据基础。
목적：통과대비연구유C은교편당의편화박막의편중화약성분유생소C체외용출도곡선，이건립학정산품일치성적방법。방법채용장법，이0.5％아류산경납（용린산조절pH＝1.5）위용출개질，온도공제재37℃±0.5℃，전속75r· min －1，이포의층탈락작위취양시간기점，고찰량충규격적산품재90min내각상동취양점적루적용출도。색보주위안기규완건합규효주（250mm ×4mm，5μm）；이을정-0.01mol· L －1린산이경갑（용린산조절pH치지2.4）（70∶30）위류동상；검측파장246nm；주온위25℃；류속위1mL· min －1；진양량10μL。결과유생소 C재2.10～210.40μg· mL－1범위내정현량호적선성관계，당의편、박막의편가양회수솔평균치분별위101.75％、100.46％。통과상사인자진행비교，박막의편화당의편중유생소C적체외용출곡선상사。결론해방법가행성、중현성균량호。차가추단이자용출시간유소차이적원인시포의재료적불동，저위후기즉장진행적생물등효성시험전정이론수거기출。
OBJECTIVE To establish a method to ensure the product consistency through comparative studying on the vitro dissolution curve of the chemical composition of Vitamin C in the sugar-coated tablets and film-coated tablets of Vitamin C Yinqiao Tablets.METHODS Paddle method was used.0.5%sodium bisulfitesolution ( pH=1.5) was used as dissolution medium, which adjusted by phosphoric acid.Temperature was at 37℃±0.5℃.The speed was kept at 75r· min-1.Coating layer shedding as a starting point of sampling time to examine the two specifi-cations products cumulative dissolution in the same sampling point within 90 min.The HPLC conditions included that aminosilane key silica gel column (250mm ×4mm,5μm),mobile phase of acetonitrile-0.01mol· L-1 potassium di-hydrogen phosphate (phosphoric acid adjusted the pH to 2.4) (70∶30),detection wavelength was set at 246nm,col-umn temperature was 25℃, the flow rate was 1 mL · min-1 , injection volume was 10μL.RESULTS Vitamin C Showed a good linear relationship within the range of 2.10-210.40μg· mL-1 ,the average plus recoveries of the sug-ar-coated tablets and the film-coated tablets were 101.75% and 100.46% respectively.By comparing the similar factors,the vitamin C in vitro dissolution curve of the sugar-coated tablets and the film-coated tablet was simi-lar.CONCLUSION The feasibility and reproducibility of this method are good.And inferred dissolution time varies of the both tables because of the different coating materials,which will lay the basis of theoretical data for the bio-equivalence testing in the upcoming.