不同包衣维C银翘片中对乙酰氨基酚体外溶出度比较研究

Study on in vitro Dissolution of Vitamin C Yinqiao Tablets in Different Coating

目的：通过对维C银翘片糖衣片和薄膜衣片中化药成分对乙酰氨基酚体外溶出度曲线的比较研究，考察产品体外溶出行为的一致性。方法：采用浆法，以0.1mol/HCL溶液为溶出介质，温度37℃±0.5℃，转速75r/min，以包衣层脱落作为取样时间起点，考察两种规格的产品在2h内各相同取样点的累积溶出度。色谱柱为Dikma C18柱（250mmx4.6mm，5μm）；流动相为甲醇-0.5%冰醋酸溶液（20：80）；检测波长249n m；柱温25℃；流速1m L·m L-1；进样量10μL。结果：对乙酰氨基酚在0.32～316u g/mL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100.7%、100.8%。通过计算相似因子进行比较，薄膜衣片和糖衣片中对乙酰氨基酚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。

Objective：To confirm product consistency through comparative study of in vitro dissolution curve of acetaminophen in sugar-coated tablets andfilm-coated tablets of Vitamin C Yinqiao Tablets.Method：Paddle method was used. 0.1mol/HCL solution was used as dissolution medium. Temperature was 37℃±0.5℃. The speed was kept at 75r/min. Coating layer shedding was set asthestarting point of sampling time to examine cumulative dissolutionof the two products in the same sampling point within 2h. The HPLC conditions included Dikma C18 column（250mmx4.6mm, 5μm）, mobile phase of methanol-0.5% acetic acid solution（20：80）, detection wavelength at 249nm,column temperature 25℃,flow rate at 1mL·min-1,injection volume at 10μL.Results： Acetaminophen showed a good linear relationship within the range of 0.32~316ug/min.The average recovery of the sugar-coated tablets and the film-coated tablets were 100.7% and 100.8% respectively. By comparing the similarity factor, in vitro acetaminophen dissolution curves of the sugar-coated tablets and the film-coated tablet were similar. Conclusion：The feasibility and reproducibility of this method are good. The dissolution time varies between the tables because of the different coating materials, which will provide theoretical data for the bioequivalence testing.