辛伐他汀片体外溶出一致性评价方法的建立

Quality Consistency Evaluation of Simvastatin Tablets

关键词:  辛伐他汀片  溶出曲线  一致性评价

Key words:  Simvastatin tablets  dissolution profile  consistency evaluation

摘要:

目的 建立辛伐他汀片体外溶出一致性评价方法，为该品种的仿制药一致性评价工作提供理论依据。方法 采用中国药典2015年版四部0931第二法（桨法），以pH 1.2，pH 4.0，pH 6.8缓冲液和水（含0.4%聚山梨酯80）900 mL为溶出介质，转速为75 r·min^-1，HPLC测定溶出度。结果 辛伐他汀在4种介质中的线性范围均为4.408~44.080 μg·mL^-1，平均回收率分别为100.2%（RSD 1.2%），100.0%（RSD 2.0%），99.8%（RSD 1.9%），99.9%（RSD 1.5%）（n=12）。5家仿制药制剂中3家与原研药相似性较高（f₂>50）。结论 建立的溶出曲线测定方法准确、可靠，可为辛伐他汀片的仿制药一致性评价提供参考。

Abstract:

OBJECTIVE To establish a method for the determination of Simvastatin tablets and provide experimental basis for generic drugs quality consistency evaluation. METHODS According to the second dissolution method(paddle method) stated in 0931 of Chinese Pharmacopeia(2015 Edition), the dissolution of simvastatin in different media (pH 1.2, pH 4.0, pH 6.8, buffer solution and water) with rotation of 75 r·min^-1 was determined by HPLC. RESULTS The linear of simvastatin was 4.408-44.080 μg·mL^-1, with the average recovery of 100.2%(RSD 1.2%), 100.0%(RSD 2.0%), 99.8%(RSD 1.9%), 99.9%(RSD 1.5%)(n=12) respectively in the four media. Three of the five generics had a highly similarity to the original(f₂>50). CONCLUSION The established method for the determination of simvastatin is accurate and reliable, which can make reference for further quality consistency evaluation of Simvastatin tablets.