非诺贝特片仿制药与原研药溶出度一致性评价研究

Study on Consistency Evaluation of the Dissolution of Generic and Original Preparations of Fenofibrate Tablet

关键词:  非诺贝特片  溶出曲线  一致性评价  制剂工艺

Key words:  fenofibrate tablet  dissolution curve  consistency evaluation  technology of pharmaceutics

摘要:

目的 建立非诺贝特片溶出度曲线测定方法，评价国内10家仿制药产品与原研药品溶出曲线的相似性。方法 用含0.025 mol·L^-1 SDS的pH 1.0盐酸溶液、pH 4.0缓冲液、pH 6.8缓冲液和水溶液4种溶出介质，分别考察非诺贝特片仿制药与原研片的溶出状况，并通过计算相似因子（f₂）评价溶出曲线的相似性。结果 国内仅1家企业产品与原研片在4种溶出介质中的溶出曲线均相似，其余企业产品与原研片相比溶出行为均不一致。结论 该方法适用于非诺贝特片的溶出曲线测定，可为非诺贝特片质量一致性评价提供参考。

Abstract:

OBJECTIVE To establish a new method for the dissolution curve determination of fenofibrate tablet, and evaluate the comparability of dissolution curve of 10 domestic generic tablets and the original tablet. METHODS Four dissolution media including pH 1.0 hydrochloric acid solution, pH 4.0 buffer solution, pH 6.8 buffer solution and water solution containing 0.025 mol·L^-1 SDS were used, the dissolution behaviors of generic and original preparations of fenofibrate tablet were detected, and the dissolution curves of consistency were evaluated by calculating the similarity factor(f₂). RESULTS The dissolution curve of only one enterprise product in China was similar with the original tablet in the four dissolution media. The dissolution of the rest of the company's products were inconsistent with the original tablet. CONCLUSION The new dissolution behavior method is suitable for dissolution curve determination of fenofibrate tablet, can make reference for further quality consistency evaluation.