流通池法测定奥美拉唑肠溶胶囊溶出度

Dissolution Determination of Omeprazole Enteric Capsules by Flow-through Cell Method

关键词:  奥美拉唑肠溶胶囊  流通池法  溶出曲线  相似因子

Key words:  omeprazole enteric capsules  flow-through cell method  dissolution curves  similarity factor

摘要:

目的 建立奥美拉唑肠溶胶囊溶出度测定方法，并考察不同厂家产品溶出度。方法 采用流通池的开环系统，以pH 1.2盐酸溶液、pH 6.0磷酸盐缓冲液、pH 6.2磷酸盐缓冲液为溶出介质，流速为4 mL·min^–1，在规定时间点取样后采用HPLC测定奥美拉唑溶出度。考察奥美拉唑肠溶胶囊仿制制剂与参比制剂的溶出情况，并通过计算相似因子（f₂）评价其溶出曲线相似性。结果 国内26家企业中7家企业市售产品与参比制剂的溶出曲线相似，其余均存在差异。结论 该方法可用于奥美拉唑肠溶胶囊溶出度测定，对于质量控制具有重要的指导意义；仿制制剂与参比制剂体外溶出存在差异，为进一步改进产品工艺和评价仿制药一致性提供重要的实验依据。

Abstract:

OBJECTIVE To develop a flow-through cell method for the dissolution test of omeprazole enteric capsules and compare the dissolution behaviors of omeprazole enteric capsules from different manufacturers. METHODS An open-loop mode of flow-through cell apparatus was employed, with pH 1.2 hydrochloric acid solution, pH 6.0 phosphate buffer solution and pH 6.2 phosphate buffer solution as the dissolution medium, and the flow rate was 4 mL·min^-1, the samples were collected at the specified time point and determined by HPLC. The dissolution profiles of omeprazole enteric capsules from different pharmaceutical manufacturers were determined, and the dissolution curves of consistency were evaluated by calculating the similarity factor(f₂). RESULTS The dissolution profiles of the products from 7 domestic pharmaceutical manufacturers were similar to those of the reference listed drug(RLD). The dissolution curves of the rest of the manufacturers' products were different with the RLD. CONCLUSION The method which can be used to determine the dissolution of omeprazole enteric capsules is instructive to the quality control of the products. There is difference of in vitro dissolution behavior between the generic preparations and the RLD, which provides assistance for further optimizing manufacturing process and evaluating the consistency of generic drugs.