国产尼莫地平片与原研制剂体外溶出度比较

发布时间：2019-05-22 22:44

【摘要】：目的考察国内9个厂家生产的尼莫地平片与原研制剂(商品名:尼膜同)的体外溶出度,比较体外溶出行为,为临床选择用药及控制国产尼莫地平的质量提供理论依据。方法采用高效液相色谱法测定尼莫地平片分别在纯化水(质量分数0.3%SDS)、p H值1.2氯化钠盐酸溶液(0.3%SDS)、p H值4.5醋酸盐缓冲液(0.3%SDS)和p H值6.8磷酸盐缓冲液(0.3%SDS)共4种溶出介质中的溶出度,并用f2相似因子法评价溶出曲线的相似性。结果只有一个厂家生产的尼莫地平片在4种溶出介质中f2相似因子大于50,与原研制剂相似;其余厂家生产的尼莫地平片在4种溶出介质中溶出行为与原研制剂不相似。结论多数国产的尼莫地平片与原研制剂溶出过程存在显著性差异,临床应用时应加以注意。厂家应积极改进现有工艺,严格控制药物的溶出速率。
[Abstract]:Objective to investigate the dissolution rate of nimodipine tablets produced by nine domestic manufacturers in vitro and to compare the dissolution behavior in vitro, so as to provide theoretical basis for clinical selection of nimodipine tablets and control of the quality of domestic nimodipine tablets. Methods Nimodipine tablets were determined by high performance liquid chromatography (HPLC) in purified water (mass fraction 0.3%SDS), p H 1.2 sodium chloride hydrochloric acid solution (0.3%SDS). The dissolution rate of acetate buffer (0.3%SDS) and pH 6.8 phosphate buffer (0.3%SDS) were 4.5. the similarity of dissolution curve was evaluated by f2 similarity factor method. Results the f _ 2 similarity factor of nimodipine tablets produced by only one manufacturer was more than 50 in four kinds of dissolution media, which was similar to that of the original preparation, while the dissolution behavior of nimodipine tablets produced by other manufacturers in the four dissolution media was not similar to that of the original preparation. Conclusion the dissolution process of most domestic nimodipine tablets is significantly different from that of the original preparation, which should be paid attention to in clinical application. Manufacturers should actively improve the existing process and strictly control the dissolution rate of drugs.
【作者单位】：沈阳药科大学药学院
【分类号】：R943

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