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目的:运用相似因子评价法,通过测定并评价原研厂家与国内仿制厂家氟康唑胶囊的体外溶出度曲线,筛选出溶出行为与原研厂家产品相似的厂家,从而进一步评价产品质量。方法:采用《中国药典》2010年版附录XC第一法的装置,用更为严格的50转转速,测定原研及仿制厂家氟康唑胶囊在0.1mol/L盐酸溶液、纯水、pH6.8磷酸盐缓冲液3种溶出介质中的体外溶出行为,绘制溶出曲线。结果:在0.1mol/L盐酸溶液介质中和纯水介质中,原研厂家A与仿制厂家B的溶出行为均一致,与仿制厂家C的溶出行为均不一致,在pH6.8磷酸缓冲液介质中,原研厂家A与仿制厂家B和仿制厂家C的溶出行为均不一致。结论:仿制厂家氟康唑胶囊在不同溶出介质中与原研产品均有不同的差异,三种介质中在pH6.8磷酸缓冲液介质中更有区分力。建议企业运用此方法进行自身产品评价,改进工艺,提高产品质量,缩短与发达国家企业间产品质量差异。
OBJECTIVE: To evaluate the product quality by measuring and evaluating the in vitro dissolution curve of fluconazole capsules from original and domestic generic manufacturers by similarity factor evaluation method, and to screen out the manufacturers whose dissolution behavior is similar to that of original manufacturers. Methods: Using the device of “Chinese Pharmacopoeia” (2010 edition) appendix XC first method, with the more rigorous 50 revolutions, the original research and imitation manufacturers fluconazole capsules in 0.1mol / L hydrochloric acid solution, pure water, pH6.8 phosphate In vitro dissolution behavior of salt buffer in 3 dissolution media, draw out the dissolution curve. Results: In 0.1mol / L hydrochloric acid solution medium and pure water medium, original research factory A and the imitation factory B dissolution behavior are consistent, and the imitation factory C dissolution behavior are inconsistent, pH6.8 phosphate buffer medium, The original manufacturer A and the imitation manufacturers B and imitation manufacturers C dissolution behavior is inconsistent. Conclusion: The generic manufacturers fluconazole capsules in different dissolution medium with the original research products have different differences in the three medium pH6.8 phosphate buffer medium more discriminating power. It is suggested that enterprises use this method to evaluate their own products, improve technology, improve product quality and shorten the product quality difference with that of developed countries.