奈韦拉平／齐多夫定／拉米夫定复方片剂的处方工艺及质量研究

目的：考察奈韦拉平/齐多夫定/拉米夫定复方片剂的处方工艺,并对其质量进行研究。方法：将奈韦拉平、齐多夫定、拉米夫定与各辅料混合,通过影响因素实验选择合适的辅料,设计6个不同的处方,测定不同处方组成片剂的颗粒流动性、片剂的硬度、脆碎度、崩解时限、有关物质和主药含量,以及在不同溶出介质中的溶出曲线,筛选最优处方。结果：筛选得到奈韦拉平/齐多夫定/拉米夫定复方片剂的最优处方,制备的片剂各项质量指标均合格,有关物质含量〈1%,加速实验稳定性良好。结论：本研究制备的奈韦拉平/齐多夫定/拉米夫定复方片剂质量良好,适合进一步开发。

Study on the preparation technology and quality of compound nevirapine-zidovudine-lamivudine tablets

Objective： To investigate the preparation technology of compound nevirapine-zidovudine-lamivudine tablets and their quality. Methods： Influencing factor tests were conducted in the mixture of nevirapine,zidovudine, lamivudine and various excipients in order to select proper excipients. Tablets were prepared with 6 different formulae, and the optimal formula was se- lected according to particle fluidity, hardness,friability, disintegration time, contents of related substances and drugs, as well as dissolution in different dissolvants. Results： The optimal formula of compound nevirapine-zidovudine-lamivudine tablets was obtained. Various quality indexes of the tablets could meet the requirements and the contents of related substances were below 1%. The tablets were proved to be stable in accelerating tests. Conclusion： The compound nevirapine-zidovudine lamivudine tablets are of good quality and worth further development.