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目的研制法莫替丁微乳制剂并对其质量进行评价,建立质量控制标准。方法通过相图研究及大鼠在体肠吸收实验进行处方筛选,并测定制剂的形态、粒径分布、含量及稳定性。结果成功筛选出吸收较好的微乳处方,制备的微乳透射电镜下为球状液滴,平均粒径为65 nm,高效液相色谱法含量测定的平均回收率为97.63%,平均相对标准差(RSD)为0.72%。结论法莫替丁微乳制备简单,质量稳定,检测方法可靠,重现性好。
Objective To develop famotidine microemulsion formulation and evaluate its quality and establish a quality control standard. Methods The phase diagram and rat intestine absorption test were used to screen the prescriptions. The morphology, particle size distribution, content and stability of the preparation were determined. Results The well-absorbed microemulsion prescription was successfully screened. The prepared microemulsion was a spherical droplet under transmission electron microscopy with an average particle size of 65 nm. The average recovery of the HPLC method was 97.63%. The mean relative standard deviation (RSD) was 0.72%. Conclusion Famotidine microemulsion preparation is simple, stable quality, reliable detection method and good reproducibility.