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目的制备并评价伏立康唑片。方法采用预胶化淀粉、一水乳糖、交联羧甲基纤维素钠、聚维酮、硬脂酸镁制备伏立康唑片,并对其进行薄膜包衣。采用正交设计法确定最佳处方。对其硬度、脆碎度和溶出度进行考察并与市售伏立康唑片比较。结果预胶化淀粉、一水乳糖、交联羧甲基纤维素钠、硬脂酸镁的用量分别为片重的40%,21%,3%和1%,采用5%聚维酮K90水溶液做黏合剂,片芯硬度为15 kg.cm 2,包衣厚度为4%左右时,伏立康唑片的溶出度接近原研产品。结论伏立康唑片的制备工艺简单,重现性好,药物的溶出行为达到预期目的。
Objective To prepare and evaluate voriconazole tablets. Methods Voriconazole tablets were prepared by using pregelatinized starch, lactose monohydrate, croscarmellose sodium, povidone, and magnesium stearate, and then film-coated. Orthogonal design method to determine the best prescription. Their hardness, friability and dissolution were examined and compared with the commercially available voriconazole tablets. Results The amount of pregelatinized starch, lactose monohydrate, croscarmellose sodium and magnesium stearate were 40%, 21%, 3% and 1% of the weight of the tablets, respectively. As a binder, core tablet hardness of 15 kg.cm 2, the coating thickness of about 4%, the dissolution of voriconazole tablets close to the original product research. Conclusion The preparation of voriconazole tablets is simple, reproducible, and the dissolution behavior of the drug achieves its intended purpose.