非那雄胺胶囊剂的制备及其稳定性研究

Preparation of finasteride capsule and its stability

目的 :开发非那雄胺制剂新品种 ,满足临床用药需要。方法 :采用溶媒分散法制粒后填装硬胶囊制备胶囊剂 ,高效液相色谱法 (HPLC)测定其含量及含量均匀度 ,同时以进口片剂为对照 ,用桨板法测定其溶出度 ,并进行光照、高温、高湿、加速及长期试验等稳定性初步研究。结果 :所建立的HPLC法准确、可靠、重现性好 ,3批样品的含量分别为 99.95 %、10 0 .5 0 %和99 .80 %,含量均匀度与溶出度均符合规定 ,稳定性初步考察结果表明 ,非那雄胺胶囊稳定性良好 ,可暂定有效期为 2年。结论 :非那雄胺胶囊是一理想的口服制剂。

Objective:To develop a new type of finasteride in order to meet the needs of clinical application.Methods: The finasteride capsules were prepared by solvent dispersal method. The high performance liquid chromatography (HPLC) method was used to determine the content and it's homogeneity. The paddle method was used to measure the dissolution rate of the self-made finasteride capsules and the imported finasteride tablets were used as controls. The primary study of stability under the sunlight, high temperature, high humidity, acceleration and long-term tests was performed. Results: The HPLC method was accurate, reliable and the repetition was good. The content of the three batches of capsules were 99.95%, 100.50%, 99.80%, respectively, and its content homogeneity and dissolution rate accorded with the quality standard. The stability results of the primary observation showed that finasteride capsule was good. Its expiry date was tentatively for two years. Conclusion: Finasteride capsule is an ideal oral preparation.