摘要
目的考察新型羟丙基淀粉空心胶囊及其在氟康唑胶囊中的应用。方法将市售氟康唑明胶胶囊的内容物取出填装入淀粉空心胶囊制得氟康唑淀粉胶囊,上述制得胶囊与市售明胶胶囊样品分别在强光[（4000±500）Lx]、高温（40℃）、高湿[相对湿度（75±5）%]的条件下放置5 d和10 d,采用高效液相色谱法检查氟康唑含量在放置前后有无变化,检测波长为261 nm,同时观察外观、色泽等药物性状的变化。结果经高温、高湿、光照试验后,测得氟康唑含量值均在92.5%~103.9%,符合标准规定（90.0%~110.0%）,且样品吸湿性均〈5%。结论新型羟丙基淀粉空心胶囊替代明胶胶囊具有可行性。
Objective To determine the effect of vacant capsules from hydroxypropyl starch on fluconazole, and compare with commercially available gelatin capsules. Methods The contents of commercial fluconazole gelatin capsules were stuffed into the starch capsules to prepare fluconazole starch capsules. The fluconazole starch capsules and gelatin capsules were placed in （4000±500） Lx, 40 ℃ , RH （75±5）% for 5 days and l0 days, respectively. HPLC method was used at 261 nm to analyze the contents of fluconazole. We observed the changes in appearance, color and other traits. Results The contents of fluconazole were 92.5% -103.9%. Hygroscopic property of all samples was less than 5%. Conclusion Vacant capsules from hydroxypropyl starch substitute gelatin capsules arc feasible
出处
《中南药学》
CAS
2015年第8期827-831,共5页
Central South Pharmacy
