首页|新型羟丙基淀粉空心胶囊替代明胶胶囊的可行性研究

新型羟丙基淀粉空心胶囊替代明胶胶囊的可行性研究

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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5d和10d,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.
New vacant capsules from hydroxypropyl starch in fluconazole
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 10 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 are feasible.

vacant capsule from hydroxypropyl starchgelatine capsulefluconazoleHPLC

帅放文、章家伟、王向峰、宋觅、周宏灏

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中南药学临床药理研究所,长沙410078

国家药用辅料工程技术研究中心,长沙410331

湖南尔康制药股份有限公司,长沙410331

羟丙基淀粉空心胶囊 明胶胶囊 氟康唑 高效液相色谱法

2015

10.7539/j.issn.1672-2981.2015.08.011

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子：0.736
ISSN：1672-2981
年,卷(期)：2015.13(8)
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