CN101138556B - 特比萘芬或其盐成膜凝胶组合物及其应用 - Google Patents
特比萘芬或其盐成膜凝胶组合物及其应用 Download PDFInfo
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- CN101138556B CN101138556B CN2006100308639A CN200610030863A CN101138556B CN 101138556 B CN101138556 B CN 101138556B CN 2006100308639 A CN2006100308639 A CN 2006100308639A CN 200610030863 A CN200610030863 A CN 200610030863A CN 101138556 B CN101138556 B CN 101138556B
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Abstract
Description
条件 | 性状 | 均匀性 | 含量(%) | 有关物质(%) |
原始 | 黄棕色半固体凝胶,具乙醇气味 | 均匀,无悬浊物 | 98.74 | 0.54 |
光照 | 黄棕色半固体凝胶,具乙醇气味 | 均匀,无悬浊物 | 97.56 | 0.63 |
高温 | 黄棕色半固体凝胶,具乙醇气味 | 均匀,无悬浊物 | 97.63 | 0.68 |
加速试验 | 黄棕色半固体凝胶,具乙醇气味 | 均匀,无悬浊物 | 96.45 | 1.12 |
室温留样 | 黄棕色半固体凝胶,具乙醇气味 | 均匀,无悬浊物 | 97.81 | 0.85 |
黏附性能 | 溶蚀状况 | 滞留时间 | |
USP Gel-A | 光滑、平整、黏附性好 | 3hr后膜开始部分溶蚀;4hr后逐渐破损;5hr膜部分脱落,7hr膜以碎片状从粘膜上脱落 | 约7hr |
USP Gel-B | 光滑、平整、黏附性好 | 1hr后膜开始溶蚀;3hr后膜变薄并部分破损;4hr后膜部分脱落、5小时膜基本消失 | 约5hr |
实施例2 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例3 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例4 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例5 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例6 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例7 | 光滑平整、 | 5hr后略有变薄,但仍保持完整;10hr后膜仍 | >10hr |
黏附性好 | 保持完整,紧紧黏附在粘膜上 | ||
实施例8 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例9 | 表面略糙、黏附性好 | 1hr后表面有部分固体脱落;5hr后膜变薄,溶液中有少量不溶性的固体,略混,10hr后,膜仍紧紧黏附在粘膜上 | >10hr |
实施例10 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例11 | 表面粗糙、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
黏附性能 | 溶蚀状况 | 滞留时间 | |
实施例12 | 表面略糙、黏附性好 | 1hr后表面有部分固体脱落;5hr后膜变薄,溶液中有少量不溶性的固体,略混,10hr后,膜仍紧紧黏附在粘膜上 | >10hr |
实施例13 | 光滑平整、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
实施例14 | 表面粗糙、黏附性好 | 5hr后略有变薄,但仍保持完整;10hr后膜仍保持完整,紧紧黏附在粘膜上 | >10hr |
样品 | 黏附性能 | 破损状况 | 滞留时间 |
USP Gel-A | 光滑、平整、黏附性好 | 5hr后开始破裂、脱落;6hr后膜不规则破碎,不完整;7hr后已基本消失。 | 约7hr |
USP Gel-B | 光滑、平整、黏附性好 | 3hr后膜破裂、脱落;4hr后膜不规则破碎,不完整;5hr时已基本消失。 | 约5hr |
实施例1 | 光滑、平整、黏附性好 | 6hr后开始慢慢变薄,但膜仍完整;约10hr后膜逐渐破损、脱落,12hr已基本消失。 | 约12hr |
实施例13 | 光滑、平整、黏附性好 | 6hr后开始慢慢变薄,但膜仍完整;约8hr后膜逐渐破损、脱落,10hr已基本消失 | 约10hr |
Claims (11)
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CN2006100308639A CN101138556B (zh) | 2006-09-06 | 2006-09-06 | 特比萘芬或其盐成膜凝胶组合物及其应用 |
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CN101138556A CN101138556A (zh) | 2008-03-12 |
CN101138556B true CN101138556B (zh) | 2010-07-14 |
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CN104997723A (zh) * | 2014-04-16 | 2015-10-28 | 上海现代药物制剂工程研究中心有限公司 | 成膜凝胶组合物、其用途及药物成膜凝胶组合物 |
CN105012960A (zh) * | 2014-04-16 | 2015-11-04 | 上海现代药物制剂工程研究中心有限公司 | 成膜凝胶组合物、其用途及护创材料 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5081158A (en) * | 1988-05-02 | 1992-01-14 | Zila Pharmaceuticals, Inc. | Compositions and in situ methods for forming films on body tissue |
US5906814A (en) * | 1995-12-07 | 1999-05-25 | The Andrew Jergens Company | Topical film-forming compositions |
CN1813697A (zh) * | 2005-12-08 | 2006-08-09 | 咸阳步长医药科技发展有限公司 | 盐酸特比萘芬阴道凝胶及其制法和质量控制方法 |
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5081158A (en) * | 1988-05-02 | 1992-01-14 | Zila Pharmaceuticals, Inc. | Compositions and in situ methods for forming films on body tissue |
US5906814A (en) * | 1995-12-07 | 1999-05-25 | The Andrew Jergens Company | Topical film-forming compositions |
CN1813697A (zh) * | 2005-12-08 | 2006-08-09 | 咸阳步长医药科技发展有限公司 | 盐酸特比萘芬阴道凝胶及其制法和质量控制方法 |
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