| 加替沙星阴道泡腾片的制备及质量控制 |
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| 引用本文： | 刘梅娟. 加替沙星阴道泡腾片的制备及质量控制[J]. 中国药房, 2006, 17(16): 1221-1223 |
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| 作者姓名： | 刘梅娟 |
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| 作者单位： | 山东省临沂市妇幼保健院,临沂市,276001 |
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| 摘 要： | 目的:制备加替沙星泡腾片并建立其质量控制方法。方法:采用正交设计试验,筛选构成泡腾剂的酸源、碱源及稳泡剂的处方辅料,制备加替沙星泡腾片;建立酸碱度、发泡量、有关物质的测定等质量控制标准以考察其稳定性。结果:该制剂为白色或类白色片,质量稳定;加替沙星检测浓度在50~400μg/ml范围内与峰面积积分值线性关系良好(r=0·9996),平均回收率为99·74%(RSD=0·7%)。结论:本处方设计合理,质量控制方法准确、可靠,可用于临床。
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| 关 键 词： | 加替沙星 泡腾片 制备 质量控制 |
| 文章编号： | 1001-0408(2006)16-1221-03 |
| 收稿时间： | 2005-12-09 |
| 修稿时间： | 2006-05-09 |
Preparation and Quality Control of Gatifloxacin Vagina Effervescent Tablet |
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| LIU Meijuan. Preparation and Quality Control of Gatifloxacin Vagina Effervescent Tablet[J]. China Pharmacy, 2006, 17(16): 1221-1223 |
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| Authors: | LIU Meijuan |
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| Affiliation: | Shandong Linyi Municipal Maternal and Child Health Hospital, Linyi 276001, China |
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| Abstract: | OBJECTIVE:To prepare gatifloxacin vagina effervescent tablet and to establish its quality control method.METHODS:The excipients consisting of acid source,alkali source and foam stabilizer were optimized by orthogonal design and the gatifloxacin vagina effervescent tablet was perpared.Quality control standards on acidity or alkalinity,effervescent quan-tity and the determination of related substances were established to investigate the stability of drugs.RESULTS:The prepa-ration was white or off-white colored tablets with stable quality.Linear concentration range of gatifloxacin was50～400μg/ml(r=0.9996),with average recovery at99.74%(RSD=0.7%).CONCLUSION:The established method is reasonable in design,accurate and reliable in quality control,and suitable for clinical assay. |
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| Keywords: | Gatifloxacin Effervescent tablet Preparation Quality control |
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