| 摘要: |
| 本文主要对重组溶葡萄球菌酶阴道泡腾片进行质量研究。通过考察泡腾片外观性状、鉴别、酸碱度、融变时限、微生物限度、发泡量、重量差异、以及含量测定，确定泡腾片质量标准。其中，主要针对含量测定进行方法学验证。同时考察泡腾片的稳定性。结果表明，重组溶葡萄球菌酶阴道泡腾片外观性状、鉴别、酸碱度、融变时限、微生物限度、发泡量、重量差异结果符合要求，含量测定为标示量的80%-150%。稳定性实验也表明在干燥、阴凉、密封条件下，重组溶葡萄球菌酶阴道泡腾片至少能保质24个月。由此确定泡腾片质量符合拟定的企业质量标准。 |
| 关键词: 重组溶葡萄球菌酶 阴道泡腾片 质量研究 |
| DOI： |
| 投稿时间：2015-09-18修订日期：2015-12-02 |
| 基金项目:国家星火计划项目（2012GA690003） |
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| Quality research of Recombinant LysostaphinVaginal Effervescent Tablets |
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| (Fudan University ,School of Life Sciences ,Insitute of Genetics,state key Laboratory og Genetic Engineering) |
| Abstract: |
| To assess the Recombinant Lysostaphin Vaginal Effervescent Tablets ,indicators,such as appearance，identification，pH, melt time, microbial limit, foam volume, weight variation, and assay, were investigated. In addition, the methodology of content derermination was validated. And the stability of the tablet was investigated.The results showed that appearance,pH, melt time, microbial limit, foam volume, weight variation of the tablet were conform to the requirement.The content of the results is 80%-150% of labelled amount.Under the conditions of dry,cool and seal,the storage phase of the tablet reached at least 24 months. Thus it was confirmed that quality of the tablet was conform to the standard of the enterprise. |
| Key words: Recombinant Lysostaphin Vaginal Effervescent Tablets Quality research |
