摘要
目的制备茶多酚阴道泡腾片并建立其质量控制方法。方法采用正交设计试验对酸碱系统的比例进行筛选，制备茶多酚阴道泡腾片；建立发泡量、酸碱度、崩解时限等质量控制标准以考察其稳定性，并对样品中的茶多酚含量进行测定。结果该制剂为棕灰色异形片，发泡量、酸碱度、崩解时限等符合阴道泡腾片的要求，质量稳定；茶多酚检测浓度在0．02～0．08mg·mL。范围内呈良好的线性关系（r=0．9991），平均回收率为100．1％，RSD=O．32％（n=6），精密度良好。结论处方设计合理，质量控制方法准确、可靠。
Objective To prepare Tea Polyphenols vaginal effervescent tablet and establish its quality control method. Methods The excipients consisting of acid source and alkali source were optimized by orthogonal design, the Tea Polyphenols vaginal effervescent was prepared. Quality control standards on acidity or alkalinity, effervescent quantity and disimegration time were established to investigate the stability of drugs and the content of Tea Polyphenols was determined by UV-visible spectrophotometry. Results The preparation was brown grey shaped tablets. Foam volume, pH and disintegration meet the requirements of the vaginal effervescent tablets and the quality was stable. Its linear range was 0.02 - 0.08mg-mLl（r=0.999 1） and average recovery was lO0.1%,RSD=O.32%（n=6）. Conclusion The performulation was reasonable and the established method for quality control was accurate and reliable.
出处
《现代中药研究与实践》
CAS
2012年第1期55-58,44,共5页
Research and Practice on Chinese Medicines
关键词
茶多酚
阴道泡腾片
制备
质量控制
Tea Polyphenols
vaginal effervescent tablet
preparation
quality control
