论文部分内容阅读
目的:建立替硝唑与盐酸左氧氟沙星复方泡腾片口捷爽的制备方法,并对其进行质量控制。方法:处方量的盐酸左氧氟沙星、替硝唑、碳酸氢钠和枸橼酸等以混合制粒法压制泡腾片,采用高效液相色谱法测定盐酸左氧氟沙星、替硝唑含量。结果:盐酸左氧氟沙星和替硝唑的平均回收率分别为98.5%(RSD1.25%)和99.05%(RSD0.90%)。结论:口捷爽复方泡腾片的制备工艺简单,稳定性好,含量测定方法准确可靠,精密度高,可以对其进行质量控制。
OBJECTIVE: To establish a method for the preparation of tinidazole and levofloxacin hydrochloride compound effervescent tablets and to control its quality. Methods: Prescription volume of levofloxacin hydrochloride, tinidazole, sodium bicarbonate and citric acid were mixed granulation method to suppress effervescent tablets, and the contents of levofloxacin hydrochloride and tinidazole were determined by high performance liquid chromatography. Results: The average recoveries of levofloxacin hydrochloride and tinidazole were 98.5% (RSD 1.25%) and 99.05% (RSD 0.90%), respectively. Conclusions: The preparation process of Kuai Jie Shuang Compound Effervescent Tablet is simple, its stability is good, the content determination method is accurate and reliable, the precision is high, and its quality control can be carried out.