普拉沙星片剂的制备及含量测定

Preparation and content determination of pradofloxacin tablets

为了制备性状稳定、含量均匀的普拉沙星片剂,采用单因素试验和响应面设计试验筛选最优处方和最佳制备工艺,并通过建立高效液相色谱的含量测定方法,检测普拉沙星片剂的含量。结果显示,普拉沙星片剂的最优处方为每100 g含有普拉沙星15 g,预胶化淀粉50 g,聚乙二醇4000 15 g,乙基纤维素10.2 g,牛肉香精6 g,滑石粉3.3 g,硬脂酸镁0.5 g;最佳制备工艺为粉末直接压片法,经此法制得的片剂的硬度、片重差异、脆碎度和崩解时限均符合要求;建立的含量测定方法专属性强、精密度好、准确度高。结果表明,本研究使用的处方合理,工艺可靠,含量测定方法科学,制备的普拉沙星片剂表面光洁、性状稳定、含量均匀。

In order to prepare pradofloxacin tablets with stable properties and uniform content,we took the single-factor test and response surface design test to screen the best formula and preparation process,and the content of pradofloxacin tables was determined by establishing the content determination method of HPLC. The results showed that the best prescription of pradofloxacin tablets contained15 g of pradofloxacin per 100 g,50 g of pregelatinized starch,15 g of polyethylene glycol 4000,10.2 g of ethyl cellulose,6 g of beef flavor,3.3 g of talcum powder,and 0.5 g of magnesium stearate.The optimal preparation process is the powder tableting method directly. The hardness,weight difference,friability,and disintegration time of the tablets are in line with the requirements;the HPLC method has high specificity,precision,and accuracy. Those results indicated that the prescription used in this study is reasonable,the process is reliable,and the content determination method is scientific. In summary,the prepared pradofloxacin tablets have smooth surfaces,stable properties,and uniform content.