【摘要】 目的:制备多潘立酮凝胶剂,对其质量进行考察。方法:采用卡波姆等辅料制备多潘立酮凝胶剂。考察制剂的性状、pH和初步稳定性,采用紫外分光光度法测定多潘立酮含量,采用高效液相色谱法(HPLC)检查该制剂中有关物质。结果:所制备的多潘立酮凝胶均匀细腻、质量稳定;在10.0～30.0mg.L-1范围内,多潘立酮浓度与吸收度之间线性关系良好,r=0.9999;方法的平均回收率为99.04%,RSD为0.59%(n=9)。结论:所制备的多潘立酮凝胶剂工艺简单,含量测定结果准确,质量控制方法准确可靠。更多还原

【Abstract】 OBJECTIVE To prepare domperidone gel and evaluate its characteristics.METHODS Carbopol-974P was used as the base excipient and domperidone as main ingredients for domperidone gel preparation.The appearance,pH and primary stability of this formulation were evaluated.The UV spectrophotometry was adopted for determination of domperidone,the HPLC method was used to assay the related substance.RESULTS The domperidone gel was coherent and stable.The calibration curve of domperidone was linear over the range of 10.0-30.0 mg·L-1 with the correlation coefficient of 0.999 9.The average recovery was 99.0%(RSD=0.95%).CONCLUSION The preparation technique of domperidone gel is simple and reasonable,the methods of content determination and quality control are accurate and reliable.更多还原