癸氧喹酯口服混悬液的研制及其质量评价

Preparation and Quality Evaluation of Decoquinate Oral Suspension

通过正交设计优化处方,制备癸氧喹酯口服混悬液。采用HPLC法建立含量测定方法,并对质量,稳定性进行评价。结果表明,所制备样品为乳白色混悬液,流动性好无沉降且在水中分散均匀,方便临床给药。癸氧喹酯质量浓度在2μg/mL～100μg/mL范围内与峰面积呈良好线性关系,平均回收率分别为100.5%、99.2%和99.8%,RSD分别为0.14%、0.20%和0.64%,重复性试验RSD为1.6%,能用于癸氧喹酯的含量测定,遮光密闭常温下保存。该处方设计合理,含量检测方法准确可靠,样品稳定,便于临床应用。

By using orthogonal design method, the optimum formulation was investigated and the deco- quinate oral suspension was prepared. The method for content determination of decoquinate oral suspension was established by using HPLC, and its quality and stability were also evaluated in this research. The results showed that the prepared samples is suspension with the homogeneous milky white colour, and there is no settlement and dispersed evenly in water, that it is convenient to the clinical administration; the linear range of decoquinate was 2 μg/mL-100 μg/mL, the average recovery were 100. 5%, 99. 2% and 99.8% ,and RSD were 0.14% ,0.20% and 0.64% ;the RSD of repeatability test was 1.6% ,it can used in determination of decoquinate oral suspension ; the sample should be stored at sealed,shading and room temperature. The formulation is reasonable and the content determination is accurate and reliable. The sample is stable, and can be used in the chlincal application.