论文部分内容阅读
本文对长效避孕栓进行体外溶出度测定。溶出度试验条件选择在溶出度5分钟达到35％以上,3小时达到60％～80％以上,6小时达到90％以上。用高效液相色谱法测定溶出样品液的浓度。结果表明:测定的三批样品溶出度均符合要求。认为本方法可满足该栓剂体外溶出度测定要求,可用于控制该产品制剂工艺,以保证产品质量。
In this paper, long-acting contraceptive suppository in vitro dissolution determination. Dissolution test conditions in the dissolution of 5 minutes to reach more than 35%, 3 hours to reach 60% to 80% or more, 6 hours to reach 90%. The concentration of the eluted sample solution was determined by high performance liquid chromatography. The results showed that the dissolution of three batches of samples all met the requirements. It is considered that the method can meet the requirement of the in vitro dissolution test of the suppository and can be used for controlling the preparation process of the product so as to ensure the product quality.