新生儿用吲哚美辛栓剂的制备与含量测定

Preparation and Quality Control of Indometacin Suppositories for Neonates

目的 :探索新生儿用吲哚美辛栓剂的制备工艺及质量控制方法。方法 :混合脂肪酸甘油酯 42g ,卡波姆0 .2g ,吲哚美辛 0 .1g ,超声波混合后 ,采用新工艺生产新生儿用吲哚美辛栓剂 ,用反相高效液相色谱法测定吲哚美辛含量。结果 :吲哚美辛在 1～ 2 0mg·L 1 的浓度范围内线性关系良好 (r =0 .9999) ,日内、日间RSD 0 .15 %～ 1.5 6% ,高、中、低浓度回收率 98.6%～ 99.7%。结论 :新生儿用吲哚美辛栓剂制法简单 ,所建方法可用于新生儿用吲哚美辛栓剂的质量控制。

Objective:To explore the preparation technology and method of quality control of indometacin suppositories for neonates. Methods:New technology was used for the preparation of indometacin suppositories for neonates. Briefly,42 g of compound glycerates of fatty acids,0.2 g of carbomer and 0.1g of indometacin were subjected to ultrasound mixing. The content of indometacin in the suppositories was determined with reverse-phase high performance liquid chromatography(RP-HPLC). Results:The calibration curve was linear when the concentration of indometacin was within a range of 1-20 mg·L -1( r =0.999 9). The RSD of intra-day and inter-days assay was 0.15%-1.56%. The rates of recovery for high,medium and low concentrations were 98.6%-99.7%. Conclusion:The preparation technology for the suppositories was simple and the RP-HPLC method proved suitable for the quality control of the preparation.