吲哚美辛栓的溶出度比较研究

目的通过溶出度实验评估不同栓剂的质量差异。方法采用《中国药典》的溶出度测定法第二法（附录XC中第二法），以磷酸盐缓冲液（pH7．4）900mL为溶出介质，转速为75r／min，照紫外检测分光光度法在320nm波长处测定吸光度。结果改良基质制备的栓剂（自研产品1）与市售产品4溶出较快，60min时溶出度大于70％，自研产品1经长期稳定性考察，其溶出度无明显变化。结论改良基质制备的栓剂（自研产品1）外观光滑，硬度适宜，溶出度及稳定性良好，符合各国药典要求。

Comparison of Dissolution of Indomethacin Suppositories

Objective To evaluate the suppositories from different manufacturer by dissolution test. Methods The dissolution test （Appendix X C, method 2） was carried out by using 900 mL of phosphate buffer （pH7.4） as dissolution medium, adjust the rotation speed of the paddle to 75 r/min. Measure The absorbance of the successive filtrate at 320 nm. Results The suppositories with modified base （ sample 1 ） and commercial product 4 showed pretty good dissolution （more than seventy percent at 60 min）. The Sample 1 had an acceptable dissolution performance during a long term stability study. Conclusion The suppository with modified base （sample 1 ） showed satisfied appearance, hardness and dissolution stability, and met the requirements of different pharmacopeia.