【摘要】 目的以溶出曲线相似性f₂为指标,筛选吡拉西坦片处方工艺,并进行放大验证。方法开发适宜的吡拉西坦片溶出曲线测定方法,采用沸腾制粒工艺制备吡拉西坦片,采用HPLC法对片剂进行溶出含量测定,对比自制制剂与原研制剂在不同溶出介质中的溶出行为。结果自制制剂与原研制剂体外溶出一致,处方工艺可行。结论吡拉西坦片体外溶出曲线一致性评价合格,并且该制备工艺简单,质量可控,工艺适应性强。更多还原

【Abstract】 Objective To take the similarity f₂ of dissolution curve as an index, the formulation process of piracetam tablets was screened and verified by amplification. Method A suitable method for determination of dissolution curve of piracetam tablets was developed. Piracetam tablets were prepared by boiling granulation process. The dissolution content of tablets was determined by HPLC. The dissolution behaviors of self-made preparation and original preparation in different dissolution media were compared. Results The self-made preparation was consistent with the original preparation in in vitro dissolution, and the prescription process was feasible. Conclusion The in vitro dissolution profile of piracetam tablets is evaluated as conformance. And the preparation process is simple, the quality is controllable, and the process adaptability is strong.更多还原