CAJ | 학술논문

目的：通过实验研究，筛选痔舒宁中空栓的最佳处方及制备工艺，以制备出外观形态与溶出效果良好的肛用中空栓剂。方法：采用热熔法制备痔舒宁中空栓，以外观形态、融变时限及溶出度为考察指标，通过单因素考察及正交试验设计方法筛选痔舒宁中空栓的最优处方。结果：通过实验确定以半合成脂肪酸酯为痔舒宁中空栓基质，药物与基质的比例为1∶4，注模温度为40℃，表面活性剂吐温-80与基质比例为1∶9。结论：按确定的处方与制备工艺制备的痔舒宁中空栓含药量高，外观光滑细腻，外层释药迅速，30 min内全部软化无硬心，符合栓剂质量要求。
목적：통과실험연구，사선치서저중공전적최가처방급제비공예，이제비출외관형태여용출효과량호적항용중공전제。방법：채용열용법제비치서저중공전，이외관형태、융변시한급용출도위고찰지표，통과단인소고찰급정교시험설계방법사선치서저중공전적최우처방。결과：통과실험학정이반합성지방산지위치서저중공전기질，약물여기질적비례위1∶4，주모온도위40℃，표면활성제토온-80여기질비례위1∶9。결론：안학정적처방여제비공예제비적치서저중공전함약량고，외관광활세니，외층석약신속，30 min내전부연화무경심，부합전제질량요구。
Objective: To screen out the best prescription and preparation technology of the hollow type suppository of Zhishuning with fine appearance morphology and satisfactory dissolution rate. Methods: A fusion method was used to prepare the hollow type suppository of Zhishuning. With the appearance mor-phology, melting time and the dissolution rate as indexes, the single-factor test and the orthogonal test were used to screen out the best prescription of the hollow type suppository of Zhishuning. Results: The optimized base was semisynthetic fatty glyceride for the hollow type suppository of Zhishuning, with the ra-tio of the drug and base as 1∶4, the temperature of injection molding at 40℃ and the ratio of the surfac-tant Tween-80 and base as 1∶9. Conclusion: The hollow type suppository of Zhishuning made according to the determined preparation technology featured high drug dosage, smooth and fine appearance, quick drug release and complete softening without hard core in 30 minutes, which conformed to the design request of preparation.