二性霉素B阴道泡腾片制备工艺探究.docVIP

二性霉素B阴道泡腾片制备工艺探究[摘要] 目的:用正交设计方法优选二性霉素B阴道泡腾片的制备工艺。方法:采用正交设计,选择干颗粒水分、制粒筛网的孔径、黏合剂的用量3个因素,每个因素安排3个水平,按L9(34)进行正交实验,用外观和稳定性2个指标的综合评分确定制备工艺条件。按选定的工艺制备3批样品,考察各项质量指标和加速试验稳定性,并与上市品对比。结果:选择本品的制备工艺如下:称取碳酸氢钠90 g,加入淀粉27 g,以10%淀粉浆制软材,40目筛制粒,干燥至水分1%,整粒,备用;称取酒石酸90 g,硼酸78 g,淀粉27 g,混匀,加入10%淀粉浆制软材,40目筛制粒,干燥至水分1%,整粒,备用。将二性霉素B 2.5 g,PEG6 000 6 g混合均匀,与上述两种颗粒混匀压片,即得。制得的样品具有较好的外观,各项质量指标合格,加速试验结果表明稳定性较好,与上市品相当。结论:本研究确定的处方工艺可用于制备二性霉素B阴道泡腾片。 [关键词] 二性霉素B;阴道泡腾片;制备;稳定性 [中图分类号] R943 [文献标识码]C [文章编号]1674-4721(2010)06(c)-125-03 Preparation process research of amphotericin B vaginal effervescent tablets FU Xuemeng1, DONG Yan2, ZHUANG Rangxiao3 (1.Hangzhou Guoguang Pharmaceutical Co, Ltd, Zhejiang Province, Hangzhou 310018, China; 2. People’s Hospital of Changxing County, Zhejiang Province, Changxing 313100, China; 3. 6th People’s Hospital Hangzhou City Zhejiang province Hangzhou 310014, China) [Abstract] Objective: Seek the optimum technique to prepare amphotericin B vaginal effervescent tablets by orthogonal test. Methods: The influencing factors such as the moisture of dried garanules, the aperture of granulating sift, the consumption of binder were studied and each was arranged 3 levels according to L9(34)orthogonal table. The comprehesive score of the two indexes, appearence and stability, was used to assess the figuration character of a technique. The selected technique was validated by preparing 3 batchs of amphotericin B vaginal effervescent tablets, thus checking their quality and stability via accelerated experiments and comparing with the same product from the market treated at the same way. Results: The advisable technique is following: take NaHCO3 90 g ,starch 27 g, mix evenly with 10% starch paster, make granules by 40-meshed sift, then dry until the moisture reach 1% and sift again, standby; take tartaric acid 90 g, boric acid 78 g and starch 27 g, mix evenly with 10% starch paster, make granules by 40-meshed sift, then dry until the moisture reach 1%, and sift again;