二性霉素B阴道泡腾片的制备工艺研究(1)
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2010年6月25日
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[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; finally blend amphotericin B2.5 g and PEG6 000 6 g, then mix with the former granules and tablet. The producst with satisfactory appearances can meet the relevant norm. Their stability were also accepted through accelerated experiments after compared with the same marketed product ......
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