司坦唑醇分散片处方与制备工艺研究.pdfVIP

广东药学院学报 摇 Journal of Guangdong Pharmaceutical College摇 Feb.2011,27(1) 摇 司坦唑醇分散片处方及制备工艺研究 蒋掬月,周明礼,韦笑,陆东,刘雪原 (广西南宁百会药业集团有限公司,广西 南宁530003) 摘要:目的对司坦唑醇分散片的处方及制备工艺进行研究。 方法 通过预试验对处方进行初步筛选,用 正交试验法对处方进行优化,并考察粒径对药物溶出度的影响。 结果 优化处方为(按 1000 片计):180 g乳糖作为填充剂,10 g羧甲淀粉钠作为内加崩解剂,质量分数5%羧甲淀粉钠作为黏合剂,占干颗粒质 量分数2%的羧甲淀粉钠和3%的微晶纤维素作为外加崩解剂,质量分数1%硬脂酸镁作为润滑剂。 结 论 司坦唑醇分散片处方合理、工艺可行,适合于工业化生产。 关键词:司坦唑醇;分散片;处方工艺 中图分类号:R944.9摇 文献标识码:A摇 doi:10.3969/ j.issn.1006鄄8783.2011.01.004 文章编号:1006鄄8783(2011)01鄄0014鄄04 Optimization of the formula and preparation technology of stanozolol dispersible tablets JIANGJu鄄yue,ZHOU Ming鄄li,WEIxiao,LU dong,LIU Xue鄄yuan (GuangxiNanning Bestway Pharmaceutical Co. Ltd. ,Nanning,Guangxi530003,China) Abstract:Objective Toinvestigatetheformulaandpreparationtechnologyof stanozololdispersibletablets. Methods Preliminary experiments were designed to screen the formula,which was optimized by the orthogonal test,and the effect of particle size on drug dissolution was examined. Results The optimized formulafor stanozolol dispersible tablets( in per 1000 tablets) were as follows:180 g lactose as filling agent,10 g CMS鄄Na as inner鄄disintegrant,5%(w) CMS鄄Na as adhesive,2%(w) CMS鄄Na and 3%(w) MCC for weight of dry particles as outer鄄disintegrants,and 1% magnesium stearate as lubricant. Conclusion The prepared stanozolol dispersibletabletsisreasonable informula,feasible intechnology and it is suitablefor industrial production. Key words:stanozolol;dispersible tablets;formula preparation technology 摇 摇 司坦唑醇是蛋白同化类固醇类药,具有促进蛋 分散片(规格:2 mg)处方工艺进行研究。 白质合成、抑制蛋白质异生、降低血胆固醇和三酰甘 1摇 仪器与材料 油、促进钙磷沉积和减轻骨髓抑制等作用。 临床上, 司坦唑醇用于慢性消耗性疾病、手术后体弱消瘦、年 1.1摇 仪器 老体弱、骨质疏松症、小儿发育不良、再生障碍性贫 Agilent1200高效液相色谱仪;BS224S型电子天 血、白细胞减少症和高脂血症等,还可用于防治长期