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菌毒清分散片处方的优选试验

Formula Optimization of Junduqing Dispersible Tablets

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【作者】 邢洁李运景唐蕾李卓亚

【Author】 Xing Jie;Li Yunjing;Tang Lei;Li Zhuoya;Department of Pharmacy,Zhongshan Municipal People’s Hospital;

【机构】 中山市人民医院药学部

【摘要】 目的:优选菌毒清分散片的处方。方法:以表面形态、崩解时限和分散均匀性为指标,采用单因素试验优选填充剂、崩解剂和粘合剂种类;以崩解时限为指标,采用正交试验进一步优选填充剂和崩解剂用量;以片剂外观和压片粘冲情况为指标,采用单因素试验优选润滑剂;以崩解时限为指标,采用单因素试验优选崩解剂的加入方法。结果:优选的处方以500片投料量计算,菌毒清浸膏61.25 g,选取52.5 g微晶纤维素和17.5 g糊精为填充剂,以8.75 g交联聚乙烯吡咯烷酮和26.25 g交联羧甲基纤维素钠为崩解剂,以70%乙醇为黏合剂,以3 g硬脂酸镁和2.25 g滑石粉为润滑剂,以3.5 g甜菊苷为矫味剂。结论:所选处方合理、可行,可为菌毒清分散片的制备提供理论依据。

【Abstract】 Objective: To optimize the formula of Junduqing dispersible tablets. Methods: Using appearance,disintegration time and dispersing uniformity as the indices,the types of filler,disintegrating agent and adhesive were optimized by single factor tests; the amount of filler and disintegrating agent was optimized by orthogonal experiments with the disintegration time as the index; using appearance and sticking as the indices,the single factor tests were also used to optimize the lubricant,and the adding method of disintegrating agent was optimized using disintegration time as the index. Results: For 500 tablets,the amount of Junduqing extract was61. 25 g,microcrystalline cellulose( 52. 5 g) and dextrin( 17. 5 g) were used as the fillers,crospolyvinylpyrrolidone( 8. 75 g) and croscarmellose sodium( 26. 25 g) were applied as the disintegrating agents,70% ethanol was the binder,magnesiumstearate( 3 g)and talcum powder( 2. 25 g) were used as the lubricants,and stevioside( 3. 5 g) was the flavoring agent. Conclusion: The formula is reasonable and feasible,which provides reference for the preparation of Junduqing dispersible tablets.

【关键词】 菌毒清分散片处方制备工艺
【Key words】 JunduqingDispersible tabletsFormulaPreparation technology
【基金】 中山市医学科研项目(编号:2014J060)
  • 【分类号】TQ461
  • 【被引频次】4
  • 【下载频次】103
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