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替硝唑分散片的制备与质量控制

Preparation of dispersible tinidazole tablets and its quality control

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【作者】 陈连剑李成李婷罗雪香刘杜妙宏瑞琼郭江赖毅勤

【Author】 CHEN Lian-Jian, LI Cheng, LI Ting, et al(The P eople’s Hospital of Futian,Guangdong Shenzhen 518033,China)

【机构】 深圳市福田人民医院广东药学院广东药学院 广东深圳518033广东深圳5180332003应届毕业生广东广州5102242003应届毕业生广东广州510224

【摘要】 目的 :制备替硝唑分散片并控制其质量。方法 :以低取代羟丙基纤维素、可溶性淀粉、硬脂酸镁、聚乙烯吡咯烷酮K3 0 为辅料研制该分散片。紫外分光光度法测定该分散片中替硝唑的含量 ,测定波长为 317nm。结果 :分散均匀性试验表明该分散片在 1min内均匀分散并通过 2号筛。替硝唑浓度在 6~ 2 4mg·L-1范围内与吸收度呈良好线性关系 ,r =0 .9999。平均回收率为 99.5 9% ,RSD为 0 .5 1% (n =5 )。结论 :该分散片符合中国药典 2 0 0 0年版的规定 ,质量控制方法可靠。

【Abstract】 OBJECTIVE To prepare dispersible tinidazole tabl et s and establish a method for its quality control. METHODS The d ispersible tablets was prepared by using low-subs tituted hydroxypropyl cellulose, soluble starch,magnesium stearate and povidone K 30 as excipients. The tinidazole content in tablets was determined by U V-spectrophotometry at 317 nm. RESULTS The uniformity test of dispersion showed that the table ts could smoothly disperse and pass through a No.2 sieve within 1 min.The tinida zole concentration was linear within the range of 6~24 mg·L -1 with r = 0.9999.The average recovery was 99.59% with RSD= 0.51%(n=5). CONCLUSIONS The dispersible tablets accord with the requirement of the Chinese Pharmacopoeia (2000) .The method of quality control is reliable.

  • 【文献出处】 中国医院药学杂志 ,Chinese Journal of Hospital Pharmacy , 编辑部邮箱 ,2004年06期
  • 【分类号】R943
  • 【被引频次】2
  • 【下载频次】180
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