文章摘要
于风平,贺敦伟,闫敏,王晓环,王洪晶.口服固体制剂中淀粉类辅料含量的“逆向工程”分析[J].中国药事,2018,32(3):348-353
口服固体制剂中淀粉类辅料含量的“逆向工程”分析
“Reverse Engineering” Analysis of Starch Excipient in Oral Solid Preparations
投稿时间:2017-06-12  
DOI:10.16153/j.1002-7777.2018.03.010
中文关键词: 逆向工程  淀粉  含量测定  口服固体制剂  碘显色法  仿制药一致性评价
英文关键词: reverse engineering  starch  determining the content  oral solid preparations  iodine colorimetry  consistency evaluation for generic drugs
基金项目:
作者单位
于风平 山东则正医药技术有限公司, 淄博 255000
淄博市食品药品检验研究院, 淄博 255000 
贺敦伟 山东则正医药技术有限公司, 淄博 255000 
闫敏 山东则正医药技术有限公司, 淄博 255000 
王晓环 山东则正医药技术有限公司, 淄博 255000 
王洪晶 山东则正医药技术有限公司, 淄博 255000 
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中文摘要:
      目的:建立盐酸小檗碱片、格列吡嗪片、卡马西平片、盐酸雷尼替丁胶囊、茶碱缓释片、对乙酰氨基酚片6种口服固体制剂中淀粉类辅料含量的"逆向工程"分析方法。方法:口服固体制剂经有机溶剂提取去除干扰成分,采用碘溶液(称取碘1.3 g、碘化钾3.6 g加水溶解稀释至100 mL)显色后,在可见波长575 nm处测定吸光度。结果:淀粉浓度在20.288~71.008 μg·mL-1范围内线性关系良好(r=0.999),6种口服固体制剂的方法回收率均在85%~110%(n=9,RSD不超过5.0%),重复性(n=6)RSD均小于5.0%。结论:所建立的淀粉类辅料含量测定方法准确、可靠、操作方便,适合用于口服固体制剂中淀粉、玉米淀粉、预胶化淀粉等辅料的含量测定。
英文摘要:
      Objective: To establish the "reverse engineering" method for determining the content of starch excipient in oral solid preparations such as berberine hydrochloride tablets, glipizide tablets, carbamazepine tablets, ranitidine hydrochloride capsules, theophylline sustained-release tablets and paracetamol tablets. Methods: The oral solid preparations were extracted by organic solvents to remove the interferential ingredients, and the iodine solution (1.3 g iodine and 3.6 g potassium iodide were dissolved in 100 mL water) was added and the absorbance was measured at wavelength of 575 nm. Results: There was a good linear relationship (r=0.999) between concentration and absorbance when the range of concentration was from 20.288 to 71.008 μg·mL-1. All the recovery rates of the 6 solid preparations were between 85% and 110% (n=9, RSD no more than 5.0%) and the repeatability RSD (n=6) was less than 5.0%. Conclusion: The method for determining the content of starch excipient was accurate, reliable and convenient to carry out, which was suitable for determining the content of excipients such as starch, corn starch and pregelatinized starch in oral solid preparations.
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