金石利咽口崩片的制备及药效学研究
投稿时间:2018-05-21     点此下载全文
引用本文:张欣荣,邱仁杰,李越,许蕊蕊,齐梵琨,王秀丽.金石利咽口崩片的制备及药效学研究[J].中国现代中药,2018,20(12):1538-1543
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作者中文名作者英文名单位中文名单位英文名E-Mail
张欣荣 ZHANG Xin-rong 河北省中医院,河北石家庄050011 Traditional Chinese medicine Hospital of Hebei Provincial,Shijiazhuang 050011,China  
邱仁杰 QIU Ren-jie 北京中医药大学,北京102488 Beijing University of Traditional Chinese Medicine,Beijing 102488,China  
李越 LI Yue 北京中医药大学,北京102488 Beijing University of Traditional Chinese Medicine,Beijing 102488,China  
许蕊蕊 XU Rui-rui 北京中医药大学,北京102488 Beijing University of Traditional Chinese Medicine,Beijing 102488,China  
齐梵琨 QI Fan-kun 南方医科大学,广东佛山528300 Southern Medical University,Foshan 528300,China  
王秀丽 WANG Xiu-li 北京中医药大学,北京102488 Beijing University of Traditional Chinese Medicine,Beijing 102488,China 王秀丽,副研究员,博士,研究方向:新型给药系统研究;Tel:(010)84738657,E-mail:Lnwangxiuli@163.com 
基金项目:河北省中医药管理局科研计划项目(2017050)
中文摘要:目的:优化金石利咽口崩片处方和制备工艺,并考察其对急性咽炎的药效。方法:以片剂外观、硬度、脆碎度、口感和崩解时间为指标优化处方和制备工艺;采用超高效液相色谱法(UPLC)对有效成分绿原酸进行含量测定;以氨水咽部喷雾方法建立急性咽炎动物模型,比较金石利咽口崩片及原制剂金石利咽颗粒的药效。结果:优化处方为羧甲基淀粉钠55%、微粉硅胶9%、滑石粉0.5%、硬脂酸镁0.5%。以此处方制备金石利咽口崩片的硬度为4~6 kg,崩解时间为56 s,脆碎度在4.8%左右;片剂中绿原酸含量为0.033%。大鼠日常表现、血常规和炎症介质PGE2含量结果均表明,金石利咽口崩片治疗急性咽炎效果优于阳性药草珊瑚含片。结论:该口崩片处方工艺可行、操作简便,含量测定方法灵敏度高、重复性好,对急性咽炎有效,与金石利咽颗粒剂药效相当,将金石利咽颗粒剂改变剂型为金石利咽口崩片合理、可行。
中文关键词:金石利咽  口崩片  制备工艺  急性咽炎
 
Study on Preparation and Efficacy of Jin Shi Li Yan Orally Disintegrating Tablets
Abstract:Objective:To optimize the formulation and preparation process of Jin Shi Li Yan orally disintegrating tablets,and investigate its efficacy in treating acute pharyngitis.Methods:The prescription and preparation process were optimized with the appearance of tablets,hardness,fragility,taste and disintegration time.The content of chlorogenic acid was determined by UPLC,and the acute pharyngitis model of Wistar rats was established by the method of ammonia water pharynx spray to compare the efficacy of Jin Shi Li Yan orally disintegrating tablet and the original preparation Jin Shi Li Yan granule.Results:The optimized prescription was sodium carboxymethyl starch(55%),silicon dioxide(9%),talcum powder(0.5%)and magnesium stearate(0.5%).While Jin Shi Li Yan orally disintegrating tablets were prepared by using this prescription and process.The hardness was 4-6 kg,the disintegration time was 56 s and the friability was about 4.8%.The content of chlorogenic acid in the tablets was 0.033%.The results of daily performance,blood routine test and PGE2 content in rats showed that the effect of Jin Shi Li Yan orally disintegrating tablets on acute pharyngitis was better than that of positive herb.Conclusion:The prescription technology of orally disintegrating tablet is feasible and easy to operate,and the content determination method has high sensitivity and good reproducibility.Pharmacodynamic studies have proved it is effective for acute pharyngitis.That provided the basis for transforming Chinese patent medicines-Jin Shi Li Yan granules into orally disintegrating tablets.
keywords:Jin Shi Li Yan  orally disintegrating tablets  preparation process  acute pharyngitis
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