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引用本文:付莉娜,郑金琪,陶巧凤.不同晶型替米沙坦对制剂溶出行为的影响[J].中国现代应用药学,2017,34(8):1137-1139.
FU Lina,ZHENG Jinqi,TAO Qiaofeng.Effect of Different Crystal Types of Telmisartan on the Dissolution Behavior of Preparation[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(8):1137-1139.
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不同晶型替米沙坦对制剂溶出行为的影响
付莉娜1, 郑金琪2, 陶巧凤1
1.浙江省药品化妆品审评中心, 杭州 310012;2.浙江省食品药品检验研究院, 杭州 310052
摘要:
目的 用拉曼光谱对不同替米沙坦片中替米沙坦的晶型进行分析,并探讨不同晶型对替米沙坦片溶出行为的影响。方法 采用拉曼光谱法分析晶型,采用桨法测定溶出度,转速为50 r·min-1结果 5个批次样品发现3种不同晶型,不同晶型的替米沙坦片溶出行为存在一定差异。结论 原料的晶型对制剂的溶出有较大影响,企业在生产过程中应关注晶型对制剂的影响。
关键词:  替米沙坦  拉曼光谱  晶型  溶出行为
DOI:10.13748/j.cnki.issn1007-7693.2017.08.014
分类号:R943
基金项目:
Effect of Different Crystal Types of Telmisartan on the Dissolution Behavior of Preparation
FU Lina1, ZHENG Jinqi2, TAO Qiaofeng1
1.Zhejiang Center for Drug and Cosmetic Evaluation, Hangzhou 310012, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
Abstract:
OBJECTIVE To study the crystal types of telmisartan in different tablets with Raman spectrometer, and the effect of different crystal types on the dissolution behavior of tablets. METHODS Raman spectrum was used in the analysis of crystal types. The dissolution apparatus Ⅱ was used with speed of 50 r·min-1. RESULTS The result showed there was three crystals of telmisartan in five batches of samples, and the dissolution behaviors of different crystal types had some differences. CONCLUSION API crystal type has bigger effect on the drug dissolution, enterprise should pay attention to the effect of crystal type on the drug during the producing.
Key words:  telmisartan  Raman spectrum  crystal type  dissolution behavior
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