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差示扫描量热法研究盐酸环丙沙星与辅料的相容性。

Differential scanning calorimetry to investigate the compatibility of ciprofloxacin hydrochloride with excipients.

作者信息

Fathy M, Hassan M A, Mohamed F A

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt.

出版信息

Pharmazie. 2002 Dec;57(12):825-8.

PMID:12561245
Abstract

The compatibility between ciprofloxacin hydrochloride (CFX) and some excipients was evaluated using differential scanning calorimetry (DSC). Physical mixture, coground mixture, compressed mixture and kneaded mixture were prepared to study the effect of sample manipulation. In addition, the samples of physical mixture were also accelerated at 55 degrees C for three weeks to obtain more reliable conclusions. Different types of excipients currently used in tablet or capsule formulations namely, calcium phosphate dibasic dihydrate (Emcompress), magnesium stearate lactose, sorbitol, mannitol, croscarmellose sodium (Ac-Di-Sol), sodium carboxymethyl starch (Primojel), microcrystalline cellulose (Avicel PH 101, Emcocil) were examined. The DSC scan of CFX displayed two endothermic peaks probably as a result of a fusion process followed by a decomposition process. CFX appeared to interact with sorbitol, mannitol, Ac-Di-Sol, Primojel, Avicel PH 101 and Emcocil.

摘要

采用差示扫描量热法(DSC)评估盐酸环丙沙星(CFX)与某些辅料的相容性。制备了物理混合物、共研磨混合物、压片混合物和捏合混合物,以研究样品处理的影响。此外,还将物理混合物样品在55℃下加速放置三周,以获得更可靠的结论。对目前片剂或胶囊制剂中使用的不同类型辅料,即磷酸氢钙二水合物(Emcompress)、硬脂酸镁、乳糖、山梨醇、甘露醇、交联羧甲基纤维素钠(Ac-Di-Sol)、羧甲基淀粉钠(Primojel)、微晶纤维素(Avicel PH 101、Emcocil)进行了研究。CFX的DSC扫描显示出两个吸热峰,这可能是熔融过程后接着分解过程的结果。CFX似乎与山梨醇、甘露醇、Ac-Di-Sol、Primojel、Avicel PH 101和Emcocil发生了相互作用。

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