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引用本文:李煜,王丹.粉末X-射线衍射技术定量测定氨糖美辛肠溶片中吲哚美辛晶型γ的含量[J].中国现代应用药学,2019,36(21):2683-2686.
LI Yu,WANG Dan.Quantitative Analysis of Indomethacin Crystal Type γ Content in Glucosamine and Indomethacin Enteric-coated Tablets by Powder X-ray Diffraction[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(21):2683-2686.
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粉末X-射线衍射技术定量测定氨糖美辛肠溶片中吲哚美辛晶型γ的含量
李煜, 王丹
浙江省食品药品检验研究院, 杭州 310052
摘要:
目的 采用粉末X-射线衍射技术(powder X-ray diffraction,PXRD)对氨糖美辛肠溶片中吲哚美辛晶型γ的含量进行定量分析。方法 采用精细扫描方法,扫描范围9~12°,扫描速度5秒/步,步长0.02°。结果 氨糖美辛肠溶片中吲哚美辛晶型γ含量线性方程为y=13 728x+1 131(r=0.990 8),检测限为21.2 mg·g-1S/N=4.6)。胶囊剂中晶型γ含量为45.73%~50.40%。结论 本法操作简单,在辅料没有干扰的情况下可用于氨糖美辛肠溶片中吲哚美辛晶型γ含量的定量分析和快速检测。
关键词:  吲哚美辛  粉末X-射线衍射  定量测定  晶型含量
DOI:10.13748/j.cnki.issn1007-7693.2019.21.010
分类号:R917.101
基金项目:浙江省食品药品监管系统科技计划项目(2018015)
Quantitative Analysis of Indomethacin Crystal Type γ Content in Glucosamine and Indomethacin Enteric-coated Tablets by Powder X-ray Diffraction
LI Yu, WANG Dan
Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
Abstract:
OBJECTIVE To establish a quantitative analysis of indomethacin crystal type γ content in glucosamine and indometacin enteric-coated tablets by powder X-ray diffraction(PXRD). METHODS The fine scanning method was adopted. The scan range was 9-12°, the scan speed was 5 s per step and the step size was 0.02°. RESULTS The linear equation was y=13 728x+1 131(r=0.990 8). The detection limit was 21.2 mg·g-1(S/N=4.6). The content of indomethacin crystal type γ in glucosamine and indometacin enteric-coated capsules was 45.73%-50.40%. CONCLUSION The method was simple in operation, which can be used for quantitative analysis of indomethacin crystal type γ content in glucosamine and indometacin enteric-coated tablets while no interference with excipient. It could be a rapid detection method for control crystal type γ content.
Key words:  indomethacin  powder X-ray diffraction  quantitative determination  crystal type content
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