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引用本文:邹华生,王燕飞.正交法优选注射用硼替佐米红外光谱鉴别中压片条件[J].中国现代应用药学,2018,35(4):472-474.
ZOU Huasheng,Wang Yanfei.Condition of Optimun Seeking Bortezomib for Injection Infrared Spectrum to Identification the Preparing Disk with Orthogonal Design[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(4):472-474.
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正交法优选注射用硼替佐米红外光谱鉴别中压片条件
邹华生, 王燕飞
扬子江药业集团上海海尼药业有限公司, 上海 201318
摘要:
目的 探索一种注射用硼替佐米红外光谱鉴别中压片最佳条件,以获得最理想的红外光谱图。方法 以硼替佐米与溴化钾的比例、压片的压力和保持压力的时间为因素设计正交设计试验,以输出的红外光谱图的基线值和最强吸收峰的透光率为指标,通过极差和方差分析,确定影响红外光谱图的主次因素,从而确定压片最佳条件。结果 优选出的最佳条件为硼替佐米2.5 mg,溴化钾200 mg,压片压力为50 kN,压片时间为3 min,录得红外光谱图最理想,基线>99%透光率,最强吸收峰透光率为3%。结论 正交法优选注射用硼替佐米红外光谱鉴别中压片条件,能方便快捷地获得理想的光谱图。
关键词:  正交法  注射用硼替佐米  硼替佐米  红外光谱图  压片  最佳条件
DOI:10.13748/j.cnki.issn1007-7693.2018.04.003
分类号:R944.1
基金项目:“重大新药创制”国家科技重大专项(2011ZX09202-101-29)
Condition of Optimun Seeking Bortezomib for Injection Infrared Spectrum to Identification the Preparing Disk with Orthogonal Design
ZOU Huasheng, Wang Yanfei
Yangtze River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd. Shanghai 201318, China
Abstract:
OBJECTIVE To explore a best condition of bortezomib for injection infrared spectrum to identification preparing disc in order to get satisfied infrared spectrum. METHODS three-factor, three-level experimental design with the ratio of bortezomib to potassium bromide, the pressure of discing and the time of pressure holding were used. According to the experiment with orthogonal design, using the output of baseline value T% as target, through range analysis and variance analysis define the main factor which influence infrared spectra to define the best condition of preparing disc. RESULTS The best infrared spectra were obtained under the optimum conditions (bortezomib 2.5 mg, KBr 200 mg, pressure of 50 kN, the pressure holding time was 3 min). The transmittance of baseline was more than 99%, and the transmittance of the strongest absorbance peak was 3%. CONCLUSION The condition of optimun seeking bortezomib for injection infrared spectrum to identification the preparing disk with orthogonal design can conveniently and quickly get the satisfied infrared spectrum.
Key words:  orthogonal design  bortezomib for injection  bortezomib  infrared spectrum  peparing disk  the best condition
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