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机构地区:[1]江西博雅生物制药股份有限公司,江西抚州344000
出 处:《药品评价》2011年第14期19-22,共4页Drug Evaluation
摘 要:目的:建立一种荷移分光光度法测定人纤维蛋白原中盐酸精氨酸含量的方法。方法:根据荷移分光光度法原理.利用盐酸精氨酸在硼砂缓冲液作用下与四氯苯醌发生荷移反应.在350nm波长下测定其吸光度,从而计算出人纤维蛋白原中盐酸精氨酸含量。结果:通过测定回收率和相对偏差来评价该方法准确度、线性范围和耐用性。平均值回收率为9967%(RSD为127%).线性范围为99.92±0696%(RSD为07%),耐用性为10043%(RSD为147%);该方法适用于25%。65%浓度区间。与药典法测定结果相比无显著差异。结论:通过对本法的准确度、线性范围、耐用性方面的验证.该方法可适用于人纤维蛋白原中盐酸精氨酸含量的测定。Objective: To establish a charge transfer spectrophotometry for the determination of arginine hydrochloride in human fibrinogen. Methods: According to the charge transfer spectrophotometry principle, a charge-transfer reaction of arginine hydrochloride with tetrachlorobenquinone was occured in borate buffer and then the absorbance of the 350nm wavelength was measured to calculate the arginine .hydrochloride content in human fibrinogen. Reatlts: The accuracy, the linear by measuring the recovery and the relative deviation, range and the durability of the method were evaluated and the value is 99.67%(RSD 1,27%)for the accuracy; 99.92 ±0.696%(RSD 0.7%) for the linear range and 100.43% (RSD 1.47%)for the durability, respectively. The method is suitable for 2.5%±6.5% concentration ranges. The results showed no significant difference comparing with Pharmacopoeia method. Conclusion: The method was validated for the determination of arginine hydrochloride in human fibrinogen by the verification of the accuracy, the linear range, durability and other aspects, and the method can be applied for the determination of arginine hydrochloride in human fibrinogen.
关 键 词:荷移分光光度法 人纤维蛋白原 盐酸精氨酸 含量测定
分 类 号:R917[医药卫生—药物分析学]
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