复方庚酸炔诺酮注射液中苯甲醛含量与茶油酸值、过氧化值的相关性研究  

Correlation of Benzaldehyde Content with Acid Value of Tea-seed Oil and Peroxide Value in Compound Norethisterone Enanthate Injection

作　　者：彭茗[1] 任飞亮[1] 朱瀛华[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药房》2013年第13期1171-1173,共3页China Pharmacy

基　　金：2011年国家药品评价抽验任务资助项目(No.2011-125)

摘　　要：目的:建立复方庚酸炔诺酮注射液(CNEI)中苯甲醛含量的测定方法,并探讨苯甲醛含量与辅料茶油酸值、过氧化值的相关性。方法:采用2010年版《中国药典》(一部)附录Ⅸ酸值、过氧化值的方法,测定市售2008年和2010年生产的各2批CNEI的酸值和过氧化值;采用气相色谱法测定其中苯甲醛的含量(以CNEI中所含苯甲醇的量计),分析苯甲醛含量与茶油酸值、过氧化值的相关性。结果:2008年生产的2批CNEI样品的酸值(0.6144、0.6213)和过氧化值(0.1354%、0.1039%)均明显高于2010年生产的2批样品的酸值(0.3617、0.3930)和过氧化值(0.0513%、0.0929%)。4批CNEI中苯甲醛含量分别为4.08%、4.08%、0.31%、0.45%,苯甲醛的含量与CNEI酸值及过氧化值的Spearman相关系数均为0.949,单侧P值均为0.026。结论:随贮存时间的延长,CNEI的过氧化值及酸值均有所增加;CNEI中苯甲醛的含量与茶油的酸值和过氧化值均呈显著的正相关。OBJECTIVE：To establish the method for the content determination of benzaldehyde in Compound norethisterone enanthate injection（CNEI）,and to investigate the relationship of benzaldehyde content with acid value of tea-seed oil and peroxide value.METHODS：According to the method stated in the appendix Ⅸ of volume Ⅰof Chinese Pharmacopeia（2010 edition）,the acid value and peroxide value of 2 batches of CNEI produced in 2008 and 2010 were determined.The content of benzaldehyde was determined by GC（by benzaldehyde content of CNEI）,and the correlation of benzaldehyde with acid value of tea-seed oil and peroxide value was analyzed.RESULTS：The acid value（0.614 4,0.621 3）and peroxide value（0.135 4%,0.103 9%）of 2 batches of samples manufactured in 2008 were all higher that the corresponding results in the samples manufactured in 2010（0.361 7,0.393 0）,（0.051 3%,0.092 9%）.The contents of benzaldehyde in 4 batches of CNEI were 4.08%,4.08%,0.31% and 0.45%.Spearman＇s rank correlation coefficients between the amount of benzaldehyde and the acid value as well as the peroxide value were both 0.949,and the one-side P values were both 0.026.CONCLUSIONS：The acid value and peroxide value of CNEI increase with the extension of storage life.The amount of benzaldehyde is positively correlated with acid value of tea-seed oil and peroxide value in CNEI.

关 键 词：复方庚酸炔诺酮注射液 茶油 酸值 过氧化值 苯甲醛 含量 

分 类 号：R927.1[医药卫生—药学]