大鼠离体子宫法与高效液相色谱法测定缩宫素效价的相关性分析  

Correlation between isolated rats uterus method and HPLC method for oxytocin assay

作　　者：许雷鸣[1] 顾倩[2] 堵伟锋[1] 雷德强[3] 武谷 廖翔[4] 林园园[5] 

机构地区：[1]安徽省食品药品检验所,安徽合肥230051 [2]皖南医学院,安徽芜湖241000 [3]华中科技大学附属协和医院,湖北武汉430022 [4]广东医学院附属南山医院,广东深圳518052 [5]解放军第174医院,福建厦门361003

出　　处：《安徽医药》2014年第1期37-40,共4页Anhui Medical and Pharmaceutical Journal

基　　金：安徽省食品药品监管系统科研项目(No 0004)

摘　　要：目的探讨大鼠离体子宫法与高效液相色谱法测定缩宫素效价的相关性。方法采用《中国药典》2010年版二部附录缩宫素生物测定法和欧洲药典HPLC法,分别对合成缩宫素标准品溶液和国内不同生产厂家多批样品的缩宫素效价进行测定。结果两法测定合成缩宫素标准品溶液的缩宫素效价结果吻合;国内4个厂家14批样品测定结果的Pearson相关性分析表明HPLC法与大鼠离体子宫法之间具有显著相关性(P<0.01,r=0.802),但HPLC法测定结果在部分厂家的样品存在明显超出生物检定可信限范围的偏差。结论无干扰情况下两法结果吻合;HPLC法测定结果在国内部分厂家的样品明显超出生物检定本身允许的误差范围可能主要缘于样品中辅料和杂质的干扰或多肽生物活性的差异。该研究为缩宫素效价测定质量标准的提高提供了参考。Objective To explore the correlation between isolated rats uterus method and HPLC method for oxytocin assay. Methods Oxytocin assays of synthetic oxytocin standards solution and samples of different manufacturers were determined according to the bioassay of oxytocin indexed in the appendix of Ch. P 2010 vol II and HPLC naethod of European Pharmacopoeia. Results The two methods applied had a high consistency in synthetic oxytoein standards sdution. The results showed a good correlation （P 〈 0.01,r 0. 802） between isolated rats uterus method and HPLC method in 14 batehs of samples from four manufacturers. However,there were some devi- ation beyond the scope of confidence limits of bioassay in samples of some manufacturers. Condusioils The two methods applied had a high consistency when there was no disturbance. The determination of HPLC method appreciably exceeded the scope of allowable devi- ation of bioassay in samples of some manufacturers,which might be largely due to disturbance of accessories and impurities in samples or difference of pdypeptide bioaetivily. This study provided reference for the improvement of the quality standard of oxytoein assays.

关 键 词：缩宫素 离体子宫 高效液相色谱法 相关性 

分 类 号：R927.2[医药卫生—药学]