论文部分内容阅读
盐酸丁卡因注射液为局部麻醉药,全国各地医院制剂手册均有收载。由于丁卡因具有酯类结构,因此在偏碱性水溶液中或加热灭菌时易水解,其水解受溶液pH的影响颇大,国外有关丁卡因的水解动力学已有过详细研究,国内有关国产原料丁卡因稳定性问题也有报道。鉴于(1)同内对丁卡因的定量方法大都采用容量法,误差大且专属性不强,(2)本品室温下贮存期未见详细报道,为此,我们采用热加速试验法考查了:(1)不同pH和不同温度对本品稳定性的影响;(2)本品在室温下的贮存期。本文参考文献方法将样品在加有pH=6
Tetracaine hydrochloride injection is a local anesthetic, hospital preparation brochures all over the country are included. Since tetracaine has an ester structure, it is easily hydrolyzed in an alkaline aqueous solution or when heat-sterilized, and its hydrolysis is greatly influenced by the pH of the solution. Hydrolysis kinetics of tetracaine in foreign countries has been studied in detail. The problem of tetracaine stability of domestic raw materials has also been reported. In view of (1) the same method for the quantitative determination of tetracaine by volume method, the error is large and the specificity is not strong, (2) the product was not reported in detail storage at room temperature, for which we use thermal accelerated test method : (1) different pH and different temperature on the stability of the product; (2) the product at room temperature storage period. This article references the method of adding the sample pH = 6