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近来盐酸普鲁卡因注射液不但用于局部麻醉,更常用于封闭疗法。由于灭菌时间过长,pH值较高,或放置时间过长等,常会失效。其分解产物为对氨基苯甲酸和2-二乙氨基乙醇: 影响这一水解反应的因素很多,主要有下列几点:(1)pH与灭菌时间、温度的影响:本品一般在偏酸性情况下灭菌较稳定。但由于酸度过高,麻醉力降低,故一般pH值多以4.5—5.0为佳。灭菌时通常採用100℃蒸气灭菌法,时间约为30分钟。倘若在加压釜中灭菌,常会使分解加速。(2)光线对本品分解亦有影响,故应避光保存。(3)其他如溶液接触的器皿、工具、设备等,均不得含有铜铁等金属,安瓿的硷度和安瓿灌液后的空间大小,均有一定关系。由于盐酸普鲁卡因注射液易分解,其分解产物的鑑别方法具有很重要意义。检查时主要看有无对氨基苯甲酸存在,手绩如下: 取一定量注射液,以氢氧化钠硷化后,用氯仿抽提几次,将未分解的普鲁卡因和2-二乙氨基乙醇抽提干净,在水溶液中应无普鲁卡因存在。取一定量水溶液,用盐酸酸化以后,在冰水中放置三分钟,加入亚硝酸钠溶液数滴,并加入数滴β-萘酚的硷性溶液,如颜色呈红色,表明有对氨基苯甲酸存在,也就是说本品已经分解。但普鲁卡因也有游离的芳香伯胺基,重氮化反应也能得到同样的颜色。为了防止水層中普鲁卡因没有抽提完全,或完全区别开普鲁卡因和对氨基苯甲酸,最好採用Marshall反应以
Recently, procaine hydrochloride injection not only for local anesthesia, more commonly used in closed therapy. Due to sterilization time is too long, high pH, or place too long, often failure. The decomposition products of p-aminobenzoic acid and 2-diethylaminoethanol: There are many factors affecting the hydrolysis reaction, mainly in the following points: (1) pH and sterilization time and temperature effects: This product is generally acidic Sterilization more stable case. However, due to high acidity, anesthesia decreased, so the general pH value of 4.5-5.0 better. Sterilization is usually used at 100 ℃ steam sterilization method, the time is about 30 minutes. If sterilized in an autoclave, decomposition will often accelerate. (2) light on the decomposition of the product also have an impact, it should be kept dark. (3) Other containers, tools, equipment, etc. that are in contact with the solution should not contain metal such as copper and iron, and the alkalinity of ampoule and the space size after ampoule filling have certain relationship. As procaine hydrochloride injection is easy to decompose, its decomposition products identification method is of great significance. Mainly to check whether there is para-aminobenzoic acid exists, the following is the record: take a certain amount of injection, with sodium hydroxide alkaline, chloroform extraction several times, unsolubilized procaine and 2-diethyl Amino ethanol extraction clean, no procaine exists in aqueous solution. Take a certain amount of aqueous solution, acidified with hydrochloric acid, placed in ice water for three minutes, adding a few drops of sodium nitrite solution, and adding a few drops of β-naphthol alkaline solution, such as the color was red, indicating the presence of para-aminobenzoic acid , That is to say this product has been decomposed. But procaine also has free aromatic primary amine, diazotization can get the same color. In order to prevent the aqueous procaine not fully extracted, or completely separated from the procaine and para-aminobenzoic acid, Marshall reaction is best to use