影响普鲁卡因注射液质量因素的探讨

The factors affecting the quality of Procaine Hydrochloride injection

目的:探讨生产条件对普鲁卡因注射液成品质量的影响。方法:对该注射液成品的含量下降进行了实验,并测定了成品 pH 值、颜色和有关物质的变化。此外,进一步测定了中间品 pH 值在4.0～5.0变化时对成品含量下降的影响。结果:中间品 pH 值和消毒时间对成品含量下降有极显著影响(P<0.01)。中间品 pH 值和酸的种类对成品 pH 值的影响差异没有显著性意义(P>0.05)。注射液成品颜色没有变化,但有关物质有所增加,q 检验表明,中间品 pH>4.8时,对成品含量下降影响与其它 pH 值比较差异有极显著性(P<0.01)。结论:生产过程中应严格控制消毒温度和时间,中间品的 pH 值应调节在4.2～4.5范围内为宜。

Objeclive:To study the factor of productive technological process that affects the quality of Procaine Hydrochloride injection.Methods:Experiments were done on the content reduc- lion,pH,color and related substances changes of the final product measured.The affects of pH change between 4.0～5.0 on the content reduction of the fina!product were measured.Results-the content reduction of the final product was affected markedly by intermediate pH and sterilizing time (P<0.01).The affects of intermediate pH and the different kinds of acid on the pH of the final product was almos,the same(P>0.05).The color of the final product does not occur change ,but its relative mater increased.Using q test,when intermediate pH is 4.8 or more,the content reduction of the final product was affected very markedly(P<0.01).Conclusions:The temperature and time of sterilizing should bc controlled,intermediate pH change between 4.2～4.5 might be selected.