pH对注射用盐酸地尔硫稳定性的影响

Effect of pH to the stability of diltiazem hydrochloride for injection

目的:确定注射用盐酸地尔硫的制备工艺并考察稳定性影响因素。方法:采用HPLC测定注射用盐酸地尔硫的含量及有关物质,考察制剂在强光、高热、高湿条件下的稳定性。结果:溶液状态时盐酸地尔硫最适pH为4,pH为5时冻干成品稳定性较好。注射用盐酸地尔硫对强光、高热条件下稳定性较差,在高湿条件下易吸潮塌陷。结论:本工艺条件能有效降低冻干成品有关物质,提高稳定性。

Objective ：To confirm the preparative technology of diltiazem hydrochloride for injection and the effect factor of stability. Methods：HPLC method was used for the determination of content and related substances of diltiazem hydrochloride, and study of the stability of the preparation at high temperature, high humidity and strong illumination. Results ： Optimum pH of diltiazem hydrochloride solution was 4, Optimum pH of diltiazen hydrochloride for injection was 5. Diltiazem hydrochloride for injection was unstable at high temperature and strong illumination. The preparation would dent at high humidity, Conclusions：This preparation procedure can reduce related substances availably and improve the stability of the preparation.