利巴韦林氯化钠注射液的制备及临床应用

Preparation and clinical application of ribavirin and sodium chloride injection

目的：建立利巴韦林氯化钠注射液的制备和质量控制方法，观察本制剂的临床疗效。方法：采用氯化钠作等渗调节剂制备输液，以ＨＰＬＣ法测定制剂中利巴韦林含量，将１６０ 例病毒感染者分组，治疗组５０ 例，对照组５０ 例，开放组６０ 例，观察指标。结果：制剂稳定，平均回收率９９．９２％ ，精密度试验ＲＳＤ＝ ０．２８％ ，临床应用表明治疗组与对照组疗效差异无显著性（ Ｐ＞０．０５），总有效率８７ ．３％ 。结论：本制备工艺可行，质量控制方法可靠。

OBJECTIVE:To establish a method for the preparation and quality control of ribavirin and sodium chloride injection and observe the effects.METHODS:The infusion was prepared by sodium chloride as a iso osmotic regulator.Ribavirin was determined by HPLC.160 cases infected by virus were assigned to therapy group(50 cases),control group(50 cases) and open group(60 cases) respectively,and observing indexes.RESULTS:The preparation was stable.The average recovery was 99.9% , RSD was 0.28% .There was no significant difference on effect between therapy group and control group( P > 0.05 ).The general effeciency rate was 87.3% .CONCLUSIONS:The preparation was practicable,the method for quality control was convenient,the clinical therapy was reliable.