盐酸伐昔洛韦中空栓的制备及质量控制

Preparation and quality control of valaciclovir hydrochloride hollow suppository

目的:制备盐酸伐昔洛韦中空栓并建立其质量控制方法。方法:以半合成脂肪酸甘油酯为基质制成中空栓;采用高效液相色谱法测定主药盐酸伐昔洛韦含量,测定波长为254nm,同时进行线性关系、精密度、稳定性、回收率的测定。结果:盐酸伐昔洛韦检测质量浓度在10.1～50.5mg/L范围内线性关系良好(Y=0.4001X+4.2351,r=0.9998),平均回收率为99.80%(RSD=0.76%)。结论:本方法简便?准确?重现性好,可用于盐酸伐昔洛韦中空栓的质量控制。

Aim： To prepare and establish quality control for the valaciclovir hydrochloride hollow suppository. Mothods ：The compound metronidazole hollow suppository was prepared with semisynthesis fatty acid glyceride as ground sub- stance. The content of valaciclovir hydrochloride was determined by using HPLC method at the wavelength of 254 nm. Resuits： There valaciclovir hydrochloride was a good linear correlation within a range of 10.1 -50.5 mg/L（ Y = 0. 400 1X ＋ 4. 235 1, r = 0. 999 8 ） of valaciclovir hydrochloride concentration. And the average reconvery was 99.8 % （RSD = O. 76% ）. Conclusion： The method is convenient, accurate, and reproducible, which could be used for the quality control of valaeiclovir hydrochloride hollow suppository.