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盐酸伐昔洛韦栓的制备及质量控制
Preparation and Quality Control of Valaciclovir Hydrochloride Suppository
【摘要】 目的:制备盐酸伐昔洛韦栓并建立其质量控制方法。方法:以明胶等为基质制备栓剂;采用高效液相色谱法测定盐酸伐昔洛韦的含量,并考察其稳定性。结果:所制栓剂软硬度合适;盐酸伐昔洛韦检测浓度线性范围为10.1~50.5μg·mL-1(r=0.9998),平均回收率为98.73%(RSD=0.76%,n=3)。结论:该处方制备工艺简单,制剂质量稳定、可控。
【Abstract】 OBJECTIVE: To prepare the valaciclovir hydrochloride suppository and to establish a quality control method. METHODS: The proper base material was gelatin. The valaciclovir hydrochloride was determined by HPLC and the stability test was performed. RESULTS: The prepared suppository had a proper hardness. There was a good linearity of calibration curve of valaciclovir hydrochloride in rang of 10.1~50.5μg·mL-1(r=0.999 8). The average recovery was 98.73%(RSD=0.76%,n=3).The suppository was stable. CONCLUSION: This method was simple, and the formulation thus prepared was stable and controllable in quality.
【Key words】 Valaciclovir hydrochloride suppository; Preparation; Quality control;
- 【文献出处】 中国药房 ,China Pharmacy , 编辑部邮箱 ,2007年07期
- 【分类号】R943
- 【被引频次】3
- 【下载频次】106