复方阿昔洛韦凝胶的制备及质量控制  

Preparation and Quality Control of Compound Aciclovir Gel

作　　者：刘铭佩[1] 朱恒[1] 陈伟[2] 王金霞[2] 

机构地区：[1]兰州大学第二医院药剂科,兰州市730030 [2]兰州大学医学院药学系,兰州市730030

出　　处：《中国药房》2006年第6期428-430,共3页China Pharmacy

摘　　要：目的:制备复方阿昔洛韦凝胶并建立其质量控制方法。方法:以阿昔洛韦、双氯芬酸钠为主药,卡波姆-940等为基质制备凝胶;色谱柱为ZORBAX-SB-C18,流动相为甲醇-水-36%冰醋酸(70∶30∶2),检测波长为260nm。结果:所制凝胶为乳白色细腻半固体物;阿昔洛韦检测浓度在8.6768～60.7376μg/ml范围内线性关系良好(r=0.9997),平均回收率为104.34%,RSD=1.05%;双氯芬酸钠检测浓度在3.4408～34.408μg/ml范围内线性关系良好(r=0.9996),平均回收率为98.92%,RSD=1.19%。结论:本制剂易于涂布,所建立的质控方法可同时测定其中2主药的含量,且简便、灵敏、可靠。OBJECTIVE： Preparation of compound aciclovir gel and establish a method of quality control by HPLC. METHODS：The principal agent was aciclovir and diclofenac sodium, carbomer - 940 was base; ZORBAX - SB- C18 column was used with the mobile phase of methanol- H2O- 36%CH3COOH（70 ： 30 ： 2） .The detection wavelenth was 260nm. RESULT： The gel is lacte and delicale semisolid aciclovir exhibited a good linear ralationship with absorbance over the range of 8.6 768～ 60.7 376μg/ml（ r=0.9 997） .The average recovery was 104.34% RSD = 1.05% ; Diclofenac sodium exhibited a good linear ralationship with absorbance over the range of 3.4 408～34.408μg/ ml（ r = 0.9 996） .The average recovery was 98.92%, RSD = 1.19% .CONCLUSION：The gel could spread easily,And this method is simple rapaid and accurate to determine the aciclovir and diclofenac sodium of the compound acivclovir gel.

关 键 词：高效液相色谱法 阿昔洛韦 双氯芬酸钠 凝胶 质量控制 

分 类 号：R927.2[医药卫生—药学] R978.7