复方阿昔洛韦凝胶的制备及质量控制

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。

Preparation and Quality Control of Compound Aciclovir Gel

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-H2 O-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.