复方达克罗宁薄荷脑润肤止痒水的制备及其质量控制  

Preparation and Quality Control of Compound Dyclonine Menthol Antipruritic Emollients Lotion

作　　者：李婷[1] 李成[1] 张开礼[1] 冯廉洁 罗意文 陈连剑[1] 

机构地区：[1]深圳市福田区人民医院,深圳市518033

出　　处：《中国药房》2011年第21期1965-1967,共3页China Pharmacy

基　　金：深圳市科技计划项目(200902144)

摘　　要：目的:制备复方达克罗宁薄荷脑润肤止痒水,并建立其质量控制方法。方法:以达克罗宁和薄荷脑为主药制备外用溶液;采用高效液相色谱法测定达克罗宁的含量、旋光法测定薄荷脑的含量。结果:所制制剂为无色澄明液体;达克罗宁的检测浓度线性范围为20.13～120.78μg·mL-(1r=0.9995),平均回收率为99.6%(RSD=0.43%);薄荷脑的检测浓度线性范围为1.13～5.65mg·mL-(1r=0.9998),平均回收率为99.6%(RSD=0.5%)。结论:该制剂制备工艺简单、质量可控。OBJECTIVE：To prepare Compound dyclonine menthol antipruritic emollients lotion and to establish its quality control method. METHODS：Lotion for external use was prepared using dyclonine and menthol as main component. HPLC method was used to determine the content of dyclonine,and optical rotation was used to determine the content of menthol. RESULTS：Prepared lotion was colourless clear and bright liquid. The linear range of dyclonine was 20.13～120.78 μg·mL-1（r=0.999 5） with an average recovery of 99.6%（RSD=0.43%）;the linear range of menthol was 1.13～5.65 mg·mL-1（r=0.999 8） with an average recovery of 99.6%（RSD=0.5%） . CONCLUSION：The preparation technology is simple and controllable.

关 键 词：复方达克罗宁薄荷脑润肤止痒水 制备 质量控制 高效液相色谱法 旋光法 

分 类 号：R943[医药卫生—药剂学] R927.2[医药卫生—药学]