氨咖黄敏胶囊中马来酸氯苯那敏的质量控制情况评价  

Eevaluation of the quality control of chlorphenamine maleate in Ankahuangmin Capsules

作　　者：丁苏苏 王威 凌真 李倚云 

机构地区：[1]江苏省扬州药品检验所,扬州225009

出　　处：《海峡药学》2012年第10期70-72,共3页Strait Pharmaceutical Journal

摘　　要：目的建立氨咖黄敏胶囊胶囊中马来酸氯苯那敏的含量测定及含量均匀度检查方法,对9个厂家生产的氨咖黄敏胶囊中马来酸氯苯那敏的质量控制情况进行比较。方法高效液相色谱法,菲罗门Gemin-i C18(250mm×4.6mm,5μm),流动相:以磷酸盐缓冲液(磷酸二氢铵11.5g,加水溶解,加H3PO41mL,加水至1000mL)-乙腈(82∶18)为流动相,检测波长为262nm。结果马来酸氯苯那敏的线性范围为8.12～162.47mg·mL-1,r为0.9999。平均回收率为98.9%(RSD=0.8%)。结论经过质量比较说明,有必要对咖黄敏胶囊中马来酸氯苯那敏进行控制。OBJECTIVE To establish a high performance liquid chromatography（HPLC） method for determination content and uniformity of chlorphenamine maleate in Ankahuangmin Capsules（PCACC Capsules）,and compare the quality of it from nine manufacteres.METHODS Used Gemini-C18（4.6mm×250mm,5μm） chromatographic column,mobile phase was（NH4H2PO4 11.5g,add H3PO41mL,add water to 1000mL）-acetonitfil（70∶30）,and flow rate was 1mL·min-1,detected at 262nm wavelength.RESULTS The linearity range of chlorphenamine maleate was 8.12～162.47μg·mL-1,and the correlation coefficient（r） were 0.9999.CONCLUSION It is necessary to control the quality of chlorphenamine maleate in Ankahuangmin Capsules.

关 键 词：氨咖黄敏胶囊 马来酸氯苯那敏 HPLC 含量均匀度 

分 类 号：R927.11[医药卫生—药学]