红花黄色素滴眼液中羟基红花黄色素A的含量测定  

Study on the Method of Quantitative Determination of Hydroxysafflor Yellow A in Safflor Yellow Eye Drops

作　　者：甄栋钦[1] 苏映雪[1] 王延东[1] 

机构地区：[1]中山大学中山眼科中心,广东广州510060

出　　处：《今日药学》2016年第10期687-690,共4页Pharmacy Today

基　　金：建设中医药强省科研课题(20121151)

摘　　要：目的研制红花黄色素滴眼液,并建立该制剂中羟基红花黄色素A的含量测定方法。方法按处方制备红花黄色素滴眼液,用高效液相色谱法(HPLC)测定红花黄色素中有效成分羟基红花黄色素A的含量,以十八烷基硅烷键合硅胶为填充剂,以甲醇-乙腈-0.7%磷酸溶液(26∶2∶72)为流动相,检测波长为403 nm,流速为1.0 mL·min^(-1)。结果该制剂制备工艺简单,可以过滤除菌,并无菌分装至5 mL的聚丙烯药用滴眼剂瓶中。羟基红花黄色素A在6.012~16.032μg·mL^(-1)范围内呈良好的线性关系,r=0.999 9,平均回收率为99.93%,RSD为0.92%(n=9)。该色谱方法重现性高,耐用性好,对照品溶液和供试品溶液在室温放置24 h内基本稳定。结论该制剂制备工艺简单,且含量测定方法可靠、准确,质量稳定,可用于老年性黄斑变性(AMD)的治疗。OBJECTIVE To prepare saffloryellow eye drops and establish a method for quantitative determination of hydroxysafflor yellow A. METHODS Saffloryellow eye drops were prepared following the formula. Hydroxysafflor yellow A contents were determined by HPLC. Conditions： Use a column packed with octadecylsilane bondedsilica gel and a mixture of methanol- acetonitrile- 0.7% Phosphoric acid（26：2：72）as the mobile phase. Detection wave-lengh is 40 nm.The flow rate is 1.0 mL. min-1. RESULTS The preparation was simple, could be sterilized by filtration, and could be filled into the 5 mL dose of polypropylene medical eye drops bottles. A good linearity of hydroxysafflor yellow A was in the range of 6.012-16.032 μg. mL-1（ r = 0.999 9）. The average recovery was 99.93% and RSD was 0.92% （n=9）. CONCLUSION The preparation technology of saffloryellow eye drops was simple,its content determination method was simple, sensitive, accurate and with good reproducibility.

关 键 词：红花黄色素滴眼液 羟基红花黄色素A 制备工艺 

分 类 号：R284.1[医药卫生—中药学]