复方红衣补血口服液含量测定方法学研究  

Methodology study on Complex Hongyibuxue Oral Solution

作　　者：胡百忠 王彦华 

机构地区：[1]山东翔宇健康制药有限公司,山东临沂276023

出　　处：《齐鲁药事》2012年第10期590-591,共2页qilu pharmaceutical affairs

摘　　要：目的建立薄层扫描法测定复方红衣补血口服液含量的方法,为提高本制剂的质量标准提供技术参考。方法采用CS-9301型薄层扫描仪,硅胶G板,定量毛细管。结果空白试验无干扰,甜菜碱在点样量4.12～20.6μg范围内线性关系良好,线性回归方程Y=165.41X-89.493(r=0.999)。同板间精密度对照品和供试品的RSD分别为1.14%和0.80%;异板间精密度含量的RSD为2.31%;供试品在80 min内斑点颜色稳定,重现性的RSD为2.32%(n=6);平均回收率为96.9%,RSD为0.62%(n=5)。结论该法专属性、重现性好,为控制复方红衣补血口服液质量提供了试验依据。Objective To establish a TLCS method for the determination of Complex Hongyibuxue Oral Solution to provide technical reference for its quality standard improvement. Methods TLC scanning method was adopted on CS - 9301 thin layer scanner,and silica gel G plate and quantitative capillary were used. Results The blank test had no interference and betaine showed good linear relationship within 4.12 - 20.6 g. The regression equation was Y = 165.41X - 89. 493 （ r = 0. 999 ）. The RSD of control and sample of precision test in the same plate were 1.14% and 0.80% ,and the RSD of the precision test in different plate was 2.31%. The spot color was stable in 80 min,the RSD of the reproducibility was 2.32%. The average recovery was 96. 9% and the RSD was 0.62% （ n = 5 ）. Conclusion The method was specific, reproducible, and it can provide basis for the quality control of Complex Hongyibuxue Oral Solution.

关 键 词：薄层扫描法 复方红衣补血口服液 含量测定 

分 类 号：R927.2[医药卫生—药学]