丹红注射液的质量标准及其稳定性研究  

Study on Quality Standard and Stability of Danhong Injection

作　　者：弋金龙[1] 黄翔[1] 何春晓[1] 汪兴宇[1] 张茹萍[1] 韩进[1] 陈波[1] 谌晓曦[1] 

机构地区：[1]浙江中医药大学,浙江杭州310053

出　　处：《中国中医急症》2013年第6期864-865,876,共3页Journal of Emergency in Traditional Chinese Medicine

基　　金：国家自然科学基金项目(30973933;81274176);浙江省自然科学基金项目(Z2101201;LR12H27001);浙江省中医药重点学科(2012-XK-A06);浙江省科技厅公益技术应用研究项目(2012C33122)

摘　　要：目的建立检测丹红注射液中有效部位含量的方法,并考察丹红注射液质量标准及其稳定性。方法丹红注射液中黄酮定量应用紫外可见分光光度法,以芦丁为标准品定量,检测波长506 nm;采用pH计法和沉淀法对注射液进行pH,鞣质、蛋白质、草酸盐、抗氧化试验和稳定性试验。结果芦丁在0.021~0.103 mg/mL范围内,浓度与吸光度成良好线性关系,r=0.9999,平均回收率100.46%,RSD为1.20%。6批注射液中总黄酮的含量分别9.68、9.85、9.58、11.80、10.42、11.67 mg/mL,pH 5.62～5.83,鞣质、蛋白质、草酸盐含量都符合药典规定。结论本实验方法操作简单,结果准确,可为丹红注射液的质量控制提供参考。Objective： To establish a method to detect the content of effective site in Danhong Injection and research for the quality standard and stability of it.Methods： The quantitative of flavonoids in Danhong Injection was tested by ultraviolet-visible spectrophotometer（UV-VIS）,rutin as standard,detection wavelength 506 nm.The pH value and stability test of the six batchs injection were determined with pH meter and the contents of tannin,protein,oxlaicacid slalt were detected by deferent methods.Results： From 0.021 to 0.103 mg/mL,the concentration and absorbance of rutin had a good linear relationship（r = 0.9999）,the average recovery rate was 100.46%,and the RSD was 1.20%.Six batchs injection of total flavonoids were 9.68,9.85,9.58,11.80,10.42,11.67 mg/mL,pH 5.62~5.83.Its content of tannin,protein,oxalate were complied Pharmacopoeia standard.Conclusion： The method is simple,accurate,and can provide a reference control for quality of Danhong injection.

关 键 词：丹红注射液 总黄酮 分光光度法 质量标准 稳定性 

分 类 号：R944.11[医药卫生—药剂学]