丹红注射液的质量标准及其稳定性研究

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.