血汗净口服液的质量控制及稳定性研究

Study on Quality Control and Stability of Xuehanjing Oral Liquid

目的建立血汗净口服液的质量控制方法并考察其制剂稳定性。方法采用分光光度法测定其总氨基酸的含量,并用留样观察法进行初步稳定性实验。结果标准曲线A=0.101 6C-0.026 9(r=0.999 6),平均回收率为99.19%,RSD为1.78%(n=6)。该制剂在3个月内,各项考察指标均无明显变化。结论该方法简便、快速、准确可靠。制剂在考察期内质量稳定。

Objective To establish the quality control method of Xuehanjing Oral Liquid and inspect the stability of the preparation. Methods Spectrophotometry was used to determine the contents of total amino acids in Xuehanjing Oral Liquid, and the samples stored in room temperature were studied. Results The standard curve was A = 0. 101 6C-0.026 9 （r = 0.999 6） , with average recovery 99.19%, RSD = 1.78% （n = 6 ）. The inspected indexes had no obvious change within 3 months. Conclusion The quantitative method is simple, rapid and reliable, and the preparation is stable during the inspected time.