莲芝消炎胶囊中脱水穿心莲内酯质控标准的研究

Quality Standard of Dehydroandrographolide in Lian Zhi Xiao Yan Capsule

以脱水穿心莲内酯为指标,线性关系,精密度、重现性、回收率为评价标准,建立莲芝消炎胶囊中脱水穿心莲内酯的RP-HPLC法的测定条件和方法,以制定莲芝消炎胶囊的质量标准。采用ODS-C18柱(YMC-peackDOS-A,A303-S-5μm,250×4.6 mm),流动相为甲醇-水(6∶4),体积流量1 mL/min,灵敏度0.005,检测波长为254 nm,柱温30℃,分离度>1,样品液达到基线分离、峰形对称,脱水穿心莲内酯的保留时间在15 min左右,其主峰两侧不存在杂质峰,完全符合含量测定要求。结果表明PR-HPLC法适用于莲芝消炎胶囊中脱水穿心莲内酯质量标准的制定,从分析多批莲芝消炎胶囊中脱水穿心莲内酯含量测定的数据得出,每粒胶囊(0.5 g)中脱水穿心莲内酯的含量控制在≥10 mg为宜。

With dehydroandrographolide as the marker,and with linear relationship,precision,reproducibility,recovery as the criteria for the evaluation,To establish the determination of the contents of dehydroandrographolide in different batches of Lian Zhi Xiao Yan Capsule by RP-HPLC for clarifying quality standards of dehydroandrographolide in Lian Zhi Xiao Yan Capsule.The use of ODS-C18 column（YMC-peack DOS-A,A303-S-5 μm,250 mm×4.6 mm）,mobile phase of methanol-water（6：4）,flow rate of 1mL/min,sensitivity 0.005,detecting wavelength of 254 nm;column temperature 30 ℃,separation1,the sample liquid to reach the baseline separation,peak shape symmetry,dehydroandrographolide retention time 15 min or so,it does not exist on both sides of the main peak of the impurity peak,in line with requirements determination.The results show that RP-HPLC method was suitable for dehydroandrographolide in Lian Zhi Xiao Yan Capsule quality standards.By analysis of data obtained from batches of Lian Zhi Xiao Yan Capsule,dehydroandrographolide quality control standards to be in each piece（0.5 g） ≥ 10 mg appropriate.