齐墩果酸滴丸的质量标准研究
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篇名: 齐墩果酸滴丸的质量标准研究
TITLE:
摘要: 目的:建立齐墩果酸滴丸的质量标准。方法:鉴别制剂性状,检测制剂重量差异、溶散时限;采用超高效液相色谱法测定制剂中齐墩果酸的含量:色谱柱为ACQUITY UPLC BEH C18,流动相为乙腈-水(70 ∶ 30,V/V),流速为0.30 mL/min,检测波长为206 nm,柱温为30 ℃,进样量为5 μL。结果:制剂鉴别特征明显,丸重差异为37.62%~46.56%,溶散时间均为24 min。齐墩果酸检测质量浓度线性范围为0.006~0.06 mg/mL(r=0.999 8);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为99.34%~100.40%(RSD=0.4%,n=6)。结论:该研究所建标准可用于齐墩果酸滴丸的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Oleanolic acid dripping pills. METHODS: The property of the preparation was identified, and weight difference and dissolution time limit were detected. UPLC method was adopted to determine the content of oleanolic acid in the preparation. The determination was performed on ACQUITY UPLC BEH C18 column with mobile phase consisted of acetonitrile-water (70 ∶ 30,V/V) at the flow rate of 0.30 mL/min. The detection wavelength was set at 206 nm, the column temperature was 30 ℃,and the sample was 5 μL. RESULTS: The characteristics of the preparation was significant; weight difference ranged 37.62%-46.56%; dissolution time limit was 24 min. Linear range of oleanolic acid ranged 0.006-0.06 mg/mL(r=0.999 8). RSDs of precision,stability and reproducibility tests were all lower than 2.0%. The recoveries were 99.34%-100.40%(RSD=0.4%,n=6). CONCLUSIONS: Established standard can be used for quality control of Oleanolic acid dripping pills.
期刊: 2017年第28卷第21期
作者: 李祥,梁颖,杨新建
AUTHORS: LI Xiang,LIANG Ying,YANG Xinjian
关键字: 齐墩果酸滴丸;超高效液相色谱法;齐墩果酸;质量标准
KEYWORDS: Oleanolic acid dripping pills; UPLC; Oleanolic acid; Quality standard
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