健脾止泻宁颗粒的质量标准提高研究
x

请在关注微信后,向客服人员索取文件

篇名: 健脾止泻宁颗粒的质量标准提高研究
TITLE:
摘要: 目的:提高健脾止泻宁颗粒的质量标准。方法:采用薄层色谱法(TLC)对制剂中黄芩、山楂、金银花、党参、莲子、黄连进行定性鉴别;采用高效液相色谱法测定制剂中盐酸小檗碱、黄芩苷的含量:色谱柱为Shimadzu VP-ODS,流动相为甲醇-乙腈-水(46 ∶ 30 ∶ 42,V/V/V,盐酸小檗碱)(含0.1%十二烷基磺酸钠和0.1%磷酸)、甲醇-0.4%磷酸溶液(50 ∶ 50,V/V,黄芩苷),流速为1.0 mL/min,检测波长为265 nm(盐酸小檗碱)、280 nm(黄芩苷),柱温为30 ℃,进样量为10 μL。 结果:黄芩、山楂、金银花、党参、莲子、黄连的TLC图斑点清晰,分离度好,阴性对照无干扰。盐酸小檗碱、黄芩苷检测质量浓度线性范围分别为6.67~33.34 μg/mL(r=0.999 8)、7.7~38.7 μg/mL(r=0.999 9);精密度、稳定性、重复性试验的RSD<1.0%;加样回收率分别为96.5%~99.9%(RSD=1.2%,n=6)、101.1%~102.9%(RSD=0.6%,n=6)。结论:提高的标准可用于健脾止泻宁颗粒的质量控制。
ABSTRACT: OBJECTIVE: To improve the quality standard of Jianpi zhixiening granules. METHODS: TLC was applied for qualitative identification of Scutellaria baicalensis, Crategi Fructus, Lonicerae japonicae, Codonopsis Radix, Nelumbo nucifera, Coptidis Rhizoma. The contents of berberine hydrochloride and baicalin were determined by HPLC. The determination was performed on Shimadzu VP-ODS column with mobile phase consisted of methanol-acetonitrile-water (46 ∶ 30 ∶ 42, V/V/V, berberine hydrochloride)) (0.1% sodium dodecylsulphate, 0.1% phosphoric acid, methanol-0.4% phosphoric acid (50 ∶ 50,V/V, baicalin) at the flow rate of 1.0 mL/min. The detection wavelengths were set at 265 nm (berberine hydrochloride) and 280 nm (baicalin). The column temperature was 30 ℃, and sample size was 10 μL. RESULTS: TLC spots of S. baicalensis, Crategi Fructus, L. Japonicae, Codonopsis Radix, N. nucifera, Coptidis Rhizoma were clear and well-separated without negative interference. The linear ranges of berberine hydrochloride and baicalin were 6.67-33.34 μg/mL(r=0.999 8)and 7.7-38.7 μg/mL (r=0.999 9). RSDs of precision, stability and reproducibility tests were all lower than 1.0%. The recoveries were 96.5%-99.9%(RSD=1.2%,n=6)and 101.1%-102.9%(RSD=0.6%,n=6). CONCLUSIONS: Improved standard can be used for quality control of Jianpi zhixiening granules.
期刊: 2017年第28卷第18期
作者: 兰杨,谯志文,唐桂英,周年华,刘勇,吕姗珊
AUTHORS: LAN Yang,QIAO Zhiwen,TANG Guiying,ZHOU Nianhua,LIU Yong,LYU Shanshan
关键字: 健脾止泻宁颗粒;盐酸小檗碱;黄芩苷;质量标准;薄层色谱法;高效液相色谱法
KEYWORDS: Jianpi zhixiening granules; Berberine hydrochloride; Baicalin; Quality standard; TLC; HPLC
阅读数: 234 次
本月下载数: 6 次

* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!