七味马钱子丸的质量标准提高研究
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篇名: 七味马钱子丸的质量标准提高研究
TITLE:
摘要: 目的:提高七味马钱子丸的质量标准。 方法:采用薄层色谱法(TLC)对制剂中诃子、木香进行定性鉴别。采用高效液相色谱法测定制剂中羟基红花黄色素 A、马钱子碱和士的宁的含量,色谱柱为Phenomenex Prodigy C18,流动相为甲醇-乙腈-0.7%磷酸溶液(26 ∶ 2 ∶ 72,V/V/V,羟基红花黄色素 A)、乙腈-0.01 mol/L庚烷磺酸钠和0.02 mol/L磷酸二氢钾等量混合溶液(以10%磷酸溶液调pH至2.8)(21 ∶ 79,V/V,马钱子碱和士的宁),流速为1.0 mL/min,检测波长为403 nm(羟基红花黄色素 A)、260 nm(马钱子碱、士的宁),柱温为25 ℃,进样量为10 μL。结果:诃子、木香的TLC图斑点清晰,分离度好,阴性对照无干扰。羟基红花黄色素A、马钱子碱和士的宁检测质量浓度线性范围分别为6.29~62.94 μg/mL(r=0.999 3)、1.83~18.30 μg/mL(r=0.999 4)、2.11~21.11 μg/mL(r=0.999 6);精密度、稳定性、重复性试验的RSD<2.0%(n=6);加样回收率分别为101.66%~104.91%(RSD=1.14%,n=6)、99.58%~104.55%(RSD=1.75%,n=6)、101.22%~104.04%(RSD=0.99%,n=6)。结论:提高的标准可更好地用于七味马钱子丸的质量控制。
ABSTRACT: OBJECTIVE: To improve the quality standard for Qiwei maqianzi pills. METHODS: TLC was used for the qualitative identification of Chebulae Fructus and Aucklandiae Radix in the preparation. HPLC method was used for the content determination of hydroxy safflor yellow A, brucine and strychnine in preparation.  The determination was performed on Phenomenex Prodigy C18 column with mobile phase consisted of methanol-acetonitrile-0.7% phosphoric acid soulution(26 ∶ 2 ∶ 72,V/V/V, for hydroxy safflor yellow A), acetonitrile-0.01 mol/L sodium heptanesulfonate mixed with same quantity of 0.02 mol/L potassium dihydrogen phosphate (pH adjusted to 2.8 using 10% phosphoric acid, 21 ∶ 79,V/V, for brucine and strychnine) at the flow rate of 1.0 mL/min. The detection wavelengths were 403 nm (for hydroxy safflor yellow A) and 260 nm (for brucine and strychnine). The column temperature was 25 ℃, and the injection volume was 10 μL. RESULTS: TLC spots of Chebulae Fructus and Aucklandiae Radix were clear and well-separated without interference from negative control. The linear range was 6.29-62.94 μg/mL for hydroxy safflor yellow A(r=0.999 3), 1.83-18.30 μg/mL for brucine(r=0.999 4) and 2.11-21.11 μg/mL for strychnine(r=0.999 6).RSDs of precision, stability and reproducibility tests were lower than 2.0%. The recoveries were 101.66%-104.91%(RSD=1.14%,n=6), 99.58%-104.55%(RSD=1.75%,n=6) and 101.22%-104.04%(RSD=0.99%,n=6), respectively. CONCLUSIONS: Improved standard can be better used for quality control of Qiwei maqianzi pills.
期刊: 2018年第29卷第2期
作者: 范莹莹,才毛,杨凤梅
AUTHORS: FAN Yingying,CAI Mao,YANG Fengmei
关键字: 七味马钱子丸;诃子;木香;羟基红花黄色素 A;马钱子碱;士的宁;薄层色谱法;高效液相色谱法;质量标准
KEYWORDS: Qiwei maqianzi pills; Chebulae Fructus; Aucklandiae Radix; Hydroxy safflor yellow A; Brucine; Strychnine;TLC; HPLC; Quality standard
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