川参胶囊的质量标准提高研究
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篇名: 川参胶囊的质量标准提高研究
TITLE:
摘要: 目的:完善和提高川参胶囊的质量标准。方法:参考2015年版《中国药典》(一部)操作,采用薄层色谱(TLC)法对川参胶囊中丹参、川芎、红花、赤芍进行定性鉴别。采用高效液相色谱法(HPLC)测定制剂中阿魏酸、丹参酮ⅡA的含量,阿魏酸、丹参酮ⅡA测定的色谱柱均为Kromasil C18,流动相分别为甲醇-1%醋酸溶液(30 ∶ 70,V/V)、甲醇-水溶液(85 ∶ 15,V/V),检测波长分别为321、270 nm,流速均为1.2 mL/min,柱温分别为40、25 ℃,进样量分别为10、20 μL。结果:在丹参、川芎、红花、赤芍TLC供试品图谱中,在与对照图谱相应位置上显相同颜色的斑点。阿魏酸、丹参酮ⅡA的线性范围分别为4.48~112.00、5.88~210.00 μg/mL(R2=0.999 0、0.999 9),平均回收率分别为102.22%、102.23%(RSD=1.63%、1.22%,n=6),精密度、稳定性、重复性试验的RSD均小于2%(n=6),平均含量分别为0.118 4、0.221 mg/粒(n=3)。结论:本研究通过定性、定量方法完善了川参胶囊的质量标准,并初步拟定其中有效成分阿魏酸的含量不低于0.10 mg/粒,丹参酮ⅡA的含量不低于0.18 mg/粒。
ABSTRACT: OBJECTIVE: To optimize and improve the quality standard for Chuanshen capsules. METHODS: Referring to 2015 edition of Chinese Pharmacopeia (Ⅰ), Salvia miltiorrhizae, Chuanxiong rhizome, Carthami flos and Paeonia radix rubra were identified qualitatively by TLC. The contents of ferulic acid and tanshinone ⅡA were determined by HPLC. The determination of ferulic acid and tanshinone ⅡA were performed on Kromasil C18 column with mobile phase consisted of methanol-1% acetic acid solution (30 ∶ 70,V/V) and methanol-water (85 ∶ 15, V/V) at the flow rate of 1.2 mL/min. The detection wavelengths were set at 321 nm and 270 nm. The column temperature was set at 40 ℃ and 25 ℃. The sample sizes were 10 μL and 20 μL. RESULTS: In TLC of S. miltiorrhizae, C. rhizome, C. flos and Paeonia radix rubra test samples, same color spots were shown in the corresponding positions of the control chromatogram. The linear range of ferulic acid and tanshinone ⅡA  were 4.48-112.00 and 5.88-210.00      μg/mL (R2=0.999 0, 0.999 9), respectively. The average recoveries were 102.22% and 102.23% (RSD=1.63%, 1.22%, n=6), respectively. RSDs of precision, stability and reproducibility tests were all lower than 2% (n=6). The average contents of them were 0.118 4 and 0.221 mg/capsule (n=3), respectively. CONCLUSIONS: The study improves the quality standard of Chuanshen capsules with qualitative and quantitative methods, and preliminarily fomulated the content of ferulic acid is not less than 0.10     mg/capsule and tanshinone ⅡA is not less than 0.18 mg/capsule.
期刊: 2018年第29卷第21期
作者: 赵超,白晓丹,李锐莉,杨志福,文爱东,曹金一
AUTHORS: ZHAO Chao,BAI Xiaodan,LI Ruili,YANG Zhifu,WEN Aidong,CAO Jinyi
关键字: 川参胶囊;质量标准;高效液相色谱法;薄层色谱法;阿魏酸;丹参酮ⅡA;含量测定
KEYWORDS: Chuanshen capsules; Quality standard; HPLC; TLC; Ferulic acid; Tanshinone ⅡA; Content determination
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