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康艾注射液质量标准研究

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目的 对康艾注射液现行标准进行增修订,对其质量进行有效控制。方法 采用薄层色谱法对人参、黄芪、苦参素进行定性鉴别;采用高效液相色谱法测定黄芪甲苷、苦参素的含量。结果 人参、黄芪、苦参素的薄层色谱图中,斑点清晰,且无阴性干扰。黄芪甲苷进样量在0。50~7。54µg、苦参素进样浓度在4。60~92。06µg/mL范围内,线性关系均良好,平均回收率分别为99。3%(RSD=1。0%)、101。3%(RSD=1。5%)。结论 建立的方法专属性强、重现性好,能够有效地控制康艾注射液的质量。
Study on the Quality Standard of Kang'ai Injection
Objective Revised the current standards for kang'ai injection to effectively control its quality. Methods TLC was used to identify ginseng,astragali radix and oxymatrine. HPLC was used to determine the astragaloside and oxymatrine. Results In the thin-layer chromatography of ginseng,astragali radix and oxymatrine,the spots were clear and had no negative interference. The linear relationship was good for the injection volume of astragaloside in the range of 0.50-7.54 µg and the injection concentration of oxymatrine in the range of 4.60-92.06 µg/mL,the average recovery rate were 99.3% (RSD=1.0%) and 101.3% (RSD=1.5%). Conclusion The established methods had strong specificity and good reproducibility,and can effectively control the quality of kang'ai injection.

Kang'ai injectionQuality controlTLCHPLC

毕红玉、张红燕、刘桂凤、张凌云

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南昌市第一医院,江西 南昌 330008

江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029

康艾注射液 质量控制 薄层色谱 高效液相色谱

2024

药品评价
江西省药学会

药品评价

影响因子:0.672
ISSN:1672-2809
年,卷(期):2024.21(8)