复方苦参灌肠剂的质量标准研究

Study on Quality Standard of Fufang Kushen Enema

目的建立复方苦参灌肠剂的质量标准。方法采用薄层色谱法鉴别苦参、黄连、黄柏、甘草;采用高效液相色谱法测定苦参碱和氧化苦参碱的总量及盐酸小檗碱的含量。结果在薄层色谱中能检出苦参、黄连、黄柏、甘草,用高效液相色谱法测定苦参碱、氧化苦参碱、盐酸小檗碱的质量浓度分别在0.02385～0.31800mg/mL(r=0.9999)、0.00835～0.11137mg/mL(r=0.9999)、6.0～36.0μg/mL(r=0.9995)与峰面积呈良好的线性关系,平均加样回收率分别为100.0%(RSD=2.9%)、104.9%(RSD=2.8%)、97.2%(RSD=1.8%)。结论此定性定量方法灵敏度和准确度较高,重现性好,专属性强,能够有效控制复方苦参灌肠剂的质量。

Objective To establish the quality standard ofFufang Kushen enema. Methods Thin layer chromatography （TLC） was used to identify Radix Sophorae Flavescentis, Coptis, phellodendron, Radix Glycyrrhizae; berberine hydrochloride, matrine and Oxymatrine was determined by high performance chromatograph （HPLC）. Results Radix Sophorae Flavescentis, Rhizoma Coptidis, Cortex Phellodendri and liquorice could be detected by TLC, matrine, oxymatrine, berberine hydrochloride concentration in 0.02385-0.31800mg.mL- 1 （r=0.9999）, 0.00835-0.11137mg.mL- 1 （r=0.9999）, 6.0-36.0μg/mL- 1 （r=0.9995） showed a good linear relationship with the peak area;The average recoveries were 100% （RSD=2.9%）, 104.9% （RSD=2.8%）, and 97.2% （RSD=l.8%）. Conclusion The qualitative and quantitative method has high sensitivity and accuracy, good reproducibility and specificity, and can effectively control the quality of Fufang Kushen enema.