基于指纹图谱分析和多成分同时定量的复方穿心莲片质量评价研究  

Quality Assessment of Compound Chuanxinlian Tablets Based on HPLC Fingerprint and Multi-components Simultaneous Determination

作　　者：敖华蓉 龚春燕 张勋丽 Ao Huarong;Gong Chunyan;Zhang Xunli(Pharmacy Department of the Second Peopled Hospital of Yichang, Hubei Yichang 443000,China)

机构地区：[1]宜昌市第二人民医院药剂科,湖北宜昌443000

出　　处：《中国药师》2019年第4期665-669,共5页China Pharmacist

摘　　要：目的:建立复方穿心莲片的HPLC指纹图谱,并对其主要药效成分进行定量分析,为评价其质量提供依据。方法:采用SHIMADZU VP-ODS(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.5%磷酸水溶液作为流动相进行梯度洗脱,流速为1.0 ml·min^(-1),柱温为25℃,检测波长226 nm及340 nm。通过相似度评价对12批次复方穿心莲片指纹图谱进行质量评价,并对指认的6个指标成分进行定量测定研究。结果:12批复方穿心莲片指纹图谱标定了共有峰12个,通过与混合对照品比较指认其中6个指标成分分别为穿心莲内酯、脱水穿心莲内酯、脱氧穿心莲内酯、新穿心莲内酯、槲皮素-3-O-葡萄糖苷和山奈素,利用相似度软件对12批样品指纹图谱进行分析,各批样品相似度均在0.95以上。穿心莲内酯、脱水穿心莲内酯、脱氧穿心莲内酯、新穿心莲内酯、槲皮素-3-O-葡萄糖苷和山奈素线性范围分别为0.501～7.510μg(r=0.999 9)、0.787～9.443μg(r=0.999 6)、0.251～3.008μg(r=0.999 1)、0.100～1.201μg(r=0.998 9)、0.543～6.522μg(r=0.999 8)和0.312～3.743μg(r=0.999 7)。12批样品中穿心莲内酯、脱水穿心莲内酯、脱氧穿心莲内酯、新穿心莲内酯、槲皮素-3-O-葡萄糖苷和山奈素质量分数分别在4.308 9～4.752 8 mg·g^(-1)、9.305 7～9.708 9 mg·g^(-1)、1.290 3～1.693 6 mg·g^(-1)、0.487 7～0.660 7 mg·g^(-1)、5.789 6～6.330 2 mg·g^(-1)和2.789 9～3.200 7 mg·g^(-1)。结论:所建立的方法灵敏度高,专属性强,HPLC指纹图谱结合多成分定量测定能全面反映其内在质量,可用于复方穿心莲片的质量控制。Objective: To establish an HPLC fingerprint method and determine six compounds in compound Chuanxinlian tablets for the effective quality control. Methods: The analysis was carried out on an analytical column SHIMADZU VP-ODS( 250 mm ×4. 6 mm,5 μm) with gradient elution by acetonitrile( A)-0. 5% phosphoric acid solution( B) at the detection wavelengths of 226 nm and 340 nm at the flow rate of 1. 0 ml·min^-1. The column temperature was 25℃. Similarity evaluation was used to evaluate the fingerprints of 12 batches of compound Chuanxinlian tablets,and the six marker components were quantified. Results: There were 12 common peaks in the fingerprints of the twelve batches of compound Chuanxinlian tablets,and six of them were identified by comparison with the references,which were andrographolide,dehydroandrographolide,deoxyandrographolide,neoandrographolide,quercetin-3-O-glucoside and kaempferol. The similar degrees of the 12 batches of samples were over 0. 95. The linear range was 0. 501-7. 510 μg( r = 0. 999 9),0. 787-9. 443 μg( r = 0. 999 6),0. 251-3. 008 μg( r = 0. 999 1),0. 100-1. 201 μg( r = 0. 9989),0. 543-6. 522 μg( 0. 999 8) and 0. 312-3. 743 μg( r = 0. 999 7) respectively for andrographolide,dehydroandrographolide,deoxyandrographolide,neoandrographolide,quercetin-3-O-glucosideand and kaempferol. The quality fraction respectively was 4. 308 9-4. 7528 mg · g^-1,9. 3057-9. 708 9 mg · g^-1,1. 2903-1. 6936 mg · g^-1,0. 487 7-0. 6607 mg · g^-1,5. 789 6-6. 3302 mg · g^-1 and 2. 789 9-3. 200 7 mg·g-1 in the 12 batches of samples. Conclusion: The method is highly sensitive and specific. The combination of HPLC fingerprint and multi-component determination reflects its inherent quality in an all-round way,which can be used for the quality control and evaluation of compound Chuanxinlian tablets.

关 键 词：复方穿心莲片 高效液相色谱法 指纹图谱 相似度分析 质量评价 

分 类 号：TQ460.72[医药卫生—药物分析学]