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基于气相色谱-质谱联用指纹图谱的鱼腥草注射液鉴别与质量评价:一种标准化方法

Identification and quality assessment of Houttuynia cordata injection using GC-MS fingerprint: a standardization approach.

作者信息

Lu H M, Liang Y Z, Chen S

机构信息

Research Center for Modernization of Chinese Herbal Medicine, College of Chemistry and Chemical Engineering, Central South University, Changsha 410083, PR China.

出版信息

J Ethnopharmacol. 2006 May 24;105(3):436-40. doi: 10.1016/j.jep.2005.11.018. Epub 2005 Dec 27.

DOI:10.1016/j.jep.2005.11.018
PMID:16384679
Abstract

Houttuynia cordata (Saururaceae) injection (HCI) was widely used to treat disease in China. At present, there were about 40 factories producing HCI, but a good quality standard for its quality control was lacking. In this study, an optimized and validated gas chromatography-mass spectrum (GC-MS) method was applied for the fingerprint analysis of 340 batches of HCI from 34 Chinese pharmaceutical factories. The results showed that HCI from the same factory had very similar GC-MS fingerprints, and evident difference existed among different factories. The representative fingerprints from 20 factories whose intra-factory correlation coefficients were over 0.90 and inter-factory correlation coefficients were over 0.75 were used to calculate the mean fingerprint of all samples. Spectral correlative chromatogram (SCC) was adopted to identify common component in different samples. Fifteen main "common components" were obtained. The mean fingerprint containing those 15 components was suggested to be used as characteristic fingerprint for the rapid identification of HCI and evaluation of the consistency of HCI from factory to factory and from batch to batch.

摘要

鱼腥草(三白草科)注射液(HCI)在中国被广泛用于治疗疾病。目前,约有40家工厂生产HCI,但缺乏用于质量控制的良好质量标准。在本研究中,采用优化并经验证的气相色谱 - 质谱(GC-MS)方法对来自34家中国制药厂的340批次HCI进行指纹图谱分析。结果表明,同一工厂生产的HCI具有非常相似的GC-MS指纹图谱,而不同工厂之间存在明显差异。选取厂内相关系数大于0.90且厂间相关系数大于0.75的20家工厂的代表性指纹图谱来计算所有样品的平均指纹图谱。采用光谱相关色谱图(SCC)来鉴定不同样品中的共同成分。共获得15种主要“共同成分”。建议将包含这15种成分的平均指纹图谱用作特征指纹图谱,以快速鉴定HCI并评估不同工厂之间以及不同批次之间HCI的一致性。

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