Pretreatments of chromatographic fingerprints for quality control of herbal medicines

Xu, Cheng‐Jian; Liang, Yi; Chau, Foo Tim; Heyden, Yvan Vander

doi:10.1016/j.chroma.2006.08.060

Cited by 114 publications

(67 citation statements)

References 28 publications

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“…Until now, similarity analysis is still the only standardized fingerprint analysis method in China, and TCM manufacturers have widely taken the similarity indexes as the quality consistency criteria of their products. During this time, similarity analysis has been widely reported in literature as the quality consistency evaluation tool of both botanical drug products and raw materials (2,13,(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37).…”

Section: Introductionmentioning

confidence: 99%

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Xiong

2013

AAPS PharmSciTech

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Abstract. Botanical drug products have batch-to-batch quality variability due to botanical raw materials and the current manufacturing process. The rational evaluation and control of product quality consistency are essential to ensure the efficacy and safety. Chromatographic fingerprinting is an important and widely used tool to characterize the chemical composition of botanical drug products. Multivariate statistical analysis has showed its efficacy and applicability in the quality evaluation of many kinds of industrial products. In this paper, the combined use of multivariate statistical analysis and chromatographic fingerprinting is presented here to evaluate batch-to-batch quality consistency of botanical drug products. A typical botanical drug product in China, Shenmai injection, was selected as the example to demonstrate the feasibility of this approach. The high-performance liquid chromatographic fingerprint data of historical batches were collected from a traditional Chinese medicine manufacturing factory. Characteristic peaks were weighted by their variability among production batches. A principal component analysis model was established after outliers were modified or removed. Multivariate (Hotelling T 2 and DModX) control charts were finally successfully applied to evaluate the quality consistency. The results suggest useful applications for a combination of multivariate statistical analysis with chromatographic fingerprinting in batch-to-batch quality consistency evaluation for the manufacture of botanical drug products.

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Section: Introductionmentioning

confidence: 99%

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Xiong

2013

AAPS PharmSciTech

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“…Chromatographic fingerprinting has become expensive and more complicated due to the expensive equipment that require specialized expertise, as well as the methods used to transform the data (Liang, et sl, 2004 ;Ji, et al, 2005;Xu et al, 2006;Alaerts, et al, 2007;Hoai and et al, 2009). Regarding the latter, all the methods for retention time warping require expertise to perform (Malmquist and Danielsson, 1994;Nielsen, et al, 1998;Kassidas, et al, 1998;Eilers, 2004;Walczak, et al, 2005 andPravdova, et al, 2002), and these methods and expertise are not available in most laboratories.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Traditional Medicines I: Identification of Phela Using Different Chromatographic Techniques

Lekhooa

Walubo²,

Plessis³

et al. 2012

Afr. J. Trad. Compl. Alt. Med.

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PHELA is a herbal mixture of four African traditional medicinal plants that has been used for decades in wasting conditions and is now being developed by the Medical Research Council (MRC) as an immune booster for patients with compromised immune system. A chromatographic fingerprint of PHELA was needed for quality control purposes. Here, a comprehensive method for fingerprinting of PHELA using different chromatographic techniques is described. It involved extraction of the PHELA by either acidic or a simple 'salting-out' method, followed by Thin Layer Chromatography (TLC) analysis and/or preparative Column Chromatography (CC). The products were thereafter analyzed by High Performance Liquid Chromatography with UV-detector (HPLC-UV), HPLC with fluorescence-detector (HPLC-FL) and Gas-Chromatography with a Mass Selective Detector spectrometer (GC-MSD). The fingerprints were successfully used to differentiate PHELA from another common herbal product made from Hypericum perforatum (St. John's Wort), thereby illustrating its high potential for use in fingerprinting of PHELA and in differentiating it from other herbal medicines. By validating the different chromatographic techniques on the standardized extraction methods, this approach will enable wide application in quality control of PHELA using acceptable procedures, thereby promoting effective monitoring of the finished product in all countries where it will be used.

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“…In addition, minor differences between very closely related species might be missed 4 . These drawbacks are taken into account by multivariate analysis.…”

mentioning

confidence: 99%

Untitled

2014

IJPSR

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Herbal Medicines (HM) and their preparations have been widely used for hundreds of years all over the world. However, they have not been officially recognized due to lack of adequate or accepted research methodology for their evaluation. Traditional systems of Indian Herbal medicine include Ayurveda, Yoga, Naturopathy, Unani and Siddha. Among them Ayurveda, Siddha and Unani systems (ASU) use plants, minerals and animal products as main drugs to cure various ailments. The quality and safety of these herbal products has now become a serious issue due to increasing pollution in air, water, soil, etc. Pharmacognostical analysis of medicinal herbs remains challenging issues for analytical chemists, as herbs are a complicated system of mixtures. This review emphasizes the significance of NIR methods in the discrimination of much herbal medicine from closely related species and from adulterants. The quality of samples from different localities and growing conditions based on their geographical origin may vary. Thus, the identification of crude herbs based on geographical origins is crucial in order to ensure authenticity, quality, safety and efficacy of the raw material before it is converted to the final product. Herbal product manufacturer always seeking for a faster and cost effective verification method since the traditional wet chemistry analysis are too laborious and time consuming. Discrimination according to geographical origin and localities, processing methods, DNA profiling and metabolomics were efficiently investigated. This paper will discuss about the various common and sophisticated techniques used for quality assessment of Indian traditional herbal medicine.

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Pretreatments of chromatographic fingerprints for quality control of herbal medicines

Cited by 114 publications

References 28 publications

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

Evaluation of Traditional Medicines I: Identification of Phela Using Different Chromatographic Techniques

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