- Email: [email protected]
Identification of chemical markers for quality control of herbal medicines
Abstracts / European Journal of Integrative Medicine 6 (2014) 686–745
Changes in IgG glycosylation have been shown to be associated with various physiological and pathological conditions. Regulation of glycosylation of IgG thereby implicated potential therapeutic strategy. Therefore, our established glycomic approach provided powerful tools not only for discovering biomarkers and exploring pathological mechanisms of diseases, but also for the evaluation of bioactivity of constituents derived from Chinese medicines with anti-inflammatory and immune activity, which is being extensively investigated in our lab. http://dx.doi.org/10.1016/j.eujim.2014.09.037 Identification of chemical markers for quality control of herbal medicines Lian-Wen Qi ∗ , Ping Li State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing, China E-mail address: [email protected] (L.-W. Qi). A strategy to discover most effective ingredients in herbs as chemical markers for quality control purposes is proposed. The major procedure of this method includes: Firstly, a large number of herbal samples are collected from different locations, components in herbal extract are characterized by high-performance liquid chromatography combined with quadruple and time-offlight mass spectrometry. Secondly, the bioactivity of different samples is tested using cellular or molecular assays. Thirdly, markers are identified that are the most relevant to the activity, using data modeling such as multiple linear regression and Back propagation-Artificial Neural Network. Fourthly, the effective combinatorial markers are prepared by a real-time fishing and knockout technology and efficacy compared with the whole extract. Ideally, the efficacy of effective combinatorial markers should contribute to the most efficacy of the whole herbal extract, such as 60% or higher. http://dx.doi.org/10.1016/j.eujim.2014.09.038 The legal framework governing the quality of (traditional) herbal medicinal products in the European Union Burt Kroes Medicine Evaluation Agency of the Netherlands, the Netherlands E-mail address: [email protected]. Pharmaceutical quality of a medicinal product is the basis for ensuring safe and effective medicines. The basic principles
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governing the assurance of the quality of medicinal products in the European Union (EU) are defined in the amended Directive 2001/83/EC, Directive 2003/63/EC and in EU scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in European legislation. The European Union regulatory framework includes a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. Legislation also encompasses specific requirements for herbal medicinal products acknowledging their complex nature and the fact that the quality of herbal medicinal products is intrinsically associated with the herbal substances and herbal preparations. Specific quality requirements include thorough product characterization, adherence to the good agricultural and collection practices, good manufacturing practices and validated manufacturing process, e.g. raw material testing, in-process testing, fingerprint characterization. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterization. The presentation gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. The requirements will be illustrated using DiaoXueKan, the first Traditional Chinese Medicine product registered in Europe, as example. http://dx.doi.org/10.1016/j.eujim.2014.09.039
Changes in IgG glycosylation have been shown to be associated with various physiological and pathological conditions. Regulation of glycosylation of IgG thereby implicated potential therapeutic strategy. Therefore, our established glycomic approach provided powerful tools not only for discovering biomarkers and exploring pathological mechanisms of diseases, but also for the evaluation of bioactivity of constituents derived from Chinese medicines with anti-inflammatory and immune activity, which is being extensively investigated in our lab. http://dx.doi.org/10.1016/j.eujim.2014.09.037 Identification of chemical markers for quality control of herbal medicines Lian-Wen Qi ∗ , Ping Li State Key Laboratory of Natural Medicines, China Pharmaceutical University, Nanjing, China E-mail address: [email protected] (L.-W. Qi). A strategy to discover most effective ingredients in herbs as chemical markers for quality control purposes is proposed. The major procedure of this method includes: Firstly, a large number of herbal samples are collected from different locations, components in herbal extract are characterized by high-performance liquid chromatography combined with quadruple and time-offlight mass spectrometry. Secondly, the bioactivity of different samples is tested using cellular or molecular assays. Thirdly, markers are identified that are the most relevant to the activity, using data modeling such as multiple linear regression and Back propagation-Artificial Neural Network. Fourthly, the effective combinatorial markers are prepared by a real-time fishing and knockout technology and efficacy compared with the whole extract. Ideally, the efficacy of effective combinatorial markers should contribute to the most efficacy of the whole herbal extract, such as 60% or higher. http://dx.doi.org/10.1016/j.eujim.2014.09.038 The legal framework governing the quality of (traditional) herbal medicinal products in the European Union Burt Kroes Medicine Evaluation Agency of the Netherlands, the Netherlands E-mail address: [email protected]. Pharmaceutical quality of a medicinal product is the basis for ensuring safe and effective medicines. The basic principles
701
governing the assurance of the quality of medicinal products in the European Union (EU) are defined in the amended Directive 2001/83/EC, Directive 2003/63/EC and in EU scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in European legislation. The European Union regulatory framework includes a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. Legislation also encompasses specific requirements for herbal medicinal products acknowledging their complex nature and the fact that the quality of herbal medicinal products is intrinsically associated with the herbal substances and herbal preparations. Specific quality requirements include thorough product characterization, adherence to the good agricultural and collection practices, good manufacturing practices and validated manufacturing process, e.g. raw material testing, in-process testing, fingerprint characterization. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterization. The presentation gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. The requirements will be illustrated using DiaoXueKan, the first Traditional Chinese Medicine product registered in Europe, as example. http://dx.doi.org/10.1016/j.eujim.2014.09.039