Control de calidad de fitofármacos con la utilización de Resonancia Magnética Nuclear (RMN) y la aplicación del análisis de componentes principales (PCA)  <span class="so-article-trans-title" dir="auto"> Translated title: Quality control of phytopharmaceuticals with the use of Nuclear Magnetic Resonance (NMR) and the application of principal component analysis (PCA) </span>

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Abstract

Resumen Los fitofármacos, aunque generalmente están compuestos de productos naturales, deben ser estrictamente controlados en cuando a su contenido de principios activos. Existen varios métodos de control de calidad entre los que se destacan la cromatografía líquida y la espectrometría de masas; en nuestra investigación llevamos a cabo un control de calidad con la utilización de Resonancia Magnética Nuclear, método el cual es de fácil utilización e interpretación, y altamente versátil, además de ser una técnica no destructiva, y consecuentemente un estudio de componentes principales para obtener una mejor visualización de los resultados. Lo que se logró demostrar es que en Costa Rica existe una gran cantidad de productos comercializados que aparentemente no contienen los principios activos que deberían tener de acuerdo al etiquetado, como pudo demostrarse en el caso de los productos de Gingko biloba, Hypericum perforatum y Silybum marianum. Para el caso de Equinacea spp, el problema de la comparación es que los diferentes productos contienen varias especies del mismo género y esto dificulta un análisis detallado. Además, el análisis de los componentes principales hizo posible demostrar que es difícil utilizar esta técnica sin un conocimiento previo de las técnicas de análisis utilizadas y qué debe interpretarse. Los resultados también indican que las regulaciones en Costa Rica no son lo suficientemente rigurosas para este tipo de productos, y estas deben ser revisadas por la Agencia Nacional Reguladora.

Translated abstract

Abstract The phytopharmaceuticals, although they are generally composed of natural products, must be strictly controlled regarding their content of active ingredients. There are several methods of quality control among which stand out liquid chromatography and mass spectrometry; in our research, we carried out a quality control with the use of Nuclear Magnetic Resonance, which is easy to use and interpret, and highly versatile, as well as non-destructive technique, and with this information a study of principal components was carried out in order to obtain a better visualization of the results. In this work we demonstrated that in Costa Rica there is a large number of products marketed that apparently do not contain the active ingredients that should have according to the labeling, as could be demonstrated in the case of the products of Gingko biloba, Hypericum perforatum and Silybum marianum. In the case of Equinacea spp, the problem of the comparison was that the different products contain several species of the same genus and this makes a detailed analysis difficult. In addition, the analysis of main components made it possible to demonstrate that it is difficult to use this technique without prior knowledge of the analysis techniques used, and what must to be interpreted. The results also indicate that regulations in Costa Rica are not rigorous enough for this type of products, and these should be reviewed by the National Regulatory Agency.

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Most cited references 22

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St John's wort (Hypericum perforatum L.): a review of its chemistry, pharmacology and clinical properties.

Melissa L. Anderson, J Phillipson, Peter Barnes (2001)

The chemical composition of St. John's wort has been well-studied. Documented pharmacological activities, including antidepressant, antiviral, and antibacterial effects, provide supporting evidence for several of the traditional uses stated for St John's wort. Many pharmacological activities appear to be attributable to hypericin and to the flavonoid constituents; hypericin is also reported to be responsible for the photosensitive reactions that have been documented for St. John's wort. With regard to the antidepressant effects of St John's wort, hyperforin, rather than hypericin as originally thought, has emerged as one of the major constituents responsible for antidepressant activity. Further research is required to determine which other constituents contribute to the antidepressant effect. Evidence from randomised controlled trials has confirmed the efficacy of St John's wort extracts over placebo in the treatment of mild-to-moderately severe depression. Other randomised controlled studies have provided some evidence that St John's wort extracts are as effective as some standard antidepressants in mild-to-moderate depression. There is still a need for further trials to assess the efficacy of St John's wort extracts, compared with that of standard antidepressants, particularly newer antidepressant agents, such as the selective serotonin reuptake inhibitors (recent comparative studies with fluoxetine and sertraline have been conducted). Also, there is a need for further studies in well-defined groups of patients, in different types of depression, and conducted over longer periods in order to determine long-term safety. St John's wort does appear to have a more favourable short-term safety profile than do standard antidepressants, a factor that is likely to be important in patients continuing to take medication. Concerns have been raised over interactions between St John's wort and certain prescribed medicines (including warfarin, ciclosporin, theophylline, digoxin, HIV protease inhibitors, anticonvulsants, selective serotonin reuptake inhibitors, triptans, oral contraceptives); advice is that patients taking these medicines should stop taking St John's wort, generally after seeking professional advice as dose adjustment of conventional treatment may be necessary.