Análisis Mediante Espectrofotometría UV/Vis de Diferentes Productos Terminados Homeopáticos de Nux Vomica 6CH, 7CH y 30CH, Comercializados en Tres Farmacias en Bogotá, Colombia / Analysis by Spectrophotometry UV / Vis of Different Products Homeopathic Finished Nux Vomica 6CH, 7CH and 30CH, Marketed in Three Pharmacies in Bogota Colombia

El aumento de la frecuencia de uso de los medicamentos homeopáticos en la población en general implica que la calidad en la elaboración de los mismos debe indagarse para evitar situaciones adversas en la población que los consume. En Colombia existen procesos legales para obtener el permiso de producción y venta; sin embargo, en éstos no hay verificación del producto terminado contrastándolo con un control. Los medicamentos homeopáticos se elaboran mediante ultradiluciones de sustancias que actúan basados en el principio similia similibus curantur. La Nux vomica es un medicamento homeopático de uso frecuente, dado su carácter de policresto para diferentes patologías, y por lo tanto es importante tener un control de calidad de dicho medicamento. En este estudio se realizaron mediciones de la concentración de Nux vomica 6CH, 7CH y 30CH comprada en diferentes farmacias (FAR) y vendida como producto terminado, comparándolos con un medicamento elaborado por las autoras de este trabajo, utilizando para ello la espectrofotometría UV/Vis, no encontrándose diferencias estadísticamente significativas entre ellos después de aplicar energía cinética. (AU)

The increasing use of homeopathic medicines in the general population implies that the quality in the preparation of those should be investigated to avoid adverse situations in the people who consumes them. In Colombia, there are legal processes to obtain the production and sale license, however, there is no verification of the finished product against a control. Homeopathic medicines are made by ultradilutions of substances that act based on the Similia similibus curentur principle. The Nux vomica is a homeopathic medicine of frequent use, given its character of policresto, for different pathologies and therefore it's important to have a quality control of that medication. In this study, measurements were made of Nux vomica 6CH, 7CH and 30CH concentration purchased in different pharmacies (FAR) and sold as a finished product, comparing them with a drug elaborated by the authors using UV/Vis spectrophotometry. No statistically significant differences were found between them. after applying kinetic energy. (AU)

Manual de buenas prácticas de dispensación / Dispensation good practice manual

La presente publicación describe un conjunto de normas, establecido con el objetivo de asegurar un uso adecuado de los medicamentos, estableciendo criterios, metodologías y requisitos para el cumplimiento de las buenas prácticas de dispensación de productos farmacéuticos establecidas en el Reglamento de Establecimientos Farmacéuticos aprobado por Decreto Supremo Nº 021-2001-SA

Homeopatía durante la gestación: un análisis crítico / Homoeopathy during pregnancy: a critical appraisal

Objetivos: realizar una revisión sobre la eficacia y seguridad de los tratamientos homeopáticos durante la gestación Métodos: revisión de la literatura. Resultados: los productos homeopáticos más utilizados durante la gestación, en el trabajo del parto y durante el puerperio, son: Caulophyllum, Actaea racemosa, Árnica montana y China rubra. Existen pocos estudios comparativos que hayan analizado la eficacia de estos productos frente a placebo o frente a tratamientos médicos tradicionales. Una revisión Cochrane no encontró evidencias para recomendar el uso de homeopatía en el trabajo de parto. Además, los tratamientos homeopáticos no están exentos de posibles efectos secundarios. Conclusiones: no existe evidencia científica de calidad para apoyar el uso de tratamientos homeopáticos durante la gestación y el trabajo de parto (AU)

Objectives: To assess the efficacy and safety of homoeopathy during pregnancy through a literature review. Methods: Literature review. Results: The homoeopathic treatments most commonly used during pregnancy, labour and the postpartum period are Caulophyllum, Actaea racemosa, Árnica montana and China rubra. Few studies have compared homoeopathy with either placebo or traditional treatments. A Cochrane review found no evidence to recommend the use of homoeopathy during labour. Moreover, homoeopathic treatments are not free from possible side effects. Conclusion: There is insufficient good quality evidence to support the use of homoeopathy during pregnancy and labour (AU)

Homeopathic drug standardization through biological evaluations: An untrodden avenue

There is a dearth of chemico-analytical or instrumental methods for standardization and quality control of higher dilutions of homeopathic drugs. Aim: This review highlights the challenges in standardization of anti-inflammatory homeopathic drugs and suggests a battery of biological assays for their standardization. Methods: We retrieved a total 57 scientific reports from the experimental studies and scientific reviews published between January 1999 and June 2014 related to anti-inflammatory homeopathic drugs and their high dilutions. These comprised of 18 reports on preclinical evaluation, 15 on source materials, 9 on isolated constituents and 15 studies on in-vitro experiments. Few recent citations which supported the initial studies were added later during the compilation of the manuscript. Conclusion: Standardization and quality control of homeopathic mother tinctures and high dilutions warrants an urgent attention. As biological activities are observed to be attributed to the high dilutions which are practically devoid of active ingredients, their standardization may be done through the suggested battery of biological investigations. It is suggested that the current methods of standardization of homeopathic drugs need to be upgraded to include sensitive, reproducible and relevant biological assays so that the end users are assured of the quality, efficacy, and safety of homeopathic dilutions...

Homeopathic drug standardization through biological evaluations: An untrodden avenue

Background: There is a dearth of chemico-analytical or instrumental methods for standardization and quality control of higher dilutions of homeopathic drugs. Aim: This review highlights the challenges in standardization of anti-inflammatory homeopathic drugs and suggests a battery of biological assays for their standardization. Methods: We retrieved a total 57 scientific reports from the experimental studies and scientific reviews published between January 1999 and June 2014 related to anti-inflammatory homeopathic drugs and their high dilutions. These comprised of 18 reports on preclinical evaluation, 15 on source materials, 9 on isolated constituents and 15 studies on in-vitro experiments. Few recent citations which supported the initial studies were added later during the compilation of the manuscript. Conclusion: Standardization and quality control of homeopathic mother tinctures and high dilutions warrants an urgent attention. As biological activities are observed to be attributed to the high dilutions which are practically devoid of active ingredients, their standardization may be done through the suggested battery of biological investigations. It is suggested that the current methods of standardization of homeopathic drugs need to be upgraded to include sensitive, reproducible and relevant biological assays so that the end users are assured of the quality, efficacy, and safety of homeopathic dilutions. (AU)

Assessment of the quality of compounded fluconazole capsules marketed in the region of Araraquara (SP, Brazil) / Avaliação da qualidade de cápsulas de fluconazol manipuladas comercializadas na região de Araraquara (SP, Brasil)

O controle de qualidade de fármacos desempenha um papel importante na saúde pública ao garantir segurança e eficácia de medicamentos. No sistema de saúde pública,as farmácias magistrais também são importantes. Elas fornecem medicamentos personalizados como produtos dermatológicos e doses específicas para crianças.Infelizmente, muitos casos de produtos magistrais fabricados fora do padrão mínimo de qualidade têm sido relatados no Brasil. Neste trabalho, a qualidade das cápsulas magistrais de fluconazol 150 mg foi avaliada e os resultados foram comparados com os valores recomendados pela Farmacopeia Brasileira. Os resultados sugerem que é possível manipular produtos que satisfaçam as especificações farmacopeicas, mas estes ainda mostram que há farmácias magistrais onde o controle de qualidade é deficiente ou inexistente. O fluconazol é um fármaco importante no tratamento de infecções fúngicas. Seu uso como forma farmacêutica manipulada sem elevados padrões de qualidade é fortemente relacionado com a falha terapêutica e intoxicações, assim como o surgimento de microorganismos resistentes. Portanto, a necessidade de melhoria dos processos nas farmácias magistrais se torna mais enfático. Existem métodos validados que podem ser utilizados com sucesso para a análise de rotina de controle de qualidade e que podem ser implementados por qualquer farmácia de manipulação...

The quality control of drugs has an important role in public health, in ensuring the efficacy and safety of medicines. In the public health system, compounding pharmacies play a vital part. They provide medicines tailored to the individual patient, for example dermatological products and specific doses for children. Unfortunately, many cases of compounded products falling below the minimum quality standard have been reported in Brazil. In this study, the quality of compounded 150 mg fluconazole capsules was assessed and the results were compared with values stipulated in the Brazilian pharmacopoeia. The results suggest that, while it is certainly possible to prepare products meeting pharmacopoeial specifications, there are pharmacies where the quality control is deficient or nonexistent. Fluconazole is an important drug in combatting fungal infections. The use of fluconazole in dosage forms manufactured without high standards of quality control is strongly linked to treatment failure and cases of intoxication, as well as the emergence of resistant microorganisms. This highlights the urgent need for process improvement in compounding pharmacies. There are validated methods that can be successfully employed for routine quality control analysis that can be implemented by any compounding pharmacy...

Información incluida en las fichas técnicas de los primeros medicamentos homeopáticos "sin indicaciones" de uso humano autorizados y registrados en España / Information included in the summary of product characteristics of the first homeopathic medicinal products "without therapeutic indications" for human use registered in Spain

No disponible

Medicamentos a base de plantas: el reto de la calidad y la Farmacopea como herramienta para alcanzarla / Herbal medicinal products: the challenge of the quality and the Pharmacopoeia as a tool for achieving it

La calidad de los medicamentos a base de plantas (MP) constituye un reto, principalmente por las dificultades ligadas a la variabilidad y complejidad de las drogas y preparados vegetales, el conocimiento limitado de sus constituyentes activos, la posibilidad de adulteraciones y contaminaciones, así como la influencia de los procesos de producción. Se trata de un reto superable. Para ello es necesario tener la calidad como objetivo desde el inicio de la cadena productiva, establecer controles estrictos de todas las etapas, mejorar el conocimiento del producto, optimizar y validar los procesos de producción, trabajar bajo las directrices internacionales aceptadas y establecer especificaciones de calidad.La Farmacopea Europea, en España dentro de la Real Farmacopea Española, constituye una herramienta clave para la superación del reto y el mantenimiento de altos niveles de calidad para los MP en la UE. Esto es así porque la Farmacopea Europea es un documento normativo actualizado, transparente, consensuado y armonizado por 37 países, que proporciona una colección singular de monografías y métodos para el análisis de drogas y preparados vegetales, siendo además un proveedor de sustancias de referencia (AU)

The quality of herbal medicinal products (HMP) is a challenge, mainly due to the difficulties linked to the variability and complexity of herbal drugs and herbal preparations, the limited knowledge of their active constituents, the possible adulterations and contaminations, as well as the influence of the production processes.This is a surmountable challenge. This requires having the quality as an objective from the beginning of the production chain, to establish strict controls on all stages, to improve the knowledge of the product, to optimize and to validate the production processes, to work under accepted international guidelines and to establish quality specifications.The European Pharmacopoeia, in Spain in the Royal Spanish Pharmacopoeia, is a key tool to overcome the challenge and maintaining high levels of quality of HMP in the EU. This is because the European Pharmacopoeia is an updated and transparent regulatory document, harmonized and agreed by 37 countries, which provides a unique collection of monographs and methods for the analysis of herbal drugs and preparations, and is also a provider of reference substances (AU)

Información incluida en las fichas técnicas de los primeros medicamentos homeopáticos «sin indicaciones» de uso humano autorizados y registrados en España / Information included in the summary of product characteristics of the first homeopathic medicinal products «without therapeutic indications» for human use registered in Spain

No disponible

Historia y utilidad de la farmacopea homeopática de los Estados Unidos Mexicanos / History and usefulness of the Homeopathic Pharmacopoeia of the United States of Mexico

La Farmacopea Homeopática de los Estados Unidos Mexicanos es un instrumento normativo de la Secretaría de Salud que, a través de la Dirección General de Control de Insumos para la Salud, permite proteger los correctos procesos de producción, almacenamiento y venta de los medicamentos homeopáticos en beneficio de la población mexicana. Es una de las pocas obras en su género oficiales en el mundo, y además de ser una referencia obligada para la industria químico-farmacéutica homeopática y para la comunidad médico homeopática mexicana en general, algunos países latinoamericanos la han adoptado como su farmacopea oficial.

The Mexican Homeopathic Pharmacopoeia it's a normative instrument of lhe Ministry of Health, witch through the General Directorate for the Control of Health Products, may supervise the correct production processes, storage and distribution of homeopathic medicines for profit of the Mexican population. It is one of the few official books of its kind in the world, and besides being a must for the chemical pharmaceutical and homeopathic industry, and for the Mexican homeopathic community in general, Latin American countries have adopted it, as their official pharmacopoeia.

Historia y utilidad de la farmacopea homeopática de los Estados Unidos Mexicanos / History and usefulness of the Homeopathic Pharmacopoeia of the United States of Mexico

La Farmacopea Homeopática de los Estados Unidos Mexicanos es un instrumento normativo de la Secretaría de Salud que, a través de la Dirección General de Control de Insumos para la Salud, permite proteger los correctos procesos de producción, almacenamiento y venta de los medicamentos homeopáticos en beneficio de la población mexicana. Es una de las pocas obras en su género oficiales en el mundo, y además de ser una referencia obligada para la industria químico-farmacéutica homeopática y para la comunidad médico homeopática mexicana en general, algunos países latinoamericanos la han adoptado como su farmacopea oficial.

The Mexican Homeopathic Pharmacopoeia it's a normative instrument of lhe Ministry of Health, witch through the General Directorate for the Control of Health Products, may supervise the correct production processes, storage and distribution of homeopathic medicines for profit of the Mexican population. It is one of the few official books of its kind in the world, and besides being a must for the chemical pharmaceutical and homeopathic industry, and for the Mexican homeopathic community in general, Latin American countries have adopted it, as their official pharmacopoeia.

Medicamentos fitoterápicos e drogas vegetais industrializados e oficializadospelo Ministério da Saúde no Brasil: regulamentação sanitária, abrangência equalidade dos estudos pré-clínicos e clínicos / Herbal medicines and herbal drugs industrialized and formalized by the Ministry of Health in Brazil: health regulations, scope and quality of preclinical studies and clinical

Os medicamentos fitoterápicos e as drogas vegetais industrializados são produtos derivados de plantas medicinais com uso terapêutico oficializado no país.Diante disso, estes produtos devem ser objeto de extenso controle sanitário.Entretanto, a avaliação científica dos produtos terapêuticos derivados de plantas medicinais ainda é um desafio, incluindo a pesquisa clínica. O objetivo geral deste trabalho foi analisar criticamente o embasamento técnico-científico do registro de produtos terapêuticos industrializados derivados de plantas medicinais no Brasil. A análise incluiu os medicamentos fitoterápicos e as drogas vegetais industrializados com uso oficializado pelo Ministério da Saúde e teve como ênfase os requisitos para comprovação científica da eficácia e da segurança que constam da regulamentação sanitária, a abrangência e a pertinência dos estudos pré-clínicos e clínicos referido sem monografias de plantas medicinais e a qualidade dos ensaios clínicos realizados com esses produtos. De acordo com os resultados encontrados a regulamentação do processo de registro dos medicamentos fitoterápicos não apresenta as mesmas exigências técnicas comparado aos critérios exigidos para o registro de medicamentos quimicamente definidos. Além disso, foi observado um padrão facilitador para o registro de medicamentos fitoterápicos, através da simplificação do registro para produtos que não apresentam boa qualidade de evidência científica para dar suporte ao seu uso terapêutico, tanto em monografias de plantas medicinais como em ensaios clínicos publicados. Dessa forma, o controle sanitário destes produtos ainda está em processo de estruturação. Enquanto estes produtos não forem avaliados cientificamente de forma adequada através de pesquisas pré clínicas e clínicas, e enquanto existir um processo de regulamentação facilitador da entrada destes produtos no mercado e, conseqüentemente da incorporação destes produtos no Sistema Único de Saúde, estes serão disponibilizados ao consumidor sem a garantia da sua eficácia e da sua segurança, perpetuando a ausência de controle sanitário adequado da área e contrariando os princípios básicos de toda política de medicamentos: o acesso seguro, a qualidade e o uso racional.

Control de la calidad de formulaciones farmacéuticas obtenidas de cassia uniflora mill / Quality control of pharmaceutical formulations obtained from cassia uniflora mill

Introducción: Cassia uniflora Mill tiene una alta biodisponibilidad; se utiliza en el tratamiento de dolores espasmódicos, erupciones cutáneas e infecciones de origen bacteriano. Sus partes más empleadas son las hojas y las semillas. Objetivo: Determinar las especificaciones del control de la calidad para las tinturas a 20 por ciento de las hojas y las semillas de Cassia uniflora Mill. Material y Métodos: Las tinturas a 20 por ciento se prepararon a partir de los polvos de las hojas y las semillas, utilizando como menstruo una solución hidroetanólica. La determinación de las especificaciones del control de la calidad de las tinturas se realizó para cuatro parámetros: pH, índice de refracción, sólidos totales y densidad relativa. Resultados: Los datos obtenidos en el control de la calidad de las tinturas a 20 por ciento se encuentran dentro de los rangos de calidad establecidos en las normas utilizadas. Discusión: Los parámetros de calidad muestran que las tinturas a 20 por ciento de hojas y semillas de Cassia uniflora Mill no tuvieron cambios relevantes que afecten su calidad farmacéutica, por tanto, poseen un determinado grado de estabilidad. Conclusiones: Las especificaciones del control de la calidad de las tinturas indican que, bajo las condiciones aplicadas, los productos elaborados presentan inocuidad, y constituyen una garantía de calidad para su empleo terapéutico(AU)

Introduction: Cassia uniflora Mill has a high biological availability; It is used in treatments for spasmodic pains, cutaneous eruptions and some infections of bacteriological origin. The most useful parts are its leaves and seeds. Objectives: To determine the specifications of quality control for tinctures made up from leaves and seeds of Cassia uniflora Mill at 20 percent. Material and methods: Tincture at 20 percent was made up of the powders of leaves and seeds, using as menses a hydroethanolic solution. Determination of quality control specifications of the tinctures were made taking into account four parameters: pH, refraction index, total solids and relative density. Results: Data obtained in the quality control of the tinctures at 20 percent are among the ranks of quality established by the standards. Discussion: Quality parameters show that tinctures at 20 percent from leaves and seeds of Cassia uniflora Mill had no relevant changes that could affect its pharmacological quality, therefore they have a certain degree of stability. Conclusions: The specifications of the quality control made to the tinctures indicate that under the conditions applied the elaborated products are innocuous, so they are totally guaranteed for therapeutically use(AU)

Autoridad reguladora de medicamentos cubana: experiencia y entrenamiento a otras autoridades latinoamericanas en la autorización de ensayos clínicos / The Cuban drug regulatory authority: experience gained and training offered to other Latin American agencies in authorizing clinical trials

El Departamento de Vacunas y Biológicos de la OMS ha desarrollado una herramienta de evaluación para identificar el estado de las funciones básicas en las autoridades reguladoras y tanto la OMS como la OPS, proponen lineamientos para el entrenamiento de las autoridades reguladoras de medicamentos. La función relacionada con la autorización de ensayos clínicos ha sido desarrollada en Cuba y existe la experiencia y calificación pertinente para esta actividad. El propósito es desarrollar entrenamientos para que las autoridades de países en desarrollo, puedan implementar con éxito su función básica en la autorización de ensayos clínicos con vacunas. Se tomaron como fuentes bibliográficas, las referencias de la OMS, la Conferencia Internacional de Armonización, Unión Europea, Consejo de la Organización Internacional de Ciencias Médicas, la Administración de Drogas y Alimentos de los Estados Unidos y otros documentos reguladores de interés. Se describen los cinco indicadores que evalúan el contenido y función de las autoridades reguladoras de medicamentos, sus características y aspectos relevantes a tener en consideración en cada uno de ellos, se brinda un resumen sobre los aspectos esenciales de los estudios clínicos en vacunas según la guía de la OMS así como la experiencia de la autoridad reguladora cubana en la autorización de ensayos clínicos en vacunas y se hace referencia a las modificaciones que actualizan estos indicadores. En resumen la Autoridad Reguladora de Medicamentos es la encargada de garantizar que los medicamentos y en particular las vacunas que se administran a los seres humanos cumplan con la calidad, seguridad y eficacia, conforme los estándares y requerimientos reguladores vigentes de cada país(AU)

The Department of Vaccines and Biologics in the World Health Organization has developed an evaluation tool to identify the condition of the regulatory functions and the training of drug regulatory authorities to comply with their functions. This article was intended to provide the drug regulatory agencies from the non-developed countries with the necessary training, so that they can successfully perform their basic function in giving authorization to clinical trials with vaccines. Literature from WHO, the International Conference of Harmonization, the European Union, the Council of the International Organization of Medical Sciences, the US Food and Drug Administration and other regulatory documents of interest was reviewed. Data related to those indicators evaluating the performance of the drug regulatory authorities in giving permission for clinical trials with vaccines were collected and the five indicators assessing the contents and function of these authorities, their characteristics and relevant aspects were described. Furthermore, a summary of the essential aspects of the clinical trials with vaccines according to the WHO guideline as well as the experience of the Cuban regulatory authority in authorizing the conduction of these clinical trials was provided. The Drug Regulatory Authority is the responsible for assuring that vaccines for human beings meet the regulatory requirements of the country in the first place, and then for the research, commercialization or introduction of the vaccine in the National Immunization Program(AU)

Autoridad reguladora de medicamentos cubana: experiencia y entrenamiento a otras autoridades latinoamericanas en la autorización de ensayos clínicos / The Cuban drug regulatory authority: experience gained and training offered to other Latin American agencies in authorizing clinical trials

El Departamento de Vacunas y Biológicos de la OMS ha desarrollado una herramienta de evaluación para identificar el estado de las funciones básicas en las autoridades reguladoras y tanto la OMS como la OPS, proponen lineamientos para el entrenamiento de las autoridades reguladoras de medicamentos. La función relacionada con la autorización de ensayos clínicos ha sido desarrollada en Cuba y existe la experiencia y calificación pertinente para esta actividad. El propósito es desarrollar entrenamientos para que las autoridades de países en desarrollo, puedan implementar con éxito su función básica en la autorización de ensayos clínicos con vacunas. Se tomaron como fuentes bibliográficas, las referencias de la OMS, la Conferencia Internacional de Armonización, Unión Europea, Consejo de la Organización Internacional de Ciencias Médicas, la Administración de Drogas y Alimentos de los Estados Unidos y otros documentos reguladores de interés. Se describen los cinco indicadores que evalúan el contenido y función de las autoridades reguladoras de medicamentos, sus características y aspectos relevantes a tener en consideración en cada uno de ellos, se brinda un resumen sobre los aspectos esenciales de los estudios clínicos en vacunas según la guía de la OMS así como la experiencia de la autoridad reguladora cubana en la autorización de ensayos clínicos en vacunas y se hace referencia a las modificaciones que actualizan estos indicadores. En resumen la Autoridad Reguladora de Medicamentos es la encargada de garantizar que los medicamentos y en particular las vacunas que se administran a los seres humanos cumplan con la calidad, seguridad y eficacia, conforme los estándares y requerimientos reguladores vigentes de cada país

The Department of Vaccines and Biologics in the World Health Organization has developed an evaluation tool to identify the condition of the regulatory functions and the training of drug regulatory authorities to comply with their functions. This article was intended to provide the drug regulatory agencies from the non-developed countries with the necessary training, so that they can successfully perform their basic function in giving authorization to clinical trials with vaccines. Literature from WHO, the International Conference of Harmonization, the European Union, the Council of the International Organization of Medical Sciences, the US Food and Drug Administration and other regulatory documents of interest was reviewed. Data related to those indicators evaluating the performance of the drug regulatory authorities in giving permission for clinical trials with vaccines were collected and the five indicators assessing the contents and function of these authorities, their characteristics and relevant aspects were described. Furthermore, a summary of the essential aspects of the clinical trials with vaccines according to the WHO guideline as well as the experience of the Cuban regulatory authority in authorizing the conduction of these clinical trials was provided. The Drug Regulatory Authority is the responsible for assuring that vaccines for human beings meet the regulatory requirements of the country in the first place, and then for the research, commercialization or introduction of the vaccine in the National Immunization Program