ABSTRACT
ABSTRACT The increased public awareness about herbal products has led to a growth of the botanicals market and attracted the interest of the pharmaceutical industry. The laws that regulate the sale of manufactured herbal products differ between regions and countries of the Western world. The European Union favors the classification of the remedies as medicinal products. However, differences in the interpretation of European law by the Member States have meant that herbal products have been assigned to various sale categories across the European market. The European Agency for the Evaluation of Medicinal Products is working to introduce changes to achieve harmonization within the market. Canada and Australia have embarked on similar reforms to improve product regulation without imposing undue restrictions on marketing. In these countries, herbal products have been assigned a status that respects their therapeutic role. Changes introduced in the United States of America in 1994 led to a deregulation of the market with herbal products being classified as dietary supplements and excluded from the stricter regulatory requirements applicable to drugs and foods. However, a United States Presidential Commission has advised that a study is needed regarding an alternative system for botanical products that are not used solely as dietary supplements but that cannot meet the requirements applicable for conventional over-the-counter drugs.
ABSTRACT
ABSTRACT A significant proportion of the general public has the misconception that herbal products are safe because they are of natural origin. Toxicity may arise from inherent properties of the herbal ingredients that result in adverse reactions, which may be serious, or from interactions with conventional drug substances. Toxicity may also be caused by misuse, abuse, and overuse of products and by adulteration of products or misidentification of plants. Regulatory authorities are undertaking to provide a reasonable assurance of efficacy and improved safety of herbal products through monitoring programs and control of herbs that are known to be toxic. Action is taken by the authorities to protect public health when herbal preparations are shown or suspected to cause harm. Case reports of toxicity due to herbal products and actions taken by regulatory authorities are summarized in this article. In the European Union, applicants for marketing authorizations may be required to provide scientific proof of safety and efficacy by reference to bibliographic data, where available. The relevance and credibility of published data needs to be assessed against recommended criteria in order to avoid unnecessary repetition of tests on animals or humans.
ABSTRACT
ABSTRACT The concept of quality in the manufacture of herbal products is directed toward ensuring that the required standard of product is attained through processes that involve good manufacturing practice and quality control. This article reviews the need for quality assurance of herbal products, approaches taken by regulatory authorities in Europe to address this issue, and analytical methods applicable to the evaluation of herbal products. The natural ingredients that are used to prepare herbal products give rise to problems that are not encountered with conventional medicinal products. Quality standards are applied to both starting materials and finished products. Pharmacopoeial monographs, even when not forming part of official compendia, lay down criteria for analytical testing, including materials and methods, test limits, and acceptance ranges for results. Analytical tests are employed to establish the identity of the plant material or of the active principles, the content of active principles or characteristic marker compounds by assay, and the purity of the product by exclusion of specific adulterants or contaminants. Advances in instrumentation and test methods provide the analyst with powerful tools to determine the level of quality. Nevertheless, there still exist limitations to testing because of the complex and variable nature of the herbal ingredients. The standards and requirements for quality of herbal products as applied in the European Union are also intended to provide further assurances on the efficacy and safety of products.
ABSTRACT
Sao analisados 28 casos operados por colecistopatias alitiasicas: polipo de colesterol (seis casos) adenomiomatose (cinco casos), colecistite cronica (sete casos), vesicula de porcelana (dois casos), colesterolose generalizada (dois casos), vesicula septada (quatro casos), papiloma (um caso) e adenite inespecifica (um caso) E discutida a indicacao da cirurgia, enfatizando-se a importancia da colica biliar e o valor da radiografia tardia (12 horas apos o colecistograma) nesta indicacao.Conseguiu-se seguimento pos-operatorio em 24 pacientes (85%): o tempo variou de um a 13 anos (media de cinco anos e meio).Vinte e um (87,5%) ficaram curados com a colecistectomia
Subject(s)
Humans , Female , Cholecystitis , Bile Duct Diseases , CholecystectomyABSTRACT
162 casos de coledocolitiase operados na Clinica de Cirurgia Geral II do Hospital do Andarai foram analisados: 14 foram considerados como litiase primaria do coledoco e as restantes 148 como secundarias. O criterio para considerar a litiase primaria foi a concomitancia de: a) calculos moles, facilmente fragmentados a pressao digital; b) coledoco muito dilatado; c)vesicula sem calculo e cistico fino, ou com calculos duros, diferentes dos do coledoco. Sao analisados a sintomatologia, os achados cirurgicos e as operacoes realizadas nos 2 grupos de coledocolitiase. Houve 7 obitos operatorios (4,3%) e foi conseguido segmento em 88 pacientes operados entre 6 meses e 13 anos. E enfatizada a necessidade da cirurgia de drenagem biliar complementar (esfincteroplastia ou coledocoduodenostomia) em todos os casos de litiase primaria e nos de litiase secundaria quando ha oddite estenosante, grande dilatacao do coledoco ou multiplos calculos nos canais biliares. O seguimento de 88 pacientes operados mostrou otimo resultado em 93,2% dos casos
