			Home About us Contact

Medicinal Drugs (medicinal + drug)

Distribution by Scientific Domains

Medical Sciences	50%

Selected Abstracts

Toxicology and risk assessment of coumarin: Focus on human data

MOLECULAR NUTRITION & FOOD RESEARCH (FORMERLY NAHRUNG/FOOD), Issue 2 2010
Klaus Abraham
Abstract Coumarin is a secondary phytochemical with hepatotoxic and carcinogenic properties. For the carcinogenic effect, a genotoxic mechanism was considered possible, but was discounted by the European Food Safety Authority in 2004 based on new evidence. This allowed the derivation of a tolerable daily intake (TDI) for the first time, and a value of 0.1,mg/kg body weight was arrived at based on animal hepatotoxicity data. However, clinical data on hepatotoxicity from patients treated with coumarin as medicinal drug is also available. This data revealed a subgroup of the human population being more susceptible for the hepatotoxic effect than the animal species investigated. The cause of the high susceptibility is currently unknown; possible mechanisms are discussed. Using the human data, a TDI of 0.1,mg/kg body weight was derived, confirming that of the European Food Safety Authority. Nutritional exposure may be considerably, and is mainly due to use of cassia cinnamon, which is a popular spice especially, used for cookies and sweet dishes. To estimate exposure to coumarin during the Christmas season in Germany, a telephone survey was performed with more than 1000 randomly selected persons. Heavy consumers of cassia cinnamon may reach a daily coumarin intake corresponding to the TDI. [source]

Current guidelines applicable for the approval of topically applied dermatological drugs in the EU

FUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2004
Myrjam Dorothea Straube
Abstract Dermatologicals as well as other medicinal products are submitted to the rules governing medicinal products in the European Union (EU) (Directive 2001/83/EC). With appreciation of the EU enlargement those regulatories deserve a recent consideration with special regard to the peculiarities of external dermatological therapy, recently passed novel and future guidelines. As regards the criteria for authorization of a medicinal product it is set out in Regulation (EEC) 2309/93 Article 11(1) that a marketing authorization shall be refused if it appears that the quality, the safety or efficacy of the medicinal product have not been adequately or sufficiently demonstrated by the applicant. Article 26(1) of Council Directive 2001/83/EC is worded a little differently but the criteria are the same irrespective of the procedure for the marketing authorization. For the final evaluation of the benefit/risk profile of a topically applied dermatological medicinal product not only the active agent but the whole galenic formulation as well has to be taken into account as the extent of penetration of the active compound might be influenced by changing the non-active substances. Furthermore the vehicle itself , independent of the active agent , influence the dermatological disorder, often in dependence on the stage of the dermatopathy. With special concern to safety/tolerability the (photo)toxic and (photo)allergic potential of the dermatological drug have to be taken into consideration too. In case of total body therapy in children the differing percutaneous resorption due to another body surface/body weight relation deserves special concern. The following review gives a survey of the current most important EU-guidelines for the evaluation of the benefit/risk profile of topically applied dermatological medicinal drugs and an outlook on further developments. As systemically applied dermatological medicinal products are assessed like other systemically applied drugs they are not treated in the following contribution. [source]

Cultivation of medicinal isabgol (Plantago ovata) in alkali soils in semiarid regions of Northern India

LAND DEGRADATION AND DEVELOPMENT, Issue 3 2006
J. C. Dagar
Abstract There is growing global demand for medicinal drugs including isabgol (Plantago ovata). With increasing demand of food for an ever-increasing population in India, it is not possible to bring arable lands under cultivation for aromatic and medicinal plants. Salt-affected lands (both saline and alkali) occupy about 8·6 million ha. Due to poor physical properties and excessive exchangeable Na+, most of these lands do not support good vegetation cover. The marginal and salt-affected lands could be successfully utilized for the cultivation of aromatic and medicinal plants. We achieved almost complete germination of isabgol seeds using up to 5000,ppm salt-solution. Grain yield (including husk) was 1·47 to 1·58,t,ha,1 at pH 9·2 showing no significant yield reduction as compared to normal soil. At pH 9·6 the grain yield was 1·03 to 1·12,t,ha,1. At higher pH there was significant reduction in yield. Sowing in good moisture (at field capacity) of soil was found best, but to save time sowing at shallow depth in dry soil, followed by irrigation was also suitable as compared to broadcasting seeds. The chlorophyll content was greater 70 days after sowing compared to younger stages (50 days after sowing). The total chlorophyll and plant biomass were lower from crops grown by broadcasting methods of sowing as compared to two other methods of sowing. The leaf area index (LAI) was higher for the broadcasting method of sowing as compared to the other two methods. Na+ absorption increased and K+ and K+/Na+ ratio decreased with increase in pH. Results reported in this paper clearly indicate that isabgol can successfully be grown on moderately alkali soils up to pH 9·6 without the application of any amendment. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Analysis of the adverse reactions induced by natural product-derived drugs

BRITISH JOURNAL OF PHARMACOLOGY, Issue 7 2010
Zhi-Ping Zeng
Compared with the therapeutic effects of established medicinal drugs, it is often considered that natural product-derived drugs are of a more benign nature in side-effects, which has made natural medicines become a popular form of therapy. Traditional Chinese medicine (TCM) is generally considered as being natural and harmless. TCM has been paid much more attention than before and widely used for the treatment nowadays. However, with the increasing cases of adverse drug reactions (ADRs), the ADRs induced by TCM are becoming more widely recognized. Some ADRs are sometimes even life-threatening. This article reviews literatures on ADRs induced by TCM which was published in the past 10 years. A total of 3122 cases including complete data are selected for the present analysis. From the data of the 3122 cases, statistics is carried out to the distribution of administration routes and time of the occurrence of ADRs, the prognosis of ADRs, sex and age factors, types and clinical symptoms of ADRs, and drugs involved in ADRs. In addition, occurrence and influencing factors of TCM-induced diseases are also analysed, which includes spices confusion, processing drugs improperly, toxic components, long-term medication, improper concerted application, interaction of TCM and Western medicine. It is concluded that the efficacy and toxicity of TCM, often using the compound prescription involving various plants and animals, resulted from a variety of chemical constituents, which lead to a comprehensive response in the human body. The ,toxicity' of TCM should be correctly recognized and reasonably utilized. [source]