Chemical Evaluation of the Effects of Storage Conditions on the Botanical Goldenseal using Marker-based and Metabolomics Approaches.

Hydrastis canadensis, commonly known as goldenseal, is a botanical native to the southeastern United States that has been used for the treatment of infection. The activity of goldenseal is often attributed to the presence of alkaloids (cyclic, nitrogen-containing compounds) present within its roots. Chemical components of botanical supplements like goldenseal may face degradation if not stored properly. The purpose of the research was to analyze the stability of known and unknown metabolites of H. canadensis during exposure to different storage conditions using mass spectrometry. Three abundant metabolites of H. canadensis, berberine, canadine, and hydrastine, were chosen for targeted analysis, and the stability of unknown metabolites was evaluated using untargeted metabolomics. The analysis and evaluation of H. canadensis samples were performed utilizing LC-MS and Principal Component Analysis (PCA). The research project focused on identifying the chemical changes in the metabolite content of H. canadensis under different temperature conditions (40°C ± 5°C, 20°C ± 5°C , and 4°C ± 5°C), different light:dark (hr:hr) cycles (16:8, 12:12, and 0:24), and different sample conditions (powdered roots versus whole roots) over a six month period. The results of this 6-month study revealed that the storage conditions evaluated had no significant effects on the chemical composition of H. canadensis roots. Hence, as long as H. canadensis roots are stored within the storage conditions tested in the study, no significant changes in chemical compositions of metabolites are expected.

Effects of lipid formulations on clove extract spray dried powders: comparison of physicochemical properties, storage stability and in vitro intestinal permeation.

Clove is an aromatic plant spice with potent antioxidant and anti-inflammatory activity. Eugenol is the main compound which contributes to such medicinal and nutritional benefits. To date, the formulation of unstable, volatile and poorly water-soluble compounds remains a challenging task. Lipid formulations can be used to improve physicochemical and biopharmaceutical properties of poorly soluble compounds. The aim of this study is to investigate the effects of lipids, such as Gelucire and Compritol on physicochemical properties; stability and in vitro intestinal permeation of spray dried powdered formulations loaded with clove's bioactive compounds. Results showed that eugenol retention in spray-dried powders could be correlated with antioxidant activity and with mass recovery after spray drying. Adding Gelucire but not Compritol to clove extract formulations, improved solubility of spray dried powders. Stability test in high humidity environment (63.5% RH) suggested that formulations including both Gelucire and Compritol were significantly more stable compared to the formulation without any lipid at the two tested temperatures (25 °C and 40 °C). This suggests that lipid additions to clove (Syzygium aromaticum) extract formulations provide protective effects for the spray dried powders in high-humidity environments. In addition, results from in vitro intestinal permeation studies suggested that eugenol uptake, was not being hindered by transporters nor was the absorption being affected by lipid formulations.

Technical issues and conservation conditions of medicines in the primary health care of the Brazilian Unified Health System.

OBJECTIVE: To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. METHODS: This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines - Services)-, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21. RESULTS: The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance. CONCLUSIONS: The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of requirements essential to the conservation of medicines. We observed a disconnection between the efforts made in the Brazilian Unified Health System to promote access to medicines for all population and the organization and qualification of pharmaceutical services.

Quality and stability of extemporaneous pyridoxal phosphate preparations used in the treatment of paediatric epilepsy.

OBJECTIVES: To assess the pyridoxal 5'-phosphate (PLP) content and stability of extemporaneous PLP liquids prepared from dietary supplements used for the treatment of vitamin B6 -dependent epilepsy. METHODS: Pyridoxal 5'-phosphate liquids were prepared in accordance with the guidelines given to patients from marketed 50 mg PLP dietary capsules and tablets. The PLP content and its stability were evaluated under conditions resembling the clinical setting using reverse phase HPLC and mass spectrometry. KEY FINDINGS: Pyridoxal 5'-phosphate content in most of the extemporaneously prepared liquids from dietary supplements was found to be different from the expected amount (~16-60 mg). Most of these PLP extemporaneous liquids were stable at room temperature (protected from light) after 24 h but unstable after 4 h when exposed to light. A key photodegradation product of PLP in water was confirmed as 4-pyridoxic acid 5'-phosphate (PAP). CONCLUSION: Pyridoxal 5'-phosphate tablets from Solgar® were found to be the most reliable product for the preparation of extemporaneous PLP liquids. This work highlighted the difference between the marketed PLP dietary supplements quality and the importance of proper storage of aqueous PLP. There is a need to develop pharmaceutical forms of PLP that ensure dose accuracy and avoid potentially unsafe impurities with the aim of enhancing safety and compliance.

Technical issues and conservation conditions of medicines in the primary health care of the Brazilian Unified Health System / Situação sanitária dos medicamentos na atenção básica no Sistema Único de Saúde

OBJECTIVE To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines - Services)-, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21. RESULTS The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance. CONCLUSIONS The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of requirements essential to the conservation of medicines. We observed a disconnection between the efforts made in the Brazilian Unified Health System to promote access to medicines for all population and the organization and qualification of pharmaceutical services.

OBJETIVO Caracterizar a situação sanitária dos medicamentos na Atenção Básica, nas regiões brasileiras, quanto a requisitos técnico-sanitários, responsável pela farmácia/unidade de dispensação, condições ambientais, de armazenamento, e de fracionamento, controle de estoque e gerenciamento de resíduos, itens de segurança contra incêndio e pane elétrica, problemas no transporte, regulamentação da propaganda e farmacovigilância. MÉTODOS Artigo integrante da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, um estudo transversal, exploratório, de natureza avaliativa, composto por um levantamento de informações numa amostra representativa de municípios, estratificada pelas regiões brasileiras, que constituem domínios do Estudo, e uma amostra de serviços de Atenção Básica. Realizou-se observação direta dos serviços farmacêuticos com registro fotográfico e entrevistas presenciais com os responsáveis pela entrega de medicamentos e por telefone com o responsável pela assistência farmacêutica. Os dados foram processados com o software SPSS® versão 21. RESULTADOS As dimensões investigadas mostraram deficiências relevantes e desigualdades entre as regiões, em geral mais favoráveis nas regiões Sudeste e Centro-Oeste e mais deficitárias nas regiões Nordeste e Norte. Constatou-se descumprimento de requisitos técnicos e sanitários imprescindíveis à conservação dos medicamentos que podem interferir na manutenção da estabilidade e, assim, na sua qualidade, eficácia e segurança. A regulação da propaganda/promoção de medicamentos ainda é incipiente e existe algum avanço na estruturação de mecanismos em relação à farmacovigilância. CONCLUSÕES A situação sanitária dos medicamentos na Atenção Básica no Brasil desperta preocupações pelo descumprimento da legislação sanitária específica para os estabelecimentos de dispensação e de um amplo conjunto de requisitos imprescindíveis à conservação dos medicamentos. Constatou-se um descompasso entre os esforços no âmbito do Sistema Único de Saúde para promover o acesso aos medicamentos para toda a população e a organização e qualificação dos serviços farmacêuticos.

Oribatid mite infestation in the stored Chinese herbal medicines / Infestación por ácaros en el almacenamiento de hierbas medicinales Chinas

Objective: to investigate the breeding status of oribatid mites and its related biological traits in the stored traditional Chinese herbal medicines. Methods: sixty-three sorts of stored traditional Chinese herbal medicines of root and stem origins were collected from Huainan City in Anhui Province. The mites were isolated by Shakesieve and Tullgren, and identified and counted under the light microscope. Results: thirteen samples in 63 were infested with the oribatid mites, which accounted for 21.67 %(13/60). A total of 11 species of oribatid mites, belonging to 6 families, were found in the 13 samples, and the most abundant species were Scheloribates laevigatus (36.19%), Scheloribates latipes (28.35%) and Trhypochthpnius japonicus (19.72%). The average breeding density of oribatid mites was about 4.51 individuals/g; the index of species richness, the diversity index, and the evenness index of species were 1.14, 1.581, and 0.212, respectively. Conclusion: oribatid mites were found in stored Chinese herbal medicines from Huainan city in Anhui province of China, suggesting that the conventional storage and processing technique should be improved in order to ensure the quality and safety of the herbal medicines (AU)

Objetivo: investigar el estado reproductivo de los ácaros oribátidos y sus rasgos biológicos en el almacenamiento de medicinas a base de hierbas chinas tradicionales. Métodos: sesenta y tres tipos de medicinas a base de hierbas chinas tradicionales extraídas de raíces y tallos almacenadas fueron recopilados en Huainan City, en la provincia de Anhui. Los ácaros fueron aislados por Shakesieve y Tullgren, y su identificación y recuento se realizó mediante microscopio de luz. Resultados: trece de cada 63 muestras estaban infestadas por los ácaros oribátidos, lo que supone un 21,67% (13/60). Un total de 11 especies de ácaros oribátidos, pertenecientes a 6 familias, fueron encontrados en las 13 muestras, y las especies más abundantes fueron: Scheloribates laevigatus (36,19%), Scheloribates latipes (28,35%) y Trhypochthpnius japonicus (19,72%). El promedio de densidad reproductiva de los ácaros oribátidos fue de alrededor de 4,51 individuos/g; el índice de riqueza de especies, el índice de diversidad y la uniformidad del índice de especies fue 1,14, 1,581 y 0,212, respectivamente. Conclusión: se detectó la presencia de ácaros oribátidos en las hierbas medicinales chinas almacenadas de Huainan City, en la provincia de Anhui, China, lo que sugiere que la técnica convencional de almacenamiento y procesamiento debe mejorarse a fin de garantizar la calidad y la seguridad de los medicamentos a base de hierbas (AU)

[Suggestions to strengthen quality management of herbal decoction pieces--based on production chain of herbal decoction pieces].

With the development of society and the improvement of people's living standards, the effect of Chinese medicine in treatment and health care is more and more prominent. The herbal decoction pieces are the important part of Chinese medicine,it can be applied directly to clinical treatment and it's also the raw material of Chinese patent medicine. Therefore, the quality of herbal decoction pieces is quite important. The parts of the production of herbal decoction pieces are numerous, and there are possibilities of adverse effects on the quality of the herbal decoction pieces in every part. In this paper, we based on the production chain of herbal decoction pieces, analyzed the main problem that affect the quality of herbal decoction pieces in the part of selection of Chinese herbal medicines, planting, purchasing, processing, packaging, storage and transport, such as the poor quality of seed and seedlings of plant-based Chinese medicines, some plants left their place of origin and have been introduced in the place that is not suitable for this kind of plant, the insufficient growth time and the excessive harmful substances. The purchasers and the accepters lack of professional knowledge and professional ethics. The mechanism of processing is not clear, the standards can not be uniformed, and lack of qualified person in processing, etc. So we suggest: intensify the basic research of key scientific issues. Improve the quality of persons who work in herbal decoction pieces; Establish an "integration" mode of operation in herbal decoction pieces enterprise; Breeding high quality plant resources, establish the large-scale planting basement; Make the packing of herbal decoction pieces standard; Establish the modernization traditional Chinese medicine logistics enterprise.

Program on immunization and cold chain monitoring: the status in eight health districts in Cameroon.

BACKGROUND: Cold chain monitoring is a precondition to ensure immunization quality, efficacy and safety. In Cameroon, the Expanded Program on Immunization (EPI) has National Standard Operating Procedure (SOP) that describes the vaccines, the cold chain system and equipment, its use and recommended procedures to control and monitor the temperatures and the cold chain. This study was conducted to assess the status of cold chain in eight health districts in Cameroon. FINDINGS: The study was carried out in eight health districts out of fifty with poor immunization coverage rate. Data were collected using a validated form by observation and consultation of related documents. District Health Services (DHS) and four Integrated. Health Centers (IHC) randomly selected were targeted per health district. Forty health facilities were included. Twenty eight (70.0%) had at least one functional refrigerator for EPI activities. The power supply was reported to be permanent in 7 (20.6%) out of 34. (85.0%) health facilities with access to power supply. The temperature monitoring chart was pasted on 27 (96.4%) of the cold chain equipment. On 16 (59.3%) of these charts, the temperature was recorded twice daily as recommended. Seven (25.9%) of 27 refrigerators assessed had temperature out of the recommended range of 2 to 8°C. Almost 23.30% of health centers did not received any supervision on cold chain monitoring during a vaccination campaign. CONCLUSION: This study documents failure of the cold chain maintenance and questions the efficacy and safety of vaccines administered during EPI activities in Cameroun. These findings indicate that appropriate actions are needed to ensure monitoring of EPI cold chain in the country.

Effect of high relative humidity on dried Plantago lanceolata L. leaves during long-term storage: effects on chemical composition, colour and microbiological quality.

INTRODUCTION: Modern phytotherapy and quality assurance requires stability data on bioactive metabolites to identify and minimise decomposing factors during processing and storage. A compound's stability in a complex matrix can be different from the stability of the purified compound. OBJECTIVE: To test the stability of iridoids and acteoside and quantify changes in colour and microbiological quality in a common herbal tea, dried P. lanceolata leaves during exposure to high-humidity air. To test the contribution of fungi to metabolite decomposition. METHODOLOGY: Dried P. lanceolata leaves were exposed to atmospheres of different relative humidity (75, 45 and 0%) for 24 weeks. Changes in aucubin and catalpol concentration were determined by CE-MEKC, and those in acteoside on TLC. Colour and chlorophyll-like pigments were measured by different spectrophotometric methods. The number of fungi was monitored; 10 strains were isolated from the plant drug, and their ability to decompose the analytes of interest was tested. RESULTS: During incubation at 75% relative humidity (RH), aucubin, catalpol and acteoside concentrations decreased by 95.7, 97.0 and 70.5%, respectively. Strong shifts were detected in CIELAB parameters a* and b* (browning) as a result of conversion of chlorophyll to pheophytin. Intensive microbial proliferation was also observed. Changes at 45 or 0% RH were typically insignificant. Seven of the 10 isolated fungal strains could decompose both iridoids, and five could decompose acteoside in vitro. CONCLUSION: It was shown that exposure to water results in loss of bioactive molecules of P. lanceolata dried leaves, and that colonising fungi are the key contributors to this loss.

Medication storage and self-medication behaviour amongst female students in Malaysia / Almacenamiento de medicación y comportamientos en auto-medicación entre mujeres estudiantes en Malasia

Objectives: The aims of this study are to determine the prevalence, attitudes and behaviours of medication storage and self-medication amongst female students at Universiti Sains Malaysia (USM). Methods: A cross-sectional survey was conducted and cluster random sampling technique was used for respondent selection. A pre-piloted questionnaire was administered to female respondents so as to collect the data. Data was analyzed using SPSS version 12 and analysis was conducted using descriptive analysis procedures. Results: Of the 481 participants (mean age; SD was 22.1; 3.3), 93.1% (n=448) students stated that they stored medicine in their rooms, while 70.7% (n=340) stated that they stopped taking a prescribed medicine without consulting a doctor. The prevalence of self-medication was 80.9% (n=389). The most common reasons for self-medication were related to their knowledge of their ailment and its treatment (58.0%), 14.4% thought it saved time and 8.5% mentioned that medication given by provider was not effective. The most common symptoms were otorhinolaryngology problems (22.5%), followed by respiratory disease (19.6%), Gastro Intestinal Tract (GIT) disease (18.1%) and headache/fever (16.8%). Commonly used medicines were analgesics & antipyretics (30.2%), ear, nose & throat drugs (10.8%), vitamins & minerals (10.8%), GIT drugs (8.5%), anti-infections (7.3%) and herbal medicines (3.5%). Prevalence of medicine storage and self-medication practice is high among educated female students in USM. Conclusions: There is a need to educate the students to ensure safe practice by increasing their awareness. Strict policies need to be implemented on the unrestricted availability of medicines so as to prevent the wastage of medicines (AU)

Objetivos: Los objetivos de este estudio son determinar la prevalencia, actitudes y comportamiento en el almacenamiento de medicamentos y la auto-medicación entre mujeres jóvenes estudiantes en la Universiti Sains Malaysia (USM). Métodos: Se realizó un estudio transversal y se utilizó una técnica de muestreo por cluster para la selección de respondentes. Para recoger los datos, se administró un cuestionario pre-pilotado a las mujeres que respondieron. Los datos fueron analizados utilizando el SPSS versión 12 y el análisis se realizó utilizando procedimientos descriptivos. Resultados: De los 481 participantes (edad media; DE era 22,1; 3,3), el 93,1% (n=448) afirmaron que almacenaban medicamentos en sus habitaciones, mientras que el 70,7% (n=340) afirmó que pararon de tomar un medicamento prescrito sin consultar al médico. La prevalencia de auto-medicación era del 80,9% (n=389). Entre las razones más frecuentes para auto-medicación estaban relacionadas con sus conocimientos de su enfermedad y su tratamiento (58,0%), el 14,4% pensaba que ahorraba tiempo y el 8,5% mencionó que la medicación proporcionada no era efectiva. Los síntomas más frecuentes fueron problemas otorrinolaringológicos (22,5%), seguidos de enfermedades respiratorias (19,6%), del tracto gastrointestinal (TGI) (18,1% y dolor de cabeza/fiebre (16,8%). Los medicamentos frecuentemente utilizados eran analgésicos y antipiréticos (30,2%), medicamentos para nariz, garganta y oídos (10,8%), vitaminas y minerales (10,8%) y plantas medicinales (3,5%). La prevalencia del hábito de almacenar medicamentos y de auto-medicación es alta entre las mujeres estudiantes de la USM. Conclusiones: Existe la necesidad de educar a los estudiantes para garantizar la práctica segura aumentando sus conocimientos. Se necesita implantar políticas estrictas sobre la disponibilidad irrestricta de medicamentos así como para prevenir el desperdicio de medicamentos (AU)

Long-term physico-chemical stability of standard parenteral nutritions for neonates.

BACKGROUND & AIMS: Two ready-to-use parenteral nutritions (PN) have been developed, for the first days of life of the premature newborn, along with syringes of lipid emulsion with or without vitamins. Long-term physico-chemical stability for storage in wards was assessed. METHODS: Physico-chemical stability of PN: visual inspection, particle size, pH, osmolarity measurement, amino acids, glucose, and electrolytes dosages. Physico-chemical stability of lipid emulsion: visual inspection, globule size, peroxide level and vitamins A, E, and C dosages. Stability was studied for 12 weeks on refrigerated (2-8 °C) and room temperature (30 ± 2 °C) samples. RESULTS: No precipitation was detected in any PN. A brown coloration was observed in PN stored for four weeks at room temperature but not in the refrigerator. Concentrations of all the nutrients remained constant over the 12 week-study period. Phase separation of the lipid emulsion occurred after three weeks, but particle size complied with the USP limits for 12 weeks. Peroxide content increased only in the samples without vitamins at room temperature. Vitamins remained stable for one week under refrigeration. CONCLUSION: The PN did not present a detectable change of the tested properties when refrigerated for 12 weeks. The lipid emulsion with vitamins is stable for one week when refrigerated.

Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures.

PURPOSE OF REVIEW: To examine the stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition admixtures in order to provide well tolerated and effective therapy. RECENT FINDINGS: Many stability investigations were carried out before 2005, but no critical appraisal of published data has been undertaken. H2-receptor antagonists are stable in most parenteral nutrition admixtures for 2-48 h, with long-term stability up to 4 weeks claimed for a few combinations. Some earlier data are questionable in the light of more recent analytical technology and pharmaceutical knowledge regarding stability assessment. As stability is dependent upon the source of constituents, we have listed all products tested and their respective manufacturers. A general recommendation is made not to store H2-receptor antagonists in parenteral nutrition for more than 24 h at refrigerated temperature before use. SUMMARY: Administration of H2-receptor antagonists in parenteral nutrition admixtures has several clinical and economical advantages, but, in order for these benefits to be well tolerated and efficacious, the stability and compatibility of the drugs, as well as the parenteral nutrition components after mixing, have to be ascertained. Factors that influence stability are assessed, the need for more controlled study protocols is evaluated and recommendations are made for safe storage and administration.

Ley de garantías y uso racional de los medicamentos y productos sanitarios. 1. Comentarios generales / Garanties Law and rational use of drugs and medical devices. 1. General comments

Se inicia una serie de comentarios sobre la Ley de garantías y uso racional de los medicamentos y productos sanitarios que empieza con una introducción que incluye el sumario o índice general comparativo con el de la anterior Ley del medicamento de 1990 y su estructura general

It is initiated a series of commentaries above the Guaranties Law and rational use of drugs and medical devices to begin by a introduction with the summary either general index comparative with the previous Drugs Law 1990, and the structure

Stability of andrographolide in powdered Andrographis herb under accelerated conditions.

The stability of andrographolide in powdered Andrographis Herb--the aerial part of Andrographis paniculata (Burm. f.) Nees (Acanthaceae)--was determined using a heat-accelerated experiment to reveal a second-order kinetics of degradation. The fast decomposition was observed regardless of the method of analysis. The rate constant of the decomposition of andrographolide at 25 degrees C ( K(25)( degrees C)), predicted from the Arrhenius plot, was 6.58 x 10 (-6) d (-1).

Preparation of a water-in-oil-in-water (W/O/W) type microcapsules by a single-droplet-drying method and change in encapsulation efficiency of a hydrophilic substance during storage.

Microcapsules of a water-in-oil-in-water (W/O/W) emulsion, which contained a hydrophilic substance, 1,3,6,8-pyrenetetrasulfonic acid tetrasodium salt (PTSA), in its inner aqueous phase, was prepared by hot-air-drying or freeze-drying the emulsion using a single-droplet-drying method. Pullulan, maltodextrin, or gum arabic was used as a wall material, and the oily phase was tricaprylin, oleic acid, olive oil, or a mixture of tricaprylin and olive oil. An encapsulation efficiency higher than 0.95 was reached except for the microcapsules prepared using gum arabic and oleic acid. The hot-air-dried microcapsules were generally more stable than the freeze-dried microcapsules at 37 degrees C and various relative humidities. The stability was higher for the microcapsules with tricaprylin as the oily phase than for the microcapsules with oleic acid. The higher stability of the microcapsules with tricaprylin would be ascribed to the lower partition coefficient of PTSA to the oily phase. There was a tendency for the stability to be higher at lower relative humidity for both the hot-air- and freeze-dried microcapsules. The volumetric fraction of olive oil in its mixture with tricaprylin did not significantly affect either the encapsulation efficiency or the stability of the hot-air-dried microcapsules.

Estudio de la idoneidad de la prescripción antibiótica en el Hospital Monte Naranco. Oviedo / Study of the appropiateness of antibiotic prescription in the Hospital Monte Naranco

Objetivos: 1. Describir la frecuencia y distribución de uso de antibióticos en el hospital para los distintos procesos tal como se diagnostican en la historia clínica. 2, Evaluar la adecuación del uso a los criterios diagnósticos y terapéuticos. Material y métodos: Se trata de un estudio observacional y trasversal a partir de una muestra aleatoria de las altas hospitalarias desde el 01/01/99 al 31/09/99. El universo poblacional fueron las altas cerradas y codificadas y la información se obtuvo de la historia clínica mediante un cuestionario diseñado a tal efecto que recoge variables de filiación, diagnóstico principal y otros diagnósticos, criterios que justifican la indicación del antibiótico, indicadores de proceso, cambio de antibiótico y motivo, indicadores de evolución de la enfermedad y clinica que justifica el diagnóstico, obteniéndose una muestra de 411 historias clínicas. La información fue recogida y revisada por los autores. Los criterios de infección y de indicación de tratamiento proceden de los establecidos por los Centers for Disease Control y las recomendaciones de diferentes sociedades científicas. Resultados: En el 25 por ciento de las historias clínicas revisadas contaba indicación de tratamiento antibiótico. Prescritos en el centro fueron el 49 por ciento de los tratamientos, de los cuales el 30 por ciento corresponden a cambios de tratamiento, mientras que el 51 por ciento de los tratamientos fueron inducidos por el centro de referencia. El 88 por ciento de las indicaciones de los tratamientos antibióticos del centro y 76 por ciento del total fueron amoxicilina-ácido clavulánico u ofloxacino. La adecuación de los diagnósticos a los criterios, varió según diagnóstico, entre el 44 por ciento para infección cutánea, con una media de 54 por ciento. La adecuación de los diagnósticos a los criterios, varió según diagnóstico, entre el 44 por ciento para infección de las vías respiratorias bajas y el 61 por ciento, para infección cutánez, con una media de 54 por ciento. La adecuación de la prescripción respecto al diagnóstico que figuraba en la historia clínica y su duración varió entre el 91,5 por ciento para infección respiratoria y 100 por ciento para neumonías. La duración media de tratamiento fue de 9,6 días, con escasa variabilidad dentro de los tratamientos y entre infecciones, y sólo el 14 por ciento de los tratamientos fue correcta para las infecciones urinarias. La vía intravenosa se mantuvo, en la media, durante el 80 por ciento del tiempo del tratamiento. Conclusiones: En este estudio se observa un uso correcto de antibióticos en relación con el diagnóstico que figura en la historia clínica. Sin embargo sólo en la mitad de los casos se cumplen los criterios diagnósticos y la duración del tratamiento de infecciones urinarias así como el tratamiento intravenoso parecen largos. Las consecuencias de esto pueden ser iatrogenia y gastos innecesarios. Por tanto, los aspectos mejorables en la utilización de antibióticos en el Hospital Monte Naranco son fundamentalmente el cumplimiento de criterios diagnósticos y la duración de los tratamientos. Se recomienda como estrategia para mejorar la calidad de prescripción de antibióticos un acercamiento multidisciplinar que incluya: 1. consenso en el uso, 2. programas de formación 3. audits médicos, 4. revisión de los criterios diagnósticos y las indicaciones terapéuticas adaptados a la población usuaria de este centro (AU)