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At least 955 records · Page 53Linked to original sources
PubMed1980

[Antibacterial effect of borreverine, an alkaloid isolated from Borreria verticillata (Rubiaceae)].

Borreria verticillata, a very common tropical plant, is used in traditional pharmacopeia to recover cutaneous infections. The Borreverine alkaloid extracted from this plant had an antimicrobial action in vitro. The minimal inhibitory concentration is lower than 50 micrograms/ml for Gram positive cocci, (specially Staphylococcus aureus) and than 6 micrograms/ml for Vibrio cholerae and upper than 200 micrograms/ml for several Gram negative rod-bacteria (Enterobacteria and Pseudomonas). These preliminary results underline the interest in the research about the antimicrobial agents from plant origin, in particular concerning naturally or chemically modified alkaloids.

Alkaloids↗
PubMed1982

Differential pulse polarographic determination of iodine in thyroid tablets: collaborative study.

A differential pulse polarographic (DPP) method for the determination of iodine in thyroid and thyroid preparations was collaboratively studied by 8 laboratories. The overall concentration of iodine in commercial thyroid tablets containing 1/4, 1,2, and 5 gr. of declared thyroid was 0.196%. The overall repeatability and reproducibility standard deviations were 0.0043 and 0.0067, respectively, and the corresponding coefficients of variation were 2.18 and 3.41%, respectively. The results obtained by the DPP method agreed with those obtained by the U.S. Pharmacopeia XX method at the various concentrations of declared thyroid studied. The DPP method has been adopted official first action.

Iodine↗
PubMed1982

Infant food problems and analytical aspects of providing safe and wholesome infant foods.

The technology of milk and infant food production, storage, and handling has advanced to the point that infant foods have had an excellent record of being free of recognized health hazards. The Infant Formula Council has published methods specifically for these foods. Methods are included from Standard Methods for the Examination of Dairy Products, Official Methods of Analysis, Bacteriological Analytical Manual, the Manual of Clinical Microbiology, and the U.S. Pharmacopeia. Criteria for microbiological quality have been issued by the Codex Alimentarius Commission, the International Commission for Microbiological Specifications for Foods, and the Public Health Service. Surveys in the United States and Canada have shown that sanitary standards are met with ease.

Consumer Product Safety↗
PubMed1980

Evaluation of patient medication counseling sources.

Seven sources of information on patient medication counseling were evaluated. Each source was reviewed for inclusion of five types of information on 20 drugs selected randomly from the top 200 prescription drugs. The ASHP's Medication Teaching Manual was the most complete source in terms of including the largest number of sample drugs. Apelgren and Rowles's Handbook for Counseling Patients on Their Medications, Griffith's Drug Information for patients, Maudlin and Young's Drug Consultation Guide, and Smith's Medication Guide for Patient Counseling were nearly as complete in this regard. In terms of including information in each of the five categories for the sample drugs, the U.S. Pharmacopeia Dispensing Information and the Medication Teaching Manual ranked highest. Cost, size, format, and indexing of the sources are compared, and special features and limitations of the source are presented. All the publications are at least adequate patient counseling sources, although some are more complete and thorough than others.

Counseling↗
PubMed1980

[Glucose determination in diluted whole blood using an enzyme electrode].

The construction and operation of a measuring device containing an enzyme electrode is described. Glucose oxidase is enclosed in an acrylamide film by means of photopolymerization. The maximal increase of the anodic current of the H2O2 being formed in the enzyme reaction serves as measuring signal. The device gives for diluted serum and blood correlation coefficients above 0,99 according to the methods given in the German Pharmacopeia 7. The measuring time for each specimen is roughly 90 s, the serial variation coefficient 2%.

Blood Glucose↗
PubMedDate not supplied

Validation of dry heat inactivation of bacterial endotoxins.

Bacterial endotoxins (ETs) are lipopolysaccharides from the cell wall of Gram negative bacteria. ETs get into the environment as a result of autolytic desintegration of the bacterial cells. There exist a number of depyrogenation methods, either serving to remove or to inactivate ET. The most common means of ET inactivation is dry heat. Unfortunately no uniform regulation exists describing the conditions for sufficient ET inactivation. While the USP and FDA require an ET reduction of 3 log steps, no European regulation exists regarding depyrogenation of final containers for parenterals. However, the Ph. Eur. specifies the temperature and time conditions for depyrogenation of glassware in the pyrogen test monograph, allowing to choose between the two variants 250 degrees C/30 minutes or 200 degrees C/60 minutes which are not equivalent. In the present study those conditions for depyrogenation of glass containers in production of parenterals were investigated which, on the one hand, are technically feasible and, on the other hand, comply with the requirements of the main Pharmacopeias; furthermore, an ET preparation suitable for validation studies was selected. The preparation of ET indicators, the dry-heat inactivation and the recovery of ET are described in detail. Based on the results obtained, it is recommended to follow a defined treating temperature and period for safe depyrogenation of glass containers for parenterals, which results in a 4 log step reduction in ET without fillers. Thereby the USP/FDA requirement for a 3 log step reduction as well as the 200 degrees C/60 minutes requirement variant given in the Ph. Eur. can be fulfilled.

Cell Wall↗
PubMed1976

Comparison of Dexon and Mersilene sutures in the closure of primary laparotomy incisions.

The study is a comparison of Dexon (polyglycolic acid) and Mersilene (polyester) sutures when employed for the primary closure of the peritoneum and aponeurotic layer in primary laparotomy incisions. The material comprises 308 closures of abdominal wounds with interrupted 2-0 sutures (United States Pharmacopeia) in the aponeurosis and continuous 2-0 suture of the peritoneum. One half of the wound was closed with Dexon and the other half with Mersilene, so that the patient acted as his own control. No significant difference was found between the two materials as evaluated from the occurrence of wound rupture within 10 days and incisional hernia within 90 days of the operation. Suture granulomas occurred in 9% of the half wounds sutured with Mersilene. The present clinical investigation demonstrates that Dexon sutures are as reliable as unabsorbable material. Dexon is superior to unabsorbable material as suture granulomas were not seen when Dexon was employed.

Adolescent↗
PubMed1994

[Development of analytical methods for the determination of Indosol and eyedrops].

Indosol is the water soluble Trometamol salt of Indomethacin. It shows promise in the combating of inflammations e.g. in ocular surgery. This paper reports on the results obtained using analytical methods of the Hungarian Pharmacopeia and the development of new analytical methods for Indosol. Solvent residues in Indosol were determined gas chromatographically after extraction with carbon tetrachloride, and an HPLC method was developed for the determination of Indosol as a pure substance or in eye-drops, using a Hypersil-ODS column and methanol-water-acetonitrile-acetic acid (55:35:10:5).

Chromatography, Gas↗
PubMed1994

Stability of fluoxetine hydrochloride in fluoxetine solution diluted with common pharmaceutical diluents.

The stability of fluoxetine hydrochloride in fluoxetine solution diluted with five common pharmaceutical diluents was studied. Fluoxetine syrup, containing fluoxetine 4 mg/mL (as the hydrochloride salt), was diluted to 1 and 2 mg/mL in each of the following: deionized water; Simple Syrup, British Pharmacopeia; Simple Syrup, USP; Aromatic Elixir, USP; and grape-cranberry drink. Each solution was divided into eight 120-mL amber glass bottles: four stored at 5 degrees C and four stored at 30 degrees C. Samples were removed from each bottle at time zero and two, four, and eight weeks and assayed in triplicate with high-performance liquid chromatographic methods for determining fluoxetine concentration and concentration of its primary degradation product, alpha-[2-(methylamino)ethyl]benzene methanol. Stability was established if the fluoxetine concentration changed by < 10% and if the concentration of the degradation product was < 1% of the initial fluoxetine concentration. No test mixture dropped below 95% of the initial fluoxetine concentration or exceeded 0.5% degradation product during the study period. Fluoxetine hydrochloride was stable for eight weeks in fluoxetine solution diluted to 1 or 2 mg/mL with common pharmaceutical diluents and stored at 5 or 30 degrees C.

Chromatography, High Pressure Liquid↗
PubMedDate not supplied

Optimization of moist heat sterilization.

The use of different combinations of sterilization time and temperature in a pilot scale autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was studied. All three programs used had the same sterilization efficacy (F0 = 15 minutes) but different sterilization temperatures (116, 121, and 126 degrees C) and total process times (98, 57, and 44 minutes). The heat distribution during the sterilization phase was, in all cases, very uniform, the greatest difference being 0.5 degrees C. Also the F0 values differed only by +/- 0.5 minutes from each other. The F0 value increases linearly with all programs until the beginning of the cooling phase. The main effect of different sterilization temperatures on the cumulative F0 curves is an increase in the slope of the curves with increasing sterilization temperature. First order temperature change constants were determined both for the heating phase and the cooling phase. The numeric values of the rate constants for the heating and the cooling phases were 0.20 +/- 0.03 and 0.046 +/- 0.005 min-1, respectively. It is concluded that the pilot autoclave used in this study controls the sterilization process very accurately. The observed variations between F0 values at different positions in the autoclave chamber are acceptable. On the basis of this study an accurately engineered and controlled autoclave is required in process optimization. It also is possible to use higher sterilization temperatures than usually suggested in pharmacopeias and thus to shorten the process time.

Hot Temperature↗
PubMedDate not supplied

Destruction of typical endotoxins by dry heat as determined using LAL assay and pyrogen assay.

The kinetics of destruction by dry heat of two typical endotoxins, Escherichia coli 055:B5 (E. coli endotoxin) and Salmonella abortus equi (S. abortus equi endotoxin), were determined using the Limulus Amebocyte Lysate (LAL) and pyrogen assays. The efficiency of recovery of these endotoxins from carriers using a pyrogen assay was also determined simultaneously. In the LAL assay 0.1-10,000 EU was used and 10-1000 EU in the pyrogen assay. Recoveries of E. coli endotoxin and S. abortus equi endotoxin were, respectively, 49.7-92.0% and 27.0-70.1% by the LAL assay, and 31.1% and 60.6% by the pyrogen assay. Fourier transformation infrared (FT-IR) spectra demonstrated the presence of chemical structural differences between the two endotoxins. By dry heat (200 or 250 degrees C), there were no significant differences in the destruction kinetics between the two endotoxins; either endotoxin can therefore be adapted for use in the endotoxin challenge test. Destruction in the pyrogen assay was significantly quicker than that predicted by the LAL assay for each of the two endotoxins. In this endotoxin destruction system, 3 log cycle reduction (the United State Pharmacopeia (USP) recommendation for the depyrogenation process) could not be obtained by challenge with 10,000 EU of endotoxin under the depyrogenation conditions of 200 degrees C for 60 min (a set of conditions described in the European Pharmacopoeia (EP)), though little pyrogenicity remained. On the other hand, at 250 degrees C for 30 min (a set of conditions described in the EP, USP and Pharmacopoeia of Japan (JP)),a 3 log cycle reduction was achieved without any pyrogenicity remaining.

Drug Contamination↗
PubMed1993

Removal of limulus reactivity and cytokine-inducing capacity from bicarbonate dialysis fluids by ultrafiltration.

Bicarbonate-based dialysate solutions support the rapid growth of bacteria. The long-term (360-h) efficacy of ultrafiltration by two polysulphone ultrafilters in removing not only endotoxin but also the cytokine(IL-1, TNF)-inducing capacity was evaluated using an experimental circuit contaminated with Pseudomonas aeruginosa filtrates. One of the polysulphone ultrafilters was submitted to a standard sanitization procedure every 12 h (hypochlorite 1.2% solution for 5 min and rinsing for 20 min). Endotoxin was detected by the kinetic quantitative chromogenic limulus amoebocyte lysate (LAL) assay. Immunoreactive IL-1 and TNF were evaluated in the lysates of peripheral blood mononuclear cells containing 5 x 10(5) human monocytes. The results of the present studies show that although LAL-reactive bacterial products were significantly removed in post-ultrafilter samples, they remained detectable, albeit below the upper limit accepted by the present European pharmacopeias (< 0.125 EU/ml). The removal of cytokine-inducing capacity was time-dependent and correlated with time of use in the case of the sanitized ultrafilter. Beyond the time of use, two other factors emerged as possibly capable of reducing the efficacy of the ultrafilter in removing LAL-reactive bacterial components, namely the pressure and the cytokine-inducing activity in pre-ultrafilter samples. Preincubation with polymyxin B, an agent that irreversibly binds lipid A and blocks lipid A-induced biological activities, did not abrogate the cytokine-inducing capacity in all post-ultrafilter samples; this suggests that either low-molecular-weight endotoxin subunits or lipid A-unrelated components may be responsible for the residual biological activity in post-ultrafilter samples.(ABSTRACT TRUNCATED AT 250 WORDS)

Acetylmuramyl-Alanyl-Isoglutamine↗
PubMed1993

The bacterial endotoxin test in the PET facility.

A method by which the gel-clot Limulus amebocyte lysate test may be performed in 20 rather than 60 min with sufficient sensitivity to satisfy the needs of the nuclear medicine or positron emission tomography laboratories has been developed and validated for use as a substitute for the Bacterial Endotoxin Test described in the United States Pharmacopeia, 22nd revision. Using this method, results may be obtained from the test prior to the human administration of radiopharmaceuticals without extensive loss of activity and with increased safety when compared to tests performed after administration. Additionally, studies on the shelf-lives of the reagents used in the test were conducted. When refrigerated between use, control standard endotoxin dilutions of 5 EU/ml or greater may be used for at least 1 mo after preparation and reconstituted lysate retains its labeled sensitivity for at least 10 days, considerably longer than the manufacturer's stated shelf-lives.

Ammonia↗
PubMedDate not supplied

Niacin. I: Dissolution profiles of sustained-release niacin products by automated and manual procedures.

Automated and manual procedures were developed to obtain dissolution profiles of sustained-release niacin formulations. The procedures are based on the United States Pharmacopeia XXII apparatus 1 (basket) at 100 rpm with 900 mL 0.1N HCl as the dissolution medium. Filtered aliquots are read at 260 nm. No interference was found from excipients. The procedures are straightforward and will discriminate between sustained-release and regular niacin formulations.

Biological Availability↗
PubMedDate not supplied

[Efforts toward the formulation of the therapeutic stereoisomer of ibuprofen].

In an on going effort to optimize ibuprofen antiinflammatory therapy, development studies on the active stereoisomer of ibuprofen have been conducted. The effects of pharmaceutical processing on the racemate (RAC-ibuprofen) and the enantiomer (S(+)-ibuprofen) were investigated. The formulation of the new stereospecific system, was impossible using wet granulation. The pharmaceutical development of S(+)-ibuprofen using direct compression appeared as a practical solution to this problem. The biopharmaceutical properties of the resulting tablets were well within pharmacopeia requirements. Nevertheless, mixing S(+)-ibuprofen with the excipients induced a drop in the enthalpy of fusion and after compaction, a low temperature eutectic appeared on the differential scanning calorimetry endotherms. Aging studies indicated that the raw material and pharmaceutical mixtures of S(+)-ibuprofen should be stored under strictly controlled conditions or processed immediately.

Ibuprofen↗
PubMedDate not supplied

Vitamin D in infant formula and enteral products by liquid chromatography: collaborative study.

Results from a collaborative study of a new liquid chromatographic (LC) method for determination of vitamin D in infant formulas and enteral products are presented. Each of 15 laboratories was provided with 11 blind duplicate samples covering a range of approximately 200-500 International Units/quart (normal dilution), a system suitability sample, and the U.S. Pharmacopeia ergo- and cholecalciferol standards. Product types included liquid and powder forms of milk (whey and casein), soy, and hydrolyzed protein-based infant formulas and enteral products. The method includes a single liquid-liquid extraction following saponification, solid-phase extraction, and then concentration by evaporation. An isocratic, nonaqueous, chromatographic system with reversed-phase, zero endcapped C18 column, and UV detector set at 265 nm are used. Statistical evaluation of data from participating laboratories show the average reproducibility and repeatability of the method across all samples to be excellent, with RSDR and RSDr values of 13.48 and 9.44, respectively, after elimination of outliers. The LC method for determination of vitamin D in infant formulas and enteral products has been adopted by AOAC INTERNATIONAL.

Chromatography, High Pressure Liquid↗
PubMedDate not supplied

Determination of reserpine and chlorothiazide in commercial tablets by liquid chromatography with fluorescence and UV absorbance detectors in series.

A procedure is presented for determination of reserpine and chlorothiazide in commercial tablets by liquid chromatography (LC). Powdered sample, equivalent to the weight of one tablet, is dissolved in 10.0 mL dimethyl sulfoxide, the mixture is diluted to 100.0 mL with methanol, and the solution is filtered; 10 mL of the filtrate is then diluted to 100.0 mL with methanol. The standard solution is prepared in the same solvent mixture and contains the 2 ingredients in approximately the same quantities as in the diluted sample solution. For LC, a 7.5 cm long normal-phase column is used; mobile phase consists of methanol containing a small volume of an aqueous solution of 1-pentanesulfonic acid, sodium salt. Two detectors are arranged in series: a fluorescence detector set at 280 nm excitation and 360 nm emission quantitates reserpine and a UV absorbance detector set at 300 nm determines chlorothiazide. Several synthetic mixtures containing the 2 ingredients in amounts ranging from 80 to 120% of quantities declared in commercial tablets were analyzed by the proposed method. Two samples of commercial tablets were also analyzed; for each sample, 5 determinations were made on a ground composite of 20 tablets; 10 individual tablets were also analyzed. The composites were also analyzed by the current U.S. Pharmacopeia method for this product.

Antihypertensive Agents↗
PubMed1995

[Preliminary survey on the traditional Chinese drug: shell of abalone or sea-ear].

According to an on-site survey of the commercial medicinal materials in China, it is demonstrated that the shells of abalone or sea-ear consist of nine types. Their original animals are Haliotios diversicolor, H. discus hannai, H. ovina, H. asinia, H. ruber, H. laevigata, H. semistrata, H. midae and H. cracherodii. Three of these types namely, H. semistrata, H. midae and H. cracherodii are not included in the Chinese Pharmacopeia. Furthermore, most of the shells of abalone or sea-ear presently on market are Haliotios ruber and H. discus hannai.

Animals↗