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At least 883 records · Page 49Linked to original sources
PubMed1995

[Use of the LAL-Test]

This article describes the use of the LAL-test as a product release test for parenterals, medical devices and dialysis solutions. Since the LAL-test has been established in the pharmaceutical industries, the possibility to use this test as product release test in lieu of the classical test for pyrogens in rabbits has been discussed: The supporters of the LAL-test argued with its high sensitivity, easy to use, low costs and last but not least with the possibility to avoid experiments with animals. Those who disapproved on the test to be used as a product release test mainly for parenterals feared that - due to the high specifity of the LAL-test - non-endotoxin pyrogens could no longer be detected. Since some years the LAL-test has been introduced into the monograph "Parenterals" of the European (German) Pharmacopeia and is mentioned under the tests the parenterals have to comply with.

Journal Article↗
PubMed1998

[A new test for the detection of pyrogens in pharmaceutical products. Examinations for the validation of the human whole blood assay]

The human whole blood assay utilises the natural fever response to detect pyrogens by determination of the release of IL-1beta. In order to replace the official method, the rabbit pyrogen test, a validation of the whole blood assay is necessary. A comparison of the results obtained from many blood samples has revealed the following: 1) Blood not stimulated by LPS does not produce IL-1beta. 2) Stimulation by LPS induces a concentration-dependent release of IL-1( beginning at a concentration of between 2-5 pg/mL LPS. 3) The amount of IL-1beta released varies greatly between samples obtained from different individuals. 4) Storing blood samples results in a right shifted LPS/IL-1beta curve with a steeper gradient and higher maximum value of IL-1beta. In this paper we suggest an experimental method for the determination of pyrogens based on the established semi-quantitative LAL gelation method as detailed in the European Pharmacopeia. Using this methodology, we were able to show that the amount of endotoxin in a number of different infusion solutions was below the LAL-endotoxin limit concentration. LPS was quantitatively determined from spiked samples.

Journal Article↗
PubMed2001

[Preparation and quality control of cross-linked agarose coated activated charcoal (CAAC-II) used as adsorbents for hemoperfusion in artificial liver support].

The preparation and the quality control of cross-linked agarose coated activated (CAAC-II) were described. The crosslinking reagent epichlorohydrin was removed. Investigations indicate that the trace elements such as Pb, Cd, As, Cr, Fe and heavy metals, the pH, NH4+, SO4(2-), and ultraviolet absorbance in sample have met the requirements in Chinese Pharmacopeia and some other relevant standard promulgated by the Ministry of Health. No epichlorohydrin was detected in CAAC-II.

Capsules↗
PubMed2002

DNA immunomodulation of asthma.

This is an exciting time in the chronology of asthma and allergic diseases. Although the pharmacopeia for treatment of these diseases has advanced greatly, most of our current therapies are aimed at the symptoms, rather than the underlying mechanism. Immunotherapy remains the only therapeutic modality that addresses the underlying mechanism, albeit by effects are still not fully understood. The approaches summarized in this chapter, alone or in combination, may yet allow one to reverse the atopic state. Meanwhile, other innovative DNA-based approaches are being developed, including the use of allergen DNA with or without CpG. Because most of the Th2 cytokines are on chromosome 5, the completion of the human genome project may open whole new venues of research aimed at controlling these cytokines at the chromosomal level.

Adjuvants, Immunologic↗
PubMed1998

[Investigation on computative spectrophotometry employed in the assay of peaonol in cortex moutan].

OBJECTIVE: To investigate the easibility of employed computative spectrophotometry in the assay of traditional Chinese medicines. METHOD: Make contents of peaonol in 10 samples of Cortex Moutan were determined by three-wavelength spectrophotometry and dual wavelength K-ratio spectrophotometry, and then compared with the method in Chinese Pharmacopeia. RESULT: The differences of the UV spectrum of different lots of samples bring about relative error. sometimes up to 10%-30% for computative spectrophotometry. CONCLUSION: Computative spectrophotometry should be used carefully in assaying traditional Chinese medicines.

Acetophenones↗
PubMedDate not supplied

Validation of a UV spectrophotometric method for the determination of melatonine in solid dosage forms.

The aim of the work described in this paper was to provide a fast, easy, inexpensive, precise, and accurate method for the determination of melatonine in solid pharmaceutical dosage forms. The developed method is based on a UV first-derivative spectrophotometric determination, which exhibits excellent linearity in aqueous solutions (r2 = 0.996) for analyte concentrations of 1.5-4.5 mg/dL within a pH range of 5-9. Neither excipients present in the formulation nor indole adulterants, such as tryptophan (up to 5%), interfere with the assay. A study of variation parameters showed that sonication temperature was the main factor for successful determination. At temperatures of <45 degrees C, the sample dissolved completely, and accurate spectrophotometric measurements were obtained. A study was conducted of all the parameters established by the United States Pharmacopeia, 23rd Rev., to validate an analytical method for a solid pharmaceutical form, i.e., linearity, range, accuracy, precision, and specificity. All the parameters were in accordance with the acceptance criteria of the Comité de Guías Oficiales de Validación de la Dirección General de Control de Insumos para la Salud de Méjico. In addition, robustness and content uniformity tests were performed to substantiate the usefulness of the method.

Antioxidants↗
PubMed1995

Orthodoxy and reform: differing medical practices in a Glasgow Jewish Victorian family.

Medical botanists formed a major and growing element in the delivery of medical care in Victorian Britain, supplementing the provision made by qualified physicians. Medical reform, introduced into Britain from the United States in the middle of the nineteenth century, combined botanical treatment, including a strong emphasis on the use of lobelia, with physiotherapy. The Levenston family in Glasgow was represented among both qualified orthodox medical practitioners and unqualified practitioners of medical botany. Samuel Levenston graduated M.D. at the University of Glasgow in 1859 and had a long career in medical practice in Glasgow after years of work as an unqualified practitioner. His father and brothers were active in medical botany in Glasgow, Edinburgh and Dublin, often posing as doctors but without appropriate qualifications. This paper examines the history of the Levenstons and contrasts the practices of the different members of the family, showing the relationships between a university-trained physician and medical chemists. The surviving Glasgow pharmacopeia of Solomon (Alexander) Levenston illustrates the style of his medical treatments, setting the practice of his medical botany into context.

Complementary Therapies↗
PubMed1970

[Not Available].

Scientists from the Eastern countries have a great merit for the enrichment of the range of medicaments, as well as for the scientific development of pharmacology. In this respect, worth of special interest is a manuscript source, dealing with the medicaments of the XIV century and entitled: "Selected Pharmacopeia, dedicated to Badia al Jemal"--Ihtiyarat of Badia, written by Ali Bin Hussein al Ansari, usually known by his nickname Hodja Zayn al Atar. Most of the concepts, found in the cited manuscript, conserve their significance up to the present day, all the more that the drugs listed, their indications, way of preparation and application are thoroughly described. The Ihtiyarat of Badia, containing the description of 1100 drug denominations of vegetable, animal and mineral origin, is not merely a historical document of medieval pharmacology, but might serve as a source for enriching the armamentarium of modern medicine with drugs.

Arab World↗
PubMed1993

[Pharmacopoeia in ancient Egypt].

Ancient Egyptian pharmacological science is high part of the Egyptian medicine, as evidenced by the so-called pharmacological papyrus Ebers, which contains prescriptions with different kinds of components of vegetable, mineral and animal origin. These data suggest that Egyptian pharmacopeia had an exceptional complexity in the whole of ancient medicine. Egyptian medical knowledge influenced Mediterranean civilizations, as evidenced not only by the Greek translations of names of components but also by the Egyptian and Egyptian-like prescriptions found in the Corpus Hippocraticum.

Egypt, Ancient↗
PubMed2002

The effect of formulation on reduced radioiodide thyroid uptake.

UNLABELLED: This investigation compared in vitro dissolution profiles from sodium iodide capsules with radioiodide thyroid uptake in patients with thyroid abnormalities, using sodium iodide capsules prepared with a formulation exhibiting complete release of radioiodide in vitro and a formulation exhibiting incomplete release. METHODS: In vitro dissolution profiles for radioactive sodium iodide capsules with 2 different formulations were determined using the U.S. Pharmacopeia (USP) XXIV dissolution test. The 2 formulations studied in vitro were sodium phosphate dibasic powder with 1% magnesium stearate and calcium phosphate dibasic powder with 3% magnesium stearate. The thyroid uptake of radioiodide from capsules exhibiting complete release or incomplete release of radioiodide was determined in patients with thyroid disorders. RESULTS: In the dissolution studies, by 20 min after initiation of the test, >95% of the radioactive iodide was released from capsules of sodium phosphate dibasic powder. The capsules of calcium phosphate dibasic powder reached 75% at 65 min, with no further release occurring thereafter. In the in vivo studies, the mean thyroid uptake at 1 h for sodium phosphate dibasic powder with 1% magnesium stearate (complete-release formulation) was 12.7%, compared with 9.3% for calcium phosphate dibasic powder with 3% magnesium stearate (incomplete-release formulation) (P < 0.05). At 24 h, the value was 56.6% for the complete-release formulation, compared with 50.3% for the incomplete-release formulation (P < 0.01, Wilcoxon signed rank test). At 1 h, the abdominal activity for the complete-release formulation was 3.4%, compared with 8.8% for the incomplete-release formulation (P < 0.01). At 24 h, the value was 0.4% for the complete-release formulation, compared with 1.0% for the incomplete-release formulation (P < 0.01). CONCLUSION: The data suggest that the incomplete dissolution profile observed in vitro may correlate with reduced bioavailability of radioiodide in vivo. The USP dissolution test can be applied to radioiodide sodium iodide capsules as a quality assurance procedure.

Adult↗
PubMedDate not supplied

Degradation of bleaching gels in vivo as a function of tray design and carbamide peroxide concentration.

This study determined the degradation of nine bleaching agents with different concentrations after two hours in vivo following the manufacturers' recommendations. The nine carbamide peroxide products are 10%, 15% and 20% Opalescence, 10%, 15% and 22% Rembrandt and 10%, 16% and 22% Nite White Excel 2. Each subject wore the tray with the bleaching agent for two hours on three separate occasions. The amount of remaining carbamide peroxide was determined after each use. Evaluation of remaining amount of carbamide peroxide was calculated by the US Pharmacopeia method. The study showed that the total carbamide peroxide percent recovered was significantly higher for Opalescence products (47% to 54%) compared to Nite White (22% to 25%) and Rembrandt bleaching gels (15% to 16%). It concluded that this difference was mostly due to the use of facial reservoirs with Opalescence products, and also that whitening gel in trays with reservoirs and trays without reservoirs degraded at the same rate.

Adult↗
PubMedDate not supplied

Liquid chromatographic determination of amphotericin B in different pharmaceuticals.

Amphotericin B (AmB) is one of the most potent antifungal agents and the drug of choice in the treatment of serious fungal infections. A liquid chromatographic (LC) method was developed to determine AmB in pharmaceutical formulations for injection, tissue culture, cream, and lotion. pBondapak C18 reversed-phase column and a simple mobile phase consisting of acetonitrile-water-acetic acid (40 + 54 + 6, v/v) was used. The flow rate was 1.8 mL/min and the effluent was monitored at 405 nm. The developed LC method uses piroxicam as an internal standard and has a limit of detection of 10 ng/mL, a limit of quantitation of 30 ng/mL, and the assay is linear from 0.01 to 100 microg/mL. AmB and piroxicam elute with retention times of 12.4 and 4.0 min, respectively, and the resolution between AmB and piroxicam was 10.6. In comparison with the official United States Pharmacopeia microbial assay for AmB, this LC method is more rapid, selective, sensitive, and offers positive identification.

Amphotericin B↗
PubMed2001

Dental education: one dean's perspective.

A dean looks at dental education and the practicing profession from the perspective of three years in dental school administration and sixteen in industry. A significant challenge is to balance costs and standards in the face of well-meaning calls for benefits from those who are not charged with meeting costs. One issue of central importance for education is keeping the curriculum properly positioned in a dynamically evolving profession. The knowledge and skills needed to manage the practice pharmacopeia are used as an example of this problem. It is proposed that schools adopt a future orientation. Dental education must be valued within the higher educational community just as dentistry is valued for its contributions to society at large. Any drift toward proprietary interests must be resisted. This can best be accomplished through a partnership between education and organized dentistry where the lobbying power of the ADA is used to gain the resources education needs and where education, including research and patient care aspects of its mission, are enlisted in support of the practicing community.

Administrative Personnel↗
PubMed1999

[Indirect determination of berberine hydrochloride by atomic absorption spectrometry].

A method for the indirect determination of berberine in tabellae berberine hydrochloride by ion pair extraction and atomic absorption spectrometry was described. Berberine reacted with inorganic complex tetrathiocyanate cobalt(II) to form a stable ion pair associated complex at certain pH value. The ion pair associated complex was extracted with organic solvent and then transferred into aqueous solution. The content of cobalt in the solution was measured by flame atomic absorption spectrometry and the amount of berberine hydrochloride was calculated according to the content of cobalt. The result of the present method agreed with pharmacopeia method. This method is sensitive, dependable, precise, and applicable.

Berberine↗
PubMed2002

Comparative cytotoxicity potential of soft contact lens care regimens.

PURPOSE: To determine the cytotoxicity potential of soft contact lens disinfection solutions. METHODS: Three modifications of the United States Pharmacopeia (USP) elution test were conducted: trypan blue uptake test; regrowth of cells after exposure; and quantitation of viable cells after exposure test. Cycled lenses were also tested according to the USP direct-contact test. We compared the cytotoxicity profile of neutralized AOSept (CIBA Vision, Duluth, GA) disinfectant, SOLO-care Soft (CIBA Vision, Duluth, GA) brand multipurpose solution, OPTI-FREE Express (Alcon, Ft. Worth, TX) multipurpose disinfecting solution (with ALDOX), ReNu (Bausch & Lomb, Rochester, NY) multipurpose solution, ReNu MultiPlus (Bausch & Lomb, Rochester, NY) multipurpose solution, and COMPLETE Comfort PLUS (Allergan, Irvine, CA) multipurpose solution. Appropriate positive and negative controls were used for each test. RESULTS: Neutralized AOSept, SOLO-care soft, and COMPLETE Comfort PLUS solutions were noncytotoxic by all four test methods. ReNu MPS and ReNu MultiPlus both were noncytotoxic by the USP direct contact test and the USP elution-based trypan blue uptake and cell regrowth tests, but both yielded less than 50% of viable cells. In the three USP Elution test methods, OPTI-FREE Express (with ALDOX) exhibited cytotoxicity. CONCLUSIONS: These solutions have shown widely varying cytotoxicity potential. Neutralized AOSept, SOLO-Care Soft, and COMPLETE Comfort Plus were noncytotoxic by all four tests. ReNu MultiPlus and ReNu MPS inhibited the growth of cells after exposure. OPTI-FREE Express (with ALDOX) may have a higher potential for ocular irritation correlating to severe cytotoxicity in vitro.

Animals↗
PubMedDate not supplied

Sequential determination of salicylic and acetylsalicylic acids by amperometric multisite detection flow injection analysis.

An amperometric multisite detection flow injection analysis (FIA) system was developed for sequential determination of 2 analytes with a single sample injection and single detector. Tubular composite carbon electrodes with an inner diameter similar to that of the FIA manifold tubing were constructed so that measurements could be made without impairing the sample plug hydrodynamic characteristics. The electrochemical behavior of the tubular voltammetric cell in a low-dispersion FIA manifold and the behavior of the FIA system incorporating this type of voltammetric cell intended for multisite detection were evaluated by performing measurements with potassium hexacyanoferrate(II). Feasibility of the approach was demonstrated in the sequential determination of salicylic and acetylsalicylic acids in pharmaceutical products at a fixed potential of 0.98 V. The system allows sequential determination of salicylic acid concentrations ranging from 1.0 x 10(-5) to 5.0 x 10(-5) M and acetylsalicylic acid concentrations between 1.0 x 10(-3) and 5.0 x 10(-3) M with good precision on both detection sites and with relative standard deviations (RSDs) > or = 1.5% (n = 10) and 2.1% (n = 10), respectively. A comparison of these results with those of the U.S. Pharmacopeia procedure showed RSDs <5.0 and 1.0% for salicylic acid and acetylsalicylic acid, respectively. The proposed method enables 15 determinations per hour, which corresponds to the analysis of approximately 8 samples per hour. The detection limits of the methodology were approximately 3.5 x 10(-6) and 1.1 x 10(-5) M, respectively, for the first and second monitoring sites.

Aspirin↗
PubMed2000

[Pharmacognostical identification of one Rhizoma Drynariae habitually used species from Yunnan].

The species recorded on the "Rhizoma Drynariae" item of Chinese Pharmacopeia is the dry rhizoma of Drynaria fortunei from Polypodiacae. But in Yunnan province, many plants (including D. delavayi) are habitually used as Rhizoma Drynariae. In this article the authors identified D. delavayi on Chinese medinal materials discriptions, microscopic characters and TLC. This proved evidences for the utilization and identification of D. delavayi in some extent.

Chromatography, Thin Layer↗
PubMedDate not supplied

Incubation time in sterility tests for pharmaceutical products.

Throughout the evolution of sterility test methodology, different periods of incubation were adopted depending on both the type of microorganism to be detected and the employed inoculation methodology. Some official compendiums, such as Brazilian and Mexican pharmacopoeias, recommend different incubation periods, according to the inoculation methodology employed for the sterility test, whereas the United States Pharmacopeia, in its last edition, started to adopt an incubation period of 14 days, independently from the methodology employed. The aim of this work was the evaluation of the influence of the incubation time on the efficiency of different methodologies for sterility test, as well as the benefits that could be achieved with the incubation time extension. The experiments led to the conclusion that an incubation period of 14 days is enough for the detection of microbiological contaminants in pharmaceutical products submitted to sterility tests, independently from the methodology employed, what values the alteration introduced in the USP XXIV, to the detriment of other pharmacopoeias which maintain different periods of time in accordance with the inoculation method employed.

Bacteria↗