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[Relation between 5 flavors and channel tropism in some traditional Chinese drugs].

In the present paper, the relationship between five flavors and channel tropism is statistically studied for 261 traditional Chinese drugs which are reported to have only on flavor in the Chinese Pharmacopeia (1990 edition). The results show that in attribution there are considerable differences between the law of bitter and the law of acrid, between the law of sweet and law of salty, and between the law of acrid and the law of salty, while the laws of other pairs of flavors are similar. The laws of channel tropism are considerably affected by the mergence of exterior and interior channels. The relationship between five flavors and channel tropism is thus widely divergent from that held by the traditional theory of five elements.

Drugs, Chinese Herbal↗

Side effect profiles of new antipsychotic agents.

Although neuroleptic drugs have become the mainstay of treating acute and chronic psychosis, they are substantially limited by troublesome side effects. The traditional neuroleptic drugs have a wide array of central nervous system and peripheral system side effects that often lead to problems in management or patient noncompliance. Of particular difficulty are the extrapyramidal symptoms and tardive dyskinesia. However, other side effects of seizures, sedation, neuroleptic malignant syndrome and cardiovascular, hematologic, endocrinological, and weight gain problems remain as clinical management challenges posed by existing antipsychotic drug therapy. Considerable progress has been made in improving the motor side effect profile with the advent of clozapine and risperidone. However, each of these drugs has its own dose-limiting side effect profile. Two new drugs, olanzapine and sertindole, are now added to the pharmacopeia for treating psychosis. They further improve the benefit/ risk ratio because they have even fewer EPS and other side effects. Overall, these new antipsychotic agents greatly improve the treatment of psychosis by reducing drug-induced morbidity and improving the quality of life for patients.

Antipsychotic Agents↗

[New acute poisoning syndromes of drug origin].

The slow but constant modifications of the pharmacopeia and prescribing habits are at the origin of changes in the causes of intoxications by medications, which are reflected in the syndromes observed in daily practice. New syndromes have appeared: serotoninergic syndrome, adrenergic syndromes, toxic malignant hyperthermia, opioid toxic syndrome, intoxication by drugs with membrane-stabilizing effect. Recognizing these syndromes is not only useful to determine the possible causes of on intoxication, but also to direct appropriate, specific therapeutic interventions.

Adrenergic Agents↗

Intravenous potassium predicament.

In 1991, United States Pharmacopeia (USP) required modification of the nomenclature and packaging standards for potassium chloride injection following reports of deaths that occurred due to inadvertent medication administration errors. The following article taken from USP Quality Review provides a brief history of the revised standards and a current Medication Errors Reporting (MER) Program database analysis of potassium chloride misadministrations. Also included is an errors table that compiles and abstracts all actual and potential errors of potassium chloride for injection concentrate that were received through August 1996. Because errors continue to be reported, USP Practitioners' Reporting Network would appreciate continual communication about the potential for error when administering potassium chloride for injection concentrate. Reprinting of this review is encouraged. A camera-ready format also is available by contacting USP Practitioners' Reporting Network at 800-487-7776.

Humans↗

[An objective index of quality and prognostication of the storage time for cod liver oil].

Through a series of tests an objective indicator of the degree of the cod oil oxidation-the content of aldehydes reacting with benzidine-has been established. Mathematic processing of experimental data helped determine the limits of the aldehydes content in the oil of different quality, while the maximum permissible standards were fixed following biological tests carried out by the Institute of Nutrition of the AMS of the USSR. These data and investigations into the quality of the oil during its preparation and subsequent storage under different conditions formed a background to be establishing maximum permissible content of aldehydes in the half-finished and final products. Through experiments there were found the increment of aldehydes and the fall of the A-vitamin activity over a storage period of one month in large bottles of 9 1 capacity at temperatures of 10+/-2 and 20+/-2 degrees. The available data enabled it to deduce a formula for fixing approximate storage periods for medicinal oil both on shipment from the production site and at the time of control checking of its quality. The maximum permissible content of aldehydes in the medicinal oil and the method of establishing storage time are recommended to be included into the corresponding intem of the state standards-GOST, or in the pharmacopeia.

Cod Liver Oil↗

Maximizing clozapine therapy: managing side effects.

Since its introduction to the United States in 1990, the benefits of clozapine use have been repeatedly validated. Clozapine remains the only antipsychotic with proven efficacy in treatment-resistant schizophrenia. Because clozapine has been part of the psychiatric pharmacopeia for considerably less time than neuroleptics, which have dominated the field for over 4 decades, its underutilization may be partly attributed to a lack of experience in managing associated side effects. Most side effects associated with clozapine are typical of antipsychotics in general, and with clozapine, these side effects are typically benign, tolerable, and manageable. It is conceivable that there remains a concern over the risk of agranulocytosis. However, the mandatory blood monitoring carried out through the Clozaril National Registry has considerably reduced the incidence of fully developed cases of agranulocytosis from premarketing values of approximately 1% to 2% to current values of 0.38% and virtually prevented mortalities. These values are likely to decrease further with the application of cytokine augmentation therapy among patients developing blood dyscrasias. Many side effects of clozapine are observed early after treatment onset and are greatly reduced by dose adjustments. Appropriate management of side effects will facilitate a maximization of the benefits of clozapine treatment. Clearly, the benefits of clozapine therapy far outweigh its risks.

Agranulocytosis↗

Determination of reserpine and rescinnamine in Rauwolfia serpentina powders and tablets: collaborative study.

A liquid chromatographic (LC) method for determining reserpine and rescinnamine in Rauwolfia serpentine powders and tablets, which uses fluorescence detection, was subjected to a collaborative study. The procedure for extraction and purification is a simplified version of that used in the current official method for analysis of these products. LC separations are performed on a normal-phase column. The mobile phase is methanol to which a small volume of an aqueous solution of 1-pentanesulfonic acid sodium salt can be added to achieve desired elution characteristics. Reserpine and rescinnamine elute at approximately the same time but can be individually quantitated by appropriate settings of the fluorescence detector. Reserpine is determined at an excitation wavelength of 280 nm and an emission wavelength of 360 nm, because rescinnamine is completely non-fluorescent at these wavelengths. Rescinnamine is determined at an excitation wavelength of 330 nm and an emission wavelength of 435 nm, because reserpine is completely nonfluorescent at these wavelengths. The following materials were used for the study: one sample of United States Pharmacopeia (USP) standard R. serpentine powder, one tablet type labeled as containing 100 mg R. serpentine and 2 tablet types labeled as containing 50 mg R. serpentine. For each of the 4 materials, 2 pairs of blind duplicates were prepared. Three materials were analyzed in duplicate by 8 laboratories. One of the 2 tablets labeled to contain 50 mg R. serpentine was analyzed only by 7 of 8 participating laboratories. Average combined content of reserpine and rescinnamine was 0.144% for the USP raw material and 0.132, 0.135, and 0.137% for the 3 commercial tablets. Reproducibility relative standard deviation values were 5.72, 5.93, 8.61, and 3.48% and repeatability relative standard deviation values were 2.57, 4.87, 3.19, and 1.99% for the 4 samples. The Associate Referee conducted a study to determine recoveries of reserpine plus rescinnamine by this method from mixtures simulating sample extracts. Average recovery of 15 determinations was 100.1%, with a relative standard deviation of 1.3%. The LC method for determination of reserpine and rescinnamine in R. serpentine powders and tablets has been adopted first action by AOAC INTERNATIONAL.

Chromatography, Liquid↗

[Novel mathematical approach to determination of antibiotics concentration by agar diffusion method. Analysis of graphical, table and mathematical options of relative biological activity estimation].

Several varieties of relative biological activity estimation are comparatively analyzed and illustrated by an example of tylosin. For visual demonstration the estimates with the equation of a straight line are represented graphically. It is concluded that the design equations in the State Pharmacopeia XI (USSR) should be respectively replaced. The advantages of the variety for the biological activity estimation with the one-point intercept form of the equation of a straight line are illustrated by particular examples.

Agar↗

Endotoxin-like reactions associated with intravenous gentamicin--California, 1998.

During April 30-July 26, 1998, 20 patients at a major medical center (hospital A) in Los Angeles County, California, developed severe shaking chills often accompanied by fever, tachycardia, and/or a decrease of > or =20 mm Hg in systolic blood pressure within 3 hours after receiving intravenous (IV) gentamicin. Receipt of IV gentamicin was the only medication or procedure temporally associated with reactions among all of the patients. No deaths or serious sequelae were associated with the reactions. Similar incidents were reported by hospital personnel from six other states to CDC or the Food and Drug Administration (FDA) during April-August 1998. All reported reactions were associated with once-daily dosing regimens of gentamicin (lot numbers 170704, 180031, 180133, and 180191) produced by Fujisawa USA, Inc. (Deerfield, Illinois). On August 13, the Los Angeles County Department of Health Services and CDC initiated an investigation with the assistance of hospital A personnel. This report summarizes the results of this investigation at hospital A, which found that gentamicin with endotoxin levels within the U.S. Pharmacopeia (USP) standards may deliver endotoxin amounts above the threshold for pyrogenic reactions with once-daily dosing.

Adult↗

Stability of several brands of ampicillin and penicillin V potassium oral liquids following reconstitution.

The stability-time profiles of the active ingredient of five generically equivalent brands of penicillin V potassium for oral solution, and of five generically equivalent brands of ampicillin for oral suspension, were studied. Three controlled conditions were employed-refrigerated, room and elevated temperature-and all the samples were assayed chemically for drug remaining at specific time intervals after reconstitution. The results showed that considerable variations in the initial concentrations of active component existed among the various ampicillin and penicillin products. In one penicillin product the official content requirement was not met. The data also showed that although the labels on each of the commerical penicillin products tested indicate that the reconstituted products may be stored in a refrigerator for 14 days without significant loss of potency, only one penicillin product still met 90% of label claim (minimal potency requirement of the United States Pharmacopeia for dry powder). All ampicillin products tested were stable when stored at the conditions recommended by the manufacturers, but the trihydrate forms exhibited greater stability than the anhydrous forms, probably because of the more rapid dissolution rate of anhydrous ampicillin.

Ampicillin↗

Evaluation of buffering capacity and acid neutralizing-pH time profile of antacids.

The antacid properties of seven antacids listed in the hospital formulary of a medical center were evaluated with in vitro tests. These included not only the preliminary antacid test and acid-neutralizing capacity test as described in the United States Pharmacopeia (USP XXIII), but also a buffering pH profile test. The preliminary antacid test measured the final pH of a 10-mL solution of 0.5 N HCl 10 minutes after addition of the minimum recommended dose of an antacid, while the neutralizing capacity test measured the amount (mEq) of HCl neutralized by the minimum recommended dose in 15 minutes. The buffering pH profile recorded the pH time course of dynamic simulated gastric fluid neutralization by a dose of an antacid. In the preliminary antacid test, magnesium oxide showed the highest pH (9.52 +/- 0.14, mean +/- standard deviation, n = 3); aluminum phosphate gel yielded a final pH of 2.51 +/- 0.01, thus failing to meet the criteria of an antacid (pH > 3.5). In the acid-neutralizing capacity test, hydrotalcite had the highest neutralizing capacity (28.26 +/- 0.3 mEq), while sodium bicarbonate had the lowest (7.40 +/- 0.12 mEq). In the buffering pH profile test, aluminum-magnesium hydroxide suspensions and hydrotalcite tablets maintained a steady optimum pH (3-5) for around 1.5 hours. One tablet of calcium carbonate, sodium bicarbonate or magnesium oxide could not raise the gastric pH to above 3, but two tablets increased the pH excessively (5.3 to 8.6). The higher dose (two tablets) of aluminum hydroxide hexitol complex could not raise the pH to the optimal level. These findings demonstrate that there is disparity in the antacid effectiveness estimated by the neutralizing capacity test and the buffering pH profile test and suggest that the efficacy of an antacid cannot be accurately predicted from its acid-neutralizing capacity. The dose of antacids greatly influences the neutralizing pH profiles. Aluminum-magnesium compounds appear to provide steadier buffering than carbonate compounds or magnesium oxide.

Aluminum Compounds↗

Clinical efficacy of amiodarone.

OBJECTIVES: To review the clinical efficacy and role of amiodarone in the management of supraventricular and ventricular arrhythmias and its effects on mortality. METHODS: Review of relevant studies and reports. RESULTS: Amiodarone exerts significant effects on atrial tissue. In most studies it was completely or partly effective in preventing recurrences of atrial fibrillation or flutter in up to 80% of patients. Amiodarone may be superior to class Ia agents for maintaining normal sinus rhythm. Large randomized trials indicate that it is a potent suppressor of ventricular arrhythmia and reduces arrhythmic death after myocardial infarction. In patients with cardiomyopathy, it suppresses asymptomatic arrhythmias and increases left ventricular ejection fraction. Meta-analysis of relevant studies indicated that amiodarone reduces the risk of arrhythmic and sudden death by 29% in high-risk patients with recent myocardial infarction or congestive heart failure. This translates into an overall 13% reduction in total mortality. CONCLUSION: Because of its effectiveness against a broad range of arrhythmias, amiodarone is a valuable addition to the antiarrhythmic pharmacopeia.

Amiodarone↗

USP--promoting the public health.

As one of the first "national" medical organizations, the first pharmacopeia contributed to a united national public health effort. The USP was the precursor to the American Medical Association. An official USP drug monograph tells manufacturers what constitutes the acceptable identity, quality, strength, and purity of a pharmaceutical product.

Adverse Drug Reaction Reporting Systems↗