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Stability, potency, and preservative effectiveness of epoetin alfa after addition of a bacteriostatic diluent.

The stability, potency, and preservative effectiveness of two dilutions of epoetin alfa containing a bacteriostatic diluent were studied. Epoetin alfa 10,000 units/mL in single-use vials was diluted 1:1 and 1:1.5 with bacteriostatic 0.9% sodium chloride injection. USP tests of preservative effectiveness were performed on samples from two batches each of the 1:1 and the 1:1.5 dilutions. Appearance assessment, Western blot analysis, radioimmunoassay, and bioassay were used to determine the stability or potency of samples from three batches of each dilution that were stored at 5 degrees C or at 30 degrees C for 12 weeks. Both batches of the 1:1.5 dilution (epoetin alfa 4,000 units/mL with 0.54% benzyl alcohol) met the USP criteria for preserved solutions, while one batch of the 1:1 dilution (epoetin alfa 5,000 units/mL with 0.45% benzyl alcohol) did not. Epoetin alfa 10,000 units/mL diluted either 1:1 or 1:1.5 with bacteriostatic 0.9% sodium chloride injection and stored at 5 degrees C or at 30 degrees C remained stable and potent for 12 weeks. The addition of 1.5 mL of bacteriostatic 0.9% sodium chloride injection to a vial containing 1 mL of epoetin alfa 10,000 units/mL makes a solution of epoetin alfa 4,000 units/mL that meets the USP criteria for preservative effectiveness and remains stable and potent for 12 weeks at 5 degrees C.

Animals↗

E-prescribing in clinical practice.

E-prescribing is coming of age. It promises to reduce medication errors and adverse reactions from incompatible drug combinations. This article provides an overview of the factors that have driven greater adoption of e-prescribing, principally the promulgation of HIPAA regulations and the Medicare Modernization Act of 2004. It discusses the financial considerations that have delayed the greater use of existing methodology, addresses current government and industry initiatives, and defines some of the standards that have been set forth to date.

Ambulatory Care Information Systems↗

[Modulation of the activities and mRNA expression of cytochrome P450 isoenzymes in rat liver by Panax gingseng and coadministration with Veratrum nigrum].

OBJECTIVE: To study the modulatory effect of Panax gingseng and coadministration with Veratrum nigrum on the activity and mRNA expression of cytochrome P450 isoenzymes in rat liver. METHOD: Rat liver microsomal cytochrome P450, b5, aminopyrine N-demethylase(APND), p-nitrophenol-hydroxylase(pNPH)activities were quantitated by UV chromatography. The mRNA expression level of five CYP isoenzymes CYP1A1, CYP2B1/2, CYP2C11, CYP2E1 and CYP3A1 were detected by semi-quantitative reverse transcriptase-polymerase chain reaction(RT-PCR). RESULT: P. gingseng coadministrated with V. nigrum obviously decreased the P450 contents of liver microsomes, and the b5 contents. Both single and combined used inhibited the activities of aminopyrine N-demethylase. At the mRNA level, the expression of CYP2C11 markedly induced exposure to V. nigrum, but combinative groups decreased the expression of CYP2C11. The combination of P. gingseng and V. nigrum induced the expression of CYP1A1. P. gingseng has inhibitory effect on CYP2B1/2 and inductive effect used with V. nigrum. The combination of P. gingseng with V. nigrum also induced the expression of CYP3A1. CONCLUSION: P. gingseng used singly has some different modulation effects compared with combinative used, which may occur because of drug-drug interaction based on cytochrome P450. To elucidate the drug-drug interaction, it needs further analysis and metabolism research.

Aminopyrine N-Demethylase↗

[Methods and modes about the theory of traditional Chinese prescription composition].

Theory and mode about compatibility of prescription are the key element for studies on complex prescription in traditional Chinese medicine. In this article, we reviewed the sources, methods and thoughtway about theory of prescription composition, and concluded the current researches about components compatibility. Through introducing the researches about compatibility of effective components, we advanced that components compatibility would be one of the new modes of compound prescription of Chinese medicine. The researches and foundation about the new modes of compound prescription of Chinese medicine would do active influence either in making modern Chinese medicine or in increasing clinical curative effect.

Diagnosis, Differential↗

[Analysis of adverse effects of cinnabar].

This article made a brief analysis of clinical adverse effects of cinnabar. Except for allergic reaction, almost all the adverse events of cinnabar were caused by unreasonable application. The majority of the poisoning cases were associated with excessive and/or long-term dosage, and improper preparation methods, such as decocting, heating or fumigating. Children showed to be prone to poisoning. The poisoning caused by unreasonable use of cinnabar should be considered to be drug alert, but not advert effect. And the toxicity of cinnabar could be avoided by normalizing the preparation method, controlling the dosage and duration.

Chemical and Drug Induced Liver Injury↗

[Study on combination components and effectiveness of Chinese traditional herbal formulas].

Chinese herbal prescriptions enhance the clinical curative effect through the use of multi-composition formulas, and the combined use of several components from herbal extracts is an enhanced mode of formulae organization and compatibility. The research with the combination components is under the guidance of the traditional Chinese medical theory which apply medical therapy following syndrome differentiation. The purpose is to enhance drug safety, clinical suitability, and to use drugs with clearer ingredients and mechanisms of action, with more stable and controllable product quality for commercial production. So the study of combination components must establish the methodology of combining standard components, confirming the main components through trial design, removing the poisonous components, and ascertaining dosage and ratios of all the components used. The mode of combination component has three forms: the one from the combined use of prepared medicinal herbs, the one from directly combined use of components, and the one from the standard ingredient composition of single herb. These three forms strictly follow the mechanisms of multi-component and multi-target medical intervention. The significance of using combined effective components is to ensure the accuracy and safety of clinical dosage, enhance the clinical effectiveness, reduce the use of medicinal herbs, decrease the side-effects, and to promote modern Chinese medicines that have clear ingredients and mechanisms. Our study on the chemistry and pharmacology of Chinese herbs provided scientific foundation to the combination effective components. Nowadays the modern medicine is faced with the complicated disease spectra, meanwhile, the single-ingredient chemical drug is not able to achieve satisfactory curative effect. So there is a need to develop new medicine with effective combination components to meet new opportunities and challenges. Therefore, it has becomes a new mode of developing combined components from effective traditional formulas and from single standard ingredient under traditional Chinese medicine theory, unlike the conventional way of clinic--experience based drug development. This new mode will promote the academic research and the industry development of traditional Chinese medicine.

Diagnosis, Differential↗

[Experimental study of the effects on proliferation and apoptosis of A549 cell line of adenocarcinoma of the lung with compatibility of Radix ex Rhizoma ginseng and Fafces Trogopterori].

OBJECTIVE: To observe the effects of the compatibility of Radix ex Rhizoma Ginseng and Fafces Trogopterori on proliferation and apoptosis of A549 cell line of adenocarcinoma of the lung, to clarify the mechanism, to explore the best proportion compatibility, and to offer the reasonable experiment evidence in clinical medicine therapy. METHOD: Twenty-five healthy Wistar rats were divided into five groups randomly, 5 rats in each group, including normal group, Radix ex Rhizoma Ginseng and Fafces Trogopterori in the ratio of 1:1 group, 1:2 group, 2:1 group, and complex recipe of beetle capsule group. After the pharmacy liquor was decocted, equivalent dose for rat was calculated. According to the weights, all rats were intragastric administrated at the standard of 1 mL x 100 g(-1), twice a day, continuously for 3 days. One hour after the last administration, the serum was collected and mixed with culture media RPMI 1640 to prepare the drug serum incubation liquid at the concentration of 10%. MTT was used to measure the growth curve and the inhibition rate of tumor cell, and the apoptosis was observed by electron microscope. RESULT: The compatibility of Radix ex Rhizoma Ginseng and Fafces Trogopterori could inhibit the cell proliferation of cell line A549 of lung adenocarcinoma and have an inducement on apoptosis. The effect was significant in the ratio of 2:1. CONCLUSION: These results indicate that inhibiting the proliferation and inducing the apoptosis of tumor cell may be one of the anticancer mechanism of the compatibility of Radix ex Rhizoma Ginseng and Fafces Trogopterori.

Adenocarcinoma↗

Stability, compatibility, and plasticizer extraction of taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers.

The stability of taxol (NSC-125973) in various diluents and containers was determined, and the extent of leaching of di(2-ethylhexyl) phthalate (DEHP) from polyvinyl chloride (PVC) bags caused by the taxol formulation was measured. A taxol formulation consisting of a 6-mg/mL solution of taxol in 50% polyoxyethylated castor oil and 50% dehydrated ethanol was added to 50- and 100-mL glass bottles, PVC infusion bags, and polyolefin containers containing 5% dextrose injection or 0.9% sodium chloride injection to give initial nominal taxol concentrations of 0.3, 0.6, 0.9, and 1.2 mg/mL. The containers were maintained at 20-23 degrees C for 12-24 hours. Samples were assayed by stability-indicating high-performance liquid chromatography, and clarity was determined visually. An experiment was run to ascertain whether DEHP would leach from a PVC administration set during a simulated infusion. There was no substantial loss of taxol over 24 hours. Filtration through a membrane resulted in no loss of taxol. All the solutions initially appeared hazy. Solutions stored in PVC bags became more hazy with time than solutions stored in glass or polyolefin containers. The haze seen in PVC bags was traced to leaching of DEHP. Agitation had no effect on the extent of leaching. Leaching was also seen during simulated delivery through PVC administration sets. No DEHP was detected when solutions were stored in glass or polyolefin containers and infused through polyethylene-lined sets. At the dilutions studied, taxol was visually and chemically stable for up to 24 hours.(ABSTRACT TRUNCATED AT 250 WORDS)

Alkaloids↗

Compatibility of dexamethasone sodium phosphate with hydromorphone hydrochloride or diphenhydramine hydrochloride.

The stability and compatibility of dexamethasone sodium phosphate and hydromorphone hydrochloride or diphenhydramine hydrochloride at various concentrations at room temperature was studied. Solutions containing equal volumes in the following ranges of concentrations were prepared: dexamethasone sodium phosphate 0-10 mg/mL, diphenhydramine hydrochloride 0-50 mg/mL, and hydromorphone hydrochloride 0-40 mg/mL. Samples of each combination were analyzed immediately after mixing and at 7 and 24 hours using a stability-indicating high-performance liquid chromatographic assay. The pH of each solution was measured, and each combination was visually inspected. Precipitation occurred in solutions containing dexamethasone and hydromorphone hydrochloride or diphenhydramine hydrochloride when equal volumes of the most concentrated solutions were mixed. Some of the combinations at lower concentrations were visually compatible, and more than 90% of the initial concentrations of both drugs (i.e., dexamethasone-hydromorphone and dexamethasone-diphenhydramine) remained in these compatible solutions. Dexamethasone is visually compatible with diphenhydramine or hydromorphone but only within specific concentration ranges. In visually compatible solutions, both drug combinations are stable for up to 24 hours at room temperature.

Chromatography, High Pressure Liquid↗

A meta-analysis of effects of heparin flush and saline flush: quality and cost implications.

The purpose of this meta-analysis was to estimate the effects of heparin flush and saline flush solutions on maintaining patency, preventing phlebitis, and increasing duration in peripheral heparin locks. The average effect size (d value) across 15 studies with a total sample size of 3,490 was .0573 for patency (clotting). The 95% credibility interval ranged from -.2267 to .3413. The average effect size across 13 studies with a total sample size of 2,356 was -.0757 for phlebitis. The 95% credibility interval ranged from -.2497 to .0983. The average effect size for duration across six samples with a total sample size of 1,960 was -.0550. The 95% credibility interval ranged from -.2424 to .1324. It can be concluded that saline is as effective as heparin in maintaining patency, preventing phlebitis, and increasing duration in peripheral intravenous locks. Quality of care can be enhanced by using saline as the flush solution, thereby eliminating problems associated with anticoagulant effects and drug incompatibilities. In addition, an estimated yearly savings of $109,100,000 to $218,200,000 U.S. health care dollars could be attained.

Catheterization, Peripheral↗

Stability of dobutamine hydrochloride in peritoneal dialysis solutions.

The stability of dobutamine hydrochloride in peritoneal dialysis solutions at 4, 26, and 37 degrees C was determined. Dobutamine (as the hydrochloride salt) was added to dialysis solutions containing 1.5% or 4.25% dextrose to concentrations of 2.5, 5.0, and 7.5 mg/mL. Samples were stored at 4, 26, and 37 degrees C to mimic refrigerator, room, and body temperature, respectively. At 0, 4, 8, and 24 hours, the samples were analyzed in triplicate by stability-indicating high-performance liquid chromatography to determine the percentage of drug remaining. More than 90% of the drug was retained under all storage conditions in 1.5% dextrose dialysate containing an initial dobutamine hydrochloride concentration of 5.0 or 7.5 micrograms/mL. The mean concentration in the samples containing an initial dobutamine hydrochloride concentration of 2.5 micrograms/mL and stored at room temperature remained greater than 90% of the initial concentration for the first four hours and then decreased to less than 90%. Dobutamine was stable in 4.25% dextrose dialysate regardless of the initial concentration or the storage condition. Dobutamine hydrochloride 5.0 and 7.5 micrograms/mL in 4.25% dextrose dialysis solution was stable under all the test conditions. Dobutamine hydrochloride 2.5 micrograms/mL was stable in 1.5% dextrose dialysate for only four hours at room temperature.

Dialysis Solutions↗

Drugs and the elderly.

Prescribing for the older individual requires a great deal of thought. Multiple pathology is usually associated with multiple drug taking and therefore a high risk of adverse drug reactions. Physiological changes have important bearing on drug usage. Constant vigilance is required to ensure safe prescribing.

Aged↗