Validation of HPLC Method for Determination of Histamine in Human Immunoglobulin Formulations

Background Histamine fixed-immunoglobulin formulations, which consisted of 0.15 µg of histamine dihydrochloride and 12 mg of human immunoglobulin in a vial, are used for anti-allergic treatments, and controlling the amounts of histamine in the formulations is essential to avoid histamine intoxication. Objective A high-performance liquid chromatography (HPLC) method for determination of histamine contents of the formulations was established and validated. Methods Histamine extracted from the formulation was labeled with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate and was analyzed by gradient elution HPLC with UV detection at 260 nm. Results The method showed linearity in the range 0.8–2.4 µM (R > 0.999), accuracy (100.1–105.8% recovery), and precision (relative standard deviation ≤ 1.93%). The validated method was applied for five lots of the pharmaceutical, and their histamine contents were determined to be 0.149–0.155 µg/vial. Conclusions These results indicated that the validated method is useful to control amounts of histamine in biopharmaceutical products. Highlights The HPLC method was developed for quantitative determination of histamine content of the histamine fixed-immunoglobulin formulations.

Evaluation of anti-asthmatic and anti-cholinergic activity of ethanolic extract of Tectina grandis Linn. bark

Background: Asthma is a chronic disease that affects approximately 300 million people worldwide. Tectona grandis Linn. bark, also known as Teak (English), is traditionally used to treat asthma. However, the scientific data on anti-asthmatic and anti-cholinergic of this plant has got little attention. An attempt has been based on ethanolic extract of bark of Tectona grandis Linn. shown a tremendous effect on asthma when comparative study was done with normal and treated group.Methods: The anti-asthmatic activity of a 95% ethanol and 5% distilled water extract of dried and fresh Tectona grandis Linn. bark, was evaluated against histamine and acetylcholine-induced preconvulsive dyspnea (PCD) in guinea pigs fasted for 24 h were exposed to an atomized fine mist of 2% histamine dihydrochloride and acetylcholine aerosol (dissolved in normal saline) using nebulizer at a pressure of 300 mmHg in the histamine chamber (24×14×24 cm, made of perplex glass. They were divided in groups Mepyramin (8 mg/kg) intraperitonially, atropine aerosol and Tectona grandis bark formulation (2.5, 5, 10 gm/kg) were administered orally 30 min prior to exposure. Animals, which did not develop typical asthma within 6 minutes, were taken as protected.Results: Ethanolic extract of Tectona grandis Linn. bark at 5 and 10 gm/kg significantly reduce bronchoconstriction as compared to control group along with significant mast cell stabilization activity.Conclusions: In conclusion, the present study shows that the ethanolic bark extract of Tectona grandis Linn. has potential antiasthamatic and antichlolinergic action in histamine and acetylcholine broncocontraction in guinea pigs.

Detection of Histamine Dihydrochloride at Low Concentrations Using Raman Spectroscopy Enhanced by Gold Nanostars Colloids

In this paper, we report a fast and easy method to detect histamine dihydrochloride using gold nanostars in colloidal aqueous solution as a highly active SERS platform with potential applications in biomedicine and food science. This colloid was characterized with SEM and UV–Vis spectroscopy. Also, numerical calculations were performed to estimate the plasmonic resonance and electric field amplification of the gold nanoparticles to compare the difference between nanospheres and nanostars. Finally, aqueous solutions of histamine dihydrochloride were prepared in a wide range of concentrations and the colloid was added to carry out SERS. We found SERS amplified the Raman signal of histamine by an enhancement factor of 1 . 0 × 10 7 , demonstrating the capability of the method to detect low concentrations of this amine molecule.

The effects of mometasone furoate and strontium chloride in a rat model of allergic rhinitis

Neurogenic inflammation plays a role in the pathophysiology of allergic rhinitis. Highly effective in reducing the sensory irritation caused by some substances, strontium salts directly affect C-type nerve fibers. The aim of this study was to compare the efficacy of mometasone furoate and strontium chloride on early-phase symptoms in a rat model of allergic rhinitis. Wistar albino rats (n = 24) were randomly divided into three groups: the mometasone group, receiving 1 μg mometasone furoate (2 µl/site); the strontium 3% group, receiving 3% strontium chloride (2 μl/site); and the strontium 5% group, receiving 5% strontium chloride (2 μl/site). To induce significant nasal symptoms of allergic rhinitis, 5 µmol of histamine dihydrochloride (HDC) (2 µl/site) was administered. Symptoms of allergic rhinitis were recorded as frequencies of sneezing and nasal rubbing during a 15-minute interval. On days 1 and 2, respectively, 0.9% sodium chloride (NaCl) (2 μl/site to each nasal cavity) and HDC were administered in all of the study groups. On days 3 and 4, the study drugs were administered 10 and 30 minutes before the administration of HDC. On day 5, the study drugs were administered 10 minutes after the administration of HDC. The results of the present study revealed that when strontium chloride or mometasone furoate was administered 30 minutes before the onset of symptoms, a significant decrease was observed in sneezing and nasal rubbing. The number of sneezing occurrences was significantly lower and the number of nasal rubbing occurrences was higher in the strontium 3% group compared to the groups in which mometasone furoate and 5% strontium chloride were administered after onset of symptoms. Recent studies have investigated the efficacy and safety of strontium chloride nasal drops compared with common pharmacologic treatments of allergic rhinitis. These studies have revealed that allergic rhinitis can be successfully and safely treated with strontium-chloride-containing products, thus offering a potential new treatment strategy.

Possibilities of preparation and storage of standard histamine solutions

Background. To explore the stability of histamine solutions of low concentrations sterilized by autoclaving and filtration as well as the possibilities of storage and use of these solutions after 1-fold and 5-fold freezing and defrosting. Methods. Histamine dihydrochloride solutions at a concentration of 10 μg/ml were sterilized by the membrane filtration or the autoclaving at 121 °C for 30 minutes. The solutions were frozen in sterile insulin syringes, followed by 1- and 5-fold defrosting. Skin prick tests have been performed with the resulting solutions. Results. When comparing the results of skin prick testing performed with autoclaved and sterilized by the filtration histamine, no statistically significant differences were found (p>0,05). Comparison of the results of skin prick tests performed with histamine that hadn't been frozen before, after 1- and 5-fold freezing and defrosting showed no statistically significant differences (p>0,05). Conclusion. It has been shown that histamine solutions sterilized by autoclaving at 121 °C for 30 minutes followed by repeated freezing and defrosting don’t change their biological activity substantially.