BACKGROUND: Cheilitis is an inflammatory disease of the lips, its red border, mucous membranes, and skin. There are meteorological, actinic, hypo-, and avitaminosis cheilitis, according to medical indications. Classification of cheilitis includes many types of diseases and is somewhat conditional. For these types of cheilitis treatment are most appropriate to use biologically active substances, in particular lipophilic extract of bee pollen. Lipophilic extract of bee pollen is a complex, concentrated plant-bee product with unique consumer and medicinal qualities. It should be noted that experiments have shown that the bee pollen lipophilic extract has a reparative effect higher than the widespread sea buckthorn oil. AIM: The aim of the work is to create therapeutic and prophylactic cream with lipophilic extract of bee pollen for the cheilitis treatment and prevention. MATERIALS AND METHODS: Cream preparation was conducted by phase inversion. Thermal and colloidal stability, pH values, the quantitative content of carotenoids, viscosity, osmotic activity, and microbiological purity were determined by generally accepted methods. RESULTS: Samples of the cream containing lipophilic extract of bee pollen are a homogeneous mass of soft consistency with light yellow color and pleasant specific odor. In estimating, the thermal stability cream samples cheilitis curing were successfully tested and proved to be stable. When centrifuging, the absence of stratification of the cream into fatty and aqueous phases after the test has showed the stability of the cream. The pH of the cream samples corresponds to the pH of the skin. During a qualitative test green color indicates the presence of carotenoids. Quantitative determination of the carotenoids amount in the cream for treatment and prevention cheilitis (in recalculation to β-carotene) corresponds to the set content of carotenoids in the cream of 5.4 mg. The viscosity of the developed cream at 16.2 s−1 is 68.38 ± 0.21 Pa x s, that fully corresponds to the viscosity of creams. In the study of osmotic activity, it was found that the cream with a glycerol content of 7% provides moderate osmotic activity of the drug for 8 h, which may indicate the absence of overdrying and irritating effect. In terms of microbiological purity, the investigated cream with lipophilic extract of bee pollen meets the requirements of the State Pharmacopoeia for finished medicines for topical use (category 2). CONCLUSION: For the cheilitis treatment and prevention has suggested the composition of the cream which contains biologically active substance – lipophilic extract of bee pollen. The technology of the cream with lipophilic extract of bee pollen was developed. Thermal and colloidal stability, pH values were studied; the quantitative content of carotenoids, viscosity, osmotic activity, and microbiological purity was determined. The research carried out made it possible to make sure of the correctness and rationality of the developed technology of the cream for the treatment and prevention of cheilitis.
Bisoprolol is a lipophilic cardioselective β-blocker, which leads to its rapid and almost complete (90%) absorption out of the gastrointestinal tract and high bioavailability. For determination bioavailability of solid dosage forms for oral administration in the conditions of pharmaceutical companies and laboratories the "dissolution" test is performed; its results allow to judge about the technology of manufacturing the drug and its bioavailability. The test on dissolution of solid dosage forms is an integral part of measures ensuring the quality of medicines. The aim of the analysis is to develop the "dissolution" test for bisoprolol tablets by absorption spectrophotometry in the ultraviolet and visible spectra. As a result of the research, the conditions for conducting the "dissolution" test for bisoprolol fumarate tablets have been grounded: the device with the blade is used, the volume of the medium is 500 ml, the temperature of the solvent medium is 37°C, the solvent is 0.1 M hydrochloric acid, the rotation rate is 75 rpm/min, the dissolution time is 20 min. The spectrophotometric method of determination of bisoprolol fumarate in 0.1 M solution of hydrochloric acid at the wavelength of 272 nm has been developed. It has been determined that the tablet excipients do not prevent spectrophotometric determination. The results obtained have shown that for 20 minutes of dissolution more than 90% of the active substance of its label claim turns into the solution. The following validation properties do not exceed the eligibility criteria: robustness (the analytical solution is stable for an hour), linearity (a=0.97% ≤ max a, 1.92%; b=0.9931), the correlation coefficient (0.9999), accuracy (0.52% ≤ max δ, 0.96%) and repeatability (2.24% ≤ max Δas, 3.0%), precision (1.42% ≤ max Δas 3.0%), which allows us to recommend the procedure for use in pharmaceutical analysis.
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