angio- and neuropathies (n
ecrobiosis lipoidica
diabeticorum, insulin lypodystrophy,
gangrene
) [1, 2].
One of the most serious diabetes complications is diabetic foot syndrome. It
manifests with different skin injuries, such as dry skin, deep and painful fissures,
hyperceratosis, ulceration, atrophic muscles changes and foot deformations. It is
known that Ukrainian diabetic patients suffer from diabetic foot syndrome much more
frequently than abroad. This situation exists due to untimely diagnostics.
As a rule, diabetic skin lesions take their course persistently with frequent
aggravations and fail to heal. The clinic management consists of pathogenic
conservative treatment, local therapy or surgery.
The pathogenic conservative treatment involves strong blood glucose level
control, provides neuroprotective, antiplatelet and antibacterial therapy, jugulates the
critical ischemia of the low extremities or influences the symptoms of the
accompanying pathological conditions. The surgery includes the removing of injured
tissues sites or minor amputations in cases of severe stage of the diabetic foot
syndrome. The local therapy in the diabetic patients is used independently or
additionally after surgery, or with aims of the effective prophylaxis of the pathological
skin conditions. Due to availability and simplicity of using the latter one takes the
principal role in the diabetic foot management. It is necessary to point out, that the
choice of the therapy’s medicines depends on pathological condition [3, 4].
In spite of big quantity of the approaches and medical products for diabetic skin
care, none of them are not perfect or absolutely efficient. Therefore, the development
of new remedies and medical technologies for controlling skin lesions in diabetic
patients remains topical.
That's why the aim of our investigation was the development of the new soft
pharmaceutical dosage form for treatment diabetes skin lesions.
Technological part of the researches. Taking into account that structural and
functional changes of the skin tissues in case of diabetes are connected with
intensifying free radicals production in cells and expressive oxidative stress, the
original succinic acid derivate (SAD) was the research object. The SAD has
antioxidative effect and has been synthesized and investigated for years in the SI
“Institute for endocrine pathology problems named after V. Ya. Danilevsky NAMS of
Ukraine”.
The wide range of the pharmacological activities of SAD (antioxidative effect,
positive impact on blood glucose and lipid levels) combines its low toxicity
(LD
50
>13 g/kg) and evidences its potential capacity to influence the pathogenesis of
the diabetes complications.
SAD is white with yellowish shade or light yellow, odorless powder, freely
soluble in dimethylformamid and dimethylsulfoxide (DMSO), slightly soluble in 96 %
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