It has been experimentally proved that under the condition of diabetes the
reparative processes lasted up to 35–40 days in experimental animals. The test sample
№ 5 applications have accelerated skin lesion reparations in rats with experimental
types 1 and 2 diabetes. On the 5
th
day of the experiment beginning the much more
expressed therapeutical effect has been observed and complete ulcers healing has
occurred in 20–25 days. It is 10–15 days earlier, than in non treated groups and in group
treated with remedies of comparison.
In spite of the fact that topical remedies are considered to be a safer than systemic
ones, they may cause toxic effects in human organism. Therefore, the studying of acute
and chronic toxicity (epicutaneous application) of the topical pharmaceutical
composition based on SAD has been included in the investigation list. The potential
functional and metabolic changes in rat’s organism during experiment have been taking
into account.
It has been determined, that the most effective test sample № 5 was practically
non toxic according to the LD
50
criterion under the condition of acute intraperitoneal
and epicutaneous applications
.
Subchronic (in dose 2500 mg/kg) and chronic (in dose
1000 mg/kg) epicutaneous application of the topical pharmaceutical composition based
on SAD haven't had toxic influence on the organs and systems functioning and on
general health state in male and female rats. Alongside with, the negative effects on
organs microstructure as well as skin haven't been observed.
Quality control of pharmaceutical composition for diabetic skin lesions
treatment. During development of analytical papers on quality control of
pharmaceutical composition based on SAD, the recommendations and analytical
methods of State Pharmacopoeia of Ukraine (2nd edition) such as “Soft pharmaceutical
dosage forms for topical administration”, “Pharmacotechnological tests”, “Physical
and Physicochemical test” have been used [9].
Preliminary screening proved that the most effective and perspective for
manufacturing was the test sample № 5 prepared on the o/w emulsion base.
It is well known, that the most important factor influenced on physical stability
of the emulsions is technology. Technological process of the o/w emulsions consists
of some stages (heating, mixing, homogenization, cooling) and demands to control
some technological parameters (temperature, humidity, processing periods etc).
The thermal behaviour of the developed emulsion and its compounds has been
researched by thermogravimetry method. It has been determined, that thermal
destroying of SAD begins at 178 ºС, DMSO – at 50 ºС, Lanette® SX 60 – at 143 ºС
and Sodium Lauryl Sulfate – at 100 ºС. Among used auxiliary substances only DMSO
has demonstrated thermolabile properties. This data have been taken into account while
determination of the temperature regimes of some technological stages such as
preparing of the oil phase and DMSO solution of SAD.
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