Optimization of "Askoeziuofito" tablets.

OBJECTIVE

To determine experimentally the optimal limits of excipients (silica colloidal anhydrous, magnesium stearate, potato starch, saccharose), which would determine the following technological properties of the tablets: sticking of the mass to the puansons, crushing strength, resistance to abrasion-off and the speed at which medicinal substances are released from the tablets.

METHODS

The following technological parameters were assessed according to the requirements of European Pharmacopoeia 04/2002:0479: mean mass, crushing strength, resistance to abrasion, duration of decomposition, speed of release of ascorbic and chicoric acids. Ferments and ascorbic acid were identified by color and precipitation reactions. Flavonoids (quercetin, quercitrin, kempferol, hyperoside, vitexin, luteolin) were identified by method of high-pressure liquid chromatography; caffeic and ascorbic acids were identified by method of thin layer chromatography; and hydroxycinnamonic acids -- by method of spectrophotometry. In tablets, ascorbic acid was quantitatively determined using the method of oxidimetry, and chicoric acid -- using the method of spectrophotometry. It has been established that the use of techniques of mathematical planning (2(4-1) fraction replica plan, maximum gradient direction and orthogonal compositional plan) made it possible to select optimal amounts of excipients which determine optimal quality requirements for production of tablets: crushing strength, resistance to abrasion, pressing, disintegration time and release rate of medicinal substances. By applying chemical and physico-chemical methods of analysis in determining active substances in tablets, technology for analyzing such preparations has been developed and stability tests have been performed.