Создание суппозиториев с рибоксином: технология, биофармацевтическая характеристика, стандартизация

There was developed the technology of suppositories with Riboxinum, there were also chosen the optimal base and auxiliary substance. By the method of dialysis through a semipermeable membrane it was established that the maximum release of Riboxinum was observed from suppositories, prepared on the basis of Witepsol and complex fat base. 3% of the TWEEN – 80 was selected as the optimal auxiliary substance. The dialytic medium was 1,5% solution of sodium bicarbonate. There was developed the methodology of identification of Riboxinum and the product of its destruction by the method of chromatography in a thin layer of the sorbent. Solvent system chloroform-acetone (1:1) was selected as optimal. There was developed the method of quantitative analysis of Riboxinum in suppositories by the spectrophotometric method at the wavelength of 247 nm. Relative error of analysis of Riboxinum in suppositories has not exceed ± 1,69%. We conducted the validation assessment of spectrophotometric analysis of Riboxinum in suppositories according to the following indices: linearity, precision, accuracy. It was established that according to all indices the technique met the requirements. We carried out the standardization of suppositories according to the following indices: description, identity, time of full deformation, melting point, homogeneity of mass, impurities, quantitative content of Riboxinum. There was set up an expiry date for suppositories 2 years.