| 摘要 |
The invention relates to the mechanically activated amorphous and amorphocrystalline compounds and compositions based thereon. Crystalline gluconic acid calcium salt or its compound with excipients is treated in grinding activator devices either up to the input specific energy value of not greater than 10.4 kJ/g and achieving an amorphocrystalline state or up to the input specific energy value of no less than 10.5 kJ/g and achieving an amorphous state. The obtainable agents are assessed by means of X-ray diffraction, IR, NMR, EPR spectroscopy, mass- or chromato-mass-spectrometry, and a differential thermal analysis. The mechanically activated amorphous and amorphocrystalline compounds are used as an active principle for preparing pharmaceutical preparations. The invention can be used in medical and food industries in the production of biologically active agents, therapeutic-prophylactic means, medicinals and in practical medicine in treatment of acute osseous, dental and other diseases related to disorders of calcium metabolism in the organism. |
| 主权项 |
1. A mechanically activated amorphous gluconic acid calcium salt composition with the following ratio of ingredients, wt. %:gluconic acid calcium salt94-97talc2-1starch2-1calcium stearate2-1for treatment of dental or osseous diseases related to disorders of calcium metabolism in an organism, with a homogeneous diffuse halo in its powder X-ray diffraction diagram, expressed characteristically by shifting the centre of gravity of an absorption band of 3000-3600 cm−1 to an area of great wave numbers thru the value of no more than 200 cm−1, presence of an absorption band with frequencies 3308 ±20, 2933±10, 1602±10, 1420±10, with an arm of 1260±40, 1085±10, 1044±10, 877±10, 682±10, 577±10 cm−1 and an additional absorption band having the frequency of 947±10 cm−1 in an IR spectrum, reducing endothermal peaks in the temperature range of 125-165° C. and increasing a peak in the temperature range of 30-100° C. with a differential thermal analysis, presence of a single intensive line with a g-factor of 2.000 to 2.006 and a width of 8 to 9 E in an electronic paramagnetic resonance spectrum, occurrence of a fine structure unresolved wide line in the regions of 60-90 ppm and 170-190 ppm in 13C NMR spectra, shifting the resonant lines of their aqueous solutions in an area of 62.8-179.2 ppm thru the value of no more than 0.1 ppm in 13C NMR spectra, shifting the resonant lines of their aqueous solutions in an area of 1.2-4.95 ppm thru the value of no more than 0.02 ppm in 1H NMR spectra, increasing intensities of 160 m/z peaks of mass-spectra not less than 2.5 times and 780-1000 m/z peaks of solution extracts thereof in ethanol not less than 3 times in a mass-spectroscopic analysis. |
