| Strontium, one kind of trace elements, is in the same column as Ca and closely chemically related to Ca. It has unique appetency to bone. It can not only inhibit bone resorption also stimulate bone formation and doesn't exert any deleterious effect on bone minerallization and mineral quality on crystallity and crystal size level. Due to its particular mechanism acting on bone, strontium salts have distinct therapeutic effect on osteoporosis. In addition, fructose-1,6-bisphosphate(FDP) has functions as follows: ①As a high-energy phosphate compound in the process of metabolism , it can facilitate the absorption of strontium by providing part energy available for the active absorption of strontium; ②Rich of PO43-, it can avoid the decrease of the content of PO43- caused by strontium.③As the intermittent metabolite of EMP, its side-effect is very thin and it can modulate activities of a lot of enzymes, renew and improve metabolic performance of cells. That is to say, strontium has great capacity in improving bone metabolism and FDP is assistant for strontium acting on bone. According to the putting-together principle in the design of new drugs, we infer that combination of FDP and strontium may have greater effect on the therapy of osteoporosis, then we design and synthesis fructose-1,6-bisphosphate strontium, this new compound named SFP. We have already applied it for patent protection. Through pharmacological and toxicological research, our prediction proved right. At the dosage of more than 100mg SFP per kilogram body, bone density of rats, whether female or male, have increased clearly. And maximal endured quantity of SFP on mice is more than 5g/kg body, which indicate that its toxicity is very small. Compared with other drugs, SFP show great advantage in the therapy of osteoporosis. So SFP is likely to become a potential new drug in the therapy of osteoporosis, with the self-innovated intellectual property . Herein, we research on it.Preparation process of SFP has been studied. Through salt-out with anhydride ethanol, SFP was precipitated from its solution. And under the method of single factor variation, a suit of precipitation process has been groped for. The optimum process is as follows: concentration of feedstock solution 90g/L, volume of anhydride ethanol 2.5 times that offeedstock solution, agitation velocity 250rpm and trickling velocity of anhydride ethanol 10mL/min. Under the process, the content of SFP of the product is 99.27%, yield 91.34%, mean particle size 0.316mm. The process is stable and reliable.The elementally physical and chemical profiles have been studied. The result was that SFP can dissolve into water, easy to absorb water, stable under 60℃ and in simulative intestinal environment but not very stable in simulative stomach environment. Based on the profiles of SFP, tablet, which is administered conveniently, and microcapsule, which can control drug release in intestines, the two dosage forms or preparation technologies have been designed for SFP. As to the two forms, preparation processes and corresponding quality evaluation have been studied.Product quality has been investigated in respect of chemical analysis, pharmacy and stability. SFP structure has been authenticated by elemental analysis, UV spectrum, IR spectrum and 13C-NMR spectrum. Impurities of the product have been analyzed by qualitative and quantitative analysis. The result of pharmacological and toxicological test of the product indicate it is effective and safe. Stability test of the product has been carried. The result indicate that the quality of the product can't be affected by light and humidity, but may be affected above 60℃.
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