Chastnoe Uchrezhdenie "Nauchno-Issledovateljskiyj Institut Citokhimii I Molekulyarnoyj Farmakologii"
发明人:
申请号：
EP08741806.7
公开号：
EP2137513B1
申请日:
2008.03.06
申请国别(地区):
EP
年份:
2018
代理人:
摘要：
The invention relates to chemical and pharmaceutical branches, in particular, to a mixture for determining originality of quality control a medicine &ldquoGlycine tablets sublingual 0.1 g.&rdquo, a method for preparation thereof and a method for determining originality of quality control of said medicine. The mixture comprises 50% ethyl alcohol and crushed to powder tablets &ldquoGlycine tablets sublingual 0.1 g.&rdquo in the range 100:0.5. The mixture is prepared by diluting 1.25 g. of crushed in powder tablets in 250 mg of the 50% ethyl alcohol during 20 min. at 40°C in a tester for determining dilution at rotation speed of an impeller mixer being 200 rev/min. The mixture is maintained at room temperature during 10 min. A method for determining the medicine originality comprises preparation of aqueous alcoholic mixture using 50 % ethyl alcohol as described above. After that a 4 ml. sample of the mixture is selected and value of optical transmission is measured with 700±2 nm wave length in a dish, a layer thickness is 1o mm. relative to the 50% ethyl alcohol. An aqueous mixture is prepared during 20 min. at 37°C by diluting 2.5 g. crushed to powder tablet in 250 ml. of purified water. The aqueous mixture is tested similar to that carried out for the aqueous mixture. Further the difference of values between the optical transmission of the aqueous alcoholic mixture and the optical transmission of the aqueous mixture is determined and subsequently the obtained value is compared with a range from 30% to 50%.
