| At present,the total number of confirmed cases of new coronary pneumonia in the world has exceeded 150 million,and the cumulative death toll has exceeded 2 million.Remdesivir(Remdesivir)developed by Gilead of the United States has shown strong inhibitory activity against the new coronavirus(SARS-Co V-2).On May 7,2020,Japan’s Health,Labor and Welfare formally approved the U.S.Gilead’s drug Remdesivir for the treatment of new coronary pneumonia.On July 3,2020,the European Commission approved Remdesivir as the EU’s first drug for the treatment of new coronavirus infections.On October 22,2020,Remdesivir was approved by the U.S.Food and Drug Administration(FDA)as the nation’s first new crown treatment drug.The marine sulfate polysaccharide compound,fucoidan,which also has the anti-coronavirus inhibitory activity,also shows the effect of inhibiting the neocorona virus.In addition,fucoidan also shows antiviral activity against influenza A virus,hepatitis B virus,etc.,and the physiological and medical activity of fucoidan is not only limited to the scope of antiviral,it also has many other physiological and medical activities,such as anti-diabetic,Anti-thrombotic,lipid-lowering and other effects.Remdesivir and fucoidan are used as generic drugs and new drugs for the development of their quality standard research is necessary and important.According to the relevant regulations of the 2020 edition of the Chinese Pharmacopoeia,a reversed-phase high performance liquid chromatography method for the determination of remdesivir and its 4 related substances is established in this paper.The column is reversed-ha e C18(4.6 250mm,5 m),M bile ha e A i 0.05%(/)ifl ace ic acid a esolution,mobile phase B is methanol,using gradient elution program,UV detector,detection a ele g h i 240 m,fl a e i 1.0m L/mi,c l m em e a e i 25,The li ea a ge f Remdesivir is 25.0-200.0 g/m L,he c ela i c efficie R~2 is 0.9996,the detection limit is0.020 g/m L,a d he a ifica i limi i 0.055 g/m L.I addi i,emde i i a d i frelated substances were characterized by infrared spectroscopy,proton nuclear magnetic spectroscopy,carbon nuclear magnetic spectroscopy and mass spectrometry.According to the relevant regulations of the 2020 edition of the Chinese Pharmacopoeia,the capsule preparation technology of fucoidan was investigated.Using drug particle fluidity,capsule filling volume,disintegration time,etc.as evaluation indicators,the selection and dosage of capsule excipients were studied.The best preparation process was selected as follows:fucoidan 100.00g,microcrystalline cellulose 174.40g,silicon dioxide 2.80g,magnesium stearate 2.80g,mixed well,passed through a 30-mesh sieve twice,and filled the capsule.The quality analysis methods such as identification,inspection and content determination of this product were investigated respectively.In addition,the properties,loading differences,disintegration time limit,moisture,and ash content of the product were studied.The polysaccharide content of the product was determined by the phenol-sulfuric acid method,and the content of sulfate groups was determined by ion chromatography.Survey.The results showed that the phenol-sulfuric acid method for the determination of the polysaccharide content of this product,the linear correlation coefficient R~2 is 0.9993,the repeatability RSD is 1.03%,stable within 3 hours,the intermediate precision RSD is 1.45%,and the average recovery rate is 97.19%.The content of sulfuric acid group was determined by ion chromatography.The linear correlation coefficient R~2 was 1,the repeatability RSD was 0.80%,and it was stable within 48 hours,the intermediate precision RSD was 1.85%,and the average recovery rate was98%.Based on the above research,a draft quality standard for fucoidan capsules was formulated. |
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