Extract and formulation including extract

Abstract

It is an object of the present invention to provide an extract from inflamed skins of rabbits inoculated with vaccinia virus wherein the quality is more stabilized, and a preparation containing the extract, etc. The use of the amount of N-acetylneuraminic acid contained in an extract from inflamed skins of rabbits inoculated with vaccinia virus and a preparation containing the extract as an index makes possible to warrant the quality of each manufacturing lot of the extract and the preparation in more stable manner. The extract from inflamed skins of rabbits inoculated with vaccinia virus and the preparation containing the extract which are manufactured as above, and in which the quality thereof becomes more stable, are warranted to maintain efficacy and safety in more strict manner, and thus extremely useful.

1 . In an extract from inflamed skins of rabbits inoculated with vaccinia virus, the extract from inflamed skins of rabbits inoculated with vaccinia virus where the amount of N-acetylneuraminic acid contained in the extract is measured and the content is confirmed to be 4000 ng or more per unit of the extract. 
     
     
         2 . In an extract as claimed in  claim 1  wherein the extract is liquid from inflamed skins of rabbits inoculated with vaccinia virus where the amount of N-acetylneuraminic acid contained in the extract is measured and the content is confirmed to be 4800 ng or more per mL of the extract. 
     
     
         3 . In a preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus, the preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus as claimed in  claim 1 . 
     
     
         4 . In an injectable preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus, the injectable preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus where the amount of N-acetylneuraminic acid contained in the injectable preparation is measured and the content is confirmed to be 4800 ng or more per mL of the injectable preparation. 
     
     
         5 . In an injectable preparation as claimed in  claim 4  wherein the injectable preparation is a 3 mL injectable preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus, the 3 mL injectable preparation containing an extract from inflamed skins of rabbits inoculated with vaccinia virus where the amount of N-acetylneuraminic acid contained in the injectable preparation is measured and the content is confirmed to be 14400 ng or more per ampoule of the injectable preparation. 
     
     
         6 . In a tablet containing an extract from inflamed skins of rabbits inoculated with vaccinia virus, the tablet containing an extract from inflamed skins of rabbits inoculated with vaccinia virus where the amount of N-acetylneuraminic acid contained in the tablet is measured and the content is confirmed to be 16000 ng or more per tablet. 
     
     
         7 . The preparation according to  claim 3 , wherein the preparation is an analgesic agent. 
     
     
         8 . The injectable preparation according to  claim 4 , wherein the injectable preparation is an analgesic agent. 
     
     
         9 . The tablet according to  claim 6 , wherein the tablet is an analgesic agent. 
     
     
         10 . In a preparation as claimed in  claim 3  wherein variations in the effect of the preparation among manufacturing lots are reduced by such a means that the amount of N-acetylneuraminic acid contained in the preparation is measured for each manufacturing lot and the content is confirmed to be 4000 ng or more per unit of the extract from inflamed skins of rabbits inoculated with vaccinia virus in the preparation. 
     
     
         11 . The preparation according to  claim 10 , wherein the effect is an analgesic effect. 
     
     
         12 . The preparation according to  claim 11 , wherein the analgesic effect is an analgesic effect for non-inflammatory pain disease. 
     
     
         13 . In an injectable preparation as claimed in  claim 4  wherein variations in the effect of the injectable preparation among manufacturing lots are reduced by such a means that the amount of N-acetylneuraminic acid contained in the injectable preparation is measured for each manufacturing lot and the content is confirmed to be 4800 ng or more per mL of the injectable preparation. 
     
     
         14 . In an injectable preparation as claimed in  claim 5  wherein the variations in the effect of the injectable preparation among manufacturing lots are reduced by such a means that the amount of N-acetylneuraminic acid contained in the injectable preparation is measured for each manufacturing lot and the content is confirmed to be 14400 ng or more per ampoule of the injectable preparation. 
     
     
         15 . The injectable preparation according to  claim 13 , wherein the effect is an analgesic effect. 
     
     
         16 . The injectable preparation according to  claim 15 , wherein the analgesic effect is an analgesic effect for non-inflammatory pain disease. 
     
     
         17 . In a tablet as claimed in  claim 6  wherein variations in the effect of the tablet among manufacturing lots are reduced by such a means that the amount of N-acetylneuraminic acid contained in the tablet is measured for each manufacturing lot and the content is confirmed to be 16000 ng or more per tablet. 
     
     
         18 . The tablet according to  claim 17 , wherein the effect is an analgesic effect. 
     
     
         19 . The tablet according to  claim 18 , wherein the analgesic effect is an analgesic effect for non-inflammatory pain disease. 
     
     
         20 . The injectable preparation according to  claim 5 , wherein the injectable preparation is an analgesic agent. 
     
     
         21 . The injectable preparation according to  claim 14 , wherein the effect is an analgesic effect.