Oral preparation useful in measuring capacity to metabolize pyridine

Abstract

An object of the present invention is to provide an oral preparation that can be used to diagnose the existence or degree of pyridine metabolic capacity disorder, pyrimidine metabolic rate, etc., with high accuracy and with little variation due to individual differences. The oral preparation is prepared using a powder material obtained by mixing and pulverizing (a) an isotope-labeled compound and/or a pyrimidine metabolite compound and (b) a sugar and/or a sugar alcohol.

1 - 18 . (canceled) 
     
     
         19 . An oral preparation
 produced using a powder material obtained by mixing component (a) and component (b) and pulverizing a resulting mixture, wherein a particle diameter at 50% of the powder material is 5 to 20 μm,   (a) at least one isotope-labeled compound selected from the group consisting of thymine, uracil and a metabolite thereof, in which at least one of carbon atoms, oxygen atoms, and nitrogen atoms is labeled with an isotope, and   (b) at least one sugar alcohol selected from the group consisting of erythritol, mannitol, xylitol, sorbitol, maltitol, reducing paratinose and lactitol.   
     
     
         20 . An oral preparation according to  claim 19 , which contains the component (a) in a proportion of 5 to 20 wt. %. 
     
     
         21 . An oral preparation according to  claim 19 , wherein the component (a) is isotope-labeled uracil. 
     
     
         22 . An oral preparation according to  claim 19 , wherein the component (b) is mannitol. 
     
     
         23 . An oral preparation according to  claim 19 , wherein the component (a) is isotope-labeled uracil and the component (b) is mannitol. 
     
     
         24 . An oral preparation according to  claim 19 , wherein the oral preparation is a solid preparation. 
     
     
         25 . An oral preparation according to  claim 24 , wherein the solid preparation is subtle granules, granules, powders, tablets, capsules or pills. 
     
     
         26 . An oral preparation according to  claim 19 , wherein the oral preparation is administered at the same time as or immediately before or after ingestion of a test meal. 
     
     
         27 . A process for producing an oral preparation, the process comprising the steps of:
 (1) producing a powder material by mixing component (a) and component (B) and pulverizing a resulting mixture, wherein a particle diameter at 50% of the powder material is 5 to 20 μm,   (a) at least one isotope-labeled compound selected from the group consisting of thymine, uracil and a metabolite thereof, in which at least one of carbon atoms, oxygen atoms, and nitrogen atoms is labeled with an isotope, and   (b) at least one sugar alcohol selected from the group consisting of erythritol, mannitol, xylitol, sorbitol, maltitol, reducing paratinose and lactitol; and   (2) formulating the powder material obtained in the above step (1) into a preparation.   
     
     
         28 . A process according to  claim 27 , wherein the oral preparation contains the component (a) in a proportion of 5 to 20 wt. %. 
     
     
         29 . A process according to  claim 27 , wherein the component (a) is isotope-labeled uracil. 
     
     
         30 . A process according to  claim 27 , wherein the component (b) is mannitol. 
     
     
         31 . A process according to  claim 27 , wherein the component (a) is isotope-labeled uracil and the component (b) is mannitol. 
     
     
         32 . A process according to  claim 27 , wherein the oral preparation is a solid preparation. 
     
     
         33 . A process according to  claim 32 , wherein the solid preparation is subtle granules, granules, powders, tablets, capsules or pills. 
     
     
         34 . A process according to  claim 27 , wherein the oral preparation is administered at the same time as or immediately before or after ingestion of a test meal.