Patent Document ID: 9778233
Application ID: 15344833
Patent Status: 1

Claim One:
1. A method of formulating a multicomponent drug, comprising: obtaining a chromatogram from a base of a multicomponent drug that is an evaluation target; evaluating whether the base meets criteria for productization based on the obtained chromatogram; and subjecting the base determined in the evaluating of the base as an accepted one meeting the criteria for productization to dosage form processing, to produce a formulated drug having a given dosage-form, wherein evaluating whether the base meets the criteria comprises: preparing a target fingerprint composed of peaks and retention time points of the peaks detected from the chromatogram; preparing a peak pattern for an assignment target peak of the target fingerprint, the peak pattern configured by n+1 peaks that include the assignment target peak and n peripheral peaks being present on at least one of sides located in front and in the rear of the assignment target peak in a time axis direction; preparing peak patterns for respective assignment candidate peaks of a reference fingerprint, the reference fingerprint corresponding to the target fingerprint and being composed of peaks and retention time points of the peaks detected from a chromatogram of a multicomponent drug that is evaluation criteria, the assignment candidate peaks having differences in retention time relative to the assignment target peak within a set range, and each one of the peak patterns configured by n+1 peaks that includes a corresponding one of the assignment candidate peaks and n peripheral peaks being present on at least one of sides located in front and in the rear of said corresponding one of the assignment candidate peaks in the time axis direction; comparing the peak pattern for the assignment target peak and the peak patterns for the assignment candidate peaks to specify corresponding peaks between the target fingerprint and the reference fingerprint; and determining a base as an accepted one meeting the criteria for productization in a case where a pattern evaluation of similarity between the target fingerprint and the reference fingerprint based on the specifying of the corresponding peaks is within a predetermined range.