METHOD OF AND APPARATUS FOR FORMULATING MULTICOMPONENT DRUG

摘要

Provided are a method of and an apparatus for formulating a multicomponent drug capable of surely making a multicomponent drug meeting criteria for productization with high accuracy into a product. The method and apparatus obtain a chromatogram from an extract or a base of a multicomponent drug, evaluate whether the base meets the criteria for productization based on the obtained chromatogram with high accuracy, and subject the base determined in the high-accuracy evaluating as an accepted one meeting the criteria to dosage form processing, to produce a formulated drug having a given dosage-form. The high-accuracy evaluating is realized by selecting with high accuracy one of reference fingerprints to which peaks of a target fingerprint prepared from the chromatogram are assigned.

主权项

1. A method of formulating a multicomponent drug, comprising:
obtaining a chromatogram from a base of a multicomponent drug; 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:
gathering as a target fingerprint peaks in which each one peak has a height that is a maximum value or an area value in signal strength and retention time points of the peaks detected from the chromatogram;patterning with a selected scale that is any one of appearance distance, height ratio and area ratio each peak of the target fingerprint and a plurality of reference fingerprints that correspond to the target fingerprint and to which peaks and retention time points of the peaks gathered so as to obtain appearance distances, height ratios or area ratios between said each peak and subsequent peaks being subsequent to said each peak in the retention time as a pattern for said each peak according to the selected scale;comparing the patterned peaks between the target fingerprint and each one of the reference fingerprints pattern by pattern in a round-robin to find numbers of matches in said any one of appearance distance, height ratio and area ratio as the selected scale; andfinding a degree of matching between the target fingerprint and said each one of the reference fingerprints with use of Tanimoto coefficient on the basis of the found numbers of matches to evaluate similarity between the target fingerprint and each one of the reference fingerprints;selecting one of the reference fingerprints based on the similarity; andassigning the peaks of the target fingerprint to peaks of the selected one of the reference fingerprints to evaluate whether the base meets the criteria for productization.