Evaluation method of multi component type medicines

摘要

At least, process (1) or (8)(1) the finger of three dimensional high performance liquid chromatography of the multi component type medicines which it should appraise The process which obtains purintodeta(2) is obtained with description above (1) besides the fact that the fingerprint data which, the standard group is formed huingapu of three dimensional high performance liquid chromatography of similar multi component type medicines The process which is combined with the lint data(3) the description above (2) concerning the fingerprint data, number of the multi component type medicines and, Dividing the variable axis in MT method liquation time or either of detection wave length one side vis-a-vis The process which is made the feature quantity in inclination and signal strength MT methodThe process which obtains the unit space (4) the description above (3) from the feature quantity, making use of MT method(5) the description above from the unit space which is obtained with (4), in every detection wave length or liquation time, everything multi The process which can Mahalanobis distance of the component type medicine making use of MT method(6) number and the variable axis was not allocated with process of the multi component type medicines (3), on the other hand opposite Doing, Mahalanobis who allocates the variable axis in MT method, obtains with process (5) The process which is made the feature quantity in distance MT methodThe process which obtains the 2nd unit space (7) the description above (6) from the feature quantity, making use of MT method(8) the description above (7) with from the 2nd unit space which is obtained, mahara of the multi component type medicines which it should appraise The process which can nobisu distance making use of MT methodBy is obtained it is evaluation method of the multi component type medicines which feature that it decides the difference from the plural multi component type medicines which are chosen making use of the Mahalanobis distance which, as the standard group of the multi component type medicines which the description above it should appraise. According to this invention, because the ripple mark it does not process HPLC peak, there is no dispersion in the data, reliability to be high, because the amount of information (the number of data points) it is not limited to the number of peaks of the specific component, be able to make the increase and decrease of the amount of information free, it not to be necessary to decide in addition combining the numerical value of content of the plural components, because it is possible, to decide at one numerical value, difference from the standard group of one multi component type medicines can be decided simply.