| 摘要 |
A method for evaluation of a multi-component medicine comprising judging the degree of difference of the multi-component medicine to be evaluated from a group of multi-component medicines selected as a reference group by using a Mahalanobis distance obtained by a process comprising the following steps (1) to (8), (1) a step of obtaining fingerprint data of three-dimensional high performance liquid chromatography of the multi-component medicine to be evaluated, (2) a step of combining the fingerprint data obtained in (1) with fingerprint data of three-dimensional high performance liquid chromatography of other multi-component medicines of the same kind forming a reference group, (3) a step of allocating variable axes in the MT method to the number of multi-component medicine and either the elution time or detection wavelength of the fingerprint data of (2) above and regarding a signal strength as a characteristic amount in the MT method, (4) a step of obtaining a unit space from the characteristic amount of (3) using the MT method, (5) a step of obtaining the Mahalanobis distance of all multi-component medicines for each detection wavelength or elution time using the MT method from the unit space obtained in (4), (6) a step of allocating variable axes in the MT method to the number of the multi-component medicine and either the elution time or detection wavelength to which the variable axes are not allocated in the step (3) and regarding the Mahalanobis distance obtained in step (5) as a characteristic amount in the MT method, (7) a step of obtaining a second unit space from the characteristic amount of (6) using the MT method, and (8) a step of obtaining the Mahalanobis distance of the multi-component medicine to be evaluated using the MT method from the second unit space obtained in (7). According to the present invention, because the waveform processing of HPLC peaks is unnecessary, dispersion among data are small, thereby bringing highly reliable results; because the amount of information (the number of data points) is not limited to the number of peaks of a specific component, the amount of information can be freely increased or decreased; in addition, because it is not necessary to judge by combining the value of the content of two or more components, but can be judged using a single numerical value, the degree of difference of the multi-component medicine to be evaluated from a reference group can be simply judged.
|
