Method for detecting microbe quantity and drug content of semisolid preparation through near infrared spectroscopy

Abstract

The invention relates to a method for detecting microbe quantity and drug content of a semisolid medicinal preparation through Fourier transform near infrared spectroscopy, which belongs to the technical field of analysis of medicinal preparations. The method comprises the following steps: 1, collecting or preparing semisolid preparation samples and recording information about the reference values of the microbe quantities and drug contents of the samples; 2, measuring the Fourier transform near infrared trans-flectance spectrums of the samples; 3, reasonably dividing the samples into a correction set and a prediction set according to to-be-detected items; 4, selecting an optimal spectral pretreatment method; 5, screening an optimal modeling spectrum range; 6, diagnosing and rejecting abnormal values; 7, correlating the spectrums of the samples in the correction set with reference values of corresponding detection items of the samples by using stoichiometric technology and establishing correction models respectively predicting microbe quantities and drug contents; 8, evaluating the performance of the established correction models; and 9, predicting the microbe quantities and drug contents of unknown samples by using the established correction models.

Description

technical field [0001] The invention relates to a method for rapidly detecting the number of microorganisms and drug content in semi-solid drug preparations, in particular to a method for rapidly and non-destructively detecting the number of microorganisms in semi-solid drug preparations by using Fourier transform near-infrared spectroscopy combined with chemometrics technology and the method for drug content belong to the technical field of pharmaceutical preparation analysis. Background technique [0002] The microbial limit and drug content in drug semi-solid preparations are two items that must be tested in the pharmacopoeias of various countries. At present, the traditional methods used for the microbial limit detection of this kind of preparation are plate method and membrane filtration method; the traditional methods of drug content determination include chromatography (mainly high performance liquid chromatography), spectroscopic method (mainly ultraviolet-visible sp...

AI Technical Summary

Problems solved by technology

However, the representativeness of sampling inspection is limited, and the qualified sample inspection does not necessarily mean that the batch of drugs is qualified, and wrong conclusions may be drawn, leading to loss of control of drug quality and even quality accidents.

In addition, the detection cycle of these conventional analysis methods is long, especially the culture medium counting method needs to go through multiple steps such as inoculation and incubation, and the operation is cumbersome and time-consuming

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