CN108072628A - A kind of near infrared spectroscopy for differentiating Medical Packing Materials material - Google Patents
A kind of near infrared spectroscopy for differentiating Medical Packing Materials material Download PDFInfo
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- CN108072628A CN108072628A CN201710646489.3A CN201710646489A CN108072628A CN 108072628 A CN108072628 A CN 108072628A CN 201710646489 A CN201710646489 A CN 201710646489A CN 108072628 A CN108072628 A CN 108072628A
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- Prior art keywords
- packing materials
- medical packing
- near infrared
- materials material
- spectrum
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light
- G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light using near infra-red light
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light
- G01N21/3563—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light for analysing solids; Preparation of samples therefor
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
- G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light
- G01N2021/3595—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infra-red light using FTIR
Abstract
The invention discloses a kind of near infrared spectroscopies for differentiating Medical Packing Materials material, the near infrared spectrum of each material Medical Packing Materials sample is first gathered under certain measuring condition, gained spectrum is without pre-processing or carrying out Chemical Measurement pretreatment, the selection modeling spectral region from gained spectroscopic data, after carrying out dimensionality reduction to the data of selected spectral region, established using chemometrics method and verify the discrimination model of Medical Packing Materials material；Then the Medical Packing Materials sample of unknown material is taken, is handled according to the multi-step that above-mentioned same procedure gathers near infrared spectrum and carries out spectroscopic data, the differentiation of Medical Packing Materials material is finally carried out using institute's established model.The present invention is based on the near infrared spectrums of unlike material Medical Packing Materials, with reference to chemometric techniques, differentiate the material of Medical Packing Materials, it is accurate, easy, quick, lossless to have the advantages that.
Description
Technical field
The invention belongs to near-infrared spectral analysis technology fields, are related to a kind of near infrared spectrum for differentiating Medical Packing Materials material
Method.
Background technology
Medical Packing Materials are meant used in the drug of pharmaceutical producing enterprise's production and the preparation that medical institutions prepare directly and medicine
The packaging material and container of product contact.As a part for drug, Medical Packing Materials quality in itself, security, performance and
Compatibility between Medical Packing Materials and drug has drug quality highly important influence.Existing Medical Packing Materials can be divided by material
Plastic, metal class, category of glass, ceramic-like, rubber and other classes (such as paper, drier), can also be by two kinds or two kinds
Above Material cladding is composed (such as composite membrane, aluminium-plastic combined cover).Rubber Medical Packing Materials have natural rubber, silicon rubber
Glue, halogenated butyl rubber etc..Different preparations needs the Medical Packing Materials of unlike material, so, differentiating the material of Medical Packing Materials has ten
Divide important meaning.Organic destruction-silver nitrate method (YBB00042005-2015 halogenated butyl rubber stopper for injection discrimination methods
(1)), coefficient of thermal expansion method etc. is to differentiate the common method of Medical Packing Materials material, but these methods destroy sample, it is impossible to be used in raw
The control of production process.
The content of the invention
It is an object of the invention to provide a kind of near infrared spectroscopies for differentiating Medical Packing Materials material, have accurate, easy, fast
The advantages of fast, lossless.
Through research, the present invention provides following technical solution：
A kind of near-infrared spectral analytical method for differentiating Medical Packing Materials material, comprises the following steps：
(1) resolution ratio and scanning times of near infrared spectrometer are set, in 10000~4000cm-1In scanning range respectively
Gather the near infrared spectrum of each material Medical Packing Materials sample；
(2) to spectrum obtained by step (1), without pre-processing or carrying out Chemical Measurement pretreatment；
(3) the selection modeling spectral region in spectroscopic data obtained by step (2)；
(4) dimensionality reduction is carried out to the data of spectral region selected by step (3)；
(5) to step (4) the data obtained, established using chemometrics method and verify the differentiation mould of Medical Packing Materials material
Type；
(6) the Medical Packing Materials sample of unknown material is taken, near infrared spectrum is gathered according to step (1) the method, according to step
(2)~(4) the method carries out the multi-step processing of spectrum, and then applying step (5) institute established model carries out Medical Packing Materials material
Differentiate.
Preferably, the resolution ratio of near infrared spectrometer is arranged to 2cm described in step (1)-1、4cm-1、8cm-1Or 16cm-1,
Scanning times are arranged to 16,32 or 64 times.
Preferably, Chemical Measurement preprocess method described in step (2) is multicomponent signal amendment, standard normal converts,
Derivative and it is smooth in one or more combinations.
It is 10000~4000cm that spectral region is modeled described in step (3)-1In one or more snippets, can be by modeling software
Automatic screening or artificial screening, also can be on the basis of modeling software automatic screening according to the near-infrared characteristic absorption of analyte
Further artificial optimization.
Preferably, dimensionality reduction is carried out to the data of spectral region selected by step (3) using Principal Component Analysis in step (4).
Preferably, the selection gist for number of principal components being modeled in step (4) described Principal Component Analysis adds up variance tribute for it
Rate is offered more than 85% and step (5) builds the calibration set right judging rate of discrimination model and verification collection right judging rate is all higher than 95%.
Preferably, chemometrics method described in step (5) is techniques of discriminant analysis.
Preferably, the performance that discrimination model is built in step (5) is commented by calibration set right judging rate and verification collection right judging rate
Valency.
Specifically, the Medical Packing Materials material is natural rubber, silicon rubber and halogenated butyl rubber.
Preferably, a kind of near-infrared spectral analytical method for differentiating Medical Packing Materials material, the Medical Packing Materials material are natural rubber
Glue, silicon rubber and halogenated butyl rubber, comprise the following steps：
(1) resolution ratio for setting near infrared spectrometer is 8cm-1, scanning times be 32 times, in 10000~4000cm-1It sweeps
The near-infrared diffusing reflection spectrum of each material Medical Packing Materials sample is gathered in the range of retouching respectively；
(2) derivative and smooth pretreatment are carried out to spectrum obtained by step (1)；
(3) 9881~4119cm is selected in spectroscopic data obtained by step (2)-1To model spectral region；
(4) dimensionality reduction is carried out to the data of spectral region selected by step (3) using Principal Component Analysis；
(5) to step (4) the data obtained, established as 4, using techniques of discriminant analysis to model number of principal components and verify Medical Packing Materials
The discrimination model of material, model performance are evaluated by calibration set right judging rate and verification collection right judging rate；
(6) the Medical Packing Materials sample of unknown rubber material is taken, is diffused according to step (1) the method acquisition near-infrared
Spectrum, the multi-step that spectrum is carried out according to step (2)~(4) the method are handled, and then applying step (5) institute established model carries out medicine
The differentiation of packaging material material.
The beneficial effects of the present invention are：The present invention is based on the near infrared spectrums of unlike material Medical Packing Materials, are counted with reference to chemistry
Technology is measured, differentiates the material of Medical Packing Materials, it is accurate, easy, quick, lossless to have the advantages that.
Description of the drawings
Fig. 1 is natural rubber, silicon rubber and halogenated butyl rubber totally 40 near-infrared diffusing reflection original spectrums.
Fig. 2 is built Medical Packing Materials material (natural rubber, silicon rubber and halogenated butyl rubber) discrimination model figure by the present invention：It is empty
Heart symbol (, zero, △) and filled symbols (■, ●, ▲) school of natural rubber, silicon rubber and halogenated butyl rubber is represented respectively
Positive collection sample and verification collection sample.
Specific embodiment
In order to make the object, technical solutions and advantages of the present invention clearer, below in conjunction with the accompanying drawings to the preferred of the present invention
Embodiment is described in detail.
The differentiation of 1 Medical Packing Materials material of embodiment (natural rubber, silicon rubber and halogenated butyl rubber)
1. instrument and software
Antaris II Fourier Transform Near Infrared instruments (Thermo companies of the U.S.), sampling apparatus are attached for integrating sphere
Part, signal acquisition software are RESULT 3.0, and Data Analysis Software is TQ Analyst 8.0.
2. Medical Packing Materials sample
Totally 40 Medical Packing Materials samples, wherein 11 are natural rubber sample, 16 are silicon rubber sample, and 13 are halogenation fourth
Base rubber sample.
3. the acquisition of near-infrared diffusing reflection spectrum
Spectral measurement condition：Resolution ratio is 8cm-1, scanning times are 32 times, and scanning range is 10000~4000cm-1。
Spectral measurement method：The Medical Packing Materials sample of each material is taken, is placed in above integrating sphere detection window, in above-mentioned spectral measurement
Under the conditions of determination sample Fourier transformation near-infrared diffusing reflection spectrum, the identical measuring condition of use is swept before the measurement of each sample
Retouch simultaneously background correction.
Each sample respectively gathers a spectrum, 40 near-infrared diffusing reflection original spectrum such as Fig. 1 of 40 Medical Packing Materials samples
It is shown.
4. the pretreatment of spectrum
Derivative and smooth pre- place are carried out to the near-infrared diffusing reflection original spectrum of acquisition with 8.0 softwares of TQ Analyst
Reason.
5. model the selection of spectral region
To pretreated spectroscopic data, the modeling spectral region chosen automatically through 8.0 softwares of TQ Analyst is 9881
~4119cm-1。
6. the dimensionality reduction of spectroscopic data
Using 8.0 softwares of TQ Analyst, using Principal Component Analysis selected modeling spectral region 9881~
4119cm-1It is interior that dimensionality reduction is carried out to pretreated spectroscopic data, when selected modeling number of principal components is 4, add up variance contribution ratio
For 94.2%, and the right judging rate of the calibration set of institute's established model and verification collection is 100.0%.
7. the foundation and verification of discrimination model
Using 8 natural rubber samples, 12 silicon rubber samples and 9 halogenated butyl rubber samples as calibration set sample,
Remaining 3 natural rubber sample, 4 silicon rubber samples and 4 halogenated butyl rubber samples are as verification collection sample.It uses respectively
More than calibration set sample and verification collection sample, modeling number of principal components as 4, being established using techniques of discriminant analysis and verifying Medical Packing Materials material
The discrimination model of matter (natural rubber, silicon rubber and halogenated butyl rubber).The results are shown in Figure 2, builds the correction of discrimination model
It is 100.0% to collect right judging rate, and verification collection right judging rate is 100.0%, illustrates that institute's established model has good differentiation performance, Neng Gouzhun
Really differentiate Medical Packing Materials material (natural rubber, silicon rubber and halogenated butyl rubber).
8. the prediction of unknown rubber material Medical Packing Materials sample
1, the Medical Packing Materials sample of unknown rubber material is taken, according to above-mentioned same procedure acquisition near-infrared diffusing reflection spectrum simultaneously
The multi-step processing of spectrum is carried out, the differentiation of Medical Packing Materials material, the results show Medical Packing Materials material are then carried out using institute's established model
For halogenated butyl rubber.
Using existing national Medical Packing Materials standard (specified in YBB00042005-2015 halogenated butyl rubber stopper for injection
Discrimination method (1)) result, which confirms, to be differentiated to above-mentioned Medical Packing Materials material, the results show that its qualification result and the method for the present invention
Differentiation result it is consistent.
Finally illustrate, the above embodiments are merely illustrative of the technical solutions of the present invention and it is unrestricted, although passing through ginseng
According to the preferred embodiment of the present invention, invention has been described, however, those skilled in the art should understand that, can be in shape
Various changes are made in formula and to it in details, without departing from the protection for the present invention that the appended claims are limited
Scope.
Claims (9)
1. a kind of near infrared spectroscopy for differentiating Medical Packing Materials material, which is characterized in that comprise the following steps：
(1) resolution ratio and scanning times of near infrared spectrometer are set, in 10000~4000cm-1It is gathered respectively in scanning range
The near infrared spectrum of each material Medical Packing Materials sample；
(2) to spectrum obtained by step (1), without pre-processing or carrying out Chemical Measurement pretreatment；
(3) the selection modeling spectral region in spectroscopic data obtained by step (2)；
(4) dimensionality reduction is carried out to the data of spectral region selected by step (3)；
(5) to step (4) the data obtained, established using chemometrics method and verify the discrimination model of Medical Packing Materials material；
(6) take the Medical Packing Materials sample of unknown material, according to step (1) the method gather near infrared spectrum, according to step (2)~
(4) the method carries out the multi-step processing of spectrum, and then applying step (5) institute established model carries out the differentiation of Medical Packing Materials material.
2. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：Institute in step (1)
The resolution ratio for stating near infrared spectrometer is arranged to 2cm-1、4cm-1、8cm-1Or 16cm-1, scanning times are arranged to 16,32 or 64 times.
3. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：Institute in step (2)
The method for stating Chemical Measurement pretreatment is multicomponent signal amendment, standard normal conversion, derivative and it is smooth in one or more
Combination.
4. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：Step is adopted in (4)
Dimensionality reduction is carried out to the data of spectral region selected by step (3) with Principal Component Analysis.
5. the near infrared spectroscopy according to claim 4 for differentiating Medical Packing Materials material, it is characterised in that：Model number of principal components
Selection gist add up variance contribution ratio more than 85% for it and step (5) is built the calibration set right judging rate of discrimination model and tested
Card collection right judging rate is all higher than 95%.
6. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：Institute in step (5)
Chemometrics method is stated as techniques of discriminant analysis.
7. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：Institute in step (5)
The performance for building discrimination model is evaluated by calibration set right judging rate and verification collection right judging rate.
8. the near infrared spectroscopy according to claim 1 for differentiating Medical Packing Materials material, it is characterised in that：The Medical Packing Materials material
Matter is natural rubber, silicon rubber and halogenated butyl rubber.
9. the near infrared spectroscopy according to claim 8 for differentiating Medical Packing Materials material, which is characterized in that including following step
Suddenly：
(1) resolution ratio for setting near infrared spectrometer is 8cm-1, scanning times be 32 times, in 10000~4000cm-1Scanning range
The near-infrared diffusing reflection spectrum of each material Medical Packing Materials sample is inside gathered respectively；
(2) derivative and smooth pretreatment are carried out to spectrum obtained by step (1)；
(3) 9881~4119cm is selected in spectroscopic data obtained by step (2)-1To model spectral region；
(4) dimensionality reduction is carried out to the data of spectral region selected by step (3) using Principal Component Analysis；
(5) to step (4) the data obtained, established as 4, using techniques of discriminant analysis to model number of principal components and verify Medical Packing Materials material
Discrimination model, the performance of institute's established model evaluated by calibration set right judging rate and verification collection right judging rate；
(6) the Medical Packing Materials sample of unknown rubber material is taken, near-infrared diffusing reflection spectrum is gathered according to step (1) the method, presses
The multi-step that spectrum is carried out according to step (2)~(4) the method is handled, and then applying step (5) institute established model carries out Medical Packing Materials
The differentiation of material.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109507142A (en) * | 2018-11-14 | 2019-03-22 | 江西省药品检验检测研究院 | A kind of composite membrane Microscopic Identification method |
| CN111398214A (en) * | 2020-04-30 | 2020-07-10 | 南京佳和牙科技术有限公司 | Dental product material identification method based on combination of machine vision and near infrared spectrum |
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