CN108333141A - The method that near-infrared consistency model quickly differentiates phenprobamate piece - Google Patents
The method that near-infrared consistency model quickly differentiates phenprobamate piece Download PDFInfo
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- CN108333141A CN108333141A CN201810287470.9A CN201810287470A CN108333141A CN 108333141 A CN108333141 A CN 108333141A CN 201810287470 A CN201810287470 A CN 201810287470A CN 108333141 A CN108333141 A CN 108333141A
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- CAMYKONBWHRPDD-UHFFFAOYSA-N Phenprobamate Chemical compound NC(=O)OCCCC1=CC=CC=C1 CAMYKONBWHRPDD-UHFFFAOYSA-N 0.000 title claims abstract description 48
- 229960002572 phenprobamate Drugs 0.000 title claims abstract description 48
- 238000000034 method Methods 0.000 title claims abstract description 45
- 238000001228 spectrum Methods 0.000 claims abstract description 46
- 238000001514 detection method Methods 0.000 claims abstract description 11
- 238000012795 verification Methods 0.000 claims abstract description 5
- 239000000523 sample Substances 0.000 claims description 49
- 238000004519 manufacturing process Methods 0.000 claims description 31
- 238000012360 testing method Methods 0.000 claims description 16
- 230000003595 spectral effect Effects 0.000 claims description 14
- 238000010606 normalization Methods 0.000 claims description 10
- 239000013074 reference sample Substances 0.000 claims description 6
- 238000007781 pre-processing Methods 0.000 claims description 5
- 238000005259 measurement Methods 0.000 claims description 4
- 238000012545 processing Methods 0.000 claims description 4
- 238000012797 qualification Methods 0.000 claims description 3
- 230000006378 damage Effects 0.000 abstract description 3
- 239000000047 product Substances 0.000 description 20
- 241000196324 Embryophyta Species 0.000 description 8
- 239000003814 drug Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 241000932822 Tinaroo virus Species 0.000 description 4
- 238000009826 distribution Methods 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 238000011835 investigation Methods 0.000 description 3
- 238000004364 calculation method Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000001647 drug administration Methods 0.000 description 2
- 238000002329 infrared spectrum Methods 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 239000003158 myorelaxant agent Substances 0.000 description 2
- 210000002027 skeletal muscle Anatomy 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 201000006792 Lennox-Gastaut syndrome Diseases 0.000 description 1
- 206010061223 Ligament injury Diseases 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 201000002481 Myositis Diseases 0.000 description 1
- 206010061533 Myotonia Diseases 0.000 description 1
- 241000208125 Nicotiana Species 0.000 description 1
- 235000002637 Nicotiana tabacum Nutrition 0.000 description 1
- 206010041349 Somnolence Diseases 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000012850 discrimination method Methods 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 208000004296 neuralgia Diseases 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 201000003068 rheumatic fever Diseases 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000010183 spectrum analysis Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
Classifications
-
- 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 infrared light
- G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
Abstract
The invention belongs to medical detection technique fields, and in particular to a kind of method that near-infrared consistency model quickly differentiates phenprobamate piece, specific steps include：（1）Phenprobamate piece sample is collected, original spectrum is acquired（2）The foundation of consistency check model（3）Verification（4）Detection.This method utilizes near infrared spectrometer, the consistency that brand is established for different enterprises quickly differentiates model, achieve the purpose that quickly to identify by comparing whether the CI limit values of unknown sample spectrum and a certain group of reference spectra are with uniformity, this method have quickly, it is accurate, to detection characteristic of the sample without destruction, the phenprobamate piece that can be produced to different enterprises using this method is quickly differentiated.
Description
Technical field
The present invention relates to a kind of methods that near-infrared consistency model quickly differentiates phenprobamate piece, belong to medicine detection skill
Art field.
Background technology
Phenprobamate（Phenprobamate）, the entitled Phenprobamate of chemistry, molecular formula
C10H13NO2, it is a kind of contrastimulant central skeletal muscle relaxant of tool, is successfully closed in nineteen sixty by Siegfried earliest
At, Japan and Germany list first.Tianjin Zhongxin Pharmaceutical Group Co., Ltd. obtained batch of raw material in 1981 first
Text；The same year, Tianjin Lisheng Pharmaceutical Co., Ltd. obtain the certification of tablet.This product only has a kind of dosage form of tablet, rule at home
Lattice are 200mg.Phenprobamate is a kind of contrastimulant central skeletal muscle relaxant of tool, is clinically usually used in muscle convulsion
The muscle such as contraction, myotonia epitonos, myalgia and neuralgia, it can also be used to inflammation around shoulder neck joint, rheumatic arthritis,
Ligament injury, myotenositis are additionally used for the auxiliary treatment of children's Lennox-Gastaut syndromes.Phenprobamate adverse reaction
Less, take occasionally has drowsiness, dizzy and slight gastrointestinal reaction phenomenon afterwards.In the prior art for phenprobamate Pian Ge enterprises
The difference of production technology be easy to cause manufacture product in the irregular problem of constituent, the quality of product etc..And medicine
Product security relationship is related to economic heath development and social stability to broad masses of the people's health and life security.Therefore,
Seek it is a kind of safe and reliable, the phenprobamate piece of the accurate and simple and quick different enterprises production of measurement result it is quick
Discrimination method is not only convenient for the quality of manufacturing enterprise's monitoring product, is also beneficial to Drug Administration department and carries out supervision investigation, brand
It cracks down on counterfeit goods.
In recent years, near infrared detection technology is since its efficient, quick, accurate, sample is without analysis characteristics such as processing, extensively
It is general to be applied to the industries such as food, agricultural, medicine, tobacco, oil, chemical industry, cosmetics.Near-infrared spectral analysis technology is available to be had
One or more chemical composition contents of the chemical machine substance in the quick estimated sample of optical characteristics of near infrared spectrum, have
Quickly, conveniently, accurately, multi-component advantage can be analyzed simultaneously.Since near-infrared analysis is the spectral signal for obtaining sample, have
When even can be measured in former container, do not need other reagents, therefore, not will produce any pollution in test process,
Belong to environmentally protective detection method.Near infrared spectrum consistency analysis technology is a kind of efficiently method of quality control, to product
Board product establishes near-infrared consistency check model, supplements fast inspection near-infrared model data, both can quickly differentiate the true and false of drug,
Meet drug surveilance and quickly investigate needs, and the brand and other similar products can be distinguished, to effective protection brand product, safeguards
Legal rights and interests of enterprises is of great significance.
Invention content
The purpose of the present invention is to provide a kind of method that near-infrared consistency model quickly differentiates phenprobamate piece, the party
Method utilizes near infrared spectrometer, and the consistency that brand is established for different enterprises quickly differentiates model, by comparing unknown sample
Whether the CI limit values of spectrum and a certain group of reference spectra are with uniformity to achieve the purpose that quickly to identify, this method has fast
Speed, it is accurate, to detection characteristic of the sample without destruction, the phenprobamate piece that different enterprises produce can be carried out using this method quick
Differentiate.
To achieve the above object, the present invention adopts the following technical scheme that：
A kind of method that near-infrared consistency model quickly differentiates phenprobamate piece, specific steps include：
（1）Phenprobamate piece sample is collected, original spectrum is acquired：Collect the certified products qualification phenprobamate piece sample of different enterprise's productions
Product acquire the phenprobamate piece of different enterprise's productions using near-infrared spectrometers respectively under conditions of constant temperature and humidity
Near-infrared diffusing reflection spectrum, spectral scanning range are 12000 cm-1~4000 cm-1, resolution ratio is 8 cm- 1,, scanning times are
32 times, every part of sample measures 6 times, and sample is not required to, through processing, be in direct contact measurement acquisition original spectrum, establish using original spectrum
Model；
（2）The foundation of consistency check model：The consistency that brand is established for different enterprises quickly differentiates model, according to difference
Enterprise take more than one modeling sample respectively, acquire near-infrared diffusing reflection spectrum, take the close red of same enterprise's qualified samples
Outer original spectrum, which is used as, refers to spectrum, separately chooses a spectrum as test spectral, preprocessing procedures from remaining each enterprise
It is 9000~7500 cm using OPUS choice of software spectral coverages for second derivative method and vector normalization method-1, 6900~5600
cm-1With 5000~4250 cm- 1,, consistency check model is established by preprocess method, sets CI limit values, CI values are consistent
Property examine index, be to establish the important index of consistency check model, CI limit values（Consistency check index limit）According to reference
The probability distribution setting of trap, calculation formula are CI limit values=TINV ((1- probability 1/ under spectrum all wavelengths point
N), (N-1)), wherein TINV indicates to give the t values of the t- distributions of degree of freedom and double tail probabilities, and n counts for wavelength, and N is
Reference spectra quantity, n and N correspond to degree of freedom, (1- probability 1/n) corresponding double tail probabilities；
（3）Verification：Using the feasibility for the CI limit values for verifying model with other batch samples of modeling sample same brand, together
Shi Liyong is used to verify the specificity of model with the sample of modeling sample different brands；
（4）Detection：Different manufacturing enterprises quickly differentiate model according to the consistency accordingly established, and take sample to be tested, acquisition close red
Outer diffusing reflection spectrum, preprocessing procedures are second derivative method and vector normalization method, are using OPUS choice of software spectral coverages
9000~7500 cm-1, 6900~5600 cm-1With 5000~4250 cm- 1,, such as CI values≤CI limit values of sample to be tested, then
Pass through test, it is believed that itself and reference sample homogeneity；Otherwise cannot be by test, i.e. sample to be tested and reference sample is heterogeneous.
The method that above-mentioned near-infrared consistency model quickly differentiates phenprobamate piece, step（4）In, if sample to be tested
Manufacturing enterprise it is unknown, then using multiple enterprises establish consistency quickly differentiate that model is tested.
Beneficial effects of the present invention are：
A kind of near-infrared consistency model of the present invention quickly differentiates that the method for phenprobamate piece utilizes near infrared spectrometer, for not
The consistency that brand is established with enterprise quickly differentiates model, is limited by comparing unknown sample spectrum and the CI of a certain group of reference spectra
Whether angle value is with uniformity to achieve the purpose that quickly to identify.This method have quickly, it is accurate, to detection of the sample without destruction
Characteristic establishes the quick discriminating model of sample, is not only convenient for manufacturing enterprise's on-line monitoring product quality parameters, is also beneficial to produce
The quality of enterprise's monitored off-line product during production circulation storage, while Drug Administration department utilizes " offline " model to carry out
Supervision investigation, brand are cracked down on counterfeit goods.Method using the present invention differentiates phenprobamate piece, it can be achieved that the fast of batch samples
Fast screening substantially reduces testing cost, reduces workload, and both can quickly differentiate the true and false of drug, it is quick to meet drug surveilance
Investigation needs, and can distinguish the brand and other similar products, has to effective protection brand product, maintaining enterprise legitimate rights and interests
Significance.
Description of the drawings
Fig. 1 is the original NIR figures of the phenprobamate piece of 5 different enterprise's productions；
Fig. 2 is phenprobamate piece（Beijing Zhongxin Pharmaceutical Plant）Second derivative method+vector normalizes the pretreated spectrogram of spectrum；
Fig. 3 is phenprobamate piece（The Anhui Hua Yuan, Shanghai Ren Ji pharmaceutical Co. Ltds）Second derivative method+vector normalization spectrum is pre-
Treated spectrogram；
Fig. 4 is phenprobamate piece（Shanghai full space biotechnology Queshan pharmaceutical Co. Ltd）Second derivative method+vector normalization light
Compose pretreated spectrogram；
Fig. 5 is phenprobamate piece（Xin Xin pharmaceutical factories of Tianjin Zhongxin Pharmaceutical Group Co., Ltd.）Second derivative method+vector is returned
One changes the spectrogram after Pretreated spectra；
Fig. 6 is phenprobamate piece（Xinan Pharmaceutical Co., Ltd.）Second derivative method+vector normalization spectrum is pretreated
Spectrogram；
Fig. 7 is phenprobamate piece（Beijing Zhongxin Pharmaceutical Plant）Consistency check modelling effect figure；
Fig. 8 is phenprobamate piece（The Anhui Hua Yuan, Shanghai Ren Ji pharmaceutical Co. Ltds）Consistency check modelling effect figure；
Fig. 9 is phenprobamate piece（Shanghai full space biotechnology Queshan pharmaceutical Co. Ltd）Consistency check modelling effect figure；
Figure 10 is phenprobamate piece（Xin Xin pharmaceutical factories of Tianjin Zhongxin Pharmaceutical Group Co., Ltd.）Consistency check model
Design sketch；
Figure 11 is phenprobamate piece（Xinan Pharmaceutical Co., Ltd.）Consistency check modelling effect figure.
Specific implementation mode
Embodiment 1
A kind of method that near-infrared consistency model quickly differentiates phenprobamate piece, specific steps include：
（1）Phenprobamate piece sample is collected, original spectrum is acquired：Collect Beijing Zhongxin Pharmaceutical Plant, the Anhui Hua Yuan, Shanghai benevolence Ji system
Medicine Co., Ltd, Shanghai full space biotechnology Queshan pharmaceutical Co. Ltd, Tianjin Zhongxin Pharmaceutical Group Co., Ltd. are new
The certified products qualification phenprobamate piece sample of pharmaceutical factory and Xinan Pharmaceutical Co., Ltd.'s production, in the condition of constant temperature and humidity
Under, the near-infrared for being acquired the phenprobamate piece of above-mentioned different enterprise's productions respectively using near-infrared spectrometers is diffused
Spectrum, spectral scanning range are 12000 cm-1~4000 cm-1, resolution ratio is 8 cm- 1,, scanning times are 32 times, every part of sample
It measures 6 times, sample is not required to, through processing, be in direct contact measurement acquisition original spectrum, model is established using original spectrum；Different enterprises
The original NIR figures of the phenprobamate piece of production are as shown in Figure 1；It can be seen from figure 1 that the NIR of the phenprobamate piece of different enterprise's productions
Figure difference is smaller, and therefore, the consistency that need to establish brand for different manufacturing enterprises by chemometrics method quickly differentiates
Model；
（2）The foundation of consistency check model：The consistency for establishing brand for above-mentioned 5 different manufacturing enterprises quickly differentiates mould
Type, each enterprise take more than one modeling sample respectively, acquire near-infrared diffusing reflection spectrum, and take corresponding enterprise's qualified samples
Near-infrared original spectrum be used as and refer to spectrum, separately choose a spectrum as test spectral from remaining each enterprise, spectrum is located in advance
Reason method is second derivative method and vector normalization method, analyzes and optimizes in full spectral limit using OPUS softwares, and selection spectral coverage is
9000~7500 cm-1, 6900~5600 cm-1With 5000~4250 cm- 1,, 5 different manufacturing enterprises modeling sample near-infrareds
Spectrogram after diffusing reflection spectrum second derivative method+vector normalization method Pretreated spectra passes through pretreatment as shown in Fig. 2-Fig. 6
Method establishes consistency check model, sets CI limit values, CI values are consistency check indexes, are to establish consistency check model
Important index, CI limit values are set according to the probability distribution of trap under reference spectra all wavelengths point, and calculation formula is
CI limit values=TINV ((1- probability 1/n), (N-1)), wherein TINV indicate to give the t- distributions of degree of freedom and double tail probabilities
T values, n is wavelength points, and N is reference spectra quantity, and n and N correspond to degree of freedom, and (1- probability 1/n) corresponding pair of tails are general
Rate；The CI limit values of setting, institute's established model can distinguish to greatest extent whether same quality sample；5 different manufacturing enterprises establish consistency
The design parameter of testing model is as shown in table 1 below, the consistency check modelling effect figure difference that 5 different manufacturing enterprises establish
As shown in Fig. 7-Figure 11；
（3）Verification：Using the feasibility for the CI limit values for verifying model with other batch samples of modeling sample same brand, together
Shi Liyong is used to verify the specificity of model with the sample of modeling sample different brands, is established with Beijing Zhongxin Pharmaceutical Plant consistent
Property testing model for, take be not belonging to Beijing Zhongxin Pharmaceutical Plant production phenprobamate flake products it is several, by above-mentioned spectra collection
Method acquires corresponding spectrogram and carries out specificity verification respectively, the results show that the CI values of every sample to be tested are more than 7 survey
Attempt to compose, is not the phenprobamate piece of Beijing Zhongxin Pharmaceutical Plant's production, and the phenprobamate piece of Beijing Zhongxin Pharmaceutical Plant's production
Sample, the CI values of sample to be tested are all≤7, it is seen that the consistency check model of the foundation has stronger practicability, can effective district
Divide the ownership of these products.
Model serviceability test：The consistency check model established using Beijing Zhongxin Pharmaceutical Plant, selects different operations
The different temperature and humidity of personnel is put test different enterprise products in different times, as a result can significantly distinguish
Go out the phenprobamate piece of different manufacturing enterprise's productions.
（4）Detection：Different manufacturing enterprises quickly differentiate model according to the consistency that corresponding method is established, and take and wait for test sample
Product acquire near-infrared diffusing reflection spectrum, and preprocessing procedures are second derivative method and vector normalization method, utilize OPUS softwares
Selection spectral coverage is 9000~7500 cm-1, 6900~5600 cm-1With 5000~4250 cm- 1,, as sample to be tested CI values≤
CI limit values then pass through test, it is believed that itself and reference sample homogeneity；Otherwise it cannot pass through test, i.e. sample to be tested and reference sample
It is heterogeneous.If the manufacturing enterprise of sample to be tested is unknown, the consistency established using multiple enterprises quickly differentiates that model is surveyed
Examination.
Claims (2)
1. a kind of method that near-infrared consistency model quickly differentiates phenprobamate piece, which is characterized in that specific steps include：
（1）Phenprobamate piece sample is collected, original spectrum is acquired：Collect the certified products qualification phenprobamate piece sample of different enterprise's productions
Product acquire the phenprobamate piece of different enterprise's productions using near-infrared spectrometers respectively under conditions of constant temperature and humidity
Near-infrared diffusing reflection spectrum, spectral scanning range are 12000 cm-1~4000 cm-1, resolution ratio is 8 cm- 1,, scanning times are
32 times, every part of sample measures 6 times, and sample is not required to, through processing, be in direct contact measurement acquisition original spectrum, establish using original spectrum
Model；
（2）The foundation of consistency check model：The consistency that brand is established for different enterprises quickly differentiates model, according to difference
Enterprise take more than one modeling sample respectively, acquire near-infrared diffusing reflection spectrum, take the close red of same enterprise's qualified samples
Outer original spectrum, which is used as, refers to spectrum, and a spectrum is separately respectively chosen from remaining enterprise as test spectral, preprocessing procedures
It is 9000~7500 cm using OPUS choice of software spectral coverages for second derivative method and vector normalization method-1, 6900~5600
cm-1With 5000~4250 cm- 1,, consistency check model is established by preprocess method, sets CI limit values；
（3）Verification：Using the feasibility for the CI limit values for verifying model with other batch samples of modeling sample same brand, together
Shi Liyong is used to verify the specificity of model with the sample of modeling sample different brands；
（4）Detection：Different manufacturing enterprises quickly differentiate model according to the consistency accordingly established, and take sample to be tested, acquisition close red
Outer diffusing reflection spectrum, preprocessing procedures are second derivative method and vector normalization method, are using OPUS choice of software spectral coverages
9000~7500 cm-1, 6900~5600 cm-1With 5000~4250 cm- 1,, such as CI values≤CI limit values of sample to be tested,
Then pass through test, it is believed that itself and reference sample homogeneity；Otherwise cannot be by test, i.e. sample to be tested and reference sample is heterogeneous.
2. the method that near-infrared consistency model according to claim 1 quickly differentiates phenprobamate piece, which is characterized in that
Step（4）In, if the manufacturing enterprise of sample to be tested is unknown, the consistency established using multiple enterprises quickly differentiates model
It is tested.
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Cited By (1)
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