CN111504977A - Method and system for measuring thickness of each component layer of pellet - Google Patents
Method and system for measuring thickness of each component layer of pellet Download PDFInfo
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- CN111504977A CN111504977A CN202010396521.9A CN202010396521A CN111504977A CN 111504977 A CN111504977 A CN 111504977A CN 202010396521 A CN202010396521 A CN 202010396521A CN 111504977 A CN111504977 A CN 111504977A
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- 239000008188 pellet Substances 0.000 title claims abstract description 66
- 238000000034 method Methods 0.000 title claims abstract description 35
- 238000001069 Raman spectroscopy Methods 0.000 claims abstract description 100
- 239000003814 drug Substances 0.000 claims abstract description 46
- 238000001228 spectrum Methods 0.000 claims abstract description 38
- 229940079593 drug Drugs 0.000 claims abstract description 37
- 239000000463 material Substances 0.000 claims abstract description 33
- 238000003384 imaging method Methods 0.000 claims abstract description 22
- 239000002994 raw material Substances 0.000 claims abstract description 10
- 239000006187 pill Substances 0.000 claims description 15
- 238000002372 labelling Methods 0.000 claims description 8
- 238000004458 analytical method Methods 0.000 claims description 7
- 238000001344 confocal Raman microscopy Methods 0.000 claims description 4
- 230000001186 cumulative effect Effects 0.000 claims description 4
- 238000009825 accumulation Methods 0.000 claims description 3
- 230000008676 import Effects 0.000 claims description 3
- 238000004611 spectroscopical analysis Methods 0.000 claims description 3
- 239000010410 layer Substances 0.000 abstract description 36
- 239000011247 coating layer Substances 0.000 abstract description 13
- 239000012792 core layer Substances 0.000 abstract description 5
- 238000009826 distribution Methods 0.000 abstract description 3
- 239000011521 glass Substances 0.000 abstract description 3
- 238000005259 measurement Methods 0.000 abstract description 3
- 238000002360 preparation method Methods 0.000 abstract description 3
- 238000005520 cutting process Methods 0.000 abstract description 2
- 239000003086 colorant Substances 0.000 abstract 1
- 238000001237 Raman spectrum Methods 0.000 description 7
- 238000013268 sustained release Methods 0.000 description 6
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 238000000576 coating method Methods 0.000 description 5
- 239000012730 sustained-release form Substances 0.000 description 5
- 238000003332 Raman imaging Methods 0.000 description 4
- 239000011248 coating agent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- RGHAZVBIOOEVQX-UHFFFAOYSA-N Metoprolol succinate Chemical compound OC(=O)CCC(O)=O.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1.COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 RGHAZVBIOOEVQX-UHFFFAOYSA-N 0.000 description 3
- 229960000939 metoprolol succinate Drugs 0.000 description 3
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000008030 elimination Effects 0.000 description 2
- 238000003379 elimination reaction Methods 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 229920006395 saturated elastomer Polymers 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 238000002965 ELISA Methods 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000003763 carbonization Methods 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
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- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000004626 scanning electron microscopy Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
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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
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/65—Raman scattering
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
- G01B11/00—Measuring arrangements characterised by the use of optical techniques
- G01B11/02—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness
- G01B11/06—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
- G01B11/00—Measuring arrangements characterised by the use of optical techniques
- G01B11/02—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness
- G01B11/06—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material
- G01B11/0616—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material of coating
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- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
Abstract
The invention discloses a method and a system for measuring the thickness of each component layer of a pellet, which comprises the steps of placing the bulk drug and auxiliary materials of the pellet on a glass slide for sample preparation; selecting conditions such as laser wavelength, power and the like to carry out Raman scanning on the glass slide with the sample, and obtaining Raman characteristic spectrums of the raw materials and the auxiliary materials; cutting the pellet with a blade, and performing Raman surface scanning on the section of the pellet; and (3) introducing the Raman characteristic spectrum of the raw and auxiliary materials into surface scanning data and analyzing, calibrating different components by using different colors to form a surface scanning component distribution image, and marking the thickness of each component layer on a Raman component imaging image by using a ruler. The method can accurately, rapidly and visually measure the thickness of the core layer, the upper medicine layer and the coating layer of the pellet simultaneously. The method has the advantages of low cost, short time consumption and accurate measurement, and can quickly, accurately and visually measure the thicknesses of the components of the core layer, the medicine feeding layer and the coating layer at the same time.
Description
Technical Field
The invention relates to the technical field of drug detection, in particular to a method and a system for measuring thicknesses of all component layers of a pellet based on a micro-confocal Raman imaging technology.
Background
Pharmaceutical pellets are a common dosage form, and the composition generally comprises: a. blank pill core (adjuvant); b. a drug layer containing active substances (namely bulk drugs), wherein the drug layer is positioned on the surface of the blank pill core; c. the slow release coating layer (auxiliary material) is formed by adding additives into high molecular polymer, and the slow release coating layer is positioned outside the active medicine layer. The preparation method comprises dissolving active ingredients and other adjuvants in the medicinal layer in appropriate amount of solvent, and adding the above medicinal materials into the hollow pill core; dissolving the sustained-release coating material and other auxiliary materials of the sustained-release coating layer in a solvent, and performing sustained-release coating on the drug-carrying pellets. The drug application process aims at loading the drug layer according to the drug application rate of the designed pellets, and the sustained-release coating process has various purposes, such as improving the drug stability or achieving the purpose of sustained and controlled release of the drug. The drug application effect of the micropills is closely related to the thickness and the uniformity of the drug application layer, and the coating performance of the coating is also greatly dependent on the thickness and the uniformity of the coating layer. Too thick or too thin a drug application layer may cause the drug application rate to be lower or higher than a set value; a slow release coating layer that is too thin may not meet its slow release behavior, while too thick may result in delayed dissolution. Therefore, it is necessary to detect the thickness of each component layer of the pellet to ensure the quality of the product.
Currently, an enzyme-linked immunosorbent assay method, a scanning electron microscope method, a micrometer, a weighing method and the like are used for measuring the thickness of the component layer of the pellet. However, the operation process of the microplate reader method is complicated: auxiliary instruments such as an oven and a specific gravity meter and reagent consumables are needed, the whole process needs long time, and the thickness of one coating layer is measured; the scanning electron microscope method is expensive and cannot correspond to components of each layer, the micrometer measurement method consumes long time, and the weighing method is simple but has larger measurement error.
Disclosure of Invention
The invention aims to solve the technical problem that the method and the system for measuring the thicknesses of the components of the micropills in the prior art are provided, auxiliary instruments and reagent consumables are not needed, and the thicknesses of the components are measured quickly, accurately and intuitively.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows: a method for measuring the thickness of each component layer of a pellet comprises the following steps:
s1, acquiring a Raman characteristic spectrum of the bulk drug and a Raman characteristic spectrum of the auxiliary material;
s2, introducing the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material into the section Raman surface scanning data of the pellet, and performing component analysis and imaging;
s3, marking the thickness of each component layer (including a pill core layer, a medicine applying layer and a coating layer) in the Raman surface scanning imaging of the section of the pellet obtained after the treatment of the step S2.
As can be seen from the above steps S1-S3, the method of the present invention does not need auxiliary instruments and reagent consumables, and can rapidly, accurately and intuitively measure the thickness of each component layer.
In order to obtain accurate data, before step S1, the method further includes:
1) taking the pellet raw material medicine and the auxiliary material, and respectively flattening and preparing samples;
2) determining the test conditions of laser Raman scanning and the parameter conditions of single-point laser Raman scanning to obtain the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material;
3) and setting the surface scanning condition of a Raman microscope to obtain the section Raman surface scanning data of the cut micro-pill.
In the step 2), the test conditions include a laser wavelength and a slit. The laser wavelength was 633nm and the slit 65 μm. 785nm, 633nm and 532nm wavelengths are common wavelengths of laser Raman, and different-component pellets respond differently when scanned by lasers with different wavelengths. The longer the wavelength is, the better the effect of eliminating the fluorescence of the substrate is, and the better the Raman spectrum response can be obtained. The shorter the wavelength is, the poorer the fluorescence effect of the basal body is, and the more difficult the Raman spectrum with good response is obtained. 785 is a line light source, and in order to obtain raman imaging with high resolution, click selection (pinhole in) is required in scanning so that the line light source becomes a point light source, but the size and effect of obtaining a point light source in this way in particular cannot be verified. The laser wavelength of 633nm is a point light source, and the wavelength scanning can give consideration to both fluorescence elimination and imaging resolution, so that the laser with the wavelength of 633nm is selected.
In the step 2), parameters of the single-point laser Raman scanning comprise laser power, exposure time and accumulated times; in step 3), the area scanning conditions include area scanning step diameter, laser power, exposure time and accumulated times: the laser power of the surface scanning is set to be the maximum power which can enable the Raman peak of each component to have response and does not cause the response saturation sample to be burnt. The larger the laser power, the stronger the corresponding signal of the Raman feature, and the higher the Raman spectrum and the imaging quality. The set laser power at least enables each component corresponding to the Raman feature in the sample to be scanned by the Raman feature map, the larger the laser power is, the better the Raman feature map is, but with the increase of the power, the component with strong Raman response in the pellet can cause CCD saturation due to the excessively strong Raman response, the Raman map cannot be obtained, in addition, the excessively large power setting can cause the change of the component of the sample due to the chemical change (such as oxidation and carbonization) of the component sensitive to the laser, and the obtained map is not the information of the sample. Therefore, the laser power X set by the invention is more than or equal to the power which enables all components to have Raman response and is less than the power when the component response in the pellet is saturated; and is less than the maximum of power just burning the sample.
In the step 3), the surface scanning conditions include a scanning area coverage, a surface scanning step diameter, a surface scanning laser frequency, a surface scanning laser power, exposure time and exposure accumulated times; the area of the surface scan covers the entire section of the pellet. The area scan exposure time was set to 1 s. The cumulative number of times was 1. The surface scanning step diameter is set to be 0.5-5 μm. The longer the exposure time, the better the quality of the obtained atlas, the longer the period of completing a sample test will become, the smaller the area of the same scan, the smaller the area scan step diameter setting, the higher the imaging resolution, but the longer the time it takes to complete a pellet area scan. The exposure time is set to be 1s, and the surface scanning step diameter is set to be 0.5 mu m; considering that the scanning area may be large when the method is applied to other pellets with larger diameters, the scanning step diameter can be set to be larger appropriately so that the sample test is completed in a reasonable time.
The invention adopts laser confocal micro-Raman spectroscopy to carry out laser Raman scanning. The laser confocal micro-Raman spectroscopy can correspond the imaging with the components in a component surface scanning imaging mode, so that the accuracy of thickness calibration corresponding to the components is ensured (relative to a scanning electron microscopy); in addition, the method can simultaneously obtain the thickness of each component in the pellet (compared with the chemical method such as enzyme labeling, and the like, only one layer of coating layer or one layer of component is obtained).
To obtain more accurate scan data, pellet sections should be flat.
The invention also provides a system for measuring the thickness of each component layer of the pellet, which comprises the following components:
the data acquisition module is used for acquiring a Raman characteristic spectrum of the bulk drug and a Raman characteristic spectrum of the auxiliary material;
the import module is used for importing the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material into the section Raman surface scanning data of the pellet for component analysis and imaging;
and the labeling module is used for labeling the thickness of each component layer in the micropellet section Raman surface scanning imaging obtained after the micropellet section Raman surface scanning imaging is processed by the guiding module.
The data acquisition module of the invention comprises:
the Raman characteristic spectrum acquisition module is used for determining the test conditions of laser Raman scanning, optimizing the parameters of single-point laser Raman scanning and acquiring the Raman characteristic spectrums of the raw material medicines and the auxiliary materials;
the micro-pill section scanning data acquisition module is used for setting the surface scanning selection area range of the Raman microscope to obtain section Raman surface scanning data of the cut micro-pills; preferably, the area scanning conditions include a scanning area coverage, an area scanning step diameter, an area scanning laser frequency, an area scanning laser power, an exposure time and an exposure accumulated number; preferably, the area of the surface scan covers the entire pellet section; preferably, the section of the pellet is smooth; the scanning area of the raman microscope covers the entire section of the pellet.
Compared with the prior art, the invention has the beneficial effects that: the method has low cost, can quickly, accurately and visually measure the thicknesses of all the component layers of the core layer, the medicine feeding layer and the coating layer simultaneously by means of auxiliary instruments and reagent consumables, and has short time consumption and accurate measurement.
Drawings
FIG. 1 is a flow chart of the method of the present invention;
FIG. 2 is a Raman feature spectrum of the bulk drug and the auxiliary materials of the embodiment of the invention;
fig. 3 is a graph of the thickness of the raman imaging component layer of the micropellets of the present invention.
FIG. 4 is a block diagram of the system of the present invention.
Detailed Description
Referring to fig. 1, in the embodiment of the present invention, laser confocal micro-raman is used to measure the thickness of the pellet component layer, and the specific implementation process is as follows:
(1) taking the raw material medicines and the auxiliary materials, respectively placing the raw material medicines and the auxiliary materials on a glass slide for flattening and sample preparation;
(2) determining laser wavelength, slit and other test conditions of laser Raman scanning, optimizing parameters of single-point laser Raman scanning, such as laser power, cumulative times of exposure time and the like, and obtaining Raman feature maps of the raw material medicines and the auxiliary materials; the laser wavelength is 633 nm; the slit was 65 μm. The laser wavelength of 633nm is a point light source, and when the wavelength is used for scanning, both fluorescence elimination and imaging resolution can be achieved, so that a laser with the wavelength of 633nm is selected in the embodiment of the invention;
(3) cutting the pellet with a blade, keeping the cut surface flat, fixing the cut pellet, placing the pellet under a Raman microscope, and setting surface scanning conditions: setting a scanning area to scan the range of the selection area, so that the scanning area covers the section of the whole pellet; setting a surface scanning step diameter, wherein the surface scanning step diameter is 0.5 mu m;
(4) setting parameters such as section surface scanning laser power and the like of the pellets according to the Raman feature spectrum of the raw and auxiliary materials (namely the raw and auxiliary materials) in the step (2), and then performing surface scanning to obtain Raman surface scanning data of the pellets; according to the Raman characteristic spectrum of the raw and auxiliary materials, the set surface scanning power is the maximum power (the laser power is 100 percent in the implementation case) which can enable Raman peaks of all components to have response and can not cause the response saturated sample to be burnt; setting exposure time, wherein the exposure time is generally 1s, or increasing or decreasing the exposure time according to the intensity of the peak in the raman spectrum, the longer the exposure time, the clearer the scanning spectrum, but the longer the overall scanning time (the exposure time is 1s in the embodiment), the more the number of times of accumulation is generally 1, the clearer the spectrum, but the longer the overall time (the number of times of accumulation is 1 in the embodiment); clicking software (using Ranishao Raman software WiRE5.2 in the invention) to start icon starting surface scanning to obtain the Raman surface scanning data of the section of the pellet;
(5) introducing the characteristic Raman spectrum in the step (2) into the Raman surface scanning data in the step (4), and performing component analysis by using Raman analysis software WiRE5.2 to form a distribution image of each component of the pellet;
(6) and labeling the thicknesses of all component layers in the Raman surface scanning imaging of the pellet.
Fig. 2 is a characteristic raman spectrum of raw material drugs and auxiliary materials of the metoprolol succinate sustained-release capsule pellet: the atlas is provided with ethyl cellulose, metoprolol succinate bulk drug (API for short) and sugar pill core from top to bottom in sequence. Fig. 3 is a graph of the thickness of the micropellet raman imaging component layer, plotted as: the characteristic Raman spectrums of the bulk drugs and the auxiliary materials are led into the surface scanning imaging data of the pellets to perform component imaging display in a surface scanning area according to the matching condition of the characteristic spectrums, the image distribution and the components can accurately correspond, and the thickness of each component layer can be conveniently, visually and clearly determined: the thickness of the center of the sugar pill core is about 415 μm, the upper medicine layer (the metoprolol succinate bulk drug) is continuously coated on the outer layer of the sugar pill core, the thickness is about 178 μm, and the thickness of the coating layer (ethyl cellulose) is about 12 μm.
As shown in fig. 4, another embodiment of the present invention provides a system for measuring the thickness of each component layer of a pellet, comprising:
the data acquisition module is used for acquiring a Raman characteristic spectrum of the bulk drug and a Raman characteristic spectrum of the auxiliary material;
the import module is used for importing the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material into the section Raman surface scanning data of the pellet for component analysis and imaging;
and the labeling module is used for labeling the thickness of each component layer (such as a pill core layer, a medicine applying layer and a coating layer) in the Raman surface scanning imaging of the section of the pellet obtained after the treatment of the introducing module.
The data acquisition module of this embodiment includes:
the Raman characteristic spectrum acquisition module is used for determining the test conditions of laser Raman scanning, optimizing the parameters of single-point laser Raman scanning and acquiring the Raman characteristic spectrums of the raw material medicines and the auxiliary materials;
the micro-pill section scanning data acquisition module is used for setting the surface scanning selection area range of the Raman microscope to obtain section Raman surface scanning data of the cut micro-pills; the surface scanning conditions comprise a scanning area coverage range, a surface scanning step diameter, a surface scanning laser frequency, a surface scanning laser power, exposure time and exposure accumulated times; the surface scanning area covers the whole section of the pellet; the section of the pellet is flat, and the scanning area of the Raman microscope covers the whole section of the pellet.
The setting of each condition and parameter in the system of this embodiment is the same as the setting of the condition and parameter in the above method, and details are not repeated here.
The method and the system for measuring the thickness of the components of the pellet have short time consumption, can finish the whole test and analysis process within 24 hours, do not need to carry out pretreatment such as long-time drying on a sample or the like, do not need to use auxiliary instrument equipment and reagent consumables, and are simple and quick to operate.
Claims (10)
1. A method for measuring the thickness of each component layer of a pellet is characterized by comprising the following steps:
s1, acquiring a Raman characteristic spectrum of the bulk drug and a Raman characteristic spectrum of the auxiliary material;
s2, introducing the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material into the section Raman surface scanning data of the pellet, and performing component analysis and imaging;
s3, marking the thickness of each component layer in the Raman surface scanning imaging of the section of the pellet obtained after the treatment of the step S2.
2. The method for measuring the thickness of each component layer of the pellet of claim 1, wherein step S1 is preceded by the steps of:
1) taking the pellet raw material medicine and the auxiliary material, and respectively flattening and preparing samples;
2) determining the test conditions of laser Raman scanning and the parameter conditions of single-point laser Raman scanning to obtain the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material;
3) setting the surface scanning condition of a Raman microscope to obtain section Raman surface scanning data of the cut pellets; preferably, the area scanning conditions include a scanning area coverage, an area scanning step diameter, an area scanning laser wavelength, an area scanning laser power, an exposure time and an exposure accumulated number; preferably, the area of the surface scan covers the entire pellet section; preferably, the pellet has a smooth cut surface.
3. The method for measuring the thickness of each component layer of the pellets according to claim 2, wherein in step 2), the test conditions comprise laser wavelength and slit; preferably, the laser wavelength is 633nm and the slit is 65 μm.
4. The method for measuring the thickness of each component layer of the pellets in the step 2), wherein the parameters of the single-point laser Raman scanning comprise laser power, exposure time and cumulative number of exposure, and preferably, the laser power is set to 10% of rated power, the exposure time is 10s, and the cumulative number of exposure is 1.
5. The method for measuring the thicknesses of the component layers of the pellets according to claim 2, wherein in the step 3), the surface scanning laser power is the maximum power which can enable the Raman peaks of the components to respond and does not cause the response saturation sample to burn out.
6. The method of claim 1, wherein the surface scanning step size is set to 0.5 μm to 5 μm.
7. The method for measuring the thicknesses of the component layers of the pellets according to any one of claims 1 to 6, wherein laser Raman scanning is performed by laser confocal micro-Raman spectroscopy.
8. A system for measuring the thickness of the component layers of a pellet, comprising:
the data acquisition module is used for acquiring a Raman characteristic spectrum of the bulk drug and a Raman characteristic spectrum of the auxiliary material;
the import module is used for importing the Raman characteristic spectrum of the bulk drug and the Raman characteristic spectrum of the auxiliary material into the section Raman surface scanning data of the pellet for component analysis and imaging;
and the labeling module is used for labeling the thickness of each component layer in the micropellet section Raman surface scanning imaging obtained after the micropellet section Raman surface scanning imaging is processed by the guiding module.
9. The system of claim 8, wherein the data acquisition module comprises:
the Raman characteristic spectrum acquisition module is used for determining the test conditions of laser Raman scanning, optimizing the parameters of single-point laser Raman scanning and acquiring the Raman characteristic spectrums of the raw material medicines and the auxiliary materials;
the micro-pill section scanning data acquisition module is used for setting the surface scanning selection area range of the Raman microscope to obtain section Raman surface scanning data of the cut micro-pills; preferably, the area scanning conditions include a scanning area coverage, an area scanning step diameter, an area scanning laser frequency, an area scanning laser power, an exposure time and an exposure accumulated number; preferably, the area of the surface scan covers the entire pellet section; preferably, the section of the pellet is smooth; the scanning area of the raman microscope covers the entire section of the pellet.
10. The system of claim 9, wherein the test conditions include a laser wavelength and a slit; preferably, the parameters of the single-point laser raman scanning include laser power, exposure time and exposure accumulation times; preferably, the surface scanning laser power is the maximum power which enables each component Raman peak to respond and does not cause response saturation sample burning.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114166821A (en) * | 2021-11-30 | 2022-03-11 | 辽宁省检验检测认证中心 | Method for simultaneously detecting content and distribution of components in levonorgestrel tablets |
| CN116124761A (en) * | 2023-02-13 | 2023-05-16 | 北京石油化工学院 | Drug coating state on-line detection equipment, detection method and device |
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