CN114720619A - Quality control method for traditional Chinese medicine - Google Patents
Quality control method for traditional Chinese medicine Download PDFInfo
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- CN114720619A CN114720619A CN202210425221.8A CN202210425221A CN114720619A CN 114720619 A CN114720619 A CN 114720619A CN 202210425221 A CN202210425221 A CN 202210425221A CN 114720619 A CN114720619 A CN 114720619A
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- chinese medicine
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- traditional chinese
- fingerprint
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- 239000003814 drug Substances 0.000 title claims abstract description 47
- 238000003908 quality control method Methods 0.000 title abstract description 8
- 239000000523 sample Substances 0.000 claims abstract description 37
- 238000000034 method Methods 0.000 claims abstract description 17
- 238000001228 spectrum Methods 0.000 claims abstract description 17
- 239000002245 particle Substances 0.000 claims abstract description 12
- 239000000843 powder Substances 0.000 claims abstract description 11
- 238000004458 analytical method Methods 0.000 claims abstract description 8
- 239000012488 sample solution Substances 0.000 claims abstract description 7
- 238000001514 detection method Methods 0.000 claims abstract description 5
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims description 6
- 238000009210 therapy by ultrasound Methods 0.000 claims description 6
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical group COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 claims description 3
- 239000007864 aqueous solution Substances 0.000 claims description 3
- 238000010790 dilution Methods 0.000 claims description 3
- 239000012895 dilution Substances 0.000 claims description 3
- 238000010828 elution Methods 0.000 claims description 3
- 235000019253 formic acid Nutrition 0.000 claims description 3
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 235000008216 herbs Nutrition 0.000 claims 1
- 238000011160 research Methods 0.000 description 3
- 229940126680 traditional chinese medicines Drugs 0.000 description 3
- 238000011161 development Methods 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000005728 strengthening Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/02—Investigating particle size or size distribution
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information
- G01N30/8686—Fingerprinting, e.g. without prior knowledge of the sample components
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
Landscapes
- Chemical & Material Sciences (AREA)
- Biochemistry (AREA)
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Dispersion Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Library & Information Science (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention belongs to the technical field of communication, in particular to a traditional Chinese medicine quality control method, which comprises the following steps of preparing a sample solution; acquiring a sample fingerprint spectrum; measuring the content of index components of the sample fingerprint; analyzing a sample fingerprint spectrum; identifying and judging the sample fingerprint and the standard fingerprint; the quality of the traditional Chinese medicine is judged by analyzing and comparing the content of the index components. The invention can quantitatively control the quality of the traditional Chinese medicine by utilizing index components. Thereby fundamentally ensuring the overall quality of the traditional Chinese medicine; the quality stability of the traditional Chinese medicine can be evaluated by utilizing the traditional Chinese medicine quality control method of the invention, so as to achieve the aim of controlling the quality stability and uniformity of the traditional Chinese medicine; the particle size detector is used for detecting the uniformity of the particle size of the Chinese medicinal powder to be detected, so that the influence of nonuniform particle size on the detection result is reduced; the method for comparing the infrared fingerprint of the sample with the infrared fingerprint of the standard ensures the accuracy of the determination and analysis.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a quality control method of a traditional Chinese medicine.
Background
The development of scientific technology provides conditions for basic research of traditional Chinese medicines and continuously improves the quality of the traditional Chinese medicines
Provides technical support. The traditional Chinese medicine fingerprint refers to the concept of medical fingerprints by reference, and comprises a traditional Chinese medicine DNA fingerprint, a protein fingerprint, a chemical fingerprint and the like; the traditional Chinese medicine fingerprint spectrum is a common peak spectrum which can mark the characteristics of the traditional Chinese medicine and is obtained by adopting a certain analysis means after the traditional Chinese medicine is properly processed, and the quality of the traditional Chinese medicine is effectively identified by grasping the characteristics of the traditional Chinese medicine fingerprint spectrum, so that the relative stability of the quality of the traditional Chinese medicine and the quality of the Chinese patent medicine are ensured.
The research and application of the traditional Chinese medicine fingerprint map can not only solve the difficult problem that the truth of the traditional Chinese medicine products in China is difficult to distinguish, but also provide scientific guarantee for strengthening the standardization of the planting and processing of the traditional Chinese medicine and the systematization and standardization of the research of the internal components of the traditional Chinese medicine, accelerating the development of the modernization of the traditional Chinese medicine and realizing the international connection, thereby providing a quality control method of the traditional Chinese medicine.
Disclosure of Invention
The invention aims to solve the problem that the truth of the traditional Chinese medicine products in China is difficult to distinguish, and provides a Chinese medicine quality control method for strengthening the planting and processing standardization of Chinese medicinal materials.
In order to achieve the purpose, the invention adopts the following technical scheme:
a method for controlling the quality of traditional Chinese medicine comprises the following steps:
s1, preparing a sample solution;
s2, obtaining a sample fingerprint;
s3, measuring the content of index components of the sample fingerprint;
s4, analyzing the fingerprint of the sample;
s5, identifying and judging the sample fingerprint and the standard fingerprint;
s6, analyzing and comparing the content of the index components to judge the quality of the traditional Chinese medicine;
preferably, the step S1 includes the following steps:
s11, weighing a certain amount of Chinese medicinal powder to be tested;
s12, detecting the uniformity of the particle size of the Chinese medicinal powder to be detected by a particle size detector;
s13, placing the traditional Chinese medicine powder into a measuring flask, and adding methanol for dilution to prepare a sample solution;
and S14, carrying out ultrasonic treatment on the sample liquid.
Preferably, high performance liquid chromatography is adopted in the step S2;
preferably, in step S4, the method includes the following steps:
s41, observing and comparing the peak position and peak shape of each peak of the infrared fingerprint spectrum and the standard infrared fingerprint spectrum of the sample;
s42, the relative peak intensities of the infrared fingerprint of the comparison sample and the standard infrared fingerprint are basically consistent;
and S43, the correlation between the infrared fingerprint of the comparison sample and the standard infrared fingerprint is more than 75%.
Preferably, the chromatographic conditions in S2 are as follows for a UPLCC18 chromatographic column; mobile phase: the mobile phase A is acetonitrile, and the mobile phase B is formic acid aqueous solution with the volume concentration of 0.1-1.0%; .
Preferably, the elution gradient in S2 is: 0-4min, 5-10% of A; 4-6min, 10-12% of A; 6-15min, 12-22% of A; 15-17min, 22% A; 17-23min, 22-27% A; 23-25min, 27-32% of A; 25-28min, 32-35% A; 28-30min, 35% A; 30-36min, 35-40% A; 36-37min, 40-100% A; 37-39min, 100-5% A; sample introduction amount: 2-10 mu L; column temperature: 20-40 ℃; flow rate: 0.2-0.5 mL/min; detection wavelength: 290 nm and 330 nm.
Preferably, in S14, the time for ultrasonic treatment is 10-15 min.
Preferably, the content determination of the index components of the sample fingerprint in S3 can adopt analysis methods such as spectrum and chromatogram verified by methodologies such as accuracy, precision, specificity, linearity and range.
The invention realizes the following beneficial effects:
1) and the quality of the traditional Chinese medicine can be quantitatively controlled by utilizing the index components. Thereby fundamentally ensuring the overall quality of the traditional Chinese medicine;
2) the quality stability of the traditional Chinese medicine can be evaluated by utilizing the traditional Chinese medicine quality control method of the invention, so as to achieve the aim of controlling the quality stability and uniformity of the traditional Chinese medicine;
3) the particle size uniformity of the Chinese medicinal powder to be detected is detected by a particle size detector, so that the influence on the detection result caused by uneven particle size is reduced;
4) the analysis methods such as spectrum and chromatogram verified by methodologies such as accuracy, precision, specificity, linearity and range are adopted to ensure the analysis effect of the index components of the sample fingerprint;
5) and the accuracy of measurement and analysis is ensured by adopting a mode of comparing the infrared fingerprint spectrum of the sample with the standard infrared fingerprint spectrum.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments.
A method for controlling the quality of traditional Chinese medicine comprises the following steps:
s1, preparing a sample solution;
s2, obtaining a sample fingerprint;
s3, measuring the content of index components of the sample fingerprint;
s4, analyzing the fingerprint of the sample;
s5, identifying and judging the sample fingerprint and the standard fingerprint;
s6, analyzing and comparing the content of the index components to judge the quality of the traditional Chinese medicine;
in this embodiment, the step S1 includes the following steps:
s11, weighing a certain amount of Chinese medicinal powder to be tested;
s12, detecting the uniformity of the particle size of the Chinese medicinal powder to be detected through a particle size detector;
s13, placing the traditional Chinese medicine powder into a measuring flask, and adding methanol for dilution to prepare a sample solution;
and S14, carrying out ultrasonic treatment on the sample liquid.
In this embodiment, high performance liquid chromatography is used in step S2;
in this embodiment, step S4 includes the following steps:
s41, observing and comparing the peak position and peak shape of each peak of the infrared fingerprint spectrum and the standard infrared fingerprint spectrum of the sample;
s42, the relative peak intensities of the infrared fingerprint of the comparison sample and the standard infrared fingerprint are basically consistent;
and S43, the correlation between the infrared fingerprint of the comparison sample and the infrared fingerprint of the standard should reach more than 75%.
In the present example, the chromatographic conditions in S2 are as follows for a UPLCC18 chromatographic column; mobile phase: the mobile phase A is acetonitrile, and the mobile phase B is formic acid aqueous solution with the volume concentration of 0.1-1.0%; .
In this example, the elution gradient in S2 is: 0-4min, 5-10% of A; 4-6min, 10-12% of A; 6-15min, 12-22% of A; 15-17min, 22% A; 17-23min, 22-27% A; 23-25min, 27-32% of A; 25-28min, 32-35% A; 28-30min, 35% A; 30-36min, 35-40% A; 36-37min, 40-100% A; 37-39min, 100-5% A; sample introduction amount: 2-10 mu L; column temperature: 20-40 ℃; flow rate: 0.2-0.5 mL/min; detection wavelength: 290-330 nm.
In this embodiment, in S14, the time for the ultrasonic treatment is 10 to 15 min.
In this embodiment, the content determination of the index component of the sample fingerprint in S3 may adopt an analysis method such as spectrum and chromatography, which is verified by methodologies such as accuracy, precision, specificity, linearity and range.
Claims (8)
1. A method for controlling the quality of traditional Chinese medicine is characterized by comprising the following steps:
s1, preparing a sample solution;
s2, obtaining a sample fingerprint;
s3, measuring the content of index components of the sample fingerprint;
s4, analyzing the fingerprint of the sample;
s5, identifying and judging the sample fingerprint and the standard fingerprint;
s6, analyzing and comparing the content of the index components to judge the quality of the traditional Chinese medicine.
2. The method for controlling the quality of a traditional Chinese medicine according to claim 1, wherein the step S1 comprises the steps of:
s11, weighing a certain amount of Chinese medicinal powder to be tested;
s12, detecting the uniformity of the particle size of the Chinese medicinal powder to be detected through a particle size detector;
s13, placing the traditional Chinese medicine powder into a measuring flask, and adding methanol for dilution to prepare a sample solution;
and S14, carrying out ultrasonic treatment on the sample liquid.
3. The method for controlling the quality of a Chinese medicine according to claim 1, wherein high performance liquid chromatography is adopted in the step S2.
4. The method for controlling the quality of a traditional Chinese medicine according to claim 1, wherein in step S4, the method comprises the following steps:
s41, observing and comparing the peak position and peak shape of each peak of the infrared fingerprint spectrum and the standard infrared fingerprint spectrum of the sample;
s42, the relative peak intensities of the infrared fingerprint of the comparison sample and the standard infrared fingerprint are basically consistent;
and S43, the correlation between the infrared fingerprint of the comparison sample and the infrared fingerprint of the standard should reach more than 75%.
5. The method for controlling the quality of Chinese herbs in claim 1, wherein the chromatographic conditions in S2 are UPLCC18 column; mobile phase: the mobile phase A is acetonitrile, and the mobile phase B is formic acid aqueous solution with volume concentration of 0.1-1.0%; .
6. The method for controlling the quality of a traditional Chinese medicine according to claim 1, wherein the elution gradient in S2 is as follows: 0-4min, 5-10% of A; 4-6min, 10-12% of A; 6-15min, 12-22% of A; 15-17min, 22% A; 17-23min, 22-27% A; 23-25min, 27-32% of A; 25-28min, 32-35% A; 28-30min, 35% A; 30-36min, 35-40% A; 36-37min, 40-100% A; 37-39min, 100-5% A; sample introduction amount: 2-10 μ L; column temperature: 20-40 ℃; flow rate: 0.2-0.5 mL/min; detection wavelength: 290 nm and 330 nm.
7. The method for controlling the quality of a Chinese medicine according to claim 1, wherein the time of the ultrasonic treatment in S14 is 10-15 min.
8. The method for controlling the quality of a traditional Chinese medicine according to claim 5, wherein the content of the index components of the fingerprint of the sample in S3 is determined by using an analysis method such as spectrum and chromatogram verified by methodologies such as accuracy, precision, specificity, linearity and range.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210425221.8A CN114720619A (en) | 2022-04-22 | 2022-04-22 | Quality control method for traditional Chinese medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210425221.8A CN114720619A (en) | 2022-04-22 | 2022-04-22 | Quality control method for traditional Chinese medicine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114720619A true CN114720619A (en) | 2022-07-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210425221.8A Pending CN114720619A (en) | 2022-04-22 | 2022-04-22 | Quality control method for traditional Chinese medicine |
Country Status (1)
| Country | Link |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1470876A (en) * | 2002-07-25 | 2004-01-28 | 浙江大学 | Chinese medicine quality control and evaluation method |
| CN111044422A (en) * | 2020-01-11 | 2020-04-21 | 河南省中医院（河南中医药大学第二附属医院） | Quality control method and device for Chinese herbal compound |
-
2022
- 2022-04-22 CN CN202210425221.8A patent/CN114720619A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1470876A (en) * | 2002-07-25 | 2004-01-28 | 浙江大学 | Chinese medicine quality control and evaluation method |
| CN111044422A (en) * | 2020-01-11 | 2020-04-21 | 河南省中医院（河南中医药大学第二附属医院） | Quality control method and device for Chinese herbal compound |
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