CN101664495A - On-line detection method of near infrared spectrum for production process of traditional Chinese medicine, pill of six ingredients with rehmannia - Google Patents
On-line detection method of near infrared spectrum for production process of traditional Chinese medicine, pill of six ingredients with rehmannia Download PDFInfo
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Abstract
The invention relates to an on-line detection method of near infrared spectrum for production process of traditional Chinese medicine, pill of six ingredients with rehmannia. The on-line detection method comprises the following steps: (1) selection of a calibration set sample; (2) property determination of the calibration set sample; (3) near infrared absorption spectrometry determination of the calibration set sample; (4) establishment of a calibration model; and (5) property determination of an unknown sample, namely leading a near infrared absorption spectrum value of the unknown sample into the calibration model established in the step (4) and then obtaining the content of target ingredients in the unknown sample after model calculation. The on-line detection method has the advantagesof simpleness, correction and good ruggedness, application for on-line quality control of the pill of six ingredients with rehmannia, and capability of resolving the problems of long time consumption,low efficiency and the like of the traditional off-line detection in production process.
Description
[technical field]
The present invention relates to the technical field of quality detection of Chinese medicine production process, specifically, is a kind of method for online detecting near infrared spectrum of Chinese medicine LIUWEI DIHUANG WAN production process.
[background technology]
LIUWEI DIHUANG WAN is the kidney invigorating name side, and record the earliest can trace back to Northern Song Dynasty well-known doctor Qian Yi and show " children's's medicine card straight determine ", is mainly used in diseases such as treating dizziness and tinnitus, soreness of the waist and knees, seminal emission night sweat.LIUWEI DIHUANG WAN is made up of Radix Rehmanniae Preparata, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Alismatis, Cortex Moutan, Poria Six-element medical material, and the ratio of each medical material of distinguishing the flavor of is 8: 4: 4: 3: 3: 3.Liuwei Dihuang preparation is divided into decoction, honeyed pill, oral liquid, concentrated pill, hard capsule and soft capsule etc., and clinical practice is extensive.
At present, more or less a hundred manufacturer production six drugs containing rehmanniae product is arranged approximately at home, more than 30 six drugs containing rehmanniae brand arranged, nearly 1,000,000,000 yuan of annual sales amount has good social benefit and economic benefit, and its market potential also will enlarge.So the big market demand is had higher requirement to drug quality, and leaching process is the critical process point that the six drugs containing rehmanniae pill is produced.Existing technology controlling and process pattern, basically still rest on traditional experience control method, promptly at physical parameters such as the temperature of production process, pressure, response time, for some important index composition, the supplementary means that adopts qualitative identification and quantitative assay to detect as paeonol, peoniflorin, loganin, gallic acid etc. as technology.But the analysis result feedback lags behind, and can only carry out quality control with offline mode, and process is loaded down with trivial details, labor intensity is big, have artificial uncertain factor, is unfavorable for continuous production.Therefore, press for, realize changing to online, automatization, intelligentized quality controling mode, promote the inherent quality of Liuwei Dihuang preparation with this from off-line, non-automaticization, artificial quality controling mode to the lifting of leaching process detection technique.
Chinese patent publication number CN101485805 relates to the method for quality control of near-infrared holographic fingerprint for pills of six ingredients with rehmannia, with fingerprint pattern technology and in conjunction with the characteristics of detected component, utilize near infrared spectrum to can be used for that all are contained the relevant sample physico-chemical property of hydrogen group and analyze and detect, guarantee that institute's composition that detects is accurate, reliably.The application of near infrared spectrum detection and chemometrics method can be held the quality of relevant medicine integral body more exactly, thereby effectively guaranteed safety, the homogeneous, stable, effective, controlled of LIUWEI DIHUANG WAN; Method of quality control is easy, the result is accurate, favorable reproducibility, can be used in medicine quality evaluated, Chinese medicine quality control and the new Chinese medicine research and development.Particularly can be with it as one of index of LIUWEI DIHUANG WAN quality control and real and fake discrimination.
Chinese patent publication number CN1403822 relates to the online detection of product quality indicator in the Chinese medicine production technology, relate to one to directly and product quality related technical parameters and quality index implement the Chinese medicine workshop of online detection; An on-line detecting system that does not need to extract from technological process any sample material is equipped with in this workshop, and this system adopts a near infrared spectrometer and industrial control computer; Adopt the online real-time analyzer of partial least square method (PLS) and neural net method can predict the quality index of Chinese medicine production process, and data analysis is provided.
Chinese patent publication number CN101078685 relates to the method for near infrared spectrum quick online detection Chinese medicine Kuhuang injection effective ingredient, the effective ingredient of Kuhuang injection mainly is aloe-emodin, chrysophanic acid, emodin, chrysophanol, physcione, sophocarpine, matrine etc., gather the near-infrared absorption spectrum of Kuhuang injection, the near infrared spectrum of high performance liquid chromatogram (HPLC) method acquisition active constituent content data with this sample is associated, set up calibration model with partial least-square regression method, realize quick online detection this injection effective ingredient.Result of study shows that near-infrared spectral analytical method can effectively detect the effective ingredient of Kuhuang injection; This method sample pretreatment is simple, detection detects a plurality of components fast, simultaneously, can be used in the real-time analysis and the line Quality Control of tcm manufacturing process.
Chinese patent publication number CN101299022 relates to the method for utilizing near-infrared spectrum technique to estimate Chinese medicine medical material comprehensive quality, at first set up calibration model, method is to collect the Chinese crude drug sample as the calibration set sample, gather the near-infrared diffuse reflection spectrum of sample, and gained spectrum carried out pretreatment, then with recording its index component content with the corresponding detection method of sample in the conventional method, collection of illustrative plates is combined with the index component content, partial least square method in the Applied Chemometrics is set up Quantitative Analysis Model, testing sample is pulverized its near infrared light spectrogram of back scanning, collection of illustrative plates is imported Quantitative Analysis Model, can record the content of index composition in this Chinese crude drug, whole process required time is short, speed is fast, accurately, but on-line measurement, enhance productivity, saved the man power and material greatly, can produce tremendous economic and social benefit.
Chinese patent publication number CN101303294 relates to the application process of near infrared online detection technology in the Chinese medicine YIQING KELI is produced, collect raw material Radix Scutellariae and Radix Scutellariae extractum and YIQING KELI sample, the utilization near infrared spectrometer scans the sample near-infrared absorption spectrum of collection respectively, get spectroscopic data, determine its quality index content, be worth as reference with this, pre-processed spectrum data then, set up the polynary calibration model of near infrared spectrum with the PLS method in the Chemical Measurement, utilizing the quantitative model of setting up to treat the cls analysis sample analyzes, testing sample is pulverized, scan its near infrared light spectrogram, extract the characteristic light spectrogram by computer and be input to calibration model, the mensuration of process calibration model promptly gets its quality index content, and this model is kept in the computer, in order to reuse, whole process time is short, speed is fast, accurately, can detect by real-time online, reduce operating cost.
Near-infrared spectrum technique is one of mature technology that is suitable for implementation in most line analysis and control in real time, is used widely in fields such as oil, chemical industry, Nicotiana tabacum L., food, pharmacy.This commercial measurement fast, accurately can be realized original position, harmless, on-line measurement, can feed back real time information fast, and simple to operate, cost is low, the pollution that can avoid measuring process to bring, this technology is known as a kind of " green analytical technology ".The present invention is applied to the online detection of LIUWEI DIHUANG WAN production process with near infrared technology, can realize the real-time detection of index components, helps to realize technology monitoring in real time and diagnosis, can guarantee that product stable uniform, safety are controlled.
[summary of the invention]
The objective of the invention is to overcome the deficiencies in the prior art, a kind of method for online detecting near infrared spectrum of Chinese medicine LIUWEI DIHUANG WAN production process is provided.
The objective of the invention is to be achieved through the following technical solutions:
A kind of method for online detecting near infrared spectrum of Chinese medicine LIUWEI DIHUANG WAN production process, its concrete steps are:
(1) selection of calibration set sample
Choosing needs the critical process point controlled in the LIUWEI DIHUANG WAN production process, form the sample correction collection with the content value of index components in this process point sample; Index components such as paeonol, peoniflorin, loganin, gallic acid etc.;
(2) mensuration of calibration set sample properties
With the index components in the high-performance liquid chromatogram determination LIUWEI DIHUANG WAN critical process point sample, the calibration set sample with the content value of this index components during as modeling; Index components such as paeonol, peoniflorin, loganin, gallic acid etc.;
(3) near-infrared absorption spectrum of calibration set sample is measured
At wavelength is 10000～4000cm
-1In the scope, adopt near infrared spectrometer to measure the spectra values of each process point sample of LIUWEI DIHUANG WAN;
(4) calibration model is set up
Adopt methods such as convolution is level and smooth, convolution differentiate, polynary scatter correction, standard normal variable conversion that resulting near infrared spectrum is carried out pretreatment, regression algorithm with the best, content data that obtains with step (2) and the near infrared spectrum absorption value that step (3) obtains are carried out related, set up calibration model; Be meant with the regression algorithm of the best select at different models that convolution is level and smooth, a kind of method in the convolution differentiate, polynary scatter correction, standard normal variable conversion calculates;
(5) mensuration of unknown sample character
The near-infrared absorption spectrum value of unknown sample is directed in the calibration model of step (4) foundation, after Model Calculation, obtains the content of index components in the unknown sample.
Compared with prior art, the invention has the advantages that:
Method for online detecting near infrared spectrum of the present invention is easy, accurate, favorable reproducibility, is used for the line Quality Control of LIUWEI DIHUANG WAN; As a kind of method of quality control that has application prospect, the present invention is expected to solve problem such as traditional offline inspection cost height in the LIUWEI DIHUANG WAN production process, length consuming time, efficient be low, and the quality for the six drugs containing rehmanniae related preparations provides strong technical guarantee simultaneously.
[description of drawings]
Fig. 1 is a LIUWEI DIHUANG WAN alcohol extraction process terminal point sample high-efficient liquid phase chromatogram;
Fig. 2 is the extraction curve of paeonol and peoniflorin in the LIUWEI DIHUANG WAN alcohol extraction process;
Fig. 3 is LIUWEI DIHUANG WAN alcohol extraction process sample near-infrared absorption spectrum figure;
Fig. 4 is a LIUWEI DIHUANG WAN extraction process by water terminal point sample high-efficient liquid phase chromatogram;
Fig. 5 is the extraction curve of loganin and gallic acid in the LIUWEI DIHUANG WAN extraction process by water;
Fig. 6 is LIUWEI DIHUANG WAN extraction process by water sample near-infrared absorption spectrum figure.
[specific embodiment]
The specific embodiment of the method for online detecting near infrared spectrum of a kind of Chinese medicine LIUWEI DIHUANG WAN of the present invention production process below is provided.
Embodiment 1
A kind of LIUWEI DIHUANG WAN alcohol extraction process process is carried out online detection, and its concrete steps are:
(1) 10 times of amounts of adding 1L, 95% ethanol in 100g Cortex Moutan decoction pieces, extracting temperature is 85 ℃, extraction time is 2h, extracts 2 times, every 10min once sampling, preparation 3 is pulled on and is stated sample for modeling usefulness;
(2) with paeonol and content of paeoniflorin in the high-performance liquid chromatogram determination above-mentioned technical process sample, the calibration set sample with this content value during as modeling;
The high performance liquid chromatography condition that adopts in the above-mentioned steps (2) is: mobile phase 0.5% formic acid (A)-acetonitrile (B), B phase gradient is, 0～8min 90～85%, and 8～20min 85～80%, 20～25min80～40%, 25～30min 40～15%; 25 ℃ of column temperatures, flow velocity 1ml/min, the detection wavelength is 250nm, running time 35min, sample size 10 μ l; The high-efficient liquid phase chromatogram of alcohol extraction process terminal point sample as shown in Figure 1, paeonol and peoniflorin extraction curve in time is as shown in Figure 2;
(3) be 10000～4000cm at wavelength
-1In the scope, adopt near infrared spectrometer to measure the spectra values of above-mentioned sample, as shown in Figure 3;
(4) measured near infrared spectrum data is carried out pretreatment, the paeonol among Fig. 2, content of paeoniflorin data and the near infrared spectrum data among Fig. 3 are carried out related, set up calibration model;
(5) method according to step in the present embodiment (1) prepares 1 batch sample as prediction usefulness, and the assay method of step (2) and (3) in the employing present embodiment is measured paeonol, paeoniflorin content value and the near-infrared absorption spectrum absorption value thereof of prediction with sample respectively; The spectral absorption value is directed in the calibration model that present embodiment step (4) set up, calculates the prediction content value of paeonol, peoniflorin in each sample; Predictive value and measured value are compared, as shown in table 1;
Table 1 LIUWEI DIHUANG WAN alcohol extraction process sample index components predictive value and measured value are relatively
Present embodiment has been set up the near infrared online detection method of index components paeonol and peoniflorin in the LIUWEI DIHUANG WAN alcohol extraction process process, and the result shows that the near-infrared rapid analysis method of being set up is suitable for the on-line determination of paeonol and peoniflorin.
Embodiment 2
A kind of LIUWEI DIHUANG WAN water soluble ingredient leaching process carries out online detection, and its concrete steps are:
(1) Fructus Corni 23g, Radix Rehmanniae Preparata 267g, Poria 100g, Rhizoma Alismatis 100g are mixed with Cortex Moutan medicinal residues among the embodiment 1, add 10 times of water gagings, decoct and extract 1.5h, every 10min once sampling, preparation 3 is pulled on and is stated sample for modeling usefulness;
(2) with the loganin in the high-performance liquid chromatogram determination above-mentioned technical process sample and the content of gallic acid, the calibration set sample with this content value during as modeling;
The high performance liquid chromatography condition is with method among the embodiment 1, the high-efficient liquid phase chromatogram of extraction process by water terminal point sample as shown in Figure 4, loganin and gallic acid extraction curve in time is as shown in Figure 5;
(3) be 10000～4000cm at wavelength
-1In the scope, adopt near infrared spectrometer to measure the spectra values of above-mentioned sample, as shown in Figure 6;
(4) measured near infrared spectrum data is carried out pretreatment, the content data and the near infrared spectrum data among Fig. 6 of the loganin among Fig. 5, gallic acid are carried out related, set up calibration model;
(5) reserve 2 in 3 batch samples with step in the present embodiment (1) preparation gained and adopt the near-infrared spectral analytical method of step (3) in the present embodiment, each sample is detected, obtain the spectral absorption value of each sample as the prediction sample; The spectral absorption value is directed in the calibration model that present embodiment step (4) set up, calculates the prediction content value of loganin, gallic acid in each sample.Predictive value and measured value are compared, as shown in table 2;
Table 2 LIUWEI DIHUANG WAN extraction process by water sample index components predictive value and measured value are relatively
Present embodiment has been set up the near infrared online detection method of index composition loganin and gallic acid in the LIUWEI DIHUANG WAN extraction process by water process, and the result shows that the near-infrared rapid analysis method of being set up is suitable for the on-line determination of loganin, gallic acid.
The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, without departing from the inventive concept of the premise; can also make some improvements and modifications, these improvements and modifications also should be considered within the scope of protection of the present invention.
Claims (3)
1. the method for online detecting near infrared spectrum of a Chinese medicine LIUWEI DIHUANG WAN production process is characterized in that, its concrete steps are:
(1) selection of calibration set sample
Choosing needs the critical process point controlled in the LIUWEI DIHUANG WAN production process, form the sample correction collection with the content value of index components in this process point sample;
(2) mensuration of calibration set sample properties
With the index components in the high-performance liquid chromatogram determination LIUWEI DIHUANG WAN critical process point sample, the calibration set sample with the content value of this index components during as modeling;
(3) near-infrared absorption spectrum of calibration set sample is measured
At wavelength is 10000～4000cm
-1In the scope, adopt near infrared spectrometer to measure the spectra values of each process point sample of LIUWEI DIHUANG WAN;
(4) calibration model is set up
Adopt that convolution is level and smooth, convolution differentiate, polynary scatter correction, standard normal variable alternative approach carry out pretreatment to resulting near infrared spectrum, regression algorithm with the best, content data that obtains with step (2) and the near infrared spectrum absorption value that step (3) obtains are carried out related, set up calibration model;
(5) mensuration of unknown sample character
The near-infrared absorption spectrum value of unknown sample is directed in the calibration model of step (4) foundation, after Model Calculation, obtains the content of index components in the unknown sample.
2. the application of the method for online detecting near infrared spectrum of a kind of Chinese medicine LIUWEI DIHUANG WAN production process as claimed in claim 1 in paeonol and the online detection of peoniflorin.
3. the application of the method for online detecting near infrared spectrum of a kind of Chinese medicine LIUWEI DIHUANG WAN production process as claimed in claim 1 in loganin and the online detection of gallic acid.
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102028710A (en) * | 2010-12-03 | 2011-04-27 | 浙江大学 | Method for measuring contents of indole alkaloids in cinobufagin alcohol precipitation liquid |
| CN102106939A (en) * | 2011-03-21 | 2011-06-29 | 江西汇仁药业有限公司 | Quality control method for extract concentrated liquor of condensed pills of six ingredients with rehmannia root |
| CN102106919A (en) * | 2011-03-21 | 2011-06-29 | 江西汇仁药业有限公司 | Method for controlling quality in extraction process of traditional Chinese medicine chuanhong blood circulation-activating capsules |
| CN102636449A (en) * | 2011-06-15 | 2012-08-15 | 江西本草天工科技有限责任公司 | Method for measuring content of paeoniflorin in radix paeoniae alba extracting process by aid of near infrared spectrums |
| CN103376242A (en) * | 2012-04-25 | 2013-10-30 | 天津天士力之骄药业有限公司 | Method for detecting paeoniflorin |
| CN105784951A (en) * | 2014-12-24 | 2016-07-20 | 九芝堂股份有限公司 | Multiple indicator rapid detection method for raw medicinal powder of condensed pill of six drugs with rehmannia |
| CN109342358A (en) * | 2018-10-24 | 2019-02-15 | 吉林省现代中药工程研究中心有限公司 | The construction method and detection method of LIUWEIDIHUANG JIAONANG near-infrared quantitative calibration models |
| CN116794181A (en) * | 2023-06-21 | 2023-09-22 | 浙江大学 | Intelligent detection method for quality of traditional Chinese medicine pharmaceutical process based on spectrum transformation fusion |
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- 2009-09-17 CN CN200910195764A patent/CN101664495A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102028710A (en) * | 2010-12-03 | 2011-04-27 | 浙江大学 | Method for measuring contents of indole alkaloids in cinobufagin alcohol precipitation liquid |
| CN102028710B (en) * | 2010-12-03 | 2012-05-16 | 浙江大学 | Method for measuring contents of indole alkaloids in cinobufagin alcohol precipitation liquid |
| CN102106939A (en) * | 2011-03-21 | 2011-06-29 | 江西汇仁药业有限公司 | Quality control method for extract concentrated liquor of condensed pills of six ingredients with rehmannia root |
| CN102106919A (en) * | 2011-03-21 | 2011-06-29 | 江西汇仁药业有限公司 | Method for controlling quality in extraction process of traditional Chinese medicine chuanhong blood circulation-activating capsules |
| CN102106939B (en) * | 2011-03-21 | 2012-07-04 | 江西汇仁药业有限公司 | Quality control method for extract concentrated liquor of condensed pills of six ingredients with rehmannia root |
| CN102636449A (en) * | 2011-06-15 | 2012-08-15 | 江西本草天工科技有限责任公司 | Method for measuring content of paeoniflorin in radix paeoniae alba extracting process by aid of near infrared spectrums |
| CN103376242A (en) * | 2012-04-25 | 2013-10-30 | 天津天士力之骄药业有限公司 | Method for detecting paeoniflorin |
| CN105784951A (en) * | 2014-12-24 | 2016-07-20 | 九芝堂股份有限公司 | Multiple indicator rapid detection method for raw medicinal powder of condensed pill of six drugs with rehmannia |
| CN105784951B (en) * | 2014-12-24 | 2019-03-29 | 九芝堂股份有限公司 | A kind of Liuwei Dihuang Wan condensed pill crude drug powder multiple index quick detecting method |
| CN109342358A (en) * | 2018-10-24 | 2019-02-15 | 吉林省现代中药工程研究中心有限公司 | The construction method and detection method of LIUWEIDIHUANG JIAONANG near-infrared quantitative calibration models |
| CN116794181A (en) * | 2023-06-21 | 2023-09-22 | 浙江大学 | Intelligent detection method for quality of traditional Chinese medicine pharmaceutical process based on spectrum transformation fusion |
| CN116794181B (en) * | 2023-06-21 | 2024-01-26 | 浙江大学 | Intelligent detection method for quality of traditional Chinese medicine pharmaceutical process based on spectrum transformation fusion |
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