CN110390422A - A kind of Reduning injection chlorogenic acid rate of transform prediction technique of data-driven - Google Patents
A kind of Reduning injection chlorogenic acid rate of transform prediction technique of data-driven Download PDFInfo
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- CN110390422A CN110390422A CN201910512584.3A CN201910512584A CN110390422A CN 110390422 A CN110390422 A CN 110390422A CN 201910512584 A CN201910512584 A CN 201910512584A CN 110390422 A CN110390422 A CN 110390422A
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Abstract
The invention proposes a kind of detection methods of Reduning injection chlorogenic acid rate of transform test model, which is characterized in that this method comprises: Step 1: collecting technological parameter and mass parameter involved in different batches Reduning injection preparation section；Step 2: collected technological parameter and mass parameter are carried out data prediction, matrix stack is constructed；Step 3: collecting the chlorogenic acid rate of transform of the different batches Reduning injection；Step 4: technological parameter and mass parameter are " input " with the chlorogenic acid rate of transform for " output ", the correlation model of " input " and " output " is established, for testing the Reduning injection chlorogenic acid rate of transform.Utilize model of the invention, the rate of transform of survey Reduning injection effective component can be predicted according to technological parameter involved in 10 processes such as Reduning injection extraction, alcohol precipitation, extraction and mass parameter, convenient intervention and process control in advance, improve Reduning injection quality control level.
Description
Technical field
The present invention relates to intelligence manufacture fields, and in particular to a kind of Reduning injection chlorogenic acid rate of transform test model
Detection method.
Background technique
The method that Reduning injection quality control at present is mainly shared according to chromatography, spectroscopic methodology or both.Such as: ultraviolet
Spectrophotometry surveys Reduning injection total organic acids content, near-infrared spectral measurement chlorogenic acid or the method for solid content etc..Always
For, the essence of such methods is to carry out sampling check for quality to the raw material, intermediate and final products of each process, belongs to quilt afterwards
It is dynamic to examine control.And quality requires to move forward to drug quality control into production process derived from design (QbD) theory, realizes in thing very
To active control in advance.Therefore, on the basis of Reduning injection intelligent plant, it is necessary to make full use of new technology or new
Method makes improvements the quality control of product.
Reduning injection production requires to realize digital factory construction, crucial production equipment, life according to intelligence manufacture
It produces unit and realizes digitlization, networking, core business realizes integrated, and the data of factory's range have been achieved with shared.It is accurate
Intelligent control is carried out to product quality, it is necessary on the basis of current intelligent facility and production big data, utilize Redujing Granules
The information such as critical component, key process parameter, production environment condition, establish Reduning injection product in injection production process
The Digital Control model of key quality parameters, to realize the on-line monitoring, judgement and prediction to Reduning injection quality.
Summary of the invention
In view of this, the present invention is intended to provide a kind of detection of Reduning injection chlorogenic acid rate of transform test model or building
Cube method predicts the Reduning injection chlorogenic acid rate of transform with realizing.
Specifically, the invention proposes a kind of detection method of Reduning injection chlorogenic acid rate of transform test model,
It is characterized in that, this method comprises:
Step 1: collecting technological parameter and mass parameter involved in different batches Reduning injection preparation section；
Step 2: collected technological parameter and mass parameter are carried out data prediction, matrix stack is constructed；
Step 3: collecting the chlorogenic acid rate of transform of the different batches Reduning injection；
Step 4: with the chlorogenic acid rate of transform for " output ", technological parameter and mass parameter are " input ", foundation " input " and
The correlation model of " output ", for testing the Reduning injection chlorogenic acid rate of transform.The chlorogenic acid rate of transform=(extraction is dense
Wet cream weight after the content of wet cream Content of Chlorogenic Acid × extraction concentration after contracting)/(inventory-inventory × medicinal material water content) × raw medicine
The content of material chlorogenic acid.
Further, Reduning injection preparation section includes medicinal material measurement, honeysuckle extraction, gold and silver in the step 1
Flower concentration, sweet wormwood are extracted, sweet wormwood is concentrated, sweet wormwood recycles, are concentrated after the green alcohol precipitation of gold, gold blueness alcohol precipitation, the acid extraction of Jin Qing tune, Jin Qingcui
Take rear concentration and recovery.
Specifically, the technological parameter includes: with mass parameter
The chlorogenic acid content of medicinal material mensuration operation, chlorogenic acid weight, medicinal material water content；
The heating-up time of honeysuckle abstraction process, first time extracting liquid volume, second of extracting liquid volume, extracting solution are overall
Product；
Cream weight is concentrated out in the concentrate specific gravity of honeysuckle enrichment process, paste outer temperature, concentration time, honeysuckle；
Steam aperture, the volatilization oil volume, heating-up time of sweet wormwood abstraction process；
Sweet wormwood enrichment process goes out cream specific gravity, paste outer temperature, concentration time；
The supernatant volume of sweet wormwood recovery process, recycling medicinal extract temperature, recovery time；
The honeysuckle concrete weight of golden blueness alcohol precipitation process, medical fluid finally contain determining alcohol, supernatant volume；
Volume, recovery time, medicinal extract volume, the medicinal extract weight of the alcohol precipitation supernatant of enrichment process after golden blueness alcohol precipitation；
Hydrochloric acid weight, extraction mean flow rate, extraction times amount, tune acidleach cream weight, extraction in Jin Qing tune acid extraction procedure
Time；
Recovery time after Jin Qing extraction in concentration and recovery process goes out cream specific gravity, paste outer temperature.
Sweet wormwood recycles the step 2 and specifically includes:
The medicinal material mensuration operation data subset is the form of matrix Z1 (m × n1), honeysuckle abstraction process data subset
For the form of matrix Z2 (m × n2), honeysuckle enrichment process data subset is the form of matrix Z3 (m × n3), and sweet wormwood extracts work
Sequence data subset is the form of matrix Z4 (m × n4), and sweet wormwood enrichment process data subset is the form of matrix Z5 (m × n5), green
Wormwood artemisia data collection subset is the form of matrix Z6 (m × n6), and gold blueness alcohol precipitation data subset is the form of matrix Z7 (m × n7), gold
Enrichment process data subset is the form of matrix Z8 (m × n8) after green alcohol precipitation, and gold blueness extraction process data subset is matrix Z9 (m
× n9) form, gold blueness concentration and recovery process data subset be matrix Z10 (m × n10), wherein Z indicates different processes, m table
Show that batch number, n indicate the number of technological parameter and mass parameter；
According to the method for the present invention, in step 2, in parameter matrix construction step, involved in each production process such as
The preceding technological parameter and mass parameter whole physical quality attribute, combination building production process technology parameter and mass parameter
Data subset matrix X (m × k), wherein k is that the physical quality attribute of selection sums it up number, k≤(n1+n2+n3+n4+n5+n6+
n7+n8+n9)；
To production process technology parameter and mass parameter attribute data subset matrix X (m × k) is preprocessed obtains matrix
X ', preprocess method can be normalization or centralization or mean value standardization.
The step 3 specifically includes: collecting the m batch Reduning injection chlorogenic acid rate of transform, thus constitutes chlorogenic acid
It shifts rate matrix Y (m × 1), with chlorogenic acid transfer rate matrix Y (m × 1) for dependent variable, with production process technology parameter and quality
Parameter attribute matrix X ' is independent variable, constructs the prediction model Y=f (X ') of the chlorogenic acid rate of transform, i.e., " inputs " and " output "
Correlation model.
Further, the correlation model of described " input " and " output " includes partial least square model, polynomial regression mould
Type, artificial neural network, support vector machines or multiple linear regression model.Preferably multiple linear regression model or partially minimum two
Multiply model.
The invention also provides the models established using aforementioned either method to survey to the Reduning injection chlorogenic acid rate of transform
The method of examination, which is characterized in that
Step 1: collecting technological parameter and mass parameter involved in different batches Reduning injection preparation section；
Step 2: collected technological parameter and mass parameter are carried out data prediction, matrix stack is constructed；
Step 3: collecting the chlorogenic acid rate of transform of the different batches Reduning injection；
Step 4: with the chlorogenic acid rate of transform for " output ", technological parameter and mass parameter are " input ", foundation " input " and
The correlation model of " output "；
Step 5: the technological parameter and mass parameter of sample to be tested are collected, according to " input " and " output " established
Correlation model acquire the chlorogenic acid rate of transform of sample to be tested.
Further, Reduning injection preparation section includes medicinal material measurement, honeysuckle extraction, gold and silver in the step 1
Flower concentration, sweet wormwood are extracted, sweet wormwood is concentrated, sweet wormwood recycles, are concentrated after the green alcohol precipitation of gold, gold blueness alcohol precipitation, the acid extraction of Jin Qing tune, Jin Qingcui
Take rear concentration and recovery.
Specifically, the correlation model of described " input " and " output " include partial least square model, polynomial regression model,
Artificial neural network, support vector machines or multiple linear regression model.
Further, the technological parameter of the sample to be tested includes: with mass parameter
The chlorogenic acid content of medicinal material mensuration operation, chlorogenic acid weight, medicinal material water content；
The heating-up time of honeysuckle abstraction process, first time extracting liquid volume, second of extracting liquid volume, extracting solution are overall
Product；
Cream weight is concentrated out in the concentrate specific gravity of honeysuckle enrichment process, paste outer temperature, concentration time, honeysuckle；
Steam aperture, the volatilization oil volume, heating-up time of sweet wormwood abstraction process；
Sweet wormwood enrichment process goes out cream specific gravity, paste outer temperature, concentration time；
The supernatant volume of sweet wormwood recovery process, recycling medicinal extract temperature, recovery time；
The honeysuckle concrete weight of golden blueness alcohol precipitation process, medical fluid finally contain determining alcohol, supernatant volume；
Volume, recovery time, the medicinal extract volume, medicinal extract weight of the alcohol precipitation supernatant of the absorption of enrichment process after golden blueness alcohol precipitation
Amount；
When the hydrochloric acid weight of Jin Qing tune acid extraction procedure, extraction mean flow rate, extraction times measure, adjust acidleach cream weight, extraction
Between；
The recovery time of concentration and recovery process, out cream specific gravity, paste outer temperature after Jin Qing extraction.
Sweet wormwood recycling is preferably chlorogenic acid content, chlorogenic acid weight in medicinal material mensuration operation；The gold of honeysuckle enrichment process
Cream weight is concentrated out in honeysuckle flower；The honeysuckle concrete weight of golden blueness alcohol precipitation process and the amount volume of supernatant；It is concentrated after golden blueness alcohol precipitation
Volume, recovery time, medicinal extract volume, the medicinal extract weight of the alcohol precipitation supernatant of process；Tune acidleach in Jin Qing tune acid extraction procedure
Cream weight, extraction time.
The invention also provides a kind of preparation methods of Reduning injection, which is characterized in that this method comprises:
Medicinal material measurement, honeysuckle are extracted, honeysuckle concentration, sweet wormwood extracts, sweet wormwood is concentrated, sweet wormwood recycling, gold green alcohol precipitation, gold
Concentration and recovery process after concentration, the acid extraction of Jin Qing tune, Jin Qing extraction after green alcohol precipitation；Wherein, the chlorogenic acid of medicinal material mensuration operation contains
Amount, chlorogenic acid weight go out cream weight, the honeysuckle concrete of gold blueness alcohol precipitation process after the honeysuckle concentration of honeysuckle enrichment process
Weight and supernatant volume, gold blueness alcohol precipitation after enrichment process alcohol precipitation supernatant volume, recovery time, medicinal extract volume, medicinal extract
Weight, the tune acidleach cream weight of Jin Qing tune acid extraction procedure, extraction time are constant setting.The constant setting refers to: this
A little key parameters are controlled in metastable range, to guarantee the stability of the target component of injection products.
Compared with the prior art, the invention has the following advantages:
The present invention is by the correlation model established between each process technological parameter, mass parameter and the chlorogenic acid rate of transform, in advance
The method for surveying the chlorogenic acid rate of transform evaluates chlorogenic acid rate of transform mode relative to existing off-line check, helps to more fully understand
Influence of the Reduning injection production process to chlorogenic acid rate of transform quality, it is convenient that the factor for influencing the chlorogenic acid rate of transform is carried out
Intervene and carry out the sustained improvement of production process quality control in advance.Moreover, by filtering out each process technological parameter, quality
The important parameter of parameter is controlled, and the Reduning injection with the more stable chlorogenic acid rate of transform can be obtained.
Detailed description of the invention
Fig. 1 is that present invention process parameter, mass parameter attribute and chlorogenic acid shift rate matrix schematic diagram.
Specific embodiment
Below in conjunction with drawings and examples, a specific embodiment of the invention is described in more details, so as to energy
The advantages of enough more fully understanding the solution of the present invention and its various aspects.However, specific embodiments described below and reality
It applies example to be for illustrative purposes only, rather than limiting the invention.
Unless otherwise defined, it anticipates known to all professional and scientific terms as used herein and one skilled in the art
Justice is identical.In addition, any method similar to or equal to what is recorded and material all can be applied to the present invention.
Embodiment 1 is based on technological parameter, the mass parameter attribute quantitative forecast chlorogenic acid rate of transform
1. sample collection
Collect technological parameter and mass parameter (formulation batch: 180101, involved in Reduning injection production process
180102、180103、180104、180105、180106、180107、180108、180109、180110、180111、
180112 ... 180907 totally 232 batches), Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov's production.
The building of technique involved in a process, qualitative attribute matrix more than 2.
Collect technological parameter involved in 232 batches of Reduning injection production processes, mass parameter attribute, building technique ginseng
Several and mass parameter attribute data collection.Wherein, technological parameter includes: that medicinal material mensuration operation data subset is with mass parameter attribute
The form of matrix Z1 (232 × 3), honeysuckle abstraction process data subset are the form of matrix Z2 (232 × 4), honeysuckle concentration
Process data subset is the form of matrix Z3 (232 × 4), and sweet wormwood abstraction process data subset is the shape of matrix Z4 (232 × 3)
Formula, sweet wormwood enrichment process data subset be matrix Z5 (232 × 3) form, sweet wormwood data collection subset be matrix Z6 (232 ×
3) form, gold blueness alcohol precipitation data subset are the form of matrix Z7 (232 × 3), and enrichment process data subset is after gold blueness alcohol precipitation
The form of matrix Z8 (232 × 4), gold blueness extraction process data subset are the form of matrix Z9 (232 × 5), gold blueness concentration and recovery
Process data subset is matrix Z10 (232 × 3).
Above-mentioned technological parameter, mass parameter include:
Chlorogenic acid content, chlorogenic acid weight in medicinal material mensuration operation, medicinal material water content；
Heating-up time, first time extracting liquid volume in honeysuckle abstraction process, second of extracting liquid volume, extracting solution are total
Volume；
Go out cream weight after concentrate specific gravity, paste outer temperature, concentration time, honeysuckle concentration in honeysuckle enrichment process
Amount；
Steam aperture, volatilization oil volume, heating-up time in sweet wormwood abstraction process；
Go out cream specific gravity, paste outer temperature, concentration time in sweet wormwood enrichment process；
Supernatant volume, recycling medicinal extract temperature, recovery time in sweet wormwood recovery process；
Honeysuckle concrete weight, medical fluid in golden blueness alcohol precipitation process is finally containing determining alcohol, obtained supernatant volume；
Volume, recovery time, the medicinal extract volume, medicinal extract weight of the alcohol precipitation supernatant of absorption after golden blueness alcohol precipitation in enrichment process
Amount；
Hydrochloric acid weight, extraction mean flow rate, extraction times amount, tune acidleach cream weight, extraction in Jin Qing tune acid extraction procedure
Time；
Recovery time after Jin Qing extraction in concentration and recovery process goes out cream specific gravity, paste outer temperature.
Sweet wormwood recycles the technique of 10 processes, qualitative attribute data subset matrix combination building production process technology, quality
Data set matrix X (232 × 35), and carry out mean value standardization pretreatment and obtain matrix X ' (232 × 35).
3. model foundation
The rate of transform of 232 batch chlorogenic acids is collected, constitutes chlorogenic acid transfer rate matrix Y (232 × 1), thus with chlorogenic acid
Shifting rate matrix Y (232 × 1) is dependent variable, with technological parameter and mass parameter attribute matrix X ' for independent variable, by [X ', Y] square
Battle array is divided into calibration set with 2:1: verifying collection, can obtain calibration set (154x36) and verifying collection (78x36) batch data, verifying collection 58
Batch.It is established by corresponding software (such as Matlab software, SIMCA software, the present embodiment is by taking SIMCA software as an example) and predicts green original
The partial least square model Y=f (X ') of acid transfer rate.Matrix is shown in Fig. 1.
In obtained Partial Least-Squares Regression Model, latent variable is because subnumber is 3, the R (Y) of model2=0.817, Q2=
0.588, it is preferable explanatory and predictive to show that model built has.
R(Y)2The fitness degree of interpretation model, value is bigger, and the fitting degree of model is bigger.
Q2The estimated performance of interpretation model, value is bigger, and the predictability of model is better.
4. model is verified
4.1 verify collection, building Reduning injection technological parameter and mass parameter attribute matrix L according to shown in 3.
4.2 bring technological parameter and mass parameter attribute matrix L into the chlorogenic acid prediction model, predict new heat
(average opposite prediction standard is inclined less than 7% for the average opposite prediction deviation of the chlorogenic acid rate of transform of malicious injection for curing production batch
Difference=average (abs (true value-predicted value)/true value) * 100% result is as shown in table 1 below.The prediction of the chlorogenic acid rate of transform
Value is close with true value, shows the quantitative forecast that established model prediction is functional, suitable for the chlorogenic acid rate of transform.
1 78 batches of verifyings of table collect prediction result
5. comparing Q by constantly rejecting the technological parameter inputted in 2 and mass parameter using SIMCA software2、R2(X)、
R2(Y) size of value finally determines 11 critical component attributes.
Embodiment 2 is based on the critical component attribute forecast Reduning injection chlorogenic acid rate of transform
Based on the model of embodiment 1,11 critical component attributes of 232 batches of Reduning injections are selected, utilization is partially minimum
Two, which multiply model, predicts the Reduning injection chlorogenic acid rate of transform.Wherein, the critical component attribute are as follows:
Chlorogenic acid content, chlorogenic acid weight in medicinal material mensuration operation；After honeysuckle concentration in honeysuckle enrichment process
Cream weight out；Honeysuckle concrete weight, the amount volume of obtained supernatant in golden blueness alcohol precipitation process；Enrichment process after golden blueness alcohol precipitation
In absorption alcohol precipitation supernatant volume, recovery time, medicinal extract volume, medicinal extract weight；Tune in Jin Qing tune acid extraction procedure
Acidleach cream weight, extraction time.
1. sample collection
Collect Reduning injection production process intermediate (formulation batch: 180101,180102,180103,180104,
180105,180106,180107,180108,180109,180110,180111,180112,180907) Jiangsu Kang Yuan medicine company stock
The production of part Co., Ltd.
2. the building of technique, qualitative attribute matrix
Collect each technique, qualitative attribute obtained by the process of 232 batch Reduning injection production processes.Building technique, matter
Measure attribute data collection, wherein technique, qualitative attribute include:
Green former content, chlorogenic acid weight in medicinal material mensuration operation form medicinal material mensuration operation qualitative attribute data subset square
Battle array Z1 (232 × 2)；
Go out cream weight after the concentration of honeysuckle obtained by enrichment process, forms enrichment process qualitative attribute data subset matrix Z2
(232×1)；
Honeysuckle concrete weight, the amount volume of obtained supernatant obtained by alcohol precipitation process, form alcohol precipitation qualitative attribute data
Subset matrix Z3 (232 × 2)；
Volume, recovery time, medicinal extract volume, the medicinal extract weight for the alcohol precipitation supernatant drawn obtained by concentration and recovery process, group
At the technique of recovery process, qualitative attribute data subset matrix Z4 (232 × 4)；
It adjusts and adjusts acidleach cream weight and extraction time obtained by acid extraction procedure, form extraction process technique, qualitative attribute data
Subset matrix Z5 (232 × 2)；
Technique, qualitative attribute data set matrix combination building production process technology and the qualitative attribute data set of 5 processes
Matrix X (232 × 11), and carry out mean value standardization pretreatment and obtain matrix X ' (232 × 11).
3. model foundation
Collect the 232 batch Reduning injection chlorogenic acid rate of transform, thus constitute chlorogenic acid transfer rate matrix Y (232 ×
1), with chlorogenic acid transfer rate matrix Y (232 × 1) for dependent variable, with technique, qualitative attribute matrix X ' for independent variable, by corresponding
Software (such as Matlab software) establishes the partial least square model of the prediction Reduning injection chlorogenic acid rate of transform.
Modeling result are as follows:+0.0195 chlorogenic acid weight of the chlorogenic acid rate of transform=0.1678-25.80 chlorogenic acid content-
+ 0.0231 alcohol precipitation of+0.0426 supernatant volume of -0.000021 honeysuckle concrete weight of cream weight is concentrated out in 0.000209 honeysuckle
+ 0.001393 medicinal extract weight -0.000309 of -0.181 medicinal extract volume of -0.000210 recovery time of supernatant volume adjusts medicinal extract after acid
+ 0.000041 extraction time of weight empirically, the modeled property index R of creation data2Adj is greater than 0.5, can illustrate that model has
Standby good predictive ability.This patent model R2Adj is 0.67, shows that modeling works well, there is certain predictive ability.
4. based on model prediction Reduning injection effective component is extracted, alcohol precipitation, extraction etc. are shifted after 10 processes totally
The method of rate
4.1 collect new production batch (formulation batch: 190101,190102,190103,190104,190105).
4.2 methods same as before collect technique, the qualitative attribute of new production batch.
Technique, the qualitative attribute matrix L of the new Reduning injection batch of 4.3 buildings.
4.4 bring constructed technique, qualitative attribute matrix L into the chlorogenic acid rate of transform prediction model, predict
The average relative error of the chlorogenic acid rate of transform of new Reduning injection production batch is less than 6%.As a result as 2 Redujing Granules of table are infused
It penetrates liquid chlorogenic acid rate of transform predicted value and true value is close, show that established model prediction is functional, be suitable for Redujing Granules
The quantitative forecast of the injection chlorogenic acid rate of transform.
2 new production data prediction result of table
A kind of preparation method of the Reduning injection of embodiment 3
It is as follows using the method for preparing injection by sweet wormwood, honeysuckle, the molecular Chinese medicine composition of Cape jasmine: 1500 weight of sweet wormwood
Measure part, 900 parts by weight of honeysuckle, 1260 parts by weight of cape jasmine.
90 DEG C of hot water of 18 times of amounts is added in extracting honeysuckle medicinal material, (honeysuckle abstraction process), extracts 2 times, 1 is small every time
When, collect that distillate is spare, and combined extract, (honeysuckle enrichment process) takes extracting solution to be concentrated under reduced pressure into medicinal extract specific gravity to be
1.10-1.12 it is stand-by to obtain honeysuckle concentrated extract.(sweet wormwood abstraction process) Artemisia annua adds honeysuckle distillate, distills 6 hours,
Volatile oil and extracting solution are collected, sweet wormwood volatile oil and sweet wormwood extracting solution are obtained；(sweet wormwood enrichment process) takes 60 DEG C of sweet wormwood extracting solution
It is 1.10 that decompression merging, which is concentrated to specific gravity, obtains sweet wormwood concentrated extract, and ethyl alcohol is added in (sweet wormwood recovery process), reaches alcohol content
80%, NaOH is added to medical fluid pH value and reaches 8, stands 12h, obtains supernatant, it is 1.10 that ethyl alcohol, which is recovered under reduced pressure, and is concentrated into specific gravity,
It obtains sweet wormwood and recycles concentrated extract；Honeysuckle concentrated extract is mixed into (gold blueness alcohol precipitation process) with sweet wormwood recycling concentrated extract, second is added
Alcohol makes alcohol content reach 75%, stands 36 hours, filtration, and (enrichment process after gold blueness alcohol precipitation) filtrate decompression is concentrated into specific gravity and is
1.20, (Jin Qing tune acid extraction procedure) is 2 with hydrochloric acid tune pH value, and (concentration and recovery process after sweet wormwood extraction) uses equivalent ethyl acetate
Extraction 10 times, takes extract liquor, is concentrated under reduced pressure into no ethyl acetate taste, pours out concentrate, is dried in vacuo, and obtains the extraction of honeysuckle sweet wormwood
Object.Cape jasmine is ground into coarse powder, is heated to reflux 3 times with 8 times of 90% ethyl alcohol of amount, 2 hours every time, merges medical fluid, filtration, filtrate recycling
Ethyl alcohol is simultaneously concentrated into the 50% of original volume, is heated 2 hours with hydrochloric acid tune pH value for 2.5,100 DEG C, the solid of 1% medicinal material amount is added
Paraffin stirs evenly, and refrigerates 12 hours, filtration, and the extracting n-butyl alcohol of filtrate equivalent 7 times is concentrated under reduced pressure to no n-butanol taste, vacuum
It is dry, obtain capejasmine extract.
It takes 1000 parts by volume of water for injection to boil, puts into sweet wormwood Honegsukle flower P.E and capejasmine extract, stirring makes two kinds
Extract dissolution, keeps boiling 5 minutes, is cooled to room temperature, and refrigerates 30 hours, filtration, and filtrate tune pH value is 3, and filtrate is taken to heat
To boiling, 1% active carbon is added, boils 12 minutes, refrigeration is filtered after 30 hours, is taken filtrate, is heated to boiling, and tune pH value is
5.05, boiling is cooled to room temperature after 12 minutes, refrigerates 50 hours, and 0.6 parts by weight sodium hydrogensulfite, constant volume 1000 is added in filtration
Parts by volume, stirring take 50 parts by volume of solution, are heated to 65 DEG C of addition 4 parts by volume of Tween-80, stir evenly, and sweet wormwood volatile oil is added, stirs
Even, filtrate is carried out ultrafiltration with the hollow-fibre membrane that molecular weight is 30000, obtains ultrafiltrate by filtration；30000 ultrafiltration medical fluids are taken, are used
The plate membrane that molecular weight is 10000 carries out ultrafiltration, obtains ultrafiltrate, crosses 0.22 μm of miillpore filter, packing, flowing steam sterilization
50min。
Parts by volume/the parts by weight are corresponding with L/kg.
It is prepared as described above method, prepares 20 batches of samples, wherein chlorogenic acid content, chlorogenic acid weight in medicinal material mensuration operation；
Go out cream weight after honeysuckle concentration in honeysuckle enrichment process；Honeysuckle concrete weight in golden blueness alcohol precipitation process obtains
The amount volume of supernatant；The volume of the alcohol precipitation supernatant of absorption after golden blueness alcohol precipitation in enrichment process, recovery time, medicinal extract body
Product, medicinal extract weight；Tune acidleach cream weight in Jin Qing tune acid extraction procedure, extraction time control respectively (0.028~
0.033) %；(22.48~26.81) kg；(1111.10~1586.00) kg；(550.40~790.00) kg；(5.10~
6.35)m3；(5.10~6.35) m3；(88.20~199.20) min；(0.29~0.36) m3；(317.10~584.60) kg；
(328.10~607.10%) kg；(547.80~1110.60) min.Other parameters are set or adjusted according to the actual situation, do not make
Special controlling.Measure the chlorogenic acid rate of transform of 20 batches of Reduning injection products.
Seen from table 3, by controlling above-mentioned parameter, the resulting injection Content of Chlorogenic Acid rate of transform content of more batches of samples is also very
Stablize, the chlorogenic acid rate of transform is stablized in 39.69%~41.82%, RSD1.7%..This shows to make by controlling above-mentioned parameter
Obtain the product of the stable chlorogenic acid rate of transform.
More than 3 batches of sample injection Content of Chlorogenic Acid rate of transform of table
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (9)
1. a kind of detection method of Reduning injection chlorogenic acid rate of transform test model, which is characterized in that this method comprises:
Step 1: collecting technological parameter and mass parameter involved in different batches Reduning injection preparation section；
Step 2: collected technological parameter and mass parameter are carried out data prediction, matrix stack is constructed；
Step 3: collecting the chlorogenic acid rate of transform of the different batches Reduning injection；
Step 4: technological parameter and mass parameter are " input " with the chlorogenic acid rate of transform for " output ", establish " input " and " defeated
Correlation model out ", for testing the Reduning injection chlorogenic acid rate of transform.
2. the method according to claim 1, wherein Reduning injection preparation section includes in the step 1
After medicinal material measurement, honeysuckle extraction, honeysuckle concentration, sweet wormwood extraction, sweet wormwood concentration, sweet wormwood recycling, golden green alcohol precipitation, golden green alcohol precipitation
Concentration and recovery after concentration, the acid extraction of Jin Qing tune, Jin Qing extraction.
3. method according to claim 1 or 2, which is characterized in that the correlation model of " input " and " output " includes
Partial least square model, polynomial regression model, artificial neural network, support vector machines or multiple linear regression model.
4. a kind of test method of the Reduning injection chlorogenic acid rate of transform, which is characterized in that
Step 1: collecting technological parameter and mass parameter involved in different batches Reduning injection preparation section；
Step 2: collected technological parameter and mass parameter are carried out data prediction, matrix stack is constructed；
Step 3: collecting the chlorogenic acid rate of transform of the different batches Reduning injection；
Step 4: technological parameter and mass parameter are " input " with the chlorogenic acid rate of transform for " output ", establish " input " and " defeated
Correlation model out "；
Step 5: the technological parameter and mass parameter of batch to be measured are collected, according to the association of " input " and " output " established
Model acquires the chlorogenic acid rate of transform of sample to be tested.
5. according to the method described in claim 4, it is characterized in that, Reduning injection preparation section includes in the step 1
After medicinal material measurement, honeysuckle extraction, honeysuckle concentration, sweet wormwood extraction, sweet wormwood concentration, sweet wormwood recycling, golden green alcohol precipitation, golden green alcohol precipitation
Concentration and recovery after concentration, the acid extraction of Jin Qing tune, Jin Qing extraction.
6. method according to claim 4 or 5, which is characterized in that the correlation model of " input " and " output " includes
Partial least square model, polynomial regression model, artificial neural network, support vector machines or multiple linear regression model.
7. according to the method described in claim 6, it is characterized in that, the technological parameter of the sample to be tested and mass parameter packet
It includes:
The chlorogenic acid content of medicinal material mensuration operation, chlorogenic acid weight, medicinal material water content；
The heating-up time of honeysuckle abstraction process, first time extracting liquid volume, second of extracting liquid volume, extracting solution total volume；
Cream weight is concentrated out in the concentrate specific gravity of honeysuckle enrichment process, paste outer temperature, concentration time, honeysuckle；
Steam aperture, the volatilization oil volume, heating-up time of sweet wormwood abstraction process；
Go out cream specific gravity, paste outer temperature, concentration time in sweet wormwood enrichment process；
Supernatant volume, recycling medicinal extract temperature, recovery time in sweet wormwood recovery process；
Honeysuckle concrete weight, medical fluid in golden blueness alcohol precipitation process finally contain determining alcohol, supernatant volume；
Volume, recovery time, medicinal extract volume, the medicinal extract weight of the alcohol precipitation supernatant of enrichment process after golden blueness alcohol precipitation；
Hydrochloric acid weight, extraction mean flow rate, extraction times amount, tune acidleach cream weight, extraction time in Jin Qing tune acid extraction procedure；
Recovery time after Jin Qing extraction in concentration and recovery process goes out cream specific gravity, paste outer temperature.
8. the method according to the description of claim 7 is characterized in that the technological parameter and mass parameter of the batch to be measured are as follows:
Chlorogenic acid content, chlorogenic acid weight in medicinal material mensuration operation；
Go out cream weight after honeysuckle concentration in honeysuckle enrichment process；
Honeysuckle concrete weight in golden blueness alcohol precipitation process, obtained supernatant volume；
Volume, recovery time, medicinal extract volume, the medicinal extract weight of the alcohol precipitation supernatant of absorption after golden blueness alcohol precipitation in enrichment process；
Tune acidleach cream weight in Jin Qing tune acid extraction procedure, extraction time.
9. a kind of preparation method of Reduning injection, which is characterized in that this method comprises: medicinal material measurement, honeysuckle are extracted, gold
Honeysuckle flower concentration, sweet wormwood are extracted, sweet wormwood is concentrated, sweet wormwood recycles, are concentrated after the green alcohol precipitation of gold, gold blueness alcohol precipitation, the acid extraction of Jin Qing tune, Jin Qing
Concentration and recovery process after extraction；Wherein, the chlorogenic acid content of medicinal material mensuration operation, chlorogenic acid weight, honeysuckle enrichment process
Honeysuckle is concentrated out cream weight, the honeysuckle concrete weight and supernatant volume of gold blueness alcohol precipitation process, and work is concentrated after gold blueness alcohol precipitation
Alcohol precipitation supernatant volume, recovery time, medicinal extract volume and the medicinal extract weight of sequence, the tune acidleach cream weight of Jin Qing tune acid extraction procedure
Amount, extraction time are constant setting.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107578104A (en) * | 2017-08-31 | 2018-01-12 | 江苏康缘药业股份有限公司 | A kind of Chinese Traditional Medicine knowledge system |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107578104A (en) * | 2017-08-31 | 2018-01-12 | 江苏康缘药业股份有限公司 | A kind of Chinese Traditional Medicine knowledge system |
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