CN105223162B - One kind production liquaemin process elution monitoring method - Google Patents
One kind production liquaemin process elution monitoring method Download PDFInfo
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- CN105223162B CN105223162B CN201510626468.6A CN201510626468A CN105223162B CN 105223162 B CN105223162 B CN 105223162B CN 201510626468 A CN201510626468 A CN 201510626468A CN 105223162 B CN105223162 B CN 105223162B
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Abstract
The present invention relates to one kind production liquaemin process elution monitoring method, the described method comprises the following steps：A. the salting liquid sampling of resin will be eluted as standard liquid calibration Composition distribution baseline；B. the monitoring to technique completeness manually is completed to the concentration mensuration for having eluted salting liquid, while utilizes differential detection detection solution index of refraction；C. the differential detection refractive power Value Data of gained is detected into gained eluent salt concentration with conventional manual to be associated, builds mathematical modeling；D. the monitoring capacity of mathematical modeling is verified.The method can be monitored in real time to elution progress, and operation is simpler compared with the upper hand inspection used of present production convenient, fast efficient.
Description
Technical field
The present invention relates to a kind of method being monitored in liquaemin production process using Composition distribution to eluent,
To reach the purpose being monitored to elution processes process.
Background technology
The monitoring during Workshop Production liquaemin to elution processes process schedule is all to having washed by worker at present
Deviate from the concentration mensuration of salting liquid to complete the monitoring to technique completeness, such a mode can not reach to the monitoring for eluting progress
To elute overall process monitoring, easily occur run medicine situation, and using artificial operating cost when it is laborious.
So exploitation can monitor elution progress and simply and easily monitoring system in real time, to producing liquaemin right and wrong
Chang Youyi and very necessary.
The content of the invention
A kind of production liquaemin process elution monitoring method that this specification is illustrated, has the characteristics that:Realize heparin
The real-time monitoring of sodium production process elution process, avoid eluting production accident that is insufficient and excessively eluting.
The technology path that this technology uses for：
This method is that production process is monitored by establishing the mathematical modeling of Composition distribution index of refraction, using showing difference
The principle of detection detection solution index of refraction realizes monitoring in real time to liquaemin elution progress.
To achieve these goals, the technical solution adopted by the present invention is：
One kind production liquaemin process elution monitoring method, it is characterized in that using following steps：
A. Composition distribution baseline is calibrated as standard liquid using after the salting liquid sampling processing for eluting resin；
B. liquaemin elution process is directed to, manually the concentration mensuration for having eluted salting liquid is completed complete to technique
Cheng Du monitoring, while detect elution salting liquid index of refraction in real time using Composition distribution；
C. conventional manual is detected into gained eluent salt concentration to be closed with corresponding differential detection refractive power Value Data
Connection, build mathematical modeling；
D. the monitoring capacity of mathematical modeling is verified.
The processing method of the salting liquid of the standard liquid of described calibration Composition distribution baseline is that 100Hz frequencies first surpass
Sound dissolves 30min, then filters.
Described mathematical modeling is eluent salt concentration obtained by refractive power value and artificial detection using differential detection as reference axis
The standard curve of structure, mathematical modeling calibration curve formula are y=1.0022x -0.0526, and y is eluent index of refraction, and x is
Eluent salt concentration.
The monitoring capacity verification method of described mathematical modeling is in new liquaemin elution process, obtained by artificial detection
Eluent salt concentration and calculate gained eluent salt concentration using the mathematical modeling that builds and contrasted, and to artificial detection institute
Obtain eluent salt concentration data and corresponding index of refraction carries out correlation analysis.
This production liquaemin process elution monitoring method, which only needs to utilize, elutes salting liquid and crude salt solution differential detection number
Elution progress is monitored in real time according to founding mathematical models can, the operation relatively upper hand inspection used of production now is more
Simple and convenient, quickness and high efficiency.Substantial amounts of manpower and materials are saved, it also avoid medicine loss caused by detection process complex steps
Problem.
Brief description of the drawings
Real-time monitoring chromatogram of Fig. 1 Composition distributions to eluent；
The mathematical modeling of Fig. 2 structures；
Fig. 3 mathematical modelings monitoring capacity verifies that is, data dependence is verified.
Embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention
It is further elaborated.The specific embodiments described herein are merely illustrative of the present invention, is not used to limit this hair
It is bright.
Embodiment
Using the monitoring system of differential detection（RI-201H）Liquaemin elution processes are monitored in real time：
A. 2.7%, 12% salting liquid is configured with purified water and injection grade sodium chloride first（w/w）, wherein 2.7% salting liquid
Configure 1200L, 12% salting liquid configuration 1000L.Filtered after taking 12% salting liquid 1000ml ultrasonic dissolutions 30min, as showing difference
The standard liquid of detection, with Calibration Base Line.
B. liquaemin elution processes step is carried out at room temperature：With 12%（w/w）NaCl solution 1000L to elution post enter
Row elution, when C post efflux index of refraction value addeds reach 4.3%, stand 2h, then start to elute again, by eluent collect to
Then with 2.7% in glass reaction kettle 3（w/w）NaCl solution 1200L to resin column carry out pressure, when elution pillar outlet
When efflux index of refraction is less than 4.0%, stop collecting eluent.
The monitoring in real time of eluent index of refraction such as Fig. 1, the parameter of Composition distribution in elution processes step is as follows：
Eluent index of refraction and corresponding eluent salt concentration data are as follows：
C. the differential detection index of refraction of gained and conventional manual's detection gained eluent salt angle value are associated and establish number
Model is learned, such as Fig. 2, can obtain its mathematical modeling calibration curve formula is y=1.0022x -0.0526, R2=0.9995, y
For eluent index of refraction, x is eluent salt concentration.
D. the monitoring capacity of mathematical modeling is verified
In new liquaemin elution processes step, eluent index of refraction is monitored in real time with Composition distribution, and chooses
Time point gathers eluent, detects its concentration.According to corresponding time point index of refraction, substitute into step C mathematical modeling y=
1.0022x -0.0526, the salinity calculated, its data are as follows：
The eluent salt concentration that the eluent index of refraction of upper table and detection obtain is built into standard curve, such as Fig. 3, can obtain
The standard variance R of curve2 =0.999。
The liquor strength deviation of the eluent obtained by mathematical modeling meets production standard requirement, that is, establishes mathematical modulo
Type, it can substitute solution salt concentration measurement using surveyed index of refraction and elution processes process is monitored in real time.
The above-described embodiments are merely illustrative of preferred embodiments of the present invention, not to the structure of the present invention
Think and scope is defined, on the premise of design concept of the present invention is not departed from, ordinary skill technical staff is to this in this area
The all variations and modifications that the technical scheme of invention is made, protection scope of the present invention all should be fallen into.
Claims (1)
1. one kind production liquaemin process elution monitoring method, it is characterized in that using following steps：
A. Composition distribution baseline, described calibration are calibrated as standard liquid using after the salting liquid sampling processing for eluting resin
The processing method of the salting liquid of the standard liquid of Composition distribution baseline is ultrasonic 100Hz dissolvings 30min, is then filtered；
B. the monitoring to technique completeness manually is completed to the concentration mensuration for having eluted salting liquid, while utilizes and show difference
Detection detection solution index of refraction；
C. the differential detection refractive power Value Data of gained is detected into gained eluent salt concentration with conventional manual to be associated, built
Mathematical modeling, described mathematical modeling are eluent salt concentration obtained by refractive power value and artificial detection using differential detection as reference axis
The standard curve of structure, mathematical modeling calibration curve formula are y=1.0022x -0.0526, and y is eluent index of refraction, and x is
Eluent salt concentration；
D. the monitoring capacity of mathematical modeling is verified, the monitoring capacity verification method of described mathematical modeling is eluted in liquaemin
During, eluent salt concentration obtained by artificial detection and calculate the concentration progress of gained eluent salt using the mathematical modeling built
Contrast, and correlation analysis is carried out to eluent salt concentration data obtained by artificial detection and corresponding index of refraction.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1831518A (en) * | 2005-12-19 | 2006-09-13 | 江西本草天工科技有限责任公司 | Quick monitoring method for elution start or end of column separation eluent of Chinese medicine |
| CN103203123A (en) * | 2012-05-09 | 2013-07-17 | 山东绿叶制药有限公司 | Automatic judgment and control for eluant receiving of buckeye extract |
| CN104845651A (en) * | 2015-06-10 | 2015-08-19 | 神华集团有限责任公司 | Method of separating components of coal tar |
| CN104865326A (en) * | 2015-05-28 | 2015-08-26 | 江苏奥迪康医学科技有限公司 | Three-gradient elution analysis method of glycosylated hemoglobin analyzer |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9442098B2 (en) * | 2012-08-02 | 2016-09-13 | Waters Technologies Corporation | Chromatographic system quality control reference materials |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1831518A (en) * | 2005-12-19 | 2006-09-13 | 江西本草天工科技有限责任公司 | Quick monitoring method for elution start or end of column separation eluent of Chinese medicine |
| CN103203123A (en) * | 2012-05-09 | 2013-07-17 | 山东绿叶制药有限公司 | Automatic judgment and control for eluant receiving of buckeye extract |
| CN104865326A (en) * | 2015-05-28 | 2015-08-26 | 江苏奥迪康医学科技有限公司 | Three-gradient elution analysis method of glycosylated hemoglobin analyzer |
| CN104845651A (en) * | 2015-06-10 | 2015-08-19 | 神华集团有限责任公司 | Method of separating components of coal tar |
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