CN214937139U - Chorionic gonadotrophin processing system - Google Patents
Chorionic gonadotrophin processing system Download PDFInfo
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- CN214937139U CN214937139U CN202120802648.6U CN202120802648U CN214937139U CN 214937139 U CN214937139 U CN 214937139U CN 202120802648 U CN202120802648 U CN 202120802648U CN 214937139 U CN214937139 U CN 214937139U
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Abstract
The utility model discloses a short nature element system of processing of fine hair, include through pipeline communicating pipe in proper order draw jar, first separation module, gunbarrel and second separation module, first separation module includes first centrifuge and the first chromatography post of mutual intercommunication, first centrifuge and draw jar intercommunication, first chromatography post and gunbarrel intercommunication, second separation module includes the second centrifuge and the second chromatography post of mutual intercommunication, second centrifuge and gunbarrel intercommunication, second chromatography post and vacuum drying case intercommunication. The utility model discloses an improvement to the system of processing for the processing of short sex hormone of fine hair is more simple and convenient, secondly has improved short sex hormone's machining efficiency greatly.
Description
Technical Field
The utility model belongs to midbody processing field, concretely relates to short sex hormone system of processing.
Background
The chorionic gonadotropin has extremely similar action with luteinizing hormone secreted by pituitary, can promote and maintain the function of corpus luteum for women, and ensures that the corpus luteum synthesizes progestogen; in combination with menotrophins having a Follicle Stimulating Hormone (FSH) component, folliculogenesis and maturation is promoted and ovulation is triggered by a physiological spike of luteinizing hormone. For men, the male can make the testis with hypopituitarism produce androgen, and promote the descent of testis and the development of male secondary sexual characteristics. The existing method has the advantages of small device capacity, complex operation, low yield and difficult popularization and utilization.
Therefore, it is necessary to provide a chorionic gonadotrophin processing system to solve the above problems.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a short nature element processing system of fine hair to solve the current processingequipment operation complicacy that proposes in the above-mentioned background art, problem inefficient.
In order to solve the above problems existing in the prior art, the utility model discloses the technical scheme who adopts is:
the chorionic gonadotrophin processing system comprises an extraction tank, a first separation component, a precipitation tank, a second separation component, a third separation component, an ultrafiltration membrane system and a vacuum drying box which are communicated with each other in sequence through pipelines.
The first separation component comprises a first centrifuge and a chromatography A column which are communicated with each other, the first centrifuge is communicated with the extraction tank, and the chromatography A column is communicated with the precipitation tank.
The second separation component comprises a second centrifuge and a chromatography B column which are communicated with each other, the second centrifuge is communicated with the sedimentation tank, and the chromatography B column is communicated with the vacuum drying box through an ultrafiltration membrane system.
The third separation component comprises a third centrifuge and a chromatography C column which are communicated with each other, the third centrifuge is communicated with the chromatography B column, and the chromatography C column is communicated with the ultrafiltration membrane system through a fourth centrifuge.
Further, the first centrifuge, the second centrifuge and the third centrifuge are all freezing centrifuges.
Furthermore, an organic polymer roll-up membrane is arranged in the ultrafiltration membrane.
Furthermore, a raw material channel and a permeate channel are arranged in the roll-type membrane element.
Furthermore, the inlet and outlet of the raw material liquid channel are arranged at two ends of the membrane element, the raw material liquid flows along the axial direction, and the section of the channel is spiral.
Furthermore, a permeate flow channel in the ultrafiltration membrane system is spiral and is gathered to the central pipe to flow out.
Further, the ultrafiltration membrane system is communicated with the vacuum drying box through a fifth centrifuge.
The processing technology comprises the following steps: the step A specifically comprises the following steps:
step A1, preparing a Tris-HCL equilibrium solution.
Step a11, Tris: purified water was mixed at a weight ratio of 1:150, and dissolved with stirring to obtain a solution a 1.
And A12, adding HCL into the solution a1, adjusting the pH to 7-9 and the conductivity to 3-5 ms/cm, and obtaining a solution a 2.
Step A13, putting the HCG intermediate into an extraction tank, adding 10 times of solution a2 (weight ratio), stirring and dissolving to obtain solution a 3.
And step A2, extracting and centrifuging.
Step A21, putting the solution a3 into a first centrifuge, adjusting the centrifuge speed to be 100-300 rpm/min, and the time: standing for 10-20min, and precipitating for 1-3 h.
Step A22, adjusting the rotating speed of a first centrifuge to 2000-5000 rpm/min, and adjusting the temperature: 0-10 ℃, time: 10-50 min.
Step a23, the supernatant of step a22 was collected to give solution a 4.
And step A24, collecting the precipitate obtained in the step A22, adding 10-30 times (by weight) of the solution A3, and repeating the steps A21-A24 to obtain a solution a 5.
Step a25, combine solution a4 and solution a5 to give solution a 6.
The step B comprises the following steps:
step B1, solution preparation.
Step B11, preparing a sodium hydroxide solution: taking sodium hydroxide by weight: the purified water was dissolved with stirring at a ratio of 1:65 to obtain a sodium hydroxide solution.
Step B12: preparing a regeneration liquid; taking sodium chloride by weight: purified water was dissolved with stirring at a ratio of 1:23 to obtain a regenerated solution.
Step B13: preparing primary eluent; taking Tris according to parts by weight: sodium chloride: dissolving purified water in a ratio of 7:17:1200 with stirring, adding HCL, and adjusting the pH to 7-9 to obtain a primary eluent.
The chromatographic column is checked before running and meets the following normal working conditions: ambient temperature: 0 to 10 ℃. The periphery of the device is free from strong electromagnetic field interference and corrosive gas. The installation place should be stable and not have strong vibration. The checking filler is cleaned, the chromatographic column is installed completely, the inlet valve, the outlet valve and the pipeline of the chromatographic column are connected correctly, and the sealing is complete. And the control system has correct management connection and complete sealing.
Working pressure: less than or equal to 0.3MPa, the flow rate is 0-150L/h, and the pH and the conductance of the final effluent are the same as those of the equilibrium solution.
Step B2, chromatography.
And step B21, enabling the solution a6 to flow through the chromatography A column at a flow rate of 0-100L/h, an inlet pressure of less than or equal to 0-0.3 MPa and an outlet pressure of less than or equal to 0.2-0.3 MPa, and obtaining a solution B1 after sample loading is finished.
And step B22, washing the solution B1 with a buffer solution until the absorption value of the ultraviolet detector at 280nm is less than 1, respectively collecting the effluent liquid B and the leacheate B, mixing the effluent liquid B and the leacheate B, and putting the mixture into a precipitation tank for alcohol precipitation to obtain a solution B2.
And step B23, washing the solution a6 with the primary eluent and the regeneration solution until the absorption value of the ultraviolet detector at 280nm is less than 1 (less than 1), respectively collecting the eluent B and the regeneration solution B, and respectively detecting the content of the solution a6 in the eluent B and the regeneration solution B.
And step B24, when the content of the solution a6 is more than or equal to 100IU/ml, repeating the step B22 and the step B23 and continuing chromatography.
When the content of the solution a6 is less than or equal to 100IU/ml, discharging the eluent b and the regeneration liquid b.
The step C comprises the following steps:
and step C1, storing ethanol (with concentration not less than 85 percent and measured by an alcohol meter at normal temperature) in a precipitation room by using a stainless steel barrel, and precooling to room temperature.
Step C2, as solution b 2: ethanol ═ 2: 9 adding cold ethanol (the temperature is 2-8 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing, sealing, standing in a refrigeration house, standing overnight to obtain a solution c 1.
And C3, putting the solution C1 into a second centrifugal machine, wherein the rotating speed is 2000-5000 rpm/min, the temperature is 0-10 ℃, and the time is 10 min. The precipitate c2 was collected.
The step D comprises the following steps:
step D1, preparing secondary eluent: taking sodium acetate by weight: sodium chloride: purified water 7: 12: and 1000, stirring for dissolving, and adding acetic acid to adjust the pH value to 5.5-8.5 to obtain a solution d 1.
Step D2, preparing an acetic acid-sodium acetate equilibrium solution: taking sodium acetate by weight: purified water 1:150, stirring and dissolving, adding acetic acid to adjust the pH to 5.5-8.5, and adjusting the conductivity to 4-8 ms/cm to obtain a solution d 2.
Step D3, as precipitate c 2: the buffer solution was mixed at 1:130 and completely dissolved to obtain solution d 3.
The step E comprises the following steps:
and E1, enabling the solution d3 to flow through the treated chromatographic column B at a flow speed of 0-100L/h, an inlet pressure of less than or equal to 0-0.3 MPa and an outlet pressure of less than or equal to 0.2-0.3 MPa, and finishing sample loading.
And E2, washing the solution d3 with a buffer until the absorption of the ultraviolet detector at 280nm is less than 1, respectively collecting the effluent liquid E and the leacheate E, and respectively detecting the content of the solution d3 in the effluent liquid E and the leacheate E.
And E3, when the content of the solution d3 is more than or equal to 100IU/ml, repeating the step E2 and continuing chromatography.
When the content of the solution d3 is less than or equal to 100IU/ml, discharging.
And E4, washing the solution d3 with a secondary eluent until the absorption value of the ultraviolet detector at 280nm is less than 1, and collecting the secondary eluent E1.
And E5, washing with the regeneration liquid until the absorption value of the ultraviolet detector at 280nm is less than 1, collecting the regeneration liquid E, and detecting the content of the solution d3 in the regeneration liquid E1.
Step E6, when the content of the solution d3 is more than or equal to 100IU/ml, repeating the step E5 and continuing chromatography;
when the content of the solution d3 is less than or equal to 100IU/ml, discharging.
The step F comprises the following steps:
and step F1, storing ethanol (with the concentration being more than or equal to 90 percent and measured by an alcohol meter at normal temperature) in a precipitation room by using a stainless steel barrel, and precooling to room temperature.
Step F2, eluting with secondary eluent e 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 2-8 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing, sealing, standing in a refrigeration house, standing overnight to obtain a solution f 1.
And F3, putting the solution F1 into a third centrifuge, wherein the rotating speed is 2000-5000 rpm/min, the temperature is 0-10 ℃, and the time is 10 min. The precipitate f2 was collected.
The step G comprises the following steps:
and G1, preparing an ultrafiltration membrane, checking that electrical appliances, instruments and the like are in good condition before starting the machine, and opening and closing each valve normally. And then carrying out integrity detection, determining the qualified product, wherein the working pressure is 0.2-0.3 MPa, the flow rate is 60-120L/h, and after the qualified product is detected, using the ultrafiltration water as endotoxin water. Adjusting the working pressure of the column chromatography system: the flow rate is less than or equal to 0.3MPa and 0-120L/h, and the pH and the conductance of the final effluent are the same as those of the equilibrium solution.
And G2, enabling the precipitate f2 to flow through the treated chromatographic C column at the flow speed of 0-120L/h, the inlet pressure of less than or equal to 0.2-0.3 MPa and the outlet pressure of less than or equal to 0.2-0.3 MPa, washing the precipitate f2 with a buffer solution until the absorption value of an ultraviolet detector at 280nm is less than 1 after sample loading is finished, respectively collecting an effluent liquid G and a leacheate G, mixing the effluent liquid G and the leacheate G, and performing alcohol precipitation for later use to obtain a solution G1.
And G3, washing the precipitate f2 with the prepared eluent and the regeneration liquid respectively until the absorption value of the ultraviolet detector at 280nm is less than 1, collecting the eluent G and the regeneration liquid G respectively, and detecting the content of endotoxin water in the eluent G and the regeneration liquid G respectively.
Repeating the above process for chromatography when the content of endotoxin water is not less than 100 IU/ml;
when the content of endotoxin water is less than or equal to 100IU/ml, discharging.
Detecting to obtain qualified endotoxin; if the endotoxin is unqualified, repeating the process, and continuing the chromatography to remove the endotoxin until the product is qualified.
As solution g 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 0-10 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing to obtain a solution g2, sealing, standing in a precipitation room, and standing overnight.
Putting the solution g2 into a fourth centrifuge, rotating at 2000-5000 rpm/min, at 0-10 ℃, and keeping for 50 min. A precipitate g3 was obtained.
The step H comprises the following steps:
preparing an ultrafiltration membrane: before starting up, the electric appliances, instruments and the like are checked to be in good condition, and the valves are normally opened and closed. And then carrying out integrity detection, confirming the qualified product, carrying out ultrafiltration membrane endotoxin removal treatment operation according to 'cleaning, disinfecting and endotoxin removal SOP' of an ultrafiltration membrane stack, wherein the working pressure is 0.2-0.3 MPa, the flow rate is 60-120L/h, and after the qualified product is detected, using the ultrafiltration water as endotoxin removal water. And detecting the integrity of the membrane by using a bubble point method, and using the membrane after the integrity is tested to be qualified. Before the membrane is used, the membrane is pretreated by circulating endotoxin-removing water for 30 min.
Step H1: the pressure valve is adjusted to the required working pressure of 0.06 MPa-0.20 MPa. The precipitate g3 was filtered off through the membrane, then 2 column volumes of the membrane core volume were washed out with endotoxin-free water to remove the membrane core, and the permeate h1 was collected.
Step H2: alcohol precipitation and centrifugation: preparing a centrifugal tank: before use, the centrifugal tank is soaked in sodium hydroxide solution prepared by using de-endotoxin water for 8 hours, and then is washed clean by using the de-endotoxin water for later use.
Step H3: according to the permeation liquid h 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 0-10 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, and uniformly mixing to obtain a solution h 2.
Step H4: and putting the solution h2 into a fifth centrifugal machine, and adjusting the rotating speed of the fifth centrifugal machine to 2000-5000 rpm/min, the temperature to 0-10 ℃ and the time to 50 min. A precipitate h3 was obtained.
And step I, quickly placing the precipitate h3 in a vacuum drying oven, closing the drying oven, setting the drying time to be 15h, ensuring that the vacuum degree is more than or equal to-0.06 MPa and the drying temperature is 0-10 ℃, drying, slowly opening an air inlet valve to admit air after ensuring that the material is fully dried, closing the equipment, taking out the material, grinding and mixing for 40 minutes, weighing, sealing, temporarily storing in a virus removal room, and storing at low temperature.
The beneficial effects of the utility model are that through the improvement to the system of processing for the short sex element's of fine hair processing is more simple and convenient, secondly has improved the machining efficiency of short sex element of fine hair greatly.
Drawings
Fig. 1 is a schematic structural diagram of the present invention.
1-an extraction tank; 2-a first centrifuge; 3-chromatography column a; 4-a settling tank; 5-a second centrifuge; 6-chromatography B column; 7-a third centrifuge; 8-chromatography C column; 9-a fourth centrifuge; 10-an ultrafiltration membrane system; 11-a fifth centrifuge; 12-vacuum drying oven.
Detailed Description
The present invention will be further explained with reference to the accompanying drawings and reference numerals.
In order to make the aforementioned objects, features and advantages of the present invention more clearly understood, the present invention will be described in detail with reference to the accompanying drawings and specific embodiments. It should be noted that the embodiments and features of the embodiments of the present application may be combined with each other without conflict.
The terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.
The following detailed description of the embodiments of the present invention will be made with reference to the accompanying drawings. It is to be understood that the description of the embodiments herein is for purposes of illustration and explanation only and is not intended to limit the invention.
Example 1:
as shown in fig. 1, the chorionic gonadotrophin processing system comprises an extraction tank 1, a first separation component, a precipitation tank 4, a second separation component, a third separation component, an ultrafiltration membrane system 10 and a vacuum drying oven 12 which are sequentially communicated with each other through pipelines.
The first separation component comprises a first centrifuge 2 and a chromatography A column 3 which are communicated with each other, the first centrifuge 2 is communicated with an extraction tank 1, and the chromatography A column 3 is communicated with a precipitation tank 4.
The second separation component comprises a second centrifuge 5 and a chromatography B column 6 which are communicated with each other, the second centrifuge 5 is communicated with the sedimentation tank 4, and the chromatography B column 6 is communicated with the vacuum drying box 12 through an ultrafiltration membrane system 10.
The third separation component comprises a third centrifuge 7 and a chromatography C column 8 which are communicated with each other, the third centrifuge 7 is communicated with a chromatography B column 6, and the chromatography C column 8 is communicated with an ultrafiltration membrane system 10 through a fourth centrifuge 9.
In embodiment 2, based on embodiment 1, the first centrifuge 2, the second centrifuge 5, and the third centrifuge 7 are all freezing centrifuges, a spiral organic polymer membrane is disposed in the ultrafiltration membrane, a raw material channel and a permeate channel are disposed in the spiral membrane, an inlet and an outlet of the raw material channel are disposed at two ends of the membrane, the raw material flows along an axial direction, a channel cross section is spiral, a permeate channel in the ultrafiltration membrane system 10 is spiral and is collected to a central tube to flow out, and the ultrafiltration membrane system 10 is communicated with a vacuum drying oven 12 through a fifth centrifuge 11.
The processing technology comprises the following steps: the step A specifically comprises the following steps:
step A1, preparing a Tris-HCL equilibrium solution.
Step a11, Tris: purified water was mixed at a weight ratio of 1:150, and dissolved with stirring to obtain a solution a 1.
And A12, adding HCL into the solution a1, adjusting the pH to 7-9 and the conductivity to 3-5 ms/cm, and obtaining a solution a 2.
Step A13, putting the HCG intermediate into an extraction tank 1, adding 10 times of solution a2 (weight ratio), stirring and dissolving to obtain solution a 3.
And step A2, extracting and centrifuging.
Step A21, putting the solution a3 into a first centrifuge 2, adjusting the centrifuge speed to 100-300 rpm/min, and the time: standing for 10-20min, and precipitating for 1-3 h.
Step A22, adjusting the rotating speed of the first centrifuge 2 to 2000 rpm/min, and adjusting the temperature: 0-10 ℃, time: 10-50 min.
Step a23, the supernatant of step a22 was collected to give solution a 4.
And step A24, collecting the precipitate obtained in the step A22, adding 10-30 times (by weight) of the solution A3, and repeating the steps A21-A24 to obtain a solution a 5.
Step a25, combine solution a4 and solution a5 to give solution a 6.
The step B comprises the following steps:
step B1, solution preparation.
Step B11, preparing a sodium hydroxide solution: taking sodium hydroxide by weight: the purified water was dissolved with stirring at a ratio of 1:65 to obtain a sodium hydroxide solution.
Step B12: preparing a regeneration liquid; taking sodium chloride by weight: purified water was dissolved with stirring at a ratio of 1:23 to obtain a regenerated solution.
Step B13: preparing primary eluent; taking Tris according to parts by weight: sodium chloride: dissolving purified water in a ratio of 7:17:1200 with stirring, adding HCL, and adjusting the pH to 7-9 to obtain a primary eluent.
The chromatographic column is checked before running and meets the following normal working conditions: ambient temperature: 0 to 10 ℃. The periphery of the device is free from strong electromagnetic field interference and corrosive gas. The installation place should be stable and not have strong vibration. The checking filler is cleaned, the chromatographic column is installed completely, the inlet valve, the outlet valve and the pipeline of the chromatographic column are connected correctly, and the sealing is complete. And the control system has correct management connection and complete sealing.
Working pressure: less than or equal to 0.3MPa, the flow rate is 0-150L/h, and the pH and the conductance of the final effluent are the same as those of the equilibrium solution.
Step B2, chromatography.
And step B21, enabling the solution a6 to flow through the chromatography A column 3 at a flow rate of 0-100L/h, an inlet pressure of less than or equal to 0-0.3 MPa and an outlet pressure of less than or equal to 0.2-0.3 MPa, and obtaining a solution B1 after the sample loading is finished.
And step B22, washing the solution B1 with a buffer solution until the absorption value of the ultraviolet detector at 280nm is less than 1, respectively collecting the effluent liquid B and the leacheate B, mixing the effluent liquid B and the leacheate B, and putting the mixture into a precipitation tank 4 for alcohol precipitation to obtain a solution B2.
And step B23, washing the solution a6 with the primary eluent and the regeneration solution until the absorption value of the ultraviolet detector at 280nm is less than 1 (less than 1), respectively collecting the eluent B and the regeneration solution B, and respectively detecting the content of the solution a6 in the eluent B and the regeneration solution B.
And step B24, when the content of the solution a6 is more than or equal to 100IU/ml, repeating the step B22 and the step B23 and continuing chromatography.
When the content of the solution a6 is less than or equal to 100IU/ml, discharging the eluent b and the regeneration liquid b.
The step C comprises the following steps:
and step C1, storing ethanol (with concentration not less than 85 percent and measured by an alcohol meter at normal temperature) in a precipitation room by using a stainless steel barrel, and precooling to room temperature.
Step C2, as solution b 2: ethanol ═ 2: 9 adding cold ethanol (the temperature is 2-8 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing, sealing, standing in a refrigeration house, standing overnight to obtain a solution c 1.
And C3, putting the solution C1 into a second centrifuge 5, wherein the rotating speed is 2000-5000 rpm/min, the temperature is 0-10 ℃, and the time is 10 min. The precipitate c2 was collected.
The step D comprises the following steps:
step D1, preparing secondary eluent: taking sodium acetate by weight: sodium chloride: purified water 7: 12: and 1000, stirring for dissolving, and adding acetic acid to adjust the pH value to 5.5-8.5 to obtain a solution d 1.
Step D2, preparing an acetic acid-sodium acetate equilibrium solution: taking sodium acetate by weight: purified water 1:150, stirring and dissolving, adding acetic acid to adjust the pH to 5.5-8.5, and adjusting the conductivity to 4-8 ms/cm to obtain a solution d 2.
Step D3, as precipitate c 2: the buffer solution was mixed at 1:130 and completely dissolved to obtain solution d 3.
The step E comprises the following steps:
and E1, enabling the solution d3 to flow through the treated chromatographic B column 6 at a flow rate of 0-100L/h, an inlet pressure of less than or equal to 0-0.3 MPa and an outlet pressure of less than or equal to 0.2-0.3 MPa, and finishing sample loading.
And E2, washing the solution d3 with a buffer until the absorption of the ultraviolet detector at 280nm is less than 1, respectively collecting the effluent liquid E and the leacheate E, and respectively detecting the content of the solution d3 in the effluent liquid E and the leacheate E.
And E3, when the content of the solution d3 is more than or equal to 100IU/ml, repeating the step E2 and continuing chromatography.
When the content of the solution d3 is less than or equal to 100IU/ml, discharging.
And E4, washing the solution d3 with a secondary eluent until the absorption value of the ultraviolet detector at 280nm is less than 1, and collecting the secondary eluent E1.
And E5, washing with the regeneration liquid until the absorption value of the ultraviolet detector at 280nm is less than 1, collecting the regeneration liquid E, and detecting the content of the solution d3 in the regeneration liquid E1.
Step E6, when the content of the solution d3 is more than or equal to 100IU/ml, repeating the step E5 and continuing chromatography;
when the content of the solution d3 is less than or equal to 100IU/ml, discharging.
The step F comprises the following steps:
and step F1, storing ethanol (with the concentration being more than or equal to 90 percent and measured by an alcohol meter at normal temperature) in a precipitation room by using a stainless steel barrel, and precooling to room temperature.
Step F2, eluting with secondary eluent e 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 2-8 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing, sealing, standing in a refrigeration house, standing overnight to obtain a solution f 1.
And F3, putting the solution F1 into a third centrifuge 7, wherein the rotating speed is 2000-5000 rpm/min, the temperature is 0-10 ℃, and the time is 10 min. The precipitate f2 was collected.
The step G comprises the following steps:
and G1, preparing an ultrafiltration membrane, checking that electrical appliances, instruments and the like are in good condition before starting the machine, and opening and closing each valve normally. And then carrying out integrity detection, determining the qualified product, wherein the working pressure is 0.2-0.3 MPa, the flow rate is 60-120L/h, and after the qualified product is detected, using the ultrafiltration water as endotoxin water. Adjusting the working pressure of the column chromatography system: the flow rate is less than or equal to 0.3MPa and 0-120L/h, and the pH and the conductance of the final effluent are the same as those of the equilibrium solution.
And G2, enabling the precipitate f2 to flow through the treated chromatographic C column 8 at the flow speed of 0-120L/h, the inlet pressure of less than or equal to 0.2-0.3 MPa and the outlet pressure of less than or equal to 0.2-0.3 MPa, washing the precipitate f2 with a buffer solution until the absorption value of an ultraviolet detector at 280nm is less than 1 after sample loading is finished, respectively collecting an effluent liquid G and a leacheate G, mixing the effluent liquid G and the leacheate G, and performing alcohol precipitation for later use to obtain a solution G1.
And G3, washing the precipitate f2 with the prepared eluent and the regeneration liquid respectively until the absorption value of the ultraviolet detector at 280nm is less than 1, collecting the eluent G and the regeneration liquid G respectively, and detecting the content of endotoxin water in the eluent G and the regeneration liquid G respectively.
Repeating the above process for chromatography when the content of endotoxin water is not less than 100 IU/ml;
when the content of endotoxin water is less than or equal to 100IU/ml, discharging.
Detecting to obtain qualified endotoxin; if the endotoxin is unqualified, repeating the process, and continuing the chromatography to remove the endotoxin until the product is qualified.
As solution g 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 0-10 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, uniformly mixing to obtain a solution g2, sealing, standing in a precipitation room, and standing overnight.
Putting the solution g2 into a fourth centrifuge 9, rotating at 2000-5000 rpm/min, at 0-10 ℃, and keeping for 50 min. A precipitate g3 was obtained.
The step H comprises the following steps:
preparing an ultrafiltration membrane: before starting up, the electric appliances, instruments and the like are checked to be in good condition, and the valves are normally opened and closed. And then carrying out integrity detection, confirming the qualified product, carrying out ultrafiltration membrane endotoxin removal treatment operation according to 'cleaning, disinfecting and endotoxin removal SOP' of an ultrafiltration membrane stack, wherein the working pressure is 0.2-0.3 MPa, the flow rate is 60-120L/h, and after the qualified product is detected, using the ultrafiltration water as endotoxin removal water. And detecting the integrity of the membrane by using a bubble point method, and using the membrane after the integrity is tested to be qualified. Before the membrane is used, the membrane is pretreated by circulating endotoxin-removing water for 30 min.
Step H1: the pressure valve is adjusted to the required working pressure of 0.06 MPa-0.20 MPa. The precipitate g3 was filtered off through the membrane, then 2 column volumes of the membrane core volume were washed out with endotoxin-free water to remove the membrane core, and the permeate h1 was collected.
Step H2: alcohol precipitation and centrifugation: preparing a centrifugal tank: before use, the centrifugal tank is soaked in sodium hydroxide solution prepared by using de-endotoxin water for 8 hours, and then is washed clean by using the de-endotoxin water for later use.
Step H3: according to the permeation liquid h 1: ethanol ═ 2: 9 adding cold ethanol (the temperature is 0-10 ℃, the refrigeration time is more than or equal to 8 hours), stirring for 50 minutes, and uniformly mixing to obtain a solution h 2.
Step H4: and putting the solution h2 into a fifth centrifugal machine 11, and adjusting the rotating speed of the fifth centrifugal machine 11 to 2000 rpm/min, the temperature to be 0-10 ℃ and the time to be 50 min. A precipitate h3 was obtained.
And step I, quickly placing the precipitate h3 in a vacuum drying oven 12, closing the drying oven, setting the drying time to be 15h, the vacuum degree to be more than or equal to-0.06 MPa and the drying temperature to be 0-10 ℃, drying, slowly opening an air inlet valve to admit air after the materials are fully dried, closing the equipment, taking out the materials, grinding and mixing for 40 minutes, weighing, sealing, temporarily storing in a virus removal room, and storing at low temperature.
The present invention is not limited to the above-mentioned optional embodiments, and any other products in various forms can be obtained by anyone under the teaching of the present invention, and any changes in the shape or structure thereof, all the technical solutions falling within the scope of the present invention, are within the protection scope of the present invention.
Claims (7)
1. Chorionic gonadotrophin processing system, which is characterized in that: comprises an extraction tank (1), a first separation component, a precipitation tank (4), a second separation component, a third separation component, an ultrafiltration membrane system (10) and a vacuum drying oven (12) which are communicated with each other in sequence through pipelines;
the first separation component comprises a first centrifuge (2) and a chromatography A column (3), the first centrifuge (2) is communicated with the extraction tank (1), and the chromatography A column (3) is arranged between the first centrifuge (2) and the sedimentation tank (4);
the second separation component comprises a second centrifuge (5) and a chromatography B column (6), the second centrifuge (5) is communicated with the settling tank (4), the chromatography B column (6) is arranged between the second centrifuge (5) and the ultrafiltration membrane system (10), and the ultrafiltration membrane system (10) is communicated with the vacuum drying box (12);
the third separation component comprises a third centrifuge (7) and a chromatography C column (8), the third centrifuge (7) is communicated with the chromatography B column (6), and a fourth centrifuge (9) is arranged between the chromatography C column (8) and the ultrafiltration membrane system (10).
2. The chorionic gonadotropin processing system according to claim 1, wherein: the first centrifugal machine (2), the second centrifugal machine (5) and the third centrifugal machine (7) are all freezing centrifugal machines.
3. The chorionic gonadotropin processing system according to claim 1, wherein: and an organic polymer roll-type membrane is arranged in the ultrafiltration membrane.
4. The chorionic gonadotropin processing system according to claim 3, wherein: and a raw material liquid channel and a permeate liquid channel are arranged in the roll-type membrane element.
5. The chorionic gonadotropin processing system according to claim 4, wherein: the inlet and outlet of the raw material liquid channel are arranged at two ends of the membrane element, the raw material liquid flows along the axial direction, and the section of the channel is spiral.
6. The chorionic gonadotropin processing system according to claim 5, wherein: and a permeate flow channel in the ultrafiltration membrane system (10) is spiral and is gathered to a central pipe to flow out.
7. The chorionic gonadotropin processing system according to claim 1, wherein: and a fifth centrifugal machine (11) is arranged between the ultrafiltration membrane system (10) and the vacuum drying box (12).
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113121674A (en) * | 2021-04-19 | 2021-07-16 | 酒泉大得利制药股份有限公司 | Chorionic gonadotrophin processing system and chorionic gonadotrophin processing technology |
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