CN112370972A - Preparation method of device for removing bacterial endotoxin - Google Patents
Preparation method of device for removing bacterial endotoxin Download PDFInfo
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- CN112370972A CN112370972A CN202011188997.XA CN202011188997A CN112370972A CN 112370972 A CN112370972 A CN 112370972A CN 202011188997 A CN202011188997 A CN 202011188997A CN 112370972 A CN112370972 A CN 112370972A
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- ultrafiltration membrane
- bacterial endotoxin
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
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Abstract
The invention discloses a preparation method of a device for removing bacterial endotoxin, which comprises the following steps of 1) selecting an ultrafiltration membrane: according to the components of the stock solution to be treated, controlling the cut-off molecular weight of the ultrafiltration membrane to be smaller than the monomer size of bacterial endotoxin in the stock solution to be treated; 2) structural design: according to the actual application, the effective membrane area and the structure type required by the device are designed corresponding to the relationship between the operating pressure and the flux; 3) casting and sealing: casting a sealing ring on the outer wall of the opening end of the ultrafiltration membrane according to the structural design requirement; 4) channel regeneration: cutting and dredging the opening end blocked by the adhesive in the process of fixing and sealing the ultrafiltration membrane according to the structural design requirement; 5) fusing the shell: matching the ultrafiltration membrane element with the proper shell. The device of the invention has simple and easy preparation method, and adopts the membrane method for normal temperature treatment to realize the high-efficiency interception of active substances such as bacterial endotoxin in the stock solution, thereby not only reducing the cost, but also simplifying the operation process and being convenient to implement.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a preparation method of a device for removing bacterial endotoxin.
Background
The major contributors to bacterial endotoxins are lipid-like substances from the outer cell wall of gram-negative bacteria, whose activity is mainly attributed to lipid a in their structure. The bacterial endotoxin is much smaller than that of bacteria, the chemical composition and the morphological structure of the bacterial endotoxin are greatly different along with the difference of strains, the thermal stability and the chemical stability are extremely strong, and the bacterial endotoxin is removed by adopting a distillation and high-temperature inactivation method in the prior art in the medical field. The method for removing bacterial endotoxin by distillation and high-temperature inactivation generally has the technical defects of high treatment cost, complex operation process and high implementation difficulty.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a preparation method of a device for removing bacterial endotoxin, and the preparation method of the device is simple and easy to realize.
The invention is realized by the following technical scheme:
the preparation method of the device for removing the bacterial endotoxin is characterized by comprising the following steps of:
1) selection of an ultrafiltration membrane: removing bacterial endotoxin by using an ultrafiltration membrane, and controlling the molecular weight cutoff of the ultrafiltration membrane to be smaller than the monomer size of the bacterial endotoxin in the stock solution to be treated according to the components of the stock solution to be treated;
2) structural design: on the basis of the ultrafiltration membrane determined in the step 1), according to actual application, an effective membrane area and a structure type required by the device are designed corresponding to the relationship between operating pressure and flux;
3) casting and sealing: casting a sealing ring on the outer wall of the opening end of the ultrafiltration membrane according to the structural design requirement of the step 2);
4) channel regeneration: cutting and dredging the opening end blocked by the adhesive in the fixing and sealing process according to the requirements of structural design to obtain an ultrafiltration membrane element;
5) fusing the shell: and the ultrafiltration membrane element is assembled with the shell, so that the treatment stock solution entering from the shell enters the hollow inner cavity of the ultrafiltration membrane after being treated by the ultrafiltration membrane and is collected and discharged out of the shell.
The preparation method of the device for removing the bacterial endotoxin is characterized in that a sealing ring is arranged between the outer wall of the opening end of the ultrafiltration membrane and the inner wall of the shell, and the sealing ring divides the inner space of the shell into two parts which are not communicated with each other.
The preparation method of the device for removing the bacterial endotoxin is characterized in that the ultrafiltration membrane is U-shaped with one end open or 1-shaped with two ends open.
The preparation method of the device for removing the bacterial endotoxin is characterized in that centrifugal casting is adopted for casting and sealing.
The preparation method of the device for removing the bacterial endotoxin is characterized in that the upper end and the lower end of the shell are both fixedly provided with a sealing cover, the sealing cover positioned at the bottom end of the shell is provided with a liquid inlet, and the sealing cover positioned at the top end of the shell is provided with a liquid outlet.
The preparation method of the device for removing the bacterial endotoxin is characterized in that spaces for liquid to flow are reserved at the upper end and the lower end of the ultrafiltration membrane with the U-shaped or 1-shaped structure and at the two ends of the shell.
The preparation method of the device for removing bacterial endotoxin is simple and easy to implement, and the active substances such as bacterial endotoxin in the stock solution are efficiently intercepted by arranging the ultrafiltration membrane in the device and adopting the membrane method for normal-temperature treatment, so that the cost is reduced, the operation process is simplified, and the implementation is convenient.
Drawings
FIG. 1 is a schematic view of an installation structure of an ultrafiltration membrane of U-shaped structure according to the present invention;
FIG. 2 is a schematic view of the installation structure of an ultrafiltration membrane of type 1 structure according to the present invention;
in the figure, 1-ultrafiltration membrane, 2-sealing ring, 3-shell, 4-sealing ring, 5-sealing cover, 6-liquid inlet and 7-liquid outlet.
Detailed Description
The invention is described in further detail below with reference to the accompanying drawings, and specific embodiments are given.
The invention relates to a preparation method of a device for removing bacterial endotoxin, which comprises the following steps of 1) selecting an ultrafiltration membrane: removing bacterial endotoxin by using an ultrafiltration membrane, and controlling the molecular weight cutoff of the ultrafiltration membrane to be smaller than the monomer size of the bacterial endotoxin in the stock solution to be treated according to the components of the stock solution to be treated; 2) structural design: on the basis of the ultrafiltration membrane determined in the step 1), according to actual application, correspondingly designing an effective membrane area and a structure type required by the device according to the relation between operating pressure and flux, wherein the ultrafiltration membrane is a U-shaped membrane with an open end or a 1-shaped membrane with open ends, and spaces for liquid to flow are reserved at the upper end and the lower end of the ultrafiltration membrane with the U-shaped structure and at the two ends of the shell; 3) casting and sealing: casting a sealing ring on the outer wall of the opening end of the ultrafiltration membrane according to the structural design requirement of the step 2), wherein the upper end surface of the sealing ring is flush with the upper end surface of the ultrafiltration membrane element, and centrifugal casting is adopted for casting and sealing; 4) channel regeneration: cutting and dredging the opening end blocked by the adhesive in the fixing and sealing process according to the requirement of structural design; 5) fusing the shell: the ultrafiltration membrane element with the realized structural design is matched with a proper shell, the upper end and the lower end of the shell are both fixedly provided with a sealing cover, a liquid inlet is arranged on the sealing cover positioned at the bottom end of the shell, a liquid outlet is arranged on the sealing cover positioned at the top end of the shell, wherein a sealing ring is arranged between the outer wall of the opening end of the ultrafiltration membrane and the inner wall of the shell, and the inner space of the shell is divided into two parts which are not communicated by the sealing ring.
Wherein, the casting and sealing conditions mainly comprise:
1) the preparation method is suitable for the selection and matching of the medical nontoxic adhesive, the diluent and the curing agent: the invention selects thermosetting polyurethane series adhesive, 501 series diluent and amine series curing agent;
2) the casting mode is as follows: centrifugal casting;
3) controlling the heat release peak value: because the thermosetting polyurethane series adhesive belongs to exothermic curing molding, the exothermic peak value and the exothermic time in the curing molding process are difficult to control, and the general curing molding is carried out in a mold, the barrier effect of the mold also blocks the heat release, so that the sealing curing layer is burst, and the element is irreproducible to be discarded. The dynamic centrifugal casting is selected to play roles of casting and radiating, and simultaneously, the exothermic peak value in the casting forming can be effectively controlled by adjusting the centrifugal speed, and bubbles generated in the casting layer are avoided.
Example 1: taking the preparation of hollow fiber ultrafiltration membrane for hemodialysis terminal water as an example
As shown in fig. 1-2, the specific structure of the device for removing bacterial endotoxin comprises a housing and sealing covers fixedly arranged at the upper end and the lower end of the housing, wherein a liquid inlet for raw liquid to be treated to enter the housing is formed in the sealing cover at the lower end of the housing, a liquid outlet for treated liquid to flow out is formed in the sealing cover at the upper end of the housing, an ultrafiltration membrane with a U-shaped structure is arranged in the housing, a sealing ring is arranged between an outer wall casting layer at the opening end of the ultrafiltration membrane and the inner wall of the housing, and a sealing ring is cast between the outer wall at the opening end of the ultrafiltration membrane with the U-.
The preparation method comprises the following steps:
1) preparing an appropriate ultrafiltration membrane according to the hemodialysis terminal water and the purity requirement thereof; the base material for preparing the membrane is represented by polysulfone as a high polymer, the pore-forming agent is represented by polyethylene glycol with molecular weight of 3500-9000, and the diluent is represented by sulfolane, and the hollow ultrafiltration membrane with the molecular weight to be intercepted is prepared by a physical melting method;
2) and (3) designing the ultrafiltration membrane element and the cavity shell matched with the ultrafiltration membrane element on the premise of the highest pressure bearing of 4.5 bar of the outer wall of the ultrafiltration membrane and the flux of the device of not less than 50ml/min by combining with the water requirement of the hemodialysis terminal for bacterial endotoxin of not more than 0.25 EU. The ultrafiltration membrane forming the element can be an ultrafiltration membrane with an opening at one end (the ultrafiltration membrane with a certain length is designed into a U shape, the number of the U is variable n), or an ultrafiltration membrane with an opening at two ends (the ultrafiltration membrane with a certain length is designed into a 1 shape, the number of the 1 is variable n), and the ultrafiltration membrane is separated from the product water by a sealing ring;
3) casting and sealing the open end of the ultrafiltration membrane element by using an adhesive represented by polyurethane, so that a channel isolation fence is formed between treated water and product water while the ultrafiltration membrane is integrated into an element;
4) the open end of the ultrafiltration membrane blocked by the adhesive during casting and sealing is cut annularly, so that the product water flow channel of the ultrafiltration membrane is smooth;
5) the integrated ultrafiltration membrane element is arranged in a cavity shell matched with the integrated ultrafiltration membrane element, and the device for removing bacterial endotoxin is formed after necessary sterilization treatment; the interception mode of the ultrafiltration membrane on the bacterial endotoxin can adopt an external pressure type or an internal pressure type; for an external pressure type example, see fig. 1 and 2 in detail. Under the operating pressure of less than or equal to 4.5 bar, raw water enters the device from the liquid inlet of the shell, bacterial endotoxin is blocked on the outer wall layer of the hollow ultrafiltration membrane, and product water with the bacterial endotoxin of less than or equal to 0.25EU entering the inner cavity is collected and then supplied for use through the outlet end.
Claims (6)
1. A method of making a device for removing bacterial endotoxin, the method comprising the steps of:
1) selection of an ultrafiltration membrane: removing bacterial endotoxin by using an ultrafiltration membrane (1), and controlling the molecular weight cut-off to be smaller than the monomer size of the bacterial endotoxin in the stock solution to be treated according to the components of the stock solution to be treated;
2) structural design: on the basis of the ultrafiltration membrane (1) determined in the step 1), according to actual application, an effective membrane area and a structure type required by the device are designed corresponding to the relationship between operating pressure and flux;
3) casting and sealing: casting a sealing ring (2) on the outer wall of the opening end of the ultrafiltration membrane (1) according to the structural design requirement of the step 2);
4) channel regeneration: cutting and dredging the opening end blocked by the adhesive in the process of fixing and sealing the ultrafiltration membrane according to the structural design requirement to obtain an ultrafiltration membrane element;
5) fusing the shell: the ultrafiltration membrane element is assembled with the shell (3) to ensure that the treatment stock solution entering from the shell (3) enters the hollow inner cavity of the ultrafiltration membrane after being treated by the ultrafiltration membrane and is collected and discharged out of the shell (3).
2. The method for preparing a device for removing the bacterial endotoxin, as claimed in claim 1, wherein a sealing ring (4) is arranged between the outer wall of the opening end of the ultrafiltration membrane (1) and the inner wall of the shell (3), and the sealing ring (4) divides the inner space of the shell (3) into two parts which are not communicated with each other.
3. The method for preparing a device for removing bacterial endotoxin as claimed in claim 1, wherein the ultrafiltration membrane (1) is of a U shape with one end open or of a 1 shape with both ends open.
4. The method of claim 1, wherein the casting seal is made by centrifugal casting.
5. The method for preparing a device for removing bacterial endotoxin as claimed in claim 1, wherein the upper end and the lower end of the housing (3) are both fixedly provided with a sealing cover (5), the sealing cover (4) positioned at the bottom end of the housing (3) is provided with a liquid inlet (6), and the sealing cover (4) positioned at the top end of the housing (3) is provided with a liquid outlet (7).
6. The method for preparing a device for removing bacterial endotoxin as claimed in claim 1, wherein the upper and lower ends of the ultrafiltration membrane (1) of the U-shaped or 1-shaped structure and the two ends of the housing (3) are provided with spaces for liquid to flow.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011188997.XA CN112370972A (en) | 2020-10-30 | 2020-10-30 | Preparation method of device for removing bacterial endotoxin |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011188997.XA CN112370972A (en) | 2020-10-30 | 2020-10-30 | Preparation method of device for removing bacterial endotoxin |
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| CN112370972A true CN112370972A (en) | 2021-02-19 |
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| CN202011188997.XA Pending CN112370972A (en) | 2020-10-30 | 2020-10-30 | Preparation method of device for removing bacterial endotoxin |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104474900A (en) * | 2014-11-10 | 2015-04-01 | 济南市水处理设备厂有限公司 | Hollow fiber ultrafiltration membrane module casting device, and casting method thereof |
| CN106334449A (en) * | 2016-11-21 | 2017-01-18 | 成都关怀科技有限公司 | Dialysis water endotoxin filter |
| CN106390774A (en) * | 2016-06-21 | 2017-02-15 | 宁波胜科环保科技有限公司 | A PVC ultrafiltration membrane, a preparing method thereof and an ultrafiltration membrane assembly |
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2020
- 2020-10-30 CN CN202011188997.XA patent/CN112370972A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104474900A (en) * | 2014-11-10 | 2015-04-01 | 济南市水处理设备厂有限公司 | Hollow fiber ultrafiltration membrane module casting device, and casting method thereof |
| CN106390774A (en) * | 2016-06-21 | 2017-02-15 | 宁波胜科环保科技有限公司 | A PVC ultrafiltration membrane, a preparing method thereof and an ultrafiltration membrane assembly |
| CN106334449A (en) * | 2016-11-21 | 2017-01-18 | 成都关怀科技有限公司 | Dialysis water endotoxin filter |
Non-Patent Citations (2)
| Title |
|---|
| 《化工百科全书》编辑委员会等编: "《化工百科全书（第19卷）》", 30 September 1998, 化学工业出版社 * |
| 时钧等主编: "《膜技术手册》", 31 January 2001, 化学工业出版社 * |
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Application publication date: 20210219 |