CN105662865A - [18F] sodium fluoride preparation device - Google Patents
[18F] sodium fluoride preparation device Download PDFInfo
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- CN105662865A CN105662865A CN201610203987.6A CN201610203987A CN105662865A CN 105662865 A CN105662865 A CN 105662865A CN 201610203987 A CN201610203987 A CN 201610203987A CN 105662865 A CN105662865 A CN 105662865A
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- sodium fluoride
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- PUZPDOWCWNUUKD-UHFFFAOYSA-M sodium fluoride Chemical compound [F-].[Na+] PUZPDOWCWNUUKD-UHFFFAOYSA-M 0.000 title claims abstract description 140
- 235000013024 sodium fluoride Nutrition 0.000 title claims abstract description 70
- 239000011775 sodium fluoride Substances 0.000 title claims abstract description 70
- 238000002360 preparation method Methods 0.000 title claims abstract description 47
- 239000007788 liquid Substances 0.000 claims abstract description 127
- 238000005349 anion exchange Methods 0.000 claims abstract description 48
- 239000002994 raw material Substances 0.000 claims abstract description 32
- 238000002347 injection Methods 0.000 claims abstract description 23
- 239000007924 injection Substances 0.000 claims abstract description 23
- 238000003860 storage Methods 0.000 claims abstract description 19
- 239000007789 gas Substances 0.000 claims description 43
- 239000000463 material Substances 0.000 claims description 32
- 238000012545 processing Methods 0.000 claims description 29
- 238000000034 method Methods 0.000 claims description 17
- 238000005406 washing Methods 0.000 claims description 17
- 230000008569 process Effects 0.000 claims description 14
- 238000009826 distribution Methods 0.000 claims description 9
- 229910052756 noble gas Inorganic materials 0.000 claims description 8
- 239000003480 eluent Substances 0.000 claims description 7
- 239000011261 inert gas Substances 0.000 claims description 7
- 230000008676 import Effects 0.000 claims description 6
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 4
- 239000012190 activator Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 230000004913 activation Effects 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 13
- 230000015572 biosynthetic process Effects 0.000 abstract description 10
- 238000003786 synthesis reaction Methods 0.000 abstract description 10
- 230000005855 radiation Effects 0.000 abstract description 6
- 238000010828 elution Methods 0.000 abstract 2
- 229940090044 injection Drugs 0.000 description 20
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 12
- 239000002699 waste material Substances 0.000 description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 12
- 239000003153 chemical reaction reagent Substances 0.000 description 10
- 238000005516 engineering process Methods 0.000 description 9
- 238000010926 purge Methods 0.000 description 9
- 150000001450 anions Chemical class 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 238000002600 positron emission tomography Methods 0.000 description 7
- 229910052757 nitrogen Inorganic materials 0.000 description 6
- 239000012071 phase Substances 0.000 description 6
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 238000005260 corrosion Methods 0.000 description 4
- 230000007797 corrosion Effects 0.000 description 4
- 239000012528 membrane Substances 0.000 description 4
- 229910000831 Steel Inorganic materials 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000001105 regulatory effect Effects 0.000 description 3
- 239000010959 steel Substances 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 230000006978 adaptation Effects 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000004886 process control Methods 0.000 description 2
- 239000000523 sample Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- XLYOFNOQVPJJNP-NJFSPNSNSA-N ((18)O)water Chemical compound [18OH2] XLYOFNOQVPJJNP-NJFSPNSNSA-N 0.000 description 1
- VRYALKFFQXWPIH-PBXRRBTRSA-N (3r,4s,5r)-3,4,5,6-tetrahydroxyhexanal Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)CC=O VRYALKFFQXWPIH-PBXRRBTRSA-N 0.000 description 1
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000005388 borosilicate glass Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000002591 computed tomography Methods 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000012864 cross contamination Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000013399 early diagnosis Methods 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 229940093181 glucose injection Drugs 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000011022 operating instruction Methods 0.000 description 1
- 238000011017 operating method Methods 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000002285 radioactive effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000011664 signaling Effects 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
- A61B6/02—Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
- A61B6/03—Computed tomography [CT]
-
- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01D—COMPOUNDS OF ALKALI METALS, i.e. LITHIUM, SODIUM, POTASSIUM, RUBIDIUM, CAESIUM, OR FRANCIUM
- C01D3/00—Halides of sodium, potassium or alkali metals in general
- C01D3/02—Fluorides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/70—Device provided with specific sensor or indicating means
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Informatics (AREA)
- High Energy & Nuclear Physics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Materials Engineering (AREA)
- Pharmacology & Pharmacy (AREA)
- Inorganic Chemistry (AREA)
- Optics & Photonics (AREA)
- Pathology (AREA)
- Radiology & Medical Imaging (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The invention discloses a [18F] sodium fluoride preparation device and relates to the field of positron medicine synthesis. The [18F] sodium fluoride preparation device comprises a control unit and an execution unit, wherein the control unit is configured to receive a preparation instruction and calculate the control data of each raw material liquid according to the preparation instruction; the execution unit is connected with the control unit and executes the preparation of [18F] sodium fluoride according to the control data calculated by the control unit; the execution unit comprises a raw material input part, a gas-liquid transport part and a liquid storage part; the raw material input part injects the raw material liquid separately according to the control data of the raw material liquid, calculated by the control unit; the gas-liquid transport part is configured to transport the raw material liquid input by the raw material input part, so that the raw material liquid flows through an anion exchange column in the gas-liquid transport part and the [18F] sodium fluoride is obtained through elution; and the liquid storage part is configured to store the gas and liquid from the gas-liquid transport part and store the [18F] sodium fluoride obtained by elution. By adopting the device disclosed by the invention, the radiation quantity can be reduced while the stability in the preparation process of a sodium fluoride injection medicine is improved.
Description
Technical field
The present invention relates to positron medicine synthesis field, particularly relate to [18F] sodium fluoride preparation facilities.
Background technology
In recent years, Positron Emission Computed Tomography PET (PositronEmissionTomography) technology of application positron medicine, because it has sensitive, safe feature, and obtain and develop rapidly. The cardinal principle of PET technology is as follows: make short-life material, decay process discharges positron and makes this positron annihilation, thus producing photon in opposite direction, by super-sensitive captured by camera, and the correction with random information and analyzing and processing it is scattered through computer, finally develop and obtain 3-D view in vivo. In view of this principle, the PET medicament used as developing agent seems most important. But, at present PET technology all development check in, the PET medicine of application almost only have fluorine [18F] deoxy-glucose injection (18FDG injection), limit potential function and the effect of PET technology. Therefore, the demand of the research and development of the positron medicine of commercially viable production and positron medicine Preparation equipment is day by day urgent.
[18F] sodium fluoride injection can high sensitivity, carry out early diagnosis, detection recurrence and Prognosis scoveillance for bone metastaes with high specificity, and assist a physician and determine optimum rational therapy scheme. It addition, research in recent years shows, [18F] sodium fluoride also is able to effectively differentiate to break high risk Coronary Atherosclerotic Plaque, contributes to this disease of early intervention to prevent bad clinical events. Therefore, commercially produce [18F] diagnosing and treating of above-mentioned disease be respectively provided with significantly high value by sodium fluoride.
But, due to [18F] sodium fluoride has activity height, irradiation is big feature, if therefore continue to use existing manual mode prepare [18F] sodium fluoride, the amount of radiation that operator are subject to is big, affects the health of operator, and affects the stability of product quality. Based on this kind of present situation, it is desirable to a kind of realization [18F] in the sodium fluoride injection whole production process from raw material to finished product, operable automatically or setting [18F] sodium fluoride injection synthesizer, make the labor intensity of producers reduce, the pollution of operating process reduces, it is often more important that make the amount of radiation of producers reduce, and [18F] sodium fluoride injection medicine preparation process stability improve.
Summary of the invention
In view of this, present disclose provides one [18F] sodium fluoride preparation facilities, solve that amount of radiation in correlation technique is big, the problem of the poor stability of product quality.
First aspect according to disclosure embodiment, it is provided that a kind of [18F] sodium fluoride preparation facilities, including:
Control unit, is configured to receive preparation instruction, and calculates the control data of each material liquid according to preparation instruction;
Performance element, is connected with described control unit, according to the described control data calculated by described control unit, perform [18F] preparation of sodium fluoride,
Described performance element includes:
Raw material input portion, according to the control data of the described material liquid calculated by described control unit, is injected separately into material liquid;
Gas-liquid transport part, be configured to described raw material input portion input material liquid be transmitted, make described material liquid flow through the anion-exchange column in described gas-liquid transport part, by drip washing obtain [18F] sodium fluoride;
Liquid storage part, is configured to gas and the liquid from described gas-liquid transport part is stored, and store described drip washing obtain [18F] sodium fluoride.
The first of first aspect in disclosure embodiment is likely in implementation, described [18F] in sodium fluoride preparation facilities,
Described performance element also includes:
Gas Input, is configured in described performance element and imports gas;
Described gas-liquid transport part is configured to the material liquid of gas that described Gas Input is inputted and the input of described raw material input portion and is transmitted, and makes described material liquid flow through the anion-exchange column in described gas-liquid transport part, by drip washing obtain [18F] sodium fluoride;
Described Gas Input described liquid storage part store described drip washing obtain [18F] change sodium after, the anion-exchange column in described gas-liquid transport part is dried up.
In conjunction with the first possibility of the first aspect of disclosure embodiment, it is likely in implementation at the second,
Described Gas Input is configured in described performance element to import noble gas.
The second in conjunction with the first aspect of disclosure embodiment is likely to, and is likely in implementation at the third,
The material liquid that described raw material input portion is injected includes activator, eluent and containing fluorine anion liquid.
In conjunction with the third possibility of the first aspect of disclosure embodiment, in the 4th kind of possible implementation,
The operation software of described control unit is worked out based on widely used Rockwell Programmable Logic Controller.
In the 5th kind of possible implementation of the first aspect of disclosure embodiment, described control unit includes: host computer computer and the programmable logic controller (PLC) being connected with described host computer computer;
Described programmable logic controller (PLC) includes: control module that the input and output template that central processing unit is connected with described central processing unit is connected with described input and output template and the system power module being connected with described central processing unit, described input and output template, described control module respectively;
Described input and output template includes: the analog quantity template of the digital quantity template processing digital quantity between described central processing unit and described control module and the process analog quantity between described central processing unit and controlled setting;
Described central processing unit controls described digital quantity template, described analog quantity template and described control module respectively, and accepts the instruction of described host computer computer; Described digital quantity template controls controlled plant by described control module; Described analog quantity template and described controlled plant and the sensor being arranged in described controlled plant are connected, and transmit analog signals; Described central processing unit, described digital quantity template, described analog quantity template, described control unit, described host computer computer, described controlled plant and sensor are carried out distribution by described system power respectively.
It is combined in the first aspect the 5th kind of possible implementation to the first aspect of disclosure embodiment of disclosure embodiment, in the 6th kind of possible implementation of the first aspect of disclosure embodiment, described raw material input portion includes: be configured to inject the adjustable syringe of range of each raw material; It is configured to drive the duplex cylinder of the adjustable syringe of described range.
It is combined in the 6th kind of possible implementation of the first aspect of disclosure embodiment, in the 7th kind of possible implementation of the first aspect of disclosure embodiment,
Described gas-liquid transport part includes: be configured in the threeway plug valve in described gas-liquid transport part; It is configured to drive the rotary cylinder of described threeway plug valve.
Being combined in the 7th kind of possible implementation of the first aspect of disclosure embodiment, in the 8th kind of possible implementation of the first aspect of disclosure embodiment, described Gas Input includes: be configured to the inert gas source of output noble gas; It is configured to control the electromagnetic valve of the conducting of described inert gas source.
It is combined in the 8th kind of possible implementation of the first aspect of disclosure embodiment, in the 9th kind of possible implementation of the first aspect of disclosure embodiment, the described first, second adjustable syringe of range is connected with the input stream in described gas-liquid transport part respectively through the first threeway plug valve, described input stream is provided with anion-exchange column, described Gas Input is arranged on described anion-exchange column place, and described liquid storage part is connected with described anion-exchange column via the output stream in described gas-liquid transport part.
The technical scheme that disclosure embodiment provides can include following beneficial effect:
By control unit input, system is given instruction by the control data of each raw material, by performance element according to built-in template and program perform [18F] preparation process of sodium fluoride, via raw material input portion therein, gas-liquid transport part, liquid storage part finally obtain [18F] sodium fluoride product. So, producers only assign control instruction, can complete [18F] preparation of sodium fluoride, the pollution of operating process reduces, and makes the amount of radiation of producers reduce, and improve [18F] stability of sodium fluoride injection medicine preparation process.
It should be appreciated that it is only exemplary and explanatory that above general description and details hereinafter describe, the disclosure can not be limited.
Accompanying drawing explanation
Following drawing appended by the application is for providing embodiment, helps correctly to utilize the present invention, and with below to together with detailed description of the invention content, promoting the understanding to the technology of the present invention thinking. The annotation being not intended to the present invention can only be limited within the scope of item described in following drawing.
Fig. 1 be [18F] structural representation of sodium fluoride preparation facilities.
Fig. 2 is another structural representation of performance element 12 in Fig. 1.
Fig. 3 is a kind of concrete pie graph of control unit 11 in Fig. 1 and Fig. 2.
Fig. 4 be [18F] the concrete structure example figure of sodium fluoride preparation facilities.
Fig. 5 is the first structural representation of performance element 12 in Fig. 4.
Fig. 6 is the second structural representation of performance element 12 in Fig. 4.
Label declaration
3-electromagnetic valve;
4-gas gauge;
5-gas pressure is popped one's head in;
7-radioactivity is popped one's head in;
8-gas sterilizing filter;
9-aseptic filter membrane;
10-product bottle;
11-waste liquid bottle;
12-reclaims water bottle;
13-wolfram steel cask flask;
14-anion-exchange column;
15-the second syringe;
16-the first syringe;
17-threeway plug valve V3;
18-threeway plug valve V5;
19-threeway plug valve V1;
20-threeway plug valve V6;
21-threeway plug valve V4;
22-threeway plug valve V2;
25-anion-exchange column radome;
26-duplex cylinder 1;
27-duplex cylinder 2;
28-rotary cylinder 3;
29-rotary cylinder 5;
30-rotary cylinder 4;
Two five-way distribution modules of 31-;
32-rotary cylinder 6;
33-rotary cylinder 1;
34-rotary cylinder 2.
Detailed description of the invention
Embodiment meant in the application is described in detail hereinafter with reference to accompanying drawing, unrelated with symbol in drawing, same or similar constituent element will be given with same with reference to coding (lower same, no longer to give repeat specification). " unit " and " portion " two suffixes used for constituent element in the following description are simply write for ease of description and are given or mix use, itself there is no Special Significance or effect. When institute's illustrated example in the application is described, as thought, when putting of example is lifted by explanation likely fuzzy the application institute of related known technology, general's description is omitted content. And accompanying drawing is only for being prone to the understanding to the lifted example of the application, the technical thinking not limited by the accompanying figures proposed in the application, it is thus understood that all changes included by its covering thinking of the present invention and technology category, equalization material, even substitute.
Fig. 1 be [18F] structural representation of sodium fluoride preparation facilities.
Fig. 1 shows, in the present invention [18F] sodium fluoride preparation facilities 1, including: control unit 11, it is configured to receive preparation instruction, and calculates the control data of each material liquid according to preparation instruction; Performance element 12, is connected with described control unit 11, according to the described control data calculated by described control unit 11, perform [18F] preparation of sodium fluoride; Described performance element 12 includes: raw material input portion 121, according to the control data of the described material liquid calculated by described control unit, is injected separately into material liquid; Gas-liquid transport part 122, be configured to described raw material input portion input material liquid be transmitted, make described material liquid flow through the anion-exchange column in described gas-liquid transport part, by drip washing obtain [18F] sodium fluoride; Liquid storage part 123, is configured to gas and the liquid from described gas-liquid transport part is stored, and store described drip washing obtain [18F] sodium fluoride.
Wherein, the control unit that disclosure embodiment provides is made up of terminal, terminal is run and has operation software, for instance based on the operation client of widely used Rockwell Programmable Logic Controller establishment, client enters the operating instructions or automatic operating order for the operator that disappear. Wherein, terminal can be mobile equipment such as the such as computer equipment such as desk computer, server or panel computer etc.
For reference, preparation instruction here both can be the concrete input for preparation parameter, it is also possible to be appointment order full-automatic, semi-automatic, manual operation Three models. When preparing instruction and being manual operation mode, it is possible to further the parameter etc. preparing product is set; When preparing instruction and being full-automatic, [18F] sodium fluoride preparation facilities will according to omnidistance execution operations automatically such as the parameters pre-set, it is not necessary to and operator get involved; When preparing instruction and being semi-automatic, [18F] sodium fluoride preparation facilities will perform operation automatically according to the parameter pre-set etc., and in this automatic operating process, operator can manual intervention or regulated.
Here, it is necessary to explanation, [18F] sodium fluoride product can flow through the anion-exchange column in gas-liquid transport part by material liquid, makes this anion-exchange column activate, more specifically, can make afterwards containing18F anion18O water flows through this anion-exchange column, final drip washing and will obtain [18F] sodium fluoride injection is stored in liquid storage part 123.
In addition, control unit 11 is when calculating control data, can by the operation software of Rockwell Programmable Logic Controller establishment, including the process control procedure based on ABStudio5000 software and the human-computer interface control program based on ABFactoryTalkViewSiteEdition software, human-computer interface control program is installed on host computer computer, it is simple to realize above-mentioned [18F] the full-automatic state of sodium fluoride process for preparing injection liquid flow process, semi-automatic state, the monitoring of manual mode Three models and control.
The offer of disclosure embodiment [18F] sodium fluoride preparation facilities 1, by control unit input, system is given instruction by the control data of each raw material, by performance element according to built-in template and program perform [18F] preparation process of sodium fluoride, via raw material input portion therein, gas-liquid transport part, liquid storage part finally obtain [18F] sodium fluoride product. So, producers only assign control instruction, can complete [18F] preparation of sodium fluoride, the pollution of operating process reduces, and makes the amount of radiation of producers reduce, and improve [18F] stability of sodium fluoride injection medicine preparation process.
Fig. 2 is another structural representation of performance element 12 in Fig. 1.
Selectable, as in figure 2 it is shown, based on the embodiment of above-mentioned offer, in a kind of possible implementation, described performance element 12 also includes: Gas Input 124, it is configured in described performance element 12 and imports gas; Described gas-liquid transport part 122 is configured to the material liquid of the gas to the input of described Gas Input 124 and the input of described raw material input portion 121 and is transmitted, make described material liquid flow through the anion-exchange column 122a in described gas-liquid transport part 122, by drip washing obtain [18F] sodium fluoride; Described Gas Input 124 described liquid storage part 123 store described drip washing obtain [18F] after sodium fluoride, the anion-exchange column in described gas-liquid transport part 122 is dried up.
Further, in alternatively possible implementation, as in figure 2 it is shown, described Gas Input 124 is configured in described performance element 12 imports noble gas.
Specifically, in alternatively possible implementation, described Gas Input may include that the inert gas source being configured to output noble gas; It is configured to control the electromagnetic valve 3 of the conducting of described inert gas source.
Here, Gas Input 124 can input noble gas in the gas-liquid transport part 122 of performance element 12, in order to drip washing obtain [18F] after sodium fluoride injection, make anion-exchange column recover dry, in order to medicine is repeatedly automatically synthesized, and by the impact of synthesis last time.
Further, in alternatively possible implementation, the material liquid that described raw material input portion 121 is injected includes activator, eluent and containing fluorine anion liquid.
In its a kind of concrete possible implementation, described raw material input portion includes: be configured to the first adjustable syringe of range of injection activation agent; It is configured to the second adjustable syringe of range of injection eluent; It is configured to drive the duplex cylinder of the described first, second adjustable syringe of range. The syringe of every kind of specification can set some different ranges in each maximum range; The liquid feeding speed of syringe can be regulated by the speed of the high accuracy duplex cylinder that adjustment drives.
For example, raw material input portion 121 can adopt two range adjustable precision syringes, for instance plastic material injector for medical purpose or borosilicate glass material syringe, distinguishes injection activation agent and eluent, and by accelerator inject containing18F anion18O water.
As it has been described above, [18F] sodium fluoride product can flow through the anion-exchange column in gas-liquid transport part by activator, and make this anion-exchange column activate, more specifically, can make afterwards containing fluorine anion liquid (such as18F anion18O water) flow through this anion-exchange column, finally make eluent that this anion-exchange column carries out drip washing and will obtain [18F] sodium fluoride injection, should [18F] sodium fluoride injection is stored in liquid storage part 123 by gas-liquid transport part 122.
As described above, in alternatively possible implementation, the operation software of described control unit 11 is worked out based on widely used Rockwell Programmable Logic Controller. In the present embodiment, it is operated by software and works out based on widely used Rockwell Programmable Logic Controller, can operate at any Windows (such as Windows7, Windowsxp, Windows8 etc.); INTERFACE DESIGN is more reasonable, and confidentiality is relatively strong, and operating procedure is able to more fully record, and data cannot be changed and persistence.
Fig. 3 is a kind of concrete pie graph of control unit 11 in Fig. 1 and Fig. 2.
As it is shown on figure 3, described control unit 11 includes: host computer computer 111 and the programmable logic controller (PLC) 112 being connected with described host computer computer 111;
Described programmable logic controller (PLC) 112 includes: control module 1123 that the input and output template 1122 that central processing unit 1121 is connected with described central processing unit 1121 is connected with described input and output template 1122 and the system power module 1124 being connected with described central processing unit 1121, described input and output template 1122, described control module 1123 respectively;
Described input and output template 1122 includes: the analog quantity template 1122b of the digital quantity template 1122a processing digital quantity between described central processing unit 1121 and described control module 1123 and the process analog quantity between described central processing unit 1121 and controlled setting;
Described central processing unit 1121 controls described digital quantity template 1122a, described analog quantity template 1122b and described control module 1123 respectively, and accepts the instruction of described host computer computer 111; Described digital quantity template 1122a controls controlled plant by described control module 1123; Described analog quantity template 1122b and described controlled plant and the sensor being arranged in described controlled plant are connected, and transmit analog signals; Described central processing unit 1121, described digital quantity template 1122a, described analog quantity template 1122b, described control module 1123, described host computer computer 111, described controlled plant are carried out distribution by described system power respectively.
It should be noted that in the present system, programmable logic controller (PLC) 112 is commanded by host computer computer 111. Such as when needing to start certain electromagnetic valve in gas-liquid transport part 122, central processing unit 1121 can receive the program commander of host computer computer 111, namely corresponding instruction is sent subsequently, digital quantity template 1122a receives order, order digital signal input/output circuitry exports a certain digital signal, starts corresponding electromagnetic valve by control module 1123 and carrys out execution. Wherein, central processing unit 1121 and host computer computer 111 can be attached by netting twine.
Certainly, host computer computer 111 here can not only be used for the programming computer of process control procedure, human-computer interface control program, it is possible to the monitoring computer simultaneously as man machine interface uses. In this case, software control system can realize the control of the automatization of technological process, semi-automatic and complete manual Three models, also can realize the monitor in real time of technical process amount such as temperature, pressure, radioactivity curve, and start real time alarm function when system physical amount such as pressure anomaly, activity exception by man machine interface program.
In alternatively possible implementation, described gas-liquid transport part includes: be configured in the threeway plug valve in described gas-liquid transport part; It is configured to drive the rotary cylinder of described threeway plug valve.
Specifically, in a kind of possible implementation, the described first, second adjustable syringe of range is connected with the input stream in described gas-liquid transport part 122 respectively through the first threeway plug valve, described input stream is provided with anion-exchange column, described Gas Input 124 is arranged on described anion-exchange column place, and described liquid storage part is connected with described anion-exchange column via the output stream in described gas-liquid transport part 122.
Below, with a specific embodiment, to the embodiment of the present invention [18F] sodium fluoride preparation facilities illustrates.
Wherein, Fig. 4 be [18F] the concrete structure example figure of sodium fluoride preparation facilities; Fig. 5 is the first structural representation of performance element 12 in Fig. 4; Fig. 6 is the second structural representation of performance element 12 in Fig. 4.
As Figure 4-Figure 6, wherein, raw material input portion 121 may include that two range adjustable precision the first syringes 165,16, two high accuracy duplex cylinders 26,27, two precision rotation cylinders 28,33, four sets stainless steel adapting piece (such as including cylinder-threeway plug valve shaft coupling, cylinder keeper, syringe connector etc.), two threeway plug valves 17,19 and for the corrosion resistant pipeline of special substance that connects and corresponding control circuit and module. Precision the first syringe 165,16 in native system can be selected for different size: 1mL, 2.5mL, 5mL, 10mL, 25mL, and the syringe of every kind of specification can set again some different ranges in each maximum range; The liquid feeding speed of syringe can be regulated by the speed of the high accuracy duplex cylinder 26,27 that adjustment drives.
Gas-liquid transport part 122 can include four precision rotation cylinders 29,30,32,34, four sets stainless steel adapting piece (such as including cylinder-threeway plug valve shaft coupling, cylinder keeper etc.), four threeway plug valves 18,20,21,22 and for the special substance anticorrosion pipeline that connects and corresponding control circuit and module. Wherein, duplex cylinder 26,27 is respectively intended to drive the first syringe 166,15; Rotary cylinder 33,34,28,30,29,32 is respectively intended to drive threeway plug valve V1～V6; All of cylinder drives by two five-way valve distributions of corresponding point. In gas-liquid transport part 122, radioactivity probe 7 is adsorbed on anion-exchange column 14 for measurement18The activity of F anion, is processed by central processing unit 1121 simultaneously, when activity exceedes prescribed limits, triggers activity overload alarm signal by man machine interface program in real time at host computer computer 111. Additionally, be outside equipped with anion-exchange column radome 25 at anion-exchange column 14, for shielding the environment impact on anion-exchange column 14. Two five-way distribution modules 31 are set to the gas in gas-liquid transport part 122 is carried out distribution control.
In raw material input portion 121 two high accuracy 26,27, two precision rotation cylinders 28,33 of duplex cylinder and in four precision rotation cylinders 29,30,32,34 be provided with initiateing, putting in place position signalling, to determine the location status of syringe that cylinder drives, threeway plug valve, and process via central processing unit system and reflected intuitively on host computer computer by man machine interface program.
Gas Input 124 can be constituted in the following manner: such as external inert gas source (is illustrated as N2, but it is not limited only to N2), one gas sterilizing filter 8 that gas is carried out bacteria removing, one for showing the gas gauge 4 of gas pressure, one gas pressure probe 5 for detected gas pressure, one two-way direct current or alternating current electromagnetic valve 3, a distribution module 31 being made up of eight two five-way electromagnetic valves and rustless steel distribution valve plate and for the corrosion resistant pipeline of special substance that connects and corresponding control circuit and module.
In addition, liquid storage part 123 can include two aseptic cillin bottles of 30mL 10 and aseptic cillin bottle 12, one 500mL mobile phase bottle 11, four 0.22um aseptic filter membranes 9 and three wolfram steel cask flasks 13 mated with the size of bottle and the corrosion resistant pipeline of special substance for being connected. Wherein cillin bottle 10 be used for receiving [18F] sodium fluoride injection products, cillin bottle 12 is used for receiving18O recycle-water, mobile phase bottle is used for storing waste liquid; Aseptic filter membrane 9 for filter be synthetically derived [18F] antibacterial in sodium fluoride injection products and fine particulates, other three aseptic filter membranes are connected air for two cillin bottles with mobile phase bottle.
Described anion-exchange column: connect feedstock input system, radioactive liquid scratch system and accelerator by special substance anticorrosion pipeline, comes from accelerator for adsorbing18F fluorion.
Specifically, in the present invention, described electromagnetic valve can be once-through type or AC type, and by corresponding power drives; Solenoid-driven cylinder, cylinder controls the conducting state of threeway plug valve. Electromagnetic valve can open and close according to certain program, and the opening controlling threeway plug valve flows to passage to form liquid/gas each group relatively independent. All on threeway plug valve all can be made up of corrosion-resistant material (preferred PTFE) with the contact point of liquids and gases. [18F] predefined relatively independent gas/liquid flows to passage and such as arranges totally 12 on sodium fluoride preparation facilities. Pipe design it is contemplated that rationally distributed, reduces the cross-contamination between reagent, factors such as flow path is the shortest, and resistance is minimum, easy to maintenance so that use convenient. Although any flow direction transfer of liquid phase involved in the present invention or gas phase is all realize by the pressure differential between two containers or pipeline, if but meet the requirement of above-mentioned pipe design, the numerous variations that those skilled in the art can thus make, is all contained in the inventive concept of the present invention.
Described [18F] sodium fluoride preparation facilities material liquid A (for ease of understand, call reagent A in the following text) acted on through threeway plug valve V1, V2, V4 by anion-exchange column 14 by the first syringe 16, and make this anion-exchange column 14 activate, liquid storage part 11 (for ease of understanding, call waste liquid bottle 11 in the following text) is entered again through threeway plug valve V5, V6; Accelerator come containing18F anion18O water, enters again through threeway plug valve V5, V6 by anion-exchange column 14 via threeway plug valve V418O Water Sproading water bottle 12,18F anion is adsorbed on anion-exchange column 14; Material liquid B (for ease of understanding, call reagent B in the following text) is acted on through threeway plug valve V3, V2, V4 by anion-exchange column 14 by the second syringe 15, drip washing obtain having prepared [18F] sodium fluoride product, and enter liquid storage part 10 (for ease of understanding, call product bottle 10 in the following text) by threeway plug valve V5; Noble gas is by after sterilizing filter 8, two three-way electromagnetic valve 3, threeway plug valve V4, further flow through anion-exchange column 14, and eventually pass through threeway plug valve V5 or V6, and with product bottle 10, waste liquid bottle 11 and liquid storage part 12 (in the present embodiment, for18O Water Sproading water bottle 12) connect, anion-exchange column 14 or connection pipeline are dried up.
Below, to the present invention [18F] preparation process of sodium fluoride preparation facilities is explained:
Synthesis phase first:
Rotation makes threeway plug valve V1, V2, V4, V5, V6 to correct status, pushes in waste liquid bottle 11 with the first syringe 16 (in the present embodiment, the preferred 5mL of syringe range) by reagent A, pushes away liquid measure 5mL every time, six times repeatedly; It is then shut off threeway plug valve V2, opens electromagnetic valve 3, with the pipeline between positive nitrogen purging threeway plug valve V2 to waste liquid bottle 11, purge 120 seconds, it is ensured that pipeline dries.
Next, rotation makes threeway plug valve V3, V2, V4, V5, V6 to correct status, is slowly pushed in waste liquid bottle 11 by reagent B through anion-exchange column 14 with the second syringe 15 (in the present embodiment, the preferred 5mL of syringe range), push away liquid measure 5mL every time, twice repeatedly; It is then shut off threeway plug valve V2, opens electromagnetic valve 3, with the pipeline between positive nitrogen purging threeway plug valve V2 to waste liquid bottle 11, purge 120 seconds, dry up anion-exchange column 14 remaining reagent B as far as possible; Reagent A, to correct status, is slowly pushed in waste liquid bottle 11 through anion-exchange column 14 with the first syringe 16, pushes away liquid measure 5mL every time by swivel tee plug valve V1, V2, V4, V5, V6, twice repeatedly; It is then shut off threeway plug valve V2, opens electromagnetic valve 3, with the pipeline between positive nitrogen purging threeway plug valve V2 to waste liquid bottle 11, purge 120 seconds, dry up anion-exchange column 14 remaining reagent A as far as possible.
After completing above-mentioned action, rotate and make threeway plug valve V4, V5, V6 to correct status, produce through cyclotron18F anion, under nitrogen carrier band, is collected into18O reclaims water bottle 12, thus,18F negative solution is caught by anion-exchange column 14 through plug valve V4,18O water entered plug valve V5, V6 and eventually entered into18O reclaims in water bottle 12.
Then, rotate and make threeway plug valve V1, V2, V4, V5, V6 to correct status, with the first syringe 16, reagent A is pushed in waste liquid bottle 11, push away liquid measure 5mL every time, three times repeatedly; It is then shut off threeway plug valve V2, opens electromagnetic valve 3, with the pipeline between positive nitrogen purging threeway plug valve V2 to waste liquid bottle 11, purge 120 seconds, it is ensured that pipeline dries.
After this, rotate and make threeway plug valve V3, V2, V4, V5 to correct status, push in product bottle 10 by slow for reagent B via anion-exchange column 14 with the second syringe 15, product under drip washing from anion-exchange column 2, thus, [18F] sodium fluoride injection enters in product bottle 10 through plug valve V5, pushes away liquid measure 5mL, quadruplication every time; It is then shut off threeway plug valve V2, opens electromagnetic valve 3, with the pipeline between positive nitrogen purging threeway plug valve V2 to product bottle 10.
Finally, rotate the state before making threeway plug valve V1, V2, V3, V4, V5, V6 extremely start, close electromagnetic valve 3, it is ensured that [18F] sodium fluoride preparation facilities original state when returning to start.
It should be noted that in above-mentioned preparation process, [18F] synthesis of sodium fluoride product, because not by the restriction of synthesis number of times, multi-stage synthesis can be carried out by repeatedly drying up the process of reduction, it is only necessary to repeat the process of above-mentioned synthesis phase first can carry out repeatedly [18F] synthesis of sodium fluoride injection.
In this embodiment, to utilize18F negative solution prepare [18F] sodium fluoride injection is that example is illustrated, and but be not restricted to that this, those skilled in the art can be adjusted according to actual needs.
Those skilled in the art, after considering description and putting into practice invention disclosed herein, will readily occur to other embodiment of the disclosure. The disclosure is intended to any modification of the disclosure, purposes or adaptations, and these modification, purposes or adaptations are followed the general principle of the disclosure and include the undocumented known general knowledge in the art of the disclosure or conventional techniques means. Description and embodiments is considered only as exemplary, and the true scope of the disclosure and spirit are pointed out by claim.
The foregoing is only the preferred embodiment of the disclosure, not in order to limit the disclosure, within all spirit in the disclosure and principle, any amendment of making, equivalent replacements, improvement etc., should be included within the scope that the disclosure is protected.
The form carried out an invention
The form carried out an invention is as it was previously stated, be usually stated as the optimal morphology making invention implement.
Industrial field applicability
Herein described technology can be applicable to positron medicine synthesis field.
Claims (10)
1. one kind [18F] sodium fluoride preparation facilities, it is characterised in that including:
Control unit, is configured to receive preparation instruction, and calculates the control data of each material liquid according to preparation instruction;
Performance element, is connected with described control unit, according to the described control data calculated by described control unit, perform [18F] preparation of sodium fluoride;
Described performance element includes:
Raw material input portion, according to the control data of the described material liquid calculated by described control unit, is injected separately into material liquid;
Gas-liquid transport part, be configured to described raw material input portion input material liquid be transmitted, make described material liquid flow through the anion-exchange column in described gas-liquid transport part, by drip washing obtain [18F] sodium fluoride;
Liquid storage part, is configured to gas and the liquid from described gas-liquid transport part is stored, and store described drip washing obtain [18F] sodium fluoride.
2. device according to claim 1, it is characterised in that described performance element also includes:
Gas Input, is configured in described performance element and imports gas;
Described gas-liquid transport part is configured to the material liquid of gas that described Gas Input is inputted and the input of described raw material input portion and is transmitted, and makes described material liquid flow through the anion-exchange column in described gas-liquid transport part, by drip washing obtain [18F] sodium fluoride;
Described Gas Input described liquid storage part store described drip washing obtain [18F] after sodium fluoride, the anion-exchange column in described gas-liquid transport part is dried up.
3. device according to claim 2, it is characterised in that
Described Gas Input is configured in described performance element to import noble gas.
4. device according to claim 3, it is characterised in that
The material liquid that described raw material input portion is injected includes activator, eluent and containing fluorine anion liquid.
5. device according to claim 4, it is characterised in that
The operation software of described control unit is worked out based on widely used Rockwell Programmable Logic Controller.
6. device according to any one of claim 1 to 5, it is characterised in that
Described control unit includes: host computer computer and the programmable logic controller (PLC) being connected with described host computer computer;
Described programmable logic controller (PLC) includes: control module that the input and output template that central processing unit is connected with described central processing unit is connected with described input and output template and the system power module being connected with described central processing unit, described input and output template, described control module respectively;
Described input and output template includes: the analog quantity template of the digital quantity template processing digital quantity between described central processing unit and described control module and the process analog quantity between described central processing unit and controlled setting;
Described central processing unit controls described digital quantity template, described analog quantity template and described control module respectively, and accepts the instruction of described host computer computer; Described digital quantity template controls controlled plant by described control module; Described analog quantity template and described controlled plant and the sensor being arranged in described controlled plant are connected, and transmit analog signals; Described central processing unit, described digital quantity template, described analog quantity template, described control module, described host computer computer, described controlled plant are carried out distribution by described system power respectively.
7. device according to claim 6, it is characterised in that described raw material input portion includes: be configured to the first adjustable syringe of range of injection activation agent; It is configured to the second adjustable syringe of range of injection eluent; It is configured to drive the duplex cylinder of the described first, second adjustable syringe of range.
8. device according to claim 7, it is characterised in that described gas-liquid transport part includes: be configured in the threeway plug valve in described gas-liquid transport part; It is configured to drive the rotary cylinder of described threeway plug valve.
9. device according to claim 8, it is characterised in that described Gas Input includes: be configured to the inert gas source of output noble gas; It is configured to control the electromagnetic valve of the conducting of described inert gas source.
10. device according to claim 9, it is characterized in that, the described first, second adjustable syringe of range is connected with the input stream in described gas-liquid transport part respectively through the first threeway plug valve, described input stream is provided with anion-exchange column, described Gas Input is arranged on described anion-exchange column place, and described liquid storage part is connected with described anion-exchange column via the output stream in described gas-liquid transport part.
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Application publication date: 20160615 |