Automatic synthesis device and method of sodium fluoride [< 18 > F] injection

A sodium chloride injection, an automatic synthesis technology, is applied in the direction of making medicines into special physical or taking forms of devices, etc., which can solve the problems of large radiation dose, unsuitable protection product quality stability, and high radioactivity. , to achieve the effect of simple operation, convenient aseptic and pyrogen-free treatment, and small footprint

Pending Publication Date: 2021-09-03
HTA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

due to fluorine [18 F] Sodium chloride has the characteristics of high radioactivity and large amount of radiation. Traditional manual methods are used to prepare fluorine[ 18 F] Sodium chloride has become more and more unsuitable for the protection of operators and the requirements for product quality stability. Chinese patents CN105662865A and CN203370133U all disclose the method for preparing fluorine [ 18 F] sodium chloride preparation equipment, but fluorine [ 18 F] When sodium chloride is used as an injection, it needs to meet strict sterile and pyrogen-free conditions, and try not to introduce external gas as a driving force for the movement of raw materials, intermediates and products. Pipes should be easily replaceable

Method used

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  • Automatic synthesis device and method of sodium fluoride [&lt; 18 &gt; F] injection
  • Automatic synthesis device and method of sodium fluoride [&lt; 18 &gt; F] injection
  • Automatic synthesis device and method of sodium fluoride [&lt; 18 &gt; F] injection

Examples

Experimental program
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Effect test

Embodiment 1

[0038] figure 1 shows a fluorine [ 18 F] the automatic synthesis device of sodium chloride injection, the synthesis device comprises 18 f - Supply device, sodium chloride injection supply device (8,9), sterile injection water supply device (8,9), first three-way valve group 21, QMA column 1, second three-way valve group 22, fluorine[ 18 F] sodium chloride injection receiving device and waste liquid recovery bottle group (5, 6), each three-way valve group includes at least one three-way valve, of course, the three-way valve group can also be replaced by other multi-way valve equivalents, In addition fluorine [ 18 F] The sodium chloride injection receiving device includes a product receiving bottle 7 and a sterilizing filter membrane, or enters a special injection liquid packaging process after being filtered through a sterilizing filter membrane.

[0039] according to figure 1 shown in the connection relationship, the 18 f - The supply device, the sodium chloride injecti...

Embodiment 2

[0058] see image 3 Shown, embodiment 2 discloses a kind of fluorine [ 18 F] The automatic synthesis method of sodium chloride injection, the automatic synthesis method can be realized by using the synthesis device disclosed in Example 1, but is not limited to the device in the above-mentioned Example 1, specifically, the automatic synthesis method includes:

[0059] Step 1. Sodium chloride injection activates the QMA column: Rinse the QMA column with sodium chloride injection for a few minutes, and use clean air to dry the residual liquid in the pipeline after rinsing.

[0060] Step 2, wash the QMA column with water: use sterile water for injection to rinse the QMA column for a few minutes, and use clean air to dry the residual liquid in the pipeline after rinsing.

[0061] Step 3, access 18 f - : Generated by accelerator shooting 18 f - Pass into the QMA column, and recover the components that are not adsorbed by the QMA column.

[0062] Step 4, clean the impurities in...

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Abstract

The invention discloses an automatic synthesis device and method of a sodium fluoride [< 18 > F] injection. The synthesis device comprises an < 18 > F <-> supply device, a sodium chloride injection supply device, a sterilization injection water supply device, a first three-way valve group, a QMA column, a second three-way valve group, a sodium fluoride [< 18 > F] injection receiving device and a waste liquid recovery bottle group, the <18>F <-> supply device, the sodium chloride injection supply device and the sterilization injection water supply device are respectively connected with the first three-way valve group, the QMA column, the second three-way valve group and the waste liquid recovery bottle group in series, and are selectively communicated under the control of the first three-way valve group and the second three-way valve group. Compared with a traditional manual mode, the automatic synthesis device of the sodium fluoride [< 18 > F] injection has the advantages that the efficiency is high, the operation is simple and convenient, the clinical use requirement of sterility and no pyrogen can be ensured through a clamping sleeve type structural design, and operators can be prevented from receiving high-dose radioactive radiation.

Description

technical field [0001] The invention belongs to the technical field of radiopharmaceuticals, in particular to a fluoro[ 18 F] Automatic synthesis device and method of sodium chloride injection. Background technique [0002] fluorine[ 18 F] Sodium chloride injection is a positron emission tomography (PET) drug, which is mainly used for the diagnosis of active osteogenic reaction bone diseases. As early as 1962, Blau et al. found that it was an excellent bone imaging agent. In 1972, the U.S. Food and Drug Administration (Food and Drug Administration, FDA) approved fluoride [ 18 F] sodium chloride injection is used clinically, but the market supply was suspended due to commercial reasons in 1975. In recent years, due to the rapid development of PET and PET / CT technology, the superiority of fluoro[18F] sodium PET imaging and the 99 Mo / 99 Tc m generator 99 The global supply shortage of Mo raw materials, the international demand for fluorine[ 18 F] The research and applic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00
CPCA61J3/00
Inventor 李光成伟华张文辉宋志浩张蕴瀚高菲董瑞林
Owner HTA CO LTD
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