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Urea [<14>C] capsules and micro-packaging method thereof

A urea and capsule technology, which is applied in the field of radiopharmaceutical urea [14C] capsules and their micro-packaging, can solve the problems of low packing accuracy and radioactive pollution cost, and achieve the advantages of reducing manual operation, short drying time and ensuring accuracy. Effect

Active Publication Date: 2012-02-01
SHENZHEN ZHONGHE HEADWAY BIO SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved in the present invention is, for existing urea [ 14 C] the subpackage accuracy of the solid subpackage method of capsule is not high, easily causes radioactive pollution and the defective of high cost, provides a kind of urea[ 14 C] Capsules and their micro-packaging methods make the drug sub-packaging process safer, the results of sub-packaging are more accurate, and the cost is lower

Method used

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  • Urea [&lt;14&gt;C] capsules and micro-packaging method thereof
  • Urea [&lt;14&gt;C] capsules and micro-packaging method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Dosing steps, the urea [ 14 C] be dissolved in dehydrated alcohol and prepare to obtain containing urea [ 14 C] absolute ethanol solution, so that the radioactivity is 0.06 μCi / μl;

[0035] Subpackage step, utilize automatic dispensing machine to contain urea[ 14 C] the dehydrated ethanol solution is divided into each gelatin capsule in the 96-well plate, wherein the liquid separation volume is set to 10 μ l;

[0036] Drying step, the aliquot containing urea[ 14 C] the gelatin capsule of absolute ethanol solution is 20 ℃ at temperature, and humidity is 40%, and continuous drying is 30 minutes, obtains the urea-containing [ 14 C] Gelatin capsules of powder such that the activity per gelatin capsule is 0.60 μCi.

[0037] Table 1 shows the radioactivity measurement results of a batch of 40 capsules produced (all in μCi). The results show that the radioactivity of all of them satisfies 0.60~0.90μCi.

[0038] Table 1

[0039] 0.62

Embodiment 2

[0041] Dosing steps, the urea [ 14 C] be dissolved in dehydrated alcohol and prepare to obtain urea [ 14 C] ethanol solution, so that the radioactivity is 0.073 μCi / μl;

[0042] Packing steps, using automatic liquid dispenser, will contain urea[ 14 C] the dehydrated ethanol solution is divided into each gelatin capsule in the 96-well plate, wherein the liquid separation volume is set to 12 μ l;

[0043] Drying step, the aliquot containing urea[ 14 C] the gelatin capsule of absolute ethanol solution is 30 ℃ at temperature, and humidity is 35%, continues to dry 20 minutes, obtains the urea-containing [ 14 C] Gelatin capsules of powder, so that the activity of each gelatin capsule is 0.876 μCi.

[0044] Table 2 shows the measurement results of radioactivity in a batch of 40 capsules produced (all units are μCi).

[0045] The results show that the radioactivity of all of them satisfies 0.60~0.90μCi.

[0046] Table 2

[0047] 0.82

Embodiment 3

[0049] Dosing steps, the urea [ 14 C] be dissolved in dehydrated alcohol and prepare to obtain containing urea [ 14 C] absolute ethanol solution, so that the radioactivity is 0.066 μCi / μl;

[0050] Subpackage step, utilize automatic dispensing machine to contain urea[ 14 C] the dehydrated ethanol solution is divided into each gelatin capsule in the 96-well plate, wherein the liquid separation volume is set to 13 μ l;

[0051] Drying step, the aliquot containing urea[ 14 C] the gelatin capsule of absolute ethanol solution is at a temperature of 15 ° C, a humidity of 45%, and is continuously dried for 40 minutes to obtain a urea-containing [ 14 C] Gelatin capsules of powder, so that the activity of each gelatin capsule is 0.858 μCi.

[0052] Table 3 shows the measurement results of radioactivity in a batch of 40 capsules produced (all in μCi). The results show that the radioactivity of all of them satisfies 0.60~0.90μCi.

[0053] table 3

[0054] 0.89

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Abstract

The invention relates to urea [<14>C] capsules and a micro-packaging method thereof. The method comprises: a solution preparation step: preparing an absolute ethyl alcohol solution containing urea [<14>C]; a split charging step: packaging the urea [<14>C]-containing absolute ethyl alcohol solution into capsules; a drying step: drying the capsules charged with the urea [<14>C]-containing absolute ethyl alcohol solution, thus obtaining the capsules containing urea [<14>C] powder. With absolute ethyl alcohol as a carrier medium, the method of the invention improves the packaging precision of theurea [<14>C] capsules. And no carrier medium residual is left in the prepared urea [<14>C] capsules, so that a hidden danger of the carrier medium is avoided and the production cost is reduced. Meanwhile, with a liquid solvent as the carrier medium, the method provided in the invention avoids pollution of radioactive powder, and the employment of an automatic liquid separator raises the packagingprecision and makes the operation process more secure simultaneously, so that influences to the environment can be reduced to the utmost.

Description

technical field [0001] The present invention relates to radiopharmaceuticals, more specifically, to a radiopharmaceutical urea[ 14 C] Capsules and micro-packaging methods thereof. Background technique [0002] Urea[ 14 C] The breath method is a non-invasive method for detecting Helicobacter pylori (HP). Urea[ 14 C] The principle of the exhalation method is that HP produces urease in the body. After the subject takes the urea labeled with C14, the urea decomposes under the action of urease to produce isotope-labeled carbon dioxide. Scintillation counter or gas nuclear mass spectrometer to detect the content of labeled carbon dioxide. Using this method to detect HP in the body has high specificity, which can be close to 100%, can be quantitatively analyzed and has high sensitivity, is simple, fast, and painless for patients, and is very reliable for detecting whether HP is radically cured. [0003] Patients usually take urea [ 14 C] Capsules for C14-urea breath test. Si...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K51/12A61K101/00
Inventor 黄晋杰郭春生沈桂富沈澄
Owner SHENZHEN ZHONGHE HEADWAY BIO SCI & TECH CO LTD
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