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A diagnostic reagent for Helicobacter pylori infection and its preparation method

A technology of Helicobacter pylori and diagnostic reagents, applied in the field of radiopharmaceuticals, can solve the problems of unacceptable, easily infected, and difficult treatment, and achieve the effect of high speed, high degree of automation, and high volume precision

Active Publication Date: 2016-05-18
上海欣科医药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Gastroscopy itself is very painful for patients, and biopsy is easy to infect diseases such as infection, and there is no specific drug for the treatment of Helicobacter pylori. To eradicate it, it is necessary to follow up and review the curative effect
In addition to first-time patients who need to undergo gastroscopy to rule out gastric cancer, gastroscopic biopsy is performed just to review the treatment of Helicobacter pylori, which is very painful for patients and expensive, and is generally not accepted
Therefore, the opportunity to cure gastric disease at one time is often missed, and the recurrence of the disease brings new difficulties to the treatment.
Although serological methods are also basically non-invasive, they can only diagnose whether they have been infected with Helicobacter pylori, but cannot judge whether they have been eradicated

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0041] 1. Urea[ 14 C] Preparation of ethanol solution:

[0042] (1) Urea [ 14 C] Dissolution:

[0043] ① take urea [ 14 C] One bottle, according to the ratio of 1mCi plus 1mL of absolute ethanol, dissolve the raw materials; take the raw material of 100mCi specification as an example: take a bottle, take 100mL of absolute ethanol with a pipette (or sterile syringe), and dissolve it to a radioactive concentration 1mCi / mL solution;

[0044] ②Take the above solution and dilute it with ethanol at a ratio of 1:5. To prepare 10mCi urea[ 14 C] ethanol solution is example: get 10mL above-mentioned solution in glass container, get dehydrated alcohol and dilute into 50mL with pipette (or sterilized syringe), shake up, be prepared into the urea that is used to produce capsule [ 14 C] ethanol solution, sent for inspection;

[0045] ③Take 2 μL of the above diluted solution and add it to a clean detection bottle, then add 3 mL of scintillation fluid, and shake well. Tested with a β-r...

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Abstract

The invention relates to a diagnostic reagent for Helicobacter pylori and a preparation method thereof. The diagnostic reagent for Helicobacter pylori comprises a radioactive urea [14C] capsule and a gas collection agent supporting the use of the capsule; the radioactive urea [14C] capsule is encapsulated with a urea [14C] ethanol solution and a capsule filler and has radioactivity of 0.85-115mu Ci; the filler is a mixture of mannitol and urea; and the gas collection agent is an absolute methanol solution of hyamine hydroxide and phenolphthalein, wherein the concentration of hyamine hydroxide is 0.475-0.525 mol / L, and the concentration of phenolphthalein is 0.70-0.80 g / L. The diagnosis for Helicobacter pylori infection with the diagnostic reagent provided by the invention has the characteristics of convenience, accuracy and safety.

Description

technical field [0001] The invention relates to a diagnostic reagent for Helicobacter pylori infection and a preparation method thereof, in particular to a diagnostic urea [ 14 C] The capsule and its gas-collecting agent and the preparation method of the capsule and the gas-collecting agent belong to the field of radiopharmaceuticals. Background technique [0002] At present, radioactive substances are widely used in various fields such as production, scientific research, medical treatment, biology, and laboratories, especially as medicines, and have been widely used in clinical applications at home and abroad. Diagnostic urea[ 14 C] Capsule and its gas-collecting agent are used in the diagnosis and detection method of gastric Helicobacter pylori infection, which has the characteristics of convenience, rapidity, economy and non-invasiveness. Helicobacter pylori is the main pathogenic bacteria of gastric ulcer and chronic atrophic gastritis, eradicating Helicobacter pylori ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K51/12A61K51/04G01N23/00
Inventor 徐鹏程戴雅琴张国华吴松年
Owner 上海欣科医药有限公司
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