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Gastric mucosa calibration reagents and preparation method

A calibration solution and gastric mucosa technology, applied in the field of labeling solution and preparation, can solve the problems of not being able to provide long-term, safe and effective labeling, and achieve the effect of long retention time

Inactive Publication Date: 2009-04-15
HANGZHOU ZHEDA GASTROENTEROPATHY DIAGNOSE TECH RES DEV +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the shortcomings that the current gastric mucosal marking solution cannot provide long-term, safe and effective marking, and provide a novel gastric mucosal calibration solution, which is prepared by medical Indian ink stock solution and sterile water for injection at a ratio of 1:10. Concentration of 1:100, 1:1000, the appearance is a black suspension, uniform, no lumps or precipitation, the pH value is 8-8.3, and the carbon content is 0.60%

Method used

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  • Gastric mucosa calibration reagents and preparation method
  • Gastric mucosa calibration reagents and preparation method
  • Gastric mucosa calibration reagents and preparation method

Examples

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Effect test

Embodiment 1

[0014] A new type of gastric mucosa calibration solution provided by the present invention is prepared from medical Indian ink stock solution and sterile water for injection to a concentration of 1:10 in volume ratio. , the pH value is 8.2, and the carbon content is 0.60%.

[0015] According to the medical requirements of the calibration solution and with reference to domestic and foreign medical literature, various calibration solution raw materials were screened. Finally, we selected the stock solution of Indian ink (Pelikan, Hanover, Germany) imported from Germany, and the quality met the European pharmaceutical standards. The main components of the stock solution are carbon, ethylene glycol, sodium tetraborate decahydrate and ammonia water.

Embodiment 2

[0017] Prepare the calibration solution according to the principles of the lowest concentration, the smallest dose, the longest time and the clearest display. The calibration solution used is medical India ink. After shaking the stock solution of Indian ink, dilute it with sterile water for injection to a concentration of 1:10, 1:100, 1:1000 in a sterile environment, and fill it into a glass vial. Sterilize with moist heat (100°C, 30 minutes) by circulating steam.

[0018] Quality standard: The appearance should be a black suspension, uniform and consistent, without lumps or precipitation. The pH was neutral, and the pH was measured on various dilutions of India ink using a pH meter (825MP, Fisher Scientific, Pittsburgh, PA). The determination of carbon content was carried out by elemental analysis (elemental analysis instrument: ThermoFinnigan, model: Flash EA1112).

[0019] Medical India ink—weighing—drying at 80°C for 48 hours—cooling in a desiccator—weighing—elemental a...

Embodiment 3

[0046] Embodiment 3 Animal experiments verify the performance, effectiveness and safety of the calibration solution

[0047] To study the clarity and local histological reaction caused by different concentrations and different doses of calibrator. Determine the appropriate concentration and dosage of calibrator, the effectiveness, long-term and safety of the label.

[0048] All animal experiments were completed in the animal laboratory of Run Run Shaw Hospital, which is a national third-level medical animal laboratory.

[0049] 1. New Zealand white rabbit experiment:

[0050] Materials and Methods:

[0051] Calibration by laparotomy. New Zealand white rabbits, adult females, weighing 2-2.5 kg. There are 6 rabbits in total. Two groups were used, the experimental conditions within the group were the same, and the doses between the groups were different. According to the dose of calibration solution injected at each point, it was divided into three groups: A, B, and C. Each...

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Abstract

The invention provides a gastric mucosa calibration solution. A stock solution of medical India ink and sterile water for injection are prepared into fixed concentrations respectively, prepared solutions are black suspensoid solutions from the appearance, are uniform, and have no cakes or precipitation, the pH value is neutral, and the carbon content is 0.60 percent. The gastric mucosa calibration solution is prepared by the following steps: the stock solution of the India ink is shaken up and then is diluted by the sterile water for injection in a sterile environment according to volume ratios; and the prepared solutions are put into small glass bottles and are subject to moist heat sterilization by an arnold steam method at the temperature of 100 DEG C for 30 minutes. As a calibration solution retained for a longer time after being injected into inside a living body, the gastric mucosa calibration solution can mark for a longer time, is safe, has no toxic side effect, and meets the national standard; the gastric mucosa calibration solution can be retained after the return visit date, and fully meet the requirement of follow-up biopsy sampling of a gastroscope; and the gastric mucosa calibration solution does not interfere and affect the observation of tissue pathologies, does not affect the recognition of cellular morphology and precancerous pathological changes such as mucosal layer morphology, intestinal metaplasia and so on, and does not affect the judgment to normal tissue morphologies.

Description

technical field [0001] The invention relates to the field of biochemical medicine, and relates to a marking liquid capable of safely, effectively and long-term marking mucous membranes in body cavities and a preparation method. Background technique [0002] The occurrence and development of many clinical gastrointestinal diseases is a long course of change. For example, changes in gastric precancerous lesions and small tumors require long-term follow-up observation. Endoscopy and endoscopic pathological biopsy are diagnostic The most accurate indicator of lesion changes, accurate positioning in monitoring is the key to long-term follow-up. However, it is difficult to accurately cut out the lesions seen in the first biopsy in the next re-examination. Even if the same endoscopist performs gastroscopy before and after treatment, it is impossible to take the same part of the tissue. Inconsistency also lacks comparability, greatly reducing the detection rate of the disease. How...

Claims

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Application Information

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IPC IPC(8): A61K49/00
Inventor 姒健敏陈淑洁王良静孙蕾民
Owner HANGZHOU ZHEDA GASTROENTEROPATHY DIAGNOSE TECH RES DEV
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