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X-ray contrast agent composition and its preparation method

A composition and contrast agent technology, applied in the direction of X-ray contrast agent preparation, etc., can solve the problems of poor continuity and stability, large proportion of barium sulfate, poor in vivo stability, etc., and achieve stable performance, no toxic side effects, and strong stability. Effect

Inactive Publication Date: 2005-10-26
SHANDONG NORMAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high specificity of barium sulfate, although suspending agent and dispersing agent are added, after adding water and mixing, it usually precipitates and hardens after 10 minutes and cannot be dispersed again, and the continuity and stability in the gastrointestinal tract are poor.
Several kinds of barium sulfate suspensions currently developed in the market are placed in airtight containers after being made to achieve the purpose of convenient use, but the preparations have poor stability and are easy to separate layers. They need to be shaken when used, and they should not be dispersed after long-term storage. The poor stability in the body seriously affects the use in medical clinics, so it is of great medical value to develop an X-ray suspension contrast agent that can be suspended for a long time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Recipe example

[0067] Barium sulfate 45, soil temperature -80 3.5, gum arabic 0.3, agar 0.2, potassium tripolyphosphate 0.01, 4-hydroxy-3-methoxybenzoic acid 0.01, balance deionized water.

[0068] The preparation process of the present invention is as follows:

[0069] Take medical barium sulfate micropowder, screen less than 2um, add surfactant and stabilizer, and grind. When the dispersed particles of coating stabilizer are more than 95%, add excipients, chelating agent and corrective agent and blend the preparation Treat it twice with a high-pressure homogenizer (colloid mill) in the liquid state, then age at 2°C for 20 hours, then adjust the pH to 7 with sodium bicarbonate, and finally degas at 50°C for 40 minutes, and then homogenize with a colloid mill Quality 1 time, get the finished product.

[0070] The above preparation is a white homogeneous liquid with a viscosity of 0.6 Pa.s, a specific gravity of 1.2 and a pH of 6.8.

Embodiment 2

[0072] Recipe example

[0073] Barium sulfate 230, linoleic acid 0.5, xanthan gum 0.8, cyclodextrin 2.0, ethylenediaminetetraacetic acid 0.02, de-brained oil 0.02, balanced deionized water.

[0074] The preparation process of the present invention is as follows:

[0075] Take medical clay, screen less than 2um, add surfactant and stabilizer, and grind. When the dispersed particles of coating stabilizer are more than 95%, add excipients, chelating agents and correctives and blend the preparations in the liquid state. Use a high-pressure homogenizer (colloid mill) to treat twice, then age at 30°C for 25 hours, then adjust the pH to 9 with sodium bicarbonate, and finally degas at 80°C for 20 minutes, and then homogenize with a colloid mill for 1 Times, get the finished product.

[0076] The above-mentioned preparation is a light gray homogeneous liquid with a viscosity of 0.3 Pa.s, a specific gravity of 1.12, and a PH value of 8.

Embodiment 3

[0078] Recipe example

[0079] Clay 40, soil temperature -80 0.1, gum arabic 0.3, cyclodextrin 0.3, ethylenediaminetetraacetic acid 0.05, lemon oil 0.03.

[0080] The preparation process of the present invention is as follows:

[0081] Take medical barium sulfate micropowder, screen less than 2um, add surfactants and stabilizers, and grind. When the dispersed particles coated with stabilizer are more than 95%, add excipients, chelating agents and correctives and blend the preparations Treat it twice with a high-pressure homogenizer (colloid mill) in the liquid state, then age at 10°C for 30 hours, then adjust the pH to 8 with sodium bicarbonate, and finally degas at 90°C for 60 minutes, and then homogenize with a colloid mill Quality 1 time, get the finished product.

[0082] The above preparation is orange homogeneous liquid, viscosity 0.8 Pa.s, specific gravity 1.22, PH value 7.

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Abstract

A composition as the X-ray contrast medium is prepared from solid reference material, surfactant, excipient, stabilizer, chelating agent, flavouring and water through mixing said solid reference material powder with surfactant and stabilizer, grinding, sequentially adding others, high-pressure homogenizing in liquid state, ageing, regulating pH=7-9 and degassing.

Description

Technical field [0001] The invention relates to medical preparations, in particular to an X-ray contrast agent composition and a preparation method thereof. Background technique [0002] The digestive tract is responsible for the intake, absorption and metabolism of human nutrition, including the oral cavity, esophagus, stomach and duodenum, small intestine, colon and other organs. Because its two ends are directly connected to the outside world, it is prone to various diseases. Since the digestive tract is a pipe-like organ, it is in a tortuous, coiled, adherent and peristaltic state, so its examination is also different from other substantial organs. [0003] The most commonly used gastrointestinal examination is X-ray barium sulfate contrast, which is divided into esophagus, gastrointestinal and colonography. Barium sulfate suspension can be divided into two types: fine and uniform type and uneven thickness. The fine and uniform barium agent is mostly synthetic barium, with fi...

Claims

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Application Information

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IPC IPC(8): A61K49/04
Inventor 桂维玲姚建
Owner SHANDONG NORMAL UNIV
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