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High-safety gastrointestinal motility marker and preparation method thereof

A gastrointestinal motility and high-safety technology, which is applied in the fields of pharmaceutical formulation, compound screening/testing, X-ray contrast agent preparation, etc., can solve problems such as difficulty in barium sulfate dispersion, affecting intestinal safety, and difficulty in observation, so as to improve clinical Application method, improvement of surface hydrophilicity, effect of controlling production cost

Active Publication Date: 2020-03-27
海南一剂堂生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] (1) CN101773674 B patent discloses a method for preparing gastrointestinal motility marker capsules, which has the following disadvantages: 1. The edges of the markers are not chamfered, and the intestinal tract will be damaged during delivery
2. Silicone rubber is used to prepare by vulcanization. Vulcanizing agents must be added for vulcanization. The vulcanizing agent is highly toxic and has low safety. If there are markers that cannot be completely discharged, they will remain in the intestinal tract for a long time. The safety of the material is low and will affect the safety of the intestinal tract.
3. The addition of barium sulfate is 15-40%. This patent uses the banburying process for barium sulfate dispersion. This process cannot add more barium sulfate, and there is difficulty in dispersion. The amount of barium sulfate added is small, and barium sulfate development is required for X-ray inspection To observe the effect of the use of gastrointestinal motility markers, the addition of barium sulfate is small, and the X-ray development is not bright enough, which is difficult to observe and affects clinical use
4. The markers must be filled in capsules before they can be taken. 5. There is no clear weight of the markers. Different weights of markers have inconsistent delivery effects under the effect of colonic peristalsis
[0004] (2) The appearance and size of the markers of the gastrointestinal motility marker capsules are small, and it is difficult to chamfer the edges during the preparation process. For example, general molding, extrusion and pelletizing cannot be realized, and the molding vulcanization process used in patent CN101773674 B cannot be realized. Chamfer the edge of the marker, the sharp edge of the right angle will damage the intestine
[0006] (4) The amount of barium sulfate added affects the practical effect of the product, and the addition of a large amount of barium sulfate has problems such as difficulty in dispersion
[0007] (5) The marker is made of plastic material. The plastic material is not smooth enough and has poor hydrophilicity. It is easy to get stuck in the throat when it is taken directly.
[0008] In summary, there are many problems in the existing gastrointestinal motility markers that need to be improved

Method used

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  • High-safety gastrointestinal motility marker and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A method for preparing a high-safety gastrointestinal motility marker, comprising the following steps:

[0038] S1. Put TPU and barium sulfate in a weight ratio of 1:0.35, add to the mixer, stir at 1800r / min for 65min, and mix well;

[0039] S2. Put the mixed TPU and barium sulfate into the micro high-pressure injection molding machine, perform high-pressure injection molding at an injection pressure of 240MPa and an injection temperature of 190°C, fully disperse the barium sulfate, and make a mold with a wall thickness of 0.8-1.2mm and a radius R Round corner markers of 0.1-0.3mm;

[0040] S3. Fix the markers on the tooling, use a numerical control spraying machine to evenly spray 10wt% gelatin aqueous solution on the surface of the markers at a spraying speed of 0.4m / min, to obtain target markers, each weighing 18-21mg.

Embodiment 2

[0042] A method for preparing a high-safety gastrointestinal motility marker, comprising the following steps:

[0043] S1. Put TPU and barium sulfate in a weight ratio of 1:0.55, add to the mixer, stir at 2300r / min for 50min, and mix well;

[0044] S2. Put the mixed TPU and barium sulfate into the micro high-pressure injection molding machine, perform high-pressure injection molding at an injection pressure of 360MPa and an injection temperature of 160°C, fully disperse the barium sulfate, and make a mold with a wall thickness of 0.8-1.2mm and a radius R Round corner markers of 0.1-0.3mm;

[0045] S3, fix the marker on the frock, use a numerical control spraying machine, evenly spray 20wt% hydroxypropyl methylcellulose aqueous solution on the surface of the marker with a spraying speed of 0.6m / min, and make the target marker, each grain weight is 18 -21 mg.

Embodiment 3

[0047] A method for preparing a high-safety gastrointestinal motility marker, comprising the following steps:

[0048] S1. Put TPU and barium sulfate in a weight ratio of 1:0.45, add to the mixer, stir at 2000r / min for 60min, and mix well;

[0049] S2. Put the mixed TPU and barium sulfate into the micro high-pressure injection molding machine, perform high-pressure injection molding at an injection pressure of 300MPa and an injection temperature of 165°C, fully disperse the barium sulfate, and make a mold with a wall thickness of 0.8-1.2mm and a radius R Round corner markers of 0.1-0.3mm;

[0050] S3. Fix the marker on the tooling, use a numerical control spraying machine, and evenly spray 15wt% gelatin aqueous solution on the surface of the marker at a spraying speed of 0.5m / min to prepare the target marker, each weighing 18-21mg.

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Abstract

The invention provides a preparation method of a high-safety gastrointestinal motility marker. The preparation method comprises the following steps of S1, uniformly mixing TPU with barium sulfate in the weight ratio being 1 to (0.35-0.55); S2, performing micro high-pressure injection molding on the TPU and the barium sulfate which are well mixed to obtain a rounding marker; and S3, fixing the marker on a tool, performing numerically-controlled spraying, and uniformly spraying a gelatin aqueous solution or a hydroxypropyl methyl cellulose aqueous solution to the surface of the marker at the spraying speed of 0.4-0.6m / min so as to obtain a target marker. The gastrointestinal motility marker prepared by the preparation method disclosed by the invention is higher in safety and better in developing effects, and can be better applied to gastrointestinal motility inspection, and the production cost can also be better controlled.

Description

technical field [0001] The invention relates to the technical field of gastrointestinal motility markers, in particular to a high-safety gastrointestinal motility marker and a preparation method thereof. Background technique [0002] Medically, the diagnosis of colonic atony constipation requires a colonic transit test, taking markers containing barium sulfate, and judging the colonic peristaltic function based on the passage of time and the number of markers remaining in the colon. [0003] (1) CN101773674 B patent discloses a method for preparing gastrointestinal motility marker capsules, which has the following disadvantages: 1. The edge of the marker is not chamfered, and the intestinal tract will be damaged during delivery in the intestinal tract. 2. Silicone rubber is used for vulcanization. Vulcanizing agents must be added for vulcanization. The vulcanizing agent is highly toxic and has low safety. If there are markers that cannot be completely discharged and remain i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00A61K49/04
CPCA61K49/0004A61K49/0404
Inventor 李伯彦
Owner 海南一剂堂生物科技有限公司
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