Indigo carmine mucosa dyeing agent and preparation method thereof

A technique for mucous membrane dyeing and indigo carmine, which is applied in the field of indigo carmine mucous membrane dye and its preparation, can solve the problems of high product price, short validity period, and increased potential safety hazards, and achieve convenient clinical use, long-term placement, and stability Good results

Pending Publication Date: 2018-01-09
CHONGQING SKYFORBIO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The increase of product impurities has increased the potential safety hazards of clinical use; the short validity period of the product, one-time

Method used

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  • Indigo carmine mucosa dyeing agent and preparation method thereof
  • Indigo carmine mucosa dyeing agent and preparation method thereof
  • Indigo carmine mucosa dyeing agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: the preparation of indigo carmine mucosa stain

[0015] The raw and auxiliary materials are composed of:

[0016]

[0017]

[0018] Preparation:

[0019] (1) Add indigo carmine to purified water at 60°C, mix and stir, and dissolve completely to obtain a solution;

[0020] (2) In a nitrogen-filled environment, the above-mentioned solution is filled into a soft bag to obtain the indigo carmine mucosa staining solution;

[0021] (3) The above-mentioned mucous membrane staining solution is finally steam sterilized to obtain a sterile product.

Embodiment 2

[0022] Embodiment 2: the preparation of indigo carmine mucosa stain

[0023] The raw and auxiliary materials are composed of:

[0024]

[0025] Preparation:

[0026] (1) Add indigo carmine to purified water at 80°C, mix and stir, and dissolve completely to obtain a solution;

[0027] (2) In a nitrogen-filled environment, the above-mentioned solution is filled into a soft bag to obtain the indigo carmine mucosa staining solution;

[0028] (3) The above-mentioned mucous membrane staining solution is finally steam sterilized to obtain a sterile product.

Embodiment 3

[0029] Embodiment 3: the preparation of indigo carmine mucosa stain

[0030] The raw and auxiliary materials are composed of:

[0031]

[0032] Preparation:

[0033] (1) Add indigo carmine to purified water near 100°C, mix and stir, and dissolve completely to obtain a solution;

[0034] (2) In a nitrogen-filled environment, the above-mentioned solution is filled into a soft bag to obtain the indigo carmine mucosa staining solution;

[0035] (3) The above-mentioned mucous membrane staining solution is finally steam sterilized to obtain a sterile product.

[0036] Stability test:

[0037] Test conditions: temperature is 25±2°C, relative humidity is 60%±10%, and the investigation time points are 0, 3, 6, 9, 12, 18, and 24 months.

[0038]

[0039] The results show that the samples from Example 1 to Example 3 have a content change of less than 6% after 24 months of storage.

[0040] Comparative test 1

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Abstract

The invention discloses an indigo carmine mucosa dyeing agent which is characterized by consisting of the following components in unit g/ml: indigo carmine with the concentration of 0.15%-1.0% and thebalance of water. The indigo carmine mucosa dyeing agent is high in stability, free of other auxiliary materials, high in security and beneficial to long-term preservation.

Description

technical field [0001] The invention relates to a pharmaceutical preparation or a medical device, in particular to an indigo carmine mucous membrane dye and a preparation method thereof. Background technique [0002] Indigo carmine mucosal staining agent is a commonly used staining agent for early gastrointestinal cancer screening. At present, the commonly used clinical concentration is 0.2%, and there are three specifications: 15ml, 25ml, and 50ml. The aqueous solution of indigo carmine is extremely unstable, and it is easy to oxidize to produce impurities, and the color becomes lighter when the content decreases. The content standards of commercialized products are set on the low side, generally 75%-125% of the indicated content. The product is only valid for one year. It is more unstable after opening the bottle clinically, and it is generally required to be used once or as soon as possible. The increase of product impurities has increased the potential safety hazards ...

Claims

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Application Information

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IPC IPC(8): A61K49/00
Inventor 王国华贺代琼王哲西
Owner CHONGQING SKYFORBIO
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