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Traditional Chinese medicine injection with low anaphylactoid reaction

A technology for allergic reactions and injections, applied in pharmaceutical formulations, drug delivery, medical preparations with inactive ingredients, etc., can solve the problems of tannin and other impurities residues, extensive production process, human body irritation, etc., to reduce safety risks , the effect of reducing allergic reactions to products

Pending Publication Date: 2022-02-22
JIANGZI QINGFENG PHARMACEUTICALS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The production process of traditional Chinese medicine injection can be basically summarized as "water extraction and alcohol precipitation", "alcohol extraction and water precipitation" and "distillation method". , tannin and other impurities remain, which in turn can be irritating to the human body

Method used

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  • Traditional Chinese medicine injection with low anaphylactoid reaction
  • Traditional Chinese medicine injection with low anaphylactoid reaction
  • Traditional Chinese medicine injection with low anaphylactoid reaction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 filtrate or combined liquid preparation

[0030] a Sulfonation: Take absolute ethanol and place it in a reaction vessel, add concentrated sulfuric acid with a chemically pure specific gravity of 1.84 on a cold water bath, add andrographolide powder, stir well, and place at room temperature.

[0031] b Neutralization: After standing for 24 hours, add ethanol and stir evenly, control the temperature on a cold water bath at 50°C, and neutralize with sodium hydroxide solution until the pH value is 7.0.

[0032] c Filtration: add ethanol, stir well, filter after standing for 2 hours, wash the filter residue with ethanol until the lotion is almost colorless, combine the filtrate and lotion to obtain the combined solution.

Embodiment 2

[0033] Embodiment 2 preparation of andrographolide sulfonate

[0034] Take the combined solution of Example 1, pour it into a nanofiltration membrane separation device, and use a nanofiltration membrane with a molecular weight cut-off of 300 Da to concentrate to obtain a concentrated solution. Add water for injection of 20 times the amount of andrographolide to the concentrated solution to carry out water sinking to obtain a water sinking liquid; the water sinking liquid uses a polyvinylidene fluoride ultrafiltration membrane with a relative molecular weight cut-off of 10,000, and the inlet pressure of the ultrafiltration membrane is controlled to be 1.0 bar. The outlet pressure of the membrane is 0.7bar, the temperature of the feed liquid is controlled at 40°C, and the pH of the feed liquid is controlled at 6.0, and ultrafiltration is performed. When the ultrafiltration is concentrated to 1 / 15 of the feed liquid, 1 / 10 of the feed liquid is added in 2 times for ultrafiltration....

Embodiment 3

[0035] Embodiment 3 preparation of andrographolide sulfonate

[0036] Take the combined solution of Example 1, pour it into a nanofiltration membrane separation device, and use a nanofiltration membrane with a molecular weight cut-off of 300 Da to concentrate to obtain a concentrated solution. Add water for injection of 20 times the amount of andrographolide to the concentrated solution to carry out water sinking to obtain a water sinking liquid; the water sinking liquid adopts a polyvinylidene fluoride ultrafiltration membrane with a relative molecular weight cut-off of 8000, and the inlet pressure of the ultrafiltration membrane is controlled to be 0.7 bar. The outlet pressure of the membrane is 0.5 bar, the temperature of the feed liquid is controlled at 50°C, the pH of the feed liquid is controlled at 5.0, and ultrafiltration is carried out. The ultrafiltrate is obtained; the ultrafiltrate is concentrated by controlling the concentration temperature at 50° C., and the conc...

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PUM

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Abstract

The invention discloses a traditional Chinese medicine injection with low anaphylactoid reaction, which can effectively remove macromolecular substances, pyrogen reactive substances, small-molecular-weight tannin, resin and other impurities in andrographolide sulfonate raw materials, and reduce the anaphylactoid reaction of a traditional Chinese medicine injection product through preparation liquid preparation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a traditional Chinese medicine injection with low hypersensitivity. Background technique [0002] The production process of traditional Chinese medicine injection can be basically summarized as "water extraction and alcohol precipitation", "alcohol extraction and water precipitation" and "distillation method". , tannin and other impurities remain, which can be irritating to the human body. Studies have shown that the macromolecular allergic impurities remaining in traditional Chinese medicine injections are the main cause of clinical allergic reactions in traditional Chinese medicine injections. Contents of the invention [0003] The invention provides a traditional Chinese medicine injection with low hypersensitivity reaction, which contains andrographolide sulfonate. The method is simple, easy, scientific and reasonable, can significantly improve the safety of the fin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/365A61K47/04A61K47/12A61K47/26A61K47/10A61K47/14
CPCA61K9/08A61K9/0019A61K31/365A61K47/02A61K47/12A61K47/26A61K47/10A61K47/14
Inventor 刘尧奇郭正友刘地发方礼陈琳王章伟王振张功俊刘芳芳张毅钟仁清简蓝
Owner JIANGZI QINGFENG PHARMACEUTICALS INC
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