Freeze-dried powder injection of andrographolide sulfonate or salt thereof with low anaphylactoid reaction

An andrographolide, allergic reaction technology, applied in freeze-drying delivery, powder delivery, drug delivery and other directions, can solve the problems of wide molecular weight range, anaphylactic-like stability, and complete removal by ultrafiltration process, and achieve a stable improvement. Effect

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] A certain proportion of macromolecular substances, tannins, and resins remaining in the extracts of traditional Chinese medicine injections used in the preparation of traditional Chinese medicine injections are the main components that cause adverse reactions in traditional Chinese medicine injections. Traditional purification processes such as water extraction and alcohol precipitation, and alcohol extraction and water precipitation are difficult to remove thoroughly. At present, it is prevalent in the industry to control macromolecular substances through ultrafiltration. However, due to the wide molecular weight range of tannins and resins, they cannot be completely removed by ultrafiltration. There is a certain risk of anaphylactoid reaction, such as CN1349986A, which has the problem of anaphylactoid reaction and poor stability

Method used

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  • Freeze-dried powder injection of andrographolide sulfonate or salt thereof with low anaphylactoid reaction
  • Freeze-dried powder injection of andrographolide sulfonate or salt thereof with low anaphylactoid reaction
  • Freeze-dried powder injection of andrographolide sulfonate or salt thereof with low anaphylactoid reaction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 mixed liquor and preparation of andrographolide sulfonate 1

[0034] 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.

[0035] b Neutralization: After standing for 24 hours, add ethanol and stir evenly, control the temperature on a cold water bath at 25°C, and neutralize with sodium hydroxide solution until the pH value is 6.5.

[0036] 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 mixed solution.

[0037] d Recover ethanol: recover ethanol and concentrate, heat and volatilize ethanol to the utmost, then cool to obtain cooling liquid.

[0038] e suction filtration, concentration and drying: add the cooling liquid to acti...

Embodiment 2

[0040] Embodiment 2 preparation of andrographolide sulfonate

[0041] Take the mixed solution of Example 1, detect its conductivity as 1.04ms / cm, pour it into a nanofiltration membrane separation device, add purified water to dilute to ethanol concentration to 50%, and set aside. Turn on the infusion pump, adjust the pressure so that the membrane inlet pressure is 1.0-1.5MPa, and use a molecular weight cut-off of 250Da for nanofiltration enrichment and concentration. During the nanofiltration process, the conductivity of the dialysate was monitored to be 2.92 us / cm. The nanofiltration permeate was collected to detect resins, tannins and allergic reactions, and the alcohol content of the concentrated solution was monitored to 5% to obtain a concentrated solution. Add water for injection of 20 times the amount of andrographolide to the concentrated solution for water precipitation to obtain a supernatant for subsequent use. The supernatant was concentrated in a vacuum of -0.08m...

Embodiment 3

[0042] Embodiment 3 preparation of andrographolide sulfonate

[0043] Take the mixed solution of Example 1, detect its conductivity as 3.00ms / cm, pour it into a nanofiltration membrane separation device, add purified water to dilute it until the concentration of ethanol reaches 50%, and set it aside. Turn on the infusion pump, adjust the pressure so that the membrane inlet pressure is 1.0-1.5MPa, and use a molecular weight cut-off of 300Da for nanofiltration enrichment and concentration. During the nanofiltration process, the conductivity of the dialysate was monitored to be 3.25 us / cm, the permeated liquid was collected to detect resin, tannin and allergic reactions, and the alcohol content of the concentrated solution was monitored to 5% to obtain a concentrated solution. Add water for injection of 20 times the amount of andrographolide to the concentrated solution for water precipitation to obtain a supernatant for subsequent use. The supernatant was concentrated in a vacu...

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Abstract

The invention discloses a freeze-dried powder injection of andrographolide sulfonate or salt thereof with low anaphylactic reaction, which is characterized by being prepared by sulfonating andrographolide to obtain the andrographolide sulfonate, dissolving the andrographolide sulfonate with a solvent, adding an excipient, and freeze-drying. Compared with the existing solution injection, the freeze-dried powder injection has the advantages of less anaphylactoid and good stability, the method is simple, easy, scientific and reasonable, and the safety and stability of the finished product are improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a freeze-dried powder injection of andrographolide sulfonate or a salt thereof with low allergic reaction. Background technique [0002] A certain proportion of macromolecular substances, tannins, and resins remaining in the extracts of traditional Chinese medicine injections used in the preparation of traditional Chinese medicine injections are the main components that cause adverse reactions in traditional Chinese medicine injections. Traditional purification processes such as water extraction and alcohol precipitation, and alcohol extraction and water precipitation are difficult to remove thoroughly. At present, it is prevalent in the industry to control macromolecular substances through ultrafiltration. However, due to the wide range of molecular weights of tannins and resins, they cannot be completely removed by ultrafiltration. There is a certain risk of anaphylacto...

Claims

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Application Information

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IPC IPC(8): A61K31/365A61K9/19A61K47/02A61K47/10A61K47/18A61K47/26
CPCA61K31/365A61K9/19A61K47/10A61K47/26A61K47/02A61K47/183A61K9/0019
Inventor 刘地发郭正友刘尧奇王章伟陈琳王振蒋春红邓双炳方礼刘芳芳魏勇翔简蓝
Owner JIANGZI QINGFENG PHARMACEUTICALS INC
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