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Preparation method of sophora flavescens freeze dried powder injection

A technology of freeze-dried powder for injection and matrine, applied in freeze-dried delivery, anti-inflammatory agent, anti-viral agent and other directions, can solve the problems of unqualified rate of clarity, influence clinical application, poor product stability, etc., and achieve clarity Improved, less irritating, more stable effects

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, many companies produce matrine freeze-dried powder injections in the domestic market, all of which are prepared by traditional techniques. The existing products have poor stability, strong irritation, poor solubility, high failure rate of clarity, and unsatisfactory curative effect. Problems such as stability can not be solved all the time, which affects clinical application

Method used

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  • Preparation method of sophora flavescens freeze dried powder injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A) Take fresh water for injection at 80°C with 60% of the prepared amount, add nitrogen into it, and add matrine in the prescription away from light, fully stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 2°C for 12 hours, and use a molecular weight cut-off of 3 Ten thousand ultrafiltration membrane ultrafiltration to obtain ultrafiltrate I.

[0024] B) Take 30% fresh water for injection at 90°C, add disodium edetate and mannitol in the prescription to dissolve, place it at room temperature, refrigerate at 2°C for 12 hours, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 30,000 , to obtain ultrafiltrate II.

[0025] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 5.5. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and filled in a vial under dark conditions. After being...

Embodiment 2

[0027] A) Take 30% fresh water for injection at 85°C of the prepared amount, add nitrogen into it, and add matrine in the prescription away from light, fully stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 10°C for 48 hours, and use a molecular weight cut-off of 2 Ten thousand ultrafiltration membrane ultrafiltration to obtain ultrafiltrate I.

[0028] B) Take 10% fresh water for injection at 85°C, add disodium edetate and mannitol in the prescription to dissolve, place it at room temperature, refrigerate at 10°C for 48 hours, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 20,000 , to obtain ultrafiltrate II.

[0029] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 5.0. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and filled in vials under dark conditions. After being fre...

Embodiment 3

[0031] A) Take fresh water for injection at 80°C with 50% of the prepared amount, add nitrogen into it, and add matrine in the prescription in the dark, stir and dissolve, place it at room temperature, seal it in shading, refrigerate at 8°C for 36 hours, and use a molecular weight cut-off of 1 Ten thousand ultrafiltration membrane ultrafiltration to obtain ultrafiltrate I.

[0032] B) Take 25% fresh water for injection at 80°C, add disodium edetate and mannitol in the prescription to dissolve, place it at room temperature, refrigerate at 8°C for 36 hours, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 10,000 , to obtain ultrafiltrate II.

[0033] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 4.5. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and filled in vials under dark conditions. After being freeze-dri...

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Abstract

A freeze-dried powder injection of kurarinol for treating chronic hepatitis B, anaphylaxis and inflammation is prepared from kurarinol through depositing in water, cold storage, ultrafiltration, adding mannitol and disodium versenate in dark condition and N2 atmosphere, pouring in containers, freeze drying and sealing.

Description

technical field [0001] The invention relates to a preparation method of matrine freeze-dried powder injection. The specific method is that matrine is treated with water precipitation, refrigeration and ultrafiltration technology, and then mixed with mannitol and edetate disodium, protected from light, and ventilated with nitrogen. After preparation, filling, and freeze-drying, it is covered and packaged to make a finished freeze-dried powder injection. It belongs to the field of chemical preparations. The product can be injected intravenously and has the effect of anti-hepatitis B virus. It can reduce the content of serum transaminase and hydroxyproline in the liver of animals, reduce the degree of liver lesions and reduce the serum DHBV- of ducks infected with hepatitis B virus (HBV). DNA level; can inhibit collagen activity and prevent liver fibrosis; can block abnormal apoptosis of liver cells; in addition, it has anti-allergic and anti-inflammatory effects, can regulate i...

Claims

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Application Information

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IPC IPC(8): A61K31/4375A61K9/19A61P1/16A61P31/14A61P29/00
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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