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Preparation method of Sophora flavescems injection

A technology for matrine and injection, which is applied in the field of preparation of matrine injection, can solve the problems of content drop, pH value drop, color deepening, etc. Effect

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, matrine injections in the domestic market are produced by many companies, all of which are prepared by traditional techniques. The existing products have poor quality stability, strong irritation of the liquid, high failure rate of clarity, and drop in pH value. Problems such as content decline, color deepening, and unstable curative effect cannot be solved
The main reason is that during the preparation process of matrine, some impurities such as protein, tannin, sophocarpine, sophoramine, etc. are not completely removed, and the instability of matrine itself causes

Method used

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  • Preparation method of Sophora flavescems injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A) Take fresh water for injection at 80°C with 70% 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 10°C for 48 hours, and use a molecular weight cut-off of 2 Ten thousand ultrafiltration membrane ultrafiltration to obtain ultrafiltrate I.

[0024] B) Take fresh water for injection with a preparation amount of 10% at 80°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 10°C for 48 hours, and ultrafilter with an ultrafiltration membrane with a molecular weight cut-off of 20,000 to obtain ultrafiltration. Filtrate II.

[0025] C) Mix the above-mentioned ultrafiltrates I and II evenly, constant volume, and adjust the pH value to 6.5. After the intermediate product is qualified, the liquid is sterilized and filtered through the terminal 0.22 μm filter membrane, and then filled under the conditio...

Embodiment 2

[0027] A) Take 40% fresh water for injection at 90°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 2°C for 12 hours, and use a molecular weight cut-off of 3 Ten thousand ultrafiltration membrane ultrafiltration to obtain ultrafiltrate I.

[0028] B) Take fresh water for injection with a preparation amount of 30% at 90°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 2°C for 12 hours, and ultrafilter it with an ultrafiltration membrane with a molecular weight cut-off of 30,000 to obtain ultrafiltration. Filtrate II.

[0029] 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 the terminal 0.22 μm filter membrane, and then filled under the co...

Embodiment 3

[0031] A) Take 60% of fresh water for injection at 85°C, add nitrogen gas, 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 fresh water for injection with a preparation amount of 15% at 85°C, add disodium edetate in the prescription to dissolve, place it at room temperature, refrigerate at 8°C for 36 hours, and ultrafilter with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain ultra- Filtrate II.

[0033] 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 the terminal 0.22 μm filter membrane, and then filled under the condition of avoiding light and filling with nitr...

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Abstract

An injection of kurarinol for treating chronic hepatitis and leukocytopenia is prepared from kurarinol through depositing in water, cold storage, ultrafiltration, further preparing in dark condition and N2 atmosphere, pouring in containers, sterilizing and lamp examining.

Description

technical field [0001] The invention relates to a preparation method of matrine injection. The method is to process matrine by water precipitation, refrigeration, and ultrafiltration to obtain matrine ultrafiltrate, which is prepared in the dark, fed with nitrogen, filled, sterilized, inspected by light, and packaged. The finished product of Chengmatulin small-capacity injection 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 the activity of collagen and prevent liver fibrosis; can block abnormal apoptosis of liver cells; can enhance the activity of NK cells, improve and correct the disordered state of the immune system, and enhance the ability of the immune system to r...

Claims

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Application Information

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IPC IPC(8): A61K31/4375A61P1/16A61P31/14A61P35/00
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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