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Stable recombinant human interferon ointment

A technology of recombinant human interferon and interferon, applied in the field of recombinant human interferon ointment, can solve problems such as out of stock, rising price of human serum albumin, blood pollution, etc.

Inactive Publication Date: 2010-06-02
HARBIN PHARMA GROUP BIOLOGICAL ENG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Human serum albumin is a kind of blood extract, which may cause the problem of blood pollution, the potential danger of pollution and infectious diseases, and the price of human serum albumin is rising, the supply of goods is tight, and industrial production will also face supply shortages. In order to better ensure the quality of interferon protectors and stabilizers, we searched for new protectors and stabilizers

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] 1 kg of recombinant human interferon ointment formula is as follows:

[0018] Ingredients Dosage (%)

[0019] Sodium carboxymethyl cellulose 800-1200 centipoise 20g

[0020] Interferon α2b stock solution 10 million IU

[0021] Glycerin 600g

[0022] Hydroxyethylated Starch-40 30g

[0023] Water-soluble Azone 20g

[0024] Propylene glycol 20g

[0025] Sodium Benzoate 3g

[0026] Citrate buffer (0.2M, pH 5.0) to 1000g

[0027] Prepare according to the conventional process of the above-mentioned water-soluble base ointment.

Embodiment 2

[0029] 1 kg of recombinant human interferon ointment formula is as follows:

[0030] Ingredients Dosage (%)

[0031] Sodium carboxymethyl cellulose 800-1200 centipoise 20g

[0032] Interferon α2b stock solution 10 million IU

[0033] Glycerin 600g

[0034] Human Serum Albumin 3g

[0035] Water-soluble Azone 20g

[0036] Propylene glycol 20g

[0037] Sodium Benzoate 3g

[0038] Citrate buffer (0.2M, pH 5.0) to 1000g

[0039] Prepare according to the conventional process of the above-mentioned water-soluble base ointment.

[0040] The samples of Example 1 and Example 2 were stored in a refrigerator at 4-10°C, and the recombinant human interferon α2b ointment was tested regularly at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months respectively. After 24 months of investigation, although the samples of the two examples have certain fluctuations, they have no significant changes, and meet the requirements of the interferon activity assay range of 80% to 150% of the labeled amount. ...

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Abstract

The invention discloses a stable recombinant human interferon ointment. The ointment is a semisolid water-soluble base ointment, wherein the formula oft the ointment contains a protecting agent, a stabilizer, and the like of the interferon; the ointment can be placed for over 2 years under the condition of 4-10 DEG C; the activity of the interferon is maintained between 80% and 150% of labeled amount, thereby being capable of satisfying the industrial and commercial requirements of medicaments.

Description

technical field [0001] The invention relates to a stable recombinant human interferon ointment, in particular to a semi-solid water-soluble matrix ointment involving interferon protective agents, stabilizers, etc. in the ointment. Background technique [0002] Interferon is a pharmacologically active biomacromolecular protein with broad-spectrum antiviral, antitumor and immunomodulatory effects. It is widely used at home and abroad to treat hepatitis B virus diseases, tumor diseases, viral skin diseases, such as condyloma acuminata, herpes zoster, herpes simplex, chickenpox, etc. Poorer, and immunocompromised persons. Among them, the interferon is prepared into an ointment, which is mainly used for the treatment of viral skin diseases. It can directly act on the lesion, change the permeability of the membrane through a transdermal absorption accelerator, and achieve an effective therapeutic dose, thereby treating the above diseases. role. [0003] The stock solution of in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K9/06A61K47/38A61K47/42A61P1/16A61P31/12A61P31/20A61P35/00A61P37/02
Inventor 王忠吴志军李宝馨
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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