CN1426813A - Recombination human epidermis growth factor spraying agent and its preparation method - Google Patents

Abstract

A recombinant human epidermal growth factor (rhEGF) spray is prepared from rhEGF as active component and medical additive. Its advantages are high curative effect, low cost, quickly taking its effect, and no pollution.

Description

Recombination human epidermal growth factor spray and preparation method

Technical field

The invention belongs to the biologic product technology field.Be specifically related to a kind of recombination human epidermal growth factor spray and preparation method.

Background technology

HEGF (hEGF) is one of human body important cytokine, has the various biological function, can with special receptors bind on the epidermis cell, information is transmitted into cell, change intracellular acid-base value and free calcium concentration, promote glycolysis and protein synthesis, increase some specificity genetic transcription, thereby promote dna replication dna and cell division, hEGF can promote epidermis cell, neurocyte and organ-tissue epithelial cell growth; Can promote the growth of newborn fetus tooth, bone and each organ; Can promote liver cell regeneration; Can promote gastrointestinal tract mucous cell growth and protect gastrointestinal tract mucous impaired.

The mid-80 has how tame laboratory and company to begin to utilize technique for gene engineering development hEGF abroad, most escherichia coli or yeast secreted expression hEGF of adopting.In addition, Ri Ben Nagoya University and the chemical industry cooperation of military field successfully construct the bacillus pumilis of secreting, expressing hEGF.At present, as reagent, U.S., day, the existing company more than 10 in West Europe produce and sell the hEGF that recombinates, goods purity reaches 98%, but as medicine, do not have commercially availablely at present as yet, U.S. chiron/Ethicon company and Amgen company have entered the clinical III phase with the test that rhEGF is used for corneal transplantation, but also approval of FDA.Cuba has developed the antimicrobial ointment that contains the hEGF that recombinates, is used for more mouth of wound, sells in China.RhEGF is China's " the Seventh Five-Year Plan ", " eight or five " and " 95 " brainstorm project, is born by Shanghai Inst. of Biochemistry, Chinese Academy of Sciences.During " the Seventh Five-Year Plan " and " eight or five ", finished the engineered laboratory research of recombinant human epidermal growth factor (rhEGF), be built into alkali phosphatase efficient secretory expression system, reach advanced world standards, they have finished rhEGF pilot scale tackling key problem task again afterwards, once obtain country's " eight or five " tackling of key scientific and technical problems major scientific and technological achievement prize.At present, Shanghai biochemical obtained the clinical certification of Ministry of Public Health about rhEGF.Water preparation " No. the 07th, authentication code (97) system Shen body " and the clinical certification of externally-used embrocation " No. the 08th, authentication code (97) system Shen body "." Kang Hesu " of great river, Shanghai biopharmaceutical company of (group) limited company is the freeze-dried formulation of recombinant human epidermal growth factor at present.But do not see relevant recombination human epidermal growth factor spray both at home and abroad.

Summary of the invention

Technical problem to be solved by this invention is to develop recombination human epidermal growth factor spray, makes medicine rapid-action, and is easy to use.

The invention provides a kind of recombination human epidermal growth factor spray.This spray is made up of as active ingredient and pharmaceutic adjuvant recombinant human epidermal growth factor (rhEGF), and active component is to form 100% composition with arbitrary proportion with pharmaceutic adjuvant.

Another technical problem to be solved by this invention has provided a kind of preparation method of recombination human epidermal growth factor spray.This method comprises the following steps:

1. put into an amount of distilled water in the adjustment bucket, added the sodium chloride stirred for several ten minutes, add protective agent and/or antiseptic, stirred 10 minutes.Add rhEGF again, stirred 10 minutes, standby with distilled water diluting restir 10 minutes to the configuration amount.

2. pH value is surveyed in sampling, and its value should be controlled in the 5.0-7.0 scope.

3. medicinal liquid through the bag type filter coarse filtration after 0.25 μ m microporous membrane filtration degerming, fill.

4. every bottle of fill 10 ± 1ml after inspection fill amount is extremely qualified, rolls lid.Use the vacuum plastic bag sealing.

5. can sample every other day, check that every bottle is always pressed time, pack by required requirement.

6. finished product detects by rules through quality supervision department, can dispatch from the factory after qualified.

Product of the present invention has kept the original configuration of albumen, and biological value height, medicine directly act on target organ and be rapid-action, do not need other instruments during use, and no pain does not pollute, and wide application prospect is arranged clinically, and market potential is very big.

The specific embodimentPrescription 1:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Protective agent is an amount of

Distilled water adds to 10L prescription 2:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Antiseptic is an amount of

Distilled water adds to 10L prescription 3:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Protective agent is an amount of

Antiseptic is an amount of

Distilled water adds to 10L prescription 4:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Protective agent is an amount of

10mmol buffer (pH=6.0) adds to 10L prescription 5:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Antiseptic is an amount of

10mmol buffer (pH=6.0) adds to 10L prescription 6:

RhEGF spray (per 1000 bottles)

rhEGF 50mg

Sodium chloride is an amount of

Protective agent is an amount of

Antiseptic is an amount of

10mmol buffer (pH=6.0) adds to 10L

Claims (2)

1. recombinant human epidermal factor spray, it is characterized in that this spray is made up of as active ingredient and pharmaceutic adjuvant recombinant human epidermal growth factor (rhEGF), and active component is that 1: 40 and pharmaceutic adjuvant are formed 100% composition with arbitrary proportion.

2. the preparation method of an a kind of recombination human epidermal growth factor spray as claimed in claim 1 is characterized in that this method comprises the following steps:

1. adjust and put into an amount of distilled water in the bucket, added the sodium chloride stirred for several ten minutes, add protective agent and/or antiseptic, stirred 10 minutes, add rhEGF again, stirred 10 minutes, standby with distilled water diluting restir 10 minutes to the configuration amount;

2. pH value is surveyed in sampling, and its value should be controlled in the 5.0-7.0 scope;

3. medicinal liquid through the bag type filter coarse filtration after 0.25 μ m microporous membrane filtration degerming, fill;

4. every bottle of fill 10 ± 1ml after inspection fill amount is extremely qualified, rolls lid.Use the vacuum plastic bag sealing;

5. can sample every other day, check that every bottle is always pressed time, pack by required requirement;

6. finished product detects by rules through quality supervision department, can dispatch from the factory after qualified.