CN106563121B - BFGF bovine basic fibroblast growth factor gel is repairing the application in acne rosacea skin lesion - Google Patents
BFGF bovine basic fibroblast growth factor gel is repairing the application in acne rosacea skin lesion Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1825—Fibroblast growth factor [FGF]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- Cosmetics (AREA)
Abstract
The present invention relates to a kind of new clinical applications of drug, and the application of acne rosacea skin lesion is repaired more particularly to bFGF bovine basic fibroblast growth factor gel.BFGF bovine basic fibroblast growth factor gel according to the present invention has apparent curative effect in treatment acne rosacea, especially to repair erythema, drying, furfur it is significant in efficacy, the present invention provides a kind of new methods for repairing acne rosacea skin lesion, can preferably be many patients service.
Description
Technical field
The invention belongs to field of medicaments, are related to a kind of new application of drug, more particularly, to a kind of reparation acne rosacea skin
The drug of damage and the application in clinic.
Technical background
Acne rosacea is a kind of common chronic inflammatory skin, involves skin of face blood vessel and pilosebaceous follicle.Rose
The generation of rare acne is related with immune, blood vessel and lymphatic vessel change etc. with heredity, the destruction of skin barrier, nerve, and skin lesion is with one
With the characteristics of the property crossed or erythema perstans, telangiectasis, papule and warts and pachydermatosis etc..The pathological change of acne rosacea because
Stadium and it is different.Erythema and telangiectasis are mainly shown as intradermal telangiectasis, nonspecific inflammation around blood vessel
Disease infiltration.Visible intradermal diffusivity inflammatory cell infiltration in papule skin lesion has big amount lymphocyte around hair follicle or sebaceous glands,
A small amount of histocyte and thick liquid cell, the visible epithelioid cell of some cases and macrophage, it is seen that peifolliculitis is in hair follicle
Granuloma is formed.The pachydermatosis phase is mainly that sebaceous glands increases, and body of gland increases, and horn cell and sebum are expanded and be full of to gland mouth, and has
Subcutaneous connective tissue hyperplasia and telangiectasis, perivascular inflammatory cell infiltration or hair follicle internal granuloma are formed.
BFGF bovine basic fibroblast growth factor (recombinant bovine basic fibroblast
Growth factor, rbFGF) (Yisheng Biological Pharmaceutical Co., Ltd., Shuhai) belong to fibroblast growth factor class drug.Weight
Group human/bovine basic fibroblast growth factor is applied to wound repair, is mainly used for burn wound, chronic wound is treated and fresh
The treatment of the mind systemic disease and corneal injury reparation such as the surface of a wound and parkinsonism, but its reparation for being applied to acne rosacea skin lesion is also
It has not been reported.
Summary of the invention
The purpose of the present invention is to provide bFGF bovine basic fibroblast growth factor gels to repair acne rosacea skin
Application in damage, the technical problem to be solved is that expand bFGF bovine basic fibroblast growth factor gel for treating range,
It improves the clinical cure rate of acne rosacea, shorten the treatment time of acne rosacea.
The skin lesion of acne rosacea some patientss will appear ulceration, shape without bFGF bovine basic fibroblast growth factor reparation
At scar, the physical and mental health of patient has been seriously affected.BFGF bovine basic fibroblast growth factor is applied to clinic by us
Acne rosacea is treated, its therapeutic effect is observed, discovery has exact therapeutic effect (Fig. 2-6), recombinant bovine basic fibroblast
Growth factor can significantly improve the quality of life of patient, be beneficial to patient's physical and mental health.
BFGF bovine basic fibroblast growth factor can promote blood vessel, regeneration, prevent skin lesion from further developing, very
Acne rosacea skin lesion is repaired to complete.
Mechanism explanation of the invention
(Basic fibroblast growth factor, is abbreviated as the basic fibroblast growth factor having found
BFGF the processes of wound repair for) participating in internal Various Tissues, is important one of wound healing factor, specific as follows:Chemotactic
Effect attracts inflammatory cell, fibroblast to enter the surface of a wound, to anti-inflammatory response；Promote the regeneration of surface of a wound capillary, improves
Local blood circulation；The synthesis of the albumen of fibroblast and extracellular matrix is directly stimulated to increase wound to form collagen
Face tension stress intensity；Induced proximity cell cytokine production；Promote migrating, divide, breaking up for dermal cell.To sum up
Described, bFGF can promote the reparation of skin, to accelerate wound healing.A large amount of basic research and clinical test confirm, alkalinity at
Fibroblast growth factor injures various chronic wounds to burn, outside with significant plerosis function, and safely,
Effectively, it has no adverse reaction.
And bFGF bovine basic fibroblast growth factor gel of the present invention is to from mesoderm and ectoderm
Cell (such as epithelial cell, dermal cell, fibroblast, vascular endothelial cell) have promote repair and palingenesis.
The bFGF bovine basic fibroblast growth factor gel is external preparation.
The composition and physicochemical property of the bFGF bovine basic fibroblast growth factor gel are as follows:
Composition: main ingredient is bFGF bovine basic fibroblast growth factor, be by containing high efficient expression ox alkalinity at
The Escherichia coli of fibroblast growth factor gene, it is fermented, separation and it is highly purified after be made.Auxiliary material is protein protective agent
(human serum albumin), gel-type vehicle (hydroxypropyl methyl cellulose and carbomer), pH adjusting agent (sodium hydroxide or hydrochloric acid) in right amount,
It is process.
Character: colorless transparent gel.
Specification: 21000IU/5g/ branch.
Usage and dosage: after the clear water face cleaning of moderate temperature, bFGF bovine basic fibroblast growth factor gel is direct
It embrocates at skin lesion, 300IU/cm2, 2 times a day, two weeks for a course for the treatment of.
Storage: 2~8 DEG C are kept in dark place and transport.
Packaging: aluminium soft tube, 1, every box.
Points for attention:This product is aseptic packaging, in operating process, is kept as far as possible sterile；This product high temperature is not placed in
Or in freezing environment；The protein denaturants such as the high concentration tincture of iodine, alcohol, hydrogen peroxide, heavy metal will affect this product activity, conventional clear
This product is being used with after normal saline flushing after wound；Sportsman is used with caution.
Detailed description of the invention
Fig. 1 is the acne rosacea skin lesion pathology figure that microscopically observation arrives.
Fig. 2 is that front and back comparison diagram is repaired in the acne rosacea skin lesion of face red spot papule.
Fig. 3 is that front and back comparison diagram is repaired in the erythematous papules acne rosacea skin lesion of mouth week.
Fig. 4 is that front and back comparison diagram is repaired in facial diffusivity erythematous papules acne rosacea skin lesion.
Fig. 5 is that front and back comparison diagram is repaired in the scaling erythematous papules acne rosacea skin lesion of face.
Fig. 6 is that front and back comparison diagram is repaired in facial diffusivity erythema acne rosacea skin lesion.
Specific embodiment
With clinical test case, the present invention is further elaborated below:
We are in March, 2015 to the 205 papule purulence treated during in December, 2015 in our hospital's Dermatology Outpatient Department
Blister type acne rosacea patient, wherein women 151, male 54, are randomly divided into two groups: recombination human/bovine basic fibroblast growth
103 people of factor reparation group；Without reparation 102 people of blank group.Reparation group uses bFGF bovine basic fibroblast growth factor gel
For partial smearing at skin lesion, blank group does not use any external drug, observes curative effect after 2 weeks.Reparation group lesions of patients has not
It improves with degree, total effective rate is 82.35%~98.33%(table one)；Blank group patient's total effective rate is 18.99%~66.67%
(table two) compares the therapeutic index (table three) of reparation group and blank group, it is seen that can make using recombinant bovine alkaline cell growth factor
Erythema, papule, furfur and the drying of acne rosacea skin lesion significantly improve.
It is above-mentioned to use 103 people of bFGF bovine basic fibroblast growth factor gel compared with without 102 people of blank group is repaired
Compared with clinical test shows: bFGF bovine basic fibroblast growth factor there is significant repair to make acne rosacea skin lesion
With.
The following are clinical observation typical cases
1, Mr. Wang, female, 44 years old, in March, 2015 went to a doctor because of " mouth Zhou Fanfu erythematous papules companion itches January " in Lanzhou hospital general skin
The outpatient service of skin section, is diagnosed as " acne rosacea ", and patient's complexion is obscure, and consciously face is dry, has tight feeling, uses the clear of moderate temperature
After water face cleaning, bFGF bovine basic fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, early, evening is respectively
1 time, treat 2 weeks, facial skin lesion disappears substantially, and consciously facial itch, tight feeling are relieved patient, and the colour of skin improves, it is facial after
Continuous medication 2 weeks, facial skin lesion recovery from illness, follow-up skin lesion in December was without recurrence (Fig. 3).
2, Zhang, female, 37 years old, in March, 2015 went to a doctor because of " facial diffusivity erythematous papules 2 months " in Lanzhou hospital general skin
Section's outpatient service is diagnosed as " acne rosacea ", after the clear water face cleaning of moderate temperature, will recombination human/bovine basic fibroblast growth because
Sub- gel is directly embrocated at skin lesion, 300IU/cm2, each 1 time early, late, after treatment 2 weeks, skin lesion disappears substantially, the conscious face of patient
Portion feels fine and smooth, and follow-up skin lesion in December is without recurrence (Fig. 4).
3, Lee, female, 40 years old, in May, 2015 went to a doctor because of " the scaling erythematous papules of face with itch, burn feeling half a year " in orchid
State hospital general Dermatology Outpatient Department, is diagnosed as " acne rosacea ", and itch is difficult to endure patient's private prosecution sometimes, uses the clear of moderate temperature
After water face cleaning, bFGF bovine basic fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, early, evening is respectively
After 1 time, treatment 2 weeks, the facial scales of skin that peel off is reduced, and patient consciously alleviate by facial itch, burn feeling, and skin of face not re-dry continues
Medication 2 weeks, face red spot papule disappeared, and continued to strengthen medication 2 weeks, and lesions of patients recovery from illness, follow-up skin lesion in December is without recurrence (figure
5).
4, Mr. Yu, female, 26 years old, in June, 2015 went to a doctor because of " facial diffusivity erythema half a month " in dermatology, Lanzhou hospital general
Outpatient service is diagnosed as " acne rosacea ", and patient facial region's color is obscure, after the clear water face cleaning of moderate temperature, by recombinant bovine alkalinity
Fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, each 1 time early, late, after treatment 2 weeks, face is red
Spot subsides, and private prosecution skin is smooth earlier above, fine and smooth, and glossy, follow-up skin lesion in December is without recurrence (Fig. 6).
The present invention is applied to clinical experimental observation, and steps are as follows:
(1) clinical data: we choose in March, 2015 and treat to during in December, 2015 in our hospital's Dermatology Outpatient Department
205 acne rosacea patients, wherein women 151 (73.66%), male 54 (26.34%), between 20~45 years old age,
Average (32.05+7.68) year, the course of disease 0.11~20 year, average (3.52+4.12) year.All patients are randomly divided into two groups: recombination
103 people of human/bovine basic fibroblast growth factor reparation group；Without reparation 102 people of blank group.The general clinical data phase of two groups of patients
Than there was no significant difference (P > 0.05), is comparable.Reparation group is solidifying using bFGF bovine basic fibroblast growth factor
Glue partial smearing is at skin lesion, 300IU/cm2, 2 times a day, 2 weeks are 1 course for the treatment of, and the course for the treatment of can be appropriately extended in the unobvious person of curative effect；It is empty
White group is not used any external drug.
(2) reagent and material
BFGF bovine basic fibroblast growth factor 21000IU/5g/ branch (manufacturing enterprise: hundred million victory bio-pharmaceuticals of Zhuhai
Co., Ltd)
(3) inclusion criteria
Be included in standard: clinical manifestation meets acne rosacea: the acne sample papule in batch on the basis of erythema, no acne
It is formed.
Exclusion criteria: pregnant woman and breast feeding women；It is associated with the severe primaries disease such as angiocarpy, liver, kidney and hemopoietic system
Patient；Mental disease, tumor patients in heilongjiang；Once diagnosing and treating crossed the patient of acne rosacea；Previously to recombination human/bovine basic fibroblast
The patient of Porcine HGF allergy.
All patients in group sign informed consent form.
(4) treatment method
Reparation group: after the clear water face cleaning of moderate temperature, bFGF bovine basic fibroblast growth factor gel is directly applied
It wipes at skin lesion, 300IU/cm2, 2 times a day, two weeks for a course for the treatment of；
Blank group: any drug is not used；
Follow-up December after the completion of reparation.
(5) observation index and efficacy assessment standard.
All patients are before and after bFGF bovine basic fibroblast growth factor gel for treating by fixed doctor to its skin
Damage scores, and index includes erythema, papule, furfur, drying, and each index scores according to level Four point system: without meter 0
Divide, slight 1 point of meter, moderate meter 2 divides, severe meter 3 divides.
After therapeutic index=(before reparation-is repaired) total mark × 100% before total mark/reparation.
Recovery from illness: therapeutic index >=90%, skin lesion clinical manifestation are that skin lesion is subsided substantially；
Effective: 60%≤therapeutic index < 90%, skin lesion are largely subsided；
Improve: 30%≤therapeutic index < 60%, skin lesion are mitigated；
Invalid: therapeutic index < 30%, skin lesion are not improved.
Total effective rate is based on fully recovering plus is effective.
(6) result
Indices situation table (unit: people) after one, rbFGF reparation of table group 2 weeks
Two, of table is without indices situation table (unit: people) after repairing blank group 2 weeks
Efficient contrast table (unit: %) is repaired in the skin lesion of three, reparation group of table and blank group
From the comparison of the indices of table 3, it can obtain bFGF bovine basic fibroblast growth factor reparation group patient's
Observation index erythema, papule, furfur, drying total effective rate be respectively 97.09%, 82.35%, 98.33%, 97.50%, blank group
The observation index erythema of patient, papule, furfur, drying total effective rate be respectively 24.51%, 66.67%, 52.08%, 18.99%.
Through х2It examines it is found that the effect of the erythema of reparation group, papule, furfur, dry four observation indexs is better than blank group (P <
0.05).Accordingly as it can be seen that bFGF bovine basic fibroblast growth factor gel can make acne rosacea show as erythema, papule, take off
Bits and dry skin lesion are clearly better, bFGF bovine basic fibroblast growth factor can promote epithelial cell, dermal cell, at
The isocellular reparation of fibrocyte, vascular endothelial cell and regeneration, and treatment cycle is short, Small side effects.
Claims (1)
1. bFGF bovine basic fibroblast growth factor gel is in the purposes of preparation treatment acne rosacea drug.
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| CN2016109679110 | 2016-11-05 | ||
| CN201610967911 | 2016-11-05 |
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| CN1733294A (en) * | 2005-08-10 | 2006-02-15 | 南海朗肽制药有限公司 | Recombined human alkaline fibroblast growth factor gelling agent and process for preparing the same |
| CN102357242A (en) * | 2011-11-02 | 2012-02-22 | 珠海亿胜生物制药有限公司 | Recombination cattle alkaline fibroblast growth factor gel |
| CN102362856A (en) * | 2011-11-02 | 2012-02-29 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast grow factor external solution |
| CN104586778A (en) * | 2015-02-12 | 2015-05-06 | 珠海亿胜生物制药有限公司 | External recombinant bovine basic fibroblast growth factor lyophilized preparation |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733294A (en) * | 2005-08-10 | 2006-02-15 | 南海朗肽制药有限公司 | Recombined human alkaline fibroblast growth factor gelling agent and process for preparing the same |
| CN102357242A (en) * | 2011-11-02 | 2012-02-22 | 珠海亿胜生物制药有限公司 | Recombination cattle alkaline fibroblast growth factor gel |
| CN102362856A (en) * | 2011-11-02 | 2012-02-29 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast grow factor external solution |
| CN104586778A (en) * | 2015-02-12 | 2015-05-06 | 珠海亿胜生物制药有限公司 | External recombinant bovine basic fibroblast growth factor lyophilized preparation |
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