CN1814279A - Regenerated human alkali fiber-cell growth factor gel former and preparing method - Google Patents
Regenerated human alkali fiber-cell growth factor gel former and preparing method Download PDFInfo
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- CN1814279A CN1814279A CN 200510009218 CN200510009218A CN1814279A CN 1814279 A CN1814279 A CN 1814279A CN 200510009218 CN200510009218 CN 200510009218 CN 200510009218 A CN200510009218 A CN 200510009218A CN 1814279 A CN1814279 A CN 1814279A
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Abstract
The invention relates to a rh-bFGF gel and the making method that is a drug used to cure wound, canker, scald, and burn. It is compounded by 146 amino acids. The main drug is rh-bFGF, and gel basal material includes thickener, humectant, antiseptic, stabilizer, pH regulator, and water. The manufacture method includes the following steps: mixing the thickener, humectant, antiseptic, stabilizer, pH regulator, and water according to certain ratio, whisking to equal to make water solubility gel basal material, adding rh-bFGF after high pressure sterilization, mixing equally to make gel and separately packaging into aluminum mold tube to make drug using rh-bFGF gel products.
Description
Technical field
The present invention relates to a kind of gel for the treatment of wound surface damages such as wound, operation wound, burn, scald and ulcer, specifically recombination human basic fibroblast growth factor (hereinafter to be referred as rh-bFGF) and suitable substrate are mixed and made into exterior-applied gel, the invention still further relates to the preparation method of this gel.
Background technology
Basic fibroblast growth factor (bFGF) is a kind of and the closely-related endogenous active factors of agglutination tissue injury, and tissue injury healing, nerve injury reparation and revascularization are had significant facilitation.The single chain polypeptide that bFGF is made up of 146 aminoacid, molecular weight are 17KD.Our company directly clones the cDNA of people bFGF from Chinese's peripheral blood leucocyte, and has realized the gene cloning and expression of bFGF, successfully develops recombinant human bfgf's expression product, declares the rh-bFGF product in 1996 as the tissue injury medicine that heals.In March, 2000, my company obtained recombination human basic fibroblast growth factor rh-bFGF (freeze dried powder, trade name the are held up Ji again) New Drug Certificate that National Drug Administration issues.Authentication code: the accurate word S20020023 of traditional Chinese medicines.Through clinical practice for many years, proof rh-bFGF (holding up Ji again) has significant promotion healing effect to human body burn, wound, operation wound etc., no part and whole body toxic and side effects, not only healing rate is fast, and the formation of minimizing cicatrix, showing the effect that it is outstanding and original aspect regeneration that promotes tissue injurys such as burn, wound and decubital ulcer and the reparation.
But holding up Ji is the external freeze dried powder again, clinical use is not too convenient, for strengthening the convenience that medicine uses, reduce patient's misery, on the basis of external freeze dried powder, be the convenience of enhancing medicine use and the curative effect of medicine, do not changing route of administration, do not change under the prerequisite of stock solution production technology, we have carried out deep research to preparation, change preparation formulation and have made " recombination human basic fibroblast growth factor (rh-bFGF) gel ".Through evidence this product steady quality, respond well, safe ready.
The dosage form that present rh-bFGF is used for the treatment of wound, burn is freeze dried powder, spray.And existing freeze dried powder, spray are in use, need earlier lysate to be added freeze dried powder dissolving back and use, and using method bothers very much, and after smearing the affected part, the pharmaceutically active retention time is short, is restricted aspect clinical practice.
Rh-bFGF external freeze dried powder on " recombination human basic fibroblast growth factor (rh-bFGF) gel " and the existing market, spray etc. are compared, and be in use easy to use, accepted by doctor, patient easilier.And after smearing the affected part, the pharmaceutically active retention time is longer, reaches better therapeutic effect.
Therefore, invent a kind of effective ingredient that had both guaranteed rh-bFGF, the rh-bFGF novel form of convenient clinically again use and better effects if is very necessary.
Summary of the invention
The object of the present invention is to provide on a kind of damage wound surface that can directly spread upon because of wound (as operation wound, burn, scald, ulcer), can promote the wound tissue healing, shorten healing time, and to the skin nonirritant, easy to use, easy cleaned rh-bFGF gel.
Another object of the present invention provides the preparation method of this rh-bFGF gel.
Key of the present invention is how to keep the biological activity of rh-bFGF, this is vital, each mixture ratio example difference will influence the biological activity of rh-bFGF, thereby influence its drug effect, so the screening of each component of the present invention is a basis for estimation with the biological activity calibrating, also preparation has been carried out every calibrating simultaneously, to guarantee its clinical drug safety, effectiveness.
The key of preparation method of the present invention is:
1. the substrate of using in the preparation can not have any stimulation and toxic and side effects to skin, should be to human body and influential to the rh-bFGF activity between each composition.
2. strengthen the stability of main active rh-bFGF.That is to say the adjunct ingredient that uses by in the research selection preparation, adjust the ratio of various adjuvant components in the substrate, guarantee the drug effectiveness of preparation in preparation, storage, transportation and patient use.
3.rh-bFGF be the bigger protein molecule of molecular weight, and certain space structure arranged, be subjected to the influence of space steric effect easily, so will adjust the ratio of each component in the preparation, rh-bFGF can continuous and effective be discharged.
Rh-bFGF gel of the present invention is made up of principal agent and gel-type vehicle:
Principal agent is: recombination human basic fibroblast growth factor (rh-bFGF) 0.1 microgram～300 micrograms/gram substrate.
Gel-type vehicle (percentage by weight %) comprising:
Thickening agent 0.1-10, wetting agent 0.1-～20, antiseptic 0.1～5, stabilizing agent 0.1～10, pH regulator agent: 0.1～5, water 50～99.4.But be not limited only to above-mentioned several matrix components, also be not limited to above-mentioned proportional limit.
Thickening agent is sodium carboxymethyl cellulose, methylcellulose, Polyethylene Glycol, carbomer, chitosan, and concentration is respectively 0.1%～10%.Wetting agent is glycerol, propylene glycol, and concentration is respectively 0.1%～20%.Antiseptic is methyl parahydroxybenzoate, ethylparaben, phenol, sorbic acid, sodium benzoate, and concentration is respectively 0.1%～5%.Stabilizing agent is mannitol, sodium lauryl sulphate, glycosides propylhomoserin, tween, dextran, hyaluronic acid, chondroitin sulfate, and concentration is respectively 0.1%-10%.The pH regulator agent is triethanolamine, sodium hydroxide, sodium bicarbonate, and concentration is respectively 0.1%-5%.But be not limited only to above-mentioned several matrix components.
The preparation method of rh-bFGF gel is: earlier with thickening agent, wetting agent, antiseptic, stabilizing agent, pH regulator agent and water mix according to the above ratio and stir, make water-soluable gel substrate, then at 0.08～0.15MPa pressure, under 100～126 ℃ of conditions, with the water-soluable gel substrate of making, autoclaving 15-30 minute, naturally cool to room temperature, the recombination human basic fibroblast growth factor that adds said ratio again, slowly mix, make gel, divide to install in the aluminum pipe (or other gel packaging materials) then and make medicinal gel finished product.
The present invention has the following advantages and effect:
1, the gel substrate selected for use of the present invention is reasonable, and is nontoxic to skin, have no stimulation, and is not infected with medicated clothing, is easy to clean.
2, the gel substrate of the present invention's employing is a network structure, and medicine dissolution can make protein drug rh-bFGF more stable therein like this, drug slow discharges, simultaneously can absorb wound exudate, form the gel of highly-hydrophilic, thus the secretion of control wound surface and the infection of antibacterial, accelerate the stripping of medicine simultaneously, play slow releasing function to a certain extent, make its effect more lasting, promote the wound tissue healing, accelerate healing rate, make the effect of rh-bFGF more directly effective.
3, gel of the present invention can directly spread upon on the damage wound surface that wound, burn, scald, ulcer bring, and is easy to use, alleviated patient's medication misery, is convenient to the patient and accepts and use.
The specific embodiment
Embodiment 1: get carbomer 1g, glycerol 2g, ethylparaben 1g, glycine 1g, above-mentioned raw materials mix the back and become acid, for guaranteeing the albumen invariance, add sodium hydroxide 0.1g, transfer the ph value, add dissolving water to 100g, mix homogeneously, then at 0.1MPa, under 121 ℃ of conditions, go out mattress 25 minutes of high pressure, cool to room temperature, make the substrate part, in substrate, add rh-bFGF 300 μ g, slowly stir simultaneously, make gel, divide to install to then and make medicinal rh-bFGF gel finished product in the aluminum pipe.
The embodiment of the invention 1 involved calibrating experiment and related experiment comprises:
1, stability experiment: the active BalB/c 3T3 cell that adopts, mtt assay is measured, and this product is responsive to heat, should not at high temperature deposit; At room temperature about can depositing 3 months can be satisfied instructions for use.Under 4～8 ℃ of conditions, place and still keep original activity after 2 years.Significant change is not all found in outward appearance, pH value, viscosity, aseptic, active every test, so illustrate that the preparation of invention has good stable under 4～8 ℃ of conditions.
2, sterility test: check, meet the requirements by version " biological product sterility test rules " A item in 2000.
3, skin allergy experiment: recombined human alkaline fibroblast growth factor gelling agent is applied to Cavia porcellus with every gram content 20 μ g, 40 μ g, 80 μ g, 100 μ g (be equivalent to the clinical consumption of people 1 times, 2 times, 4 times, 5 times) respectively and normally reaches damaged skin and be subjected to the examination district, and area is 2cm
2The result shows, once gives approximately and multiple dosing matched group and administration group comparative observation, the skin irritation response strength all＜0.5 minute, illustrate that recombined human alkaline fibroblast growth factor gelling agent single administration and multiple dosing all do not have the property of irritating to Cavia porcellus complete sum damaged skin.
4, extracorporeal releasing experiment: with reference to DiBaseMD etc. (PbarmActa Helv, 1991,66 (5-6): method 165) is carried out, release in vitro meets the zero order kinetics pattern.
Clinical practice situation of the present invention is as follows:
The rh-bFGF gel that clinical practice the present invention produces, directly spread upon on the damage wound surface because of wound (as operation wound, burn, scald, ulcer), can promote the wound tissue healing, shorten healing time, curative effect is better, and to the skin nonirritant, easy to use, be easy to clean and be convenient to operation, be applicable to clinical.
Usage and consumption: it is an amount of to get this product, after directly be applied in injury place after the debridement, suitably wrapping gets final product, the optimum dose of rh-bFGF is about 60IU/cm
2∽ 90IU/cm
2The wound surface area.Every day 1～2 time.
The evaluation of tiring: clinical application effect by the doctor by the subjective symptoms and the finding Comprehensive Assessment of having a medical check-up, be divided into recovery from illness, produce effects, effective, invalid four classes, recovery from illness, produce effects, effectively add up to effectively, rh-bFGF gel treatment group and matched group (zinc sulfadiazine) are relatively, the result shows: the clinical verification of rh-bFGF gel, and treatment burn, scald and ulcer, effective percentage is respectively more than 95%, proof rh-bFGF gel is feasible, and is more reasonable.And matched group has rate more than 74%.
Embodiment 2: get sodium carboxymethyl cellulose 2g, and glycerol 5g, methyl parahydroxybenzoate 3g, tween 80 0.1g adds dissolving water to 100g, mix homogeneously, then at 0.1MPa, under 121 ℃ of conditions, autoclaving 25 minutes, cool to room temperature is made the substrate part.In substrate, add rh-bFGF 300 μ g, slowly stir simultaneously, make gel, divide to install to then and make medicinal rh-bFGF gel finished product in the aluminum pipe.Make the rh-bFGF gel.
Embodiment 3: taking polyethylene glycol 5g, and propylene glycol 5g, sorbic acid 3g, tween 3g adds dissolving water to 100g, mix homogeneously, then at 0.1MPa, under 121 ℃ of conditions, autoclaving 25 minutes, cool to room temperature is made the substrate part.In substrate, add rh-bFGF 300 μ g and slowly stir simultaneously, make gel, divide to install to then and make medicinal rh-bFGF gel finished product in the aluminum pipe.
Embodiment 4: get methylcellulose 2g, and glycerol 5g, methyl parahydroxybenzoate 1g, glycine 1g adds dissolving water to 100g, mix homogeneously, then at 0.1MPa, under 121 ℃ of conditions, autoclaving 25 minutes, cool to room temperature is made the substrate part.In substrate, add rh-bFGF 400 μ g and slowly stir simultaneously, make gel, divide to install to then and make medicinal rh-bFGF gel finished product in the aluminum pipe.
Embodiment 5: get chitosan 2g, and propylene glycol 5g, sodium benzoate 0.5g, tween 1g adds dissolving water to 100g, mix homogeneously, then at 0.1MPa, under 121 ℃ of conditions, autoclaving 25 minutes, cool to room temperature is made the substrate part.In substrate, add rh-bFGF 300 μ g and slowly stir simultaneously, make gel, divide to install to then and make medicinal rh-bFGF gel finished product in the aluminum pipe.
Claims (7)
1, a kind of recombination human basic fibroblast growth factor (be called for short rh-bFGF) gel is characterized in that it is made up of principal agent and gel-type vehicle:
Principal agent is recombination human basic fibroblast growth factor (rh-bFGF), preferred dose: 0.1 microgram-300 microgram/gram substrate.
Gel-type vehicle comprises (preferred dose, percentage by weight %):
Thickening agent 0.1～10, wetting agent 0.1～20, antiseptic 0.1～5, stabilizing agent 0.1～10, pH regulator agent 0.1～5, water 50～99.4.
2, recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: the thickening agent preferred feedstock is sodium carboxymethyl cellulose, methyl fiber rope, Polyethylene Glycol, carbomer, chitosan, and concentration is respectively 0.1%～10%.
3, recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: the wetting agent preferred feedstock is glycerol, propylene glycol, and concentration is respectively 0.1%～20%.
4, recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: the antiseptic preferred feedstock is methyl parahydroxybenzoate, ethylparaben, phenol, sorbic acid, sodium benzoate, and concentration is respectively 0.1%～5%.
5, recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: the stabilizing agent preferred feedstock is mannitol, sodium lauryl sulphate, glycosides propylhomoserin, tween, dextran, hyaluronic acid, chondroitin sulfate, and concentration is respectively 0.1%-10%.
6, recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: pH regulator agent preferred feedstock is triethanolamine, sodium hydroxide, sodium bicarbonate, and concentration is respectively 0.1%-5%.
7, the preferred for preparation method of recombination human basic fibroblast growth factor according to claim 1 (rh-bFGF) gel, it is characterized in that: earlier with thickening agent, wetting agent, antiseptic, stabilizing agent, pH regulator agent and water mix according to the above ratio and stir, make water-soluable gel substrate, then at 0.08～0.15MPa pressure, under 100～126 ℃ of conditions, with the water-soluable gel substrate autoclaving made 15～30 minutes, naturally cool to room temperature, recombination human basic fibroblast growth factor (rh-bFGF) 0.1 microgram-300 microgram/gram substrate that adds said ratio again, slowly mix, make gel, divide to install in the aluminum pipe (or other gel packaging materials) then and make medicinal gel finished product.
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100402086C (en) * | 2006-12-20 | 2008-07-16 | 张纲 | Slow released nano microsphere gel of alkaline fibroblast growth factor and polylactic acid and its preparing method |
| CN101143212B (en) * | 2006-09-13 | 2010-10-13 | 广州暨南大学医药生物技术研究开发中心 | Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof |
| 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 |
| CN102389392A (en) * | 2011-11-02 | 2012-03-28 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast growth factor gel for eye use |
| CN103211753A (en) * | 2013-03-15 | 2013-07-24 | 北京中美联医学科学研究院有限公司 | Gel matrix |
| CN104689301A (en) * | 2015-03-27 | 2015-06-10 | 吴开刚 | Medicine for removing striae gravidarum and preparing method for medicine for removing striae gravidarum |
| CN104971345A (en) * | 2015-06-26 | 2015-10-14 | 重庆大学 | Novel emodin gelatin microsphere and nano-silver composite gel preparation for treating burn injury and scald injury |
| CN104984326A (en) * | 2015-07-14 | 2015-10-21 | 珠海亿胜生物制药有限公司 | Recombinant human basic fibroblast growth factor gel without bacteriostatic agent and preparation method thereof |
| CN105392468A (en) * | 2013-05-20 | 2016-03-09 | 高敏 | Preparation method of mussel adhesive protein gel, mussel adhesive protein gel and use thereof |
| CN109331037A (en) * | 2018-12-26 | 2019-02-15 | 粤肽生物科技(珠海)有限公司 | External application presses down scar gel combination |
| CN109646671A (en) * | 2018-12-26 | 2019-04-19 | 陕西三八妇乐科技股份有限公司 | A kind of growth-factor preparation and its preparation method and application |
| CN114010763A (en) * | 2021-10-12 | 2022-02-08 | 上海腾瑞制药股份有限公司 | Recombinant human acidic fibroblast growth factor gel and preparation method thereof |
| CN114129710A (en) * | 2021-12-09 | 2022-03-04 | 温州医科大学附属第二医院（温州医科大学附属育英儿童医院） | Fibroblast growth factor hydrogel and preparation method thereof |
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2005
- 2005-01-31 CN CN 200510009218 patent/CN1814279A/en active Pending
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101143212B (en) * | 2006-09-13 | 2010-10-13 | 广州暨南大学医药生物技术研究开发中心 | Recombination human acidic mechanocyte growth factor temperature sensitive type gel preparation and preparation method thereof |
| CN100402086C (en) * | 2006-12-20 | 2008-07-16 | 张纲 | Slow released nano microsphere gel of alkaline fibroblast growth factor and polylactic acid and its preparing method |
| 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 |
| CN102389392A (en) * | 2011-11-02 | 2012-03-28 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast growth factor gel for eye use |
| CN102389392B (en) * | 2011-11-02 | 2012-10-24 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast growth factor gel for eye use |
| CN103211753A (en) * | 2013-03-15 | 2013-07-24 | 北京中美联医学科学研究院有限公司 | Gel matrix |
| CN103211753B (en) * | 2013-03-15 | 2016-03-09 | 北京中美联医学科学研究院有限公司 | A kind of gel substrate |
| CN105392468A (en) * | 2013-05-20 | 2016-03-09 | 高敏 | Preparation method of mussel adhesive protein gel, mussel adhesive protein gel and use thereof |
| CN104689301A (en) * | 2015-03-27 | 2015-06-10 | 吴开刚 | Medicine for removing striae gravidarum and preparing method for medicine for removing striae gravidarum |
| CN104971345A (en) * | 2015-06-26 | 2015-10-14 | 重庆大学 | Novel emodin gelatin microsphere and nano-silver composite gel preparation for treating burn injury and scald injury |
| CN104984326A (en) * | 2015-07-14 | 2015-10-21 | 珠海亿胜生物制药有限公司 | Recombinant human basic fibroblast growth factor gel without bacteriostatic agent and preparation method thereof |
| CN109331037A (en) * | 2018-12-26 | 2019-02-15 | 粤肽生物科技(珠海)有限公司 | External application presses down scar gel combination |
| CN109646671A (en) * | 2018-12-26 | 2019-04-19 | 陕西三八妇乐科技股份有限公司 | A kind of growth-factor preparation and its preparation method and application |
| CN114010763A (en) * | 2021-10-12 | 2022-02-08 | 上海腾瑞制药股份有限公司 | Recombinant human acidic fibroblast growth factor gel and preparation method thereof |
| CN114129710A (en) * | 2021-12-09 | 2022-03-04 | 温州医科大学附属第二医院（温州医科大学附属育英儿童医院） | Fibroblast growth factor hydrogel and preparation method thereof |
| CN114129710B (en) * | 2021-12-09 | 2024-04-26 | 温州医科大学附属第二医院（温州医科大学附属育英儿童医院） | Fibroblast growth factor hydrogel and preparation method thereof |
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