CN104257639A - Film coating agent for wound surface treatment and preparation method of film coating agent - Google Patents
Film coating agent for wound surface treatment and preparation method of film coating agent Download PDFInfo
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- CN104257639A CN104257639A CN201410544706.4A CN201410544706A CN104257639A CN 104257639 A CN104257639 A CN 104257639A CN 201410544706 A CN201410544706 A CN 201410544706A CN 104257639 A CN104257639 A CN 104257639A
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Abstract
The invention discloses a film coating agent for wound surface treatment and a preparation method of the film coating agent. The film coating agent comprises chitosan, a film-forming material, a plasticizer and a solvent, wherein the plasticizer is glycerin with the amount accounting for 2-15% of the total weight of the film coating agent. The film coating agent has the advantages that the film coating agent is better in antibacterial effect, more convenient to use and better in waterproofness, is not limited by shapes and sizes of skin wound surfaces, does not affect normal limb movement and the like.
Description
Technical field
The present invention relates to a kind of liniment for Wound treating and preparation method thereof, this liniment is applicable to the treatment of skin surface either shallow wound, surgical wound surface, empyrosis wound surface and ulcer wound surface, belongs to medical art.
Background technology
Skin is the maximum organ of human body, is also one of most important organ of human body, mainly carries protection health, perspire, feels cold and hot and the function of pressure; Skin covers whole body, and it to make in body various tissue and organ from the invasion and attack of physical property, mechanicalness, chemical and pathogenic microorganism.Meanwhile, skin trauma is also a kind of common surgery frequently-occurring disease, and the factors such as the burn in daily life, scald, knife injury, infection, medicine and immunoreation all may make skin histology sustain damage.The wound surface that skin trauma causes easily causes bleeding on the one hand, oozing of blood, and the pain that wound surface and extraneous contact cause can have a strong impact on work and the life of patient, even leaves cicatrix impact attractive in appearance; On the other hand, if dealt with improperly, can cause infection, bring various complication, severe patient is threat to life even.Therefore, to effective nursing of skin wound be field of medicaments research important content.
20 th America Johson & Johnson take the lead in releasing adhesive bandage, and through the development of last 100 years, the adhesive bandage of various forms specification is applied.Adhesive bandage can hemostasis by compression, protection wound surface, prevention infection, volume is little, use the advantages such as simple and easy to carry, uses extensively so far.But adhesive bandage has fixed dimension, to the wound surface poor selectivity of different area and character, and external adhesive plaster poor air permeability, the normocrinic steam of body local and perspiration can not penetrate this layer of adhesive plaster, can produce action of soaking to local skin; In addition, adhesive bandage water resistance is poor, and affects the orthobiosis of patient after using.
Liniment is a kind of by medicine dissolution or in being scattered in containing filmogen solvent, is coated with film forming liquid preparation for external application after putting affected part on the skin.It is compared with adhesive bandage class external preparation, there is preparation process thereof simpler, without the need to back lining materials, do not need special machine equipment, use more convenient, be not subject to the restriction of skin wound shape and size, do not affect normal limb activity, water resistance is better, reduces the anaphylactic reaction because using binding agent to cause, water white transparency, does not affect advantages such as using position attractive in appearance.Therefore, liniment causes the world of medicine to pay attention to day by day.Such as patent application CN-201310421208.6 discloses a kind of liquid Wound dressing (i.e. liniment), following raw material primarily of parts by weight obtains: medical high polymer filmogen 100-180 part, chitosan 0-20 powder, PEG400 10-25 part, glycerol 10-28 part, mixed solvent 800-1000 part of etoh solvent or ethanol and deionized water; Chitosan 2% acetic acid solution dissolves; Wherein macromolecule filming material is the mixture of the wherein a kind of and carbomer in a kind of or polyvinyl alcohol in polyvinyl alcohol and polyvinyl butyral resin and polyvinyl butyral resin.
Within 2005, the version Pharmacopoeia of the People's Republic of China embodies strengthening by attention degree of liniment to recording of liniment, and the innovation research developing into liniment of polymer material science and percutaneous technique provides opportunity, except filming performance, the important content of person's concern that the pharmacodynamic feature of bio-compatible, biodegradation, filmogen self and the interaction between formulation materials and prescription drug also become pharmacy work.
Summary of the invention
The present invention aims to provide a kind of liniment and preparation method thereof, and it is applicable to the auxiliary treatment of skin surface either shallow wound, otch, surgical wound surface, burn wound, ulcer wound surface, has and promotes wound healing, antibacterial, the effect that alleviates cicatrization.
In existing liniment, general glycerol content is lower, mainly plays the effect of moisturizing, lubrication, increase product viscosity and adhesion.The present inventor is surprisingly found out that, after increasing substantially glycerol content, under physical property (film property and adhesion etc.) the impregnable prerequisite of liniment, can improve the fungistatic effect of product significantly.
Liniment for Wound treating of the present invention, comprise chitosan, filmogen, plasticizer and solvent, wherein said plasticizer is glycerol, the amount of glycerol is the 2-15% of product gross weight, the amount being preferably glycerol is the 5-12% of product gross weight, it is an option that the amount of glycerol is 10% of product gross weight.
Liniment for Wound treating of the present invention, formula is (mass percent):
Be preferably, the liniment for Wound treating of the present invention, formula is (mass percent):
It is an option that: the liniment for Wound treating of the present invention, formula is (mass percent):
Water-soluble chitosan 2.0%
Polyvinyl alcohol 2,488 5.0%
Glycerol 10.0%
Water
82.97％
Ethylparaben sodium
0.03％。
Of the present invention in the liniment of Wound treating, described chitosan is chitosan or modified water-soluble chitosan, described filmogen is polyvinyl alcohol, sodium alginate, polyvinyl formal-acetal, polyvinyl butyral resin, carbomer, sodium carboxymethyl cellulose and hydroxypropyl methylcellulose, described solvent is water, prioritizing selection distilled water or deionized water, if needed, also can use containing aqueous acid, as contained 2% second aqueous acid; Described antiseptic is parabens, sodium benzoate or benzalkonium bromide.Chitosan can not be water-soluble, can only be dissolved in dilute acid soln, such as 2% acetic acid solution, and water-soluble chitosan can be completely soluble in water, avoids employing acetic acid solution, decreases the zest of wound.
The preparation method of the liniment for Wound treating of the present invention, comprises the steps:
A, by the appropriate dissolution with solvents of the antiseptic of recipe quantity, obtained solution one;
B, the filmogen of recipe quantity and chitosan are placed in appropriate vessel, add the solvent of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two;
C, to be cooled to after room temperature until solution two and to add solution one, be uniformly mixed;
D, the mixture of step C gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free.
Be preferably, the preparation method of the liniment for Wound treating of the present invention, comprises the steps:
A, the antiseptic suitable quantity of water of recipe quantity to be dissolved, obtained solution one;
B, the polyvinyl alcohol 2488 of recipe quantity and water-soluble chitosan are placed in appropriate vessel, add the water of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two;
C, to be cooled to after room temperature until solution two and to add solution one, be uniformly mixed;
D, the mixture of step C gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free.
Compared with existing product, it is better that liniment of the present invention has fungistatic effect, uses more convenient, use not by skin wound shape and size limits, and does not affect normal limb activity, reduces the anaphylactic reaction because using binding agent to cause, water white transparency, does not affect advantages such as using position attractive in appearance.
In the present invention, all amounts, part are mass percent unit, and all raw materials all can be buied from market.
By the following specific examples further illustrate the invention, but embodiment only for illustration of, can not limit scope of the present invention, any amendment made technical scheme of the present invention is all within the scope of the invention.
Detailed description of the invention
Embodiment 1: the preparation of liniment
(1) prescription composition:
The prescription composition of table 1 liniment
In prescription 1-5, polyvinyl alcohol 2488 can use sodium alginate, polyvinyl formal-acetal, polyvinyl butyral resin, carbomer, sodium carboxymethyl cellulose and hydroxypropyl methylcellulose to replace.Coloring agent or the correctives of reasonable addition is also included in ethylparaben sodium.
(2) preparation method of the liniment of prescription one to prescription five:
1, the antiseptic suitable quantity of water of recipe quantity is dissolved, obtained solution one;
2, the polyvinyl alcohol 2488 of recipe quantity and water-soluble chitosan are placed in appropriate vessel, add the distilled water of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two;
3, be cooled to after room temperature until solution two and add solution one, be uniformly mixed;
4, the mixture of step 3 gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free, obtain liniment of the present invention.
Embodiment 2: the bacteriostatic experiment of liniment
(1) strain: staphylococcus aureus CMCC (B) 26003] the 4th generation; (note: Guangdong Province's Culture Collection provides)
(2) bacterium solution preparation: get above-mentioned staphylococcus aureus, making every 1ml containing bacterium number with 0.9% aseptic sodium chloride solution is the bacteria suspension of 50 ~ 100cfu.
(3) test sample test group: the above-mentioned bacteria suspension (50 ~ 100cfu/ml) of the liniment and 1ml of getting the preparation of a certain amount of embodiment 1 prescription one to prescription five injects plate, pours into nutrient agar immediately.Often criticize the parallel preparation of test sample 2 plates, cultivate 3 days at 30-35 DEG C, then measure its bacterium number by Plating.
Viable bacteria group: get above-mentioned bacteria suspension 1ml (50 ~ 100cfu/ml) and inject plate, pour into nutrient agar immediately.Parallel preparation 2 plates, cultivate 3 days, measure its bacterium number by Plating at 30-35 DEG C.
(4) bacteriostasis rate calculates
Bacterium number × 100 of suppression ratio (%)=(the bacterium number of the bacterium number-test group of viable bacteria group)/viable bacteria group
The antibacterial of each test group the results are shown in Table 2.
The antibacterial result of table 2
According to the data of table 2, the liniment of prescription one to prescription five all can suppress the growth of staphylococcus aureus effectively.But compared with the liniment of the prescription one of same amount, there were significant differences (p<0.05) for the bacteriostasis rate of the liniment of prescription three and prescription five; The liniment of prescription four has the difference (p<0.01) of highly significant.As can be seen here, the fungistatic effect of consumption on liniment of glycerol has obvious impact, and the glycerol of 5%-12% can increase the fungistatic effect of liniment significantly, and especially the glycerol of 10% can increase the fungistatic effect of liniment very significantly.
Embodiment 3: the preparation of liniment
(1) prescription composition:
The prescription composition of table 3 liniment
In prescription 6-10, polyvinyl alcohol 2488 can use sodium alginate, polyvinyl formal-acetal, polyvinyl butyral resin, carbomer, sodium carboxymethyl cellulose and hydroxypropyl methylcellulose to replace.Coloring agent or the correctives of reasonable addition is also included in ethylparaben sodium.Water can be deionized water or distilled water.
(2) preparation method of the liniment of prescription six to prescription ten:
1, the antiseptic suitable quantity of water of recipe quantity is dissolved, obtained solution one.
2, the polyvinyl alcohol 2488 of recipe quantity and water-soluble chitosan are placed in appropriate vessel, add the water of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two.
3, be cooled to after room temperature until solution two and add solution one, be uniformly mixed.
4, the mixture of step 3 gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free, obtain liniment of the present invention.
(3) the film property test of prescription six to prescription ten:
Temperature 20 ~ 25 DEG C, under relative humidity 45 ~ 65% condition, liniment is sprayed at curtain coating on dry plate glass and paves evenly, after natural drying, timing forms transparent or semitransparent film.
Film forming in prescription six 10min, film forming in prescription seven 30min, prescription eight and film forming in prescription nine 7min, film forming in prescription ten 5min.Show consumption when polyvinyl alcohol in prescription >=5% time, filming performance is excellent.
(4) bacteriostatic test of prescription six to prescription ten:
(1) strain: staphylococcus aureus CMCC (B) 26003] the 4th generation; (note: Guangdong Province's Culture Collection provides)
(2) bacterium solution preparation: get above-mentioned staphylococcus aureus, making every 1ml containing bacterium number with 0.9% aseptic sodium chloride solution is the bacteria suspension of 50 ~ 100cfu.
(3) test sample test group: the above-mentioned bacteria suspension (50 ~ 100cfu/ml) of the liniment and 1ml of getting the preparation of a certain amount of prescription six to prescription ten injects plate, pours into nutrient agar immediately.Often criticize the parallel preparation of test sample 2 plates, cultivate 3 days at 30-35 DEG C, then measure its bacterium number by Plating.
Viable bacteria group: get above-mentioned bacteria suspension 1ml (50 ~ 100cfu/ml) and inject plate, pour into nutrient agar immediately.Parallel preparation 2 plates, cultivate 3 days, measure its bacterium number by Plating at 30-35 DEG C.
(4) bacteriostasis rate calculates
Bacterium number × 100 of suppression ratio (%)=(the bacterium number of the bacterium number-test group of viable bacteria group)/viable bacteria group
The antibacterial of each test group the results are shown in Table 4.
The antibacterial result of table 4
According to the data of table 4, the liniment of prescription six to prescription ten all can suppress the growth of staphylococcus aureus effectively.
Claims (9)
1. for a liniment for Wound treating, it is characterized in that comprising chitosan, filmogen, plasticizer and solvent, wherein said plasticizer is glycerol, and the amount of glycerol is the 2-15% of product gross weight.
2. the liniment for Wound treating according to claim 1, is characterized in that the amount of glycerol is the 5-12% of product gross weight.
3. the liniment for Wound treating according to claim 1, is characterized in that the amount of glycerol is 10% of product gross weight.
4., according to the liniment for Wound treating one of claim 1-3 Suo Shu, it is characterized in that formula is (mass percent):
5., according to the liniment for Wound treating one of claim 1-3 Suo Shu, it is characterized in that formula is (mass percent):
6. the liniment for Wound treating according to any one of claim 4 or 5, it is characterized in that described chitosan is chitosan or modified water-soluble chitosan, described filmogen is polyvinyl alcohol, sodium alginate, polyvinyl formal-acetal, polyvinyl butyral resin, carbomer, sodium carboxymethyl cellulose and hydroxypropyl methylcellulose, described solvent is water, and described antiseptic is parabens, sodium benzoate or benzalkonium bromide.
7., according to the liniment for Wound treating one of claim 1-3 Suo Shu, it is characterized in that formula is (mass percent):
Water-soluble chitosan 2.0%
Polyvinyl alcohol 2,488 5.0%
Glycerol 10.0%
Water
82.97％
Ethylparaben sodium
0.03％。
8. the preparation method of the liniment for Wound treating according to any one of claim 1 to 3, is characterized in that comprising the steps:
A, by the appropriate dissolution with solvents of the antiseptic of recipe quantity, obtained solution one;
B, the filmogen of recipe quantity and chitosan are placed in appropriate vessel, add the solvent of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two;
C, to be cooled to after room temperature until solution two and to add solution one, be uniformly mixed;
D, the mixture of step C gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free.
9. the preparation method of the liniment for Wound treating according to claim 7, is characterized in that comprising the steps:
A, the antiseptic suitable quantity of water of recipe quantity to be dissolved, obtained solution one;
B, the polyvinyl alcohol 2488 of recipe quantity and water-soluble chitosan are placed in appropriate vessel, add the water of residue recipe quantity wherein, limit edged stirring and evenly mixing, the glycerol of recipe quantity is added after swelling 30 minutes, intensification limit is stirred to 80 DEG C gradually, until all dissolve, and obtained solution two;
C, to be cooled to after room temperature until solution two and to add solution one, be uniformly mixed;
D, the mixture of step C gained is at room temperature placed about 24h, reduce pressure degassed to fill after bubble-free.
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Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105288697A (en) * | 2015-11-13 | 2016-02-03 | 邢月军 | Medical film for surgery |
| CN105311684A (en) * | 2015-11-13 | 2016-02-10 | 邢月军 | Surgical film for stopping bleeding and relieving pain |
| CN105327384A (en) * | 2015-11-19 | 2016-02-17 | 耿文真 | Absorbable medical biological membrane dressing and preparation method thereof |
| CN105363065A (en) * | 2015-11-13 | 2016-03-02 | 邢月军 | Antibacterial and anti-inflammatory membrane |
| CN105381499A (en) * | 2015-11-19 | 2016-03-09 | 耿文真 | Medical membrane with effect of promoting wound healing and preparation process thereof |
| CN105434404A (en) * | 2015-12-18 | 2016-03-30 | 江苏海智生物医药有限公司 | Film coating agent used for protecting wound surfaces |
| CN105497976A (en) * | 2016-01-07 | 2016-04-20 | 青岛大学 | Preparation method of externally applied functional ointment for traumatic wounds |
| CN105561381A (en) * | 2016-01-07 | 2016-05-11 | 青岛大学 | Preparation method of marine organism nano antibacterial gel-liquid adhesive bandage |
| CN105797202A (en) * | 2016-03-23 | 2016-07-27 | 广州瑞辉生物科技股份有限公司 | Liquid band-aid and preparing method thereof |
| CN105816908A (en) * | 2016-04-29 | 2016-08-03 | 哈尔滨乾佰纳生物药业有限公司 | Waterproof liquid wound protection film and preparation method thereof |
| CN105963281A (en) * | 2016-07-05 | 2016-09-28 | 青岛明药堂医疗股份有限公司 | Chitin scar-restraint gel coating as well as preparation method and application thereof |
| CN106075560A (en) * | 2016-07-26 | 2016-11-09 | 上海第二工业大学 | A kind of preparation method of polymeric liquid adhesive bandage |
| CN106178096A (en) * | 2016-08-30 | 2016-12-07 | 张阳 | A kind of wound fluid film and preparation method thereof |
| CN107670099A (en) * | 2017-11-28 | 2018-02-09 | 苏州汇涵医用科技发展有限公司 | A kind of liquid dressing and preparation method thereof |
| CN107951959A (en) * | 2017-12-22 | 2018-04-24 | 海南医学院 | A kind of callicarpa nudiflora plastics and preparation method thereof |
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Cited By (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105311684A (en) * | 2015-11-13 | 2016-02-10 | 邢月军 | Surgical film for stopping bleeding and relieving pain |
| CN105363065A (en) * | 2015-11-13 | 2016-03-02 | 邢月军 | Antibacterial and anti-inflammatory membrane |
| CN105288697A (en) * | 2015-11-13 | 2016-02-03 | 邢月军 | Medical film for surgery |
| CN105327384A (en) * | 2015-11-19 | 2016-02-17 | 耿文真 | Absorbable medical biological membrane dressing and preparation method thereof |
| CN105381499A (en) * | 2015-11-19 | 2016-03-09 | 耿文真 | Medical membrane with effect of promoting wound healing and preparation process thereof |
| CN105434404A (en) * | 2015-12-18 | 2016-03-30 | 江苏海智生物医药有限公司 | Film coating agent used for protecting wound surfaces |
| CN105434404B (en) * | 2015-12-18 | 2018-07-17 | 江苏海智生物医药有限公司 | A kind of plastics for protecting wound surface |
| CN105497976B (en) * | 2016-01-07 | 2018-07-10 | 青岛大学 | A kind of trauma wound is applied with the preparation method with functional ointment |
| CN105497976A (en) * | 2016-01-07 | 2016-04-20 | 青岛大学 | Preparation method of externally applied functional ointment for traumatic wounds |
| CN105561381A (en) * | 2016-01-07 | 2016-05-11 | 青岛大学 | Preparation method of marine organism nano antibacterial gel-liquid adhesive bandage |
| CN105797202A (en) * | 2016-03-23 | 2016-07-27 | 广州瑞辉生物科技股份有限公司 | Liquid band-aid and preparing method thereof |
| CN105816908A (en) * | 2016-04-29 | 2016-08-03 | 哈尔滨乾佰纳生物药业有限公司 | Waterproof liquid wound protection film and preparation method thereof |
| CN105963281A (en) * | 2016-07-05 | 2016-09-28 | 青岛明药堂医疗股份有限公司 | Chitin scar-restraint gel coating as well as preparation method and application thereof |
| CN106075560A (en) * | 2016-07-26 | 2016-11-09 | 上海第二工业大学 | A kind of preparation method of polymeric liquid adhesive bandage |
| CN106178096A (en) * | 2016-08-30 | 2016-12-07 | 张阳 | A kind of wound fluid film and preparation method thereof |
| CN107670099A (en) * | 2017-11-28 | 2018-02-09 | 苏州汇涵医用科技发展有限公司 | A kind of liquid dressing and preparation method thereof |
| CN107951959A (en) * | 2017-12-22 | 2018-04-24 | 海南医学院 | A kind of callicarpa nudiflora plastics and preparation method thereof |
| CN107951959B (en) * | 2017-12-22 | 2021-01-26 | 海南医学院 | Callicarpa nudiflora film coating agent and preparation method thereof |
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Effective date of registration: 20190613 Address after: 523000 Tea Health Products Factory Building, No. 7 Changyuan Road, Songshan Lake High-tech Industrial Development Zone, Dongguan City, Guangdong Province, 3rd Floor Patentee after: Dongguan Gejiu Health Technology Co., Ltd. Address before: 651701 No. 5 Huashi Road, Yanglin Industrial Development Zone, Songming County, Kunming City, Yunnan Province Patentee before: Kunming Yuanrui Pharmaceutical Co., Ltd. |
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| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20200424 Address after: 651701 Huashi Road, Yanglin Industrial Development Zone, Kunming, Yunnan Patentee after: KUNMING YUANRUI PHARMACEUTICAL Co.,Ltd. Address before: 523000 Tea Health Products Factory Building, No. 7 Changyuan Road, Songshan Lake High-tech Industrial Development Zone, Dongguan City, Guangdong Province, 3rd Floor Patentee before: Dongguan Gejiu Health Technology Co., Ltd. |