CN104258453A - Raw material composition of active wound repair material and preparation method of raw material composition - Google Patents
Raw material composition of active wound repair material and preparation method of raw material composition Download PDFInfo
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- CN104258453A CN104258453A CN201410490158.1A CN201410490158A CN104258453A CN 104258453 A CN104258453 A CN 104258453A CN 201410490158 A CN201410490158 A CN 201410490158A CN 104258453 A CN104258453 A CN 104258453A
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- raw material
- wound repair
- sodium hyaluronate
- wound
- repair material
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Abstract
The invention discloses a raw material composition of an active wound repair material and a preparation method of the raw material composition. The raw material composition is prepared from the following components in percentage by weight: 15-51% of an analytically pure reagent anhydrous sodium carbonate, 14-19% of calcium carbonate, 25-57% of silicon dioxide, 6-20% of calcium fluoride, 4-17% of tricalcium phosphate and 2-20% of medical sodium hyaluronate, or 9-51% of an analytically pure reagent anhydrous sodium carbonate, 5-50% of calcium carbonate, 38-58% of silicon dioxide, 5-22% of tricalcium phosphate and 2-20% of medical sodium hyaluronate. The raw material composition can be prepared into external preparations such as gel and ointment for treating the skin wound. The active wound repair material disclosed by the invention can be used for inducing proliferation and differentiation of human epithelial cells, promoting the regeneration of soft tissues, quickening the generation of granulation tissues, promoting the wound to heal and reducing the formation of scars, and therefore has a wide medical application prospect.
Description
Technical field
The present invention relates to a kind of vulnerary material, i.e. active wound repair material, belong to medical material and dressing technical field.
Background technology
Prior art cure wound surface dressing have a lot, but absorb at wound exudate, angiogenic growth, improve microcirculation, short wound healing, reduce the aspect effects such as cicatrization and have much room for improvement, particularly to the wound surface being difficult to heal that diabetic ulcer, decubital ulcer, burn and unknown cause cause, treatment effect is poorer, brings the misery on larger mind & body to patient, adds the financial burden of patient.
Also there is novel wound repair material in recent years, patent 200510104916.2 proposes employing silicon dioxide, oxidation is received, calcium oxide and phosphorus pentoxide physical mixed, wound repair material is mixed and made into hyaluronic acid again after pulverizing, screening (300 μm), many materials mixed powder that this patent adopts physical mixed technology to prepare, its crystal structure remains independent monocrystalline compound, and the uniformity of tissue, biological activity, therapeutic effect are to be improved.
Summary of the invention
The object of this invention is to provide a kind of feedstock composition and preparation method of active wound repair material, can effective angiogenic growth, improve microcirculation, short wound healing, reduces cicatrization.
The present invention openly produces the feedstock composition of active wound repair material, the component of this feedstock composition and the percentage by weight of each component are: analytical reagent natrium carbonicum calcinatum 15-51%, calcium carbonate 14-19%, silicon dioxide 25-57%, calcium fluoride 6-20%, tricalcium phosphate 4-17% and sodium hyaluronate 2-20% form, or, analytical reagent natrium carbonicum calcinatum 9-51%, calcium carbonate 5-50%, silicon dioxide 38-58%, tricalcium phosphate 5-22% and sodium hyaluronate 2-20% form.
The method that employing above-mentioned raw materials compositions disclosed by the invention prepares active wound repair material is: (1) with analytical reagent natrium carbonicum calcinatum, calcium carbonate, silicon dioxide, calcium fluoride, tricalcium phosphate for raw material, various raw material dosage is calculated by above-mentioned raw materials compositions percentage composition, precise, Homogeneous phase mixing; (2) compound is placed in platinum crucible, melts 90min at 1350 DEG C; (3) the hyaloid liquid quenching in deionized water will melted; (4) dry; (5) grind, screening of sieving, bioactivity glass powder processed, gets the powder being less than 50 microns; By get be less than 50 microns powder and sodium hyaluronate by constant weight percentage mix.
Producing active wound repair material shape by above-mentioned method is gel or unguentum.
Active wound repair material is produced, the following component containing by weight percentage by above-mentioned method:
SiO
2 30—60%
Na
2O 10—30%
CaO 10—30%
CaF
2 6—20%
P
2O
5 2—8%
Sodium hyaluronate 2-20%
Or:
SiO
2 40—60%
Na
2O 5—30%
CaO 5—30%
P
2O
5 2—10%
Sodium hyaluronate 2-20%
Active wound repair material provided by the invention, possess unique crystal composite structure, powder particles is little, and large with wound surface contact area, surface activity is strong.When contacting with soft tissue wound surface, series reaction can be there is with tissue, pass through ion exchange, improve partial pressure of oxygen and the pH value of wound surface, form stronger negative potential on surface, by a series of biochemical reaction, form the porous network that a hydroxyapatite (HAP) forms, can adsorb and assemble a large amount of various materials relevant with tissue regeneration, as fibrin, collagen protein and various factor for supporting wound healing (as EGF, bDGF).Meanwhile, HAP network, again as the support of cambium, makes cambium be climbed smoothly and moves.Sodium hyaluronate is a kind of high molecular straight-chain polysaccharide, be distributed widely in animal and human's body connective tissue cell epimatrix, it has wound healing and organizes Concentrations of Epidermal Growth Factor content to increase, regulation and control collage synthesis, effect such as adjustment fiber-reactive and antiinflammatory etc.On the other hand, sodium hyaluronate can also suppress collagenous tissue contracture, until tissue obtains reproducibility reparation and do not leave cicatrix.In whole repair process, sodium hyaluronate, under the combined effect of these effective ingredient, forms a wound surface environment having antibacterial protective effect, prevent wound infection, and wound surface cell accelerates secretion collagen protein and the various promotion wound healing factor.
Active wound repair material provided by the invention can be used for the wound surface being difficult to heal that skin ulcer, decubital ulcer, light degree Ⅱ burn and unknown cause cause, the wound surface that various operation and wound cause.
Detailed description of the invention
In conjunction with an example, to feedstock composition and the preparation method of active wound repair material provided by the invention, and the result of use of active wound repair material is described in detail.
Embodiment one
The preparation of active wound repair material
(1) with analytical reagent natrium carbonicum calcinatum 15-51%, calcium carbonate 14-19%, silicon dioxide 25-57%, calcium fluoride 6-20%, tricalcium phosphate 4-17%, precise natrium carbonicum calcinatum, calcium carbonate, silicon dioxide, calcium fluoride, tricalcium phosphate, inserts container, Homogeneous phase mixing; (2) compound is placed in platinum crucible, melts 90min at 1350 DEG C; (3) the hyaloid liquid quenching in deionized water will melted; (4) dry; (5) grind, screening of sieving, obtains the powder being less than 50 microns; By get the powder that is less than 50 microns and sodium hyaluronate is mixed in proportion, obtain the agent of active wound repair material gel, after testing, this active wound repair material gel agent following component by weight percentage:
SiO
2 35%
Na
2O 22%
CaO 18%
CaF
2 12%
P
2O
5 6%
Sodium hyaluronate 7%
Clinical observation result
The present inventor is after national departments concerned approval, and carried out clinical verification in certain Affiliated Hospital of medical university, clinical observation result is as follows:
One. case selection
1. inclusion criteria:
In March, 2011 is in hospital or out-patient to Affiliated Hospital of JIUYUE medical university, tool wound surface and need the person of changing dressings, and a. disease is planted: chronic wound, comprises chronic ulcer, decubital ulcer etc.; Acute wound, comprises small size burn wound surface, postoperative wound opening need person's of changing dressings (liquefaction of fat, hydrops, infection etc.), wound and wound surface etc.; B. the range of age: 18-80 year.
2. exclusion standard
malignant ulcer wound surface, specific infection wound surface (as tuberculosis, fungus and tetanus).
the infull person of the serious heart, brain, lung, Liver and kidney function.
serious hypoproteinemia, the glycosuria patient using 17-hydroxy-11-dehydrocorticosterone person and cannot effectively control.
psychological abnormality person.
3. reject standard
The complete observation person in research cycle can not be completed.
Two. survey plan
1. clinical investigation material requested
Investigation material: the active wound repair material gel agent that the present inventor provides.
Control material: matched group uses normal saline, neomycin or kpetrolatum gauze as required.
2. Investigation and Design
2.1 investigation groupings
Selected patient is divided into two groups at random, and A group uses the agent of active wound repair material gel, and B group uses contrast dressing on demand.
2.2 observation items:
(1) wound granulation growth healing state.
(2) local of wound red, swollen, hot, bitterly, ooze out, play the local response such as rash and the general reaction such as heating, dizziness sign and allergic phenomena.
(3) clinical manifestation and biochemical indicator: blood WBC, HB, ALT, SGPT, AKP, BUN etc.
2.3 observe the time limit
As wound surface heals in surrounding, observe to wound healing day; As wound healing time is greater than surrounding, observe to 4th week.Each observation item situation of change is recorded respectively at the 1st, 4,7,11,14,21 and 28 day.
2.4 curative effect evaluation
Wound healing or reduce more than 2/3 and granulation well-grown is effective in surrounding; In medication surrounding, wound surface reduces more than 1/3 is effective; In surrounding, wound surface reduces less than more than 1/3 for effectively suspicious; Wound surface delayed union or be designated as without significant change person invalid.
2.5 statistical method
Enumeration data is with X
2inspection, measurement data is normal distribution, and person checks with t, and partial velocities person detects its significance of difference with rank test.
Three. survey result
1. case is selected in situation
This MethodsThe cases enrolled totally 60 example, investigation team 30 example, matched group 30 example, wherein male 27 example, women 33 example, the age be 21-77 year (the median age 51.5 years old).Two groups of case basic conditions are in Table 1-3.
Table 1 liang group case Sex distribution
Table 2 liang group case age distribution
Age (year) | 21- | 31- | 41- | 51- | 61- | 71- |
Investigation team | 1 | 3 | 2 | 14 | 4 | 6 |
Matched group | 2 | 5 | 3 | 11 | 5 | 5 |
Table 3 liang group case ill-distribution
The age of case between investigation team and matched group, sex and sick distribution zero difference (P>0.05) of planting can be found out from table 1-3.
2. observation of curative effect
After two groups of case treatments, wound surface growing state is in table 4, and cosmetic effect evaluating method is shown in above-mentioned survey plan.
Table 4 liang group comparitive study
The wound surface growing state of investigation team's case is obviously better than matched group as can be seen from Table 4, and its total effects is 90%, is better than the 70%(P<0.05 of matched group).
3. side effect is observed
Before and after investigation team's case application wound repair gel, blood biochemistry index situation of change is in table 5.
Blood biochemistry index situation of change before and after table 5 investigation team application wound repair gel
Hb | WBC | ALT | AKP | BUN | PLT | |
Before application | 131 | 6.71 | 17 | 22 | 2.5 | 167 |
After application | 123 | 7.34 | 25 | 16 | 2.3 | 179 |
Apply wound repair gel as seen from Table 5 not affect (P>0.05) every blood biochemistry index, and this investigation, also by the observation to the EKG before and after application wound repair gel, confirms that wound repair gel is to heart nonhazardous effect.Have during 3 routine patient (10%) application wound repair gel and have transient local excitation symptom.
Claims (4)
1. produce a feedstock composition for active wound repair material, it is characterized in that: the component of this feedstock composition and the percentage by weight of each component are: analytical reagent natrium carbonicum calcinatum 15-51%, calcium carbonate 14-19%, silicon dioxide 25-57%, calcium fluoride 6-20%, tricalcium phosphate 4-17%, sodium hyaluronate 2-20%, or, analytical reagent natrium carbonicum calcinatum 9-51%, calcium carbonate 5-50%, silicon dioxide 38-58%, tricalcium phosphate 5-22%, sodium hyaluronate 2-20%.
2. adopt the method preparing active wound repair material of feedstock composition according to claim 1, it is characterized in that: (1) with analytical reagent natrium carbonicum calcinatum, calcium carbonate, silicon dioxide, calcium fluoride, tricalcium phosphate for raw material, various raw material dosage is calculated by claim 1 percentage composition, precise, Homogeneous phase mixing; (2) compound is placed in platinum crucible, melts 90min at 1350 DEG C; (3) the hyaloid liquid quenching in deionized water will melted; (4) dry; (5) grind, screening of sieving, bioactivity glass powder processed, gets the powder being less than 50 microns; By get the powder that is less than 50 microns and sodium hyaluronate by weight percentage 5:1 mix.
3. adopt the described method of claim 2 to produce active wound repair material, it is characterized in that: the form of this material is gel or unguentum.
4. adopt the described method of claim 2 to produce active wound repair material, it is characterized in that: the following component containing by weight percentage:
SiO
2 30—60%
Na
2O 10—30%
CaO 10—30%
CaF
2 6—20%
P
2O
5 2—8%
Sodium hyaluronate 2-20%
Or:
SiO
2 40—60%
Na
2O 5—30%
CaO 5—30%
P
2O
5 2—10%
Sodium hyaluronate 2-20%.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105169458A (en) * | 2015-09-25 | 2015-12-23 | 胡方 | Biological activity mineral substance material and application of biological activity mineral substance material to soft tissue anabrosis and long-time erosion wound cell regeneration and melanoma restraining |
CN105709271A (en) * | 2016-03-24 | 2016-06-29 | 广东泰宝医疗科技股份有限公司 | Glass wound repair gel with biological activity and preparation method thereof |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1208338A (en) * | 1996-09-19 | 1999-02-17 | 美国生物材料公司 | Composition and method for acceleration of wound and burn healing |
CN1569246A (en) * | 2004-05-14 | 2005-01-26 | 上海硅健生物材料有限公司 | Application of biological active glass in the preparation process of ulcer and erosion wound treating dressing |
CN1935267A (en) * | 2005-09-22 | 2007-03-28 | 奚珊珊 | Wound surface active repair material |
WO2009013497A1 (en) * | 2007-07-26 | 2009-01-29 | Nova Thera Limited | Sol-gel bioactive glass |
CN101522164A (en) * | 2006-09-13 | 2009-09-02 | 提升肤质产品公司 | Cosmetic composition for the treatment of skin and methods thereof |
-
2014
- 2014-09-24 CN CN201410490158.1A patent/CN104258453A/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1208338A (en) * | 1996-09-19 | 1999-02-17 | 美国生物材料公司 | Composition and method for acceleration of wound and burn healing |
CN1569246A (en) * | 2004-05-14 | 2005-01-26 | 上海硅健生物材料有限公司 | Application of biological active glass in the preparation process of ulcer and erosion wound treating dressing |
CN1935267A (en) * | 2005-09-22 | 2007-03-28 | 奚珊珊 | Wound surface active repair material |
CN101522164A (en) * | 2006-09-13 | 2009-09-02 | 提升肤质产品公司 | Cosmetic composition for the treatment of skin and methods thereof |
WO2009013497A1 (en) * | 2007-07-26 | 2009-01-29 | Nova Thera Limited | Sol-gel bioactive glass |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105169458A (en) * | 2015-09-25 | 2015-12-23 | 胡方 | Biological activity mineral substance material and application of biological activity mineral substance material to soft tissue anabrosis and long-time erosion wound cell regeneration and melanoma restraining |
CN105709271A (en) * | 2016-03-24 | 2016-06-29 | 广东泰宝医疗科技股份有限公司 | Glass wound repair gel with biological activity and preparation method thereof |
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Effective date of registration: 20151207 Address after: 441300 No. 1987 traffic Avenue, Hubei, Suizhou Applicant after: HUBEI SHUANGXING PHARMACEUTICAL CO., LTD. Address before: 441300 No. 1987 traffic road, Suizhou Economic Development Zone, Hubei, China Applicant before: HUBEI HUAZHONG MEDICAL MATERIAL CO., LTD. |
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Application publication date: 20150107 |