CN111265594A - Medicinal preparation for repairing wound and preparation method thereof - Google Patents
Medicinal preparation for repairing wound and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title abstract description 32
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 45
- 206010052428 Wound Diseases 0.000 claims abstract description 30
- 208000027418 Wounds and injury Diseases 0.000 claims abstract description 30
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- RQFQJYYMBWVMQG-IXDPLRRUSA-N chitotriose Chemical compound O[C@@H]1[C@@H](N)[C@H](O)O[C@H](CO)[C@H]1O[C@H]1[C@H](N)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)N)[C@@H](CO)O1 RQFQJYYMBWVMQG-IXDPLRRUSA-N 0.000 claims abstract description 24
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 23
- 239000012153 distilled water Substances 0.000 claims abstract description 20
- 229920001661 Chitosan Polymers 0.000 claims abstract description 18
- 239000000126 substance Substances 0.000 claims abstract description 17
- 238000001914 filtration Methods 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 12
- 238000001816 cooling Methods 0.000 claims abstract description 12
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 12
- 240000007695 Nandina domestica Species 0.000 claims abstract description 8
- 239000000706 filtrate Substances 0.000 claims abstract description 6
- 238000010438 heat treatment Methods 0.000 claims abstract description 6
- 238000010992 reflux Methods 0.000 claims abstract description 6
- 238000006243 chemical reaction Methods 0.000 claims abstract description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 15
- 102000004190 Enzymes Human genes 0.000 claims description 14
- 108090000790 Enzymes Proteins 0.000 claims description 14
- 229940088598 enzyme Drugs 0.000 claims description 14
- 241000922974 Callicarpa bodinieri Species 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 8
- 239000004365 Protease Substances 0.000 claims description 6
- 241000288015 Bambusicola <bird> Species 0.000 claims description 3
- 108090000526 Papain Proteins 0.000 claims description 3
- 108091005804 Peptidases Proteins 0.000 claims description 3
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- 230000003301 hydrolyzing effect Effects 0.000 claims description 3
- 230000000415 inactivating effect Effects 0.000 claims description 3
- 229940055729 papain Drugs 0.000 claims description 3
- 235000019834 papain Nutrition 0.000 claims description 3
- 239000008194 pharmaceutical composition Substances 0.000 claims description 3
- 235000019419 proteases Nutrition 0.000 claims description 3
- 239000006228 supernatant Substances 0.000 claims description 3
- 235000017166 Bambusa arundinacea Nutrition 0.000 claims description 2
- 235000017491 Bambusa tulda Nutrition 0.000 claims description 2
- 241001330002 Bambuseae Species 0.000 claims description 2
- 241000133556 Nandina Species 0.000 claims description 2
- 235000015334 Phyllostachys viridis Nutrition 0.000 claims description 2
- 239000011425 bamboo Substances 0.000 claims description 2
- 239000006188 syrup Substances 0.000 claims description 2
- 235000020357 syrup Nutrition 0.000 claims description 2
- 230000037314 wound repair Effects 0.000 abstract description 12
- 230000000694 effects Effects 0.000 abstract description 11
- 230000007794 irritation Effects 0.000 abstract description 5
- 231100000252 nontoxic Toxicity 0.000 abstract description 5
- 230000003000 nontoxic effect Effects 0.000 abstract description 5
- 230000008901 benefit Effects 0.000 abstract description 4
- 241000404844 Callicarpa nudiflora Species 0.000 abstract description 3
- 239000002994 raw material Substances 0.000 abstract description 3
- 235000014220 Rhus chinensis Nutrition 0.000 abstract 1
- 240000003152 Rhus chinensis Species 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 11
- 239000003814 drug Substances 0.000 description 6
- 241001465754 Metazoa Species 0.000 description 5
- 230000029663 wound healing Effects 0.000 description 5
- 239000000047 product Substances 0.000 description 4
- 241000699670 Mus sp. Species 0.000 description 3
- 238000010171 animal model Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 229940057847 polyethylene glycol 600 Drugs 0.000 description 3
- 231100000403 acute toxicity Toxicity 0.000 description 2
- 230000007059 acute toxicity Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 231100000086 high toxicity Toxicity 0.000 description 2
- 238000004895 liquid chromatography mass spectrometry Methods 0.000 description 2
- 230000001766 physiological effect Effects 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 230000035807 sensation Effects 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000209128 Bambusa Species 0.000 description 1
- 241001073507 Callicarpa Species 0.000 description 1
- 229920002101 Chitin Polymers 0.000 description 1
- 241000168525 Haematococcus Species 0.000 description 1
- 238000012449 Kunming mouse Methods 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000006196 deacetylation Effects 0.000 description 1
- 238000003381 deacetylation reaction Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000000419 plant extract Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
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- 238000006467 substitution reaction Methods 0.000 description 1
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- 230000008733 trauma Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/85—Verbenaceae (Verbena family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention discloses a medicinal preparation for repairing wounds and a preparation method thereof, wherein the medicinal preparation comprises the following components: chitosan oligosaccharide, folium Callicarpae Formosanae, Galla chinensis, Nandina Domestica, glycerol, polyethylene glycol and distilled water; the preparation method comprises the following steps: adding Callicarpa nudiflora, Chinese gall, Nanzhu and ethanol into a reaction bottle in sequence, stirring uniformly, heating and refluxing, extracting filtrate, concentrating under reduced pressure, cooling, standing, filtering to remove insoluble substances, concentrating to dryness, adding distilled water for dissolving, cooling, standing, filtering to remove insoluble substances, adding chitosan, glycerol and polyethylene glycol with molecular weight of 600 in sequence, stirring to fully dissolve, adding distilled water for fixing volume, and obtaining the pharmaceutical preparation for repairing wounds. The medicinal preparation is non-toxic, has an obvious wound repair effect and small irritation, and has a great clinical application value and social benefits when being used for repairing wounds; the preparation raw materials of the pharmaceutical preparation are easy to obtain, the preparation method is simple, and industrialization is convenient to realize.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a medicinal preparation for repairing wounds and a preparation method thereof.
Background
Most of traditional wound repair medicinal preparations have the problems of high toxicity, high irritation, obvious foreign body sensation of high polymer materials, poor effect and the like. The chitosan is a secondary product obtained by biologically degrading chitin or other methods, has certain physiological activity, such as wound repair, bacteriostasis and the like, but has poor water solubility and low repair effect after acting on the wound. The chitosan oligosaccharide is a derivative of chitosan degraded under specific conditions, has the advantages of unique spatial configuration, high water solubility, stable chemical structure, strong physiological activity and the like, but has no obvious effect when being applied to wound repair alone. Researches show that the chitosan oligosaccharide and the natural plant extract are combined according to certain conditions and proportion to form a stable combination to prepare the wound repair preparation, and the problems of high toxicity, high irritation, obvious foreign body sensation of high polymer materials, poor effect and the like of the traditional wound repair medicinal preparation can be solved.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a non-toxic, high-efficiency and low-irritation pharmaceutical preparation for repairing wounds and a preparation method thereof.
In order to achieve the purpose, the invention provides the following technical scheme:
in a first aspect of the invention, a pharmaceutical preparation for repairing a wound is provided, which comprises the following components in parts by weight: 1-10 parts of chitosan oligosaccharide, 1-5 parts of callicarpa bodinieri, 1-5 parts of gallnut, 1-5 parts of Nandina bambusicola, 1-5 parts of glycerol, 1-5 parts of polyethylene glycol with the molecular weight of 600 and 65-94 parts of distilled water.
The optimal weight fraction ratio of the pharmaceutical preparation is as follows: 5 parts of chitosan oligosaccharide, 2 parts of callicarpa bodinieri, 2 parts of gallnut, 2 parts of nandina domestica, 2 parts of glycerol, 2 parts of polyethylene glycol with the molecular weight of 600 and 85 parts of distilled water.
The callicarpa bodinieri has the main effects of resisting bacteria and stopping bleeding, the gallnut has the main effects of stopping bleeding and detoxifying, and the Nanzhu has the main effects of clearing heat and removing dampness.
Preferably, the average molecular weight of the chitosan oligosaccharide is 650-1900, and the chitosan oligosaccharide with the molecular weight section has high water solubility, is easy to prepare into solution, has better biological activity and better clinical use effect.
In a second aspect of the invention, there is provided a process for the preparation of a pharmaceutical formulation for use in the repair of wounds: adding callicarpa bodinieri, gallnut, southern bamboo and ethanol into a reaction bottle in sequence, stirring uniformly, heating and refluxing for 1-3 times, each time for 0.5-3 hours, extracting filtrate, concentrating under reduced pressure to obtain syrup, cooling to 0-10 ℃, standing for 0.5-48 hours, filtering to remove insoluble substances, concentrating to dryness, adding distilled water for dissolving, cooling to 0-10 ℃, standing for 12-72 hours, filtering to remove insoluble substances, then adding chitosan, glycerol and polyethylene glycol with the molecular weight of 600 in sequence, stirring to fully dissolve the chitosan, glycerol and polyethylene glycol with the molecular weight of 600, and adding a proper amount of distilled water for constant volume to obtain the medicinal preparation for repairing wounds.
Wherein the preparation method of the chitosan oligosaccharide comprises the following steps: dissolving chitosan in acetic acid, stirring for dissolving, adding mixed enzyme with enzyme content of 52u, hydrolyzing at 45 ℃ for 30 minutes, inactivating enzyme at 110 ℃ for 15 minutes, centrifuging to obtain supernatant, and freeze-drying to obtain chitosan oligosaccharide, wherein the chitosan (unit: g): acetic acid (unit: ml): the amount of the mixed enzyme (unit: ml) is 1: 35-40: 0.9-1.1.
Preferably, the mixed enzyme consists of 45 wt% of malic protease and 55 wt% of papain, and the mixed enzyme with the proportion can improve the enzyme degradation efficiency and the yield of the chitosan oligosaccharide, and more importantly, has great influence on the molecular weight range of the produced chitosan oligosaccharide.
Compared with the prior art, the invention has the beneficial effects that: the medicinal preparation is non-toxic, has an obvious wound repair effect and small irritation, can be used for preparing a wound repair medicament, and has a relatively high clinical application value and social benefits when used for repairing a wound; in addition, the preparation raw materials of the pharmaceutical preparation are easy to obtain, the preparation method is simple, and the industrialization is convenient to realize.
Detailed Description
The following describes embodiments of the present invention in detail.
Example 1
Dissolving chitosan 20g with acetic acid 800ml, with chitosan concentration of 0.025g/ml, adding mixed enzyme composed of malic protease and papain 20ml for hydrolysis, hydrolyzing at 45 deg.C for 30 mm, inactivating enzyme at 110 deg.C for 15min, centrifuging to obtain supernatant, and freeze drying to obtain chitosan oligosaccharide 18.52 g. LC-MS test proves that the chitosan oligosaccharide is chitosan oligosaccharide, the average molecular weight is 1260, and the purity is more than or equal to 99%.
The chitosan is purchased from ocean engineering Limited of sea Shell of Haematococcus of Jinan, the deacetylation degree is 95%, the water content is 4.6%, the ash content is 0.5%, and the viscosity-average molecular weight is 10 ten thousand.
The LC-MS test result of the chitosan oligosaccharide obtained in the embodiment is as follows: the average molecular weight is 1260, and the purity is more than or equal to 99%.
Example 2
A pharmaceutical preparation for repairing wounds comprises the following components by weight: 5g of chitosan oligosaccharide, 2g of callicarpa bodinieri, 2g of gallnut, 2g of nandina domestica, 2g of glycerol, 2g of polyethylene glycol with the molecular weight of 600 and 85mL of distilled water; wherein the oligochitosan was prepared as in example 1.
The preparation method of the medicinal preparation for repairing the wound comprises the following steps: adding 2g of Callicarpa nudiflora, 2g of Galla chinensis and 2g of Nandina domestica into a 1000ml flask, mixing with 500ml of 80% ethanol, stirring thoroughly to mix them uniformly, heating and refluxing for 3 hours, filtering off insoluble substances, and concentrating under reduced pressure to 100 ml. Cooling the concentrated solution to 1 ℃, standing for 24 hours, filtering to remove insoluble substances, concentrating the filtrate to dryness, adding 50ml of distilled water for dissolving, cooling to 1 ℃, standing for 48 hours, filtering to remove the insoluble substances, adding 5g of chitosan oligosaccharide, 2g of glycerol and 2g of polyethylene glycol 600, stirring to fully dissolve, adding distilled water to reach a constant volume of 100ml, and obtaining the pharmaceutical preparation.
Example 3
A pharmaceutical preparation for repairing wounds comprises the following components by weight: 5g of chitosan oligosaccharide, 1g of callicarpa bodinieri, 3g of gallnut, 2g of bambusa bambusicola, 4g of glycerol, 3g of polyethylene glycol with the molecular weight of 600 and 82mL of distilled water; wherein the oligochitosan was prepared as in example 1.
The preparation method of the medicinal preparation for repairing the wound comprises the following steps: adding 1g of Callicarpa Formosanae, 3g of Galla chinensis, and 2g of Nandina Domestica into a 1000ml flask, mixing with 500ml of 80% ethanol, stirring thoroughly to mix well, heating and refluxing for 3 hr, filtering off insoluble substances, and concentrating under reduced pressure to 100 ml. Cooling the concentrated solution to 1 ℃, standing for 24 hours, filtering to remove insoluble substances, concentrating the filtrate to dryness, adding 50ml of distilled water for dissolving, cooling to 1 ℃, standing for 48 hours, filtering to remove the insoluble substances, adding 5g of chitosan oligosaccharide, 4g of glycerol and 3g of polyethylene glycol 600, stirring to fully dissolve, adding distilled water to reach a constant volume of 100ml, and obtaining the pharmaceutical preparation.
Example 4
A pharmaceutical preparation for repairing wounds comprises the following components by weight: 7g of chitosan oligosaccharide, 4g of callicarpa bodinieri, 1g of gallnut, 2g of nandina domestica, 4g of glycerol, 1g of polyethylene glycol with the molecular weight of 600 and 81mL of distilled water; wherein the oligochitosan was prepared as in example 1.
The preparation method of the medicinal preparation for repairing the wound comprises the following steps: adding 4g Callicarpa nudiflora, 1g Galla chinensis, and 2g Nandina domestica into 1000ml flask, mixing with 500ml 80% ethanol, stirring, heating under reflux for 3 hr, filtering to remove insoluble substances, and concentrating under reduced pressure to 100 ml. Cooling the concentrated solution to 1 ℃, standing for 24 hours, filtering to remove insoluble substances, concentrating the filtrate to dryness, adding 50ml of distilled water for dissolving, cooling to 1 ℃, standing for 48 hours, filtering to remove the insoluble substances, adding 7g of chitosan oligosaccharide, 4g of glycerol and 1g of polyethylene glycol 600, stirring to fully dissolve, adding distilled water to reach a constant volume of 100ml, and obtaining the pharmaceutical preparation.
Example 5
Acute toxicity test was performed on the pharmaceutical preparation for wound repair prepared in example 2.
Experimental animals: 70 Kunming mice weighing 17-22 g and half male and female were purchased from Shanghai Si Laike laboratory animals Co.
Animal grouping: the method adopts a respectively-male and female random equilibrium grouping method, and the groups are divided into 7 groups, each group contains 10 animals, and one group is a blank control group.
Experimental samples: prepared as in example 2.
And (3) dose determination: the dosage is designed to be 3ml/kg, 10ml/kg, 50ml/kg, 100 ml/kg.
Administration: disposable administration by intragastric administration: fasting is carried out for 3-5 h before administration, and fasting is carried out for 1-2 h after administration, and water is not forbidden. Batch administration is adopted, the first batch administration of the control group, the 3ml/kg group and the 10ml/kg group is carried out, after the administration, the set dosage is determined to be appropriate, and then the 50ml/kg group and the 100ml/kg group are administered. The observation was continued for 7 or more days after the administration, followed by 14 days each day in the morning and afternoon. The various observations were recorded in detail and are shown in table 1.
The experimental results are as follows:
TABLE 1
| Group of | Dosage (ml/kg) | Quantity (only) | Survival rate (%) |
| 1 | 0 | 10 | 100 |
| 2 | 3 | 10 | 100 |
| 3 | 10 | 10 | 100 |
| 4 | 50 | 10 | 100 |
| 5 | 100 | 10 | 100 |
And (4) conclusion: no mortality occurred in the test when the test substance was administered at a dose of 100ml/kg by gavage (equivalent to 5.5mg/kg of solid drug). The tested medicine can be regarded as non-toxic according to the judgment of acute toxicity grading standard.
Example 6
The pharmaceutical preparation for wound repair prepared in example 2 was subjected to a wound repair test.
Test animals: c57 mice, 16-18g, male, purchased from Shanghai Spiker laboratory animals, Inc.
The test method comprises the following steps: the test mice were divided into blank groups, control group 1(3M medical tape), control group 2 (easy care in germany), control group 3 (jieyoushen), experimental group (prepared in example 2), and 20 mice per group. Removing hair on the back of the mouse, making a cut, disinfecting the wound surface by iodophor, debriding by using a proper amount of normal saline, and covering the product of a control group 1 and the product of a control group 2 on the surface; spraying the control group 3 product and the experimental group medicine, naturally drying, and finally covering with sterile gauze. Controls were performed for 3 days, 7 days and 14 days of wound recovery, respectively. The results are shown in Table 2.
The experimental results are as follows:
TABLE 2
And (4) conclusion: the experimental animal has fast wound healing speed, no obvious scar after wound healing, and various data are greatly superior to those of a control group and a blank group.
Example 7
The pharmaceutical preparation for wound repair prepared in example 2 was subjected to clinical trials.
The test method comprises the following steps: 40 volunteer patients were selected and divided into 4 groups, namely a test group (prepared in example 2), a control group 1(3M medical tape), a control group 2 (Germany Yiritu) and a control group 3 (Jie you Shen), and the trauma properties, types and sizes of the patients in each group were basically similar. After the wound is debrided, test and control drugs are covered or sprayed on the surface of the wound, the wound is naturally dried, and finally sterile gauze is used for covering. Controls were performed for 3 days, 5 days and 7 days of wound recovery, respectively. The results are shown in Table 3.
And (3) test results:
TABLE 3
And (4) test conclusion: the experimental group has high wound healing speed, and is greatly superior to each control group.
In conclusion, the pharmaceutical preparation of the present invention is subjected to acute toxicity experiments, animal experiments and clinical experiments in examples 5, 6 and 7, and experimental results prove that the pharmaceutical preparation of the present invention is non-toxic, has significant wound healing effect and small irritation, can be used for preparing wound healing drugs, and has great clinical application value and social benefit for healing wounds; in addition, the preparation raw materials of the pharmaceutical preparation are easy to obtain, the preparation method is simple, and the industrialization is convenient to realize.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (6)
1. The pharmaceutical preparation for repairing the wound is characterized by comprising the following components in parts by weight: 1-10 parts of chitosan oligosaccharide, 1-5 parts of callicarpa bodinieri, 1-5 parts of gallnut, 1-5 parts of Nandina bambusicola, 1-5 parts of glycerol, 1-5 parts of polyethylene glycol with the molecular weight of 600 and 65-94 parts of distilled water.
2. The pharmaceutical formulation for repairing a wound of claim 1, wherein the pharmaceutical formulation comprises the following components in parts by weight: 5 parts of chitosan oligosaccharide, 2 parts of callicarpa bodinieri, 2 parts of gallnut, 2 parts of nandina domestica, 2 parts of glycerol, 2 parts of polyethylene glycol with the molecular weight of 600 and 85 parts of distilled water.
3. A pharmaceutical preparation for use in repairing a wound according to claim 1 or 2, wherein the oligochitosan has an average molecular weight of 650 to 1900.
4. The method for preparing the pharmaceutical preparation for repairing wounds according to claim 1 is characterized by sequentially adding callicarpa bodinieri, gallnut, south bamboo and ethanol into a reaction bottle, uniformly stirring, heating and refluxing for 1-3 times for 0.5-3 hours each time, extracting filtrate, concentrating under reduced pressure to syrup shape, cooling to 0-10 ℃, standing for 0.5-48 hours, filtering to remove insoluble substances, concentrating to dryness, adding distilled water for dissolving, cooling to 0-10 ℃, standing for 12-72 hours, filtering to remove the insoluble substances, sequentially adding chitosan, glycerol and polyethylene glycol with the molecular weight of 600, stirring to fully dissolve, adding a proper amount of distilled water for constant volume, and obtaining the pharmaceutical preparation for repairing wounds.
5. The method of preparing a pharmaceutical preparation for repairing a wound of claim 4, wherein the oligo-chitosan is prepared by the following method: dissolving chitosan in acetic acid, stirring for dissolving, adding mixed enzyme with enzyme content of 52u, hydrolyzing at 45 ℃ for 30 minutes, inactivating enzyme at 110 ℃ for 15 minutes, centrifuging to obtain supernatant, and freeze-drying to obtain the chitosan oligosaccharide, wherein the chitosan (unit: g): acetic acid (unit: ml): the amount of the mixed enzyme (unit: ml) is 1: 35-40: 0.9-1.1.
6. The method of claim 5, wherein the mixed enzyme is composed of 45 wt% of malic protease and 55 wt% of papain.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114796362A (en) * | 2022-05-13 | 2022-07-29 | 深圳市容宜生物工程有限公司 | Biological preparation for rust scratch repair cells |
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| CN102961479A (en) * | 2012-12-14 | 2013-03-13 | 重庆市科学技术研究院 | Plastics for promoting healing of skin wound and preparation method of plastics |
| CN104013639A (en) * | 2014-06-20 | 2014-09-03 | 天津嘉氏堂科技有限公司 | Composition with function of repairing skin and gel agent thereof |
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