CN107281261B - Easy-to-absorb oral ulcer patch and preparation method thereof - Google Patents
Easy-to-absorb oral ulcer patch and preparation method thereof Download PDFInfo
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- CN107281261B CN107281261B CN201710490178.2A CN201710490178A CN107281261B CN 107281261 B CN107281261 B CN 107281261B CN 201710490178 A CN201710490178 A CN 201710490178A CN 107281261 B CN107281261 B CN 107281261B
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- 208000007117 Oral Ulcer Diseases 0.000 title claims abstract description 44
- 208000002399 aphthous stomatitis Diseases 0.000 title claims abstract description 44
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 239000004530 micro-emulsion Substances 0.000 claims abstract description 53
- 239000004480 active ingredient Substances 0.000 claims abstract description 47
- 239000003242 anti bacterial agent Substances 0.000 claims abstract description 31
- 239000011248 coating agent Substances 0.000 claims abstract description 26
- 241000241413 Propolis Species 0.000 claims abstract description 21
- 229940069949 propolis Drugs 0.000 claims abstract description 21
- 239000000314 lubricant Substances 0.000 claims abstract description 18
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 17
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 17
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 17
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 15
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 claims abstract description 8
- 229940116229 borneol Drugs 0.000 claims abstract description 8
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 claims abstract description 8
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000284 extract Substances 0.000 claims description 59
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 52
- 239000003814 drug Substances 0.000 claims description 46
- 239000002245 particle Substances 0.000 claims description 37
- 229920001610 polycaprolactone Polymers 0.000 claims description 32
- 239000004632 polycaprolactone Substances 0.000 claims description 32
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 24
- 239000004094 surface-active agent Substances 0.000 claims description 23
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 21
- 238000003756 stirring Methods 0.000 claims description 21
- JAHNSTQSQJOJLO-UHFFFAOYSA-N 2-(3-fluorophenyl)-1h-imidazole Chemical compound FC1=CC=CC(C=2NC=CN=2)=C1 JAHNSTQSQJOJLO-UHFFFAOYSA-N 0.000 claims description 20
- LVHBHZANLOWSRM-UHFFFAOYSA-N methylenebutanedioic acid Natural products OC(=O)CC(=C)C(O)=O LVHBHZANLOWSRM-UHFFFAOYSA-N 0.000 claims description 20
- 229940126673 western medicines Drugs 0.000 claims description 20
- WIYVVIUBKNTNKG-UHFFFAOYSA-N 6,7-dimethoxy-3,4-dihydronaphthalene-2-carboxylic acid Chemical compound C1CC(C(O)=O)=CC2=C1C=C(OC)C(OC)=C2 WIYVVIUBKNTNKG-UHFFFAOYSA-N 0.000 claims description 19
- 239000003921 oil Substances 0.000 claims description 18
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims description 15
- 229920000428 triblock copolymer Polymers 0.000 claims description 15
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims description 14
- 239000007795 chemical reaction product Substances 0.000 claims description 14
- 239000012299 nitrogen atmosphere Substances 0.000 claims description 14
- GVGUFUZHNYFZLC-UHFFFAOYSA-N dodecyl benzenesulfonate;sodium Chemical group [Na].CCCCCCCCCCCCOS(=O)(=O)C1=CC=CC=C1 GVGUFUZHNYFZLC-UHFFFAOYSA-N 0.000 claims description 11
- 229940080264 sodium dodecylbenzenesulfonate Drugs 0.000 claims description 11
- 239000008187 granular material Substances 0.000 claims description 9
- 238000006116 polymerization reaction Methods 0.000 claims description 9
- 229940111630 tea tree oil Drugs 0.000 claims description 9
- 239000010677 tea tree oil Substances 0.000 claims description 9
- BTBJBAZGXNKLQC-UHFFFAOYSA-N ammonium lauryl sulfate Chemical compound [NH4+].CCCCCCCCCCCCOS([O-])(=O)=O BTBJBAZGXNKLQC-UHFFFAOYSA-N 0.000 claims description 8
- 238000000576 coating method Methods 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 8
- YOCIJWAHRAJQFT-UHFFFAOYSA-N 2-bromo-2-methylpropanoyl bromide Chemical compound CC(C)(Br)C(Br)=O YOCIJWAHRAJQFT-UHFFFAOYSA-N 0.000 claims description 7
- 229910021589 Copper(I) bromide Inorganic materials 0.000 claims description 7
- NKNDPYCGAZPOFS-UHFFFAOYSA-M copper(i) bromide Chemical compound Br[Cu] NKNDPYCGAZPOFS-UHFFFAOYSA-M 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 7
- 238000001914 filtration Methods 0.000 claims description 7
- 230000001376 precipitating effect Effects 0.000 claims description 7
- 238000001556 precipitation Methods 0.000 claims description 7
- 239000000047 product Substances 0.000 claims description 7
- 238000009736 wetting Methods 0.000 claims description 7
- 229930182816 L-glutamine Natural products 0.000 claims description 6
- 241000628997 Flos Species 0.000 claims description 5
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 claims description 5
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 4
- IDBYLPRJLWSMAI-UHFFFAOYSA-M sodium;1,2,3,3a,4,5,6,7,8,8a-decahydroazulene-1-sulfonate Chemical compound [Na+].C1CCCCC2C(S(=O)(=O)[O-])CCC21 IDBYLPRJLWSMAI-UHFFFAOYSA-M 0.000 claims description 4
- 235000003143 Panax notoginseng Nutrition 0.000 claims description 3
- 241000180649 Panax notoginseng Species 0.000 claims description 3
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 235000021355 Stearic acid Nutrition 0.000 claims description 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 3
- -1 polypropylene Polymers 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 239000011347 resin Substances 0.000 claims description 3
- 229920005989 resin Polymers 0.000 claims description 3
- 239000008117 stearic acid Substances 0.000 claims description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- 238000009413 insulation Methods 0.000 claims description 2
- 235000019359 magnesium stearate Nutrition 0.000 claims description 2
- 239000000454 talc Substances 0.000 claims description 2
- 229910052623 talc Inorganic materials 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000741 silica gel Substances 0.000 claims 1
- 229910002027 silica gel Inorganic materials 0.000 claims 1
- 230000000844 anti-bacterial effect Effects 0.000 abstract description 14
- 208000025865 Ulcer Diseases 0.000 abstract description 8
- 210000002200 mouth mucosa Anatomy 0.000 abstract description 8
- 239000004615 ingredient Substances 0.000 abstract description 7
- 231100000397 ulcer Toxicity 0.000 abstract description 7
- 230000006378 damage Effects 0.000 abstract description 6
- 230000004044 response Effects 0.000 abstract description 3
- 229940127554 medical product Drugs 0.000 abstract description 2
- 239000000126 substance Substances 0.000 description 8
- 229940063953 ammonium lauryl sulfate Drugs 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
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- 208000002193 Pain Diseases 0.000 description 6
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- 239000000203 mixture Substances 0.000 description 5
- 238000012719 thermal polymerization Methods 0.000 description 5
- 208000027418 Wounds and injury Diseases 0.000 description 4
- 239000012790 adhesive layer Substances 0.000 description 4
- 239000003899 bactericide agent Substances 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 206010052428 Wound Diseases 0.000 description 3
- 239000013543 active substance Substances 0.000 description 3
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- 239000000463 material Substances 0.000 description 3
- 230000007935 neutral effect Effects 0.000 description 3
- 210000004927 skin cell Anatomy 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 239000004599 antimicrobial Substances 0.000 description 2
- 208000020670 canker sore Diseases 0.000 description 2
- 210000005260 human cell Anatomy 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000012466 permeate Substances 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- 229910002012 Aerosil® Inorganic materials 0.000 description 1
- 241000205585 Aquilegia canadensis Species 0.000 description 1
- 208000003322 Coinfection Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 125000003338 L-glutaminyl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])C([H])([H])C(=O)N([H])[H] 0.000 description 1
- 239000009277 Panax notoginseng extract Substances 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 240000005373 Panax quinquefolius Species 0.000 description 1
- 241000207929 Scutellaria Species 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
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- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
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- 238000013329 compounding Methods 0.000 description 1
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- 230000003467 diminishing effect Effects 0.000 description 1
- 229940002508 ginger extract Drugs 0.000 description 1
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- 230000035876 healing Effects 0.000 description 1
- 229920002674 hyaluronan Polymers 0.000 description 1
- 229960003160 hyaluronic acid Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 229940105902 mint extract Drugs 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
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- 230000001737 promoting effect Effects 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 150000003242 quaternary ammonium salts Chemical group 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/765—Polymers containing oxygen
- A61K31/78—Polymers containing oxygen of acrylic acid or derivatives thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K9/7007—Drug-containing films, membranes or sheets
Abstract
The invention relates to the field of medical products, and provides an easily-absorbed dental ulcer patch and a preparation method thereof. The dental ulcer patch comprises the following components in parts by weight: 20-30 parts of active ingredient microemulsion, 30-40 parts of propolis, 10-20 parts of borneol, 1-5 parts of antibacterial agent, 4-6 parts of lubricant, 5-10 parts of sodium carboxymethylcellulose and 2-6 parts of coating agent. 0-10 parts of pH regulator. The oral ulcer patch contains active ingredient microemulsion which contains medicinal ingredients, and the medicinal ingredients are easy to be absorbed by oral mucosa, so that the oral ulcer patch has quick response. In addition, the invention contains the antibacterial agent with high antibacterial activity and good mildness, and can not cause excessive damage to cells.
Description
Technical Field
The invention relates to the field of medical products, in particular to an easily-absorbed dental ulcer patch and a preparation method thereof.
Background
The oral ulcer is caused by ulcerative injury of oral mucosa, the pain is severe when the oral ulcer is attacked, the local burning pain is obvious, severe patients can influence diet and speaking, and the daily life is greatly influenced. Various types of oral patches are currently commercially available.
The patent CN200410060586.7 discloses an oral ulcer patch, which consists of two layers of a medicine-containing adhesive layer and a waterproof protective layer, wherein the medicine-containing adhesive layer is formed by mixing and directly tabletting effective medicines with an adhesive material, and the weight part ratio of the effective raw materials in the medicine-containing adhesive layer is 0.5-10: 0.05-2; the ratio of the total amount of the raw material medicaments to the total amount of the adhesive is 1: 2-8; the patch is convenient to apply, can quickly treat and reduce pain, is combined with a plurality of medicines, has complementary effects, treats oral mucosa ulcer, and has the effects of sterilizing, diminishing inflammation, relieving pain and promoting healing; the drug-containing adhesive layer can be adhered to the wound surface of the dental ulcer for 2-4 hours, so that the drugs in the preparation are uniformly released, the therapeutic effect can be achieved, and the wound surface can be protected.
However, the canker sore patches of the above patents also have certain disadvantages, and the pharmaceutical active ingredients cannot be sufficiently absorbed by oral mucosa after the patches are attached, so that the effect is slow.
Disclosure of Invention
In order to solve the technical problems, the invention provides an easy-to-absorb oral ulcer patch and a preparation method thereof. The oral ulcer patch contains active ingredient microemulsion which contains medicinal ingredients, and the medicinal ingredients are easy to be absorbed by oral mucosa, so that the oral ulcer patch has quick response. In addition, the invention contains the antibacterial agent with high antibacterial activity and good mildness, and can not cause excessive damage to cells.
In order to achieve the purpose, the invention provides an easy-to-absorb dental ulcer patch which comprises the following components in parts by weight:
20-30 parts of active ingredient microemulsion particles,
30-40 parts of propolis, namely,
10-20 parts of borneol,
1-5 parts of an antibacterial agent,
4-6 parts of a lubricating agent,
5-10 parts of sodium carboxymethyl cellulose,
2-6 parts of a coating agent,
0-10 parts of pH regulator.
The formula of the invention contains active ingredient microemulsion particles coated with traditional Chinese medicine and western medicine ingredients, and compared with the traditional method of directly adding medicines in the formula, the formula has the advantages of rapid oral mucosa absorption and better effect. The Borneolum has effects of clearing away heat and toxic materials, and relieving swelling and pain. Propolis is used as main carrier material and has good adhesion to oral mucosa. Meanwhile, the formula of the invention also contains an antibacterial agent, which can sterilize ulcer parts and prevent secondary infection of wounds.
Preferably, the active ingredient microemulsion is an aqueous-in-oil-in-aqueous microemulsion containing traditional Chinese medicine extracts for treating the oral ulcer and western medicines for treating the oral ulcer.
Preferably, the Chinese medicinal extract is at least one selected from mint extract, scutellaria extract, honeysuckle extract, panax notoginseng extract and panax quinquefolius extract.
Preferably, the western medicines are at least one of L-glutamine and sodium azulene sulfonate.
The traditional Chinese medicine and the western medicine are selected for compounding, the western medicine takes effect quickly, can relieve pain and relieve swelling quickly, the traditional Chinese medicine can be cured radically, and the traditional Chinese medicine and the western medicine are matched with each other, so that the effect is better.
Preferably, the preparation method of the active ingredient microemulsion comprises the following steps:
dissolving the Chinese medicinal extract and western medicines in water, adding surfactant, and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicine and surfactant, and stirring to obtain water-in-oil granule; and finally adding the water-in-oil particles into water containing traditional Chinese medicine extracts, western medicines and surfactants, fully stirring and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The active ingredient microemulsion particle prepared by the method has a three-layer coating structure of water phase-oil phase and water phase-water phase, and each layer of water/oil phase contains active substances (ginger extract, hyaluronic acid), so that the active ingredient microemulsion particle has the advantages that a plurality of hydrophilic substances (cell sap, cytoplasm and the like) and lipophilic substances (cell membranes and the like) are contained in skin cells, when the active ingredient microemulsion particle is used, the active ingredient microemulsion particle can permeate into the skin cells layer by layer, and when the active ingredient microemulsion particle meets the hydrophilic substances, the water phase layer substances are dissolved in the hydrophilic substances, so that the active substances are released; when encountering lipophilic substances, the oil phase layer substances thereof dissolve therein, also releasing the active substances. Therefore, it can sufficiently and rapidly permeate into skin cells, promote absorption and take effect. In addition, the tea tree oil is selected as the oil phase material, and the tea tree oil also has good antioxidant and antibacterial effects.
Preferably, the surfactant is sodium dodecylbenzene sulfonate or ammonium lauryl sulfate.
Preferably, the lubricant is selected from at least one of stearic acid, magnesium stearate, aerosil or talc; the coating agent is medical polypropylene resin.
Preferably, the antimicrobial agent is a triblock copolymer of hydroxyl-terminated polycaprolactone, itaconic acid, and 2- (dimethylamino) ethyl methacrylate.
Preferably, the preparation method of the triblock copolymer of polycaprolactone containing hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate comprises the following steps:
dissolving 8-10 parts by weight of polycaprolactone containing hydroxyl at a terminal group in chloroform, dropwise adding 0.2-0.4 part by weight of bromoisobutyryl bromide under the condition of nitrogen atmosphere and 0-5 ℃, reacting for 16-20h, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.2-0.4 part by weight of cuprous bromide, adding 8-12 parts by weight of itaconic acid in nitrogen atmosphere, carrying out polymerization reaction at 75-85 ℃ for 8-12h, then adding 10-15 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal insulation polymerization reaction for 4-6h, and precipitating and filtering a reaction product to obtain the triblock copolymer.
When the oral ulcer part is infected by bacteria, the infected cells secrete acid substances such as lactic acid and the like, so that the infected part of the oral ulcer part is weakly acidic. When the canker sore is not infected or the infected site heals, it returns to its original neutral state. According to this characteristic, the present inventors have produced the above-mentioned antibacterial agent. The antibacterial agent is obtained by copolymerizing three monomers (polycaprolactone with hydroxyl at the terminal group, itaconic acid and 2- (dimethylamino) ethyl methacrylate), wherein the 2- (dimethylamino) ethyl methacrylate has antibacterial property due to the quaternary ammonium salt functional group. The above copolymer had the following characteristics: under a weak acid environment, the chain segment of the itaconic acid is neutral, the polycaprolactone and 2- (dimethylamino) ethyl methacrylate) chain segments at the two ends of the itaconic acid are stretched, the whole copolymer is positive, and at the moment, the copolymer has antibacterial property. In a neutral environment, the middle chain segment of the itaconic acid is negatively charged, and the polycaprolactone and 2- (dimethylamino) ethyl methacrylate) chain segments at the two ends of the itaconic acid are positively charged, so that the antibacterial property is greatly reduced under the electrostatic action. Compared with other traditional antibacterial agents, the antibacterial agent of the invention can show better antibacterial property only after the oral ulcer part is infected with weak acidity, and has no antibacterial property for the part which is not infected or is cleaned from infection. Because the antibacterial agent can also cause damage to human cells while resisting bacteria, the antibacterial agent of the invention can rapidly avoid antibacterial action after bacteria are killed, and can not cause excessive damage to human cells.
Preferably, the antimicrobial agent is a nano-sized particle.
A preparation method of an absorbable oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7-8, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
The invention has the following beneficial effects: the oral ulcer patch contains active ingredient microemulsion which contains medicinal ingredients, and the medicinal ingredients are easy to be absorbed by oral mucosa, so that the oral ulcer patch has quick response. In addition, the invention contains the antibacterial agent with high antibacterial activity and good mildness, and can not cause excessive damage to cells.
Detailed Description
The following is a detailed description of embodiments of the invention, but the invention can be implemented in many different ways, as defined and covered by the claims.
Example 1
An absorbable oral ulcer patch comprises the following components in parts by weight:
25 parts of active ingredient microemulsion particles,
35 parts of propolis, namely, propolis,
15 parts of borneol,
3 parts of an antibacterial agent, namely 3 parts of a bactericide,
5 parts of a lubricating agent, namely 5 parts of,
8 parts of sodium carboxymethyl cellulose,
4 parts of a coating agent, namely 4 parts of,
and a proper amount of pH regulator.
Wherein the active ingredient microemulsion particles are water-in-oil-in-water microemulsion which contains traditional Chinese medicine extract for treating the oral ulcer and western medicine for treating the oral ulcer. The preparation method comprises the following steps: dissolving the Chinese medicinal extract and western medicines in water, adding surfactant (sodium dodecyl benzene sulfonate), and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicines and surfactant (sodium dodecylbenzenesulfonate), and stirring to obtain water-in-oil granule; and finally adding the water-in-oil particles into water containing traditional Chinese medicine extract, western medicine and surfactant (sodium dodecyl benzene sulfonate), fully stirring, and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The Chinese medicinal extract is a mixture of herba Menthae extract, Scutellariae radix extract, and flos Lonicerae extract. The western medicines are L-glutamine and azulene sodium sulfonate.
The lubricant is stearic acid; the coating agent is medical polypropylene resin.
The nano-scale antibacterial agent particles are triblock copolymers of polycaprolactone with hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps: dissolving 9 parts by weight of polycaprolactone containing hydroxyl at a terminal group in chloroform, dropwise adding 0.3 part by weight of bromoisobutyryl bromide into the chloroform at 2 ℃ in a nitrogen atmosphere, reacting for 18 hours, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.3 part by weight of cuprous bromide, adding 10 parts by weight of itaconic acid in nitrogen atmosphere, carrying out polymerization reaction for 10 hours at 80 ℃, then adding 12 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal polymerization reaction for 5 hours, and precipitating and filtering a reaction product to obtain the triblock copolymer.
The preparation method of the easy-to-absorb oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7.5, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
Example 2
An absorbable oral ulcer patch comprises the following components in parts by weight:
20 parts of active ingredient microemulsion particles,
30 parts of propolis, namely, propolis,
10 parts of borneol,
the parts of the antibacterial agent are as follows,
the parts of the lubricant are as follows,
5 parts of sodium carboxymethyl cellulose, namely sodium carboxymethyl cellulose,
2 parts of a coating agent, namely 2 parts of,
and a proper amount of pH regulator.
Wherein the active ingredient microemulsion particles are water-in-oil-in-water microemulsion which contains traditional Chinese medicine extract for treating the oral ulcer and western medicine for treating the oral ulcer. The preparation method comprises the following steps: dissolving the Chinese medicinal extract and western medicines in water, adding surfactant (ammonium laurylsulfate), and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicines and surfactant (ammonium laurylsulfate), and stirring to obtain water-in-oil granule; and finally adding the water-in-oil granules into water containing traditional Chinese medicine extract, western medicine and surfactant (ammonium lauryl sulfate), fully stirring, and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The Chinese medicinal extract is the mixture of radix Scutellariae extract, flos Lonicerae extract, Notoginseng radix extract, and radix Panacis Quinquefolii extract. The western medicine is L-glutamine.
The nano-scale antibacterial agent particles are triblock copolymers of polycaprolactone with hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps: dissolving 8 parts by weight of polycaprolactone containing hydroxyl at the terminal group in chloroform, dropwise adding 0.2 part by weight of bromoisobutyryl bromide into the chloroform at 0 ℃ in a nitrogen atmosphere, reacting for 16 hours, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.2 part by weight of cuprous bromide, adding 8 parts by weight of itaconic acid in a nitrogen atmosphere, carrying out polymerization reaction for 12 hours at 75 ℃, then adding 10 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal polymerization for 6 hours, and precipitating and filtering a reaction product to obtain the triblock copolymer.
The preparation method of the easy-to-absorb oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
Example 3
An absorbable oral ulcer patch comprises the following components in parts by weight:
30 parts of active ingredient microemulsion particles,
40 parts of propolis, namely, propolis,
20 parts of borneol,
5 parts of an antibacterial agent, namely a bactericide,
6 parts of a lubricating agent, namely 6 parts of,
10 parts of sodium carboxymethyl cellulose,
6 parts of a coating agent, namely 6 parts of,
and a proper amount of pH regulator.
Wherein the active ingredient microemulsion particles are water-in-oil-in-water microemulsion which contains traditional Chinese medicine extract for treating the oral ulcer and western medicine for treating the oral ulcer. The preparation method comprises the following steps: dissolving the Chinese medicinal extract and western medicines in water, adding surfactant (sodium dodecyl benzene sulfonate), and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicines and surfactant (sodium dodecylbenzenesulfonate), and stirring to obtain water-in-oil granule; and finally adding the water-in-oil particles into water containing traditional Chinese medicine extract, western medicine and surfactant (sodium dodecyl benzene sulfonate), fully stirring, and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The Chinese medicinal extract is a mixture of herba Menthae extract, Scutellariae radix extract, flos Lonicerae extract, Notoginseng radix extract, and radix Panacis Quinquefolii extract. The western medicine is sodium azulene sulfonate.
The nano-scale antibacterial agent particles are triblock copolymers of polycaprolactone with hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps: dissolving 10 parts by weight of polycaprolactone containing hydroxyl at a terminal group in chloroform, dropwise adding 0.4 part by weight of bromoisobutyryl bromide into the chloroform at 5 ℃ in a nitrogen atmosphere, reacting for 20 hours, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.4 part by weight of cuprous bromide, adding 12 parts by weight of itaconic acid in nitrogen atmosphere, carrying out polymerization reaction for 8 hours at 85 ℃, then adding 15 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal polymerization reaction for 6 hours, and precipitating and filtering a reaction product to obtain the triblock copolymer.
The preparation method of the easy-to-absorb oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 8, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
Example 4
An absorbable oral ulcer patch comprises the following components in parts by weight:
22 parts of active ingredient microemulsion particles,
38 parts of propolis, namely, propolis,
12 parts of borneol,
4 parts of an antibacterial agent, namely a bactericide,
5 parts of a lubricating agent, namely 5 parts of,
6 parts of sodium carboxymethyl cellulose, namely 6 parts of sodium carboxymethyl cellulose,
3 parts of a coating agent, namely 3 parts of,
and a proper amount of pH regulator.
Wherein the active ingredient microemulsion particles are water-in-oil-in-water microemulsion which contains traditional Chinese medicine extract for treating the oral ulcer and western medicine for treating the oral ulcer. The preparation method comprises the following steps: dissolving the Chinese medicinal extract and western medicines in water, adding surfactant (sodium dodecyl benzene sulfonate), and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicines and surfactant (sodium dodecylbenzenesulfonate), and stirring to obtain water-in-oil granule; and finally adding the water-in-oil particles into water containing traditional Chinese medicine extract, western medicine and surfactant (sodium dodecyl benzene sulfonate), fully stirring, and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The Chinese medicinal extract is mixture of Scutellariae radix extract and flos Lonicerae extract. The western medicines are L-glutamine and azulene sodium sulfonate.
The nano-scale antibacterial agent particles are triblock copolymers of polycaprolactone with hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps: dissolving 8 parts by weight of polycaprolactone containing hydroxyl at the terminal group in chloroform, dropwise adding 0.3 part by weight of bromoisobutyryl bromide into the chloroform at 0 ℃ in a nitrogen atmosphere, reacting for 18 hours, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.3 part by weight of cuprous bromide, adding 8-12 parts by weight of itaconic acid in nitrogen atmosphere, carrying out polymerization reaction at 80 ℃ for 9 hours, then adding 14 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal polymerization reaction for 5.5 hours, and precipitating and filtering a reaction product to obtain the triblock copolymer.
The preparation method of the easy-to-absorb oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7.5, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
Example 5
An absorbable oral ulcer patch comprises the following components in parts by weight:
28 parts of active ingredient microemulsion particles,
32 parts of propolis, namely 32 parts of propolis,
16 parts of borneol,
4 parts of an antibacterial agent, namely a bactericide,
6 parts of a lubricating agent, namely 6 parts of,
8 parts of sodium carboxymethyl cellulose,
5 parts of a coating agent, namely 5 parts of,
and a proper amount of pH regulator.
Wherein the active ingredient microemulsion particles are water-in-oil-in-water microemulsion which contains traditional Chinese medicine extract for treating the oral ulcer and western medicine for treating the oral ulcer. The preparation method comprises the following steps: dissolving the Chinese medicinal extract and western medicines in water, adding surfactant (ammonium laurylsulfate), and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicines and surfactant (ammonium laurylsulfate), and stirring to obtain water-in-oil granule; and finally adding the water-in-oil granules into water containing traditional Chinese medicine extract, western medicine and surfactant (ammonium lauryl sulfate), fully stirring, and separating to obtain the water-in-oil-in-water active ingredient microemulsion.
The Chinese medicinal extract is mixture of herba Menthae extract and Scutellariae radix extract. The western medicines are L-glutamine and azulene sodium sulfonate.
The nano-scale antibacterial agent particles are triblock copolymers of polycaprolactone with hydroxyl at the terminal, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps: dissolving 8 parts by weight of polycaprolactone containing hydroxyl at a terminal group in chloroform, dropwise adding 0.2 part by weight of bromoisobutyryl bromide into the chloroform at 1 ℃ in a nitrogen atmosphere, reacting for 16 hours, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.2 part by weight of cuprous bromide, adding 8 parts by weight of itaconic acid in nitrogen atmosphere, carrying out polymerization reaction at 80 ℃ for 9 hours, then adding 12 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal polymerization reaction for 4.5 hours, and precipitating and filtering a reaction product to obtain the triblock copolymer.
The preparation method of the easy-to-absorb oral ulcer patch comprises the following steps:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (4)
1. An absorbable oral ulcer patch is characterized by comprising the following components in parts by weight:
20-30 parts of active ingredient microemulsion particles,
30-40 parts of propolis, namely,
10-20 parts of borneol,
1-5 parts of an antibacterial agent,
4-6 parts of a lubricating agent,
5-10 parts of sodium carboxymethyl cellulose,
2-6 parts of a coating agent,
0-10 parts of a pH regulator;
the active ingredient microemulsion is an aqueous-in-oil-in-aqueous microemulsion containing traditional Chinese medicine extracts for treating oral ulcer and western medicines for treating oral ulcer, and the preparation method comprises the following steps:
dissolving the Chinese medicinal extract and western medicines in water, adding surfactant, and stirring to obtain water phase solution; adding the water phase solution into tea tree oil containing Chinese medicinal extract, western medicine and surfactant, and stirring to obtain water-in-oil granule; finally adding the water-in-oil particles into water containing traditional Chinese medicine extract, western medicine and surfactant, fully stirring and separating to obtain water-in-oil-in-water active ingredient microemulsion particles;
the antibacterial agent is a triblock copolymer of polycaprolactone containing hydroxyl at a terminal group, itaconic acid and 2- (dimethylamino) ethyl methacrylate, and the preparation method comprises the following steps:
dissolving 8-10 parts by weight of polycaprolactone containing hydroxyl at a terminal group in chloroform, dropwise adding 0.2-0.4 part by weight of bromoisobutyryl bromide under the condition of nitrogen atmosphere and 0-5 ℃, reacting for 16-20h, and adding a reaction product into anhydrous methanol for precipitation to obtain modified polycaprolactone; dissolving modified polycaprolactone in dimethyl sulfoxide, adding 0.2-0.4 part by weight of cuprous bromide, adding 8-12 parts by weight of itaconic acid in a nitrogen atmosphere, carrying out polymerization reaction at 75-85 ℃ for 8-12h, then adding 10-15 parts by weight of 2- (dimethylamino) ethyl methacrylate, carrying out thermal insulation polymerization reaction for 4-6h, and precipitating and filtering a reaction product to obtain a triblock copolymer;
the Chinese medicinal extract is at least one selected from herba Menthae extract, Scutellariae radix extract, flos Lonicerae extract, Notoginseng radix extract, and radix Panacis Quinquefolii extract;
the western medicines are at least one of L-glutamine and azulene sodium sulfonate.
2. The absorbable oral ulcer patch as claimed in claim 1, wherein the surfactant is sodium dodecylbenzene sulfonate or ammonium dodecylsulfate.
3. The absorbable oral ulcer patch as claimed in claim 1, wherein the lubricant is at least one selected from stearic acid, magnesium stearate, silica gel micropowder or talc; the coating agent is medical polypropylene resin.
4. A method of making an absorbable oral ulcer patch as claimed in any one of claims 1 to 3, comprising the steps of:
1) preparing active ingredient microemulsion particles;
2) mixing active ingredient microemulsion, propolis, Borneolum Syntheticum, antibacterial agent, lubricant, and sodium carboxymethylcellulose, adding water for wetting, adding pH regulator to adjust pH to 7-8, and tabletting;
3) finally coating with a coating agent, and drying to obtain the finished product.
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