CN108938674A - Purposes of the Lyopgized Nocardia rubra-cell Wall Skeleton in preparation treatment cutaneous lesions drug - Google Patents
Purposes of the Lyopgized Nocardia rubra-cell Wall Skeleton in preparation treatment cutaneous lesions drug Download PDFInfo
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- CN108938674A CN108938674A CN201710392695.6A CN201710392695A CN108938674A CN 108938674 A CN108938674 A CN 108938674A CN 201710392695 A CN201710392695 A CN 201710392695A CN 108938674 A CN108938674 A CN 108938674A
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- China
- Prior art keywords
- cell wall
- wall skeleton
- nocardia rubra
- lyopgized nocardia
- weight
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 241000187654 Nocardia Species 0.000 title claims abstract description 50
- 239000003814 drug Substances 0.000 title claims abstract description 33
- 230000003902 lesion Effects 0.000 title claims abstract description 25
- 229940079593 drug Drugs 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title claims abstract description 7
- 201000004624 Dermatitis Diseases 0.000 claims abstract description 18
- 201000009053 Neurodermatitis Diseases 0.000 claims abstract description 10
- 201000004681 Psoriasis Diseases 0.000 claims abstract description 9
- 208000010668 atopic eczema Diseases 0.000 claims abstract description 9
- 206010012438 Dermatitis atopic Diseases 0.000 claims abstract description 7
- 201000008937 atopic dermatitis Diseases 0.000 claims abstract description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 63
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 24
- 235000011187 glycerol Nutrition 0.000 claims description 21
- 239000004088 foaming agent Substances 0.000 claims description 20
- 235000021355 Stearic acid Nutrition 0.000 claims description 18
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 18
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 18
- 239000008117 stearic acid Substances 0.000 claims description 18
- 239000002904 solvent Substances 0.000 claims description 17
- YYGNTYWPHWGJRM-UHFFFAOYSA-N (6E,10E,14E,18E)-2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene Chemical compound CC(C)=CCCC(C)=CCCC(C)=CCCC=C(C)CCC=C(C)CCC=C(C)C YYGNTYWPHWGJRM-UHFFFAOYSA-N 0.000 claims description 16
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 16
- BHEOSNUKNHRBNM-UHFFFAOYSA-N Tetramethylsqualene Natural products CC(=C)C(C)CCC(=C)C(C)CCC(C)=CCCC=C(C)CCC(C)C(=C)CCC(C)C(C)=C BHEOSNUKNHRBNM-UHFFFAOYSA-N 0.000 claims description 16
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N dodecahydrosqualene Natural products CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 claims description 16
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 16
- 229940031439 squalene Drugs 0.000 claims description 16
- TUHBEKDERLKLEC-UHFFFAOYSA-N squalene Natural products CC(=CCCC(=CCCC(=CCCC=C(/C)CCC=C(/C)CC=C(C)C)C)C)C TUHBEKDERLKLEC-UHFFFAOYSA-N 0.000 claims description 16
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims description 14
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 14
- 125000004079 stearyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 14
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims description 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 12
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- 239000004909 Moisturizer Substances 0.000 claims description 10
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 10
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- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 8
- 239000003002 pH adjusting agent Substances 0.000 claims description 8
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- 229960004793 sucrose Drugs 0.000 claims description 8
- 239000008055 phosphate buffer solution Substances 0.000 claims description 7
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- 239000002253 acid Substances 0.000 claims description 6
- 239000003963 antioxidant agent Substances 0.000 claims description 6
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- 235000019441 ethanol Nutrition 0.000 claims description 6
- 239000003755 preservative agent Substances 0.000 claims description 6
- 239000005720 sucrose Substances 0.000 claims description 6
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 5
- 150000002148 esters Chemical class 0.000 claims description 5
- ALYNCZNDIQEVRV-UHFFFAOYSA-N 4-aminobenzoic acid Chemical compound NC1=CC=C(C(O)=O)C=C1 ALYNCZNDIQEVRV-UHFFFAOYSA-N 0.000 claims description 4
- DLFVBJFMPXGRIB-UHFFFAOYSA-N Acetamide Chemical compound CC(N)=O DLFVBJFMPXGRIB-UHFFFAOYSA-N 0.000 claims description 4
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 4
- 239000005711 Benzoic acid Substances 0.000 claims description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 4
- ATUOYWHBWRKTHZ-UHFFFAOYSA-N Propane Chemical compound CCC ATUOYWHBWRKTHZ-UHFFFAOYSA-N 0.000 claims description 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 4
- 229920002125 Sokalan® Polymers 0.000 claims description 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 235000010233 benzoic acid Nutrition 0.000 claims description 4
- 239000000872 buffer Substances 0.000 claims description 4
- 229960001631 carbomer Drugs 0.000 claims description 4
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 4
- 229920000053 polysorbate 80 Polymers 0.000 claims description 4
- 230000002335 preservative effect Effects 0.000 claims description 4
- 108010039939 Cell Wall Skeleton Proteins 0.000 claims description 3
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 3
- 150000001335 aliphatic alkanes Chemical class 0.000 claims description 3
- 210000004520 cell wall skeleton Anatomy 0.000 claims description 3
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- 239000007788 liquid Substances 0.000 claims description 3
- IJDNQMDRQITEOD-UHFFFAOYSA-N sec-butylidene Natural products CCCC IJDNQMDRQITEOD-UHFFFAOYSA-N 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- DDMOUSALMHHKOS-UHFFFAOYSA-N 1,2-dichloro-1,1,2,2-tetrafluoroethane Chemical compound FC(F)(Cl)C(F)(F)Cl DDMOUSALMHHKOS-UHFFFAOYSA-N 0.000 claims description 2
- KNENSDLFTGIERH-UHFFFAOYSA-N 2,2,4,4-tetramethyl-3-phenylpentan-3-ol Chemical compound CC(C)(C)C(O)(C(C)(C)C)C1=CC=CC=C1 KNENSDLFTGIERH-UHFFFAOYSA-N 0.000 claims description 2
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 2
- 229920001661 Chitosan Polymers 0.000 claims description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 claims description 2
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims description 2
- 229920002690 Polyoxyl 40 HydrogenatedCastorOil Polymers 0.000 claims description 2
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- 229920002385 Sodium hyaluronate Polymers 0.000 claims description 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 2
- 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 description 2
- 229960004050 aminobenzoic acid Drugs 0.000 claims description 2
- JTZPPHUZZDKEOC-RBQAPOGLSA-A chembl2367706 Chemical compound O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)O.O[Al](O)OS(=O)(=O)O[C@@H]1[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](COS(=O)(=O)O[Al](O)O)O[C@H]1O[C@@]1(COS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)O1 JTZPPHUZZDKEOC-RBQAPOGLSA-A 0.000 claims description 2
- 235000012000 cholesterol Nutrition 0.000 claims description 2
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- JRBPAEWTRLWTQC-UHFFFAOYSA-N dodecylamine Chemical compound CCCCCCCCCCCCN JRBPAEWTRLWTQC-UHFFFAOYSA-N 0.000 claims description 2
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- 235000010241 potassium sorbate Nutrition 0.000 claims description 2
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(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- Chemical compound [Na+].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 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 2
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- 235000006708 antioxidants Nutrition 0.000 claims 3
- NNPPMTNAJDCUHE-UHFFFAOYSA-N isobutane Chemical compound CC(C)C NNPPMTNAJDCUHE-UHFFFAOYSA-N 0.000 claims 2
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- 208000003251 Pruritus Diseases 0.000 abstract description 7
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- 206010024438 Lichenification Diseases 0.000 abstract description 6
- 230000001684 chronic effect Effects 0.000 abstract description 6
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- 231100000321 erythema Toxicity 0.000 abstract description 6
- 238000006748 scratching Methods 0.000 abstract description 6
- 230000002393 scratching effect Effects 0.000 abstract description 6
- 208000028990 Skin injury Diseases 0.000 abstract description 5
- 230000008961 swelling Effects 0.000 abstract description 5
- 208000017520 skin disease Diseases 0.000 abstract description 2
- 239000000463 material Substances 0.000 description 22
- 239000008194 pharmaceutical composition Substances 0.000 description 16
- 230000000052 comparative effect Effects 0.000 description 11
- 230000001225 therapeutic effect Effects 0.000 description 10
- 238000000746 purification Methods 0.000 description 7
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Classifications
-
- 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
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
Abstract
The invention discloses purposes of the Lyopgized Nocardia rubra-cell Wall Skeleton in preparation treatment cutaneous lesions drug, and the cutaneous lesions include at least one of eczema, neurodermatitis, non-specific dermatitis, atopic dermatitis and psoriasis.When Lyopgized Nocardia rubra-cell Wall Skeleton is applied to skin disease of the treatment including eczema, neurodermatitis, non-specific dermatitis, atopic dermatitis and psoriasis by the present invention, the exudation of patient's diseased region can be effectively relieved, swelling, erythema, epidermis thicken coarse, lichenification, the scales of skin that peel off, itch etc., reducing patient's scratching, chronic friction and caused skin injury etc. finally improves or cures above-mentioned cutaneous lesions.
Description
Technical field
The present invention relates to medicine fields, and in particular, to Lyopgized Nocardia rubra-cell Wall Skeleton treats skin disease in preparation
Become the purposes in drug.
Background technique
Eczema, neurodermatitis and psoriasis and non-specificity or atopic dermatitis are common cutaneous lesions, patient
Unbearably, very painful, the state of an illness is not cured normal itch easily repeatedly, throughout the year, and very big stress and financial burden are brought to patient.
Such cutaneous lesions drug therapy tradition medication is external application glucocorticoid, but side effect is more, easy to recur after deactivating, and is made for a long time
With easily to drug generation dependence.
Therefore the therapeutic agent for needing to develop a kind of new cutaneous lesions can be effectively relieved the exudation of patient's diseased region, swell
Swollen, erythema, epidermis thicken coarse, lichenification, the scales of skin that peel off, itch etc., and it is broken to reduce patient's scratching, chronic friction and caused skin
Damage etc. finally improves or cures above-mentioned cutaneous lesions.
Summary of the invention
The object of the present invention is to provide a kind of methods for treating cutaneous lesions, can be effectively improved the pain of cutaneous lesions patient
It is bitter.
To achieve the goals above, the present invention provides Lyopgized Nocardia rubra-cell Wall Skeletons treats cutaneous lesions in preparation
Purposes in drug.
Heretofore described Lyopgized Nocardia rubra-cell Wall Skeleton is fermented, broken for nocardia rubra, extracts and obtains
It obtains cell wall skeleton (Nocardia rubra cell wall skeleton, NCWS), mainly contains the group of the bacteria cell wall
Divide mycolic acid, arabogalactan and mucopeptide etc., hormone-free and antibiotic.The Lyopgized Nocardia rubra-cell Wall Skeleton can
To be prepared by fermentation, broken and extractive technique.
Through the above technical solutions, it includes eczema, mind that Lyopgized Nocardia rubra-cell Wall Skeleton is applied to treatment by the present invention
When through cutaneous lesions and non-specificity or atopic dermatitis including property dermatitis and psoriasis, patient's lesion can be effectively relieved
Position exudation, swelling, erythema, epidermis thicken coarse, lichenification, the scales of skin that peel off, itch etc., reduce patient's scratching, chronic friction with
And caused skin injury etc. finally improves or cures above-mentioned cutaneous lesions.
Other features and advantages of the present invention will the following detailed description will be given in the detailed implementation section.
Specific embodiment
Detailed description of the preferred embodiments below.It should be understood that described herein specific
Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The present invention provides purposes of the Lyopgized Nocardia rubra-cell Wall Skeleton in preparation treatment cutaneous lesions drug.
Through the above technical solutions, it includes eczema, mind that Lyopgized Nocardia rubra-cell Wall Skeleton is applied to treatment by the present invention
When through cutaneous lesions including property dermatitis, non-specific dermatitis, atopic dermatitis and psoriasis, patient's lesion can be effectively relieved
Position exudation, swelling, erythema, epidermis thicken coarse, lichenification, the scales of skin that peel off, itch etc., reduce patient's scratching, chronic friction with
And caused skin injury etc. finally improves or cures above-mentioned cutaneous lesions.
According to the present invention, the cutaneous lesions include eczema, neurodermatitis, non-specific dermatitis, atopic dermatitis and
At least one of psoriasis.
According to the present invention, the drug is topical drug, and the drug, which is applied to affected part, can reduce skin surface
Exudation, swelling, erythema, epidermis thicken skin injury caused by coarse, lichenification, the scales of skin that peel off, itch and scratching, chronic friction.
According to the present invention, drug of the present invention can be prepared into pharmaceutically various common topical agents via conventional method
Type;Preferably, the drug is emulsion, paste, gelling agent, spray, patch, foaming agent, pulvis or freeze dried powder.
According to the present invention, in order to keep the stability of the drug and using effect purposes according to claim 1,
Wherein, the drug contains Lyopgized Nocardia rubra-cell Wall Skeleton and auxiliary element;The Lyopgized Nocardia rubra-cell Wall Skeleton
Weight ratio with the auxiliary element is 1:(99-49999);Preferably, the Lyopgized Nocardia rubra-cell Wall Skeleton and described
The weight ratio of auxiliary element is 1:(499-19999);It is highly preferred that the Lyopgized Nocardia rubra-cell Wall Skeleton and the auxiliary
The weight ratio of ingredient is 1:(1999-9999);Most preferably, the Lyopgized Nocardia rubra-cell Wall Skeleton and the auxiliary element
Weight ratio be 1:(2999-4999).
According to the present invention, the auxiliary element can use various auxiliary elements according to the difference of pharmaceutical dosage form;It is described auxiliary
Co-ingredients can use the conventional use of various materials of those skilled in the art, and the present invention is not particularly limited this.
Under preferable case, the auxiliary element includes matrix, moisturizer, solvent, solubilizer, emulsifier, antioxidant, throwing
Penetrate agent, pH adjusting agent and at least one of the preservatives.
The matrix is selected from albolene, carbomer, hydroxypropyl methylcellulose, methylcellulose, sodium cellulose glycolate, shell
At least one of glycan, ulcerlmin chitosan polyvinylpyrrolidone, polyvinyl alcohol and sodium hyaluronate.
The moisturizer is selected from least one of glycerol and propylene glycol.
The solvent in water, ethyl alcohol, hexadecanol, octadecyl alcolol, p-aminobenzoic acid, acetamide and isopropanol at least
It is a kind of.
Wherein, water used can be at least one of deionized water, purified water and water for injection.
The solubilizer is selected from least one of Tween-60, Tween-80 and Cremophor RH40.
The emulsifier be selected from stearic acid, glycerin monostearate, Tripolyglycerol monostearates, fatty acid cane sugar ester,
Sucrose ester, Sucrose Acetate acid sucrose sugar ester, sorbitol anhydride tristearate, isopropyl myristate, cholesterol, squalene, angle
Shark alkane, n-butanol, ethylene glycol, ethyl alcohol, propylene glycol and polyglycerol ester at least one.
The antioxidant in sulphite, cysteine, di-tert-butyl hydroxy toluene and potassium sorbate at least
It is a kind of.
The propellant is selected from F-11, dicholorodifluoromethane, dichlorotetra-fluoroethane, propane, tetrafluoroethane, different
At least one of butane and normal butane.
The pH adjusting agent is selected from phosphate buffer solution, triethanolamine, sodium hydroxide, ethylenediamine, lauryl amine, sodium bicarbonate
At least one of with hydrochloric acid.
The preservative in parabens, thimerosal, chloreresol, anesin and benzoic acid and sodium benzoate extremely
Few one kind.
The Lyopgized Nocardia rubra-cell Wall Skeleton, the matrix, the moisturizer, the solvent, the emulsifier, institute
The weight ratio for stating antioxidant, the propellant, the pH adjusting agent and the preservative is 1:(0.1-1000): (0.1-
7000): (100-10000): (0.1-2000): (0.1-1000): (0.1-1000): (0.01-30000): (0.1-1000).
According to the present invention, there is better using effect, under preferable case, the bubble when pharmaceutical dosage form is foaming agent
Foam agent contains Lyopgized Nocardia rubra-cell Wall Skeleton, matrix, solvent, moisturizer, emulsifier, solubilizer, propellant and suitable
PH adjusting agent;The Lyopgized Nocardia rubra-cell Wall Skeleton, the matrix, the solvent, the moisturizer, the emulsifier,
The weight ratio of the solubilizer and the propellant is 1:(250-840): (2400-7200): (100-400): (270-900):
(60-240): (150-540).
According to the present invention, the foaming agent contains Lyopgized Nocardia rubra-cell Wall Skeleton, albolene, hexadecanol, 18
Alcohol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate, tetrafluoroethane, phosphoric acid buffer
Liquid and water have better therapeutic effect using the foaming agent that formula is prepared.
It is in terms of 100% by the total weight of the foaming agent, the spray contains in the case of, according to the invention it is preferred to
The Lyopgized Nocardia rubra-cell Wall Skeleton of 0.01-0.05%, the albolene of 2-10%, 0.1-2% hexadecanol, 0.1-2%
Octadecyl alcolol, the Tween-60 of 1-10%, the glycerol of 1-5%, the squalene of 0.01-0.2%, 0.1-2.0% stearic acid,
The tetrafluoroethane of the glycerin monostearate of 0.1-2.%, the isopropyl myristate of 2-7% and 1-6%, the phosphoric acid buffer
The dosage of liquid makes the pH value 6.5-7.5 of the foaming agent;The foaming agent also contains the water having a margin.
The present invention is further illustrated below by embodiment, but therefore the present invention is not any way limited.The present invention
Middle Lyopgized Nocardia rubra-cell Wall Skeleton is prepared by Fujian Province mountains and rivers pharmaceutcal corporation, Ltd and is produced.
Embodiment 1
Described pharmaceutical composition is prepared by following steps: first by Lyopgized Nocardia rubra-cell Wall Skeleton, benzene first
Acid, ethylparaben, albolene, stearic acid, glycerol and partial purification water are uniformly mixed, and the use of 0.1M and pH value are 7.2
PH is adjusted to 7 by phosphate buffer solution, adds remaining purified water, and the inventory of above-mentioned each material contains the mixed material
There is the nipalgin second of the Lyopgized Nocardia rubra-cell Wall Skeleton of 0.005 weight %, the benzoic acid of 0.1 weight %, 0.1 weight %
Ester, the albolene of 25 weight %, the stearic acid of 25 weight % and 15 weight % glycerol.By the above mixed material with 50 turns/
The rate of minute stirs 10 minutes and 0.005 weight % Lyopgized Nocardia rubra-cell Wall Skeleton emulsion is prepared.
Embodiment 2
Described pharmaceutical composition is prepared by following steps: first by Lyopgized Nocardia rubra-cell Wall Skeleton, benzene first
Acid, sodium sulfite, carbomer, Tween-80, glycerol and partial purification water are uniformly mixed, and use 0.1M, the phosphoric acid that pH value is 7.2
PH is adjusted to 7 by buffer solution, adds remaining purified water, and the inventory of above-mentioned each material contains the mixed material
The Lyopgized Nocardia rubra-cell Wall Skeleton of 0.2 weight %, the carbomer of 1.5 weight %, the Tween-80 of 0.1 weight %, 0.1 weight
Measure the glycerol of the benzoic acid of %, the sodium sulfite of 0.2 weight %, 5 weight %.By the above mixed material with 50 revs/min of speed
Rate stirs 10 minutes and 0.2 weight % Lyopgized Nocardia rubra-cell Wall Skeleton gelling agent is prepared.
Embodiment 3
Described pharmaceutical composition is prepared by following steps: first by Lyopgized Nocardia rubra-cell Wall Skeleton, Bai Fan
Intellectual circle, hexadecanol, octadecyl alcolol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate and
Partial purification water is uniformly mixed, and pH is adjusted to 7 using 0.1M, the phosphate buffer solution that pH value is 7.2, adds remaining purifying
Water obtains mixed material, and the above mixed material is stirred 10 minutes with 50 revs/min of rate, and described in tetrafluoroethane is pressed into
In medicament, the inventory of above-mentioned each material make in the medicament containing 0.05 weight % Lyopgized Nocardia rubra-cell Wall Skeleton,
The albolene of 10 weight %, the hexadecanol of 1 weight %, the octadecyl alcolol of 1 weight %, the Tween-60 of 2 weight %, 4 weight %
Glycerol, the squalene of 0.1 weight %, the stearic acid of 1 weight %, the glycerin monostearate of 1 weight %, 6 weight % Pork and beans
Described pharmaceutical composition is poured into spray bottle and 0.05 weight % is prepared by the tetrafluoroethane of cool isopropyl propionate and 5 weight %
Lyopgized Nocardia rubra-cell Wall Skeleton foaming agent.
Embodiment 4
Described pharmaceutical composition is prepared by following steps: first by Lyopgized Nocardia rubra-cell Wall Skeleton, Bai Fan
Intellectual circle, hexadecanol, octadecyl alcolol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate and
Partial purification water is uniformly mixed, and pH is adjusted to 7 using 0.1M, the phosphate buffer solution that pH value is 7.2, adds remaining purifying
Water obtains mixed material, and the above mixed material is stirred 10 minutes with 50 revs/min of rate, and described in tetrafluoroethane is pressed into
In medicament, the inventory of above-mentioned each material make in the medicament containing 0.02 weight % Lyopgized Nocardia rubra-cell Wall Skeleton,
The albolene of 10 weight %, the hexadecanol of 1 weight %, the octadecyl alcolol of 1 weight %, the Tween-60 of 2 weight %, 4 weight %
Glycerol, the squalene of 0.1 weight %, the stearic acid of 1 weight %, the glycerin monostearate of 1 weight %, 6 weight % Pork and beans
Described pharmaceutical composition is poured into spray bottle and 0.02 weight % is prepared by the tetrafluoroethane of cool isopropyl propionate and 5 weight %
Lyopgized Nocardia rubra-cell Wall Skeleton foaming agent.
Embodiment 5
Described pharmaceutical composition is prepared by following steps: first by Lyopgized Nocardia rubra-cell Wall Skeleton, Bai Fan
Intellectual circle, hexadecanol, octadecyl alcolol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate and
Partial purification water is uniformly mixed, and pH is adjusted to 7 using 0.1M, the phosphate buffer solution that pH value is 7.2, adds remaining purifying
Water obtains mixed material, and the above mixed material is stirred 10 minutes with 50 revs/min of rate, and described in tetrafluoroethane is pressed into
In medicament, the inventory of above-mentioned each material make in the medicament containing 0.03 weight % Lyopgized Nocardia rubra-cell Wall Skeleton,
The albolene of 10 weight %, the hexadecanol of 1 weight %, the octadecyl alcolol of 1 weight %, the Tween-60 of 2 weight %, 4 weight %
Glycerol, the squalene of 0.1 weight %, the stearic acid of 1 weight %, the glycerin monostearate of 1 weight %, 6 weight % Pork and beans
Described pharmaceutical composition is poured into spray bottle and 0.03 weight % is prepared by the tetrafluoroethane of cool isopropyl propionate and 5 weight %
Lyopgized Nocardia rubra-cell Wall Skeleton foaming agent.
Comparative example 1
Described pharmaceutical composition is prepared by following steps: first by dexamethasone, albolene, hexadecanol, ten
Eight alcohol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate and the mixing of partial purification water
Uniformly, pH is adjusted to 7 using 0.1M, the phosphate buffer solution that pH value is 7.2, adds remaining purified water and obtains mixture
The above mixed material is stirred 10 minutes with 50 revs/min of rate, and tetrafluoroethane is pressed into the medicament by material, above-mentioned
The inventory of each material makes in the medicament containing 0.02 weight % dexamethasone, the albolene of 10 weight %, 1 weight %
Hexadecanol, the octadecyl alcolol of 1 weight %, the Tween-60 of 2 weight %, the glycerol of 4 weight %, the squalene of 0.1 weight %, 1 weight
Measure the stearic acid of %, the glycerin monostearate of 1 weight %, the isopropyl myristate of 6 weight % and the tetrafluoro second of 5 weight %
Described pharmaceutical composition is poured into spray bottle and 0.02 weight % dexamethasone foaming agent is prepared by alkane.
Comparative example 2
Described pharmaceutical composition is prepared by following steps: will inactivate short corynebacteria first
(Corynebacterium parvum), albolene, hexadecanol, octadecyl alcolol, Tween-60, glycerol, squalene, stearic acid, list
Tristerin, isopropyl myristate and partial purification water are uniformly mixed, and use 0.1M, the phosphoric acid buffer that pH value is 7.2
PH is adjusted to 7 by solution, is added remaining purified water and is obtained mixed material, by the above mixed material with 50 revs/min of rate
Stirring 10 minutes, and tetrafluoroethane is pressed into the medicament, the inventory of above-mentioned each material to contain in the medicament
0.02 weight % inactivates short corynebacteria, the albolene of 10 weight %, the hexadecanol of 1 weight %, the octadecyl alcolol of 1 weight %, 2
The Tween-60 of weight %, the glycerol of 4 weight %, the squalene of 0.1 weight %, the stearic acid of 1 weight %, the list of 1 weight % are hard
Described pharmaceutical composition is poured into spray by the tetrafluoroethane of glycerol, the isopropyl myristate of 6 weight % and 5 weight %
0.02 weight % inactivation short corynebacteria foaming agent is prepared in mist bottle.
Testing example 1
This testing example, which is used to detect, to be prepared the use of pharmaceutical composition and relaxes in embodiment 1-5 and comparative example 1-2
Therapeutic effect appropriate and to eczema, neurodermatitis and psoriasis.
Treatment chronic eczema, neurodermatitis patient and psoriatic each 28 are participated in this testing example, totally 84
Example the age 24~65 years old, excludes the patient with severe cardiac, Liver and kidney function damage and serious immunologic hypofunction;By all trouble
Person is randomly divided into 7 groups every group 12, wherein every group of 12 patients include patients with chronic eczema 4, neurodermatitis patient 4 and
Psoriatic 4.
Once in the morning and once at night by the pharmaceutical composition scumbling being prepared in the embodiment 1-5 and comparative example 1-2 in affected part,
A moment is gently rubbed, administration time is 3 weeks;It must be arrived with the use feeling of subject and evaluate the usage comfort of drug;Wherein
"+" indicates that comfortable, " ± " indicates that insentience, "-" indicate uncomfortable, and the results are shown in Table 1.With before using, use rear patient's
EASI scores to indicate the therapeutic effect of patient, and for EASI score value between 0-72, formula (1) is shown in the calculating of therapeutic effect.It is described
Pharmaceutical composition is shown in Table 2 to the treatment results of patients with chronic eczema, 3 is shown in Table to the treatment results of neurodermatitis patient, to silver
The treatment results of bits patient are shown in Table 4.
Therapeutic effect=100% × (scoring after scoring-treatment before treating)/grading type (1) before treating.
Table 1
Table 2
Use preceding average score | Use rear average score | Therapeutic effect | |
Embodiment 1 | 36 | 20 | 44.4% |
Embodiment 2 | 35 | 19 | 45.7% |
Embodiment 3 | 37 | 16 | 56.7% |
Embodiment 4 | 42 | 13 | 69.0% |
Embodiment 5 | 39 | 13 | 66.6% |
Comparative example 1 | 37 | 25 | 32.4% |
Comparative example 2 | 37 | 23 | 37.8% |
Table 3
Use preceding average score | Use rear average score | Therapeutic effect | |
Embodiment 1 | 37 | 21 | 43.2% |
Embodiment 2 | 37 | 22 | 40.5% |
Embodiment 3 | 32 | 14 | 56.3% |
Embodiment 4 | 40 | 16 | 60.0% |
Embodiment 5 | 41 | 15 | 63.4% |
Comparative example 1 | 32 | 27 | 15.6% |
Comparative example 2 | 30 | 26 | 13.3% |
Table 4
Use preceding average score | Use rear average score | Therapeutic effect | |
Embodiment 1 | 39 | 21 | 46.15% |
Embodiment 2 | 33 | 17 | 48.48% |
Embodiment 3 | 38 | 17 | 55.26% |
Embodiment 4 | 40 | 15 | 62.50% |
Embodiment 5 | 42 | 16 | 61.90% |
Comparative example 1 | 34 | 28 | 17.65% |
Comparative example 2 | 35 | 30 | 14.29% |
Through embodiment 1-5 in table 1-4 as can be seen that of the invention by nocardia rubracell wall compared with comparative example 1-2
When skeleton is applied to cutaneous lesions of the treatment including eczema, neurodermatitis and psoriasis, disease can be effectively relieved
Change position exudation, swelling, erythema, epidermis thicken coarse, lichenification, the scales of skin that peel off, itch etc., reduce patient's scratching, chronic friction
And caused skin injury etc. finally improves or cures above-mentioned cutaneous lesions.In addition, embodiment 1-2 is compared with embodiment 3-5
As can be seen that the content of nocardia rubra-cell wall skeleton and auxiliary element is preferably treated to have when 1:(1999-9999)
Cutaneous lesions therapeutic effect;Through embodiment 1-3 as can be seen that being preferably carried out range i.e. in the present invention compared with embodiment 4-5
The weight ratio of Lyopgized Nocardia rubra-cell Wall Skeleton and auxiliary element is 1:(2999-4999) when, there is better therapeutic effect,
Especially when the dosage form of described pharmaceutical composition is foaming agent, there is best using effect.
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above
Detail within the scope of the technical concept of the present invention can be with various simple variants of the technical solution of the present invention are made, this
A little simple variants all belong to the scope of protection of the present invention.
It is further to note that specific technical features described in the above specific embodiments, in not lance
In the case where shield, it can be combined in any appropriate way.In order to avoid unnecessary repetition, the present invention to it is various can
No further explanation will be given for the combination of energy.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally
The thought of invention, it should also be regarded as the disclosure of the present invention.
Claims (10)
1. purposes of the Lyopgized Nocardia rubra-cell Wall Skeleton in preparation treatment cutaneous lesions drug.
2. purposes according to claim 1, wherein the cutaneous lesions include eczema, neurodermatitis, non-specific skin
At least one of scorching, atopic dermatitis and psoriasis.
3. purposes according to claim 1, wherein the drug is topical drug.
4. purposes according to claim 3, wherein the drug be emulsion, paste, gelling agent, spray, foaming agent,
Patch, pulvis or freeze dried powder.
5. purposes according to claim 1, wherein the drug contain Lyopgized Nocardia rubra-cell Wall Skeleton and auxiliary at
Point;The weight ratio of the Lyopgized Nocardia rubra-cell Wall Skeleton and the auxiliary element is 1:(99-49999);Preferably, described
The weight ratio of Lyopgized Nocardia rubra-cell Wall Skeleton and the auxiliary element is 1:(499-19999);It is highly preferred that the red
The weight ratio of nocardial cell wall skeleton and the auxiliary element is 1:(1999-9999).
6. purposes according to claim 5, wherein the Lyopgized Nocardia rubra-cell Wall Skeleton and the auxiliary element
Weight ratio is 1:(2999-4999).
7. purposes according to claim 5 or 6, wherein the auxiliary element includes matrix, moisturizer, solvent, solubilising
Agent, emulsifier, antioxidant, pH adjusting agent, propellant and at least one of the preservatives;
It is poly- that the matrix is selected from albolene, carbomer, hydroxypropyl methylcellulose, methylcellulose, sodium cellulose glycolate, shell
At least one of sugar, ulcerlmin chitosan polyvinylpyrrolidone, polyvinyl alcohol and sodium hyaluronate;
The moisturizer is selected from least one of glycerol and propylene glycol;
The solvent in water, ethyl alcohol, hexadecanol, octadecyl alcolol, p-aminobenzoic acid, acetamide and isopropanol at least one
Kind;The solubilizer is selected from least one of Tween-60, Tween-80 and Cremophor RH40;
The emulsifier is selected from stearic acid, glycerin monostearate, Tripolyglycerol monostearates, fatty acid cane sugar ester, sucrose
Ester, Sucrose Acetate acid sucrose sugar ester, sorbitol anhydride tristearate, isopropyl myristate, cholesterol, squalene, saualane,
N-butanol, ethylene glycol, ethyl alcohol, propylene glycol and polyglycerol ester at least one;
The antioxidant is selected from least one of sulphite, cysteine, di-tert-butyl hydroxy toluene and potassium sorbate;
The propellant is selected from F-11, dicholorodifluoromethane, dichlorotetra-fluoroethane, propane, tetrafluoroethane, iso-butane
At least one of with normal butane;
The pH adjusting agent is selected from phosphate buffer solution, triethanolamine, sodium hydroxide, ethylenediamine, lauryl amine, sodium bicarbonate and salt
At least one of acid;
The preservative in parabens, thimerosal, chloreresol, anesin and benzoic acid and sodium benzoate at least one
Kind;
It is the Lyopgized Nocardia rubra-cell Wall Skeleton, the matrix, the moisturizer, the solvent, the emulsifier, described anti-
Oxidant, the propellant, the pH adjusting agent and the preservative weight ratio be 1:(0.1-1000): (0.1-7000):
(100-10000): (0.1-2000): (0.1-1000): (0.1-1000): (0.01-30000): (0.1-1000).
8. purposes according to claim 4, wherein the foaming agent contain Lyopgized Nocardia rubra-cell Wall Skeleton, matrix,
Solvent, moisturizer, emulsifier, solubilizer, propellant and suitable pH adjusting agent;The Lyopgized Nocardia rubra-cell Wall Skeleton,
The matrix, the solvent, the moisturizer, the emulsifier, the solubilizer and the propellant weight ratio be 1:
(250-840): (2400-7200): (100-400): (270-900): (60-240): (150-540).
9. purposes according to claim 8, wherein foaming agent contain Lyopgized Nocardia rubra-cell Wall Skeleton, albolene,
Hexadecanol, octadecyl alcolol, Tween-60, glycerol, squalene, stearic acid, glycerin monostearate, isopropyl myristate, tetrafluoro second
Alkane, phosphate buffer and water.
10. purposes according to claim 9, wherein by the total weight of the foaming agent be 100% in terms of, the foaming agent
The albolene of Lyopgized Nocardia rubra-cell Wall Skeleton, 2-10%, the hexadecanol of 0.1-2%, 0.1- containing 0.01-0.05%
2% octadecyl alcolol, the Tween-60 of 1-10%, the glycerol of 1-5%, the squalene of 0.01-0.2%, 0.1-2.0% stearic acid,
The tetrafluoroethane of the glycerin monostearate of 0.1-2.0%, the isopropyl myristate of 2-7% and 1-6%, the phosphoric acid buffer
The dosage of liquid makes the pH value 6.5-7.5 of the foaming agent;The foaming agent also contains the water having a margin.
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CN111727236A (en) * | 2019-01-15 | 2020-09-29 | 辽宁格瑞仕特生物制药有限公司 | Use of Rhodococcus ruber products for treating diseases caused by Candida albicans infection |
WO2020216283A1 (en) | 2019-04-24 | 2020-10-29 | 辽宁格瑞仕特生物制药有限公司 | Use of nocardia rubra cell wall skeleton in treatment of thermal injury |
WO2021147900A1 (en) | 2020-01-21 | 2021-07-29 | 辽宁格瑞仕特生物制药有限公司 | Use of nocardia rubra cell wall skeleton in regenerative medicine |
WO2022199452A1 (en) * | 2021-03-24 | 2022-09-29 | 辽宁格瑞仕特生物制药有限公司 | Use of nocardia rubra cell wall skeleton in treatment of radiation sickness |
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US20220241348A1 (en) * | 2019-01-15 | 2022-08-04 | Liaoning Greatest Bio-Pharmaceutical Co. Ltd. | Product derived from rhodococcus ruber, and pharmaceutical use thereof |
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