CN108969531B - Application of polyethylene glycol as active ingredient in preparation of psoriasis treatment medicine and medicine thereof - Google Patents
Application of polyethylene glycol as active ingredient in preparation of psoriasis treatment medicine and medicine thereof Download PDFInfo
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- CN108969531B CN108969531B CN201810048207.4A CN201810048207A CN108969531B CN 108969531 B CN108969531 B CN 108969531B CN 201810048207 A CN201810048207 A CN 201810048207A CN 108969531 B CN108969531 B CN 108969531B
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Abstract
The invention relates to application of polyethylene glycol as an active ingredient in preparing a medicament for treating psoriasis and a medicament thereof. The applicant of the invention finds through experiments that the polyethylene glycol has a remarkable treatment effect on psoriasis, can effectively reduce the increase of splenomegaly and MDSCs cell populations, and proves that the treatment effect of the polyethylene glycol is superior to that of first-line medicine calcipotriol for clinical external treatment of psoriasis according to psoriasis skin damage area and severity index (PASI), the polyethylene glycol has no toxic or side effect, does not cause skin allergy, is stable and not easy to deteriorate, and simultaneously fixes water molecules through a large number of hydrogen bonds to ensure that the water is kept in the stratum corneum or dermis of the skin, so that the water retention of the skin is increased, the permeability of the skin is enhanced, the moisturizing effect is achieved, the continuous curative effect is ensured, the pH value of the skin is not influenced, the pharmaceutical cost is far lower than that of clinical medicines such as calcipotriol, the economic burden of patients can be remarkably reduced, and the market prospect.
Description
Technical Field
The invention relates to the field of medicines, in particular to application of polyethylene glycol as an active ingredient in preparation of a psoriasis treatment medicine and a medicine thereof.
Background
Psoriasis is a common chronic, recurrent and inflammatory skin disease, which is clinically mainly manifested by erythema and scale, and has histopathology specificity, and is manifested by hyperproliferation of epidermal keratinocytes, hyperkeratosis with parakeratosis, hypertrophy of the spinous layer, infiltration of sparse inflammatory cells around superficial dermal blood vessels, and the like. The incidence rate of psoriasis in natural people is 0.1-3%, and the pathogenesis of psoriasis is complex and easy to relapse. Most psoriasis is light and medium patients, and external drug therapy is a main treatment method and occupies an indispensable position.
The psoriasis external medicine comprises glucocorticoid, tretinoin, vitamin DR derivative, dithranol, tar preparation, calcineurin inhibitor, etc. Dithranol, tar preparations and glucocorticoids are limited in use due to the large side effects, and the therapeutic effects of tretinoin, calcineurin inhibitors and vitamin DR derivatives are not very desirable. The recent marketed calcipotriol betamethasone ointment which is a compound preparation of glucocorticoid and vitamin DR derivatives has a slightly better effect than calcipotriol, but the cost is high, so that the significance of developing a new medicine for treating psoriasis is great.
Disclosure of Invention
Therefore, a medicine for treating psoriasis with better curative effect and lower cost is needed.
The invention provides application of polyethylene glycol as an active ingredient in preparation of a psoriasis treatment medicament.
In one embodiment, the psoriasis treatment drug is in the form of a solution, lotion, liniment, ointment, plaster, paste, or patch.
The invention also provides a medicament for treating psoriasis, the active component of which mainly comprises polyethylene glycol.
In one embodiment, in the psoriasis treatment medicament, the mass percentage of the polyethylene glycol is 50-100%.
In one embodiment, the psoriasis treatment medicine further comprises 0-15% of glycerol by mass percent.
In one embodiment, the psoriasis treatment medicine mainly comprises the following components in percentage by mass: 88 to 93 percent of polyethylene glycol and 7 to 12 percent of glycerol.
In one embodiment, the psoriasis treatment medicine mainly comprises the following components in percentage by mass: 45-55% of polyethylene glycol 400, 35-45% of polyethylene glycol 4000 and 5-15% of glycerol.
In one embodiment, the number average molecular weight of the polyethylene glycol is 400-4000.
In one embodiment, the psoriasis treatment medicament further comprises one or more of an excipient, a preservative, a stabilizer, a solubilizer and a flavoring agent.
In one embodiment, the method comprises the following steps: heating and stirring polyethylene glycol at 50-70 ℃, cooling, adding glycerol, and stirring to obtain the psoriasis treatment medicine.
Polyethylene glycol (PEG) has excellent properties of water solubility, non-volatility, physiological inertness, mildness, lubricity and the like, and is therefore widely used in industries such as cosmetics, pharmaceuticals, chemical fibers, food processing and the like as an auxiliary agent such as a wetting agent, a suspending agent, a thickening agent, a carrier base and the like, for example, polyethylene glycol is added to a detergent as a suspending agent and a thickening agent, polyethylene glycol is added to medicines and cosmetics as a base of ointments, creams, ointments and suppositories and the like, however, the properties of polyethylene glycol in the aspect of disease treatment have not been discovered yet, and therefore, the application of polyethylene glycol as a pharmaceutical active ingredient has not been reported yet. The applicant of the invention finds through experiments that the polyethylene glycol has obvious treatment effect on psoriasis, can effectively reduce splenomegaly and increase of MDSCs (myeloid-derived suppressor cell) cell population, the treatment effect of the polyethylene glycol is proved to be superior to that of the first-line medicine calcipotriol for the clinical external treatment of psoriasis according to the psoriasis skin damage area and severity index (PASI) score, and the polyethylene glycol has no toxic or side effect, can not cause skin allergy, is stable and is not easy to deteriorate, meanwhile, water molecules are fixed through a large number of hydrogen bonds to ensure that the water is reserved in the horny layer or the corium layer of the skin, the water retention amount of the skin is increased, the permeability of the skin is enhanced, the moisturizing effect is achieved, the continuous curative effect is ensured, the pH value of the skin is not influenced, the pharmaceutical cost is far lower than that of clinical medicines such as calcipotriol and the like, the economic burden of a patient can be obviously reduced, and the method has extremely wide market prospect.
Drawings
Fig. 1 is a photograph of the back of the seventh day of the first to twelfth groups of mice in an IMQ-induced mouse psoriasis model trial;
FIG. 2 is a graph of the day one to day seven PASI scores of the back lesions of mice in the first, second, eighth, tenth, eleventh and twelfth groups in an IMQ-induced psoriasis model test in mice;
FIG. 3 is a graph of the combined scores of PASI at day seven for the dorsal lesions of mice in the first, second, eighth, tenth, eleventh and twelfth groups in an IMQ-induced psoriasis model trial;
FIG. 4 is an electron microscope result chart of HE staining of dorsal skin lesions of mice of the first group to the twelfth group in an IMQ-induced psoriasis model test;
figure 5 is a graph of dorsal epidermal thickness of mice in a first, second, eighth, tenth, eleventh and twelfth group in an IMQ-induced mouse psoriasis model experiment;
FIG. 6 is a graph of spleen cell flow results for mice in the first, second, eighth and tenth groups in an IMQ-induced mouse psoriasis model assay;
FIG. 7 is a graph of dorsal dermal cell flow results of mice of the first, second, eighth and tenth groups in an IMQ-induced mouse psoriasis model experiment;
figure 8 is a photograph of the first patient in a clinical trial after treatment with calcipotriol and the psoriasis treatment drug of example 7, respectively;
figure 9 is a photograph of a second patient in a clinical trial after treatment with calcipotriol and the psoriasis treatment drug of example 7, respectively.
Detailed Description
In order that the invention may be more fully understood, a more particular description of the invention will now be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
The invention provides application of polyethylene glycol as an active ingredient in preparation of a psoriasis treatment medicament.
Alternatively, the psoriasis treatment drug may be in the form of a solution, lotion, liniment, ointment, plaster, paste or patch, etc., but is not limited thereto and may be selected as needed.
The psoriasis treatment medicine of one embodiment of the invention has the active ingredient mainly composed of polyethylene glycol.
Polyethylene glycol (PEG) has excellent properties of water solubility, non-volatility, physiological inertness, mildness, lubricity and the like, and is therefore widely used in industries such as cosmetics, pharmaceuticals, chemical fibers, food processing and the like as an auxiliary agent such as a wetting agent, a suspending agent, a thickening agent, a carrier base and the like, for example, polyethylene glycol is added to a detergent as a suspending agent and a thickening agent, polyethylene glycol is added to medicines and cosmetics as a base of ointments, creams, ointments and suppositories and the like, however, the properties of polyethylene glycol in the aspect of disease treatment have not been discovered yet, and therefore, the application of polyethylene glycol as a pharmaceutical active ingredient has not been reported yet. The applicant of the invention finds through experiments that the polyethylene glycol has obvious treatment effect on psoriasis, can effectively reduce splenomegaly and increase of MDSCs (myeloid-derived suppressor cell) cell population, the treatment effect of the polyethylene glycol is proved to be superior to that of the first-line medicine calcipotriol for the clinical external treatment of psoriasis according to the psoriasis skin damage area and severity index (PASI) score, and the polyethylene glycol has no toxic or side effect, can not cause skin allergy, is stable and is not easy to deteriorate, meanwhile, water molecules are fixed through a large number of hydrogen bonds to ensure that the water is reserved in the horny layer or the corium layer of the skin, the water retention amount of the skin is increased, the permeability of the skin is enhanced, the moisturizing effect is achieved, the continuous curative effect is ensured, the pH value of the skin is not influenced, the pharmaceutical cost is far lower than that of clinical medicines such as calcipotriol and the like, the economic burden of a patient can be obviously reduced, and the method has extremely wide market prospect.
Myeloid-derived suppressor cells (MDSCs) are a heterogeneous population of cells derived from bone marrow, are precursors of Dendritic Cells (DCs), macrophages and/or granulocytes, and have the ability to significantly suppress immune cell responses. According to the literature report, the quantity of MDSCs in psoriasis patients is obviously increased compared with that in normal people, and the quantity of MDSCs in an IMQ-induced psoriasis model is also obviously increased compared with that in normal mice. The mechanism is that psoriasis is an immunological disease, and MDSCs are negatively fed back to regulate MDSCs to be differentiated into immunocytes along with the increase of the number of immunocytes such as dendritic cells and macrophages, so that the number of MDSCs is increased, and the MDSCs can be used as a marker for judging the activity of the psoriasis.
In one embodiment, the mass percent of the polyethylene glycol in the psoriasis treating medicine is 50-100%.
Further, the psoriasis treatment medicine also comprises 0 to 15 mass percent of glycerin. Experiments show that the combination of the polyethylene glycol and the glycerol can further improve the moisturizing effect by increasing the local osmotic pressure and effectively enhance the treatment effect of the polyethylene glycol on psoriasis, and the combination of the polyethylene glycol and the moisturizing substances such as vaseline does not have the effect of enhancing the treatment effect.
In one embodiment, the psoriasis treatment medicament consists essentially of the following components in mass percent: 88 to 93 percent of polyethylene glycol and 7 to 12 percent of glycerol.
Optionally, the number average molecular weight of the polyethylene glycol is 400-4000, tests show that the lower the molecular weight of the polyethylene glycol is, the better the effect of improving psoriasis skin lesions is, the lower the molecular weight of the polyethylene glycol is, the liquid polyethylene glycol is, the solid polyethylene glycol is, the high molecular weight polyethylene glycol can be selected and matched according to different formulations, and the polyethylene glycol with the number average molecular weight of 400-4000 is selected to be more convenient for production and preparation.
In one embodiment, the psoriasis treatment medicament consists essentially of the following components in mass percent: 45-55% of polyethylene glycol 400, 35-45% of polyethylene glycol 4000 and 5-15% of glycerol. The medicine is semisolid under the condition of the proportion, has the best ductility, spreadability and fluidity, and is suitable for preparing liniment, ointment and the like.
Optionally, the psoriasis treatment medicament further comprises one or more of excipients, preservatives, stabilizers, solubilizers and aromatics. It is understood that pharmaceutically acceptable excipients may be added without limitation thereto.
The preparation method of the psoriasis treatment medicine provided by the embodiment of the invention comprises the following steps: heating and stirring polyethylene glycol at 50-70 ℃, cooling, adding glycerol, and stirring to obtain the psoriasis treatment medicine.
The following are specific examples.
Example 1
10g of polyethylene glycol 400 is weighed, and the polyethylene glycol 400 with smaller molecular weight is in a liquid state and can be directly used as a psoriasis treatment medicament.
Example 2
Respectively weighing 8g of polyethylene glycol 400 and 2g of polyethylene glycol 4000, stirring for 10min in a constant-temperature water bath at 60 ℃, then cooling to 40 ℃, and uniformly mixing and stirring to obtain the psoriasis treatment medicament in a liquid state.
Example 3
Respectively weighing 7g of polyethylene glycol 400 and 3g of polyethylene glycol 4000, stirring for 10min in a constant-temperature water bath at 60 ℃, then cooling to 40 ℃, and uniformly mixing and stirring to obtain the psoriasis treatment medicament in a liquid state.
Example 4
Respectively weighing 6g of polyethylene glycol 400 and 4g of polyethylene glycol 4000, stirring for 10min in a constant-temperature water bath at 60 ℃, then cooling to 40 ℃, and uniformly mixing and stirring to obtain the psoriasis treatment medicament in a semi-solid state.
Example 5
Respectively weighing 5g of polyethylene glycol 400 and 5g of polyethylene glycol 4000, stirring for 10min in a constant-temperature water bath at 60 ℃, then cooling to 40 ℃, and uniformly mixing and stirring to obtain the psoriasis treatment medicament in a semi-solid state.
Example 6
10g of polyethylene glycol 4000 is weighed, and the polyethylene glycol 4000 is dissolved in water when in use because the polyethylene glycol 4000 has a large molecular weight and is in a solid state.
Example 7
Respectively weighing 5g of polyethylene glycol 400 and 4g of polyethylene glycol 4000, stirring for 10min in a constant-temperature water bath at 60 ℃, then cooling to 40 ℃, adding 1g of medicinal glycerol, and uniformly mixing and stirring to obtain the psoriasis treatment medicament in a semi-solid state.
Comparative example 1
10g of glycerol was directly weighed as a therapeutic drug.
Comparative example 2
10g of vaseline is directly weighed as a therapeutic drug.
Comparative example 3
10g of calcipotriol is directly weighed as a therapeutic drug.
IMQ-induced psoriasis model test in mice
The mouse model induced by imiquimod can well simulate psoriasis symptoms similar to human beings in the aspects of skin thickening, keratinocyte related protein abnormality, inflammatory cell infiltration, related inflammatory cytokines and the like. The model is simple and easy to operate, and is stable, so that the model is one of psoriasis models which are researched and applied most widely.
40 BALB/C mice of SPF grade (no particular pathogen grade experimental animals) for 8 weeks were randomly divided into 10 groups of 4 mice each, with a shaving range of 4cm by 5cm on the back. The first group is a normal group and is not processed; a second group of backs was only smeared with imiquimod; the psoriasis treatment drugs of examples 1 to 7 were applied to the back of the third to ninth groups, respectively, 6 hours after applying imiquimod to the back; the tenth group was coated with imiquimod on the back for 6 hours, followed by the treatment of comparative example 1; the tenth group was coated with the therapeutic agent of comparative example 2 6 hours after coating imiquimod on the back; the tenth group was coated with the therapeutic agent of comparative example 3 6 hours after coating imiquimod on the back. After each group is continuously coated with the medicine for 6 days, the psoriasis skin lesion area and the severity index (PASI) of the back skin lesions of each group of mice are scored to inspect the psoriasis-like symptoms of the mice, then the mice are weighed and photographed to be killed, the back skin lesions are taken to perform an HE staining experiment to inspect the thickness of epidermis, namely the proliferation condition of keratinocytes, and simultaneously the spleen of the mice is taken to weigh and photograph to perform a cell flow type inspection to inspect the quantity change of MDSCs.
As shown in fig. 1, which is a photograph of the back of each group of mice on the seventh day, it can be seen that the second group had marked erythema, thickening, scaling compared to the back skin lesions of the first group, demonstrating successful psoriasis model induction after application of imiquimod. The third to ninth groups all had significantly reduced erythema, infiltration, and thickening compared to the second group, indicating that polyethylene glycol was effective in treating psoriasis. Compared with the third group to the tenth group, the inflammation of the skin lesions in the third group is the lightest, the inflammation of the skin lesions in the fourth group and the fifth group is the heaviest, and the inflammation of the skin lesions in the ninth group is obviously lighter compared with the ninth group in the seventh group, which shows that the more the polyethylene glycol 400 with lower molecular weight is, the better the effect of inhibiting the inflammation of psoriasis is, and the better the effect of inhibiting the inflammation by adding a certain amount of glycerin into the polyethylene glycol is compared with the effect of inhibiting the inflammation by singly using the polyethylene glycol. Compared with the tenth group, the second group had slightly reduced erythema, infiltration and thickening, but far less effective than polyethylene glycol. Compared with the eleventh group, the second group has the advantages that erythema and phosphorus debris are reduced, thickening is not obviously improved, the vaseline only has a moisturizing effect and does not have a treatment effect of inhibiting keratinocyte proliferation, the vaseline serving as a humectant clinically is an auxiliary medicament for treating psoriasis, and a control in the experiment proves that the polyethylene glycol which is also commonly used as a humectant can inhibit psoriasis inflammation, so that the polyethylene glycol not only has a moisturizing effect, but also has a treatment effect. In comparison with the twelfth group, calcipotriol was found to be less effective in inhibiting psoriasis-like inflammation in the psoriasis mouse experiment than polyethylene glycol.
FIG. 2 is a graph showing the day one to day seven PASI scores of the back lesions of mice in the first, second, eighth, tenth, eleventh and twelfth groups, wherein Erythema (Erythema) means red or dark red inflammatory plaques, which are not completely discolored by compression; infiltration (Infiltration) refers to the tendency of skin damage to spread around, with blurred boundaries and substantial pressure; scales (Scales) refer to silvery-white flaky or about to shed stratum corneum cells, often evolved from hyperkeratosis, parakeratosis; cumulative (clinical) refers to the sum of erythema, infiltration, and phosphorus debris. Fig. 3 is a graph showing the PASI scores at day seven for the dorsal lesions of the mice of the first, second, eighth, tenth, eleventh and twelfth groups, showing that peg is effective in treating psoriasis and has a better therapeutic effect than calcipotriol.
Fig. 4 shows HE staining electron microscope results of dorsal skin lesions of mice in each group, and fig. 5 shows dorsal epidermal thickness of mice in the first, second, eighth, tenth, eleventh and twelfth groups, which indicates that peg can effectively inhibit keratinocyte proliferation and has significant efficacy.
As shown in fig. 6, which is a flow-through result graph of spleen cells of mice in the first group, the second group, the eighth group and the tenth group, and fig. 7, which is a flow-through result graph of skin cells on the back of mice in the first group, the second group, the eighth group and the tenth group, it can be seen that the number of MDSCs cell population in the second group is obviously increased, while polyethylene glycol can obviously inhibit IMQ-induced MDSCs increase, and skin flow shows that polyethylene glycol and glycerol can inhibit MDSCs increase, but the inhibition effect of polyethylene glycol is more obvious.
Clinical sheet blind test
In the case of two patients with moderate psoriasis who were treated with the psoriasis treatment drug of example 7 and calcipotriol in a control manner, as shown in fig. 8, which is a photograph of the first patient after being treated with the psoriasis treatment drug of example 7 and calcipotriol, respectively, and in fig. 9, which is a photograph of the second patient after being treated with the psoriasis treatment drug of example 7 and example 7, respectively, it can be seen that the skin lesions of the two patients treated with the psoriasis treatment drug of example 7 have better improvement effect than those treated with the calcipotriol, and the erythema, infiltration and thickening are all reduced remarkably.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (7)
1. The application of polyethylene glycol as an active ingredient in preparation of an external psoriasis treatment medicament is characterized in that the mass percentage of the polyethylene glycol in the psoriasis treatment medicament is 50-100%, and the number average molecular weight of the polyethylene glycol is 400-4000.
2. The use according to claim 1, wherein the psoriasis treatment medicament is in the form of a solution, lotion, liniment, ointment, plaster, paste or patch.
3. The use of claim 1, wherein the medicament for the treatment of psoriasis further comprises 0 to 15% by weight of glycerin.
4. The use of claim 1, wherein the topical psoriasis treatment medicament consists essentially of the following components in mass percent: 88 to 93 percent of polyethylene glycol and 7 to 12 percent of glycerol.
5. The use of claim 1, wherein the topical psoriasis treatment medicament consists essentially of the following components in mass percent: 45-55% of polyethylene glycol 400, 35-45% of polyethylene glycol 4000 and 5-15% of glycerol.
6. The use of claim 1, wherein the medicament for the treatment of psoriasis comprises the following components in percentage by mass: 50% polyethylene glycol 400, 40% polyethylene glycol 4000 and 10% glycerol.
7. The use according to claim 1, wherein the psoriasis treatment medicament further comprises one or more of excipients, preservatives, stabilizers, solubilizers and fragrances.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008012107A2 (en) * | 2006-07-28 | 2008-01-31 | Flen Pharma N.V. | Use of polyethylene glycol in inflammatory skin conditions and wound healing |
| WO2012136934A2 (en) * | 2011-04-06 | 2012-10-11 | Biopass S.A. | Healing composition for topical application |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008012107A2 (en) * | 2006-07-28 | 2008-01-31 | Flen Pharma N.V. | Use of polyethylene glycol in inflammatory skin conditions and wound healing |
| WO2012136934A2 (en) * | 2011-04-06 | 2012-10-11 | Biopass S.A. | Healing composition for topical application |
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