CN108969531A - Polyethylene glycol is preparing application and its drug in curing psoriasis drug as active constituent - Google Patents
Polyethylene glycol is preparing application and its drug in curing psoriasis drug as active constituent Download PDFInfo
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- A61K31/74—Synthetic polymeric materials
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Abstract
The present invention relates to a kind of polyethylene glycol as active constituent preparing in curing psoriasis drug application and its drug.Applicant of the present invention is found by experiment that, polyethylene glycol has significant therapeutic effect to psoriasis, increasing for splenomegaly and MDSCs cell mass can effectively be mitigated, fiest-tire medication Calcipotriol of the therapeutic effect better than clinically psoriasis external curing of polyethylene glycol is proved according to psoriatic lesion area and severity index (PASI) scoring, and polyethylene glycol has no toxic side effect, it will not cause skin allergy, stabilization is unlikely to deteriorate, moisture is set to be retained in keratoderma or skin corium by the fixed hydrone of a large amount of hydrogen bonds simultaneously, increase the ownership of moisture of skin, enhance the permeability of skin, play moistening effect, and ensure to continue that curative effect occurs, the pH value of skin is not influenced, pharmacy cost is also far below the clinical medicines such as Calcipotriol, the financial burden of patient can be significantly reduced, with extremely vast market prospect.
Description
Technical field
The present invention relates to field of medicaments, are preparing curing psoriasis as active constituent more particularly to a kind of polyethylene glycol
Application and its drug in drug.
Background technique
Psoriasis is a kind of common chronic, recurrent, inflammatory dermatoses, is clinically mainly shown as erythema, the scales of skin that peel off,
Its histopathology has specificity, shows as epidermal keratinocyte hyper-proliferative, and hyperkeratinization is with parakeratosis, acanthosis, very
Sparse inflammatory cell infiltration etc. around skin shallow-layer blood vessel.Disease incidence of the psoriasis in general population is 0.1%~3%, hair
Interpretation of the cause, onset and process of an illness system is complicated, easy recurrent exerbation.Most of psoriasis are light medium-sized patients, and external medication is main treatment method,
Occupy indispensable status.
Common psoriasis external drug has glucocorticoid, Tretinoin, vitamin D R derivative, Dithranol, tar preparation
And calcineurin inhibitors etc..Dithranol, tar preparation and glucocorticoid are used because side effect is larger and are limited, Tretinoin,
The therapeutic effect of calcineurin inhibitors and vitamin D R derivative is not very ideal.The glucocorticoid that lists recently with
The effect of the compound preparation Calcipotriol betamethasone ointment of vitamin D R derivative is slightly excellent compared with Calcipotriol, but its is at high cost
It is high, therefore the new drug for developing treatment psoriasis is significant.
Summary of the invention
Based on this, it is necessary to provide a kind of drug of preferable, the lower-cost treatment psoriasis of curative effect.
The present invention provides a kind of polyethylene glycol as active constituent is preparing the application in curing psoriasis drug.
In one of the embodiments, the dosage form of the curing psoriasis drug be solution, lotion, liniment, ointment,
Emplastrum, paste or patch.
The present invention also provides a kind of curing psoriasis drug, active constituent is mainly made of polyethylene glycol.
In one of the embodiments, in the curing psoriasis drug, the mass percent of the polyethylene glycol is
50%~100%.
Further include in the curing psoriasis drug in one of the embodiments, mass percent be 0%~15%
Glycerol.
The medicine for psoriasis object mainly consists of the following mass percentage components in one of the embodiments:
88%~93% polyethylene glycol and 7%~12% glycerol.
The medicine for psoriasis object mainly consists of the following mass percentage components in one of the embodiments:
45%~55% polyethylene glycol 400,35%~45% Macrogol 4000 and 5%~15% glycerol.
The number-average molecular weight of the polyethylene glycol is 400~4000 in one of the embodiments,.
It further include in one of the embodiments, excipient, preservative, stabilizer, increasing in the curing psoriasis drug
One of solvent and aromatic are a variety of.
In one of the embodiments, the following steps are included: by polyethylene glycol in 50 DEG C~70 DEG C heating stirrings, after cooling
Glycerol is added to stir up to the curing psoriasis drug.
Polyethylene glycol (PEG) has the advantageous properties such as water solubility, fixedness, physiological inertia, mildness and lubricity, because
This is widely used in cosmetics, pharmacy, chemical fibre often as auxiliary agents such as wetting agent, suspending agent, thickener and carrier matrixes
Polyethylene glycol is added as suspending agent and thickener, in drug and makeup in the industries such as food processing, such as in cleaning agent
Matrix etc. of the polyethylene glycol as ointment, emulsion, ointment and suppository is added in product, however polyethylene glycol is in terms of disease treatment
Property be not yet exploited, therefore it also has not been reported as the application of active pharmaceutical ingredient.Applicant of the present invention passes through examination
It issues after examination and approval now, polyethylene glycol has significant therapeutic effect to psoriasis, can effectively mitigate splenomegaly and the MDSCs (inhibition of derived from bone marrow
Property cell) cell mass increases, polyethylene glycol is proved according to psoriatic lesion area and severity index (PASI) scoring
Therapeutic effect is better than the fiest-tire medication Calcipotriol of clinically psoriasis external curing, and polyethylene glycol has no toxic side effect, will not
Cause skin allergy, stabilization is unlikely to deteriorate, while by a large amount of hydrogen bonds fixation hydrone make moisture be retained in keratoderma or
Skin corium increases the ownership of moisture of skin, enhances the permeability of skin, plays moistening effect, and ensures to continue that curative effect occurs,
The pH value of skin is not influenced, pharmacy cost is also far below the clinical medicines such as Calcipotriol, can significantly reduce the warp of patient
Ji burden, has extremely vast market prospect.
Detailed description of the invention
Fig. 1 is the 7th day back photo of first group to the 12nd group mouse in the test of IMQ inducing mouse psoriasis model；
Fig. 2 is first group, second group, the 8th group, the tenth group, the 11st group in the test of IMQ inducing mouse psoriasis model
With the 12nd group of first day to the 7th day PASI scoring figure of back of mice skin lesion；
Fig. 3 is first group, second group, the 8th group, the tenth group, the 11st group in the test of IMQ inducing mouse psoriasis model
With the 12nd group of back of mice skin lesion the 7th day PASI comprehensive score figure；
Fig. 4 is first group to the 12nd group back of mice skin lesion HE dyeing electricity in the test of IMQ inducing mouse psoriasis model
Mirror result figure；
Fig. 5 is first group, second group, the 8th group, the tenth group, the 11st group in the test of IMQ inducing mouse psoriasis model
With the 12nd group of back of mice epidermal thickness figure；
The mice spleen that Fig. 6 is first group, second group, the 8th group and the tenth group in the test of IMQ inducing mouse psoriasis model
Dirty cell streaming result figure；
The mouse back that Fig. 7 is first group, second group, the 8th group and the tenth group in the test of IMQ inducing mouse psoriasis model
Portion's Skin Cell streaming result figure；
Fig. 8 is that first patient is controlled using the curing psoriasis drug of Calcipotriol and embodiment 7 respectively in clinical test
Photo after treatment；
Fig. 9 is that second patient is controlled using the curing psoriasis drug of Calcipotriol and embodiment 7 respectively in clinical test
Photo after treatment.
Specific embodiment
To facilitate the understanding of the present invention, below will to invention is more fully described, and give it is of the invention compared with
Good embodiment.But the invention can be realized in many different forms, however it is not limited to embodiment described herein.Phase
Instead, purpose of providing these embodiments is makes the disclosure of the present invention more thorough and comprehensive.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.Term as used herein "and/or" includes one or more phases
Any and all combinations of the listed item of pass.
The present invention provides a kind of polyethylene glycol as active constituent is preparing the application in curing psoriasis drug.
Optionally, the dosage form of curing psoriasis drug is solution, lotion, liniment, ointment, emplastrum, paste or patch
Agent etc., it is without being limited thereto, it can select as needed.
The curing psoriasis drug of an embodiment of the present invention, active constituent are mainly made of polyethylene glycol.
Polyethylene glycol (PEG) has the advantageous properties such as water solubility, fixedness, physiological inertia, mildness and lubricity, because
This is widely used in cosmetics, pharmacy, chemical fibre often as auxiliary agents such as wetting agent, suspending agent, thickener and carrier matrixes
Polyethylene glycol is added as suspending agent and thickener, in drug and makeup in the industries such as food processing, such as in cleaning agent
Matrix etc. of the polyethylene glycol as ointment, emulsion, ointment and suppository is added in product, however polyethylene glycol is in terms of disease treatment
Property be not yet exploited, therefore it also has not been reported as the application of active pharmaceutical ingredient.Applicant of the present invention passes through examination
It issues after examination and approval now, polyethylene glycol has significant therapeutic effect to psoriasis, can effectively mitigate splenomegaly and the MDSCs (inhibition of derived from bone marrow
Property cell) cell mass increases, polyethylene glycol is proved according to psoriatic lesion area and severity index (PASI) scoring
Therapeutic effect is better than the fiest-tire medication Calcipotriol of clinically psoriasis external curing, and polyethylene glycol has no toxic side effect, will not
Cause skin allergy, stabilization is unlikely to deteriorate, while by a large amount of hydrogen bonds fixation hydrone make moisture be retained in keratoderma or
Skin corium increases the ownership of moisture of skin, enhances the permeability of skin, plays moistening effect, and ensures to continue that curative effect occurs,
The pH value of skin is not influenced, pharmacy cost is also far below the clinical medicines such as Calcipotriol, can significantly reduce the warp of patient
Ji burden, has extremely vast market prospect.
The inhibitory cells (Myeloid-derived suppressor cells, MDSCs) of derived from bone marrow are marrow
The a group heterogeneity cell in source, before being Dendritic Cells (dendritic cells, DCs), macrophage and (or) granulocyte
Body has the ability for significantly inhibiting immune cell responses.According to the literature, the quantity of psoriatic MDSCs compares normal person
Apparent increase, while IMQ induction psoriasis model MDSCs quantity also compared with normal mouse apparent increase.Its mechanism is silver
Considering disease to be worth doing is a kind of immunity disease, is increased with immunocytes quantity such as Dendritic Cells, macrophages, negative-feedback regu- lation
MDSCs is divided into immunocyte, to make the quantity of MDSCs increase, therefore MDSCs can be used as the mark for judging psoriasis activity
Object.
In one embodiment, in curing psoriasis drug, the mass percent of polyethylene glycol is 50%~100%.
Further, further include in curing psoriasis drug mass percent be 0%~15% glycerol.Experiments have shown that
Polyethylene glycol and glycerol, which share, to further increase moistening effect by increasing local penetration pressure, and can effectively enhance poly- second two
Alcohol shares then without the curative effect humidification therapeutic effect of psoriasis with moisturizing materials such as vaseline.
In one embodiment, medicine for psoriasis object mainly consists of the following mass percentage components: 88%~
93% polyethylene glycol and 7%~12% glycerol.
Optionally, the number-average molecular weight of polyethylene glycol is 400~4000, experiments have shown that molecular weight polyethylene glycol is lower, is changed
The effect of kind psoriatic lesion is better, and the polyethylene glycol of low molecular weight is liquid, and the polyethylene glycol of high molecular weight is solid, can root
It selects to arrange in pairs or groups according to different dosage forms, number-average molecular weight is selected to be more convenient for producing preparation for 400~4000 polyethylene glycol.
In one embodiment, medicine for psoriasis object mainly consists of the following mass percentage components: 45%~
55% polyethylene glycol 400,35%~45% Macrogol 4000 and 5%~15% glycerol.Drug is half under ratio combination
Solid, ductility, smear and mobility are best, suitable for preparing liniment, ointment etc..
It optionally, further include in excipient, preservative, stabilizer, solubilizer and aromatic in curing psoriasis drug
It is one or more.It is appreciated that without being limited thereto, pharmaceutically acceptable auxiliary material can be added.
The preparation method of the above-mentioned curing psoriasis drug of an embodiment of the present invention, comprising the following steps: by poly- second two
Alcohol is added glycerol after cooling and stirs up to above-mentioned curing psoriasis drug in 50 DEG C~70 DEG C heating stirrings.
The following are specific embodiments.
Embodiment 1
10g polyethylene glycol 400 is weighed, is liquid condition since the molecular weight of polyethylene glycol 400 is smaller, it can be directly as silver
Consider sick therapeutic agent to be worth doing.
Embodiment 2
8g polyethylene glycol 400 and 2g Macrogol 4000 are weighed respectively, 10min are stirred under 60 DEG C of waters bath with thermostatic control, then
40 DEG C are cooled to be mixed evenly to get the curing psoriasis drug of liquid condition is arrived.
Embodiment 3
7g polyethylene glycol 400 and 3g Macrogol 4000 are weighed respectively, 10min are stirred under 60 DEG C of waters bath with thermostatic control, then
40 DEG C are cooled to be mixed evenly to get the curing psoriasis drug of liquid condition is arrived.
Embodiment 4
6g polyethylene glycol 400 and 4g Macrogol 4000 are weighed respectively, 10min are stirred under 60 DEG C of waters bath with thermostatic control, then
40 DEG C are cooled to be mixed evenly to get the curing psoriasis drug of semi-solid state is arrived.
Embodiment 5
5g polyethylene glycol 400 and 5g Macrogol 4000 are weighed respectively, 10min are stirred under 60 DEG C of waters bath with thermostatic control, then
40 DEG C are cooled to be mixed evenly to get the curing psoriasis drug of semi-solid state is arrived.
Embodiment 6
10g Macrogol 4000 is weighed, since the molecular weight of Macrogol 4000 is solid state, thus it is molten when use
In Xie Yushui.
Embodiment 7
5g polyethylene glycol 400 and 4g Macrogol 4000 are weighed respectively, 10min are stirred under 60 DEG C of waters bath with thermostatic control, then
40 DEG C are cooled to, 1g medicinal glycerin is added and is mixed evenly to get the curing psoriasis drug of semi-solid state is arrived.
Comparative example 1
Directly 10g glycerol is weighed as therapeutic agent.
Comparative example 2
Directly 10g vaseline is weighed as therapeutic agent.
Comparative example 3
Directly 10g Calcipotriol is weighed as therapeutic agent.
The test of IMQ inducing mouse psoriasis model
The mouse model of imiquimod induction, can well from pachyderma, keratinocyte GAP-associated protein GAP it is abnormal,
Inflammatory cell infiltration and related inflammation cell factor etc. simulation psoriasis symptom similar with people.Such model is due to simple
Easy to operate, model stability has become one of research and most widely used psoriasis model.
40 SPF grades (no-special pathogen grade experimental animal) 8 weeks BALB/C mices are taken to be randomly divided into 10 groups, every group 4
Only, back shaving range 4cm × 5cm.First group is normal group, without any processing；Only smear imiquimod in second group of back；
Third group after back is smeared imiquimod 6 hours, smears the curing psoriasis of 1~embodiment of embodiment 7 to the 9th group respectively
Drug；Tenth group after back is smeared imiquimod 6 hours, is smeared the therapeutic agent of comparative example 1；11st group is smeared at back
After imiquimod 6 hours, the therapeutic agent of comparative example 2 is smeared；12nd group after back is smeared imiquimod 6 hours, is smeared
The therapeutic agent of comparative example 3.Every group of continuous coating is after 6 days, to each group back of mice skin lesion progress psoriatic lesion area and sternly
Mouse psoriasiform symptom is investigated in weight extent index (PASI) scoring, and then weighing, which is taken pictures, puts to death mouse, and back skin lesion is taken to be HE
Coloration experiment investigates thickness, that is, horn cell proliferative conditions of epidermis, and takes mouse spleen weighing to take pictures simultaneously and do cell streaming
Investigate the quantity variation of MDSCs.
It is as shown in Figure 1 the 7th day back photo of each group mouse, it is seen that second group compared with first group of back skin lesion
There is apparent erythema, thicken, the scales of skin that peel off, it was demonstrated that psoriasis model induces successfully after smearing imiquimod.Third group to the 9th group with
Second group is compared, it is seen that erythema infiltrates, thickens significant mitigation, illustrates that polyethylene glycol can effectively treat psoriasis.Third
Group is to being compared to each other between the tenth group, it is seen that and third group skin lesion inflammation is most light, and followed by the 4th group and the 5th group, the 8th group of skin lesion
Inflammation is most heavy, the 7th group compared with the 9th group, the 9th group of skin lesion inflammation is considerably lighter, illustrates the lower polyethylene glycol of molecular weight
400 contents, and the effect for inhibiting psoriasis inflammation is better, and a certain amount of glycerol is added than being used alone in polyethylene glycol
Polyethylene glycol inhibits the effect of inflammation more preferable.Second group compared with the tenth group, erythema infiltrates, thickens and slightly mitigate but can not show a candle to
The effect of polyethylene glycol is good.Second group compared with the 11st group, erythema, phosphorus bits mitigate, but thicken and are not improved, illustrate all scholars
Woods only serves moisture-keeping function, does not play the therapeutic effect for inhibiting keratinocyte proliferation, and clinically vaseline is as moisturizer
The adjuvant drug of curing psoriasis proves it is equally to be commonly used for the polyethylene glycol of moisturizer to press down as control in this experiment
Psoriasis inflammation processed not only there is moisture-keeping function to also act therapeutic effect.Third group to the tenth group compared with the 12nd group,
It can be seen that Calcipotriol inhibits the effect of psoriasiform inflammation to be not so good as polyethylene glycol in psoriasis mice experiment.
It is illustrated in figure 2 first group, second group, the 8th group, the tenth group, the 11st group and the 12nd group of back of mice skin
First day to the 7th day PASI of damage scores figure, and wherein erythema (Erythema) refers to the red or inflammatory spot of kermesinus, pressure no
It fades completely；Infiltration (Infiltration) refers to that the trend of sprawling is spread in skin lesion around, and obscurity boundary is unclear, and pressure has essence
Sense；The scales of skin that peel off (Scales) refers to the corneocyte that silvery white sheet has fallen off or will fall off, often by hyperkeratinization, angling
It is not evolved entirely；Accumulation (Cumulative) refers to the summation of erythema, infiltration and phosphorus bits.Fig. 3 show first group, second
Group, the 8th group, the tenth group, back of mice skin lesion the 7th day PASI comprehensive score figure of the 11st group and the 12nd group, it is seen that
Polyethylene glycol can effectively treat psoriasis, and curative effect is better than Calcipotriol.
It is illustrated in figure 4 each group back of mice skin lesion HE dyeing Electronic Speculum result figure, Fig. 5 is first group, second group, the 8th
Group, the tenth group, the back of mice epidermal thickness figure of the 11st group and the 12nd group, illustrate that polyethylene glycol can effectively inhibit angle
Cell plastid proliferation, curative effect highly significant.
It is illustrated in figure 6 first group, second group, the 8th group and the tenth group of Mouse spleen cells streaming result figure, Fig. 7 institute
It is shown as first group, second group, the 8th group and the tenth group of back of mice Skin Cell streaming result figure, it is seen that second group
MDSCs cell mass quantity increased significantly, and the MDSCs that polyethylene glycol can obviously inhibit IMQ to induce increases, and skin streaming shows poly-
Ethylene glycol and glycerol can inhibit MDSCs to increase, but the inhibiting effect of polyethylene glycol is more obvious.
Clinical single blind trial
Two moderate psoriatics are carried out pair using the curing psoriasis drug and Calcipotriol of embodiment 7 respectively
According to treatment, it is illustrated in figure 8 after first patient uses Calcipotriol and the curing psoriasis drug of embodiment 7 to treat respectively
Photo, Fig. 9 show the photo after second patient uses Calcipotriol and embodiment 7 to treat respectively, it is seen that two patient's warps
Embodiment 7 curing psoriasis drug treatment skin lesion it is more preferable than the skin lesion improvement that Calcipotriol is treated, erythema, infiltration,
Thicken significant mitigation.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality
It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (10)
1. a kind of polyethylene glycol is preparing the application in curing psoriasis drug as active constituent.
2. application according to claim 1, which is characterized in that the dosage form of the curing psoriasis drug is solution, washes
Agent, liniment, ointment, emplastrum, paste or patch.
3. a kind of curing psoriasis drug, which is characterized in that its active constituent is mainly made of polyethylene glycol.
4. curing psoriasis drug according to claim 3, which is characterized in that described in the curing psoriasis drug
The mass percent of polyethylene glycol is 50%~100%.
5. curing psoriasis drug according to claim 4, which is characterized in that further include in the curing psoriasis drug
The glycerol that mass percent is 0%~15%.
6. curing psoriasis drug according to claim 4, which is characterized in that the medicine for psoriasis object mainly by with
The group of lower mass percent is grouped as: 88%~93% polyethylene glycol and 7%~12% glycerol.
7. curing psoriasis drug according to claim 4, which is characterized in that the medicine for psoriasis object mainly by with
The group of lower mass percent is grouped as: 45%~55% polyethylene glycol 400,35%~45% Macrogol 4000 and 5%~
15% glycerol.
8. according to the described in any item curing psoriasis drugs of claim 3~7, which is characterized in that the number of the polyethylene glycol
Average molecular weight is 400~4000.
9. according to the described in any item curing psoriasis drugs of claim 3~7, which is characterized in that the medicine for psoriasis
It further include one of excipient, preservative, stabilizer, solubilizer and aromatic or a variety of in object.
10. a kind of preparation method of the described in any item curing psoriasis drugs of claim 5~7, which is characterized in that including with
Lower step: by polyethylene glycol in 50 DEG C~70 DEG C heating stirrings, glycerol is added after cooling and stirs up to the medicine for psoriasis
Object.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810048207.4A CN108969531B (en) | 2018-01-18 | 2018-01-18 | Application of polyethylene glycol as active ingredient in preparation of psoriasis treatment medicine and medicine thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810048207.4A CN108969531B (en) | 2018-01-18 | 2018-01-18 | Application of polyethylene glycol as active ingredient in preparation of psoriasis treatment medicine and medicine thereof |
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| CN108969531B CN108969531B (en) | 2020-12-11 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113975249A (en) * | 2021-10-14 | 2022-01-28 | 中山大学·深圳 | Preparation of Tris-BNP nano-particles and application thereof in treatment of skin diseases |
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| 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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2018
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| 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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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113975249A (en) * | 2021-10-14 | 2022-01-28 | 中山大学·深圳 | Preparation of Tris-BNP nano-particles and application thereof in treatment of skin diseases |
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