CN107028919A - A kind of compound Aescinate A, B liposome hydrogel patches - Google Patents
A kind of compound Aescinate A, B liposome hydrogel patches Download PDFInfo
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- CN107028919A CN107028919A CN201710325262.9A CN201710325262A CN107028919A CN 107028919 A CN107028919 A CN 107028919A CN 201710325262 A CN201710325262 A CN 201710325262A CN 107028919 A CN107028919 A CN 107028919A
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- aescinate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
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Abstract
The invention discloses a kind of anti-swelling pharmaceutical composition, it is made up of Aescinate A or its salt, Aescinate B or its salt, Diethylamine Salicylate in 0.3~1.5: 0.5 1: 2~5 ratio.The invention also discloses the compound Aescinate A containing said composition, B liposome hydrogel patches and preparation method thereof.Compared with prior art, the present invention has more preferable Transdermal absorption effect, anti-swelling effect and security.
Description
Technical field
The invention belongs to pharmaceutical field, it is related to a kind of anti-swelling pharmaceutical composition, contains the group the invention further relates to one kind
The compound Aescinate A of compound, B liposome hydrogel patches and preparation method thereof.
Background technology
Otoginsenoside be also known as otoginsenoside acid, be from Hippocastanaceae buckeye seed extract obtain total saposins,
The general name of β-otoginsenoside or different otoginsenoside etc., belongs to triterpene saponin.The water solubility of otoginsenoside is poor, to increase it
Solubility, is often made into sodium salt.Research has shown that the higher composition of content is Aescinate A, B, C, D in otoginsenoside.Seven leaves
Saponin(e can reduce pathologic capillary permeability and increase, and increase intravenous tension, reduce Inflammatory substances and ooze out, with anti-inflammatory, disappear
The effects such as swollen, analgesic, improvement blood circulation, the recovery of promotion acute and closed soft tissue injury.
Otoginsenoside oral administration biaavailability is not high, injects larger to blood vessel irritation, and topical administration passes through medicine
The osmosis of skin reaches internal body, has the following advantages that：1. the first pass effect and medicine of liver can be avoided in intestines and stomach
Interior degraded, drug absorption is not influenceed by gastrointestinal factors, reduces the individual difference of medication；2. single administration can be for a long time
Medicine is entered internal with constant speed, reduce administration number of times, extend dosing interval；3. blood caused by oral administration is avoided
Concentration peak valley phenomenon, reduces toxicity.
Have the exterior-applied formulations such as Sodium Aescinate ointment, aerosol, liniment at present to come out, existing otoginsenoside external preparation
Have the shortcomings that Transdermal absorption effect is poor, treatment time is short, skin irritation is big, anti-swelling effect is undesirable.
Diethylamine Salicylate has the effect of anti-inflammatory and antalgic, is mainly used in being used for rheumatism and rheumatoid arthritis.
The content of the invention
The purpose of the present invention primarily directed to existing otoginsenoside external preparation Transdermal absorption effect is poor, skin irritation
The defect such as greatly, treatment time is short, anti-swelling effect is undesirable is there is provided a kind of anti-swelling pharmaceutical composition, and contains the combination
The compound Aescinate A of thing, B liposome hydrogel patches and preparation method thereof.
The anti-swelling pharmaceutical composition that the present invention is provided is by Aescinate A or its salt, Aescinate B or its salt, salicylic acid
Diethylamine is constituted, and the Aescinate A or its salt, Aescinate B or its salt, the weight ratio of Diethylamine Salicylate are 0.3-1.5:
0.5-1∶2-5。
Compound Aescinate A that the present invention is provided, B liposome hydrogel patches, including adhesive-layer, back sheet and be covered in
Liposome hydrogel on adhesive-layer, the active component of the liposome hydrogel is above-described anti-swelling drug regimen
Thing, remaining is liposome hydrogel matrix.
Preferably, the liposome hydrogel is made up of the composition of following weight proportion：
It is further preferred that the liposome hydrogel is made up of the composition of following weight proportion：
Preferably, the phosphatide is soybean lecithin or lecithin.
Preferably, the antioxidant is ascorbic acid.
Preferably, the gel-type vehicle high polymer material be cellulose derivative, carbomer, alginate, polyvinyl alcohol,
One or more in polyvinylpyrrolidone, tragacanth, gelatin, carragheen.Wherein, cellulose derivative includes but not limited
In ethyl cellulose, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethylcellulose etc..
Preferably, the NMF is the one or more in glycerine, sorbierite, propane diols.
Preferably, the penetrating agent is the one or more in azone, borneol, peppermint.
Preferably, the solvent is the ethanol solution that weight concentration is 20-50%.
Compound Aescinate A that the present invention is provided, the preparation method of B liposome hydrogel patches comprise the following steps：
1) phosphatide, cholesterol, antioxidant are taken, solvent dissolving is added, adds Aescinate A or its salt, Aescinate B
Or its salt, Diethylamine Salicylate, it is well mixed, water bath with thermostatic control at a temperature of being placed in 30~50 DEG C, and rotary evaporation is to forming film,
The buffer solution that pH is 5~7, stirring shaking are added, until forming suspension, filtering obtains liposome solutions；
2) gel-type vehicle high polymer material is taken, solubilizer stirring is fully swelled, and adds NMF, penetrating agent and step 1)
Obtained liposome solutions, regulation pH value continues to stir and evenly mix and ultrasound degassing is to bubble-free, be coated on viscose glue to 4.0~6.5
On layer, dry to surface cure, then cover upper back sheet, cut into suitable size, closed, encapsulation is produced.
The beneficial effects of the invention are as follows：
1. compared with common patch, the present invention has more preferable Transdermal absorption effect, is mainly reflected at following 2 points：1) it is total saturating
Cross rate high；2) there is slow controlled-release effect, medicine can slowly be discharged with given pace, so that it is dense that constant blood medicine is formed in skin
Degree, is conducive to extending the treatment time of medicine.
2. with more preferable anti-swelling ability, Aescinate A, Aescinate B, Diethylamine Salicylate have significant collaboration
Synergistic effect.
3. skin irritation is small, safe.
Embodiment
The present invention is described in detail by the following examples.
Embodiment 1
Preparation method：1) soybean lecithin 25g, cholesterol 5g, ascorbic acid 0.5g are taken in container, 30% ethanol is added molten
Liquid 200g dissolves, and adds Aescinate A 1g, Aescinate B 0.6g, Diethylamine Salicylate 2.5g, is well mixed, is placed in 45
Water bath with thermostatic control at a temperature of DEG C, and rotary evaporation removes solvent to film is formed, and then adds the PBS that pH is 6, stirring is shaken
Shake, until forming suspension, filtering collects filtrate, obtains liposome solutions 65g；
2) take carbomer 5g, plus 30% ethanol solution 60g stirrings to be fully swelled, add glycerine 2g, azone 3.5g and step
The rapid liposome solutions 65g 1) obtained, with salt acid for adjusting pH value to 6, continues to stir and evenly mix and ultrasound degassing is to bubble-free, must answer
Square otoginsenoside liposome hydrogel 135g, coating is dried to surface cure, and back sheet in covering cuts into suitable size,
Closed, the 100g of hydrogel containing liposome patch is made in encapsulation.
Embodiment 2
Preparation method：1) lecithin 15g, cholesterol 8g, ascorbic acid 0.2g are taken in container, 40% ethanol solution is added
150g dissolves, and adds Aescinate A sodium salt 1.2g, Aescinate B sodium salt 0.5g, Diethylamine Salicylate 2g, is well mixed, is placed in
Water bath with thermostatic control at a temperature of 40 DEG C, and rotary evaporation removes solvent to film is formed, and then adds the PBS that pH is 5.5, stirs
Shaking is mixed, until forming suspension, filtering collects filtrate, obtains liposome solutions 55g；
2) take hydroxypropyl methyl cellulose 3g, plus 40% ethanol solution 70g stirrings are fully swelled, add glycerine 1.5g,
Propane diols 0.5g, borneol 1.5g, peppermint 1g and step 1) obtained liposome solutions 55g, with salt acid for adjusting pH value to 5, continues
Stir and evenly mix and ultrasound degassing is to bubble-free, obtain compound otoginsenoside liposome hydrogel 132g, be coated with, dry solid to surface
Change, back sheet in covering cuts into suitable size, closed, the 100g of hydrogel containing liposome patch is made in encapsulation.
Embodiment 3
Preparation method：1) lecithin 20g, cholesterol 3g, ascorbic acid 0.8g are taken in container, 25% ethanol solution is added
150g dissolves, and adds Aescinate A lysine salt 0.5g, Aescinate B lysine salt 1g, Diethylamine Salicylate 4g, mixes
Uniformly, water bath with thermostatic control at a temperature of being placed in 50 DEG C, and rotary evaporation removes solvent to film is formed, and then adds pH and delays for 7 PBS
Fliud flushing, stirring shaking, until forming suspension, filtering collects filtrate, obtains liposome solutions 70g；
2) take sodium alginate 4g, gelatin 2g, plus 25% ethanol solution 60g stirrings to be fully swelled, add glycerine 1g, azone
2g and step 1) obtained liposome solutions 70g, with salt acid for adjusting pH value to 5.5, continues to stir and evenly mix and ultrasound degassing is to nothing
Bubble, obtains compound otoginsenoside liposome hydrogel 139g, coating, dries to surface cure, and back sheet in covering cuts into conjunction
Suitable size, closed, encapsulation, is made the 100g of hydrogel containing liposome patch.
Test example
1. Transdermal absorption is tested
SD rats are taken, using 10%Na2The S aqueous solution is taken off except back wool, and next day, disconnected neck was put to death, and skin of back is cut immediately,
Hypodermis and fat are rejected, after physiological saline is rinsed well repeatedly, appropriately sized, inspection skin integrity is cut into.Using changing
(effective area is 2.92cm to good Franz vertical double-chambers diffusion cell2), the rat skin handled well is fixed on to two Room of diffusion cell
Between, stratum corneum side is to supply chamber.0.5g is taken to be placed in supply chamber the embodiment 1-3 liposome hydrogel patch precisions prepared,
7mL reception liquids are added into receiving chamber, reception liquid is PBS (0.01M, pH7.4).Water bath with thermostatic control is set as 32 DEG C, with
150r/min magnetic agitations.0.5mL reception liquids are taken respectively at 2,4,6,8,10,12h, while 0.5mL PBSs are supplemented, warp
After 0.45 μm of membrane filtration, 20 μ L sample introductions are taken to determine Aescinate A or its salt, Aescinate B or its salt, Diethylamine Salicylate,
Calculate drug concentration and accumulation transmitance.
Aescinate A or its salt, Aescinate B or its salt, Diethylamine Salicylate accumulation transmitance-time the results are shown in Table
1-3.
The accumulation transmitance (%) of the embodiment 1 of table 1
The accumulation transmitance (%) of the embodiment 2 of table 2
The accumulation transmitance (%) of the embodiment 3 of table 3
As can be seen from the above results, 1) present invention has the 12 of higher total transmitance, wherein Aescinate A or its salt
Hour total transmitance is up to more than 35%, and 12 hours total transmitances of Aescinate B or its salt are up to more than 28%, Diethylamine Salicylate
12 hours total transmitances up to more than 27%, obviously higher than common patch；2) present invention has slow-releasing and controlled-releasing action, can be with one
Constant speed rate slowly discharges, so as to form constant blood concentration in skin, is conducive to extending the treatment time of medicine, and common
The rate of release of patch quickly, reaches peak value in 4 hours or so.
2. anti-swelling test
Using mice ear model, if blank group, Aescinate A group, Aescinate B group, Diethylamine Salicylate group, seven
Swelling is determined after leaf saponin A+Aescinate B+Diethylamine Salicylate composition group, every group of 10 animals, coating, be the results are shown in Table
4。
The anti-swelling Experiment on Function result (n=10) of table 4
Result above shows that the anti-swelling ability of composition is substantially better than exclusive use Aescinate A, Aescinate B, water
Poplar diethylammonium salt, it was demonstrated that three has the effect of Synergistic.
3. skin irritation test
Healthy rabbits (2.0 ± 0.2kg) 20 are taken, 2 groups are randomly divided into, every group of male and female half and half investigate prepared by embodiment 1
Liposome hydrogel patch and the common patch of the Aescinate A prepared according to a conventional method (are free of Aescinate B and salicylic acid diethyl
Amine) skin irritation.In 24h before administration, animal backbone diamond wool is taken off with 10% sodium sulfide solution, per side unhairing scope
About 3cm × 3cm, can not damage epidermis.Experiment uses consubstantiality left and right sides Self-control method.Fat is given respectively in left and right side unhairing area
Plastid gel and water.2 times a day, successive administration one week, residual test medicine was washed away in the 8th day with warm water, observed medicine-feeding part
Erythema and oedema situation are whether there is, no erythema or oedema are set to 0 grade, have erythema or oedema then by being set to 1-4 grades from light to heavy.As a result
It is shown in Table 5.
The skin irritation test result of table 5
As can be seen from the above results, skin wound repair incidence of the present invention is relatively low, occurs without 1 erythema, oedema,
And the skin wound repair incidence of the common patch of Aescinate A is higher, and symptom is even more serious, takes a turn for the better slower, is discontinued 6 hours
Still respectively having 1 afterwards has slight erythema and oedema, illustrates that the security of the present invention is more preferable than common patch.
Claims (9)
1. a kind of anti-swelling pharmaceutical composition, it is characterised in that by Aescinate A or its salt, Aescinate B or its salt, salicylic acid
Diethylamine is constituted, and the Aescinate A or its salt, Aescinate B or its salt, the weight ratio of Diethylamine Salicylate are 0.3-1.5:
0.5-1∶2-5。
2. a kind of compound Aescinate A, B liposome hydrogel patches, including adhesive-layer, back sheet and it is covered on adhesive-layer
Liposome hydrogel, it is characterised in that：The active component of the liposome hydrogel is the anti-swelling medicine described in claim 1
Composition, remaining is liposome hydrogel matrix.
3. compound Aescinate A as claimed in claim 2, B liposome hydrogel patches, it is characterised in that：The liposome
Hydrogel is made up of the composition of following weight proportion：
4. compound Aescinate A as claimed in claim 3, B liposome hydrogel patches, it is characterised in that：The liposome
Hydrogel is made up of the composition of following weight proportion：
5. compound Aescinate A as claimed in claim 3, B liposome hydrogel patches, it is characterised in that：The gel base
Matter high polymer material be cellulose derivative, carbomer, alginate, polyvinyl alcohol, polyvinylpyrrolidone, tragacanth,
One or more in gelatin, carragheen.
6. compound Aescinate A as claimed in claim 3, B liposome hydrogel patches, it is characterised in that：The NMF
For the one or more in glycerine, sorbierite, propane diols.
7. compound Aescinate A as claimed in claim 3, B liposome hydrogel patches, it is characterised in that：The penetrating agent
For the one or more in azone, borneol, peppermint.
8. compound Aescinate A as claimed in claim 3, B liposome hydrogel patches, it is characterised in that：The solvent is
Weight concentration is 20~50% ethanol solution.
9. a kind of compound Aescinate A prepared described in claim 3-8 any one, the method for B liposome hydrogel patches,
It is characterized in that comprising the following steps：
1) take phosphatide, cholesterol, antioxidant, add solvent dissolving, add Aescinate A or its salt, Aescinate B or its
Salt, Diethylamine Salicylate, are well mixed, water bath with thermostatic control at a temperature of being placed in 30~50 DEG C, and rotary evaporation is to forming film, then add
Enter the buffer solution that pH is 5~7, stirring shaking, until forming suspension, filtering obtains liposome solutions；
2) gel-type vehicle high polymer material is taken, solubilizer stirring is fully swelled, and adds NMF, penetrating agent and step 1) obtain
Liposome solutions, regulation pH value to 4.0~6.5, continue to stir and evenly mix and ultrasound degassing to bubble-free, be coated on adhesive-layer
On, dry to surface cure, then cover upper back sheet, cut into suitable size, closed, encapsulation is produced.
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| CN201710325262.9A CN107028919B (en) | 2017-05-10 | 2017-05-10 | Compound aescin A, B liposome hydrogel patch |
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| CN201710325262.9A CN107028919B (en) | 2017-05-10 | 2017-05-10 | Compound aescin A, B liposome hydrogel patch |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496358A (en) * | 2017-09-06 | 2017-12-22 | 苏州大学 | A kind of enhanced hydrogel of liposome and its application |
| CN108567885A (en) * | 2018-07-27 | 2018-09-25 | 山东今古医疗科技有限公司 | Nano traditional Chinese medicine liposome aqueogel and preparation method for treating fat and fatty liver |
| CN108635524A (en) * | 2018-07-27 | 2018-10-12 | 山东今古医疗科技有限公司 | Nano traditional Chinese medicine liposome aqueogel for treating anorectal disease and preparation method |
| CN108837056A (en) * | 2018-07-27 | 2018-11-20 | 山东今古医疗科技有限公司 | For treating the nano traditional Chinese medicine liposome aqueogel and preparation method of skeletal joint disease |
| CN109464623A (en) * | 2018-11-23 | 2019-03-15 | 山东今古医疗科技有限公司 | For treating thyroid nodule Chinese medicine alcohol ester body cold compress gel and preparation method |
| CN111249226A (en) * | 2020-03-24 | 2020-06-09 | 中南大学 | Aescin injectable hydrogel and preparation method and application thereof |
| CN112546083A (en) * | 2020-12-22 | 2021-03-26 | 黑龙江迪龙制药有限公司 | Compound preparation containing sodium aescinate for relieving swelling and pain and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496358A (en) * | 2017-09-06 | 2017-12-22 | 苏州大学 | A kind of enhanced hydrogel of liposome and its application |
| CN108567885A (en) * | 2018-07-27 | 2018-09-25 | 山东今古医疗科技有限公司 | Nano traditional Chinese medicine liposome aqueogel and preparation method for treating fat and fatty liver |
| CN108635524A (en) * | 2018-07-27 | 2018-10-12 | 山东今古医疗科技有限公司 | Nano traditional Chinese medicine liposome aqueogel for treating anorectal disease and preparation method |
| CN108837056A (en) * | 2018-07-27 | 2018-11-20 | 山东今古医疗科技有限公司 | For treating the nano traditional Chinese medicine liposome aqueogel and preparation method of skeletal joint disease |
| CN109464623A (en) * | 2018-11-23 | 2019-03-15 | 山东今古医疗科技有限公司 | For treating thyroid nodule Chinese medicine alcohol ester body cold compress gel and preparation method |
| CN111249226A (en) * | 2020-03-24 | 2020-06-09 | 中南大学 | Aescin injectable hydrogel and preparation method and application thereof |
| CN111249226B (en) * | 2020-03-24 | 2021-06-15 | 中南大学 | Aescin injectable hydrogel and preparation method and application thereof |
| CN112546083A (en) * | 2020-12-22 | 2021-03-26 | 黑龙江迪龙制药有限公司 | Compound preparation containing sodium aescinate for relieving swelling and pain and preparation method thereof |
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| CN107028919B (en) | 2020-07-31 |
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