CN108926525A - A kind of arthritis externally applied transdermal absorption preparation - Google Patents
A kind of arthritis externally applied transdermal absorption preparation Download PDFInfo
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- CN108926525A CN108926525A CN201811076198.6A CN201811076198A CN108926525A CN 108926525 A CN108926525 A CN 108926525A CN 201811076198 A CN201811076198 A CN 201811076198A CN 108926525 A CN108926525 A CN 108926525A
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- arthritis
- oridonin
- transdermal absorption
- externally applied
- absorption preparation
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Physical Education & Sports Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of arthritis externally applied transdermal absorption preparations, contain Oridonin, its pharmaceutically acceptable derivates or its prodrug.Transdermal drag delivery is utilized in the present invention, the concentration of Oridonin is comprehensively considered, the selection of matrix, the factors such as the selection of skin penetration enhancer, it is absorbed into Oridonin in vivo through skin, and the joint that can go directly, overcome the bad defect of Oridonin oral result, experiment proves that, the acute arthritis of Oridonin externally applied transdermal absorption preparation Carrageenan induction in the present invention has the characteristics that direct and significantly inhibiting effect, show that it can be used as an arthritis topical class pharmaceutical dosage form, treatment for related diseases such as arthritis.
Description
Technical field
The present invention relates to a kind of arthritis externally applied transdermal absorption preparations, and in particular to one kind contains Oridonin, its medicine
The arthritis externally applied transdermal absorption preparation of acceptable derivates or its prodrug on.
Background technique
Rheumatoid arthritis (rheumatoid arthritis, RA) is a kind of persistent hyperplastic, cartilage and bone with synovial membrane
Autoimmune disease based on the pathological characteristics of destruction mainly with chronic inflammation, multiple arthroncus, pain and its causes
Anchylosis in addition function lose be clinical manifestation, the cause of disease and pathogenesis remain unknown.
Osteoarthritis influence is more than 3.8% people, and the people of rheumatoid arthritis influence about 0.24% is in general, with
The growth at age, disease become more universal.Therefore, the drug for continuing to study anti-osteoarthritis seems especially urgent.
Rabdosia rubescens (Rabdosiarubescens (Hemsl.) Hara), is Labiatae Rabdosia plant, is distributed widely in
China Yellow River basin and its on the south wide geographic area.Sweet-bitter flavor, cold nature have relieving superficies by cooling, anti-inflammatory analgetic, stomach invigorating promoting blood circulation and resist
The effects of tumour.Oridonin (Oridonin) is a kind of active Diterpenes native compound from Rabdosia rubescens, is colourless
Prism-shaped crystallization, taste is extremely bitter, not soluble in water.Oridonin can pass through the number of mechanisms such as growth of tumour cell, apoptosis-induced
Significantly antitumor action is played, the treatment of liver cancer, the cancer of the esophagus, cancer of pancreas etc. is clinically mainly used for.In addition, also there is document report
Road Oridonin also has inhibiting effect to rheumatoid arthritis fibroblast sample synovial cell (RAFLS), can lower LPS
The Raw264.7 cell proinflammatory factor expression of induction has the function of inhibiting osteoclast differentiation.But have no at present it is related with
Report of the Oridonin as main active treatment rheumatoid arthritis and osteoarthritis drugs.
Process study shows to be absorbed quickly after Oridonin enters in vivo Oridonin in vivo, and divides extensively
It is distributed in each tissue, in liver, pancreas and is to be distributed into tissue more, is distributed in thymus gland, marrow, brain and bone less.And
And since Oridonin is practically insoluble in water, oral result is poor, it is difficult to reach therapeutic effect.There is provided it is a kind of new to
Medicine system, which enables Oridonin to be more effectively used for arthritic treatment, to be necessary.
Summary of the invention
The purpose of the present invention is to provide a kind of arthritis externally applied transdermal absorption preparations, wherein containing Oridonin, its
Pharmaceutically acceptable derivates or its prodrug.
The technical solution used in the present invention is:
Oridonin, its pharmaceutically acceptable derivates or its prodrug are in preparation arthritis externally applied transdermal absorption preparation
In application.
A kind of arthritis externally applied transdermal absorption preparation, containing Oridonin, its pharmaceutically acceptable derivates or its
Prodrug.
Further, transdermal absorption formulation is gelling agent, ointment, any one in cream.
Further, also containing pharmaceutic adjuvant in transdermal absorption formulation, pharmaceutic adjuvant is gel-type vehicle, transdermal enhancer,
PH adjusting agent, one or more of preservative and stabilizer；
Gel-type vehicle be selected from atoleine, vaseline, chitosan, ulcerlmin, propylene glycol, ethyl alcohol, glycerol, polyethylene glycol,
Polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl
One of sodium cellulosate is a variety of；
Transdermal enhancer is selected from ethyl alcohol, propylene glycol, isopropanol, menthol, peppermint oil, eucalyptus oil, borneol, urea, oleic acid
One of or it is a variety of；
PH adjusting agent is one of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, phosphate or a variety of；
Preservative is selected from ethyl alcohol, chloreresol, potassium sorbate, anesin, methylparaben, ethylparaben, Ni Bo
It is golden propyl ester, sulphite, cysteine ??acid, vitamin C, vitamin E, one or more in di-t-butyl toluene；
Stabilizer is selected from metal-chelator disodium EDTA, two calcium salt of ethylenediamine tetra-acetic acid or diethyl acid amide five
One of acetic acid is a variety of.
Further, contain Oridonin in arthritis externally applied transdermal absorption preparation, atoleine, vaseline, the third two
Alcohol.
Further, the content of each ingredient are as follows: Oridonin 5-15mg/g, atoleine 750-850mg/g, vaseline
80-100mg/g, propylene glycol 100mg/g.
Further, the content of each ingredient are as follows: Oridonin 10mg/g, atoleine 800mg/g, vaseline 90mg/
G, propylene glycol 100mg/g.
The beneficial effects of the present invention are: utilizing transdermal drag delivery in the present invention, the dense of Oridonin has been comprehensively considered
The factors such as degree, the selection of matrix, the selection of skin penetration enhancer, are absorbed into Oridonin in vivo through skin, and
Can go directly joint, overcome the bad defect of Oridonin oral result, experiment proves that, the Rabdosia rubescens in the present invention
The acute arthritis of A prime externally applied transdermal absorption preparation Carrageenan induction has the characteristics that direct and significantly inhibiting effect, table
Bright its can be used as an arthritis topical class pharmaceutical dosage form, the treatment for related diseases such as arthritis.
Detailed description of the invention
Fig. 1 is that the treatment of the acute arthritis mouse of Oridonin externally applied transdermal absorption preparation Carrageenan induction is made
Use test result；
Fig. 2 is that the treatment of the acute arthritis mouse of Oridonin externally applied transdermal absorption preparation Carrageenan induction is made
With, and compared on the same object of reference；
Fig. 3 is that the treatment of the acute arthritis mouse of Oridonin externally applied transdermal absorption preparation Carrageenan induction is made
Result statistical chart (n=6), including sufficient thickness difference (mm) and lumping weight poor (mg) (note: compared with blank control group, ###P <
0.001；Compared with model group, P < 0.001 * * P < 0.01, * * *)；
Specific embodiment
The object of the present invention is to provide a kind of externally applied transdermal absorption preparations containing Oridonin, utilize Transdermal absorption skill
Art has comprehensively considered the factors such as the selection of the concentration, matrix of Oridonin, the selection of skin penetration enhancer, has passed through drug
Skin is absorbed into vivo, and the joint that can go directly, and overcomes the bad defect of Oridonin oral result, the present invention
Additionally provide the preparation method and its medicinal application of the transdermal absorption formulation containing Oridonin.
Further, arthritis transdermal absorption formulation is gelling agent, ointment, any one in cream.
Further, also contain pharmaceutic adjuvant in arthritis externally applied transdermal absorption preparation, pharmaceutic adjuvant be transdermal enhancer,
PH adjusting agent, one or more of preservative and stabilizer；
Gel-type vehicle be selected from atoleine, vaseline, chitosan, ulcerlmin, propylene glycol, ethyl alcohol, glycerol, polyethylene glycol,
Polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl
One of sodium cellulosate is a variety of；
Transdermal enhancer is selected from ethyl alcohol, propylene glycol, isopropanol, menthol, peppermint oil, eucalyptus oil, borneol, urea, oleic acid
One of or it is a variety of；
PH adjusting agent is one of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, phosphate or a variety of；
Preservative is selected from ethyl alcohol, chloreresol, potassium sorbate, anesin, methylparaben, ethylparaben, Ni Bo
It is golden propyl ester, sulphite, cysteine ??acid, vitamin C, vitamin E, one or more in di-t-butyl toluene；
Stabilizer is selected from metal-chelator disodium EDTA, two calcium salt of ethylenediamine tetra-acetic acid or diethyl acid amide five
One of acetic acid is a variety of.
Further, contain Oridonin in arthritis externally applied transdermal absorption preparation, atoleine, vaseline, the third two
Alcohol.
Further, the content of each ingredient are as follows: Oridonin 5-15mg/g, atoleine 750-850mg/g, vaseline
80-100mg/g, propylene glycol 100mg/g.
Further, the content of each ingredient are as follows: Oridonin 10mg/g, atoleine 800mg/g, vaseline 90mg/
G, propylene glycol 100mg/g.
Below in conjunction with embodiment, the present invention is further explained, it should be appreciated that following embodiment be merely to illustrate the present invention and
It is not used in and limits the scope of the invention.
Embodiment 1
1, the preparation of carrageenan (1%)
The carrageenan weighed up is poured into small mortar by the small mortar for taking a high pressure sterilization to cross, first on a small quantity sterile
The grinding of 0.9% physiological saline, it is then slowly a small amount of again repeatedly to add remaining physiological saline.Note: configuring within experiment first 24 hours,
4 degree of refrigerators are stood overnight.It is used when use in grinding.
2, the preparation of Oridonin externally applied transdermal absorption preparation (1% ointment)
Raw material: Oridonin 10mg, atoleine 800mg, vaseline 90mg, propylene glycol 100mg.
Method: taking Oridonin to set in mortar, and a small amount of atoleine is added to grind, and is repeatedly ground to uniform and smooth paste on a small quantity
Shape, then progressively increase by several times vaseline and propylene glycol are ground well to full dose to obtain the final product.
3, the effect of the acute arthritis of Oridonin externally applied transdermal absorption preparation Carrageenan induction
6 weeks big female C57BL/6 mouse are taken, clean animal house is placed in advance and adapts to environment after a week, by mouse point
For blank control group, model group, Oridonin group and positive drug group, then model group, Oridonin group and positive drug group
Mouse take position of lying prone, and the left and right hind leg of mouse smear respectively simultaneously not drug containing solvent paste (atoleine 800mg,
Vaseline 90mg, propylene glycol 100mg are mixed), Oridonin Transdermal absorption paste, positive drug Fuatlin Cream agent, often
Every 5min coating 1 time, continuous 6 times.1% carrageenan of vola pedis s.c, 30 μ l causes inflammation after every mouse is right when 30min after administration.5h
After put to death mouse, measurement mouse or so toes thickness, and mouse foot is symmetrically cut from ankle, weighing, with left and right sufficient weight difference
As mouse degree of paw swelling.Such as Fig. 1,2, such as Fig. 3 is as a result counted.According to Fig. 1,2,3 it is found that compared with blank control group, model group
The right metapedes of mouse have obvious tumefaction, and Oridonin Transdermal absorption paste and positive drug can be substantially reduced foot swelling.It is comprehensive
On, Oridonin Transdermal absorption paste can be substantially reduced the acute arthritis of carrageenan induction.
Claims (7)
1. Oridonin, its pharmaceutically acceptable derivates or its prodrug are in preparation arthritis externally applied transdermal absorption preparation
Application.
2. a kind of arthritis externally applied transdermal absorption preparation, containing Oridonin, its pharmaceutically acceptable derivates or its before
Medicine.
3. arthritis externally applied transdermal absorption preparation according to claim 2, it is characterised in that: transdermal absorption formulation is gel
Agent, ointment, any one in cream.
4. arthritis externally applied transdermal absorption preparation according to claim 2, it is characterised in that: also contain pharmaceutic adjuvant, medicine
It is gel-type vehicle, transdermal enhancer, pH adjusting agent, one or more of preservative and stabilizer with auxiliary material；
Gel-type vehicle is selected from atoleine, vaseline, chitosan, ulcerlmin, propylene glycol, ethyl alcohol, glycerol, polyethylene glycol, poly- second
Enol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose
One of plain sodium is a variety of；
Transdermal enhancer is selected from ethyl alcohol, propylene glycol, isopropanol, menthol, peppermint oil, eucalyptus oil, borneol, urea, in oleic acid
It is one or more；
PH adjusting agent is one of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, phosphate or a variety of；
Preservative is selected from ethyl alcohol, chloreresol, potassium sorbate, anesin, methylparaben, ethylparaben, nipalgin third
It is ester, sulphite, cysteine ??acid, vitamin C, vitamin E, one or more in di-t-butyl toluene；
Stabilizer is selected from metal-chelator disodium EDTA, two calcium salt of ethylenediamine tetra-acetic acid or oxalic acid triamine pentaacetic acid
One of or it is a variety of.
5. arthritis externally applied transdermal absorption preparation according to claim 2, it is characterised in that: contain Oridonin, liquid
Body paraffin, vaseline, propylene glycol.
6. arthritis externally applied transdermal absorption preparation according to claim 5, it is characterised in that: the content of each ingredient are as follows: winter
Insult careless A prime 5-15mg/g, atoleine 750-850mg/g, vaseline 80-100mg/g, propylene glycol 100mg/g.
7. arthritis externally applied transdermal absorption preparation according to claim 5, it is characterised in that: the content of each ingredient are as follows: winter
Insult careless A prime 10mg/g, atoleine 800mg/g, vaseline 90mg/g, propylene glycol 100mg/g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811076198.6A CN108926525B (en) | 2018-09-14 | 2018-09-14 | External transdermal absorption preparation for arthritis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811076198.6A CN108926525B (en) | 2018-09-14 | 2018-09-14 | External transdermal absorption preparation for arthritis |
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| CN108926525A true CN108926525A (en) | 2018-12-04 |
| CN108926525B CN108926525B (en) | 2021-08-31 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111135280A (en) * | 2020-01-15 | 2020-05-12 | 威海盛朗生物科技有限公司 | A pharmaceutical composition, ointment and plaster for treating arthritis |
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|---|---|---|---|---|
| CN1839926A (en) * | 2006-01-23 | 2006-10-04 | 张海 | Medicine for treating acute and chronic pharyngitis, tumour, and the rabdosia extraction method |
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2018
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Cited By (1)
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|---|---|---|---|---|
| CN111135280A (en) * | 2020-01-15 | 2020-05-12 | 威海盛朗生物科技有限公司 | A pharmaceutical composition, ointment and plaster for treating arthritis |
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| CN108926525B (en) | 2021-08-31 |
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