CN108926525B - External transdermal absorption preparation for arthritis - Google Patents
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- CN108926525B CN108926525B CN201811076198.6A CN201811076198A CN108926525B CN 108926525 B CN108926525 B CN 108926525B CN 201811076198 A CN201811076198 A CN 201811076198A CN 108926525 B CN108926525 B CN 108926525B
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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
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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
- A61K9/06—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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Abstract
The invention discloses an external transdermal absorption preparation for arthritis, which contains oridonin, a pharmaceutically acceptable derivative thereof or a prodrug thereof. The invention utilizes the transdermal absorption technology, comprehensively considers the factors such as the concentration of the oridonin, the selection of a matrix, the selection of a transdermal absorption enhancer and the like, leads the oridonin to enter the body by skin absorption and to directly reach the joint, overcomes the defect of poor oral effect of the oridonin, and tests prove that the oridonin external transdermal absorption preparation has the characteristic of directly and obviously inhibiting the acute carrageenan-induced arthritis, thereby showing that the oridonin external transdermal absorption preparation can be used as an external arthritis drug preparation and is used for treating related diseases such as arthritis.
Description
Technical Field
The invention relates to an external transdermal absorption preparation for arthritis, in particular to an external transdermal absorption preparation for arthritis, which contains oridonin, a pharmaceutically acceptable derivative thereof or a prodrug thereof.
Background
Rheumatoid Arthritis (RA) is an autoimmune disease mainly characterized by the pathological features of continuous synovial membrane proliferation and cartilage and bone destruction, and is clinically manifested by chronic inflammation, multiple joint swelling and pain and the resulting joint stiffness, even loss of function, and the etiology and pathogenesis of the disease are unknown.
Osteoarthritis affects more than 3.8% of people, while rheumatoid arthritis affects about 0.24% of people overall, and the disease becomes more prevalent with age. Therefore, the continuous research on anti-osteoarthritis drugs is urgent.
Rabdosia rubescens (Hemsl.) Hara is a plant of Rabdosia of Labiatae, and is widely distributed in yellow river basin and its area in south China. Has sweet and bitter taste and slightly cold property, and has effects of clearing heat, relieving exterior syndrome, relieving inflammation and pain, invigorating stomach, promoting blood circulation and resisting tumor. Oridonin is an active diterpene natural compound from Rabdosia rubescens, and is colorless prismatic crystal, extremely bitter in taste, and insoluble in water. Oridonin can play a significant role in resisting tumors through various mechanisms such as tumor cell growth, apoptosis induction and the like, and is mainly used for treating liver cancer, esophageal cancer, pancreatic cancer and the like clinically. In addition, the document reports that oridonin also has an inhibiting effect on rheumatoid arthritis fibroblast-like synoviocytes (RAFLS), can reduce the expression of LPS-induced proinflammatory factors of Raw264.7 cells and has an effect of inhibiting osteoclast differentiation. However, there is no report on a drug for treating rheumatoid arthritis and osteoarthritis using oridonin as a main active ingredient.
The research on the in vivo process of the oridonin shows that the oridonin is quickly absorbed after entering the body and widely distributed in various tissues, more in the liver, pancreas and tissues, and less in the thymus, bone marrow, brain and bones. Furthermore, oridonin is almost insoluble in water, so the oral administration effect is poor and the treatment effect is difficult to achieve. It is highly desirable to provide a new delivery system that allows rubescensin to be more effectively used in the treatment of arthritis.
Disclosure of Invention
The invention aims to provide an external transdermal absorption preparation for arthritis, which contains oridonin, a pharmaceutically acceptable derivative or a prodrug thereof.
The technical scheme adopted by the invention is as follows:
the application of oridonin, pharmaceutically acceptable derivatives thereof or prodrugs thereof in preparing external transdermal absorption preparations for arthritis.
An external transdermal absorption preparation for arthritis contains oridonin, its pharmaceutically acceptable derivatives or its prodrug.
Further, the transdermal absorption preparation is any one of gel, ointment and cream.
Furthermore, the transdermal absorption preparation also contains pharmaceutic adjuvant which is one or more of gel matrix, transdermal enhancer, pH regulator, preservative and stabilizer;
the gel matrix is selected from one or more of liquid paraffin, vaseline, chitosan, sucralfate, propylene glycol, ethanol, glycerol, polyethylene glycol, polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, and sodium carboxymethylcellulose;
the skin penetration enhancer is selected from one or more of ethanol, propylene glycol, isopropanol, menthol, oleum Menthae Dementholatum, oleum Eucalypti, Borneolum Syntheticum, urea, and oleic acid;
the pH regulator is one or more of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid and phosphate;
the antiseptic is selected from one or more of ethanol, chlorocresol, potassium sorbate, chlorobutanol, methyl paraben, ethyl paraben, propyl paraben, sulfite, cysteine, vitamin C, vitamin E, and di-tert-butyltoluene;
the stabilizer is one or more selected from metal chelating agent disodium salt of ethylenediamine tetraacetic acid, dicalcium salt of ethylenediamine tetraacetic acid or diammine pentaacetic acid diacetate.
Further, the external transdermal absorption preparation for arthritis contains oridonin, liquid paraffin, vaseline and propylene glycol.
Further, the content of each component is as follows: 5-15mg/g of oridonin, 750-850mg/g of liquid paraffin, 80-100mg/g of vaseline and 100mg/g of propylene glycol.
Further, the content of each component is as follows: oridonin 10mg/g, liquid paraffin 800mg/g, vaseline 90mg/g, and propylene glycol 100 mg/g.
The invention has the beneficial effects that: the invention utilizes the transdermal absorption technology, comprehensively considers the factors such as the concentration of the oridonin, the selection of a matrix, the selection of a transdermal absorption enhancer and the like, leads the oridonin to enter the body by skin absorption and to directly reach the joint, overcomes the defect of poor oral effect of the oridonin, and tests prove that the oridonin external transdermal absorption preparation has the characteristic of directly and obviously inhibiting the acute carrageenan-induced arthritis, thereby showing that the oridonin external transdermal absorption preparation can be used as an external arthritis drug preparation and is used for treating related diseases such as arthritis.
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FIG. 1 shows the results of the test of the therapeutic effect of the oridonin external transdermal absorption preparation on carrageenan-induced acute arthritis mice;
FIG. 2 shows the therapeutic effect of the external transdermal preparation of oridonin on carrageenan-induced acute arthritis mice, and the results are compared with a reference;
FIG. 3 is a statistical graph of the results of the therapeutic effect of oridonin external transdermal absorption preparation on carrageenan-induced acute arthritis mice (n ═ 6), including the difference in foot thickness (mm) and the difference in foot weight (mg) (note: P <0.001 in comparison with blank control group; P <0.01 in comparison with model group; P <0.001 in comparison with model group);
Detailed Description
The invention aims to provide an external transdermal absorption preparation containing oridonin, which utilizes a transdermal absorption technology and comprehensively considers the concentration of the oridonin, the selection of a matrix, the selection of a transdermal absorption promoter and other factors, so that a medicament is absorbed into the body through the skin and can directly reach the joints, and the defect of poor oral effect of the oridonin is overcome.
Further, the arthritis transdermal absorption preparation is any one of gel, ointment and cream.
Furthermore, the external transdermal absorption preparation for arthritis also contains pharmaceutic adjuvants, wherein the pharmaceutic adjuvants are one or more of a transdermal enhancer, a pH regulator, a preservative and a stabilizer;
the gel matrix is selected from one or more of liquid paraffin, vaseline, chitosan, sucralfate, propylene glycol, ethanol, glycerol, polyethylene glycol, polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, and sodium carboxymethylcellulose;
the skin penetration enhancer is selected from one or more of ethanol, propylene glycol, isopropanol, menthol, oleum Menthae Dementholatum, oleum Eucalypti, Borneolum Syntheticum, urea, and oleic acid;
the pH regulator is one or more of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid and phosphate;
the antiseptic is selected from one or more of ethanol, chlorocresol, potassium sorbate, chlorobutanol, methyl paraben, ethyl paraben, propyl paraben, sulfite, cysteine, vitamin C, vitamin E, and di-tert-butyltoluene;
the stabilizer is one or more selected from metal chelating agent disodium salt of ethylenediamine tetraacetic acid, dicalcium salt of ethylenediamine tetraacetic acid or diammine pentaacetic acid diacetate.
Further, the external transdermal absorption preparation for arthritis contains oridonin, liquid paraffin, vaseline and propylene glycol.
Further, the content of each component is as follows: 5-15mg/g of oridonin, 750-850mg/g of liquid paraffin, 80-100mg/g of vaseline and 100mg/g of propylene glycol.
Further, the content of each component is as follows: oridonin 10mg/g, liquid paraffin 800mg/g, vaseline 90mg/g, and propylene glycol 100 mg/g.
The present invention will be further illustrated with reference to the following examples, which are intended to illustrate the invention and are not intended to limit the scope of the invention.
Example 1
1. Preparation of carrageenan (1%)
Taking an autoclaved small mortar, pouring the weighed carrageenan into the small mortar, grinding with a small amount of sterile 0.9% physiological saline, and slowly adding the remaining physiological saline for a plurality of times. Note that: the preparation is carried out 24 hours before the experiment, and the preparation is placed in a 4-degree refrigerator overnight. When in use, the product is used while being ground.
2. Preparation of oridonin external transdermal absorption preparation (1% ointment)
Raw materials: oridonin 10mg, liquid paraffin 800mg, vaseline 90mg, and propylene glycol 100 mg.
The method comprises the following steps: placing oridonin in a mortar, adding small amount of liquid paraffin, grinding for several times to obtain uniform and fine paste, adding vaseline and propylene glycol to full amount, and grinding.
3. Application of oridonin in preparation for external transdermal absorption for treating acute carrageenan-induced arthritis
Taking a 6-week-old female C57BL/6 mouse, putting the mouse in a clean animal room in advance to adapt to the environment for one week, dividing the mouse into a blank control group, a model group, an oridonin group and a positive drug group, taking the grovelin position of the mouse of the model group, the oridonin group and the positive drug group, simultaneously smearing solvent paste (formed by mixing 800mg of liquid paraffin, 90mg of vaseline and 100mg of propylene glycol) without drugs, transdermal absorption paste of the oridonin and cream of the positive drug, and smearing the drugs for 1 time and 6 times continuously every 5 min. At 30min post-dose, s.c 1% carrageenan was found to cause inflammation in 30. mu.l of the right hind paw of each mouse. After 5h, the mice were sacrificed, the thickness of the left and right toes of the mice was measured, and the feet of the mice were cut symmetrically from the ankle joints, and the difference between the weights of the left and right feet was taken as the swelling degree of the feet of the mice. The results are shown in fig. 1 and 2, and the statistics are shown in fig. 3. According to the figures 1, 2 and 3, compared with the blank control group, the right hind foot of the mouse of the model group has obvious swelling, and the transdermal absorption paste of the oridonin and the positive drug can obviously reduce the swelling of the foot. In conclusion, the oridonin transdermal absorption ointment can obviously reduce acute arthritis induced by carrageenan.
Claims (7)
1. The application of the oridonin, the pharmaceutically acceptable derivative thereof or the prodrug thereof in preparing the external transdermal absorption preparation for arthritis, wherein the arthritis is rheumatoid arthritis.
2. An external transdermal absorption preparation for arthritis contains oridonin, pharmaceutically acceptable derivatives thereof or prodrugs thereof, wherein the arthritis is rheumatoid arthritis.
3. The external transdermal formulation for arthritis according to claim 2, wherein: the transdermal absorption preparation is any one of gel, ointment and cream.
4. The external transdermal formulation for arthritis according to claim 2, wherein: also contains pharmaceutic adjuvant which is one or more of gel matrix, transdermal enhancer, pH regulator, preservative and stabilizer;
the gel matrix is selected from one or more of liquid paraffin, vaseline, chitosan, sucralfate, propylene glycol, ethanol, glycerol, polyethylene glycol, polyvinyl alcohol, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, and sodium carboxymethylcellulose;
the skin penetration enhancer is selected from one or more of ethanol, propylene glycol, isopropanol, menthol, oleum Menthae Dementholatum, oleum Eucalypti, Borneolum Syntheticum, urea, and oleic acid;
the pH regulator is one or more of sodium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid and phosphate;
the antiseptic is selected from one or more of ethanol, chlorocresol, potassium sorbate, chlorobutanol, methyl paraben, ethyl paraben, propyl paraben, sulfite, cysteine, vitamin C, vitamin E, and di-tert-butyltoluene;
the stabilizer is one or more selected from metal chelating agent disodium salt of ethylenediamine tetraacetic acid, dicalcium salt of ethylenediamine tetraacetic acid or diammine pentaacetic acid diacetate.
5. The external transdermal formulation for arthritis according to claim 2, wherein: contains oridonin, liquid paraffin, vaseline, and propylene glycol.
6. The external transdermal formulation for arthritis according to claim 5, wherein: the contents of the components are as follows: 5-15mg/g of oridonin, 750-850mg/g of liquid paraffin, 80-100mg/g of vaseline and 100mg/g of propylene glycol.
7. The external transdermal formulation for arthritis according to claim 5, wherein: the contents of the components are as follows: oridonin 10mg/g, liquid paraffin 800mg/g, vaseline 90mg/g, and propylene glycol 100 mg/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 |
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| CN201811076198.6A CN108926525B (en) | 2018-09-14 | 2018-09-14 | External transdermal absorption preparation for arthritis |
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| CN108926525A CN108926525A (en) | 2018-12-04 |
| CN108926525B true CN108926525B (en) | 2021-08-31 |
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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 |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839926A (en) * | 2006-01-23 | 2006-10-04 | 张海 | Medicine for treating acute and chronic pharyngitis, tumour, and the rabdosia extraction method |
| CN101401783A (en) * | 2007-09-16 | 2009-04-08 | 杨喜鸿 | Percutaneous absorption agent containing Ailamode, preparation method and medical uses thereof |
| CN101780281A (en) * | 2010-01-04 | 2010-07-21 | 中国药科大学 | Application of N-arginine chitosan as percutaneous sorbefacient |
| CN102908385A (en) * | 2011-08-03 | 2013-02-06 | 彭莉 | Rabdosia rubescens liquid extract and preparation method and application thereof |
| CN103536652A (en) * | 2012-07-10 | 2014-01-29 | 彭莉 | Nanometer structure and application of water extract of Herba Rabdosiae leaves |
| CN103585074A (en) * | 2013-12-02 | 2014-02-19 | 河南省济源市济世药业有限公司 | Rabdosia rubescens aqueous extract, use of rabdosia rubescens aqueous extract, rabdosia rubescens extract, skin care product and preparation methods of rabdosia rubescens aqueous extract and skin care product |
| CN104208288A (en) * | 2013-06-03 | 2014-12-17 | 天津药物研究院 | Anti-inflammatory and analgesic externally-applied preparation, and preparing method and use thereof |
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| CN106038901A (en) * | 2016-06-25 | 2016-10-26 | 魏志刚 | Traditional Chinese medicine composition for treating pain in neck, shoulders, waist and legs |
-
2018
- 2018-09-14 CN CN201811076198.6A patent/CN108926525B/en active Active
Patent Citations (9)
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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 |
| CN101401783A (en) * | 2007-09-16 | 2009-04-08 | 杨喜鸿 | Percutaneous absorption agent containing Ailamode, preparation method and medical uses thereof |
| CN101780281A (en) * | 2010-01-04 | 2010-07-21 | 中国药科大学 | Application of N-arginine chitosan as percutaneous sorbefacient |
| CN102908385A (en) * | 2011-08-03 | 2013-02-06 | 彭莉 | Rabdosia rubescens liquid extract and preparation method and application thereof |
| CN103536652A (en) * | 2012-07-10 | 2014-01-29 | 彭莉 | Nanometer structure and application of water extract of Herba Rabdosiae leaves |
| CN104208288A (en) * | 2013-06-03 | 2014-12-17 | 天津药物研究院 | Anti-inflammatory and analgesic externally-applied preparation, and preparing method and use thereof |
| CN103585074A (en) * | 2013-12-02 | 2014-02-19 | 河南省济源市济世药业有限公司 | Rabdosia rubescens aqueous extract, use of rabdosia rubescens aqueous extract, rabdosia rubescens extract, skin care product and preparation methods of rabdosia rubescens aqueous extract and skin care product |
| CN105726465A (en) * | 2016-03-31 | 2016-07-06 | 常州达奥新材料科技有限公司 | Preparation method of pectic matrix oridonin nano lipid gel |
| CN106038901A (en) * | 2016-06-25 | 2016-10-26 | 魏志刚 | Traditional Chinese medicine composition for treating pain in neck, shoulders, waist and legs |
Non-Patent Citations (1)
| Title |
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| "Oridonin is a covalent NLRP3 inhibitor with strong anti-inflammasome activity";Hongbin He etal;《NATURE COMMUNICATIONS》;20180629;第9卷(第1期);摘要，第5页右栏第1段-第6页左栏第1段，第10页左栏第6段 * |
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