CN115192633A - A topical Chinese medicinal patch for treating rheumatic arthralgia - Google Patents
A topical Chinese medicinal patch for treating rheumatic arthralgia Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/237—Notopterygium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/254—Acanthopanax or Eleutherococcus
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
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- 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
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/10—Antioedematous agents; Diuretics
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- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to a traditional Chinese medicine external patch for treating rheumatic arthralgia, which is prepared by processing ten kinds of Chinese taxillus twig, nux vomica, lycopodium clavatum, garden balsam stem, hiraute shiny bugleweed herb, cassia twig, notopterygium root, frankincense, cortex acanthopanacis and erythrina bark; the composition has effects of dispelling pathogenic wind, removing dampness, relieving swelling and pain; the invention is mainly used for treating rheumatism pain, joint ache, rheumatism edema and other diseases, and is characterized in that the invention is an external preparation, which is safe, has no toxic and side effect, has obvious curative effect on rheumatism pain, joint ache and rheumatism edema, and is convenient to use. The clinical pharmacodynamics test has obvious effect, high bioavailability and no toxic or side effect.
Description
Technical Field
The invention relates to a traditional Chinese medicine external patch for treating rheumatic arthralgia, belonging to the technical field of pharmacy.
Technical Field
Rheumatic arthritis and rheumatoid arthritis are autoimmune diseases of human beings, and the causes of the diseases are not clear at present; the main symptoms are persistent joint swelling and pain, the pain is aggravated in rainy days, and serious people can cause disability and labor loss, thereby seriously harming the physical health of human beings. At present, the externally applied medicaments for treating the rheumatoid arthritis are related to joint pain relieving paste and other medicaments, but most of the medicaments have unsatisfactory curative effect and can also cause skin allergy of patients. Retrieval in the prior art: 1. chinese patent gazette 2020, 12.4.12 discloses a patent application named 'a medicinal paste for treating rheumatoid and rheumatic arthritis and a preparation method thereof' publication No. CN112022998A, and the proportion of the raw material medicines for composing the invention is as follows: 10 parts of wooly datchmanspipe herb, 10 parts of cortex acanthopanacis, 10 parts of diverse wormwood herb, 10 parts of glabrous greenbrier rhizome, 10 parts of siegesbeckia herb, 10 parts of radix gentianae macrophyllae, 10 parts of pawpaw, 10 parts of epimedium herb, 10 parts of Japanese ardisia herb, 10 parts of radix clematidis, 10 parts of kadsura pepper stem, 10 parts of safflower, 10 parts of beautiful sweetgum fruit, 10 parts of suberect spatholobus stem, 10 parts of morinda officinalis, 10 parts of rhizoma corydalis, 10 parts of arisaema cum bile, 10 parts of kusnezoff monkshood root, 10 parts of loofah sponge, 10 parts of cochinchina momordica seed, 10 parts of pyrola, 10 parts of common clubmoss herb, 10 parts of white mustard seed, 10 parts of erythrina bark, 10 parts of tuber fleeceflower stem, 10 parts of paniculate swallowwort root, 10 parts of aspongopus, 10 parts of sapanwood, 10 parts of nux vomica, 10 parts of achyranthes bidentata, 10 parts of garden balsam stem, 10 parts of common burreed rhizome 10 parts of zedoary, 10 parts of monkshood, 10 parts of asarum, 10 parts of eucommia bark, 10 parts of ligusticum wallichii, 10 parts of loranthus parasiticus, 10 parts of drynaria rhizome, 10 parts of pachyrhizus angulatus, 10 parts of ramulus mori, 10 parts of ephedra, 10 parts of turmeric, 10 parts of rice husk, 10 parts of honeysuckle, 10 parts of scorpion, 10 parts of ground beetle, 10 parts of centipede, 10 parts of chizushi, 10 parts of frankincense, 10 parts of myrrh, 10 parts of kamura kefir, 10 parts of leech, 10 parts of tripterygium wilfordii, 10 parts of dragon's blood, 10 parts of natural ketone, 10 parts of catechu, 10 parts of pseudo-ginseng, 10 parts of dipsacus root, 10 parts of pangolin scales, 10 parts of borneol, 10 parts of earthworm, 10 parts of musk, 10 parts of cassia twig, 10 parts of rhizoma cibotii and 10 parts of elecampane. The applicant conducts experimental research on the prior art and finds that the effect of the traditional Chinese medicine composition for treating rheumatoid arthritis and rheumatoid arthritis is not ideal and the composition is complex. Therefore, the external patch with simple prescription and obvious curative effect for treating rheumatic arthralgia, joint pain and rheumatic edema is developed and can generate great social and economic benefits. The composition has effects of dispelling pathogenic wind, removing dampness, relieving swelling and pain; the invention is mainly used for treating rheumatism pain, joint ache, rheumatism edema and other diseases, and is characterized in that the invention is an external preparation, which has obvious curative effect, safety, no toxic or side effect and convenient use for patients. The clinical pharmacodynamics test has obvious effect, high bioavailability and no toxic or side effect, the prescription medicinal materials are processed into mixed ointment, and proper auxiliary materials of the patch are added according to the conventional process of the patch to process into the patch.
Disclosure of Invention
The invention aims to overcome the defects of the prior art in the field, and provides a traditional Chinese medicine external patch for treating rheumatic arthralgia, which is scientific in prescription, remarkable in curative effect and free of toxic and side effects on a human body through a large number of pharmacodynamic experiments and a large number of clinical pharmacodynamic researches.
Another object of the present invention is to provide a method for preparing the external patch of the present invention.
In order to achieve the purpose, the invention adopts the technical scheme that:
the invention relates to a traditional Chinese medicine external patch for treating rheumatic arthralgia, which comprises the following components in formula:
the preferred formula of the traditional Chinese medicine composition comprises the following components:
the preparation method of the traditional Chinese medicine external patch for treating rheumatic arthralgia comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba Speranskiae Tuberculatae, herba Lycopi, ramulus Cinnamomi, notopterygii rhizoma, olibanum, cortex Acanthopanacis and cortex Erythrinae into fine powder respectively, mixing well, adding matrix made of suitable adjuvants of patch, making into coating, cutting into segments, covering with lining, perforating, and cutting into small pieces to obtain patch.
The "suitable auxiliary materials for patch" in the above process are general auxiliary materials for patch in the field, and may include: rubber, rosin and the like, but is not limited to the above auxiliary materials.
At present, the externally applied medicaments for treating the rheumatoid arthritis are related to joint pain relieving paste and other medicaments, but most of the medicaments have unsatisfactory curative effect and can also cause skin allergy of patients. Retrieval in the prior art: 1. chinese patent gazette 2020, 12.4.12 discloses a patent application named 'a medicinal paste for treating rheumatoid and rheumatic arthritis and a preparation method thereof' publication No. CN112022998A, and the proportion of the raw material medicines for composing the invention is as follows: 10 parts of wooly datchmanspipe herb, 10 parts of cortex acanthopanacis, 10 parts of diverse wormwood herb, 10 parts of glabrous greenbrier rhizome, 10 parts of siegesbeckia herb, 10 parts of radix gentianae macrophyllae, 10 parts of pawpaw, 10 parts of epimedium herb, 10 parts of Japanese ardisia herb, 10 parts of radix clematidis, 10 parts of kadsura pepper stem, 10 parts of safflower, 10 parts of beautiful sweetgum fruit, 10 parts of suberect spatholobus stem, 10 parts of morinda officinalis, 10 parts of rhizoma corydalis, 10 parts of arisaema cum bile, 10 parts of kusnezoff monkshood root, 10 parts of loofah sponge, 10 parts of cochinchina momordica seed, 10 parts of pyrola, 10 parts of common clubmoss herb, 10 parts of white mustard seed, 10 parts of erythrina bark, 10 parts of tuber fleeceflower stem, 10 parts of paniculate swallowwort root, 10 parts of aspongopus, 10 parts of sapanwood, 10 parts of nux vomica, 10 parts of achyranthes bidentata, 10 parts of garden balsam stem, 10 parts of common burreed rhizome 10 parts of zedoary, 10 parts of monkshood, 10 parts of asarum, 10 parts of eucommia bark, 10 parts of ligusticum wallichii, 10 parts of loranthus parasiticus, 10 parts of drynaria rhizome, 10 parts of pachyrhizus angulatus, 10 parts of ramulus mori, 10 parts of ephedra, 10 parts of turmeric, 10 parts of rice husk, 10 parts of honeysuckle, 10 parts of scorpion, 10 parts of ground beetle, 10 parts of centipede, 10 parts of chizushi, 10 parts of frankincense, 10 parts of myrrh, 10 parts of kamura kefir, 10 parts of leech, 10 parts of tripterygium wilfordii, 10 parts of dragon's blood, 10 parts of natural ketone, 10 parts of catechu, 10 parts of pseudo-ginseng, 10 parts of dipsacus root, 10 parts of pangolin scales, 10 parts of borneol, 10 parts of earthworm, 10 parts of musk, 10 parts of cassia twig, 10 parts of rhizoma cibotii and 10 parts of elecampane. The applicant conducts experimental research on the prior art and finds that the effect of the traditional Chinese medicine composition for treating rheumatoid arthritis and rheumatoid arthritis is not ideal and the composition is complex.
Aiming at the problems in the prior art, the inventor combines a large number of traditional Chinese medicine formula theories and a large number of pharmacodynamics experiments to invent an external patch with obvious curative effect on treating rheumatic arthralgia, joint ache and rheumatic edema. The composition has effects of dispelling pathogenic wind, removing dampness, relieving swelling and pain; the invention is mainly used for treating rheumatism pain, joint pain, rheumatism edema and other diseases, and the invention is characterized in that the invention is an external preparation with obvious curative effect, safety, no toxic and side effect and convenient use for patients. The clinical pharmacodynamics test has obvious effect, high bioavailability and no toxic or side effect, the prescription medicinal materials are processed into mixed ointment, and proper auxiliary materials of the patch are added according to the conventional process of the patch to process the patch.
Main pharmacodynamic tests:
1. the prescription screening test of the invention: the formula raw material medicine proportion of the invention is the best raw material medicine proportion obtained by strict pharmacological screening test.
Preparation of prescription screening experimental drugs:
a group: the formula proportion is as follows:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of adjuvant suitable for patch, making into coating, cutting into segments, lining, perforating, and cutting into small pieces.
Group b: the formula proportion is as follows:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of adjuvant suitable for patch, making into coating, cutting into segments, lining, perforating, and cutting into small pieces.
And c, group: the formula proportion is as follows:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba Speranskiae Tuberculatae, herba Lycopi, ramulus Cinnamomi, notopterygii rhizoma, olibanum, cortex Acanthopanacis and cortex Erythrinae into fine powder respectively, mixing well, adding matrix made of suitable adjuvants of patch, making into coating, cutting into segments, covering with lining, perforating, and cutting into small pieces to obtain patch.
And d, group: the formula proportion is as follows:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of adjuvant suitable for patch, making into coating, cutting into segments, lining, perforating, and cutting into small pieces.
Purpose of the experiment: through pharmacological experimental study on the effects of resisting inflammation, easing pain, improving microcirculation, inhibiting secondary lesion of adjuvant arthritis and the like of the groups a, b, c and d, the four prescription groups are compared to observe the strength of the pharmacological effect.
The test method comprises the following steps: influence of groups a, b, c and d on mouse auricle swelling caused by xylene; the effect on granuloma of a rat tampon; effect on pain caused by tail root pressurization in mice; effects on mouse auricle microcirculation; influence on secondary lesions of adjuvant arthritis in rats.
1. Effect of Paraxylene-induced auricle swelling in mice
Experimental Material
1. Animals: the Kunming mouse has both male and female bodies and has the weight of 18-22 g.
2. Medicine preparation: four prescription groups of a group, b group, c group and d group. The medicine is prepared into paint according to the preparation process before the experiment, and is smeared for administration.
Experimental methods
50 Kunming mice with half male and half female and 18-22 g weight are randomly divided into 5 groups of 10 mice. 24h before the experiment, the back of the mouse is unhaired by sodium sulfide, the application is respectively coated on the back of the mouse, and the same amount of matrix is coated on a control group; the application of groups a, b, c and d is 0.8g crude drug/kg. The medicine is continuously administered for 5 days, 1 time per day, and after 2 hours of the last administration, the medicine is coated on the inner and outer surfaces of the right ear by 0.3ml of 100% dimethylbenzene, the left ear is used as a control, the mouse is anesthetized by ether after 4 hours of inflammation, the round ear pieces are respectively punched on the same part of the mouse by using a punch with the diameter of 9mm for reducing the number of the two ears, and the round ear pieces are weighed. The swelling degree of mouse auricle (the weight difference between the right and left ear of mouse) was calculated. The experimental results are as follows: see Table 1
TABLE 1 Effect of Paraxylene-induced ear swelling in mice
P < 0.01 compared to control; * P is less than 0.05; the ratio of delta P to group a is less than 0.05.
The results show that: the groups a, b, c and d can obviously inhibit the auricle swelling of mice caused by xylene. The group a has very significant difference (P < 0.01) compared with the control group; the group b, the group c and the group d have significant difference (P is less than 0.05) compared with the control group; the group a has significant difference (P < 0.05) compared with the group b, the group c and the group d. As can be seen, group a had a stronger anti-inflammatory effect than groups b, c and d.
2. Effect on rat Cotton boll granuloma
Experimental materials
1. Animals: wistar rats, both male and female, weigh 180-220 g.
2. Medicine preparation: four prescription groups of a group, b group, c group and d group. The medicine is prepared into paint according to the preparation process before the experiment, and is smeared for administration.
Experimental method
Wistar rats of 50 animals, half male and half female, weighing 180-220 g, were randomly divided into 5 groups of 10 animals each. 24h before the experiment, rats were dehaired on their backs with sodium sulfide. During the test, the rat is anesthetized with light ether, the rat's chest hair is cut off, the iodine tincture is disinfected, the chest skin is cut open, 20mg of sterile cotton balls are respectively inserted into the armpits of the two forelimbs from the cut, the aseptic cotton balls are respectively filled in the armpits of the two forelimbs (the aseptic cotton balls are soaked in 0.2ml of streptomycin mixed solution and dried after being autoclaved), the skin is sutured, and the streptomycin is injected into the muscle to resist infection. The application of the drug on the back of the rat is started on the day of the operation in each group, and the same amount of matrix is applied on the control group; group a, group b, group c and group d are respectively coated with 0.4g crude drug/kg. Continuously administering for 10 days, 1 time daily, killing rat at 11d cervical dislocation, stripping cotton ball granulation tissue, oven drying at 70 deg.C, and weighing. Subtracting the original weight of the cotton ball from the weighed weight to obtain the weight of granuloma. The experimental results are as follows: see Table 2
TABLE 2 Effect on rat Cotton boll granuloma
P < 0.01 compared to control; * P is less than 0.05; the ratio of delta P to group a is less than 0.05.
The results show that: the group a, the group b, the group c and the group d have obvious inhibition effect on rat granulation tissue hyperplasia caused by cotton balls, and the weight of granulation tissue is reduced. The group a has very significant difference (P < 0.01) compared with the control group; the group b, the group c and the group d have significant difference (P is less than 0.05) compared with the control group; the group a has significant difference compared with the group b, the group c and the group d (P is less than 0.05). It can be seen that group a has a stronger anti-inflammatory effect than groups b, c and d.
3. Influence on pain caused by pressurization of tail root of mouse
Experimental Material
1. Animals: the Kunming mouse has both male and female bodies and the weight is 18 to 22g.
2. Medicine preparation: four prescription groups of a group, b group, c group and d group. The medicine is prepared into paint according to the preparation process before the experiment, and is smeared for administration.
Experimental methods
A mouse tail root tendering method is adopted, a position 1cm away from the tail root of a mouse is used as a tendering point, a tendering instrument is used for measuring a pain threshold value, 50 mice with pain threshold values within 10 g-45 g are screened according to the condition that the mice are hoarse due to tail stressed pain, the weight of the mice is 18-22 g in each half of male and female. The pain threshold was determined twice by dividing into 5 groups of 10 individuals at random, and the mean value was used as the predrug value. Respectively administering the above materials, applying the medicine on the pressure pain point, and applying the same amount of matrix on the control group; the application of the groups a, b, c and d is 0.8g crude drug/kg, and the pain threshold is determined after 1 h. The experimental results are as follows: see Table 3
TABLE 3 Effect on pain caused by compression of the mouse tail root
P < 0.01, P < 0.05 compared to control; the ratio of delta P to group a is less than 0.05.
The results show that: the group a, the group b, the group c and the group d all have obvious analgesic effect on pain caused by pressurization of the tail root of the mouse, and can increase the pressure of the tenderness. The group a has very significant difference (P < 0.01) compared with the control group; the groups b, c and d have significant difference (P is less than 0.05) compared with the control group; the group a has significant difference compared with the group b, the group c and the group d (P is less than 0.05). As can be seen, the analgesic effect was stronger in group a than in groups b, c and d.
4. Effect on mouse auricle microcirculation
Experimental materials
1. Animals: the Kunming mouse has both male and female bodies and the weight is 18 to 22g.
2. Medicine preparation: four prescription groups of a group, b group, c group and d group. The medicine is prepared into paint according to the preparation process before the experiment, and is smeared for administration.
Experimental methods
50 Kunming mice with half male and half female and 18-22 g weight are randomly divided into 5 groups of 10 mice. Depilating the back of the mouse by using sodium sulfide, respectively smearing the depilating agent on the back of the mouse, and smearing the same amount of matrix on a control group; the application of groups a, b, c and d is 0.8g crude drug/kg. Continuously administering for 5d, 1 time every day, 2h after the last administration, injecting 0.45% pentobarbital sodium 0.1ml/10g into abdominal cavity of mouse, fixing mouse on observation table in prone position, dripping paraffin oil on auricle outer side, observing normal mouse auricle microcirculation with 6 × 10 microscope, at this time, injecting adrenaline hydrochloride 0.1 μ g subcutaneously to cause microcirculation disturbance, observing the microcirculation recovery condition of medicine, and recording the time for recovering normal blood flow. The experimental results are as follows: see Table 4
TABLE 4 Effect on mouse auricle microcirculation
P < 0.01 compared to control; * P is less than 0.05; the ratio of delta P to group a is less than 0.05.
The results show that: the group a, the group b, the group c and the group d can obviously improve the disorder of the mouse auricle microcirculation, and the group a has extremely obvious difference (P is less than 0.01) compared with a control group; the group b, the group c and the group d have significant difference (P is less than 0.05) compared with the control group; the group a has significant difference compared with the group b, the group c and the group d (P is less than 0.05). Thus, group a showed a stronger microcirculation improving effect than groups b, c and d.
5. Influence on secondary lesion of adjuvant arthritis of rats
Experimental Material
1. Animals: male rats of Wistar species weigh 180-220 g.
2. Medicine preparation: four prescription groups of a group, b group, c group and d group. The medicine is prepared into paint according to the preparation process before the experiment, and is smeared for administration.
Experimental method
Male Wistar rats of 50 weight 180-220 g were randomly divided into 5 groups of 10 rats. 24h before the experiment, rats were dehaired on their backs with sodium sulfide. Measuring the volume of the right hind foot sole by a volume capillary method, then injecting 0.05ml of Freund's complete adjuvant into the right hind foot sole to cause inflammation, and respectively smearing the inflammation-causing 19d on the back of a rat, and smearing the same amount of matrix on a control group; group a, group b, group c, group dThe respective application dose is 0.4g crude drug/kg. The administration was continued for 7d 1 time a day, so that the volume of the right hind metatarsal was measured again at 26d after inflammation, and the difference between the volume at 26d before and after inflammation was taken as the degree of swelling. The experimental results are as follows: see Table 5 Effect on Secondary lesions of adjuvant arthritis in rats
P < 0.01 compared to control; * P is less than 0.05; the ratio of delta P to group a is less than 0.05.
The results show that the group a, the group b, the group c and the group d have obvious inhibition effect on secondary pathological changes of rat adjuvant arthritis. The group a has very significant difference (P < 0.01) compared with the control group; the group b, the group c and the group d have significant difference (P is less than 0.05) compared with the control group; the group a has significant difference compared with the group b, the group c and the group d (P is less than 0.05). As can be seen, the secondary pathological changes of adjuvant arthritis were stronger in group a than in groups b, c and d.
The experimental results are as follows: the groups a, b, c and d can obviously inhibit the auricle swelling of mice caused by xylene; the compound has obvious inhibition effect on rat granulation tissue proliferation caused by cotton balls; the pain relieving effect on the pain caused by the pressurization of the tail root of the mouse is obvious; can obviously improve the disorder of mouse auricle microcirculation; obviously inhibit the secondary lesion of the adjuvant arthritis of the rats.
And (4) conclusion: the group a has stronger effects of resisting inflammation, easing pain, improving microcirculation, inhibiting secondary pathological changes of adjuvant arthritis and the like than the group b, the group c and the group d, so the clinical treatment effect of the group a on dispelling wind and removing dampness and relieving swelling and pain is better than that of the group b, the group c and the group d, and the prescription of the group a is determined to be the prescription of the invention.
2. The pharmacodynamic test of the invention comprises: compared with the prior art, the traditional Chinese medicine external patch has obvious pharmacodynamic test effect.
Through patent retrieval, the prior art documents are as follows:
comparison document 1: chinese patent gazette 2020, 12.4.12 discloses a patent application named 'a medicinal paste for treating rheumatoid and rheumatic arthritis and a preparation method thereof' publication No. CN112022998A, and the proportion of the raw material medicines for composing the invention is as follows: 10 parts of wooly datchmanspipe herb, 10 parts of cortex acanthopanacis, 10 parts of diverse wormwood herb, 10 parts of glabrous greenbrier rhizome, 10 parts of siegesbeckia herb, 10 parts of radix gentianae macrophyllae, 10 parts of pawpaw, 10 parts of epimedium herb, 10 parts of Japanese ardisia herb, 10 parts of radix clematidis, 10 parts of kadsura pepper stem, 10 parts of safflower, 10 parts of beautiful sweetgum fruit, 10 parts of suberect spatholobus stem, 10 parts of morinda officinalis, 10 parts of rhizoma corydalis, 10 parts of arisaema cum bile, 10 parts of kusnezoff monkshood root, 10 parts of loofah sponge, 10 parts of cochinchina momordica seed, 10 parts of pyrola, 10 parts of common clubmoss herb, 10 parts of white mustard seed, 10 parts of erythrina bark, 10 parts of tuber fleeceflower stem, 10 parts of paniculate swallowwort root, 10 parts of aspongopus, 10 parts of sapanwood, 10 parts of nux vomica, 10 parts of achyranthes bidentata, 10 parts of garden balsam stem, 10 parts of common burreed rhizome 10 parts of curcuma zedoary, 10 parts of monkshood, 10 parts of asarum, 10 parts of eucommia bark, 10 parts of ligusticum wallichii, 10 parts of loranthus parasiticus, 10 parts of drynaria rhizome, 10 parts of pachyrhizus angulatus, 10 parts of ramulus mori, 10 parts of ephedra, 10 parts of curcuma longa, 10 parts of rice husk, 10 parts of honeysuckle, 10 parts of scorpion, 10 parts of ground beetle, 10 parts of centipede, 10 parts of tsutsugami, 10 parts of frankincense, 10 parts of myrrh, 10 parts of homalomena rhizome, 10 parts of leech, 10 parts of tripterygium wilfordii, 10 parts of dragon's blood, 10 parts of natural ketone, 10 parts of catechu, 10 parts of pseudo-ginseng, 10 parts of dipsacus root, 10 parts of pangolin scales, 10 parts of borneol, 10 parts of earthworm, 10 parts of musk, 10 parts of cassia twig, 10 parts of rhizoma cibotii and 10 parts of elecampane.
The main pharmacodynamic tests prove that:
compared with the patch prepared by the weight ratio of the comparison document 1, the pharmacodynamics test result of the patch prepared by the weight ratio of the raw materials of the invention is obviously higher than that of the patch prepared by the comparison document 1. The main pharmacodynamic tests are as follows:
preparation of experimental drugs:
1. the invention relates to a rheumatism arthralgia patch group: a patch was prepared according to the present specification, example 1.
2. Group A Patch prepared according to the method of example one of the embodiments of the patent application publication No. CN112022998A of the comparative document 1.
3. Group B, joint pain relieving plaster, commercially available.
(II) pharmacodynamic experiment process:
purpose of the experiment: through pharmacological experimental research on the effects of resisting inflammation, easing pain, improving microcirculation, inhibiting secondary pathological changes of adjuvant arthritis and the like of the rheumatism arthralgia patch group, the group A and the group B, the rheumatism arthralgia patch group is compared with the group A and the group B, and the strength of the pharmacological effect is observed.
The test method comprises the following steps: the rheumatism arthralgia patch group of the invention, the group A and the group B have the influence on mouse auricle swelling caused by dimethylbenzene; effects on mouse agar granulation; effect on pain caused by tail root pressurization in mice; effects on mouse auricle microcirculation; influence on secondary lesions of adjuvant arthritis in rats.
1. Effect of Paraxylene-induced auricle swelling in mice
Experimental Material
1. Animals: the Kunming mouse has both male and female bodies and the weight is 18 to 22g.
2. Medicine preparation: the invention relates to a rheumatism arthralgia patch group, an A group and a B group. The medicine is taken off before the experiment, pasted and applied.
Experimental methods
40 Kunming mice, each half of male and female, with the weight of 18-22 g, were randomly divided into 4 groups of 10 mice each. 24h before the experiment, the back of the mouse is unhaired by sodium sulfide, the application is respectively coated on the back of the mouse, and the same amount of matrix is coated on a control group; the rheumatism arthralgia patch group, the group A and the group B are respectively coated with 0.8g of crude drugs/kg. Continuously administering for 5d 1 time per day, after last administration for 2 hr, coating with 0.3 ml/piece of 100% xylene on the inner and outer surfaces of right ear, using left ear as control, killing mice after 4 hr inflammation by ether anesthesia, removing ears, punching round ear pieces on the same part of mice with a 9mm diameter punch, and weighing. The swelling degree of the mouse auricle (the weight difference between the right and left ear of the mouse) was calculated. The experimental results are as follows: see Table 1
TABLE 1 Effect of Paraxylene-induced ear swelling in mice
P < 0.01 compared to control; * P is less than 0.05; compared with the rheumatism arthralgia patch of the invention, delta P is less than 0.05.
The results show that: the rheumatism arthralgia patch group, the group A and the group B can obviously inhibit the swelling of auricles of mice caused by dimethylbenzene. Compared with a control group, the rheumatism arthralgia patch group has extremely significant difference (P is less than 0.01); the A group and the B group have significant difference (P is less than 0.05) compared with the control group; compared with the A group and the B group, the rheumatism arthralgia patch group has significant difference (P is less than 0.05). Therefore, the anti-inflammatory effect of the rheumatism arthralgia patch group is stronger than that of the A group and the B group.
2. Effect on agar granulation in mice
Experimental Material
1. Animals: the Kunming mouse has both male and female bodies and has the weight of 18-22 g.
2. Medicine preparation: the invention relates to a rheumatism arthralgia patch group, an A group and a B group. The medicine is taken off before the experiment, pasted and applied.
Experimental methods
40 Kunming mice, each half of male and female, with the weight of 18-22 g, were randomly divided into 4 groups of 10 mice each. Mice were depilated on the back with sodium sulfide 24h prior to the experiment. Sterilizing armpit, injecting 2% agar 2ml subcutaneously, and smearing on mouse back for administration after 24h, and smearing matrix with same amount on control group; the rheumatism arthralgia patch group, the group A and the group B are respectively coated with 0.8g of crude drugs/kg. Continuously administering for 10 days, 1 time per day, 2 hr after the last administration, killing cervical vertebra by dislocation, carefully stripping granuloma, and weighing wet weight. The experimental results are as follows: see Table 2
TABLE 2 Effect on agar granulation in mice
P < 0.01 compared to control; * P is less than 0.05; compared with the rheumatism arthralgia patch of the invention, the delta P is less than 0.05.
The results show that: the rheumatism arthralgia patch group, the group A and the group B can obviously inhibit the proliferative pathological change of chronic inflammation and inhibit the formation of granuloma. Compared with a control group, the rheumatism arthralgia patch group has extremely significant difference (P is less than 0.01); the A group and the B group have significant difference (P is less than 0.05) compared with the control group; compared with the A group and the B group, the rheumatism arthralgia patch group has significant difference (P is less than 0.05). Therefore, the anti-inflammatory effect of the rheumatism arthralgia patch group is stronger than that of the A group and the B group.
3. Influence on pain caused by pressurization of the tail root of a mouse
Experimental Material
1. Animals: the Kunming mouse has both male and female bodies and the weight is 18 to 22g.
2. Medicine preparation: the invention relates to a rheumatism arthralgia patch group, an A group and a B group. The medicine is taken off before the experiment, pasted and applied.
Experimental methods
A mouse tail root tendering method is adopted, a position 1cm away from the tail root of a mouse is used as a tendering point, a tendering instrument is used for measuring a pain threshold value, and 40 mice with pain threshold values within 10 g-45 g are screened, half of each of the male and the female, and 18-22 g of body weight are screened according to the condition that the mice are hoarsed due to tail stressed pain. The pain threshold was determined twice by dividing into 4 groups of 10 individuals at random, and the mean value was used as the predrug value. Respectively administering the above materials, applying the medicine on the pressure pain point, and applying the same amount of matrix on the control group; the rheumatism arthralgia patch group, the group A and the group B are respectively coated with 0.8g of crude drugs/kg. After 1h of administration, the pain threshold was determined. The experimental results are as follows: see Table 3
TABLE 3 Effect on pain caused by compression of the mouse tail root
P < 0.01 compared to control group; * P is less than 0.05; compared with the rheumatism arthralgia patch of the invention, delta P is less than 0.05.
The results show that: the rheumatism arthralgia patch group, the group A and the group B have obvious analgesic effect on pain caused by tail root pressurization of mice, and can increase the pressure of tenderness. Compared with a control group, the rheumatism arthralgia patch group has extremely significant difference (P is less than 0.01); the A group and the B group have significant difference (P is less than 0.05) compared with the control group; compared with the A group and the B group, the rheumatism arthralgia patch group has significant difference (P is less than 0.05). Therefore, the rheumatism arthralgia patch group has stronger analgesic effect than the group A and the group B.
4. Effect on mouse auricle microcirculation
Experimental materials
1. Animals: the Kunming mouse has both male and female bodies and has the weight of 18-22 g.
2. Medicine preparation: the invention relates to a rheumatism arthralgia patch group, a group A and a group B. The medicine is taken off before the experiment, pasted and applied.
Experimental methods
40 Kunming mice with half male and half female and 18-22 g weight are randomly divided into 4 groups of 10 mice. Depilating the back of the mouse by using sodium sulfide, respectively coating the depilated back of the mouse with a drug, and coating the same amount of matrix on a control group; the rheumatism arthralgia patch group, the group A and the group B are respectively coated with 0.8g of crude drugs/kg. Continuously administering for 5d, 1 time every day, 2h after the last administration, injecting 0.45% pentobarbital sodium 0.1ml/10g into abdominal cavity of mouse, fixing mouse on observation table in prone position, dripping paraffin oil on auricle outer side, observing normal mouse auricle microcirculation with 6 × 10 microscope, at this time, injecting adrenaline hydrochloride 0.1 μ g subcutaneously to cause microcirculation disturbance, observing the microcirculation recovery condition of medicine, and recording the time for recovering normal blood flow. The experimental results are as follows: see Table 4
TABLE 4 Effect on mouse auricle microcirculation
P < 0.01 compared to control; * P is less than 0.05; compared with the rheumatism arthralgia patch of the invention, the delta P is less than 0.05.
The results show that: the rheumatism arthralgia patch group, the group A and the group B can obviously improve the disorder of the microcirculation of auricles of mice. Compared with a control group, the rheumatism arthralgia patch group has extremely significant difference (P is less than 0.01); the A group and the B group have significant difference (P is less than 0.05) compared with the control group; compared with the A group and the B group, the rheumatism arthralgia patch group has significant difference (P is less than 0.05). Therefore, the rheumatism arthralgia patch group has stronger microcirculation improving effect than the A group and the B group.
5. Action on secondary pathological changes of adjuvant arthritis of rats
Experimental Material
1. Animals: male rats of Wistar species weigh 180-220 g.
2. Medicine preparation: the invention relates to a rheumatism arthralgia patch group, an A group and a B group. The medicine is taken off before the experiment, pasted and applied.
Experimental method
Male Wistar rats, 40, weighing 180-220 g, were randomly divided into 4 groups of 10 rats each. 24h before the experiment, rats were dehaired on their backs with sodium sulfide. Measuring the volume of the right hind foot sole by a volume capillary method, then injecting 0.05ml of Freund's complete adjuvant into the right hind foot sole to cause inflammation, and respectively smearing the inflammation on the back of the mouse at 19d after causing inflammation, and smearing the same amount of matrix on a control group; the rheumatism arthralgia patch group, the group A and the group B are respectively coated with 0.4g of crude drugs/kg. The administration was continued for 7d 1 time a day, so that the volume of the right hind metatarsal was measured again at 26d after inflammation, and the difference between the volume at 26d before and after inflammation was taken as the degree of swelling. The experimental results are as follows: see Table 5
TABLE 5 Effect on secondary lesions of adjuvant arthritis in rats
P < 0.01 compared to control group; * P is less than 0.05; compared with the rheumatism arthralgia patch of the invention, the delta P is less than 0.05.
The results show that the rheumatism arthralgia patch group, the group A and the group B have obvious inhibiting effect on secondary lesion of rat adjuvant arthritis, and compared with a control group, the rheumatism arthralgia patch group has extremely significant difference (P is less than 0.01); the A group and the B group have significant difference (P is less than 0.05) compared with the control group; compared with the A group and the B group, the rheumatism arthralgia patch group has significant difference (P is less than 0.05). Therefore, the rheumatism arthralgia patch group has stronger effect on treating secondary pathological changes of adjuvant arthritis than the A group and the B group.
The experimental results are as follows: the rheumatism arthralgia patch group, the group A and the group B can obviously inhibit the auricle swelling of mice caused by dimethylbenzene; can obviously inhibit the proliferative pathological change of chronic inflammation and inhibit the formation of granuloma; the pain relieving effect on the pain caused by the pressurization of the tail root of the mouse is obvious; can obviously improve the disorder of mouse auricle microcirculation; can obviously inhibit secondary lesion of adjuvant arthritis of rats.
And (4) conclusion: the rheumatism arthralgia patch group has stronger effects of resisting inflammation, easing pain, improving microcirculation, inhibiting secondary pathological changes of adjuvant arthritis and the like than the group A and the group B, so the rheumatism arthralgia patch group has better treatment effects of dispelling wind, removing dampness, reducing swelling and relieving pain than the group A and the group B clinically.
The specific implementation mode of the invention is as follows:
example 1
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba Speranskiae Tuberculatae, herba Lycopi, ramulus Cinnamomi, notopterygii rhizoma, olibanum, cortex Acanthopanacis and cortex Erythrinae into fine powder respectively, mixing well, adding matrix made of suitable adjuvants of patch, making into coating, cutting into segments, covering with lining, perforating, and cutting into small pieces to obtain patch.
Example 2
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of adjuvant suitable for patch, making into coating, cutting into segments, lining, perforating, and cutting into small pieces.
Example 3
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba Speranskiae Tuberculatae, herba Lycopi, ramulus Cinnamomi, notopterygii rhizoma, olibanum, cortex Acanthopanacis and cortex Erythrinae into fine powder respectively, mixing well, adding matrix made of suitable adjuvants of patch, making into coating, cutting into segments, covering with lining, perforating, and cutting into small pieces to obtain patch.
Example 4
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of rubber and Colophonium, making into coating, cutting into segments, lining, perforating, and cutting into small pieces to obtain patch.
Example 5
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of rubber and Colophonium, making into coating, cutting into segments, lining, perforating, and cutting into small pieces to obtain patch.
Example 6
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of rubber and Colophonium, making into coating, cutting into segments, lining, perforating, and cutting into small pieces to obtain patch.
Example 7
Prescription:
the preparation method comprises the following steps:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of rubber and Colophonium, making into coating, cutting into segments, covering with lining, perforating, and cutting into small pieces to obtain patch.
Claims (5)
1. A traditional Chinese medicine external patch for treating rheumatic arthralgia is characterized in that the traditional Chinese medicine external patch comprises the following components in formula:
2. the external patch of traditional Chinese medicine according to claim 1, wherein said external patch of traditional Chinese medicine is preferably formulated as:
3. the external traditional Chinese medicine patch according to claim 1 or 2, characterized in that: the traditional Chinese medicine external patch is a pharmaceutical external patch.
4. The method for preparing a patch for external use of traditional Chinese medicine according to claim 1, 2 or 3, characterized in that:
pulverizing herba Taxilli, semen Strychni, herba Lycopodii, herba speranskiae tuberculatae, herba Lycopi, ramulus Cinnamomi, rhizoma Et radix Notopterygii, olibanum, cortex Acanthopancis, and cortex erythrinae into fine powder, mixing, adding matrix made of adjuvant suitable for patch, making into coating, cutting into segments, lining, perforating, and cutting into small pieces.
5. A patch for external application of Chinese medicine according to claim 1, 2, 3 or 4, which is used for treating rheumatalgia, joint pain, rheumatic edema, etc.
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| CN1088465A (en) * | 1993-12-31 | 1994-06-29 | 黄天恩 | A kind of electromagnetic wave medicine therapeutic apparatus |
| CN101708321A (en) * | 2009-12-28 | 2010-05-19 | 万小明 | Steaming-washing medicament for treating bone damage disease |
| CN107441192A (en) * | 2016-06-01 | 2017-12-08 | 陈丽 | A kind of Wash-out medicine for controlling rheumatoid |
| CN110327403A (en) * | 2019-08-23 | 2019-10-15 | 李森 | A kind of Chinese medicine fuming-lotion that treating rheumatic arthralgia and its application method |
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2022
- 2022-08-17 CN CN202210988610.1A patent/CN115192633B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1088465A (en) * | 1993-12-31 | 1994-06-29 | 黄天恩 | A kind of electromagnetic wave medicine therapeutic apparatus |
| CN101708321A (en) * | 2009-12-28 | 2010-05-19 | 万小明 | Steaming-washing medicament for treating bone damage disease |
| CN107441192A (en) * | 2016-06-01 | 2017-12-08 | 陈丽 | A kind of Wash-out medicine for controlling rheumatoid |
| CN110327403A (en) * | 2019-08-23 | 2019-10-15 | 李森 | A kind of Chinese medicine fuming-lotion that treating rheumatic arthralgia and its application method |
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| 俞力行,等: "熏洗方治疗外伤后期关节僵硬76例疗效观察", 中医正骨, vol. 16, no. 11, pages 10 * |
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