CN114869936A - External traditional Chinese medicine composition with effects of dispelling wind and cold, promoting blood circulation and relieving pain and preparation method and application thereof - Google Patents
External traditional Chinese medicine composition with effects of dispelling wind and cold, promoting blood circulation and relieving pain and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to an external traditional Chinese medicine composition with the functions of dispelling wind and cold, promoting blood circulation and relieving pain, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 5-10 parts of cinnamon, 5-10 parts of clove, 5-10 parts of angelica dahurica, 10-15 parts of ligusticum wallichii, 10-15 parts of corydalis tuber, 5-10 parts of medicinal cyathula root, 5-10 parts of safflower, 2-6 parts of borneol, 1-5 parts of eucalyptus oil and 0.5-2 parts of ketoprofen. The traditional Chinese medicine formula is improved on the basis of a classic external traditional Chinese medicine formula with the effects of dispelling wind and cold and promoting blood circulation to arrest pain, and the inventor surprisingly finds that the effects of dispelling wind and cold and promoting blood circulation to arrest pain are remarkably enhanced by adding a small amount of eucalyptus oil and ketoprofen into the classic formula. The traditional Chinese medicine composition has the advantages of quick response, lasting efficacy, convenient use, safety and reliability, and can be used for treating scapulohumeral periarthritis, cervical spondylosis, lumbago and leg pain, muscle and joint pain, rheumatic arthritis, rheumatoid arthritis and gouty arthritis.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to an external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain, and a preparation method and application thereof, which are suitable for patients with scapulohumeral periarthritis, cervical spondylosis, lumbago and leg pain, muscle and joint pain, rheumatic arthritis, rheumatoid arthritis and gouty arthritis.
Background
The cervical spondylosis is considered as a general term for cervical osteoarthritis, proliferative cervical spondylitis, cervical radicular syndrome and cervical disc herniation which are based on the degenerative change of cervical intervertebral discs in western medicine theory, and is mainly characterized in that cervical spinal cord, nerve roots or vertebral arteries are pressed due to long-term strain of cervical vertebrae, hyperosteogeny, cervical disc herniation and thickening and calcification of cervical ligaments, and the clinical manifestations of neck back pain, weakness of upper/lower limbs, finger numbness, dizziness, nausea and vomiting and even blurred vision, dysphagia and the like can occur.
Scapulohumeral periarthritis, also known as scapulohumeral periarthritis, commonly known as fifty-shoulder, is a chronic aseptic inflammation caused by soft tissue injury and degeneration of shoulder joint capsule and joint periphery, and is clinically manifested as shoulder joint pain, motor dysfunction, muscular atrophy and the like.
Lumbago and leg pain refers to pain in the lower waist, lumbosacral, sacroiliac, hip and the like, which can be accompanied by pain in one or both lower limbs, cauda equina, which is common among physical workers, athletes, drivers and sedentary people, has complex etiology, various clinical manifestations and frequent and repeated attacks, and serious patients can influence the mobility of patients and normal life.
The muscle joint pain refers to the muscle joint pain caused by systemic diseases and/or local diseases, wherein the muscle pain can be divided into two types of acute muscle pain and chronic muscle pain, wherein the acute muscle pain is mostly seen in traumas, muscle strains, acute febrile diseases and the like, and the chronic muscle pain is seen in traumas, chronic muscle strains, rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus and the like. Joint pain is usually caused by trauma, such as joint fracture, dislocation, cartilage fracture, soft tissue contusion around joints, infection, such as suppurative arthritis, connective tissue disease, mechanical strain, gout, aseptic joint necrosis, osteoarthritis, etc.
Aiming at cervical spondylosis, scapulohumeral periarthritis, lumbocrural pain and muscle and joint pain, western medicine usually adopts symptomatic treatment, for example, non-steroidal anti-inflammatory drugs and the like are taken, although pain symptoms can be relieved to a certain extent, symptoms and root causes are usually cured, the medicine is easy to repeat after the taking of the medicine is stopped, and severe side effects such as digestive tract ulcer, osteoporosis and the like are usually brought in the treatment process due to the large side effect of western medicine.
Cervical spondylosis, scapulohumeral periarthritis, lumbocrural pain and muscle and joint pain belong to the category of arthralgia in the theory of traditional Chinese medicine, wherein the arthralgia belongs to the concept of traditional Chinese medicine, and means that due to the fact that external evil factors such as interstitial space, deficiency of qi and blood, deficiency of liver and kidney, wind, cold, dampness, heat and the like attack a human body, meridian obstruction and unsmooth qi and blood circulation are caused, and further symptoms such as soreness, numbness, bending and stretching difficulty and the like of muscles, bones and joints are caused, and the symptoms comprise a series of diseases such as rheumatic arthritis, rheumatoid arthritis, hyperosteogeny, spondylitis, scapulohumeral periarthritis, osteoarthritis and the like. The occurrence of arthralgia syndrome has close relationship with the constitution, climatic conditions, living environment and the like.
For arthralgia, there is a special article in Huangdi's Canon for emphasizing the invasion of exogenous pathogens, and the categories of migratory arthralgia, painful arthralgia and migratory arthralgia are immediately distinguished according to the preponderance of pathogenic qi, which is recorded as: the combination of wind-cold-dampness and qi-qi is also arthralgia, with the preponderance of wind-qi being arthralgia, the preponderance of cold-qi being arthralgia and the preponderance of damp-qi being arthralgia. "wherein migratory arthralgia: pain in the affected area, wandering, difficulty in flexion and extension of joints, aversion to wind and fever; pain and numbness: severe pain, unfavorable joint flexion and extension, swelling and deformation, and aggravation of pain in case of cold; the arthralgia is caused: the limb is heavy, sore or swollen, pain is localized, the movement is inconvenient, and the muscle is numb. The arthralgia syndrome can be classified into skin arthralgia, muscle arthralgia, tendon arthralgia, vessel arthralgia and bone arthralgia according to the difference of seasons and parts where pathogenic qi causes diseases. The record of Huangdi's classic on medicine: "it is arthralgia in the bones in winter, tendon in spring, vessel in summer, muscle in yin and skin in autumn. The arthralgia syndrome is called as "almanac disease" in Zhang Zhongjing of Han dynasty, white tiger disease in Tang and Song dynasties, and gout in Yi nationality of Jinyuan.
The traditional Chinese medicine is used for treating symptoms and signs, and for migratory arthralgia: mainly dispel wind, dispel cold and promote diuresis, and take qi-moving and blood-activating herbs; for painful arthralgia: mainly warming meridians and dispelling cold, and dispelling wind and removing dampness, because blood congeals when meeting cold, blood circulation-promoting and stasis-removing herbs are often used in the treatment; for the migratory arthralgia: it is mainly used to promote diuresis and is combined with wind-dispelling, cold-dispelling and blood-activating herbs. The flavor of the aconite soup appears in sequence: ephedra, astragalus root, peony each 20g, prepared Sichuan aconite root, Chinese angelica each 9g, licorice root 10 g; modified Fuzi Tang (Aconiti lateralis decoction): 15g of processed aconite, 12g of white peony root, 12g of tuckahoe, 9g of dodder, 9g of pawpaw, 9g of coix seed, 9g of medlar, 18g of codonopsis pilosula, 12g of yam and other traditional Chinese medicine compositions for treating rheumatism.
Compared with the oral administration of traditional Chinese medicines, the method for treating the diseases by external application of the medicine has a plurality of advantages, the medicine can be positioned and used, the medicine directly acts on focus, the efficacy of the medicine can directly reach the focus, so the effect is quick, the oral administration of the traditional Chinese medicines is avoided, the toxic and side effects are small, the use is safer, the first pass effect of the liver and the interference and inactivation of gastrointestinal factors can also be avoided, and the difference among patients can be reduced.
In order to further enhance the treatment effect of the original Wantong muscle and bone preparation on the rheumatic arthralgia, the applicant further carries out long-term and deep compatibility research on the basis of the original Wantong muscle and bone preparation and the prior improved preparation (CN201810112216.5), and tries to provide an external traditional Chinese medicine composition which has the effects of expelling wind, clearing away cold, promoting blood circulation and relieving pain, has more excellent treatment effect, better safety and lower consumption of active ingredients.
Disclosure of Invention
The invention aims to provide an improved external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain, and a preparation method and application thereof.
The invention aims to provide an external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain, which is characterized by being prepared from the following raw material medicines in parts by weight: 5-10 parts of cinnamon, 5-10 parts of clove, 5-10 parts of angelica dahurica, 10-15 parts of ligusticum wallichii, 10-15 parts of corydalis tuber, 5-10 parts of medicinal cyathula root, 5-10 parts of safflower, 2-6 parts of borneol, 1-5 parts of eucalyptus oil and 0.5-2 parts of ketoprofen.
Preferably, the external traditional Chinese medicine composition with the effects of expelling wind and removing cold and promoting blood circulation to arrest pain is prepared from the following raw material medicines in parts by weight: 7-9 parts of cinnamon, 7-9 parts of clove, 7-9 parts of angelica dahurica, 12-14 parts of ligusticum wallichii, 12-14 parts of corydalis tuber, 7-9 parts of medicinal cyathula root, 7-9 parts of safflower, 3-5 parts of borneol, 1-4 parts of eucalyptus oil and 0.5-1.5 parts of ketoprofen.
More preferably, the external traditional Chinese medicine composition with the effects of expelling wind and removing cold and promoting blood circulation to arrest pain is prepared from the following raw material medicines in parts by weight: 8 parts of cinnamon, 8 parts of clove, 8 parts of angelica dahurica, 13 parts of ligusticum wallichii, 13 parts of corydalis tuber, 8 parts of medicinal cyathula root, 8 parts of safflower, 4 parts of borneol, 2 parts of eucalyptus oil and 1 part of ketoprofen.
Furthermore, the external traditional Chinese medicine composition with the effects of expelling wind and removing cold and promoting blood circulation to arrest pain is added with pharmaceutically acceptable auxiliary materials to prepare an external medicine, and the external medicine is preferably selected from the following components: ointment, tincture, lotion, membrane, patch, gel, etc.
More preferably, the external medicine is a patch, an ointment or a tincture.
The pharmaceutically acceptable auxiliary materials are selected from: a substrate, a solvent, etc.
Preferably, the matrix is selected from rubber, rosin, lanolin, vaseline, etc., and the solvent is selected from water or ethanol solution;
more preferably, the ethanol solution is 40% -60% ethanol solution.
Most preferably, the ethanol solution is a 56% ethanol solution.
The external traditional Chinese medicine composition with the functions of dispelling wind and cold, promoting blood circulation and relieving pain is suitable for patients with scapulohumeral periarthritis, cervical spondylosis, lumbago and leg pain, muscle and joint pain, rheumatic arthritis, rheumatoid arthritis and gouty arthritis.
The invention also aims to provide a preparation method of the external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain, which comprises the following steps:
(1) preparing materials: weighing the raw materials according to a formula;
(2) ethanol extraction: pulverizing cortex Cinnamomi, flos Caryophylli, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, rhizoma corydalis, radix Cyathulae, and Carthami flos into coarse powder, extracting with 2-5 times of 75-90% ethanol for three times (2 hr for the first time and 1.5 hr for the second and third times respectively), mixing extractive solutions, recovering ethanol, and concentrating to obtain extract with relative density of 1.25-1.35 at 50 deg.C;
(3) preparing the traditional Chinese medicine composition into corresponding external preparations according to the conventional method in the field to obtain the external traditional Chinese medicine composition with the functions of dispelling wind and cold, promoting blood circulation and relieving pain.
Preferably, 3 times of 90% ethanol is added in the step (2);
preferably, in the step (3), one or more of rubber, rosin, lanolin or vaseline is taken to prepare a matrix, the extract obtained in the step (2) is added with borneol, eucalyptus oil and ketoprofen, and the mixture is stirred uniformly; preparing a coating, coating paste, drying, covering a lining, and slicing to obtain the patch with the effects of expelling wind and removing cold, and promoting blood circulation to stop pain;
preferably, the step (3) is to add 5 times of beeswax into the extract obtained in the step (2), then add borneol, eucalyptus oil and ketoprofen, and stir evenly, so as to obtain the ointment with the functions of expelling wind and removing cold, and promoting blood circulation and relieving pain;
preferably, the (3) step of adding the extract obtained in the step (2) into 56% ethanol solution which is 10 times of the weight of the crude drugs, then adding borneol, eucalyptus oil and ketoprofen, stirring for 20 minutes, and then sieving with a 100-mesh sieve for filtering to obtain the tincture with the effects of expelling wind, removing cold, promoting blood circulation and relieving pain.
The invention also aims to provide the application of the external traditional Chinese medicine composition prepared from 5-10 parts of cinnamon, 5-10 parts of clove, 5-10 parts of angelica dahurica, 10-15 parts of ligusticum wallichii, 10-15 parts of corydalis tuber, 5-10 parts of medicinal cyathula root, 5-10 parts of safflower, 2-6 parts of borneol, 1-5 parts of eucalyptus oil and 0.5-2 parts of ketoprofen in preparing the external traditional Chinese medicine composition for expelling wind, clearing away cold, promoting blood circulation and relieving pain.
The preferable external traditional Chinese medicine composition for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 7-9 parts of cinnamon, 7-9 parts of clove, 7-9 parts of angelica dahurica, 12-14 parts of ligusticum wallichii, 12-14 parts of corydalis tuber, 7-9 parts of medicinal cyathula root, 7-9 parts of safflower, 3-5 parts of borneol, 1-4 parts of eucalyptus oil and 0.5-1.5 parts of ketoprofen.
More preferably, the external traditional Chinese medicine composition for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 8 parts of cinnamon, 8 parts of clove, 8 parts of angelica dahurica, 13 parts of ligusticum wallichii, 13 parts of corydalis tuber, 8 parts of medicinal cyathula root, 8 parts of safflower, 4 parts of borneol, 2 parts of eucalyptus oil and 1 part of ketoprofen.
The beneficial effects of the invention are as follows:
1. the external traditional Chinese medicine composition with the effects of expelling wind and removing cold, and promoting blood circulation and relieving pain is convenient and safe to use, has no stimulation, has no toxic or side effect, and has higher curative effect, safer effect and lower active ingredient dosage compared with the Wantong muscle and bone patch and the prior improved preparation (CN 201810112216.5).
2. The external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain has reasonable compatibility, has excellent treatment effect on anemofrigid-damp arthralgia, and is suitable for patients with scapulohumeral periarthritis, cervical spondylosis, lumbago and skelalgia, muscle and joint pain, rheumatic arthritis, rheumatoid arthritis and gouty arthritis. Particularly, the invention discovers for the first time that the improved traditional Chinese medicine composition has better curative effect on gouty arthritis.
3. The external traditional Chinese medicine composition with the effects of expelling wind and removing cold, and promoting blood circulation and relieving pain adopts an external preparation form, can directly act on a focus, and has the advantages of quick response, lasting efficacy, convenient use and good patient compliance.
4. The external traditional Chinese medicine composition with the effects of expelling wind and removing cold, and promoting blood circulation to arrest pain has a simple preparation method, and is suitable for industrial production.
Detailed Description
The invention is further illustrated with reference to specific examples. It should be understood that the specific embodiments described herein are illustrative only and are not limiting upon the scope of the invention.
The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products which are not known to manufacturers and are available from normal sources.
The experimental procedures in the following examples are conventional unless otherwise specified. The test materials used in the following examples are all commercially available products unless otherwise specified.
Preparation examples:
example 1:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol, 20g of eucalyptus oil and 10g of ketoprofen.
The preparation method comprises the following steps:
(1) preparing materials: weighing the raw materials according to a formula;
(2) ethanol extraction: pulverizing cortex Cinnamomi, flos Caryophylli, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, rhizoma corydalis, radix Cyathulae, and Carthami flos into coarse powder, extracting with 3 times of 90% ethanol for three times (2 hr for the first time and 1.5 hr for the second and third times respectively), mixing extractive solutions, recovering ethanol, and concentrating to obtain extract with relative density of 1.25-1.35 at 50 deg.C;
(3) preparing one or more of rubber, rosin, lanolin or vaseline into a matrix, adding the extract obtained in the step (2), borneol, eucalyptus oil and ketoprofen, and uniformly stirring; preparing into paint, coating ointment, drying, covering a lining and slicing to obtain the patch for expelling wind and clearing away cold, and activating blood and relieving pain.
Example 2:
an ointment for expelling wind and clearing away cold and promoting blood circulation to arrest pain is prepared from the following raw material medicines in parts by weight: 50g of cinnamon, 50g of clove, 50g of angelica dahurica, 100g of ligusticum wallichii, 100g of corydalis tuber, 50g of medicinal cyathula root, 50g of safflower, 20g of borneol, 10g of eucalyptus oil and 5g of ketoprofen.
The preparation method comprises the following steps:
(1) preparing materials: weighing the raw materials according to a formula;
(2) ethanol extraction: pulverizing cortex Cinnamomi, flos Caryophylli, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, rhizoma corydalis, radix Cyathulae, and Carthami flos into coarse powder, extracting with 3 times of 90% ethanol for three times (2 hr for the first time and 1.5 hr for the second and third times respectively), mixing extractive solutions, recovering ethanol, and concentrating to obtain extract with relative density of 1.25-1.35 at 50 deg.C;
(3) adding beeswax 5 times the weight of the crude drugs into the extract obtained in the step (2), adding borneol, eucalyptus oil and ketoprofen, and uniformly stirring to obtain the ointment for expelling wind, clearing away cold, promoting blood circulation and relieving pain.
Example 3:
a tincture for dispelling wind and cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 10g of cinnamon, 10g of clove, 10g of angelica dahurica, 15g of ligusticum wallichii, 15g of corydalis tuber, 10g of medicinal cyathula root, 10g of safflower, 6g of borneol, 4g of eucalyptus oil and 1.5g of ketoprofen.
The preparation method comprises the following steps:
(1) preparing materials: weighing the raw materials according to a formula;
(2) ethanol extraction: pulverizing cortex Cinnamomi, flos Caryophylli, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, rhizoma corydalis, radix Cyathulae, and Carthami flos into coarse powder, extracting with 3 times of 90% ethanol for three times (2 hr for the first time and 1.5 hr for the second and third times respectively), mixing extractive solutions, recovering ethanol, and concentrating to obtain extract with relative density of 1.25-1.35 at 50 deg.C;
(3) and (3) adding the extract obtained in the step (2) into an ethanol solution which is 10 times of the weight of the crude drugs and is 56 percent, then adding borneol, eucalyptus oil and ketoprofen, stirring for 20 minutes, and filtering through a 100-mesh sieve to obtain the tincture for expelling wind, clearing away cold, promoting blood circulation and relieving pain.
Comparative example 1:
the patch of CN201810112216.5 in example 1 is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 170g of ligusticum wallichii, 170g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol, 40g of menthol and 20g of methyl salicylate.
Comparative example 2:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol and 10g of ketoprofen.
The preparation method is the same as example 1.
Comparative example 3:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol and 20g of eucalyptus oil.
The preparation method is the same as example 1.
Comparative example 4:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower and 40g of borneol.
The preparation method is the same as example 1.
Comparative example 5:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol, 20g of eucalyptus oil and 10g of methyl salicylate.
The preparation method is the same as example 1.
Comparative example 6:
a patch for expelling wind and removing cold, and promoting blood circulation and relieving pain is prepared from the following raw material medicines in parts by weight: 80g of cinnamon, 80g of clove, 80g of angelica dahurica, 140g of ligusticum wallichii, 140g of corydalis tuber, 80g of medicinal cyathula root, 80g of safflower, 40g of borneol, 20g of menthol and 10g of ketoprofen.
The preparation method is the same as example 1.
Effect embodiment:
effect example 1: the traditional Chinese medicine composition has the treatment effect on rats with type II collagen-induced arthritis
See, for experimental procedure, CN201810112216.5, effect example 1.
1.1 Experimental drugs
The Chinese medicinal composition patches of example 1 and comparative examples 1-6;
dissolving bovine type II collagen in 0.1mol/L acetic acid with a concentration of 10mg/mL, stirring at 4 ℃ to fully dissolve, standing overnight at 4 ℃, heating autoclaved liquid paraffin to 70 ℃, adding inactivated attenuated BCG vaccine into the liquid paraffin with a concentration of 10mg/mL, fully grinding to fully dissolve, and using the inactivated attenuated BCG vaccine as a complete adjuvant.
1.2 Experimental animals
Male Wistar rats (purchased from longshoving biotechnology, inc., liaoning) weighed 100 ± 10g, 72 animals, and were randomly divided into a blank group, a model group, an example 1 group, a comparative example 2 group, a comparative example 3 group, a comparative example 4 group, a comparative example 5 group, and a comparative example 6 group, each of which had 8 animals.
The joint volume of the left hind paw of all rats was measured using the water volume method and is reported as the pro-inflammatory volume.
Bovine type II collagen acetic acid solution with the concentration of 10mg/mL and complete adjuvant are mixed in equal volume and emulsified to obtain suspension, the suspension is injected into plantar meat pads of right hind feet of rats in a model group, an example 1 group and a comparative example 1-6 group in an intradermal mode, the injection amount is 0.1mL, the injection is reinforced once at the tail root of the rat after 7 days, and the blank group is injected with 0.1mL of autoclaved liquid paraffin.
The patches prepared in example 1 and comparative examples 1-6 were cut into 2cmx 2cm squares 4 hours after bovine type II collagen injection, attached to the right rear soles and joints of rats, and a blank patch was used in the model group and the blank group was normally maintained. After 5 continuous weeks, replacing once a day, measuring the joint volume of the right hind paw of the rat by using a water volume method before replacing the patch on the 7 th, 21 th and 35 th days, calculating the joint swelling rate (%) of the left hind paw of the rat and the joint swelling inhibition rate of the rat, and eliminating the rats of which the joint swelling rate (%) of the right hind paw of the rat in the model group, the example 1 group and the comparative examples 1-6 group in the experimental process is smaller than that of the rats in the blank group, wherein the specific experimental results are shown in the tables 1-2, wherein:
the swelling rate (%) of the left hind paw joint of the rat is (volume of the postinflammatory joint-volume of the pro-inflammatory joint)/volume of the pro-inflammatory joint x 100%;
the rat paw joint swelling inhibition rate (%) (model group paw joint volume-experimental group paw joint volume)/model group paw joint volume x 100%.
1.3 results of the experiment
A multi-factor analysis of variance module of statistical software SPSS is used for data analysis, and P <0.05 indicates that the difference has statistical significance.
Table 1: the influence of the traditional Chinese medicine composition on the volume of the foot joints of rats with type II collagen-induced arthritis
Note: comparison with model groups: * p<0.05, ** p<0.01; comparison with comparative example 1 group: # p<0.05, ## p<0.01
table 2: the traditional Chinese medicine composition has the inhibition rate on II-type collagen-induced arthritic foot joint swelling of rats
The experimental results in tables 1 and 2 show that the joint volume of the rat foot of the model group injected with the plantar meat pad of the right hind foot of the rat with the bovine type II collagen is obviously increased relative to the empty group, and the method for injecting the bovine type II collagen into the plantar meat pad of the right hind foot of the rat in an intradermal manner is proved to be capable of molding the rat with the rheumatoid arthritis.
The experimental results show that the volumes of the right foot joints of the rats in the group of example 1 and the group of comparative example 1 are obviously reduced compared with the volume of the right foot joints of the rats in the model group ( * p<0.05, ** p<0.01), and the rats of the example 1 group had statistically significant differences in the left joint volume compared with the comparative example 1 group ( # p<0.05, ## p<0.01), which shows that the effect of the traditional Chinese medicine composition of the invention in the example 1 on treating rheumatoid arthritis is significantly better than that of the previous improved scheme shown in the comparative example 1.
As can be seen from the experimental results of comparative example 2 to comparative example 4, the effect of treating rheumatoid arthritis is insufficient when eucalyptus oil, ketoprofen, or both are not contained in the Chinese medicinal composition of the present invention. When the external traditional Chinese medicine composition does not contain eucalyptus oil and ketoprofen, the external effect of the external traditional Chinese medicine composition is only slightly better than that of a model group, and when the external traditional Chinese medicine composition does not contain eucalyptus oil or ketoprofen, the external traditional Chinese medicine composition has a remarkably-lower effect on treating rheumatoid arthritis than that of the group in the example 1, even than that of the group in the comparative example 1, which shows that the external traditional Chinese medicine composition containing eucalyptus oil and ketoprofen in specific amounts and proportions generates a remarkable synergistic effect on treating rheumatoid arthritis.
From the experimental results of comparative example 5 and comparative example 6, it can be seen that the combination of eucalyptus oil and methyl salicylate or the combination of menthol and ketoprofen in the traditional Chinese medicine composition has no effect on treating rheumatoid arthritis as long as the eucalyptus oil and ketoprofen are added into the traditional Chinese medicine composition in specific amount and ratio.
Effect example 2: the traditional Chinese medicine composition has the treatment effect on the gouty arthritis rats
2.1 Main test materials
Experimental drugs: the patches of the traditional Chinese medicine compositions of example 1, comparative example 1 and comparative example 4, the positive control drug colchicine;
animals: 48 SPF-grade SD male rats (8 weeks old, weight 200-. All rats were kept in an environment with a temperature of 22. + -. 1 ℃ and a humidity of 55. + -. 5%. The rats were free to ingest food and water by keeping the lighting for 12 hours/dark for 12 hours, uniformly illuminating natural light.
2.2 Experimental methods
Grouping and administration of rats: selecting 48 SPF grade healthy SD male rats, randomly dividing the rats into 6 groups, 8 rats in each group, wherein the groups are respectively as follows: blank control group, model group, colchicine group, example 1 group, comparative example 4 group.
Wherein colchicine group (3mg/kg) is diluted with distilled water to appropriate drug concentration. The administration is carried out by intragastric administration at 9:00 morning with intragastric volume of 10mL/kg body weight for 8 days. The patches prepared in example 1 and comparative examples 1 and 4 were cut into 2cmx 2cm squares and attached to the right rear soles and joints of rats, and the model group was fed with a blank patch and the blank group was fed normally. The replacement was carried out once a day for 8 consecutive days. At 1 hour before the administration on the 6 th morning, the rats in each group except the blank group were injected with 100. mu.L of sodium urate suspension in the right posterior ankle joint cavity, and the blank group was injected with an equal volume of physiological saline. The right hind ankle circumference of the rat was measured and recorded by a roping method at 0 hour and 24 hours after injection for calculation of the degree of ankle swelling of the rat.
Rat ankle swelling assay: the respective groups of rats obtained from the 0 hour measurement had their own ankle circumferences as a normalization control (100%), and the degree of swelling of the ankle of the rats at the 24 hour time point was calculated in equal proportion.
The data processing method comprises the following steps: experimental data are expressed as mean ± standard deviation (mean ± s.d.). Statistically significant differences the differences between groups were examined according to the one-way ANOVA analysis of IBM SPSS Statistics 23 software (LSD test performed afterwards), and when p <0.05, the differences between groups were considered significant and statistically significant.
2.3 results of the experiment
2.3.1 rat ankle swelling assay results
The normalization treatment was performed based on the average value of the circumference of the rats measured for 0h for each group of rats. By comparing the change of the ankle joint circumference of rats in each group after the injection of the sodium urate, the relieving effect of the drug treatment on joint swelling caused by the sodium urate can be intuitively reflected, so that the anti-gouty arthritis activity of each group is evaluated.
The experimental results are shown in the following table 3, compared with the blank control group, the ankle joint swelling degree of the rat in the model group only injected with sodium urate is remarkably increased after 24 hours, which indicates that the rat joint is severely swollen due to the sodium urate injection, and the gouty arthritis is successfully modeled. The positive group rats are treated by colchicine to effectively inhibit joint swelling of the rats caused by sodium urate injection, and the joint swelling result of the colchicine group rats is close to that of the blank group.
For the group of example 1, the experimental results showed that at 24h, the degree of joint swelling was significantly reduced (p <0.01) in the rats of this group compared to the model group, the results of which have been close to those of the positive control colchicine group. In addition, the experimental result of the group 1 is obviously better than that of the group 1 (p is less than 0.05), which indicates that the external application of the traditional Chinese medicine composition has obvious effect of treating the gouty arthritis, while the effect of the prior improved scheme shown in the group 1 on treating the gouty arthritis is not obvious. In addition, comparative example 4, which did not contain eucalyptus oil and ketoprofen, had little effect on the treatment of gouty arthritis.
Table 3: the traditional Chinese medicine composition has the influence on joint swelling of rats with gouty arthritis
| Group of | 0h | 24h |
| Blank group | 100±2.97 | 104±2.95 |
| Model set | 100±3.01 | 132±5.98 |
| Colchicine group | 100±2.94 | 108±4.02 **,## |
| EXAMPLE 1 group | 100±2.92 | 110±3.86 **,# |
| Comparative example 1 group | 100±3.03 | 123±3.52 |
| Comparative example 4 group | 100±2.98 | 129±5.94 |
Note: in comparison with the set of models, * p<0.05, ** p<0.01; in comparison with the group of comparative example 1, # p<0.05, ## p<0.01。
it will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (10)
1. A topical Chinese medicinal composition with effects of dispelling pathogenic wind, dispelling cold, promoting blood circulation and relieving pain is characterized by being prepared from the following raw material medicines in parts by weight: 5-10 parts of cinnamon, 5-10 parts of clove, 5-10 parts of angelica dahurica, 10-15 parts of ligusticum wallichii, 10-15 parts of corydalis tuber, 5-10 parts of medicinal cyathula root, 5-10 parts of safflower, 2-6 parts of borneol, 1-5 parts of eucalyptus oil and 0.5-2 parts of ketoprofen.
2. The external traditional Chinese medicine composition with the effects of expelling wind and removing cold and promoting blood circulation to arrest pain according to claim 1 is characterized by being prepared from the following raw material medicines in parts by weight: 7-9 parts of cinnamon, 7-9 parts of clove, 7-9 parts of angelica dahurica, 12-14 parts of ligusticum wallichii, 12-14 parts of corydalis tuber, 7-9 parts of medicinal cyathula root, 7-9 parts of safflower, 3-5 parts of borneol, 1-4 parts of eucalyptus oil and 0.5-1.5 parts of ketoprofen.
3. The external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain as claimed in claim 2, which is characterized by being prepared from the following raw material medicines in parts by weight: 8 parts of cinnamon, 8 parts of clove, 8 parts of angelica dahurica, 13 parts of ligusticum wallichii, 13 parts of corydalis tuber, 8 parts of medicinal cyathula root, 8 parts of safflower, 4 parts of borneol, 2 parts of eucalyptus oil and 1 part of ketoprofen.
4. The external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain as claimed in any one of claims 1 to 3, characterized in that the external traditional Chinese medicine composition is selected from the group consisting of: ointment, tincture, lotion, membrane, patch or gel.
5. The external traditional Chinese medicine composition with effects of dispelling wind and cold, promoting blood circulation and relieving pain according to claim 4, which is characterized in that the external traditional Chinese medicine composition is selected from: patch, paste or tincture.
6. The preparation method of the external traditional Chinese medicine composition with the effects of dispelling wind and cold, promoting blood circulation and relieving pain as claimed in any one of claims 1 to 5 is characterized by comprising the following steps:
(1) preparing materials: weighing the raw materials according to a formula;
(2) ethanol extraction: pulverizing cortex Cinnamomi, flos Caryophylli, radix Angelicae Dahuricae, rhizoma Ligustici Chuanxiong, rhizoma corydalis, radix Cyathulae, and Carthami flos into coarse powder, extracting with 2-5 times of 75-90% ethanol for three times (2 hr for the first time and 1.5 hr for the second and third times respectively), mixing extractive solutions, recovering ethanol, and concentrating to obtain extract with relative density of 1.25-1.35 at 50 deg.C;
(3) preparing into corresponding external preparation according to the conventional method in the field.
7. The preparation method according to claim 6, wherein step (3) is to take one or more of rubber, rosin, lanolin or vaseline as a base, add the extract obtained in step (2) with borneol, eucalyptus oil and ketoprofen, and stir; making into coating, coating paste, drying, covering with lining, and slicing to obtain patch.
8. The preparation method according to claim 6, wherein the step (3) comprises adding 5 times of beeswax into the extract obtained in step (2), adding Borneolum Syntheticum, oleum Eucalypti, and ketoprofen, and stirring to obtain unguent.
9. The preparation method of claim 6, wherein the step (3) comprises adding the extract obtained in step (2) into 56% ethanol solution 10 times of the weight of the crude drugs, adding Borneolum Syntheticum, oleum Eucalypti, and ketoprofen, stirring for 20 min, sieving with 100 mesh sieve, and filtering to obtain tincture.
10. Use of the topical Chinese medicinal composition with effects of dispelling pathogenic wind and cold, promoting blood circulation and relieving pain of any one of claims 1-5 in the preparation of topical medicine for treating scapulohumeral periarthritis, cervical syndrome, lumbago and leg pain, muscle and joint pain, and rheumatic arthritis, rheumatoid arthritis and gouty arthritis.
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| JP2008231081A (en) * | 2007-02-23 | 2008-10-02 | Hisamitsu Pharmaceut Co Inc | Ketoprofen-containing external preparation |
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| KR20100086332A (en) * | 2009-01-22 | 2010-07-30 | 사노피-아벤티스 | New combination of active ingredients containing a non steroidal anti inflammatory drug and a colchicoside derivative |
| CN103565954A (en) * | 2012-07-29 | 2014-02-12 | 潘首德 | Application of Wantong muscle and bone patch in medicament for treating scapulohumeral periarthritis |
| CN106692114A (en) * | 2016-12-27 | 2017-05-24 | 毛嘉明 | Novel ketoprofen patch and preparation method thereof |
| CN108159150A (en) * | 2018-02-05 | 2018-06-15 | 通化万通药业股份有限公司 | A kind of Chinese medicine composition for treating rheumatic Bi syndrome and its preparation method and application |
| CN108159125A (en) * | 2018-02-05 | 2018-06-15 | 通化万通药业股份有限公司 | A kind of external medicine composition and its preparation method and application of expelling wind and clearing away cold, promoting blood circulation and stopping pain |
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|---|---|---|---|---|
| JP2008231081A (en) * | 2007-02-23 | 2008-10-02 | Hisamitsu Pharmaceut Co Inc | Ketoprofen-containing external preparation |
| KR20100086332A (en) * | 2009-01-22 | 2010-07-30 | 사노피-아벤티스 | New combination of active ingredients containing a non steroidal anti inflammatory drug and a colchicoside derivative |
| CN101721480A (en) * | 2009-12-29 | 2010-06-09 | 乌力吉 | Traditional Chinese medicine composition for treating diseases of bone, joint and skin and preparation method thereof |
| CN103565954A (en) * | 2012-07-29 | 2014-02-12 | 潘首德 | Application of Wantong muscle and bone patch in medicament for treating scapulohumeral periarthritis |
| CN106692114A (en) * | 2016-12-27 | 2017-05-24 | 毛嘉明 | Novel ketoprofen patch and preparation method thereof |
| CN108159150A (en) * | 2018-02-05 | 2018-06-15 | 通化万通药业股份有限公司 | A kind of Chinese medicine composition for treating rheumatic Bi syndrome and its preparation method and application |
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