A Chinese medicine composition for external use for treating and / or relieving human pain and its preparation method

Abstract

The invention discloses a Chinese medicine composition for external use for treating and / or relieving human pain and a preparation method thereof. The Chinese medicine composition is made of the following raw materials in parts by mass: 18-90 parts of rhubarb, 26-110 parts of gardenia, 18-90 parts of angelica dahurica, 26-100 parts of scutellaria baicalensis, 18-90 parts of millennium jian, 10-44 parts of geranium, 18-90 parts of belladonna fluid extract, 10-44 parts of menthol, 18-90 parts of camphor and 18-90 parts of borneol. The preparation method is as follows: 1) except for borneol, belladonna fluid extract, menthol and camphor, the remaining raw materials are extracted with water or ethanol aqueous solution, filtered, and the filtrate is collected and concentrated to an appropriate amount; 2) borneol, belladonna fluid extract, menthol and camphor are added to the concentrate to obtain. The Chinese medicine composition has good effects of promoting blood circulation and removing blood stasis, resisting inflammation and reducing swelling, and relieving pain. It not only avoids some side effects of western medicine, but also overcomes the defect of slow efficacy of traditional Chinese medicine, and has important practical application value.

Description

Technical Field

[0001] The present invention belongs to the field of medicine, and in particular relates to a Chinese medicine composition for treating and / or alleviating human pain and a preparation method thereof. Background Art

[0002] At present, there are many drugs for treating pain caused by rheumatism, bone hyperplasia, bruises, sprains, etc. Although Western medicine has good efficacy, it has certain side effects and is not suitable for long-term use by patients; many traditional Chinese medicines also have certain efficacy, but the effect is slow.

[0003] Therefore, it is of great significance to develop a drug that has good analgesic effect, quick effect, good blood circulation and blood stasis removal, anti-inflammatory, swelling and pain relief effects. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for external use for treating and / or relieving pain in the neck, shoulders, waist, legs, joints and muscles caused by rheumatism, bone hyperplasia, traumatic injury, etc. and a preparation method thereof. The external medicine composition has good effects of promoting blood circulation and removing blood stasis, anti-inflammatory, reducing swelling and relieving pain.

[0005] The external Chinese medicine composition provided by the present invention is prepared from the following raw materials in parts by weight: 18-90 parts of rhubarb, 26-110 parts of gardenia, 18-90 parts of angelica dahurica, 26-100 parts of scutellaria baicalensis, 18-90 parts of gentiana japonica, 10-44 parts of geranium, 18-90 parts of belladonna fluid extract, 10-44 parts of menthol, 18-90 parts of camphor and 18-90 parts of borneol.

[0006] The preferred weight proportions of the above raw materials are: 28-80 parts of rhubarb, 46-90 parts of gardenia, 28-80 parts of angelica dahurica, 46-90 parts of scutellaria baicalensis, 28-80 parts of gentiana japonica, 16-38 parts of geranium, 28-80 parts of belladonna fluid extract, 16-38 parts of menthol, 28-80 parts of camphor and 28-80 parts of borneol.

[0007] More preferred parts by mass are: 38-70 parts of rhubarb, 56-80 parts of gardenia, 38-70 parts of angelica dahurica, 56-80 parts of scutellaria baicalensis, 38-70 parts of angelica sinensis, 16-38 parts of geranium, 38-70 parts of belladonna fluid extract, 16-38 parts of menthol, 38-70 parts of camphor and 38-70 parts of borneol.

[0008] The most preferred mass proportions of each raw material are: 54 parts of rhubarb, 68 parts of gardenia, 54 parts of angelica dahurica, 68 parts of scutellaria baicalensis, 54 parts of angelica sinensis, 27 parts of geranium, 54 parts of belladonna fluid extract, 27 parts of menthol, 54 parts of camphor and 54 parts of borneol.

[0009] The raw materials used to make the external Chinese medicine composition of the present invention are proportioned according to parts by mass, and can be increased or decreased according to the corresponding proportion during production. For example, large-scale production can be measured in kilograms or tons, and small-scale production can also be measured in grams. The mass can be increased or decreased, but the mass ratio of each raw material remains unchanged.

[0010] The invention also provides a method for preparing the external Chinese medicine composition.

[0011] The preparation method includes the following two methods.

[0012] Method 1 comprises the following steps:

[0013] 1) except borneol, belladonna fluid extract, menthol and camphor, extract the raw materials used to prepare the Chinese medicine composition of the present invention with water or ethanol aqueous solution, filter, collect the filtrate, and concentrate to an appropriate amount, i.e., concentrate 1;

[0014] 2) adding borneol, belladonna fluid extract, menthol and camphor to the concentrate 1 to obtain the external Chinese medicine composition.

[0015] Wherein, the volume percentage of ethanol in the ethanol aqueous solution is greater than 0 and less than or equal to 85%; the mass ratio of the raw material to water or the ethanol aqueous solution is 1:5-8.

[0016] The extraction may be specifically reflux extraction; when reflux extraction is adopted, the extraction is performed at least once, and the time of each extraction may be 1-3 hours.

[0017] The extraction can also be cold soaking extraction or percolation extraction; when cold soaking extraction or percolation extraction is adopted, the extraction solvents used are ethanol aqueous solution, and the volume percentage of ethanol in the ethanol aqueous solution can be specifically 60-85%; the time of cold soaking extraction can be 7-15 days.

[0018] When cold soaking extraction is adopted, the concentrate 1 obtained by cold soaking extraction can be directly added with borneol, belladonna fluid extract, menthol, camphor, etc., and prepared into a solution with an ethanol content of 30-55% using ethanol solution and purified water. The supernatant is taken and filled into a spray bottle to prepare a spray.

[0019] When preparing external preparations such as patches and sprays, the concentrate 1 is a concentrate of 1.05-1.30 (50°C-60°C); then belladonna fluid extract, menthol, camphor, borneol powder or ethanol solution are added to the concentrate to obtain a traditional Chinese medicine composition; then auxiliary materials or matrix can be added to the traditional Chinese medicine composition to prepare an external preparation.

[0020] Method 2 comprises the following steps:

[0021] 1) except borneol, belladonna fluid extract, menthol and camphor, extract the raw materials used for preparing the Chinese medicine composition of the present invention with water, filter, collect the filtrate, concentrate the filtrate into a concentrate (50° C.-60° C.) with a relative density of 1.05-1.15, then add ethanol to the concentrate so that the volume percentage of ethanol in the concentrate is 50-80%, place it in a sealed container, let it stand for 24-48 hours, filter the supernatant, collect the filtrate, and concentrate to an appropriate amount to obtain concentrate 2;

[0022] 2) adding borneol, belladonna fluid extract, menthol and camphor to the concentrate 2 to obtain the external Chinese medicine composition;

[0023] Wherein, the mass ratio of the raw material to water is 1:5-10.

[0024] The extraction is generally performed at least once, and the time for each extraction may be 1-3 hours.

[0025] When preparing external preparations such as patches and sprays, auxiliary materials or bases can be added to the traditional Chinese medicine composition prepared by the above method 2 to prepare the external preparation.

[0026] In the above method 2, belladonna fluid extract, menthol, camphor and borneol can be directly added to concentrate 2 in the form of ethanol solution, and after preparation, the ethanol content is 30-55%. The supernatant is taken and filled into a spray bottle to prepare a spray.

[0027] Another object of the present invention is to provide an application of the external Chinese medicine composition.

[0028] The application of the external Chinese medicine composition provided by the present invention is its application in preparing a medicine having at least one of the following effects: 1) promoting blood circulation and removing blood stasis; 2) anti-inflammatory and detumescence; 3) treating and / or relieving pain.

[0029] The pain may specifically be pain caused by rheumatism and rheumatoid arthritis, bone hyperplasia (osteoarthritis), cervical spondylosis, frozen shoulder, lumbar disc herniation, lumbar muscle strain, contusions, soft tissue injury, fractures, bruises, stiff neck, tenosynovitis, phlebitis, costochondritis, tennis elbow, as well as muscle soreness, neuralgia or heel pain.

[0030] At the same time, external-use medicines prepared with the external-use Chinese medicine composition provided by the present invention as an active ingredient or one of the active ingredients also fall within the protection scope of the present invention.

[0031] The drug can be introduced into the body through external application, penetration, absorption, physical or chemical mediation; or can be introduced into the body after being mixed or wrapped with other substances.

[0032] When necessary, one or more pharmaceutically acceptable carriers may be added to the above-mentioned drugs, including conventional diluents, excipients, fillers, binders, wetting agents, disintegrants, absorption promoters, surfactants, adsorption carriers and lubricants in the pharmaceutical field.

[0033] The medicine prepared by the pharmaceutical composition of the present invention with the effects of promoting blood circulation and removing blood stasis, resisting inflammation and reducing swelling and relieving pain can be made into external preparations, which include: patches, wine preparations, tinctures, gels, ointments, liniments, suppositories, aerosols, sprays and film coatings.

[0034] The drugs in the above-mentioned various dosage forms can be prepared according to conventional methods in the pharmaceutical field.

[0035] Another object of the present invention is to provide a Chinese medicine composition patch.

[0036] The Chinese medicine composition patch, whose active ingredients include the above-mentioned Chinese medicine composition, is prepared according to the following method: six medicinal materials of rhubarb, gardenia, angelica dahurica, scutellaria baicalensis, scutellaria baicalensis and geranium are cleaned and sliced ​​or segmented, extracted with ethanol aqueous solution by reflux, filtered, combined filtrate, ethanol is recovered until there is no alcohol taste, and the medicinal liquid is concentrated to an extract with a relative density of 1.16-1.30 (50℃-60℃); open the melt glue tank, add hot melt glue, and after melting, put it into an insulation stirring tank for insulation; evenly sprinkle talcum powder on the glue surface, stir evenly, add the Chinese medicine extract, belladonna fluid extract, menthol, borneol, camphor, methyl salicylate, stir to make an adhesive paste; apply the paste, cover with a lining, cut into segments, roll up, and slice to obtain the paste.

[0037] The pharmaceutical composition provided by the present invention is a pure Chinese medicine preparation. Modern pharmacological studies have shown that rhubarb contains anthraquinones, which have analgesic, anti-inflammatory and bactericidal effects, and can also relieve muscle pain and arthritis pain, reduce pain and inflammatory reactions, and effectively reduce the swelling of local tissues; the main chemical component of gardenia, gardenia glycoside, has significant analgesic and anti-inflammatory effects; the coumarins, volatile oils and other components contained in angelica dahurica can play an anti-inflammatory, analgesic and antibacterial role; the baicalin contained in scutellaria baicalensis has anti-tumor, antibacterial, antioxidant, neuron protection and other effects, and external application can play an anti- The chemical composition of Qiannianjian is rich, mainly volatile oil and sesquiterpenes, which have anti-inflammatory, analgesic, antioxidant and antibacterial effects. It can be used externally to treat rheumatoid arthritis. Geranium mainly contains tannins, flavonoids, organic acids and volatile oils, and also contains a small amount of triterpenes, sterols, lignans and organic esters, which have antibacterial effects. Belladonna fluid extract has analgesic effects and can effectively relieve pain caused by various reasons. Borneol has the effects of clearing heat and reducing swelling, cooling blood and relieving pain. Menthol and camphor both have the effect of promoting skin penetration and accelerating the absorption of effective ingredients by the human body. The combination of these medicines can promote blood circulation and remove blood stasis, fight inflammation and reduce swelling, and relieve pain. This medicine has significant therapeutic effect on relieving pain in the neck, shoulders, waist, legs, joints and muscles caused by rheumatism, bone hyperplasia, bruises and sprains. It is suitable for pain caused by rheumatism and rheumatoid arthritis, bone hyperplasia (osteoarthritis), cervical spondylosis, periarthritis of the shoulder, lumbar disc herniation, lumbar muscle strain, bruises and sprains (soft tissue injury), fractures, contusions, stiff neck, tenosynovitis, phlebitis, costochondritis or tennis elbow, as well as muscle soreness, neuralgia or heel pain.

[0038] Clinical experiments have shown that the above-mentioned Chinese medicine combination has good effects of promoting blood circulation and removing blood stasis, anti-inflammatory and detumescence, and relieving pain. It not only avoids some side effects of Western medicine, but also overcomes the defect of slow efficacy of traditional Chinese medicine, and has important practical application value. DETAILED DESCRIPTION

[0039] The present invention is further described in detail below in conjunction with specific embodiments, and the examples provided are only for illustrating the present invention, rather than for limiting the scope of the present invention. The examples provided below can be used as a guide for further improvements by those of ordinary skill in the art, and do not constitute a limitation of the present invention in any way.

[0040] The experimental methods in the following examples, unless otherwise specified, are all conventional methods, and are performed according to the techniques or conditions described in the literature in the field or according to the product instructions. The materials, reagents, etc. used in the following examples, unless otherwise specified, can all be obtained from commercial channels.

[0041] The rhubarb, gardenia, angelica, scutellaria, millennium jian, geranium, belladonna fluid extract, menthol, camphor and borneol used in the following examples all comply with the relevant provisions of the Chinese Pharmacopoeia (2020 edition) under the main text of each medicinal material. Before feeding, it was identified that the actual medicinal materials were consistent with the names and the quality met the standards.

[0042] In the following examples, Examples 1-8 are preparations of pharmaceutical preparations, Example 9 is a clinical experimental result, and Example 10 is an animal experimental result.

[0043] Preparation of pharmaceutical preparations:

[0044] Example 1: Preparation of Chinese medicine composition patch

[0045] Take 54g of rhubarb, 68g of gardenia, 54g of angelica, 68g of scutellaria, 54g of millennium jian, 27g of geranium, 54g of belladonna fluid extract, 27g of menthol, 54g of camphor, and 54 of borneol, and crush the borneol into fine powder for standby use. The six medicinal materials of rhubarb, gardenia, angelica, scutellaria, millennium jian, and geranium are cleaned and sliced ​​or segmented, and refluxed with 80% ethanol aqueous solution by volume for 3 times (the mass of the added extraction solvent is 6 times the mass of the medicinal material), each time for 1.5 hours, filtered, combined filtrate, ethanol is recovered until there is no alcohol taste, and the medicinal liquid is concentrated to an extract with a relative density of 1.16-1.30 (50°C-60°C). Open the melt tank, add 1351g of hot melt adhesive, and after melting, put it into an insulation stirring tank for insulation. Evenly sprinkle 1351g talcum powder on the surface of the glue, slowly stir evenly, add the above-mentioned Chinese medicine extract, belladonna fluid extract, menthol, borneol, camphor, 27g methyl salicylate (or wintergreen oil), stir for 10 minutes, and make a glue paste. Apply the paste, cover the backing, cut into sections, roll up, slice, cover the backing, cut into small pieces, and make 1000 patches (7cm×10cm).

[0046] Example 2: Preparation of Chinese medicine composition patch

[0047] The preparation method is basically the same as that in Example 1, except that the Chinese medicine composition is made of the following raw materials: 38g of rhubarb, 80g of gardenia, 38g of angelica dahurica, 80g of scutellaria baicalensis, 38g of millennium jian, 38g of geranium herb, 38g of belladonna fluid extract, 38g of menthol, 38g of camphor, and 70g of borneol.

[0048] Example 3: Preparation of Chinese medicine composition patch

[0049] The preparation method is basically the same as that in Example 1, except that the Chinese medicine composition is made of the following raw materials: 70g of rhubarb, 56g of gardenia, 70g of angelica dahurica, 56g of scutellaria baicalensis, 70g of millennium jian, 16g of geranium, 70g of belladonna fluid extract, 16g of menthol, 70g of camphor, and 38g of borneol.

[0050] Example 4: Preparation of Chinese medicine composition patch

[0051] The preparation method is basically the same as that in Example 1, except that the Chinese medicine composition is made of the following raw materials: 28g of rhubarb, 46g of gardenia, 80g of angelica dahurica, 90g of scutellaria baicalensis, 28g of millennium jian, 38g of geranium, 80g of belladonna fluid extract, 16g of menthol, 28g of camphor, and 80g of borneol.

[0052] Example 5: Preparation of Chinese medicine composition patch

[0053] The preparation method is basically the same as that in Example 1, except that the Chinese medicine composition is made of the following raw materials: 80g of rhubarb, 46g of gardenia, 28g of angelica dahurica, 90g of scutellaria baicalensis, 28g of millennium jian, 38g of geranium, 80g of belladonna fluid extract, 16g of menthol, 28g of camphor, and 80g of borneol.

[0054] Example 6: Preparation of Chinese medicine composition patch

[0055] The preparation method is basically the same as that in Example 1, except that the Chinese medicine composition is made of the following raw materials: 28g of rhubarb, 46g of gardenia, 80g of angelica dahurica, 46g of scutellaria baicalensis, 80g of millennium jian, 16g of geranium, 28g of belladonna fluid extract, 38g of menthol, 80g of camphor, and 28g of borneol.

[0056] Example 7: Preparation of Chinese medicine composition spray

[0057] Take 54g of rhubarb, 68g of gardenia, 54g of angelica, 68g of scutellaria, 54g of millennium scutellaria, 27g of geranium, 54g of belladonna fluid extract, 27g of menthol, 54g of camphor, and 54g of borneol, and crush the borneol into fine powder for standby use. Make slices or sections of six medicinal materials, including rhubarb, gardenia, angelica, scutellaria, millennium scutellaria, and geranium, and airtightly soak the medicinal materials in ethanol aqueous solution with a volume content of 80% for 10 days. The quality of the extraction solvent added is 6 times the quality of the medicinal materials, and the filtrate is filtered to obtain a filtrate. Directly add borneol, belladonna fluid extract, menthol, and camphor to the filtrate, and prepare a solution with an ethanol content of 55% with purified water, take the supernatant, and fill it into a spray bottle to prepare a spray.

[0058] Example 8: Preparation of Chinese medicine composition patch

[0059] Take 54g of rhubarb, 68g of gardenia, 54g of angelica, 68g of scutellaria, 54g of millennium scutellaria, 27g of geranium, 54g of belladonna fluid extract, 27g of menthol, 54g of camphor, and 54g of borneol, and crush the borneol into fine powder for standby use. Prepare slices or segments of six medicinal materials, rhubarb, gardenia, angelica, scutellaria, millennium scutellaria, and geranium, and extract them with water reflux for 3 times (the mass of the added extraction solvent is 6 times the mass of the medicinal materials), each time for 2 hours, filter, combine the filtrate, and concentrate the medicinal liquid to a concentrated solution with a relative density of 1.05-1.15 (50°C-60°C). Add ethanol to the concentrated solution to make the alcohol content 75%, place it in a closed container, let it stand for 36 hours, take the supernatant and filter it, collect the filtrate, and concentrate it to an extract with a relative density of 1.16-1.30 (50°C-60°C). Open the glue melting tank, add 1351g of hot melt glue, and after melting, put it into the heat preservation stirring tank for heat preservation. Sprinkle 1351g of talcum powder evenly on the glue surface, slowly stir evenly, add the above extract, belladonna fluid extract, menthol, borneol, camphor, 27g of methyl salicylate (or wintergreen oil), stir for 10 minutes, and make a glue paste. Apply the paste, cover the lining, cut into sections, roll up, slice, cover the lining, cut into small pieces, and make 1000 patches (7cm×10cm).

[0060] Clinical efficacy trials

[0061] Embodiment 9,

[0062] The sample of Example 1 was used for clinical trials. Through clinical observation of 60 inpatients and outpatients, the results showed that the patch provided by the present invention has significant therapeutic effects on relieving pain in the neck, shoulders, waist, legs, joints, and muscles caused by rheumatism, bone hyperplasia, cervical spondylosis, scapulohumeral periarthritis, lumbar disc herniation, lumbar muscle strain, traumatic sprains, etc., and is safe and reliable with no side effects.

[0063] 1. Case selection

[0064] 60 patients were randomly divided into treatment group, control group 1 and control group 2. There were 20 cases in the treatment group, including 9 males and 11 females aged 28-60 years old; there were 20 cases in control group 1, including 11 males and 9 females aged 25-55 years old; there were 20 cases in control group 2, including 10 males and 10 females aged 30-58 years old.

[0065] II. Basis for Admission

[0066] The 60 patients were diagnosed with rheumatism, bone hyperplasia, cervical spondylosis, frozen shoulder, lumbar disc herniation, lumbar muscle strain, and sprains, with pain in the neck, shoulders, waist, legs, joints, and muscles as the main clinical manifestations.

[0067] 3. Treatment Methods

[0068] Treatment group: Apply this product externally, directly to the affected area, once a day.

[0069] Control group 1: Apply the "patch" to the affected area once a day.

[0070] Control group 2: Apply “Shangshi Qutong Ointment” to the affected area once a day.

[0071] The patch used in the control group 1 was prepared as follows:

[0072] Take 80g of rhubarb, 80g of gardenia, 70g of scutellaria and 70g of angelica, clean and slice them, extract the above medicinal materials with 70% ethanol aqueous solution for 3 times, the extraction time is 2, 2 and 1 hours respectively, the mass of the added extraction solvent is 6, 6 and 5 times the mass of the medicinal materials respectively, after each extraction, filter, collect the filtrate, combine the three filtrates, and recover ethanol, concentrate the filtrate into an extract with a relative density of 1.10-1.20 (70°C), add laurocapram (the addition amount is 1.1% of the total mass of the medicinal materials) into the extract, stir and mix, then add a matrix made of rubber, rosin, zinc oxide, vaseline, lanolin and liquid paraffin equivalent to 8 times the mass of the extract (wherein the mass ratio of each substance is 10:4:15:1.6:1.6:0.8) to make a coating. Apply ointment, cut into sections, cover with lining, cut into small pieces, and make 1000 patches (7cm×10cm) to obtain a plaster.

[0073] The Shangshi Qutong Ointment used in Control Group 2 was produced by Jilin Yizheng Pharmaceutical Group Co., Ltd., with approval number: National Medicine Standard Z22020087.

[0074] Treatment course: 7 days.

[0075] IV. Efficacy Standards

[0076] The clinical judgment indicators are the degree of pain relief, the degree of relief of joint stiffness and swelling, and the degree of improvement of limited joint movement.

[0077] 1. Significant effect: Pain is relieved, joint swelling is reduced, and joint movement is significantly improved.

[0078] 2. Effective: Pain is relieved, joint swelling is reduced, and limited joint movement is improved.

[0079] 3. Ineffective: No relief of pain, no improvement in joint swelling and mobility.

[0080] V. Result analysis:

[0081] The drug of the present invention was used for external use to observe 60 patients with neck, shoulder, waist, leg, joint and muscle pain caused by rheumatism, bone hyperplasia, cervical spondylosis, scapulohumeral periarthritis, lumbar disc herniation, lumbar muscle strain, traumatic sprain and the like. The results are shown in Table 1.

[0082] Table 1

[0083]

[0084] As shown in Table 1, in the treatment group, 10 cases were markedly effective, 9 cases were effective, 1 case was ineffective, and the total effective rate was 95%. In the control group 1, 7 cases were markedly effective, 11 cases were effective, 2 cases were ineffective, and the total effective rate was 90%. In the control group 2, 3 cases were markedly effective, 13 cases were effective, 4 cases were ineffective, and the total effective rate was 80%.

[0085] The total effective rate of the treatment group was higher than that of control group 1 and control group 2, and the marked effective rate of the treatment group was significantly higher than that of control group 1.

[0086] Animal Experimentation:

[0087] Example 10: Test report on improving microcirculation function of the patch of the present invention

[0088] 1 Test materials

[0089] 1.1 Test substance: the patch prepared in Example 1.

[0090] 1.2 Positive substance: Yunnan Baiyao anhydride, specification: 50mL / bottle, batch number: ZCB2202, produced by Yunnan Baiyao Group Co., Ltd.

[0091] 1.3 Animals, feed and breeding environment

[0092] Experimental animals: ICR mice, SPF grade, male, weighing 18g-20g, purchased from Liaoning Changsheng Biotechnology Co., Ltd., production license number: SCXK (Liao) 2020-0001, quality certificate number: 210726230102632152;

[0093] Feed: SPF-grade breeding feed for rats and mice, batch number: 23092821, purchased from Liaoning Changsheng Biotechnology Co., Ltd., production license number: SCXK (Liao) 2020-0002;

[0094] Breeding environment: barrier environment, temperature: 20℃~24C, relative humidity: 40%~70%, rat and mouse use license number: SYXK(Ji)2022-0004.

[0095] 1.4 Test substance dosage design

[0096] According to the requirements of Jilin Provincial Local Standard DB 22 / T 397.8-2017, the dose of the test substance was 0.5 g / mouse.

[0097] 1.5 Main instruments and test drugs

[0098] BI 2000 image analysis system, Chengdu Taimeng Technology Co., Ltd.; animal electronic balance, model: T1000, Changshu Shuangjie Testing Instrument Factory; 1 / 10,000 balance, model: ALC-2014, Beijing Sartorius Scientific Instrument Co., Ltd. Pentobarbital sodium, batch number: 127K1005, SIGMA; epinephrine hydrochloride injection, specification: 1mL:1mg, batch number: 6220930133, Suicheng Pharmaceutical Co., Ltd.; liquid paraffin, batch number: 20230202, Wuyi Yanwei Medical Technology Co., Ltd.

[0099] 2 Test methods

[0100] Thirty mice were randomly divided into three groups, with 10 mice in each group, namely, blank control group, positive control group and test group. The mice in the blank control group were not treated; the positive substance was evenly applied on two layers of gauze at a dose of 0.5 mL / mouse, and applied to the front and back sides of the right ear of the mice in the positive control group, and then fixed with a non-irritating adhesive tape; the test substance was applied to the front and back sides of the right ear of the mice in the test group at a dose of 0.5 g / mouse. After 15 minutes, 1% sodium pentobarbital 0.1 mL / 10 g BW was injected intraperitoneally to anesthetize the animals, followed by a tail vein injection of 0.1% epinephrine hydrochloride 0.1 mL / 10 g BW. After removing the patch, the caliber (μm) of the arterioles and venules in the right ear of the mice and the number of capillaries within a diameter range of 0.2 mm were immediately observed.

[0101] 3. Statistics

[0102] SPSS statistical software was used for data analysis, and group t-test was used to compare the means of the two groups.

[0103] 4 Test results

[0104] The results showed that the caliber of the auricle arterioles in the test group was significantly larger than that in the blank control group (P<0.01), and the caliber of the venules was significantly larger than that in the blank control group (P<0.01), as shown in Table 2.

[0105] Table 2 Effect of the patch of the present invention on the caliber of the auricular arterioles and venules of mice

[0106]

[0107] The results showed that there was no significant difference in the number of capillaries within the 0.2 mm diameter range of the auricle of the mice in the test group compared with the blank control group (P>0.05), as shown in Table 3.

[0108] Table 3 Effect of the patch of the present invention on the number of capillaries in the auricle of mice

[0109]

[0110] 5. Summary

[0111] The test group applied the patch to the auricle of mice at a dose of 0.5g / mouse. The calibers (μm) of the mouse arterioles and venules were significantly different from those of the blank control group (P<0.01, P<0.01); the number of capillaries within the diameter of 0.2mm was not significantly different from that of the blank control group (P>0.05).

[0112] 397.8-2017 result judgment standard, it can be determined that the patch of the present invention has the function of assisting in improving microcirculation under the test dosage conditions.

[0113] Example 11, Test report on pain relief function of the patch of the present invention

[0114] 1 Test materials

[0115] 1.1 Test substance: the patch prepared in Example 1.

[0116] 1.2 Positive substance: Yunnan Baiyao anhydride, specification: 50mL / bottle, batch number: ZCB2202, produced by Yunnan Baiyao Group Co., Ltd.

[0117] 1.3 Animals, feed and breeding environment

[0118] Experimental animals: ICR mice, SPF grade, male, weighing 18g-20g, purchased from Liaoning Changsheng Biotechnology Co., Ltd., production license number: SCXK (Liao) 2020-0001, quality certificate number: 210726230102632231;

[0119] Feed: SPF-grade breeding feed for rats and mice, batch number: 23092821, purchased from Liaoning Changsheng Biotechnology Co., Ltd., production license number: SCXK (Liao) 2020-0002;

[0120] Breeding environment: barrier environment, temperature: 20℃~24C, relative humidity: 40%~70%, rat and mouse use license number: SYXK(Ji)2022-0004.

[0121] 1.4 Test substance dosage design

[0122] According to the requirements of Jilin Provincial Local Standard DB 22 / T 397.8-2017, the dose of the test substance was 0.5 g / mouse.

[0123] 1.5 Main instruments and test drugs

[0124] Animal electronic balance, model: T1000, Changshu Shuangjie Testing Instrument Factory; 1 / 10,000 balance, model: ALC-2014, Beijing Sartorius Scientific Instrument Co., Ltd.; counter, model: i30, Shenzhen Haitiandi Technology Co., Ltd. Veetin Silky Refreshing Hair Removal Cream, batch number: C220822001, Veetin Innovative Silky Refreshing Technology; acetic acid (glacial acetic acid), purity: ≥99.5%, batch number: 20210804, Sinopharm Chemical Reagent Co., Ltd.

[0125] 2 Test methods

[0126] The mouse writhing method was used. Thirty mice were taken and the abdomen was depilated. The depilation range was 3.0cm x 2.8cm. The mice were randomly divided into three groups, 10 in each group, namely the blank control group, the positive control group and the test group. After 24 hours, each mouse in the blank control group was intraperitoneally injected with 0.6% acetic acid at 0.1mL / 10g BW, and the number of writhing of each mouse within 15min after the administration of the analgesic was recorded with a counter; the positive substance was evenly applied on two layers of gauze at a dose of 0.5mL / mouse, applied to the depilated area of ​​the abdomen of the mice in the positive control group, covered with sulfuric acid paper, and then fixed with non-irritating adhesive tape; the test substance was applied to the depilated area of ​​the abdomen of the mice in the test group at a dose of 0.5g / mouse, and then fixed with non-irritating adhesive tape. After 30min, the covering was removed respectively, and then acetic acid was injected according to the method of the blank control group and the number of mouse writhing was recorded.

[0127] 3. Statistics

[0128] SPSS statistical software was used for data analysis, and group t-test was used to compare the means of the two groups.

[0129] 4 Test results

[0130] The results showed that the number of body twisting within 15 minutes in the test group was significantly less than that in the blank control group (P<0.001), see Table 4.

[0131] Table 4 Effect of the patch of the present invention on the number of writhing times of mice

[0132]

[0133] 5. Summary

[0134] The mouse writhing method was adopted, and the patch of the present invention was applied to the abdomen of mice at a dose of 0.5 g / mouse. The number of mouse writhing times was significantly different from that of the blank control group (P<0.001). According to the result judgment standard of Jilin Provincial Local Standard DB 22 / T 397.9-2017, it can be determined that the patch of the present invention has the function of relieving pain under the test dosage conditions.

[0135] The present invention has been described in detail above. It will be apparent to those skilled in the art that the present invention may be implemented in a wide range under equivalent parameters, concentrations and conditions without departing from the spirit and scope of the present invention and without the need for unnecessary experimentation. Although the present invention provides specific embodiments, it should be understood that further improvements may be made to the present invention. In short, according to the principles of the present invention, this application intends to include any changes, uses or improvements to the present invention, including changes made by conventional techniques known in the art that depart from the scope disclosed in this application. Applications of some of the basic features may be made within the scope of the following appended claims.

Claims

1. A Chinese medicine composition for external use for treating and / or relieving human pain, which is prepared from the following raw materials in parts by weight: 18-90 parts of rhubarb, 26-110 parts of gardenia, 18-90 parts of angelica dahurica, 26-100 parts of scutellaria baicalensis, 18-90 parts of millennium jian, 10-44 parts of geranium, 18-90 parts of belladonna fluid extract, 10-44 parts of menthol, 18-90 parts of camphor and 18-90 parts of borneol.

2. The external Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-80 parts of rhubarb, 46-90 parts of gardenia, 28-80 parts of angelica dahurica, 46-90 parts of scutellaria baicalensis, 28-80 parts of gentiana japonica, 16-38 parts of geranium, 28-80 parts of belladonna fluid extract, 16-38 parts of menthol, 28-80 parts of camphor and 28-80 parts of borneol.

3. The external Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 38-70 parts of rhubarb, 56-80 parts of gardenia, 38-70 parts of angelica dahurica, 56-80 parts of scutellaria baicalensis, 38-70 parts of gentiana japonica, 16-38 parts of geranium, 38-70 parts of belladonna fluid extract, 16-38 parts of menthol, 38-70 parts of camphor and 38-70 parts of borneol.

4. The external Chinese medicine composition according to claim 3, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 54 parts of rhubarb, 68 parts of gardenia, 54 parts of angelica dahurica, 68 parts of scutellaria baicalensis, 54 parts of gentiana japonica, 27 parts of geranium, 54 parts of belladonna fluid extract, 27 parts of menthol, 54 parts of camphor and 54 parts of borneol.

5. A method for preparing a Chinese medicine composition for external use for treating and / or relieving pain in the human body according to any one of claims 1 to 4, comprising the following steps: 1) except borneol, belladonna fluid extract, menthol and camphor, extracting the raw materials used to prepare the Chinese medicine composition with water or ethanol aqueous solution, filtering, collecting the filtrate, and concentrating to an appropriate amount, i.e., concentrate 1; 2) adding borneol, belladonna fluid extract, menthol and camphor to the concentrate 1 to obtain the external Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that: The volume percentage of ethanol in the ethanol aqueous solution is greater than 0 and less than or equal to 85%; the mass ratio of the raw material to water or the ethanol aqueous solution is 1:5-8; And / or, the extraction is reflux extraction; in the extraction, at least one extraction is performed, and the time of each extraction may be 1-3 hours; And / or, the extraction is cold soaking extraction or percolation extraction; during the cold soaking extraction or percolation extraction, the extraction solvents used are ethanol aqueous solution, the volume percentage of ethanol in the ethanol aqueous solution is 60-85%, and the time of the cold soaking extraction is 7-15 days.

7. A method for preparing a Chinese medicine composition for external use for treating and / or relieving pain in the human body according to any one of claims 1 to 4, comprising the following steps: 1) except borneol, belladonna fluid extract, menthol and camphor, extract the raw materials used to prepare the Chinese medicine composition with water, filter, collect the filtrate, concentrate the filtrate into a concentrate (50° C.-60° C.) with a relative density of 1.05-1.15, then add ethanol to the concentrate so that the volume percentage of ethanol in the concentrate is 50-80%, place it in a sealed container, let it stand for 24-48 hours, take the supernatant and filter, collect the filtrate, recover the ethanol and concentrate it to an appropriate amount, which is the concentrate 2; 2) adding borneol, belladonna fluid extract, menthol and camphor to the concentrate 2 to obtain the external Chinese medicine composition.

8. The preparation method according to claim 7, characterized in that: The mass ratio of the raw material to water is 1:5-10; And / or, the extraction is generally performed at least once, and each extraction lasts for 1-3 hours.

9. The use of the external Chinese medicine composition according to any one of claims 1 to 4, wherein the use is the use of the composition in the preparation of a drug having at least one of the following effects: 1) promoting blood circulation and removing blood stasis; 2) anti-inflammatory and detumescence; 3) treating and / or relieving pain; Furthermore, the pain is pain caused by rheumatism and rheumatoid arthritis, bone hyperplasia (osteoarthritis), cervical spondylosis, frozen shoulder, lumbar disc herniation, lumbar muscle strain, contusion, soft tissue injury, fracture, bruise, stiff neck, tenosynovitis, phlebitis, costochondritis or tennis elbow, as well as muscle soreness, neuralgia or heel pain.

10. An external medicine, the active ingredient of which comprises the Chinese medicine composition according to any one of claims 1 to 4.

11. The drug according to claim 10, characterized in that: The drug has at least one of the following effects: 1) promoting blood circulation and removing blood stasis; 2) anti-inflammatory and swelling reduction; 3) treating and / or relieving pain; And / or, the dosage form of the drug is an external preparation including: a patch, an alcoholic solution, a tincture, a gel, an ointment, a liniment, a suppository, an aerosol, a spray and a film coating.

12. A Chinese medicine composition patch, wherein the active ingredient comprises the Chinese medicine composition according to any one of claims 1 to 4, and is prepared according to the following method: six medicinal materials, namely, rhubarb, gardenia, angelica dahurica, scutellaria baicalensis, scutellaria baicalensis, and geranium, are cleaned and sliced ​​or segmented, extracted with ethanol aqueous solution by reflux, filtered, combined the filtrate, and ethanol is recovered until there is no alcohol taste, and the medicinal liquid is concentrated to an extract with a relative density of 1.16-1.30 (50°C-60°C); open a melt glue tank, add hot melt glue, and after melting, put it into an insulated stirring tank for insulation; sprinkle talcum powder evenly on the glue surface, stir evenly, add the Chinese medicine extract, belladonna fluid extract, menthol, borneol, camphor, methyl salicylate or wintergreen oil, stir to make an adhesive paste; apply the paste, cover with a lining, cut into segments, roll up, and slice to obtain the product.

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