Composition for treating pain and arthralgia based on traditional Chinese medicinal materials and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a composition for treating pain and arthralgia based on traditional Chinese medicinal materials and a preparation method thereof. The preparation method comprises the following steps: crushing acanthopanax, lamiophlomis rotata, oldenlandia diffusa, safflower, fructus psoraleae, radix clematidis, divaricate saposhnikovia root, curcuma zedoary and corydalis tuber, adding water, heating and extracting, and then adding snail protease and ficin protease for combined enzymolysis; the preparation method comprises the following steps of: inoculating the raw materials into a fermentation tank, then inoculating zymophyte consisting of bacillus subsp. Stutzeri with the number of CICC 24224 and lactobacillus delbrueckii subsp. Bulgaricus with the number of CICC 6097 for fermentation, then adding ethanol for extraction, and then performing filtration, ultrafiltration, concentration and drying to obtain the composition. The composition disclosed by the invention has an excellent effect of treating pain and can effectively inhibit inflammation accompanied by the pain.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a pain and arthritis treatment composition based on traditional Chinese medicines and a preparation method thereof. Background Art

[0002] Pain and arthritis are common conditions that cause great distress and suffering to patients. Pain and arthritis are a feeling of discomfort or pain in the body, usually caused by illness, injury or inflammation. It can occur in different parts of the body, such as the head, back, joints, etc. The severity and duration of pain vary from person to person. Symptoms Common symptoms of pain include pain, itching, numbness and tingling; patients may also experience redness, swelling, fever and limited movement.

[0003] The causes of pain and arthritis are varied, including but not limited to the following: neurological causes: caused by nerve damage or neuropathy; injury or inflammation: caused by external physical damage or inflammatory response in the body; others: such as metabolic disorders, side effects of drugs, etc.

[0004] At present, there are many types of Chinese medicine compositions for the treatment of pain and arthritis, and the quality is uneven and the efficacy is not high. Therefore, providing a Chinese medicine composition for effectively treating pain and arthritis is a technical problem that needs to be solved at present. Summary of the invention

[0005] In view of the above technical problems, the present invention proposes a technical solution of the present invention, which includes a pain and arthritis treatment composition based on traditional Chinese medicine and a preparation method thereof.

[0006] The invention provides a pain and arthritis therapeutic composition based on traditional Chinese medicine, comprising the following raw materials: Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Radix Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis.

[0007] Preferably, the Chinese medicinal materials-based composition for treating pain and arthritis comprises, in parts by mass, 1-5 parts of Acanthopanax senticosus, 1-4 parts of Lamiophloea lappa, 1-5 parts of Hedyotis diffusa, 1-3 parts of Carthamus tinctorius, 1-2 parts of Psoralea corylifolia, 1-3 parts of Clematidis, 1-4 parts of Saposhnikovia divaricata, 1-5 parts of Curcuma zedoaria and 1-5 parts of Corydalis yanhusuo.

[0008] The present invention also provides a method for preparing the Chinese medicinal material-based composition for treating pain and arthritis, comprising the following steps:

[0009] Step 1: weighing dried Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Radix Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis according to the dosage;

[0010] Step 2: Add the raw materials into a grinder, grind them to obtain a mixed powder, add 10-30 times the mass of the powder into water, heat and extract to obtain the material;

[0011] Step 3: Cooling the material to obtain a cooled product, then adding snail protease and fig protease to obtain a pre-enzyme hydrolysis material, enzymolysis, enzyme inactivation, cooling, and obtaining an enzymolysis product;

[0012] Step 4: inoculating fermentation bacteria, a carbon source and a nitrogen source into the enzymatic hydrolysate for fermentation, sterilizing, and obtaining a fermentation product;

[0013] Step 5: adding ethanol to the fermented product to obtain a mixed material, heating and stirring to obtain an intermediate product;

[0014] Step 6: The intermediate product is filtered, the filtrate is ultrafiltered, and then the ultrafiltrate is concentrated and dried to obtain the Chinese medicinal material-based composition for treating pain and arthritis.

[0015] Preferably, in step 2, the powder is crushed to a particle size of less than 5 mm.

[0016] Preferably, in step 2, the heating extraction temperature is 70-90° C. and the time is 4-10 hours.

[0017] Preferably, in step 3, the usage ratio of snail protease to ficin in the pre-enzyme hydrolysis material is 1:2-3.5.

[0018] Preferably, in step 3, the total amount of snail protease and ficin in the pre-enzyme hydrolysis material is 800-2000u / g pre-enzyme hydrolysis material.

[0019] Preferably, in step 3, the enzymatic hydrolysis temperature is 30-58° C. and the time is 2-6 hours.

[0020] Preferably, in step 4, the fermentation bacteria inoculation amount is 5.8×10 10 -1.2×10 11 cfu / g hydrolysate.

[0021] Preferably, in step 4, the fermentation bacteria are composed of Bacillus subtilis subspecies Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097 in a quantitative ratio of 2-4:1;

[0022] Preferably, in step 4, the carbon source is at least one of glucose, sucrose and fructose.

[0023] Preferably, in step 4, the carbon source is 1-3.5% of the mass of the mixed powder in step 1.

[0024] Preferably, in step 4, the nitrogen source includes at least one of dipotassium hydrogen phosphate and peptone.

[0025] Preferably, in step 4, the nitrogen source is 0.02-0.5% of the mass of the mixed powder in step 1.

[0026] Preferably, in step 4, the fermentation temperature is 30-40° C. and the fermentation time is 60-120 hours.

[0027] Preferably, in step 5, the mass percentage content of ethanol in the mixed material is 15-30%.

[0028] Preferably, in step 5, the heating and stirring temperature is 40-55° C. and the time is 5-12 hours.

[0029] Preferably, in step 6, ultrafiltration is performed using an ultrafiltration membrane with a molecular weight cutoff lower than 2000Da.

[0030] Preferably, in step 6, the concentration is reduced pressure concentration, the pressure is 0.01-0.02 MPa, and the temperature is 55-62°C.

[0031] Preferably, in step 6, the ultrafiltrate is concentrated to 6-12% by mass.

[0032] Preferably, in step 6, the drying is freeze-drying, and the drying is performed until the water content is less than 5.5%.

[0033] The present invention also provides the use of the pain and arthritis treatment composition based on traditional Chinese medicine in the preparation of finished medicines.

[0034] Preferably, the finished medicine includes at least one of an ointment, a patch, an emulsion, an aqueous solution, a cream, a tincture, and a powder.

[0035] Preferably, the finished medicine is a patch and is directly applied to the painful area for treatment.

[0036] Beneficial effects of the present invention:

[0037] The invention crushes Acanthopanax senticosus, Herba Lysimachiae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Radix Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis, adds water for heating and extraction, then adds snail protease and ficin for joint enzymolysis; then inoculates fermentation bacteria composed of Bacillus subtilis sternii subspecies numbered CICC24224 and Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097 for fermentation, then adds ethanol for extraction, and then filters, ultrafilters, concentrates and dries to obtain a Chinese medicinal material-based pain and arthritis therapeutic composition which has excellent pain therapeutic effect and can effectively inhibit inflammation associated with pain.

[0038] When the mouse writhing experiment was conducted, it was shown that the number of writhing times of the mice in the model group was 39.24±4.13 times within half an hour, while that of the composition of the present invention was as low as 9.28±2.37 times, which can effectively reduce pain symptoms.

[0039] When conducting the anti-swelling effect test, the average swelling rate of mice in the blank group was as high as 138.53%, while that of the composition of the present invention was as low as 65.24%, which can effectively reduce the occurrence of swelling; the composition of the present invention reduced the swelling rate by 52.91% compared with the blank group.

[0040] The invention adopts Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Herba Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis to prepare a composition with excellent pain treatment and swelling reduction effects, wherein Acanthopanax senticosus, Herba Lycopodiellae, Rhizoma Curcumae and Rhizoma Corydalis can effectively promote the improvement of the effect of the composition of the invention.

[0041] The present invention adopts snail protease and fig protease for combined enzymolysis, thereby improving the effect of the composition; when the ratio of the two is 1:2-3.5 and the total dosage in the pre-enzymolysis material is 800-2000u / g, the quality pain and anti-swelling effects of the composition can be effectively improved.

[0042] The present invention adopts the combined fermentation of Bacillus subtilis subspecies Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097, which helps to synergistically improve the effect of the composition. The combined fermentation of the two increases the efficacy of the active ingredients of the composition, giving the composition excellent quality pain and anti-swelling effects. When the fermentation amount ratio of the two is 2-4:1, the obtained composition has better effect.

[0043] The invention further extracts the raw materials by heat extraction, compound enzyme hydrolysis and compound bacteria fermentation, and then adds ethanol to further extract, which helps to improve the effect of the composition, especially when the mass percentage content of ethanol in the mixed material is 15-30%, the effect of the composition shows better performance. The composition of the invention has excellent pain treatment and anti-swelling effects, a simple preparation method and good application prospects.

[0044] The composition of the present invention can be designed into different dosage forms in combination with actual application requirements, and can be designed into a patch according to requirements. The patch can be applied to the painful area and achieve a therapeutic effect, and is easy to use and simple to operate. DETAILED DESCRIPTION

[0045] The present invention will be described below in conjunction with the specific embodiments, and the various effects of the present invention will be more clearly presented. It should be understood by those skilled in the art that these specific embodiments are used to illustrate the present invention, rather than to limit the present invention. The subtilis subspecies Steinerii numbered CICC 24224 and the Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097 in the specific embodiments were purchased from the China Industrial Microbiological Culture Collection Administration Center.

[0046] 1. Preparation of the composition

[0047] Composition 1:

[0048] Step 1: weigh dried Acanthopanax senticosus, Herba Lycopodii, Herba Hedyotis diffusae, Carthamus tinctorius, Herba Psoraleae, Herba Clematis, Herba Saposhnikoviae, Herba Curcumae and Herba Corydalis according to the dosage; the specific dosage is: 3.2 parts of Acanthopanax senticosus, 2.5 parts of Herba Lycopodii, 2.1 parts of Herba Hedyotis diffusae, 1.8 parts of Carthamus tinctorius, 1.3 parts of Herba Psoraleae, 2.1 parts of Herba Clematis, 2.7 parts of Herba Saposhnikoviae, 3.2 parts of Herba Curcumae and 3.1 parts of Herba Corydalis;

[0049] Step 2: Add the raw materials into a grinder and grind them to a particle size of less than 2 mm to obtain a mixed powder, add 18.3 times the mass of the powder into water, heat at 85°C and stir at 60 rpm for 6.2 hours to extract the material;

[0050] Step 3: Cool the material to room temperature to obtain a cooled product, then add snail protease and fig protease to obtain a pre-enzyme hydrolysis material, stir at 55°C and 60rpm for 2.5 hours, inactivate the enzyme, cool to room temperature, and obtain an enzymolyzate;

[0051] The usage ratio of snail protease and fig protease is 1:3, and the total usage of the two in the pre-enzyme hydrolysis material is 1300u / g pre-enzyme hydrolysis material;

[0052] Step 4: The enzymatic hydrolysate is inoculated with fermentation bacteria, carbon source glucose and nitrogen source dipotassium hydrogen phosphate, fermented at 35° C. for 87 hours, sterilized, and a fermentation product is obtained;

[0053] Among them, the total amount of fermentation bacteria inoculated was 8.3×10 10 cfu / g hydrolysate, the fermentation bacteria consisted of Bacillus subtilis subsp. Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subsp. bulgaricus numbered CICC 6097 in a quantitative ratio of 2.8:1;

[0054] The carbon source and nitrogen source are 2.7% and 0.06% of the mass of the mixed powder in step 1, respectively;

[0055] Step 5: adding ethanol to the fermented material to obtain a mixed material, heating at 50° C. and stirring at 70 rpm for 6.2 hours to obtain an intermediate product; wherein the mass percentage content of ethanol in the mixed material is 22.5%;

[0056] Step 6: The intermediate product is filtered using a filter membrane with a pore size of 1 micron, and the filtrate is ultrafiltered using an ultrafiltration membrane with a molecular weight cutoff of 1200Da, and then the ultrafiltrate is concentrated to 10.7% of the ultrafiltrate mass under 0.015MPa and 58°C, and freeze-dried at -35°C to a water content of 2.35% to obtain the composition.

[0057] Composition 2:

[0058] Step 1: weigh dried Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Herba Psoraleae, Herba Clematis, Herba Saposhnikoviae, Herba Curcumae and Herba Corydalis according to the dosage; the specific dosage is: 3.5 parts of Acanthopanax senticosus, 2.7 parts of Herba Lycopodiellae, 2.0 parts of Herba Hedyotis diffusae, 2.5 parts of Carthamus tinctorius, 1.6 parts of Herba Psoraleae, 2.7 parts of Herba Clematis, 2.2 parts of Herba Saposhnikoviae, 3.7 parts of Herba Curcumae and 3.0 parts of Herba Corydalis;

[0059] Step 2: Add the raw materials into a grinder and grind them to a particle size of less than 2 mm to obtain a mixed powder, add 19.5 times the mass of the powder into water, heat at 83°C and stir at 60 rpm for 5.8 hours to extract the material;

[0060] Step 3: Cool the material to room temperature to obtain a cooled product, then add snail protease and fig protease to obtain a pre-enzyme hydrolysis material, stir at 52°C and 60rpm for 2.7 hours, inactivate the enzyme, cool to room temperature, and obtain an enzymolyzate;

[0061] Among them, the usage ratio of snail protease and fig protease is 1:2.2, and the total usage of the two in the pre-enzyme hydrolysis material is 1350u / g pre-enzyme hydrolysis material;

[0062] Step 4: The enzymatic hydrolysate is inoculated with fermentation bacteria, carbon source glucose and nitrogen source dipotassium hydrogen phosphate, fermented at 34.5° C. for 92 hours, sterilized, and a fermentation product is obtained;

[0063] Among them, the total amount of fermentation bacteria inoculated was 8.6×10 10 cfu / g hydrolysate, the fermentation bacteria consisted of Bacillus subtilis subsp. Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subsp. bulgaricus numbered CICC 6097 in a quantitative ratio of 2.05:1;

[0064] The carbon source and nitrogen source are 2.9% and 0.058% of the mass of the mixed powder in step 1, respectively;

[0065] Step 5: adding ethanol to the fermented material to obtain a mixed material, heating at 52° C. and stirring at 70 rpm for 6 hours to obtain an intermediate product; wherein the mass percentage content of ethanol in the mixed material is 16.2%;

[0066] Step 6: The intermediate product is filtered using a filter membrane with a pore size of 1 micron, and the filtrate is ultrafiltered using an ultrafiltration membrane with a molecular weight cutoff of 1200Da, and then the ultrafiltrate is concentrated to 10.2% of the ultrafiltrate mass under 0.015MPa and 58°C, and freeze-dried at -35°C to a water content of 2.41% to obtain the composition.

[0067] Composition 3: The difference from composition 1 is that Acanthopanax senticosus, Herba Lysimachiae, Rhizoma Curcumae and Rhizoma Corydalis are not used. That is, step 1 is: weighing dried Hedyotis diffusa, safflower, psoralea corylifolia, clematis radix and saposhnikovia diffusa according to the dosage; the specific dosage is: 2.1 parts of Hedyotis diffusa, 1.8 parts of safflower, 1.3 parts of psoralea corylifolia, 2.1 parts of clematis radix and 2.7 parts of saposhnikovia diffusa; the rest are the same as composition 1.

[0068] Composition 4: The difference from composition 1 is that: step 3: cooling the material to room temperature to obtain a cooling product, then adding snail protease to obtain a pre-enzyme hydrolysis material, stirring at 55°C and 60rpm for 2.5 hours, inactivating the enzyme, cooling to room temperature, and obtaining an enzymolyzate; wherein the amount of snail protease in the pre-enzyme hydrolysis material is 1300u / g pre-enzyme hydrolysis material. The rest is the same as composition 1.

[0069] Composition 5: The difference from composition 1 is that: step 3: cooling the material to room temperature to obtain a cooling product, then adding ficin to obtain a pre-enzyme hydrolysis material, stirring at 55°C and 60rpm for 2.5 hours, inactivating the enzyme, cooling to room temperature, and obtaining an enzymolyzate; wherein the amount of ficin in the pre-enzyme hydrolysis material is 1300u / g pre-enzyme hydrolysis material. The rest is the same as composition 1.

[0070] Composition 6: The difference from composition 1 is: step 3: cooling the material to room temperature to obtain a cooling product, then adding snail protease and fig protease to obtain a pre-enzyme hydrolysis material, stirring at 55°C and 60rpm for 2.5 hours, inactivating the enzyme, cooling to room temperature, and obtaining an enzymolyzate; wherein the amount ratio of snail protease to fig protease is 1:1, and the total amount of the two in the pre-enzyme hydrolysis material is 1300u / g pre-enzyme hydrolysis material. The rest is the same as composition 1.

[0071] Composition 7: The difference from composition 1 is that the total amount of fermentation bacteria inoculated is 8.3×10 10 cfu / g enzymolysate, the fermentation bacteria is Bacillus subtilis subsp. Steinernema numbered CICC 24224. Others are the same as composition 1.

[0072] Composition 8: The difference from composition 1 is that the total amount of fermentation bacteria inoculated is 8.3×10 10 cfu / g enzymolysate, the fermentation bacteria is Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097. Others are the same as composition 1.

[0073] Composition 9: The difference from composition 1 is that the total amount of fermentation bacteria inoculated is 8.3×10 10cfu / g hydrolysate, the fermentation bacteria consisted of Bacillus subtilis subspecies Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097 in a quantitative ratio of 0.5:1. Others were the same as composition 1.

[0074] Composition 10: The difference from composition 1 is that the total amount of fermentation bacteria inoculated is 8.3×10 10 cfu / g hydrolysate, the fermentation bacteria consisted of Bacillus subtilis subspecies Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subspecies bulgaricus numbered CICC 6097 in a quantitative ratio of 8:1. The rest was the same as composition 1.

[0075] Composition 11 is different from Composition 1 in that the mass percentage content of ethanol in the mixed material in step 5 is 5.5%. Other components are the same as Composition 1.

[0076] Composition 12 is different from Composition 1 in that the mass percentage of ethanol in the mixed material in step 5 is 62%. Other components are the same as Composition 1.

[0077] 2. Effect test of the composition

[0078] 1. Pain treatment effect

[0079] SPF male Kunming mice weighing 20±2g were taken and adaptively raised for 1 week; the mice were randomly divided into 15 groups, namely, composition groups 1-12, positive drug groups (diclofenac diethylamine emulsion, Beijing Novartis Pharmaceutical Co., Ltd.), blank groups and model groups, with 12 mice in each group. Composition group 1-2 was smeared with 1.5g of drug preparation on the abdomen of mice (the preparation was composed of 0.3g of composition and 1.2g of glycerol aqueous solution, wherein the glycerol aqueous solution was composed of equal mass of glycerol and water); the positive drug group was smeared with 0.6g of diclofenac diethylamine emulsion on the abdomen of mice; the blank group and the model group were smeared with 1.2g of normal saline. 45 minutes after administration, except for the blank group, each group of mice was intraperitoneally injected with 0.6% glacial acetic acid at 10mL / kg of mice, and the blank group was intraperitoneally injected with the same amount of normal saline. Then the number of twisting of mice in each group within half an hour after the occurrence of twisting reaction was observed. The obtained data were then statistically analyzed, and P<0.05 was considered statistically significant. The test results are shown in Table 1; compared with the blank group and the model group, each group showed P < 0.05, and the differences among the groups were statistically significant.

[0080] Table 1: Effects of pain treatment

[0081] Group Number of twists Blank Group 2.13±0.47 Model Group 39.24±4.13 Positive drug group 8.02±1.78 Composition 1 set 9.28±2.37 Composition 2 sets 9.57±0.93 Composition 3 groups 21.46±3.29 Composition 4 groups 10.93±1.02 Composition 5 groups 11.65±2.61 Composition 6 groups 10.16±1.37 Composition 7 groups 14.68±1.54 Composition 8 groups 15.52±1.93 Composition 9 groups 11.27±2.24 Composition 10 groups 12.34±1.62 Composition 11 groups 15.69±3.01 Composition 12 groups 14.51±2.95

[0082] 2. Anti-swelling effect test

[0083] SPF male Kunming mice weighing 20±2g were taken and adaptively raised for 1 week; the mice were randomly divided into 15 groups, namely, composition groups 1-12, a positive drug group (dexamethasone physiological saline solution with a concentration of 0.5g / L), and a blank group, with 12 mice in each group.

[0084] Positive drug group: Compound dexamethasone acetate cream (Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd.) was applied to the left ear of mice at a rate of 1.5 g cream / kg mouse; Composition 1-12 group: The composition was diluted with a 3-fold mass of glycerol aqueous solution to obtain a composition drug for administration, the glycerol aqueous solution is composed of equal masses of glycerol and water, and the left ear of mice was coated with 2 g of the composition drug / kg mouse; the blank group was not treated; the frequency was 1 time / day, and the administration was continuous for 7 days.

[0085] 30 minutes after the last administration, 0.05 mL of xylene was evenly applied to the left ears of mice in each group to induce inflammation for 15 minutes. The mice were then killed and the same part of both ears was taken with a 6.5 mm diameter puncher and weighed. The average value of the difference between the weight of the left and right ear pieces and the ratio of the weight of the right ear piece was used as the measurement standard, which was recorded as the average swelling rate. Then, the reduction ratio of the swelling rate of each group compared with the blank group was calculated, and the results are shown in Table 2.

[0086] Table 2: Average swelling rate of each group and the reduction ratio of swelling rate compared with the blank group

[0087]

[0088]

[0089] According to the above tests, it can be seen that the composition prepared by the present invention has an excellent effect in treating pain and can effectively inhibit inflammation associated with pain.

[0090] When the mouse writhing experiment was conducted, it was shown that the number of writhing times of the mice in the model group was 39.24±4.13 times within half an hour, while that of the composition of the present invention was as low as 9.28±2.37 times, which can effectively reduce pain symptoms.

[0091] When conducting the anti-swelling effect test, the average swelling rate of mice in the blank group was as high as 138.53%, while that of the composition of the present invention was as low as 65.24%, which can effectively reduce the occurrence of swelling; the composition of the present invention reduced the swelling rate by 52.91% compared with the blank group.

[0092] The present invention adopts Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Herba Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis to prepare a composition with excellent pain treatment and swelling reduction effects, wherein Acanthopanax senticosus, Herba Lycopodiellae, Rhizoma Curcumae and Rhizoma Corydalis can effectively promote the improvement of the effect of the composition of the present invention, and the above content is obtained in combination with the test results of compositions 1-3.

[0093] The present invention adopts snail protease and fig protease for combined enzymolysis to improve the effect of the composition; when the ratio of the two is 1:2-3.5 and the total amount in the pre-enzymolysis material is 800-2000u / g, the quality pain and anti-swelling effect of the composition can be effectively improved. The content can be obtained in combination with the test data of compositions 1, 4-6.

[0094] The present invention adopts the joint fermentation of Bacillus subtilis subspecies Steinerii numbered CICC 24224 and Lactobacillus delbrueckii subspecies Bulgarian numbered CICC 6097, which helps to synergistically improve the effect of the composition. The two ferment together to increase the efficacy of the active ingredients of the composition, giving the composition excellent quality pain and anti-swelling effects. When the fermentation amount ratio of the two is 2-4:1, the obtained composition has better effect. The above content can be obtained in combination with the test results of compositions 1, 7-10.

[0095] After the heat extraction, compound enzyme hydrolysis and compound bacteria fermentation, the present invention adds ethanol for further extraction, which helps to improve the effect of the composition, especially when the mass percentage content of ethanol in the mixed material is 15-30%, the effect of the composition shows better performance. The above content can be obtained in combination with the test results of compositions 1 and 11-12.

[0096] 3. Application Examples

[0097] 1. Preparation and use of patches

[0098] The preparation steps include: preparing 3 kg of the above-mentioned composition 1 (pre-crushed to a particle size of less than 500 meshes) and 100 kg of a matrix (composed of vaseline, lanolin and liquid paraffin in a mass ratio of 8:1:1); then heating and melting the matrix, adding the composition 1, stirring evenly, coating it on the surface of the patch non-woven fabric, cooling, cutting into required specifications, and ultraviolet sterilization to obtain the patch.

[0099] Directions: Apply the patch to the painful area.

[0100] 2. Preparation and use of cream products

[0101] The preparation steps include: preparing 3 kg of the above composition 1 (pre-crushed to a particle size of less than 500 meshes), 2.5 kg of carbomer-94, 2 kg of xanthan gum, 3 kg of glycerin and 90.5 kg of sterile water; heating the carbomer-94, xanthan gum and sterile water to 55° C. and stirring and mixing; then adding glycerin and the above composition 1 and continuing to stir and mix; then cooling to room temperature to obtain the frosty product.

[0102] How to use: Apply the cream to the painful area.

[0103] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these 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 these modifications and variations.

Claims

1. A composition for treating pain and arthritis based on Chinese medicinal materials, characterized in that: The ingredients include: Acanthopanax senticosus, Herba Lycopodii, Herba Hedyotis diffusae, Safflower, Psoralea corylifoliae, Herba Clematis, Saposhnikovia divaricata, Rhizoma Curcumae and Corydalis yanhusuo.

2. The composition for treating pain and arthritis based on Chinese medicinal materials according to claim 1, characterized in that: In terms of weight, it includes 1-5 parts of Acanthopanax senticosus, 1-4 parts of Lamiophloea chinensis, 1-5 parts of Hedyotis diffusa, 1-3 parts of Carthamus tinctorius, 1-2 parts of Psoralea corylifolia, 1-3 parts of Clematis chinensis, 1-4 parts of Saposhnikovia divaricata, 1-5 parts of Curcuma zedoaria and 1-5 parts of Corydalis yanhusuo.

3. A method for preparing a composition for treating pain and arthritis based on Chinese medicinal materials according to any one of claims 1 to 2, characterized in that: The following steps are involved: Step 1: weighing dried Acanthopanax senticosus, Herba Lycopodiellae, Herba Hedyotis diffusae, Carthamus tinctorius, Fructus Psoraleae, Radix Clematis, Radix Saposhnikoviae, Rhizoma Curcumae and Rhizoma Corydalis according to the dosage; Step 2: Add the raw materials into a grinder, grind them to obtain a mixed powder, add 10-30 times the mass of the powder into water, heat and extract to obtain the material; Step 3: Cooling the material to obtain a cooled product, then adding snail protease and fig protease to obtain a pre-enzyme hydrolysis material, enzymolysis, enzyme inactivation, cooling, and obtaining an enzymolysis product; Step 4: inoculating fermentation bacteria, a carbon source and a nitrogen source into the enzymatic hydrolysate for fermentation, sterilizing, and obtaining a fermentation product; Step 5: adding ethanol to the fermented product to obtain a mixed material, heating and stirring to obtain an intermediate product; Step 6: The intermediate product is filtered, the filtrate is ultrafiltered, and then the ultrafiltrate is concentrated and dried to obtain the Chinese medicinal material-based composition for treating pain and arthritis.

4. The preparation method according to claim 3, characterized in that: In step 2, the powder is crushed to a particle size of less than 5 mm.

5. The preparation method according to claim 3, characterized in that: In step 2, the heating extraction temperature is 70-90° C. and the time is 4-10 hours.

6. The preparation method according to claim 3, characterized in that: In step 3, in the pre-enzyme hydrolysis material, the usage ratio of snail protease and ficin is 1:2-3.5, and the total usage of the two in the pre-enzyme hydrolysis material is 800-2000u / g pre-enzyme hydrolysis material; And / or, in step 3, the enzymatic hydrolysis temperature is 30-58° C. and the time is 2-6 hours.

7. The preparation method according to claim 3, characterized in that: In step 4, the fermentation bacteria inoculation amount is 5.8×10 10 -1.2×10 11 cfu / g hydrolysate; And / or, in step 4, the fermentation bacteria are composed of Bacillus subtilis subsp. Steinernema numbered CICC 24224 and Lactobacillus delbrueckii subsp. bulgaricus numbered CICC6097 in a quantitative ratio of 2-4:1; And / or, in step 4, the fermentation temperature is 30-40° C. and the fermentation time is 60-120 hours.

8. The preparation method according to claim 3, characterized in that: In step 5, the mass percentage content of ethanol in the mixed material is 15-30%; And / or, in step 5, the heating and stirring temperature is 40-55° C. and the time is 5-12 hours.

9. Use of a composition for treating pain and arthritis based on Chinese medicinal materials prepared by the preparation method according to any one of claims 3 to 8 in preparing finished drugs, characterized in that: The finished medicine includes at least one of an ointment, a patch, an emulsion, an aqueous solution, a cream, a tincture, and a powder.

10. The use according to claim 9, characterized in that: The finished medicine is a patch and is directly applied to the painful area for treatment.

Images