Traditional Chinese medicine composition for diminishing inflammation and easing pain as well as preparation method, application and medicine thereof

Abstract

The invention provides a traditional Chinese medicine composition with anti-inflammatory and analgesic effects as well as a preparation method, application and a medicine thereof, and relates to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 30-55 parts of pseudo-ginseng, 26-40 parts of notopterygium root, 15-35 parts of safflower, 15-35 parts of berba aristolochiae mollissimae, 20-40 parts of liquorice, 10-20 parts of acanthopanax and 10-30 parts of dandelion. Performing reflux extraction on the pseudo-ginseng, the notopterygium root, the safflower and the dandelion by using an ethanol solution to obtain an ethanol extracting solution and medicine residues; mixing the medicine residues, berba aristolochiae mollissimae, liquorice and acanthopanax, decocting with water, and then carrying out microwave treatment to obtain a water extracting solution; combining the ethanol extracting solution and the water extracting solution, and drying to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition disclosed by the invention has synergistic effects of diminishing inflammation, easing pain and diminishing swelling; when the compound is applied to medicine preparation, the obtained medicine can remarkably reduce the pain degree and the osteoarthritis index and improve the joint motion range.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition with anti-inflammatory and analgesic effects, a preparation method thereof, an application thereof and a medicine thereof. Background Art

[0002] Pain is a feeling of discomfort caused by potential or actual tissue damage, usually associated with noxious stimuli. Pain can be divided into acute pain and chronic pain according to its duration and nature. Acute pain is generally caused by clear injury or disease and lasts for a short time; chronic pain usually lasts for a long time and may be caused by a variety of reasons such as tissue damage, chronic diseases, and psychological factors. In the drug treatment of pain, opioids and non-steroidal analgesics (NSAIDs) are traditional analgesics that are widely used in clinical practice. Although the analgesic effect of the above drugs is good, the side effects, adverse reactions, risk types and drug resistance after taking them cannot be ignored, and the pain worsens after stopping the drug, and the drug dependence is strong. Physical analgesia can avoid the serious side effects of analgesics, but the treatment effect is not lasting. Traditional Chinese medicine has a long history of research in the treatment of chronic pain and anti-inflammatory, and there are many traditional Chinese medicine prescriptions for anti-inflammatory and analgesia.

[0003] Chinese invention patent CN116870076A discloses an anti-inflammatory and analgesic Chinese medicine composition, a preparation method and an application thereof. The Chinese medicine composition comprises the following components in percentage by mass: 25%-35% of Herba Lysimachiae, 10%-20% of Taraxaci, 10%-20% of Viola yedoensis, 5%-15% of Carthamus tinctorius, 5%-10% of Angelica sinensis, 5%-10% of Ligusticum chuanxiong, 2%-10% of Rehmannia glutinosa, 2%-10% of Centella asiatica and 1%-3% of natural borneol. This patent combines 9 Chinese medicinal materials such as Herba Lycoris Radiatae, Herba Taraxaci, and Herba Violae yedoensis; uses ethanol to extract Herba Lycoris Radiatae, Herba Angelicae Sinensis, Herba Centellae Gotu Kolae, Herba Taraxaci, Herba Violae yedoensis, and Herba Safflower to obtain ethanol extract; extracts Rhizoma Chuanxiong and Herba Rehmanniae Root with water to obtain water extract; mixes the ethanol extract and the water extract, adds natural borneol, heats and concentrates the mixture to obtain an extract, and obtains a Chinese medicine composition, which has certain effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, and having anti-inflammatory and antibacterial effects.

[0004] Chinese invention patent CN101642522A discloses a Chinese medicine composition, which uses 2-3 parts by weight of Astragalus, 1-2 parts by weight of Panax notoginseng, 0.8-1.2 parts by weight of Geranium and 1-2 parts by weight of Paris polyphylla. The preparation method of the composition is to extract Paris polyphylla, Astragalus and Panax notoginseng with ethanol with a mass concentration of 70%-90%, extract the residues obtained after alcohol extraction and Geranium with water, then concentrate Paris polyphylla, Astragalus and Panax notoginseng alcohol extracts into extracts, dry and crush them into alcohol extract powder, concentrate the water extracts into extracts, dry and crush them into water extract powder, and finally mix the water extract powder and the alcohol extract powder. The invention composition can be used to prepare anti-inflammatory, analgesic or anti-thrombotic drugs.

[0005] Zhang Xiangjie et al. (Research progress on the analgesic effects of four traditional Chinese medicines: Zanthoxylum bungeanum, Corydalis yanhusuo, Myrrha, and Panax notoginseng [J]. Modern Distance Education in Traditional Chinese Medicine, 2009, 7(01): 96-98.) studied the analgesic effects of various traditional Chinese medicines. Among them, Panax notoginseng, total saponins of Panax notoginseng, etc. had obvious analgesic effects in various analgesic model experiments such as the hot plate method, writhing method, and light radiation tail flick method in rats, and also had obvious analgesic effects on chemically induced pain.

[0006] The analgesic effects of traditional Chinese medicines are generally multi-level and multi-target, with complex mechanisms. If only single traditional Chinese medicines are used, their analgesic effects have certain limitations, and the traditional Chinese medicine components with analgesic effects may not necessarily bring good anti-inflammatory effects. In addition, although there are numerous compound formulas with analgesic and anti-inflammatory effects, there are still relatively few traditional Chinese medicine formulas with reasonable compatibility and synergistic effects. Therefore, it is necessary to conduct compound research on traditional Chinese medicine components with analgesic and anti-inflammatory effects to obtain a traditional Chinese medicine composition with significantly improved anti-inflammatory and analgesic effects. Summary of the Invention

[0007] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition with anti-inflammatory and analgesic effects, its preparation method, application, and medicine, which are prepared from Panax notoginseng, Notopterygium incisum, Carthamus tinctorius, Aristolochia mollissima, Glycyrrhiza uralensis, Acanthopanax senticosus, and Taraxacum mongolicum. Each component interacts with each other and complements each other, and the traditional Chinese medicine composition prepared by a specific ratio and preparation method brings synergistic anti-inflammatory, analgesic, and detumescence effects; at the same time, it has obvious therapeutic effects on patients with osteoarthritis. After 2 weeks of treatment, it can significantly reduce the pain degree and osteoarthritis index and improve the joint range of motion.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] First of all, the present invention provides a traditional Chinese medicine composition with anti-inflammatory and analgesic effects, which is made up of the following components in parts by weight: 30-55 parts of Panax notoginseng, 26-40 parts of Notopterygium incisum, 15-35 parts of Carthamus tinctorius, 15-35 parts of Aristolochia mollissima, 20-40 parts of Glycyrrhiza uralensis, 10-20 parts of Acanthopanax senticosus, and 10-30 parts of Taraxacum mongolicum.

[0010] Preferably, the traditional Chinese medicine composition is made up of the following components in parts by weight: 35-45 parts of Panax notoginseng, 28-35 parts of Notopterygium incisum, 20-32 parts of Carthamus tinctorius, 18-30 parts of Aristolochia mollissima, 25-35 parts of Glycyrrhiza uralensis, 14-18 parts of Acanthopanax senticosus, and 15-25 parts of Taraxacum mongolicum.

[0011] More preferably, the traditional Chinese medicine composition is made up of the following components in parts by weight: 40 parts of Panax notoginseng, 30 parts of Notopterygium incisum, 28 parts of Carthamus tinctorius, 22 parts of Aristolochia mollissima, 30 parts of Glycyrrhiza uralensis, 16 parts of Acanthopanax senticosus, and 20 parts of Taraxacum mongolicum.

[0012] Then, the present invention provides a preparation method of the above traditional Chinese medicine composition, comprising the steps of:

[0013] (1) Notoginseng, Notopterygium root, Safflower, and Dandelion are subjected to reflux extraction with an ethanol solution to obtain an ethanol extract and medicinal residues;

[0014] (2) The medicinal residues from step (1), Aristolochia mollissima Hance, Licorice root, and Acanthopanax senticosus are mixed, decocted with water and then subjected to microwave treatment, and filtered to obtain a water extract;

[0015] (3) The ethanol extract from step (1) and the water extract from step (2) are combined, concentrated and dried to obtain the traditional Chinese medicine composition.

[0016] Preferably, in step (1), the volume concentration of the ethanol solution is 30%-50%.

[0017] More preferably, in step (1), the volume concentration of the ethanol solution is 40%.

[0018] Preferably, in step (1), the reflux extraction is specifically: extracting at 45-60°C for 1-3 h.

[0019] More preferably, in step (1), the reflux extraction is specifically: extracting at 50°C for 2 h.

[0020] Preferably, in step (1), the solid-liquid ratio of the reflux extraction is 1:20-40 g / mL.

[0021] More preferably, in step (1), the solid-liquid ratio of the reflux extraction is 1:30 g / mL.

[0022] Preferably, in step (2), the decoction is specifically: with a solid-liquid ratio of 1:10-25 g / mL, decocting for 1-3 h.

[0023] More preferably, in step (2), the decoction is specifically: with a solid-liquid ratio of 1:20 g / mL, decocting for 2 h.

[0024] Preferably, in step (2), for the microwave treatment, the treatment power is 500-800 W and the treatment time is 5-15 min.

[0025] More preferably, in step (2), for the microwave treatment, the treatment power is 700 W and the treatment time is 11 min.

[0026] Preferably, in step (3), before the ethanol extract is combined, the ethanol needs to be separated, and the separation method is not limited to reduced pressure concentration.

[0027] Preferably, in step (3), the drying is specifically carried out at a temperature below 60°C, and is not limited to freeze-drying.

[0028] Furthermore, the present invention provides the use of the traditional Chinese medicine composition in the preparation of a drug having anti-inflammatory and analgesic effects; the traditional Chinese medicine composition is the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0029] Finally, the present invention provides a drug having anti-inflammatory and analgesic effects, comprising the component: the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0030] Preferably, the drug is specifically a drug for treating chronic pain, acute pain, and eliminating inflammation.

[0031] Preferably, the components of the drug may further include: a drug carrier. The drug carrier can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gas carriers include carbon dioxide and nitrogen.

[0032] When preparing the composition in an oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations such as suspensions and solutions; while carriers such as starch, sugar, microcrystalline cellulose, diluent, granulating agent, emulsifier, lubricant, binder, disintegrant can be used to form oral solid preparations such as powders, capsules and tablets. Due to their ease of administration, tablets and capsules are preferred oral dosage units using solid drug carriers. Standard aqueous or non-aqueous techniques can be optionally used to coat the tablets.

[0033] Tablets containing the Chinese medicine composition or extract of the present invention can be prepared by tabletting or molding, and one or more auxiliary ingredients or adjuvants can be optionally used. Tablets can be prepared by tabletting the active ingredient in a free-flowing form (such as powder or granules) in a suitable machine, optionally mixed with binders, lubricants, inert diluents, surface active substances or dispersants. Molded tablets can be molded in a suitable machine, i.e., a mixture of powdered compounds moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of the active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of the active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of the active drug, mixed with a suitable and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of the active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0034] The pharmaceutical composition suitable for parenteral administration in the present invention can be prepared as an aqueous solution or suspension of the active compound. Appropriate surfactants can be included, such as hydroxypropyl cellulose. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and their oil mixtures. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0035] The drugs of the present invention can be in a form suitable for topical use, such as aerosols, creams, ointments, lotions, powders or the like. In addition, the composition can be in a suitable form for transdermal delivery devices. The Chinese medicine composition of the present invention can be used to prepare these prescriptions by conventional processing methods. For example, creams or ointments with the desired consistency are prepared by mixing hydrophilic materials and water, and about 5 wt% to about 10 wt% of the compound.

[0036] The drugs of the present invention can be in a form suitable for rectal administration, where the carrier is solid. It is preferably to make the mixture into unit-dose suppositories. Suitable carriers include cocoa butter and other commonly used materials in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, and then cooling and shaping in a mold.

[0037] In addition to the above carrier components, the above pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surface active substances, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients can be added, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., coloring agents and flavoring agents, etc. Make the preparation isotonic with the blood of the intended recipient. Components containing the Chinese medicine composition of the present invention can also be prepared in powder or concentrated solution form.

[0038] Preferably, the dosage form of the drug is not limited to dosage forms for administration such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, ointments, etc., and suitable drug carriers in the art can be selected according to different dosage forms.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] 1. The traditional Chinese medicine composition of the present invention is prepared from notoginseng, notopterygium root, safflower, schizonepeta root, licorice, acanthopanax senticosus and dandelion. Each component interacts with each other and complements each other, bringing a synergistic effect of anti-inflammatory, analgesic and detumescence; at the same time, the treatment effect on patients with osteoarthritis is obvious. After 2 weeks of treatment, the pain degree and osteoarthritis index can be reduced, and the joint mobility can be improved.

[0041] 2. In the traditional Chinese medicine composition of the present invention, 7 components are combined in a specific ratio, and the anti-inflammatory, analgesic and detumescence effects are better than those of the traditional Chinese medicine composition with a ratio other than that of the present invention; in addition, the traditional Chinese medicine composition prepared by first extracting notoginseng, notopterygium root, safflower and dandelion with alcohol to obtain an ethanol extract and medicinal residues, and then mixing the filter residues with schizonepeta root, licorice and acanthopanax senticosus and adopting the methods of decocting and microwave treatment can fully exert the effects of the active ingredients in each traditional Chinese medicine component, and significantly improve the treatment score evaluation of arthritis. Detailed implementation manners

[0042] The following non-limiting examples can enable those of ordinary skill in the art to more comprehensively understand the present invention, but do not limit the present invention in any way. The following content is only an exemplary illustration of the scope claimed by the present invention. Those skilled in the art can make various changes and modifications to the present invention according to the disclosed content, and they should also fall within the scope claimed by the present invention.

[0043] When the examples give numerical ranges, it should be understood that unless otherwise specified in the present invention, both endpoints of each numerical range and any value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention belongs.

[0044] The present invention will be further described below by way of specific examples. All chemical reagents used in the examples of the present invention are obtained through conventional commercial channels unless otherwise specified. Products from different manufacturers do not have a significant impact on the effects.

[0045] Examples 1 - 3

[0046] The traditional Chinese medicine composition for anti-inflammatory and analgesic, and the component formula by weight is shown in Table 1:

[0047] Table 1

[0048] parts by weight Example 1 Example 2 Example 3 Panax notoginseng 40 35 45 Notopterygium incisum 30 28 35 Carthamus tinctorius 28 20 32 Aristolochia mollissima 22 18 30 Glycyrrhiza uralensis 30 25 35 Acanthopanax senticosus 16 14 18 Taraxacum mongolicum 20 15 25

[0049] The traditional Chinese medicine composition for relieving inflammation and pain described in Examples 1 - 3, and its preparation method is as follows:

[0050] (1) Mix notoginseng, notopterygium root, safflower and dandelion, add an ethanol solution with a volume concentration of 40%, and reflux and extract at 50 °C for 2 h under a solid - liquid ratio of 1:30 g / mL. Filter to obtain an ethanol extract and medicinal residues.

[0051] (2) Wash the medicinal residues from step (1) with water to remove the ethanol on the surface, then mix them with aristolochia mollissima, licorice root, and acanthopanax senticosus, add water, and decoct for 2 h under a solid - liquid ratio of 1:20 g / mL to obtain a decoction mixture. The decoction mixture is subjected to microwave treatment at a power of 700 W for 11 min, and then filtered to obtain an aqueous extract.

[0052] (3) Concentrate the ethanol extract from step (1) under reduced pressure to remove ethanol, mix it with the aqueous extract from step (2), concentrate and freeze - dry to obtain the traditional Chinese medicine composition.

[0053] Example 4

[0054] The traditional Chinese medicine composition for relieving inflammation and pain, and its components by weight are: 30 parts of notoginseng, 26 parts of notopterygium root, 15 parts of safflower, 15 parts of aristolochia mollissima, 20 parts of licorice root, 10 parts of acanthopanax senticosus, and 10 parts of dandelion.

[0055] The preparation method of this traditional Chinese medicine composition for relieving inflammation and pain is as follows:

[0056] (1) Mix notoginseng, notopterygium root, safflower, and dandelion, add an ethanol solution with a volume concentration of 30%, and reflux and extract at 60 °C for 1 h under a solid - liquid ratio of 1:40 g / mL. Filter to obtain an ethanol extract and medicinal residues.

[0057] (2) Wash the medicinal residues from step (1) with water to remove the ethanol on the surface, then mix them with aristolochia mollissima, licorice root, and acanthopanax senticosus, add water, and decoct for 1 h under a solid - liquid ratio of 1:10 g / mL to obtain a decoction mixture. The decoction mixture is subjected to microwave treatment at a power of 800 W for 15 min, and then filtered to obtain an aqueous extract.

[0058] (3) Concentrate the ethanol extract from step (1) under reduced pressure to remove ethanol, then mix it with the aqueous extract from step (2), concentrate and freeze - dry to obtain the traditional Chinese medicine composition.

[0059] Example 5

[0060] The traditional Chinese medicine composition for relieving inflammation and pain, and its components by weight are: 55 parts of notoginseng, 40 parts of notopterygium root, 35 parts of safflower, 35 parts of aristolochia mollissima, 40 parts of licorice root, 20 parts of acanthopanax senticosus, and 30 parts of dandelion.

[0061] The traditional Chinese medicine composition for relieving inflammation and pain is prepared by the following method:

[0062] (1) Notoginseng, Notopterygium incisum, Safflower and Taraxacum mongolicum are mixed, and an ethanol solution with a volume concentration of 50% is added. Under the condition of a solid-liquid ratio of 1:20 g / mL, reflux extraction is carried out at 45 °C for 3 h, followed by filtration to obtain an ethanol extract and medicinal residues;

[0063] (2) The medicinal residues from step (1) are washed with water to remove the ethanol on the surface, and then mixed with Aristolochia mollissima Hance, Licorice and Acanthopanax senticosus. Water is added, and decoction is carried out at a solid-liquid ratio of 1:25 g / mL for 3 h to obtain a decoction mixture; the decoction mixture is subjected to microwave treatment at a power of 500 W for 5 min, followed by filtration to obtain a water extract;

[0064] (3) The ethanol extract from step (1) is concentrated under reduced pressure to remove ethanol, and then mixed with the water extract from step (2), followed by concentration and freeze-drying to obtain the traditional Chinese medicine composition.

[0065] Comparative Example 1

[0066] Different from Example 1, the components of the traditional Chinese medicine composition are different, and it only contains the components notoginseng, notopterygium incisum, licorice and acanthopanax senticosus.

[0067] The traditional Chinese medicine composition for relieving inflammation and pain has the following components by weight: 40 parts of notoginseng, 30 parts of notopterygium incisum, 30 parts of licorice and 16 parts of acanthopanax senticosus.

[0068] The traditional Chinese medicine composition for relieving inflammation and pain is prepared by the following method:

[0069] (1) Notoginseng and notopterygium incisum are mixed, and an ethanol solution with a volume concentration of 40% is added. Under the condition of a solid-liquid ratio of 1:30 g / mL, reflux extraction is carried out at 50 °C for 2 h, followed by filtration to obtain an ethanol extract and medicinal residues;

[0070] (2) The medicinal residues from step (1) are washed with water to remove the ethanol on the surface, and then mixed with licorice and acanthopanax senticosus. Water is added, and decoction is carried out at a solid-liquid ratio of 1:20 g / mL for 2 h to obtain a decoction mixture; the decoction mixture is subjected to microwave treatment at a power of 700 W for 11 min, followed by filtration to obtain a water extract;

[0071] (3) The ethanol extract from step (1) is concentrated under reduced pressure to remove ethanol, and then mixed with the water extract from step (2), followed by concentration and freeze-drying to obtain the traditional Chinese medicine composition.

[0072] Comparative Example 2

[0073] Different from Example 1, the components of the traditional Chinese medicine composition are different, and it only contains the components safflower, Aristolochia mollissima Hance and Taraxacum mongolicum.

[0074] A traditional Chinese medicine composition for anti-inflammatory and analgesic, the components in parts by weight are: 28 parts of safflower, 22 parts of sanguisorba root and 20 parts of dandelion.

[0075] The preparation method of the traditional Chinese medicine composition for anti-inflammatory and analgesic is as follows:

[0076] (1) Mix safflower and dandelion, add an ethanol solution with a volume concentration of 40%, and reflux and extract at 50 °C for 2 h under the condition of a solid-liquid ratio of 1:30 g / mL, filter to obtain an ethanol extract and medicinal residues;

[0077] (2) Wash the medicinal residues obtained in step (1) with water to wash away the ethanol on the surface, then mix with sanguisorba root, add water, and decoct for 2 h under the condition of a solid-liquid ratio of 1:20 g / mL to obtain a decoction mixture; the decoction mixture is microwave-treated at a power of 700 W for 11 min, and filtered to obtain a water extract;

[0078] (3) Concentrate the ethanol extract obtained in step (1) under reduced pressure to remove ethanol, then mix it with the water extract obtained in step (2), concentrate and freeze-dry to obtain a traditional Chinese medicine composition.

[0079] Comparative Example 3

[0080] The difference from Example 1 is that dandelion is replaced by flos daturae.

[0081] The preparation method of the traditional Chinese medicine composition for anti-inflammatory and analgesic is as follows:

[0082] (1) Mix notoginseng, notopterygium root, safflower and flos daturae, add an ethanol solution with a volume concentration of 40%, and reflux and extract at 50 °C for 2 h under the condition of a solid-liquid ratio of 1:30 g / mL, filter to obtain an ethanol extract and medicinal residues;

[0083] (2) Wash the medicinal residues obtained in step (1) with water to wash away the ethanol on the surface, then mix with sanguisorba root, liquorice and acanthopanax senticosus, add water, and decoct for 2 h under the condition of a solid-liquid ratio of 1:20 g / mL to obtain a decoction mixture; the decoction mixture is microwave-treated at a power of 700 W for 11 min, and filtered to obtain a water extract;

[0084] (3) Concentrate the ethanol extract obtained in step (1) under reduced pressure to remove ethanol, then mix it with the water extract obtained in step (2), concentrate and freeze-dry to obtain a traditional Chinese medicine composition.

[0085] Comparative Example 4

[0086] The difference from Example 1 is that the ratio of each component in the traditional Chinese medicine composition is different.

[0087] A traditional Chinese medicine composition for anti - inflammation and analgesia, the components by weight are: 70 parts of Panax notoginseng, 30 parts of Notopterygium incisum, 10 parts of Carthamus tinctorius, 11 parts of Aristolochia mollissima Hance, 45 parts of Glycyrrhiza uralensis Fisch, 16 parts of Acanthopanax senticosus and 4 parts of Taraxacum mongolicum Hand.-Mazz.

[0088] The rest are the same as in Example 1.

[0089] Comparative Example 5

[0090] Different from Example 1, the preparation method of the traditional Chinese medicine composition is different. Specifically, the components in steps (1) and (2) are replaced.

[0091] The preparation method of this traditional Chinese medicine composition is as follows:

[0092] (1) Aristolochia mollissima Hance, Glycyrrhiza uralensis Fisch and Acanthopanax senticosus are mixed, and an ethanol solution with a volume concentration of 40% is added. Under the condition of a solid - liquid ratio of 1:30 g / mL, reflux extraction is carried out at 50 °C for 2 h, filtered to obtain an ethanol extract and medicinal residues;

[0093] (2) The medicinal residues in step (1) are washed with water to remove the ethanol on the surface, and then mixed with Panax notoginseng, Notopterygium incisum, Carthamus tinctorius and Taraxacum mongolicum Hand.-Mazz., added with water, and decocted at a solid - liquid ratio of 1:20 g / mL for 2 h to obtain a decoction mixture; the decoction mixture is microwave - treated at a power of 700 W for 11 min, filtered to obtain an aqueous extract;

[0094] (3) The ethanol extract in step (1) is concentrated under reduced pressure to remove ethanol, and then mixed with the aqueous extract in step (2), concentrated and freeze - dried to obtain the traditional Chinese medicine composition.

[0095] Comparative Example 6

[0096] Different from Example 1, the preparation method of the traditional Chinese medicine composition is different. Specifically, the volume concentration of the ethanol solution in step (1) is 80%. The rest are the same as in Example 1.

[0097] Experiment 1: Analgesia experiment on mice

[0098] The analgesic effect of the traditional Chinese medicine composition of the present invention was evaluated by the acetic acid writhing method.

[0099] Experimental animals: SPF - level ICR mice, half male and half female, 6 - 8 weeks old, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd., with the experimental animal production license number: SCXK(Yue)2022 - 0063, quarantined for 4 days. During the experiment, the experimental animals normally ingested feed and water. Before the experiment, they were fasted for 24 hours.

[0100] The experiment was divided into 13 groups, namely the blank control group; the model control group; and 11 experimental groups: Example 1 - Example 5 groups (5 groups) and Comparative Example 1 - Comparative Example 6 groups (6 groups in total). Each group had 10 mice, with 5 males and 5 females.

[0101] The mice in the blank control group were not given any treatment. The number of writhings of the mice within 10 minutes was observed, and the average writhing value was recorded. The test results are shown in Table 2.

[0102] Treatment of the mice in the model control group: The four limbs of the mice were fixed on a flat plate, and after abdominal hair removal, 100 mg of sodium hyaluronate was applied to the abdomen of the mice and fixed with gauze. The gauze was removed after 3 hours; an intraperitoneal injection was given with an acetic acid solution (20 mL / kg) with a mass concentration of 0.6%. The number of writhings of the mice within 10 minutes (abdominal contraction and concavity, extension of the hind limbs, elevation of the buttocks, creeping) was observed, and the average number of writhings was recorded. The test results are shown in Table 2.

[0103] Treatment of the mice in the example and comparative example groups: The four limbs of the mice were fixed on a flat plate, and after abdominal hair removal, 20 mg of the corresponding traditional Chinese medicine composition was mixed with 80 mg of sodium hyaluronate and applied to the abdomen of the mice and fixed with gauze. The gauze and the traditional Chinese medicine composition were removed after 3 hours, and an intraperitoneal injection was given with an acetic acid solution (20 mL / kg) with a mass concentration of 0.6%. The number of writhings of the mice within 10 minutes (abdominal contraction and concavity, extension of the hind limbs, elevation of the buttocks, creeping) was observed, and the average number of writhings was recorded. The test results are shown in Table 2.

[0104] Table 2

[0105] Number of twists (times) Blank control group 2.5±0.7 Model control group <![CDATA[38.0±1.3 ## > Example 1 group <![CDATA[5.4±0.9 && > Example 2 group <![CDATA[6.2±1.0 && > Example 3 group <![CDATA[6.4±1.2 && > Example 4 group <![CDATA[7.3±1.1 && > Example 5 group <![CDATA[7.5±0.5 && > Comparative example 1 group <![CDATA[27.2±1.5 &△△ > Comparative example 2 group <![CDATA[24.8±2.2 &△△ > Comparative example 3 group <![CDATA[18.0±1.1 &△ > Comparative example 4 group <![CDATA[19.6±1.6 &△ > Comparative example 5 group <![CDATA[20.7±1.3 &△ > Comparative example 6 group <![CDATA[15.9±1.5 &△ >

[0106] In Table 2, compared with the blank control group, the model control group ## had a significant difference with P < 0.01, indicating that the model of the present invention was successfully established; compared with the model control group, each experimental group & had P < 0.05, && P < 0.01, showing a significant difference, indicating that the traditional Chinese medicine composition had a certain analgesic effect on the modeled mice; compared with Example 1 group, each comparative example group △ had P < 0.05, △△ P < 0.01, showing a significant difference, indicating that the traditional Chinese medicine composition of the present invention had a significantly improved analgesic effect compared with the comparative examples.

[0107] From the comparison of the technical effects in Table 2, it can be seen that the traditional Chinese medicine composition of the present invention can significantly reduce the number of twists and bring excellent analgesic effects. Although the traditional Chinese medicine composition of the comparative example reduces the number of twists to a certain extent, there are still significant differences in the number of twists compared with the examples. In particular, Comparative Example 1 containing 4 components and Comparative Example 2 containing 3 other components, even if the effects of improving the writhing times of Comparative Example 1 and Comparative Example 2 are added together, they still cannot achieve the improvement effect described in the present application. This shows that the 7 components of the present invention have synergistic effects and bring a significantly improved analgesic effect.

[0108] After replacing dandelion with other traditional Chinese medicine Flos Daturae with analgesic and anti-inflammatory effects in Comparative Example 3, the number of writhing times increased significantly compared with the examples; after changing the component ratios of the traditional Chinese medicine composition in Comparative Example 4, the analgesic effect decreased and the mice writhed multiple times. Thus, it can be seen that the components of the traditional Chinese medicine composition of the present invention cannot be replaced arbitrarily, and the ratios between the components are not adjusted conventionally.

[0109] Finally, from the data of the number of writhing times in Comparative Example 5 and Comparative Example 6, it can be seen that only by using a specific extraction method to prepare the traditional Chinese medicine composition can the high analgesic effect be achieved and the number of writhing times of mice be significantly reduced.

[0110] In this effect experiment, the purpose of using sodium hyaluronate is only that sodium hyaluronate has a certain viscosity, which is convenient for applying the traditional Chinese medicine composition to the skin of mice and playing the role of the traditional Chinese medicine composition.

[0111] Experiment 2 Anti-inflammatory experiment on rats

[0112] 1. Experimental animals

[0113] SD rats, male, 6 - 8 weeks old, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd., with the experimental animal production license number: SCXK(Yue)2022 - 0063, and quarantined for 4 days.

[0114] 2. Modeling

[0115] An acetic acid solution of bovine type II collagen (typeⅡcollagen, CⅡ) (containing 2.0 mg·mL of bovine CⅡ) -1 ) was completely mixed with an equal volume of complete Freund's adjuvant (CFA), fully emulsified, and the emulsion was formulated to a degree that it did not spread when dropped into water, and finally an emulsion containing 1.0 mg·mL of bovine CⅡ was prepared. -1 The emulsion was taken and injected intradermally at four points on the back and the root of the tail (two points on the back and two points on the root of the tail) at a dose of 0.2 mL per mouse for primary immunization (d0). Seven days (d7) after the primary immunization, a booster immunization was performed again according to the above method.

[0116] The results of the model establishment experiment are as follows: After intradermal injection of the emulsion containing bovine CⅡ into the model rats, ulcers appeared at the injection sites, and they could generally scab and heal in about 7 days. On the 7th day (d7) after the first immunization, a little swelling and redness were visible at the small toe joints of the hind feet of some rats. After the second immunization, the swelling of the hind paws of the rats gradually increased, and the swelling of the front paws appeared later than that of the hind paws. On the 14th day (d14), obvious swelling and redness were visible in the paws of most rats. The successfully modeled rats with obvious arthritis symptoms were selected for grouping.

[0117] 3. Grouping

[0118] The successfully modeled rats were randomly divided into 12 groups, namely 11 groups including a model control group and experimental groups: Example 1 - Example 5 groups (5 groups) and Comparative Example 1 - Comparative Example 6 groups (6 groups); there were 10 rats in each group.

[0119] For the rats without model establishment, 10 rats were selected as the blank control group.

[0120] 4. Administration

[0121] The grouped rats were given intragastric administration. Each experimental group was intragastrically administered with the corresponding traditional Chinese medicine composition at 24 mg / kg / d. The blank control group and the model control group were intragastrically administered with distilled water.

[0122] The intragastric administration was carried out once a day for 4 consecutive weeks.

[0123] 5. Effect detection

[0124] 5.1 Measurement of rat paw swelling degree: On the 14th day (d14) after the first immunization and 4 weeks after intragastric administration (after treatment), the thickness (mm) of the right hind paw of the rats was measured at a fixed site with a vernier caliper. The improvement effect of the swelling degree = the thickness of the right hind paw on the 14th day after immunization - the thickness of the right hind paw 4 weeks after intragastric administration. The improvement effect of the swelling degree is shown in Table 3.

[0125] 5.2 Determination of the content of prostaglandin 2 (PGE2) in rats: Detection was carried out using a rat prostaglandin 2 ELISA kit. After 4 weeks of intragastric administration, rat serum was taken, and the content of PGE2 in the serum was detected by the enzyme-linked immunosorbent assay (ELISA) method according to the instructions of the kit. The results of the PGE2 content (A / g) are shown in Table 3.

[0126] Table 3

[0127] Improvement effect of swelling degree PGE2 content (A / g) Blank control group / 108.27±9.52 Model control group 0.10 <![CDATA[138.88±9.26 ## > Example 1 group <![CDATA[2.06 && > <![CDATA[112.29±10.19 && > Example 2 group <![CDATA[1.99 && > <![CDATA[114.05±11.26 && > Example 3 group <![CDATA[2.02 && > <![CDATA[113.68±9.54 && > Example 4 group <![CDATA[1.94 && > <![CDATA[115.22±10.38 && > Example 5 group <![CDATA[1.93 && > <![CDATA[114.97±8.72 && > Comparative example 1 group <![CDATA[0.64 &&△△ > <![CDATA[130.07±12.03 &△△ > Comparative example 2 group <![CDATA[0.86 &&△△ > <![CDATA[128.54±11.43 &△△ > Comparative example 3 group <![CDATA[1.16 &&△△ > <![CDATA[124.51±10.20 &△ > Comparative example 4 group <![CDATA[1.13 &&△△ > <![CDATA[123.86±9.95 &△ > Comparative example 5 group <![CDATA[1.19 &&△△ > <![CDATA[125.00±9.08 &△ > Comparative example 6 group <![CDATA[1.42 &&△△ > <![CDATA[121.06±9.73 &&△ >

[0128] Among the data in the same column of Table 3, compared with the blank control group, the model control group ##P < 0.01 indicates successful model establishment; compared with the model control group, & P < 0.05, && P < 0.01; compared with Example 1 group, each pair - comparison group △ P < 0.05, △△ P < 0.01, indicating that the technical effects of improving the swelling degree and reducing the PGE2 content in the comparative examples are significantly lower than those in the examples.

[0129] As can be seen from Table 3, the traditional Chinese medicine composition of the present invention, under specific component and ratio conditions, brings significant technical effects of anti - inflammation, reducing the swelling degree and reducing the PGE2 content; there are significant differences in the anti - inflammatory and detumescence effects between the examples and the comparative examples.

[0130] Experiment 3: Experiment on the effective rate of treating osteoarthritis

[0131] 1. Research objects

[0132] Patients with joint pain, aged 50 - 70 years, meet the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)".

[0133] Diagnostic criteria reference: "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)"; ① Repeated knee joint pain within the past 1 month; ② X - ray film (standing or weight - bearing position) shows joint space narrowing, subchondral bone sclerosis and / or cystic changes, and osteophyte formation at the joint edge; ③ Age ≥ 50 years; ④ Morning stiffness ≤ 30 min; ⑤ There is a bone friction sound (sensation) during activity. Meeting any two of the five items of ①, ②, ③, ④, and ⑤ is judged as an arthritis patient.

[0134] The patients are informed of the treatment method and sign the treatment informed consent form.

[0135] 2. Treatment methods

[0136] Health education is carried out for arthritis patients, and appropriate activities are carried out every day. Randomly divided into 5 groups, with 10 patients in each group. Each group is treated with the traditional Chinese medicine compositions of Example 1 - Example 3, Comparative Example 3, and Comparative Example 5. During treatment, the traditional Chinese medicine compositions of each group are prepared into patches, each patch containing 2 g of the traditional Chinese medicine composition, applied once a day, and continuously applied for 2 weeks.

[0137] 3. Observation indicators and standards

[0138] 3.1 Visual Analogue Scale (VAS): A ruler marked with scales from 1 to 10 is used to represent the pain degree. 0 means no pain, 1 - 3 means mild pain, 4 - 6 means moderate pain, 7 - 9 means severe pain, and 10 means extreme pain. The subject draws a mark point corresponding to their own pain intensity, and the higher the score, the heavier the pain degree.

[0139] 3.2 Range of motion (ROM): The degree of knee joint flexion is used to represent the effect.

[0140] 3.3 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): The Western Ontario and McMaster Universities Osteoarthritis Index scale is used. This scale includes 5 items related to joint pain, 2 items related to stiffness, and 17 items related to functional activities, with a total of 24 item scores. Each item has a minimum score of 0 and a maximum score of 4. The higher the score, the more severe the symptoms.

[0141] The average scores (points) of the visual analogue scale, range of motion, and osteoarthritis index of the 5 groups of patients before and after treatment are shown in Table 4.

[0142] Average score result = total score / number of evaluated patients.

[0143] Table 4

[0144]

[0145] It can be seen from the data in Table 4 that after treatment with the traditional Chinese medicine compositions of Examples 1 - 3, the scoring results of the patients for the above three items are significantly better than those of Comparative Example 3 and Comparative Example 5. This shows that the components of the traditional Chinese medicine composition of the present invention are not conventionally replaced, and the traditional Chinese medicine composition obtained by using specific components and preparation methods has a significantly improved therapeutic effect.

[0146] During the treatment process, none of the above 5 groups of patients had skin irritation reactions, skin allergy reactions, or other discomforts.

[0147] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than a limitation on the protection scope of the present invention. Any simple modification or equivalent replacement of the technical solution of the present invention by those of ordinary skill in the art does not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for relieving inflammation and pain, characterized in that, It is made of the following components by weight parts: 30 - 55 parts of Panax notoginseng, 26 - 40 parts of Notopterygium incisum, 15 - 35 parts of Carthamus tinctorius, 15 - 35 parts of Aristolochia mollissima Hance, 20 - 40 parts of Glycyrrhiza uralensis Fisch., 10 - 20 parts of Acanthopanax senticosus and 10 - 30 parts of Taraxacum mongolicum Hand.-Mazz.

2. The traditional Chinese medicine composition according to claim 1, wherein It is made of the following components by weight parts: 35 - 45 parts of Panax notoginseng, 28 - 35 parts of Notopterygium incisum, 20 - 32 parts of Carthamus tinctorius, 18 - 30 parts of Aristolochia mollissima Hance, 25 - 35 parts of Glycyrrhiza uralensis Fisch., 14 - 18 parts of Acanthopanax senticosus and 15 - 25 parts of Taraxacum mongolicum Hand.-Mazz.

3. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, It includes the steps: (1) Panax notoginseng, Notopterygium incisum, Carthamus tinctorius and Taraxacum mongolicum Hand.-Mazz. are subjected to reflux extraction with an ethanol solution to obtain an ethanol extract and medicinal residues; (2) The medicinal residues from step (1), Aristolochia mollissima Hance, Glycyrrhiza uralensis Fisch. and Acanthopanax senticosus are mixed, decocted with water and then subjected to microwave treatment, and filtered to obtain a water extract; (3) The ethanol extract from step (1) and the water extract from step (2) are combined, concentrated and dried to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, In step (1), the volume concentration of the ethanol solution is 30% - 50%.

5. The preparation method according to claim 4, characterized in that, In step (1), the volume concentration of the ethanol solution is 40%.

6. The preparation method according to claim 3, characterized in that In step (1), the specific reflux extraction is: extraction at 45 - 60 °C for 1 - 3 h, and the solid-liquid ratio of the reflux extraction is 1:20 - 40 g / mL.

7. The preparation method according to claim 3, characterized in that, In step (2), the specific decoction is: with a solid-liquid ratio of 1:10 - 25 g / mL, decocted for 1 - 3 h.

8. The preparation method according to claim 3, characterized in that, In step (2), for the microwave treatment, the treatment power is 500 - 800 W and the treatment time is 5 - 15 min.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 - 2 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 - 8 in the preparation of a drug having anti-inflammatory and analgesic effects.

10. A drug with anti-inflammatory and analgesic effects, characterized in that, It includes the component: the traditional Chinese medicine composition according to any one of claims 1 - 2 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 - 8.

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