Traditional Chinese medicine composition with swelling and pain relieving effect, preparation method thereof and traditional Chinese medicine preparation

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and particularly discloses a traditional Chinese medicine composition with swelling and pain relieving effects, a traditional Chinese medicine preparation and a preparation method and application thereof. The traditional Chinese medicine composition with the swelling and pain relieving effect is prepared from the following raw material components in parts by mass: 10 to 20 parts of psammosilene tunicoides, 15 to 25 parts of edible tulip, 5 to 10 parts of periploca forrestii schltr, 5 to 10 parts of root of dentiferous dendropanax, 5 to 10 parts of erycibe obtusifolia benth, 5 to 10 parts of cortex moutan, 1 to 5 parts of herba violae, 1 to 5 parts of centella asiatica, 1 to 5 parts of borneol and 1 to 5 parts of camphor. The traditional Chinese medicine composition and small molecular collagen peptide are used as main raw materials to prepare a traditional Chinese medicine preparation, the traditional Chinese medicine preparation has excellent swelling and pain relieving effects, the preparation method is simple and convenient, the cost is low, and the problems that in the prior art, a traditional Chinese medicine preparation with the swelling and pain relieving effects is tedious in preparation process, low in cost and the like are effectively solved. The cost is high; and the pesticide effect is not obvious.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with the effects of detumescence and pain relief, a preparation method thereof, and a traditional Chinese medicine preparation. Background Art

[0002] In daily life, injuries from falls, bumps, swelling and pain are very common, such as sports injuries, accidental collisions, etc. At present, there are many drugs for detumescence and pain relief on the market, including western medicine preparations and traditional Chinese medicine preparations. Western medicine preparations usually use non-steroidal anti-inflammatory drugs, etc. Although the pain relief effect is relatively rapid, there may be adverse reactions such as gastrointestinal irritation and liver and kidney function damage. Traditional Chinese medicine preparations have received more and more attention due to their advantages of small side effects and good effects in detumescence and pain relief.

[0003] However, the existing traditional Chinese medicine compositions for detumescence and pain relief still have certain deficiencies in terms of curative effect, safety, stability, etc. Some traditional Chinese medicine compositions have complex formulas and cumbersome preparation processes, resulting in high costs; there are also some traditional Chinese medicine compositions with insufficiently significant drug effects and unable to quickly and effectively relieve swelling and pain symptoms. Therefore, it has important practical significance to develop a traditional Chinese medicine composition for detumescence and pain relief with definite curative effect, simple preparation and high safety. Summary of the Invention

[0004] Aiming at the problems of cumbersome preparation process, high cost and insignificant drug effect in the existing traditional Chinese medicine preparations with the effects of detumescence and pain relief, the present invention provides a traditional Chinese medicine composition with the effects of detumescence and pain relief, a preparation method thereof, and a traditional Chinese medicine preparation. The raw materials of the traditional Chinese medicine composition include Psammosilene tunicoides, Cremastra appendiculata, Periploca forrestii, root of Semiliquidambar cathayensis, Erycibe obtusifolia, Cortex Moutan, Panax notoginseng, Cassia obtusifolia, Viola yedoensis, Centella asiatica, borneol and camphor. On this basis, the present invention prepares a traditional Chinese medicine preparation with the traditional Chinese medicine composition and small molecule collagen peptide as the main raw materials. The traditional Chinese medicine preparation has excellent detumescence and pain relief effects, and the preparation method is simple and the cost is low, making up for the deficiencies of the existing technology.

[0005] To achieve the above invention purpose, the present invention provides the following technical solutions: The first aspect of the present invention provides a traditional Chinese medicine composition with the effects of detumescence and pain relief, including the following raw material components in parts by mass: 10-20 parts of Psammosilene tunicoides, 15-25 parts of Cremastra appendiculata, 5-10 parts of Periploca forrestii, 5-10 parts of root of Semiliquidambar cathayensis, 5-10 parts of Erycibe obtusifolia, 5-10 parts of Cortex Moutan, 1-5 parts of Viola yedoensis, 1-5 parts of Centella asiatica, 1-5 parts of borneol and 1-5 parts of camphor.

[0006] Compared with the prior art, the present invention prepares a traditional Chinese medicine composition with the effect of detumescence and pain relief from Psammosilene tunicoides, Cremastra appendiculata, Periploca forrestii, root of Semiliquidambar cathayensis, Erycibe obtusifolia, Cortex Moutan, Viola philippica, Centella asiatica, Borneol and Camphor. Among them, Psammosilene tunicoides is pungent, sweet and warm in nature, and belongs to the heart, lung and kidney meridians. It has the effects of promoting blood circulation to remove stasis, relieving pain, detoxifying and detumescence, and can be used to treat traumatic injuries, epigastric pain, rheumatic arthralgia, sores and ulcers, etc. Moreover, the active ingredients in Psammosilene tunicoides can regulate the signal transduction pathway of cells, inhibit the synthesis and release of related inflammatory mediators, thereby reducing the change of vascular permeability and achieving the purpose of detumescence. At the same time, the active ingredients of Psammosilene tunicoides interact with the ion channels on the nerve cell membrane, prevent the generation and conduction of nerve impulses, and thus reduce the transmission of pain signals to the central nervous system, achieving the effect of relieving pain. Cremastra appendiculata is sweet, slightly pungent and cool in nature, and belongs to the liver and spleen meridians. It has the effects of clearing heat and detoxifying, resolving phlegm and dissipating nodules. Its active ingredients can inhibit the synthesis and release of inflammatory mediators, and then reduce the production of inflammatory mediators, relieve the inflammatory reaction, and achieve the effect of detumescence. Periploca forrestii is pungent, bitter and warm in nature, slightly poisonous, and belongs to the liver and kidney meridians. It has the effects of dredging meridians, dispelling wind and dampness, promoting blood circulation and reducing inflammation. It can play an analgesic role by regulating the endogenous analgesic system, promote the release of endogenous opioid peptides or enhance their binding to opioid receptors, and activate the signal pathway mediated by opioid receptors, thereby producing an analgesic effect.

[0007] The root of Semiliquidambar cathayensis is sweet, pungent and warm in nature, and belongs to the liver, spleen and kidney meridians. It has the effects of expelling wind and dampness, promoting blood circulation to remove stasis, relieving cough and asthma. It can improve local blood circulation, help to take away the metabolic products and pain-causing substances accumulated in the inflamed area, such as lactic acid, bradykinin, etc. At the same time, the active ingredients in the root of Semiliquidambar cathayensis can provide more nutrients for the damaged tissue, promote the repair and regeneration of the tissue. Erycibe obtusifolia is warm in nature and pungent in taste, and belongs to the liver and kidney meridians. It has the effects of clearing heat and drying dampness, detoxifying and detumescence. Its active ingredients can act on the peripheral nerve endings, reduce the sensitivity of pain receptors, and reduce the generation of pain signals.

[0008] Cortex Moutan is bitter, pungent and slightly cold in nature, and belongs to the heart, liver and kidney meridians. It has the effects of clearing heat and cooling blood, promoting blood circulation to remove stasis. Cortex Moutan can promote blood circulation to remove stasis, promote blood circulation, eliminate blood stasis blockage, make qi and blood smooth, and thus relieve pain and swelling. Viola philippica is bitter, pungent and cold in nature, and belongs to the heart and liver meridians. It has the effects of clearing heat and detoxifying, cooling blood and detumescence, etc. Viola philippica can relieve the symptoms of swelling and pain by regulating immune function, maintaining the internal environment stability of the body, and promoting the repair and regeneration of damaged tissues. Centella asiatica is pungent, bitter and cold in nature, and belongs to the liver, spleen and kidney meridians. It has the effects of clearing heat and promoting diuresis, anti-inflammatory and repair. The active ingredients in Centella asiatica can promote the proliferation of fibroblasts and the synthesis of collagen. After tissue injury, fibroblasts can synthesize and secrete extracellular matrix such as collagen, participate in tissue repair and regeneration, and reduce swelling and pain caused by untimely repair of tissue injury.

[0009] In the present invention, Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium hypoglaucum are used as the monarch drugs, Schefflera arboricola and Erycibe obtusifolia are used as the minister drugs, Paeonia suffruticosa, Viola philippica, and Centella asiatica are used as the assistant drugs, and borneol and camphor are used as the envoy drugs. The formula of the traditional Chinese medicine composition is simple, and the raw materials are inexpensive and easily available, effectively solving the problems of complex formula and high cost of the traditional Chinese medicine composition with the efficacy of detumescence and pain relief in the prior art.

[0010] Preferably, the traditional Chinese medicine composition with the effect of detumescence and pain relief comprises the following raw material components in parts by mass: 15-20 parts of Psammosilene tunicoides, 15-22 parts of Cremastra appendiculata, 6-8 parts of Tripterygium hypoglaucum, 5-8 parts of Schefflera arboricola, 5-8 parts of Erycibe obtusifolia, 5-8 parts of Paeonia suffruticosa, 1-4 parts of Viola philippica, 1-3 parts of Centella asiatica, 1-3 parts of borneol, and 1-3 parts of camphor.

[0011] The second aspect of the present invention provides a preparation method of a traditional Chinese medicine composition with the effect of detumescence and pain relief, comprising the following steps: Step 1: Weigh Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium hypoglaucum according to the designed ratio, mix, pulverize, soak in a eutectic solvent, perform solid-liquid separation, and obtain the monarch drug extract. Step 2: Weigh the other raw material components except Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium hypoglaucum according to the designed ratio, mix evenly, pulverize, and pass through a sieve to obtain a mixture; impregnate the mixture in an alcohol solution, decoct at 60-80°C, perform solid-liquid separation, and obtain the first medicinal liquid and the filter residue. Step 3: Impregnate the filter residue in an alcohol solution and decoct at 60-80°C to obtain the second medicinal liquid. Step 4: Mix the monarch drug extract, the first medicinal liquid, and the second medicinal liquid evenly, and concentrate at 80°C-100°C to obtain the traditional Chinese medicine composition with the effect of detumescence and pain relief.

[0012] The present invention uses a eutectic solvent to extract the monarch drug components, which can effectively improve the extraction efficiency of the active ingredients in the monarch drug. Moreover, the eutectic solvent has good biocompatibility, biodegradability, and stability, will not interfere with the drug components, and is more environmentally friendly and safe.

[0013] Preferably, in Step 1, the eutectic solvent is glucose and lactic acid with a mass ratio of 1.5:1-2:1.

[0014] Glucose is a polyhydroxy compound and can be used as a hydrogen bond donor; lactic acid contains a carboxyl group and a hydroxyl group, can both provide and accept hydrogen bonds, and the eutectic solvent composed of them has characteristics such as low vapor pressure, good solubility, and strong designability.

[0015] Preferably, in Step 1, the mass-volume ratio of the total mass of Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium hypoglaucum to the eutectic solvent is 1 g:5 mL-1 g:7 mL.

[0016] Preferably, in step one, the soaking time is 2h - 4h.

[0017] Preferably, in step two, the alcohol solution is an ethanol aqueous solution with a mass concentration of 45% - 60%.

[0018] Preferably, in step two, the mass - to - volume ratio of the mixture to the alcohol solution is 1g:10mL - 1g:15mL.

[0019] Preferably, in step two, the decocting time is 1h - 2h.

[0020] Preferably, in step three, the alcohol solution is an ethanol solution with a mass concentration of 45% - 60%.

[0021] Preferably, in step three, the mass - to - volume ratio of the filter residue to the alcohol solution is 1g:15mL - 1g:20mL.

[0022] Preferably, in step three, the decocting time is 1h - 3h.

[0023] Preferably, in step four, the relative density of the traditional Chinese medicine composition with the effect of detumescence and pain relief is 1.10 - 1.20.

[0024] In the third aspect of the present invention, a traditional Chinese medicine preparation with the effect of detumescence and pain relief includes a traditional Chinese medicine composition with detumescence and pain relief prepared by the preparation method of the traditional Chinese medicine composition with the effect of detumescence and pain relief, small - molecule collagen peptides, and pharmaceutically acceptable excipients.

[0025] The traditional Chinese medicine preparation provided by the present invention is a compound preparation of a traditional Chinese medicine composition and small - molecule collagen peptides. The traditional Chinese medicine extract and small - molecule collagen peptides can play a synergistic role in anti - inflammation. Small - molecule collagen peptides have the effects of promoting wound healing and repairing tissues, and can accelerate the regeneration of damaged tissues by supplementing collagen, thereby indirectly relieving swelling and pain caused by trauma or inflammation. The components in the traditional Chinese medicine composition can promote local blood circulation, increase the nutritional supply and oxygen delivery of tissues, accelerate the excretion of metabolic wastes, be beneficial to tissue repair and regeneration, and relieve swelling and pain caused by inflammation. Small - molecule collagen peptides promote tissue repair at the cellular level, while traditional Chinese medicine components eliminate pathological factors by regulating qi and blood circulation. The two work synergistically to significantly enhance the antioxidant and anti - inflammatory effects, not only relieving swelling but also delaying tissue aging.

[0026] Preferably, in the traditional Chinese medicine preparation, the mass ratio of the traditional Chinese medicine composition with detumescence and pain relief to the small - molecule collagen peptides is 10:1 - 15:1.

[0027] Preferably, the small - molecule collagen peptides are collagen tripeptides.

[0028] Preferably, the pharmaceutically acceptable excipients are one or more of diluents, wetting agents, binders, disintegrants, lubricants, surfactants or penetration enhancers.

[0029] Preferably, the traditional Chinese medicine preparation is a spray, external aqueous solution, liniment, tincture or other pharmaceutically acceptable external dosage forms.

[0030] In summary, in the present invention, Psammosilene tunicoides, Cremastra appendiculata and Tripterygium hypoglaucum are used as the monarch drugs, Semiliquidambar cathayensis and Erycibe obtusifolia are used as the minister drugs, Paeonia suffruticosa, Viola yedoensis and Centella asiatica are used as the assistant drugs, and borneol and camphor are used as the envoy drugs. A traditional Chinese medicine composition with the effect of detumescence and pain relief is prepared by utilizing the relationship of monarch, minister, assistant and envoy. The formula of the traditional Chinese medicine composition is simple, and the raw materials are cheap and easy to obtain. Moreover, the present invention also prepares a traditional Chinese medicine preparation by using the traditional Chinese medicine composition and small molecule collagen peptide as the main raw materials. The traditional Chinese medicine preparation has excellent detumescence and pain relief effects, and the preparation method is simple, and the cost is low. The technical scheme of the present invention effectively solves the problems of complex formula and high cost of the traditional Chinese medicine composition with the effect of detumescence and pain relief in the prior art. Detailed Embodiments

[0031] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0032] Example 1 This example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method, which specifically includes the following contents: The traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following raw material components in parts by mass: 18 g of Psammosilene tunicoides, 20 g of Cremastra appendiculata, 7 g of Tripterygium hypoglaucum, 7 g of Semiliquidambar cathayensis, 7 g of Erycibe obtusifolia, 6 g of Paeonia suffruticosa, 3 g of Viola yedoensis, 2 g of Centella asiatica, 2 g of borneol and 2 g of camphor.

[0033] The preparation method of the traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following steps: Step 1: Weigh Psammosilene tunicoides, Cremastra appendiculata and Tripterygium hypoglaucum according to the designed ratio, mix, pulverize, soak in 250 mL of a mixed solvent of glucose and lactic acid with a mass ratio of 1.8:1 for 3 h, filter to obtain the extract of the monarch drugs; Step 2: Weigh the other raw material components except Psammosilene tunicoides, Cremastra appendiculata and Tripterygium hypoglaucum according to the designed ratio, mix evenly, pulverize, and sieve to obtain a mixture; immerse the mixture in 350 mL of a 50 wt% ethanol solution, decoct at 70 °C for 1.5 h, and perform solid-liquid separation to obtain the first medicinal liquid and the filter residue; Step 3: Immerse the filter residue in 450 mL of 50 wt% ethanol solution, decoct at 80 °C for 2.5 h to obtain the second medicinal liquid. Step 4: Mix the extract of the monarch drug, the first medicinal liquid and the second medicinal liquid evenly, concentrate at 90 °C until the relative density of the medicinal liquid is 1.15 to obtain a traditional Chinese medicine composition with the effect of detumescence and pain relief.

[0034] Example 2 This example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method, which specifically includes the following content: The traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following raw material components in parts by mass: 20 g of Psammosilene tunicoides, 15 g of Cremastra appendiculata, 6 g of Periploca forrestii, 5 g of roots of Semiliquidambar cathayensis, 8 g of Erycibe obtusifolia, 6 g of Paeonia suffruticosa, 3 g of Viola philippica, 2 g of Centella asiatica, 2 g of Borneol and 2 g of Camphor.

[0035] The preparation method of the traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following steps: Step 1: Weigh Psammosilene tunicoides, Cremastra appendiculata and Periploca forrestii according to the designed ratio, mix, pulverize, soak in 250 mL of a mixed solvent of glucose and lactic acid with a mass ratio of 1.8:1 for 3 h, filter to obtain the extract of the monarch drug. Step 2: Weigh the other raw material components except Psammosilene tunicoides, Cremastra appendiculata and Periploca forrestii according to the designed ratio, mix evenly, pulverize, sieve to obtain a mixture; immerse the mixture in 350 mL of 50 wt% ethanol solution, decoct at 70 °C for 1.5 h, perform solid-liquid separation to obtain the first medicinal liquid and the filter residue. Step 3: Immerse the filter residue in 450 mL of 50 wt% ethanol solution, decoct at 80 °C for 2.5 h to obtain the second medicinal liquid. Step 4: Mix the extract of the monarch drug, the first medicinal liquid and the second medicinal liquid evenly, concentrate at 90 °C until the relative density of the medicinal liquid is 1.15 to obtain a traditional Chinese medicine composition with the effect of detumescence and pain relief.

[0036] Example 3 This example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method, which specifically includes the following content: The traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following raw material components in parts by mass: 15 g of Psammosilene tunicoides, 22 g of Cremastra appendiculata, 8 g of Periploca forrestii, 8 g of roots of Semiliquidambar cathayensis, 5 g of Erycibe obtusifolia, 5 g of Paeonia suffruticosa, 3 g of Viola philippica, 2 g of Centella asiatica, 2 g of Borneol and 2 g of Camphor.

[0037] The preparation method of the traditional Chinese medicine composition with the effect of detumescence and pain relief includes the following steps: Step 1: Weigh Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium regelii according to the designed ratio, mix them, pulverize them, soak them in 250 mL of a mixed solvent of glucose and lactic acid with a mass ratio of 1.8:1 for 3 hours, filter to obtain the extract of the monarch drug. Step 2: Weigh the other raw material components except Psammosilene tunicoides, Cremastra appendiculata, and Tripterygium regelii according to the designed ratio, mix them evenly, pulverize them, and sieve them to obtain a mixture; immerse the mixture in 350 mL of a 50 wt% ethanol solution, decoct it at 70 °C for 1.5 hours, perform solid-liquid separation to obtain the first medicinal liquid and the filter residue. Step 3: Immerse the filter residue in 450 mL of a 50 wt% ethanol solution and decoct it at 80 °C for 2.5 hours to obtain the second medicinal liquid. Step 4: Mix the extract of the monarch drug, the first medicinal liquid, and the second medicinal liquid evenly, and concentrate them at 90 °C until the relative density of the medicinal liquid is 1.15 to obtain a traditional Chinese medicine composition with the effect of detumescence and pain relief.

[0038] Comparative Example 1 This comparative example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method. The difference from Example 1 is that Psammosilene tunicoides is replaced with an equal amount of myrrh, and the other components and preparation processes remain unchanged, which will not be elaborated here.

[0039] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method. The difference from Example 1 is that Cremastra appendiculata is replaced with an equal amount of Impatiens balsamina, and the other components and preparation processes remain unchanged, which will not be elaborated here.

[0040] Comparative Example 3 This comparative example provides a traditional Chinese medicine composition with the effect of detumescence and pain relief and its preparation method. The difference from Example 1 is that Tripterygium regelii is replaced with an equal amount of Dracaena cochinchinensis, and the other components and preparation processes remain unchanged, which will not be elaborated here.

[0041] Experimental Example 1 This experimental example provides a traditional Chinese medicine spray with the effect of detumescence and pain relief, which specifically includes the following content: Mix 200 g of the traditional Chinese medicine composition with the effect of detumescence and pain relief provided by each example or comparative example and 15 g of collagen tripeptide evenly, add 50 mL of a 75 wt% ethanol solution as a diluent, mix evenly, seal, let it stand for 24 hours, and fill it to obtain a traditional Chinese medicine spray with the effect of detumescence and pain relief.

[0042] Experimental Example 2 This experimental example provides a traditional Chinese medicine tincture with the effect of detumescence and pain relief, which specifically includes the following content: Mix 200 g of the traditional Chinese medicine composition with the effect of detumescence and pain relief provided in each example or comparative example and 15 g of collagen tripeptide evenly, add 50 mL of 75 wt% ethanol solution as a diluent, mix evenly, and slowly percolate. Collect the percolate to obtain a tincture of traditional Chinese medicine with the effect of detumescence and pain relief.

[0043] Other traditional Chinese medicine preparations are prepared according to the conventional preparation methods and will not be elaborated here.

[0044] To further demonstrate the technical effects of the present invention, the following tests were conducted on the traditional Chinese medicine spray prepared in Test Example 1: Statistical method: The test results are recorded using Excel 2003 software, and t-tests or chi-square tests are performed using SPSS 19.0 to compare the significance of differences between groups.

[0045] (1) Mouse hot plate pain experiment: Select female mice weighing 18 - 22 g, with the hot plate temperature at 55 °C. Measure the pain threshold twice. Using the appearance of the reaction of licking the hind paw as an indicator, those with an average pain threshold within 5 - 30 s are qualified. Select 70 qualified mice, namely the blank control group, the solution control group (50% ethanol solution), Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and the western medicine group. Apply the medicine to the mouse toes at a dosage of 5 g / mL based on the mouse body weight, once a day for 7 consecutive days. At 30 min, 60 min, and 120 min after the last administration, record the time from when the mouse is placed on the hot plate until it shows the reaction of licking the paw as the pain threshold. The results are shown in Table 1.

[0046] Table 1 Results of the mouse hot plate pain experiment

[0047] Note: Compared with the blank control group, *P < 0.05.

[0048] As can be seen from Table 1, compared with the blank control group, the pain threshold of the Example 1 group increased significantly after administration, with a significant difference (P < 0.05). The pain thresholds of the Comparative Example 1 group - Comparative Example 3 group also increased after administration, with a significant difference, and the effect of increasing the pain threshold was significantly worse than that of the Example 1 group. The pain threshold of the western medicine group also increased significantly after administration, with a significant difference. This shows that the traditional Chinese medicine spray provided by the Example 1 group can effectively increase the pain threshold of mice.

[0049] (2) Mouse writhing test: Mice weighing 18 - 22 g, with an equal number of males and females, were randomly divided into 7 groups, with 10 mice in each group, namely the blank control group, the solution control group (50% ethanol solution), the Example 1 group, the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, and the western medicine group. The hair on the abdomen of the mice was cut off with scissors, and the hair-cutting area was about 2×2 cm. The medicine was applied to the abdomen of the mice, and the dosage was 5 g / mL according to the body weight of the mice, once a day for 7 consecutive days. 0.2 mL of glacial acetic acid solution with a volume concentration of 5% was intraperitoneally injected 1 h after the last administration, and the number of writhing reactions of the mice within 15 min was observed and recorded (manifestation of writhing reaction: concave abdomen, extension of the trunk and hind legs, elevation of the buttocks). Statistical analysis was performed, and the results are shown in Table 2.

[0050] Table 2 Test results of mouse writhing test

[0051] Note: Compared with the blank control group, *P < 0.05, **P < 0.01.

[0052] It can be seen from Table 2 that compared with the blank control group, the number of writhing times after administration in the Example 1 group decreased significantly, and the difference was significant (P < 0.01). The number of writhing times after administration in the Comparative Example 1 group - Comparative Example 3 group decreased significantly, and the difference was significant (P < 0.05). The pain threshold also increased significantly after administration in the western medicine group, and the difference was significant (P < 0.01). This indicates that the traditional Chinese medicine spray provided by the Example 1 group can effectively reduce the number of writhing reactions of mice.

[0053] (3) Mouse cotton ball granuloma test: Mice weighing 18 - 22 g, with an equal number of males and females, were randomly divided into 7 groups, with 10 mice in each group, namely the blank control group, the solution control group (50% ethanol solution), the Example 1 group, the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, and the western medicine group. During the experiment, the mice were anesthetized with ether, and after routine disinfection, an incision was made on the right abdomen of the mice, and a sterilized cotton ball (10 mg each) that had been weighed was implanted into the axilla on the opposite side of the mice, and the wound was sutured. Each group began to apply the corresponding drug or solvent to the skin area where the cotton ball was implanted in the axilla on the day of the operation. The blank control group was given normal saline, and the dosage was 5 g / mL according to the body weight of the mice, once a day for 10 consecutive days. The mice were sacrificed 1 h after the last administration, the cotton ball granulation tissue was taken out, dried at 60 °C for 4 h, and the weight of the cotton ball granuloma was weighed. Statistical analysis was performed, and the results are shown in Table 3.

[0054] Table 3 Results of mouse cotton ball granuloma test

[0055] Note: Compared with the blank control group, *P < 0.05, **P < 0.01.

[0056] As can be seen from Table 3, compared with the blank control group, the change in the weight of cotton ball granuloma after treatment in the solvent control group was smaller, while the weight of cotton ball granuloma in the Example 1 group after administration decreased significantly, and the difference was significant (P < 0.01). The weight of cotton ball granuloma in the Comparative Example 1 group - Comparative Example 3 groups after administration also decreased significantly, and the difference was significant (P < 0.01). The weight of cotton ball granuloma in the western medicine group after administration decreased significantly, and the difference was significant (P < 0.01). This indicates that the traditional Chinese medicine spray provided by the Example 1 group can significantly inhibit the hyperplasia of cotton ball granuloma in mice.

[0057] (4)Mouse soft tissue impact injury test: Select mice weighing 18 - 22 g, with half male and half female, and randomly divide them into 7 groups, with 10 mice in each group, namely the blank control group, the solution control group (50% ethanol solution), the Example 1 group, the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, and the western medicine group. Use a cylinder impactor to cause soft tissue injury in the upper segment of the hind legs of mice. After a few minutes, it can be seen that the bruised tissue becomes congested and edematous; each group starts to apply the corresponding drug in the afternoon of the same day. The blank control group is given physiological saline, and the dosage of the applied drug is calculated according to the mouse body weight at 5 g / mL, once a day for 5 consecutive days. The mice are sacrificed 1 hour after the last administration, and the injured part is dissected. The repair situation is evaluated according to the soft tissue injury scoring standard. The soft tissue injury criteria are as follows: (1) Recovery: Basically restored to the same as normal tissue; (2) Marked effect: There is no bleeding focus on the tissue surface. When the tissue is cut, punctate or congested foci are seen, and there is no edema; (3) Effective: There is a 0.5 - 1.0 cm 2 bleeding or congested focus, and the edema area is less than 1.0 cm 2 ; (4) Ineffective: There is bleeding, congestion, and edema with a size greater than 1.0 cm 2 . Statistical analysis, and the results are shown in Table 4.

[0058] Table 4 Results of mouse soft tissue impact injury test

[0059] Note: Compared with the blank control group, *P < 0.05.

[0060] As can be seen from Table 4, compared with the blank control group, the number of markedly effective and effective mice increased after treatment in the solvent control group, while the number of recovered mice increased significantly after administration in the Example 1 group, and the difference was significant (P < 0.05). The number of recovered mice in the Comparative Example 1 group - Comparative Example 3 groups after administration also increased significantly, and the difference was significant (P < 0.05). The number of recovered mice in the western medicine group after administration increased significantly, and the difference was significant (P < 0.05). This indicates that the traditional Chinese medicine spray provided by the Example 1 group can effectively treat mouse soft tissue impact injury.

[0061] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, or improvements made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with the functions of detumescence and pain relief, characterized in that: It comprises the following raw material components in parts by mass: 10 - 20 parts of Psammosilene tunicoides, 15 - 25 parts of Cremastra appendiculata, 5 - 10 parts of Periploca forrestii Schltr., 5 - 10 parts of root of Semiliquidambar cathayensis, 5 - 10 parts of Erycibe obtusifolia Benth., 5 - 10 parts of Cortex Moutan, 1 - 5 parts of Viola philippica Cav., 1 - 5 parts of Centella asiatica (L.) Urban, 1 - 5 parts of Borneol and 1 - 5 parts of Camphor.

2. The traditional Chinese medicine composition with the effect of detumescence and pain relief according to claim 1, characterized in that: It comprises the following raw material components in parts by mass: 15 - 20 parts of Psammosilene tunicoides, 15 - 22 parts of Cremastra appendiculata, 6 - 8 parts of Periploca forrestii Schltr., 5 - 8 parts of root of Semiliquidambar cathayensis, 5 - 8 parts of Erycibe obtusifolia Benth., 5 - 8 parts of Cortex Moutan, 1 - 4 parts of Viola philippica Cav., 1 - 3 parts of Centella asiatica (L.) Urban, 1 - 3 parts of Borneol and 1 - 3 parts of Camphor.

3. A preparation method of a traditional Chinese medicine composition with the effect of detumescence and pain relief as described in any one of claims 1 or 2, characterized in that: It comprises the following steps: Step 1: Weigh Psammosilene tunicoides, Cremastra appendiculata and Periploca forrestii Schltr. according to the designed ratio, mix, pulverize, soak in the eutectic solvent, perform solid-liquid separation to obtain the monarch drug extract. Step 2: Weigh the other raw material components except Psammosilene tunicoides, Cremastra appendiculata and Periploca forrestii Schltr. according to the designed ratio, mix evenly, pulverize, sieve to obtain a mixture; immerse the mixture in an alcohol solution, decoct at 60 - 80 °C, perform solid-liquid separation to obtain the first medicinal liquid and the filter residue. Step 3: Immerse the filter residue in an alcohol solution and decoct at 60 - 80 °C to obtain the second medicinal liquid. Step 4: Mix the monarch drug extract, the first medicinal liquid and the second medicinal liquid evenly, concentrate at 80 °C - 100 °C to obtain a traditional Chinese medicine composition with the effect of detumescence and pain relief.

4. The preparation method of the traditional Chinese medicine composition with the effects of detumescence and pain relief according to claim 3, characterized in that: In Step 1, the eutectic solvent is glucose and lactic acid with a mass ratio of 1.5:1 - 2:1; and / or In Step 1, the mass-volume ratio of the total mass of Psammosilene tunicoides, Cremastra appendiculata and Periploca forrestii Schltr. to the eutectic solvent is 1 g:5 mL - 1 g:7 mL; and / or In Step 1, the soaking time is 2 h - 4 h.

5. The preparation method of the traditional Chinese medicine composition with the effects of detumescence and pain relief according to claim 3, characterized in that: In Step 2, the alcohol solution is an ethanol aqueous solution with a mass concentration of 45% - 60%; and / or In Step 2, the mass-volume ratio of the mixture to the alcohol solution is 1 g:10 mL - 1 g:15 mL; and / or In Step 2, the decocting time is 1 h - 2 h.

6. The preparation method of the traditional Chinese medicine composition with the functions of detumescence and pain relief according to claim 3, characterized in that: In Step 3, the mass-volume ratio of the filter residue to the alcohol solution is 1 g:15 mL - 1 g:20 mL; and / or In Step 3, the decocting time is 1 h - 3 h.

7. The preparation method of the traditional Chinese medicine composition with the effects of detumescence and pain relief as claimed in claim 3, wherein: In Step 4, the relative density of the traditional Chinese medicine composition with the effect of detumescence and pain relief is 1.10 - 1.

20.

8. A traditional Chinese medicine preparation with the functions of detumescence and pain relief, characterized in that: It comprises a traditional Chinese medicine composition with the effect of detumescence and pain relief prepared by the preparation method of the traditional Chinese medicine composition with the effect of detumescence and pain relief according to any one of claims 3 - 7, small molecule collagen peptide and pharmaceutically acceptable excipients.

9. The traditional Chinese medicine preparation with the functions of detumescence and pain relief according to claim 8, wherein: In the traditional Chinese medicine preparation, the mass ratio of the traditional Chinese medicine composition with the effect of detumescence and pain relief to the small molecule collagen peptide is 10:1 - 15:1; and / or The small molecule collagen peptide is collagen tripeptide; and / or The pharmaceutically acceptable excipients are one or more of diluents, wetting agents, binders, disintegrants, lubricants, surfactants or penetration enhancers.

10. The traditional Chinese medicine preparation with the functions of detumescence and pain relief according to claim 8, wherein: The traditional Chinese medicine preparation is a spray, external aqueous solution, liniment, tincture or other pharmaceutically acceptable external dosage forms.

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