Traditional Chinese medicine composition for adjuvant therapy of acute sprain and contusion and preparation process thereof

Abstract

The invention relates to a traditional Chinese medicine composition for adjuvant therapy of acute sprain and contusion and a preparation process of the traditional Chinese medicine composition for adjuvant therapy of acute sprain and contusion. The traditional Chinese medicine composition is mainly prepared from the following traditional Chinese medicine raw materials: 20-30 g of schisandra propinqua, 20-30 g of radix zanthoxyli, 20-30 g of smilax riparia, 20-30 g of ardisia crenata, 20-30 g of pseudo-ginseng, 6-12 g of ground beeltle, 10-15 g of cassia twig, 10-15 g of radix stephaniae tetrandrae, 10-15 g of processed rhizoma arisaematis, 10-15 g of curcuma zedoary, 10-15 g of sappan wood, 2-4 g of camphor, 1.5-2.4 g of The invention also comprises a preparation process of the traditional Chinese medicine composition for adjuvant therapy of acute sprain and contusion. Appropriate medicines are selected, and the refined tincture is externally used, can quickly reach the affected part with the efficacy, and is quick to take effect and convenient to use; both symptoms and root causes can be treated; side effects are few. The traditional Chinese medicine has a remarkable curative effect on bruise, sprain and rheumatic arthralgia.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition and its preparation process, and particularly to a traditional Chinese medicine composition for adjuvant treatment of acute sprains and contusions and its preparation process. Background Art

[0002] There are many existing Chinese and Western medicines for treating acute sprains and contusions. Western medicines include non-steroidal anti-inflammatory drugs, muscle relaxants, and closed therapy. Traditional Chinese medicines include oral proprietary Chinese medicines, external proprietary Chinese medicines, and traditional Chinese medicine prescriptions. Different drugs or combined medications are used according to the degree of sprain and contusion, the cause of the disease, the patient's constitution, etc.

[0003] Non-steroidal anti-inflammatory drugs in Western medicines can relieve pain and reduce inflammatory reactions, and are commonly used to relieve symptoms such as local swelling, pain, and limited movement caused by acute sprains and contusions. Common drugs include ibuprofen, diclofenac sodium, celecoxib, meloxicam, loxoprofen sodium tablets, etc. When a sports sprain first occurs, diclofenac sodium aerosol, indomethacin cataplasm, ibuprofen gel, etc. containing Western medicine anti-inflammatory and pain-relieving ingredients can also be used to achieve rapid pain relief. When the pain is relatively severe in the acute stage, Celebrex can also be used to relieve pain; Muscle relaxants refer to when acute sprains and contusions cause muscle tension and spasm, muscle relaxants can be used to relax the muscles and relieve pain, thereby achieving the effect of treating acute sprains and contusions. Representative varieties mainly include chlorzoxazone tablets, etoperidone hydrochloride tablets, tizanidine hydrochloride tablets, etc.; The usage of closed therapy means that when the condition of acute lumbar sprain patients is relatively serious, closed therapy can be used, and generally procaine is used for treatment, but attention should be paid to its side effects.

[0004] Oral proprietary Chinese medicines for treating acute sprains and contusions in traditional Chinese medicines mainly include Panax Notoginseng Tablets, Dieda Pills, Yunnan Baiyao Capsules, Compound Danshen Tablets, etc.; External proprietary Chinese medicines include Yunnan Baiyao Spray, Honghua Oil, Musk Pain-relieving Plaster, Compound Nanxing Pain-relieving Plaster, etc.; Traditional Chinese medicine prescriptions include Taoren Chengqi Decoction, modified Jingjie Decoction, Ten-flavor External Application Mud, etc.

[0005] Although these Chinese and Western medicines have significant curative effects. Generally speaking, there are still the following deficiencies: some can only relieve the symptoms but not cure the root cause; some have relatively large side effects. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition for adjuvant treatment of acute sprains and contusions and its preparation process. The traditional Chinese medicine composition is used for adjuvant treatment of acute sprains and contusions, can relieve the symptoms and cure the root cause, has better curative effects, and fewer side effects.

[0007] The technical solution adopted by the present invention to solve its technical problems is:

[0008] The traditional Chinese medicine composition (abbreviated as Wumianxing Chushi Tincture) for adjuvant treatment of acute sprains and contusions of the present invention is mainly made from the following traditional Chinese medicine raw materials:

[0009] Schisandra 20-30g, Zanthoxylum bungeanum 20-30g, Oxtail Herb 20-30g, Cinnabar Root 20-30g, Panax Notoginseng 20-30g, Eupolyphaga sinensis 6-12g, Cassia Twig 10-15g, Stephania tetrandra 10-15g, Processed Arisaema 10-15g, Curcuma 10-15g, Sappan Wood 10-15g, Camphor 2-4g, Menthol 1.5-2.4g, Borneol 2-6g.

[0010] The preferred solution is:

[0011] Schisandra 22-28g, Zanthoxylum bungeanum 22-28g, Oxtail Herb 22-28g, Cinnabar Root 22-28g, Panax Notoginseng 22-28g, Eupolyphaga sinensis 7-11g, Cassia Twig 11-14g, Stephania tetrandra 11-14g, Processed Arisaema 11-14g, Curcuma 11-14g, Sappan Wood 11-14g, Camphor 2.5-3.5g, Menthol 1.6-2.3g, Borneol 3-5g.

[0012] A further preferred solution is:

[0013] Schisandra 24-26g, Zanthoxylum bungeanum 24-26g, Oxtail Herb 24-26g, Cinnabar Root 24-26g, Panax Notoginseng 24-26g, Eupolyphaga sinensis 8-10g, Cassia Twig 12-13g, Stephania tetrandra 12-13g, Processed Arisaema 12-13g, Curcuma 12-13g, Sappan Wood 12-13g, Camphor 2.8-3.2g, Menthol 1.7-2.1g, Borneol 3.5-4.5g.

[0014] A more preferred solution is:

[0015] Schisandra 24.2g, Zanthoxylum bungeanum 24.2g, Oxtail Herb 24.2g, Cinnabar Root 24.2g, Panax Notoginseng 24.2g, Eupolyphaga Scolopendra 9.1g, Cinnamon Twig 12.1g, Stephania Tetrandra 12.1g, Processed Arisaema 12.1g, Curcuma 12.1g, Sappan Wood 12.1g, Camphor 3g, Menthol 1.8g, Borneol 4g.

[0016] The preparation process of the Chinese medicine composition (five-sided star dehumidifying tincture) for assisting the treatment of acute sprain and contusion of the present invention comprises the following steps:

[0017] (1) Clean, cut, dry, and grind Schisandrae chinensis, Zanthoxylum bungeana, Cinnabaris chinensis, Panax notoginseng, Eupolyphaga sinensis, Cinnamon twig, Stephania tetrandra, processed Arisaema confusa, Curcuma zedoaria, and Sappan wood (eleven medicinal materials) into coarse powder for later use;

[0018] (2) soaking and percolating the medicinal materials pretreated in step (1) according to the percolation method under the fluid extract and extract (see 0189 of the General Rules of Part IV of the 2020 edition of the Chinese Pharmacopoeia) to obtain a percolation liquid; distilling the medicinal residues to collect the initial medicinal residue distillate;

[0019] Further, in step (2), according to the percolation method under the item of liquid extract and extract (see General Principles 0189, Part IV of Chinese Pharmacopoeia 2020 Edition), using 2102 ml of ethanol with a volume concentration of 55% as the solvent, after impregnating the medicinal materials pretreated in step (1) for 48 hours, slowly percolate at a rate of 1 - 3 ml per minute, collect 530 ml of the initial percolate and store it separately; continue percolation, collect 1400 ml of the subsequent percolate, and concentrate it under reduced pressure to about 70 ml; distill the medicinal residues and collect 70 ml of the initial medicinal residue distillate;

[0020] (3) Dissolve camphor, menthol, and borneol in the medicinal residue distillate obtained in step (2);

[0021] (4) Combine the percolate and the medicinal residue distillate obtained in step (2), mix well, add ethanol and purified water, adjust the total volume to make the ethanol volume content 55 - 60%, let it stand, filter, and fill into containers to obtain the product. (The alcohol content of the medicinal liquid after mixing the percolate and the distillate changes, and appropriate amounts of ethanol and purified water are added to adjust the ethanol volume concentration to 55% - 60%).

[0022] Further, in step (4), combine 530 ml of the initial percolate, 70 ml of the subsequent percolate, and 70 ml of the medicinal residue distillate obtained in step (2), mix well, add ethanol and purified water, adjust the total volume to 1000 ml to make the ethanol volume content 55 - 60%, let it stand, filter, and fill into containers to obtain the product.

[0023] Usage of the traditional Chinese medicine composition - Wumianxing Chushi Tincture of the present invention:

[0024] (1) For patients with pain, tenderness, swelling, ecchymosis, limited movement, etc. caused by acute contusion and sprain, apply an appropriate amount topically, wipe or apply on the affected area with absorbent cotton several times a day, and 3 - 7 days is a treatment course.

[0025] (2) For patients with symptoms such as pain, tenderness, swelling, numbness, heaviness, and limited flexion and extension caused by arthralgia syndrome, wipe or apply on the affected area with absorbent cotton several times a day, and 3 - 7 days is a treatment course.

[0026] In the traditional Chinese medicine composition of the present invention - Wumianxing Shiding, in the formula, Wuweiteng is used as the monarch drug, taking its functions of promoting blood circulation to remove blood stasis, dispelling wind and dampness, and having the effects of detumescence and pain relief. Zanthoxylum nitidum, Smilax riparia, and Ardisia crenata are used as the minister drugs. Zanthoxylum nitidum has strong effects of removing stasis, detumescence, and pain relief; Smilax riparia is good at dredging meridians and collaterals, promoting blood circulation to remove blood stasis; Ardisia crenata is good at dispelling wind and dampness, promoting blood circulation to relieve pain. Notoginseng, Sappanwood, Stephania tetrandra, Rhizoma Zedoariae, Eupolyphaga seu Steleophaga, Rhizoma Arisaematis Praeparatum, Borneol, and Camphor are used as the assistant drugs. Notoginseng and Rhizoma Zedoariae disperse stasis and stop bleeding, reduce swelling and relieve pain, and are important drugs for traumatic injuries, strengthening the effects of the monarch drug and minister drugs on relieving pain and detumescence for traumatic injuries. Stephania tetrandra and Cinnamon Twig dispel wind and dampness, activate collaterals and relieve pain, and further strengthen the therapeutic effects of the monarch drug and minister drugs on rheumatic arthralgia; using Rhizoma Zedoariae and Eupolyphaga seu Steleophaga aims to strengthen the effect of dispersing stasis and relieving pain more significantly. Menthol has strong aromaticity and is good at leading all the drugs in the formula to reach the affected area, and is used as the guiding drug.

[0027] Looking at the whole formula, when all the drugs are combined, they together form a prescription for promoting blood circulation to remove blood stasis, reducing swelling and relieving pain, and dispelling wind and dampness. It is used for traumatic sprains, rheumatic arthralgia and other symptoms.

[0028] The present invention selects appropriate drugs and refines the tincture for external use, so that the medicinal power can quickly reach the affected area, with quick results and convenient use; it can not only treat the symptoms but also the root cause; and it has few side effects. It has significant curative effects on traumatic sprains and rheumatic arthralgia. Detailed implementation methods

[0029] The following further elaborates on the present invention in combination with specific embodiments.

[0030] Embodiment

[0031] The traditional Chinese medicine composition of this embodiment - Wumianxing Chushi Ding is made from the following traditional Chinese medicine raw materials: 24.2 g of Wuweiteng, 24.2 g of Zanthoxylum nitidum, 24.2 g of Smilax riparia, 24.2 g of Ardisia crenata, 24.2 g of Notoginseng, 9.1 g of Eupolyphaga seu Steleophaga, 12.1 g of Cinnamon Twig, 12.1 g of Stephania tetrandra, 12.1 g of Rhizoma Arisaematis Praeparatum, 12.1 g of Rhizoma Zedoariae, 12.1 g of Sappanwood, 3 g of Camphor, 1.8 g of Menthol, and 4 g of Borneol.

[0032] Preparation method:

[0033] (1) For the above fourteen flavors, except for Camphor, Menthol, and Borneol, the remaining eleven flavors, namely Wuweiteng, Zanthoxylum nitidum, Smilax riparia, Ardisia crenata, Notoginseng, Eupolyphaga seu Steleophaga, Cinnamon Twig, Stephania tetrandra, Rhizoma Arisaematis Praeparatum, Rhizoma Zedoariae, and Sappanwood, are purified, cut, dried, and crushed into coarse powder;

[0034] (2) According to the percolation method under the item of fluid extract and extract (General Principles 0189, Volume IV, Chinese Pharmacopoeia 2020 Edition), using 2102 ml of ethanol with a volume concentration of 55% as the solvent, after impregnating the medicinal materials pretreated in step (1) for 48 hours, slowly percolate at a speed of 1 - 3 ml per minute, collect 530 ml of the initial percolate and store it separately; continue percolation, collect 1400 ml of the subsequent percolate, and concentrate it under reduced pressure to about 70 ml; distill the medicinal residues and collect 70 ml of the initial medicinal residue distillate;

[0035] (3) Add camphor, menthol, and borneol to the medicinal residue distillate in step (2) to dissolve them;

[0036] (4) Combine the 530 ml of the initial percolate, 70 ml of the subsequent percolate, and 70 ml of the medicinal residue distillate in step (2), mix well, add ethanol and purified water, adjust the total volume to 1000 ml, make the ethanol volume content 55 - 60%, add appropriate amounts of ethanol and purified water, let it stand, filter, fill into containers, and obtain the product.

[0037] The clinical efficacy of the traditional Chinese medicine composition - Wumianxing Chushi Tincture in this example was verified, and the results are summarized as follows:

[0038] Clinical data

[0039] A clinical study on the Wumianxing Chushi Tincture jointly carried out by the Second Affiliated Hospital of Guangxi University of Chinese Medicine, Guangxi Minzu Hospital, and the Traditional Chinese Medicine Hospital of Yulin Region, Guangxi.

[0040] There were a total of 120 cases in the treatment group and the control group. Among them, 60 cases were treated for acute contusion and sprain, with a total effective rate of 98.33%, and 60 cases were treated for arthralgia, with a total effective rate of 96.67%. There was no significant difference in the curative effects on these two diseases compared with Zheng Gu Shui produced by Guangxi Yulin Pharmaceutical Factory (P > 0.05). This product has a rapid effect on relieving pain and reducing swelling, and is safe and reliable, with no obvious toxic and side effects.

[0041] I) General information:

[0042] A total of 180 patients were observed, including 90 cases of acute contusion and sprain and 90 cases of arthralgia. The ratio of the treatment group to the control group was 2:1. The treatment group was treated with Wumianxing Chushi Tincture, and the control group was treated with Zheng Gu Shui produced by Guangxi Yulin Pharmaceutical Factory. There was no significant difference in the distribution of gender, age, etc. between the two groups of patients (P > 0.05). (See Table I) II) Treatment results

[0043] 1. The effects on clinical symptoms and signs are shown in Table II.

[0044] 1) The effects on the integral of clinical symptoms and signs of patients with acute contusion and sprain:

[0045] Both groups of drugs had good therapeutic effects on symptoms such as pain, tenderness, swelling and pain, ecchymosis, and movement disorders caused by acute contusion and sprain, and the decrease in the witness scores was significantly significant (P < 0.01 or P < 0.05). When comparing the two groups of drugs, the difference was not significant (P > 0.05).

[0046] 2) Effects on the clinical symptoms and witness scores of arthralgia diseases:

[0047] Both groups of drugs had good therapeutic effects on symptoms such as joint pain, tenderness, swelling, numbness and heaviness, and limited flexion and extension caused by arthralgia diseases. The decrease in the witness scores was significantly significant (P < 0.01 or P < 0.05). When comparing the two groups of drugs, the difference was not significant (P > 0.05).

[0048] 2. Effects on the pain relief time and disappearance time of pain and distending pain in patients with acute contusion and sprain are shown in Table Ⅲ.

[0049] 1) The pain relief start time of the treatment group was 11.71 ± 7.61 (h), and the pain relief start time of the control group was 17.82 ± 10.19 (h), and the difference was not significant (P > 0.05); the pain disappearance time of the treatment group was 3.74 ± 1.32 (d), and the pain disappearance time of the control group was 3.88 ± 1.30 (d), and the difference was not significant (P > 0.05).

[0050] 2) The swelling relief start time of the treatment group was 1.24 ± 0.83 (d), and the swelling relief start time of the control group was 1.70 ± 4.90 (d), and the difference was not significant (P > 0.05); the swelling disappearance time of the treatment group was 3.19

[0051] ± 4.51 (d), and the swelling disappearance time of the control group was 3.32 ± 1.80 (d), and the difference was not significant (P > 0.05).

[0052] 3. Comparison of the curative effects of the two groups of drugs (Ridit analysis)

[0053] 1) There were 60 cases in the treatment group for acute contusion and sprain, 27 cases were cured, 23 cases were markedly effective, 9 cases were effective, and 1 case was ineffective, and the total effective rate was 98.33%; there were 30 cases in the control group, 11 cases were cured, 9 cases were markedly effective, 9 cases were effective, and 1 case was ineffective, and the total effective rate was 96.67%. When comparing the two groups of drugs, the difference in curative effects was not significant (P > 0.05). 2) There were 60 cases in the treatment group for arthralgia diseases, 8 cases were clinically cured, 34 cases were markedly effective, 16 cases were effective, and 2 cases were ineffective,

[0054] and the total effective rate was 96.67%; there were 30 cases in the control group, 1 case was clinically cured, 13 cases were markedly effective, 14 cases were effective, and 2 cases were ineffective, and the total effective rate was 93.3%. When comparing the two groups of drugs, the difference in curative effects was not significant (P > 0.05).

[0055] There were 120 cases in the treatment group, with 35 cases cured, 57 cases markedly effective, 25 cases effective, and 3 cases ineffective, with a total effective rate of 97.5%; there were 60 cases in the control group, with 12 cases cured, 22 cases markedly effective, 23 cases effective, and 3 cases ineffective, with a total effective rate of 95%. When comparing the two groups of drugs, there was no significant difference in curative effect (P>0.05), see Table Ⅳ.

[0056] 4. Toxic and side effects

[0057] None of the patients in this group had obvious toxic and side effects during the observation period. Except for 3 cases with slight prurigo, the rest had no adverse reactions.

[0058] Table Ⅰ Composition distribution of gender, age, etc. of two groups of patients

[0059]

[0060] Table Ⅱ: Influence on the integral of clinical symptom signs (X±SD)

[0061]

[0062]

[0063] Table Ⅲ: Influence on the time when pain and swelling start to relieve and disappear (X±SD)

[0064]

[0065] Table Ⅳ: Comparison of curative effects of two groups of drugs (Ridit analysis)

[0066]

[0067] Note: There was no significant difference in curative effect between groups (P>0.05), indicating that the product of the present invention has a curative effect similar to that of the control group.

[0068] III) Conclusion

[0069] Through clinical verification, it is shown that Wumianxing Chushi Tincture has the effects of promoting blood circulation to remove blood stasis, detumescence and pain relief, expelling wind and removing dampness, and is applicable to acute contusions and sprains, rheumatic arthralgia and other diseases. For the treatment of 120 cases of acute contusions and sprains and arthralgia, the total effective rate is 97.5%. When compared with the control group (Zhenggu Shui), there is no significant difference in curative effect. It has a significant effect on various symptoms and signs of acute contusions and sprains and arthralgia.

[0070] The dosage form of this medicine is reasonable, easy to use, and has no obvious toxic and side effects. This medicine is safe and effective.

Claims

1. A traditional Chinese medicine composition for adjuvant treatment of acute contusions and strains, characterized in that, It is mainly made from the following traditional Chinese medicine raw materials: 20 - 30 g of Schisandra glabra (Champ.) Merr., 20 - 30 g of Zanthoxylum nitidum (Roxb.) DC., 20 - 30 g of Smilax riparia A. DC., 20 - 30 g of Ardisia crenata Sims, 20 - 30 g of Panax notoginseng (Burkill) F. H. Chen ex C. Hoo & Tsai, 6 - 12 g of Eupolyphaga seu Steleophaga, 10 - 15 g of Cinnamomum cassia Presl, 10 - 15 g of Stephania tetrandra S. Moore, 10 - 15 g of Rhizoma Pinelliae Praeparatum, 10 - 15 g of Curcuma zedoaria (Christm.) Rosc., 10 - 15 g of Caesalpinia sappan L., 2 - 4 g of Borneol camphor, 1.5 - 2.4 g of Menthol, 2 - 6 g of Borneol.

2. The traditional Chinese medicine composition for adjuvant treatment of acute sprains and contusions according to claim 1, wherein It is mainly made from the following traditional Chinese medicine raw materials: 22 - 28 g of Schisandra glabra (Champ.) Merr., 22 - 28 g of Zanthoxylum nitidum (Roxb.) DC., 22 - 28 g of Smilax riparia A. DC., 22 - 28 g of Ardisia crenata Sims, 22 - 28 g of Panax notoginseng (Burkill) F. H. Chen ex C. Hoo & Tsai, 7 - 11 g of Eupolyphaga seu Steleophaga, 11 - 14 g of Cinnamomum cassia Presl, 11 - 14 g of Stephania tetrandra S. Moore, 11 - 14 g of Rhizoma Pinelliae Praeparatum, 11 - 14 g of Curcuma zedoaria (Christm.) Rosc., 11 - 14 g of Caesalpinia sappan L., 2.5 - 3.5 g of Borneol camphor, 1.6 - 2.3 g of Menthol, 3 - 5 g of Borneol.

3. The traditional Chinese medicine composition for adjuvant treatment of acute contusion and sprain according to claim 1 or 2, wherein, It is mainly made from the following traditional Chinese medicine raw materials: 24 - 26 g of Schisandra glabra (Champ.) Merr., 24 - 26 g of Zanthoxylum nitidum (Roxb.) DC., 24 - 26 g of Smilax riparia A. DC., 24 - 26 g of Ardisia crenata Sims, 24 - 26 g of Panax notoginseng (Burkill) F. H. Chen ex C. Hoo & Tsai, 8 - 10 g of Eupolyphaga seu Steleophaga, 12 - 13 g of Cinnamomum cassia Presl, 12 - 13 g of Stephania tetrandra S. Moore, 12 - 13 g of Rhizoma Pinelliae Praeparatum, 12 - 13 g of Curcuma zedoaria (Christm.) Rosc., 12 - 13 g of Caesalpinia sappan L., 2.8 - 3.2 g of Borneol camphor, 1.7 - 2.1 g of Menthol, 3.5 - 4.5 g of Borneol.

4. The traditional Chinese medicine composition for adjuvant treatment of acute contusion and sprain according to claim 1 or 2, wherein, It is mainly made from the following traditional Chinese medicine raw materials: 24.2 g of Schisandra glabra (Champ.) Merr., 24.2 g of Zanthoxylum nitidum (Roxb.) DC., 24.2 g of Smilax riparia A. DC., 24.2 g of Ardisia crenata Sims, 24.2 g of Panax notoginseng (Burkill) F. H. Chen ex C. Hoo & Tsai, 9.1 g of Eupolyphaga seu Steleophaga, 12.1 g of Cinnamomum cassia Presl, 12.1 g of Stephania tetrandra S. Moore, 12.1 g of Rhizoma Pinelliae Praeparatum, 12.1 g of Curcuma zedoaria (Christm.) Rosc., 12.1 g of Caesalpinia sappan L., 3 g of Borneol camphor, 1.8 g of Menthol, 4 g of Borneol.

5. A process for preparing the traditional Chinese medicine composition for adjuvant treatment of acute contusion and sprain as described in any one of claims 1-4, characterized in that, It includes the following steps: (1) Clean, cut and dry Schisandra glabra (Champ.) Merr., Zanthoxylum nitidum (Roxb.) DC., Smilax riparia A. DC., Ardisia crenata Sims, Panax notoginseng (Burkill) F. H. Chen ex C. Hoo & Tsai, Eupolyphaga seu Steleophaga, Cinnamomum cassia Presl, Stephania tetrandra S. Moore, Rhizoma Pinelliae Praeparatum, Curcuma zedoaria (Christm.) Rosc., Caesalpinia sappan L., and then crush them into coarse powder for standby; (2) According to the percolation method under the items of liquid extract and extract, soak and percolate the medicinal materials pretreated in step (1) to obtain percolate; distill the medicinal residues and collect the initial medicinal residue distillate; (3) Add Borneol camphor, Menthol and Borneol into the medicinal residue distillate obtained in step (2) and dissolve them; (4) Combine the percolate and the medicinal residue distillate obtained in step (2), mix them evenly, add ethanol and purified water, adjust the total amount to make the volume content of ethanol 55 - 60%, let it stand, filter, fill, and then it is obtained.

6. The preparation process of the traditional Chinese medicine composition for adjuvant treatment of acute contusion and sprain according to claim 5, characterized in that, In step (2), according to the percolation method under the items of liquid extract and extract, use 2102 ml of ethanol with a volume concentration of 55% as the solvent, soak the medicinal materials pretreated in step (1) for 48 hours, and then slowly percolate at a speed of 1 - 3 ml per minute, collect 530 ml of the initial percolate and store it separately; continue percolating, collect 1400 ml of the subsequent percolate, and concentrate it under reduced pressure to about 70 ml; distill the medicinal residues and collect 70 ml of the initial medicinal residue distillate.

7. The preparation process of the traditional Chinese medicine composition for adjuvant treatment of acute contusion and sprain according to claim 5 or 6, characterized in that, In step (4), the initial percolate (530 ml), subsequent percolate (70 ml) and distillate from medicinal residues (70 ml) obtained in step (2) are combined, mixed well, ethanol and purified water are added, and the total volume is adjusted to 1000 ml to make the ethanol volume content 55-60%. It is allowed to stand, filtered, filled, and then obtained.

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