A pharmaceutical composition for treating traumatic injuries and a preparation method thereof

Abstract

The present invention relates to a pharmaceutical composition for treating traumatic injuries and its preparation method. The pharmaceutical composition comprises radix touga, radix dabogu, radix ramie, radix jigu, radix shatangmu, cassia twig, angelica sinensis, and radix dactylospermi. The preparation method comprises coarse grinding of the medicinal materials, distillation extraction, enzymatic extraction, purification, and batching. The film-coating prepared by this method is sprayed directly on the affected area, eliminating the step of releasing the active ingredients from the medicinal materials during the conventional application process. The drug takes effect more quickly, has a stronger therapeutic effect, and is easy to use and carry.

Description

Technical Field

[0001] The present invention relates to the field of medicine, and in particular to a pharmaceutical composition for treating traumatic injuries and a preparation method thereof. Background Art

[0002] Traumatic injuries, also known as acute soft tissue injuries, primarily refer to injuries to subcutaneous, non-bone tissues including muscles, ligaments, fascia, tendons, synovium, joint capsules, and peripheral nerves and blood vessels caused by blunt or sharp impact, such as sprains, abrasions, contusions, falls, and impacts, as well as forceful twisting, pulling, and compression. Acute soft tissue injuries generally do not involve fractures or dislocations. Instead, they manifest as pain and swelling at the affected area, sometimes forming wounds and ulcers, and in severe cases, functional impairment.

[0003] Currently, accelerating the repair of damaged tissue and reducing disability rates have become hot research topics in the surgical field. Western medicine treatments primarily include immobilization, bandaging, local blockades, medications, and physical therapy, all of which are not only ineffective but can also produce adverse reactions. Acute soft tissue injuries fall under the category of "muscle injuries" in Traditional Chinese Medicine (TCM) orthopedics. Acute soft tissue injuries are often caused by blood stasis, with the primary pathogenesis being blood stasis, qi stagnation, and disharmony in the meridians. Traditional Chinese Medicine (TCM) has a long history of treating acute soft tissue injuries. Through long-term practice, a comprehensive treatment system has been established that combines dynamic and static methods, prioritizes both muscles and bones, addresses both internal and external treatments, and uses medications in stages. Its superiority is becoming increasingly apparent.

[0004] Shangjin Waifu Powder is an empirical formula from Guizhou Provincial People's Hospital. It consists of 12 Chinese herbs, including Touguxiang, Dabogu, Honghema, Jiguxiang, Shatangmu, Guizhi, Danggui, and Dishazi. It is said to promote blood circulation, remove blood stasis, regulate qi and relieve pain, and cool blood and reduce swelling. Over 10 years of clinical validation have demonstrated the formula's efficacy. However, the current clinical application method for Shangjin Waifu Powder is to grind the prescribed herbs into a fine powder, then mix it with rapeseed oil to form a paste and apply it to the affected area. This results in a slow release of the active ingredients, and the large amount of rapeseed oil used makes it difficult to wash off the skin, resulting in discomfort for patients and making it extremely inconvenient to carry.

[0005] To address these technical challenges, the Guizhou Provincial People's Hospital team conducted a series of experiments to investigate the preparation method of the empirically formulated Shangjin Waifu Powder, including the amount of water added for volatile oil extraction, distillation time, amount of water added for enzymatic hydrolysis, amount of complex enzymes used, extraction time, purification process, matrix screening, and matrix ratio. Ultimately, they employed a "distillation followed by enzymatic hydrolysis" method to extract the active ingredients from the formula and then create a film-coating. This extraction method improved the dissolution of the active ingredients, resulting in a film-coating with faster onset and stronger efficacy, reaching an overall effectiveness rate of 98.0%. It is also convenient to use and carry. Summary of the Invention

[0006] The purpose of the present invention is to provide a pharmaceutical composition for treating traumatic injuries.

[0007] Another object of the present invention is to provide a method for preparing a medicinal composition for treating traumatic injuries.

[0008] The pharmaceutical composition of the present invention comprises 20-30 parts of tougaxiang, 15-20 parts of dabogu, 10-15 parts of red hemlock, 10-15 parts of jiguxiang, 10-15 parts of sandtangmu, 15-20 parts of cassia twig, 15-20 parts of angelica, 10-15 parts of ground brush, 15-20 parts of white poplar, 10-50 parts of avens root, 6-10 parts of ground peach flower and 6-10 parts of red peony root.

[0009] Preferably, the pharmaceutical composition of the present invention is composed of 20 parts of tougaxiang, 15 parts of dabogu, 10 parts of red hema, 15 parts of jiguxiang, 10 parts of sandtangmu, 15 parts of cassia twig, 15 parts of angelica, 15 parts of ground brush, 20 parts of poplar, 20 parts of water bayberry root, 6 parts of ground peach flower, and 6 parts of red peony root.

[0010] The preparation method of the invention comprises the following steps: coarse crushing of medicinal materials, distillation extraction, enzymatic extraction, purification and batching.

[0011] The coarse grinding of medicinal materials of the present invention is specifically as follows: all medicinal materials in the composition are mixed and then ground into coarse powder with a size of more than 10 mesh.

[0012] The distillation extraction of the present invention specifically comprises the following steps: adding water in an amount of 6 to 10 times the total amount of the medicinal materials, heating and distilling for 2 to 4 hours, collecting volatile oil for later use, filtering, and collecting filtrate for later use.

[0013] Preferably, the distillation extraction of the present invention is specifically as follows: adding water 8 times the total amount of the medicinal material, heating and distilling for 3 hours, collecting volatile oil for later use, filtering, and collecting the filtrate for later use.

[0014] The enzymatic extraction of the present invention is specifically as follows: adding water 6 times the total amount of the medicinal material to the medicinal residue, then adding 2.0% of complex enzyme, soaking for 24 hours at 45°C and pH 5.0, heating and boiling, and then filtering to obtain an enzymatic extraction solution.

[0015] Preferably, the complex enzyme is: cellulase: pectinase: papain = 3:1:1

[0016] The purification of the present invention is specifically as follows: combining the water decoction and the enzymatic extraction solution, concentrating to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, adding ethanol to make the alcohol content reach 70%, leaving it overnight, filtering, and concentrating the filtrate to a thick paste.

[0017] The ingredients of the present invention are specifically as follows: 60g of polyvinyl alcohol PVA-124 is dissolved in an appropriate amount of 60% ethanol, the volatile oil and thick paste are added, 20g of glycerol and 10g of azone are added, stirred evenly, and 60% ethanol is added to adjust the total amount to 1000ml to obtain a coating agent.

[0018] The portion described in the present invention may be a conventional unit in the art, such as g, kg, etc.

[0019] Beneficial effects:

[0020] 1. In the prescription of the present invention, Dabogu, Touguxiang, and Honghema promote blood circulation and dissipate blood stasis, reduce swelling, Jiguxiang and Shatangmu regulate qi and relieve pain, and Guizhi warms the meridians and dredges the collaterals. They are matched with Angelica sinensis to replenish blood, and both eliminate and replenish qi. If blood stasis is blocked, the qi flow is not smooth, and phlegm and dampness are easily gathered. Therefore, Di Shuai and Bai Yang are used to eliminate dampness and resolve phlegm. If blood stasis generates heat, then the root of Myrica chinensis, Di Taohua, and Chi Shao are added to clear away heat and dampness, detoxify and disperse stagnation, and promote blood circulation and cool blood. The whole prescription treats cold and heat, eliminates and replenishes qi, and emphasizes both the local and the overall. Each drug acts on different links in the pathogenesis and treatment, synergizing and complementing each other. The combination of these drugs has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain, cooling blood and reducing swelling, and is used for various acute soft tissue injuries. This prescription has a reasonable and precise formula, is low-priced, and the drugs are easily available. After more than 10 years of clinical practice, it has been found to be definite in efficacy, creating huge economic and social benefits.

[0021] 2. The original prescription is used in powder form, that is, the medicinal materials are crushed and then mixed with rapeseed oil for application. The active ingredients in the medicinal materials are released slowly. The present invention adopts the "distillation enzymatic hydrolysis method" to extract the active ingredients in the prescription and then make a film-forming agent which is directly sprayed on the affected area, eliminating the step of releasing the active ingredients from the medicinal materials. The drug takes effect faster and has a stronger therapeutic effect.

[0022] 2. The results of clinical efficacy tests show that the coating of the present application can enhance the therapeutic effect of acute soft tissue injuries, with a total effective rate of 98.0%, which is significantly different from the total effective rate of 86.0% in control group 1 and 92.0% in control group 2. This shows that the present invention can effectively improve the clinical symptoms of patients and has significant clinical efficacy.

[0023] 3. The original clinical method of using Shangjin Waifu Powder used a large amount of vegetable oil, which made it difficult to clean the skin, resulting in poor patient experience. The film-coating prepared by the present invention can form a conjunctiva within 5 minutes after being sprayed on the affected area without contaminating clothing. After the drug's effect ends, the film can be torn off without the need for skin cleaning. Therefore, patient compliance is higher.

[0024] 4. After the tendon injury external application powder is made into a coating agent in the present invention, it is more convenient for patients to use, carry and store compared with the original method of use. DETAILED DESCRIPTION

[0025] The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0026] Example 1

[0027] Prescription: Tougaxiang 20g, Dabogu 15g, Honghema 10g, Jiguxiang 15g, Shatangmu 10g, Guizhi 15g, Danggui 15g, Dishazi 15g, Baiyang 20g, Shuiyuegen 20g, Ditaohua 6g, Chishao 6g.

[0028] Example 2

[0029] Prescription: Tougaxiang 20g, Dabogu 15g, Honghema 10g, Jiguxiang 10g, Shatangmu 10g, Guizhi 15g, Angelica 15g, Dishuazi 10g, Baiyang 15g, Shuiyuegen 10g, Ditaohua 6g, Chishao 6g.

[0030] Example 3

[0031] Prescription: 30g of Touguxiang, 20g of Dabogu, 15g of Honghema, 15g of Jiguxiang, 15g of Shatangmu, 20g of Guizhi, 20g of Angelica, 15g of Dishuazi, 20g of Baiyang, 50g of Shuimeigen, 10g of Ditaohua, and 10g of Chishao.

[0032] Example 4

[0033] Prescription: Tougaxiang 25g, Dabogu 18g, Honghema 12g, Jiguxiang 12g, Shatangmu 12g, Guizhi 18g, Danggui 18g, Dishazi 12g, Baiyang 18g, Shuiyuegen 30g, Ditaohua 8g, Chishao 8g.

[0034] Example 5

[0035] Prescription: Tougaxiang 28g, Dabogu 16g, Honghema 13g, Jiguxiang 13g, Shatangmu 13g, Guizhi 16g, Angelica 16g, Dishuazi 13g, Baiyang 16g, Shuimeigen 40g, Ditaohua 9g, Chishao 9g.

[0036] The formula of Examples 1-5 is prepared according to any one of the preparation methods of Examples 6-12 below.

[0037] Example 6 Preparation method

[0038] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0039] (2) Distillation extraction: Add 8 times the total amount of water of the medicinal materials, heat and distill for 3 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0040] (3) Enzymatic extraction: Add 6 times the amount of water to the medicinal material, and then add 2% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 45 ° C and pH 5.0 for 24 hours, heat and boil, and filter to obtain the enzymatic extract.

[0041] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, add ethanol to make the alcohol content reach 70%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0042] (5) Ingredients: 60 g of polyvinyl alcohol PVA-124 is dissolved in an appropriate amount of 60% ethanol, and the above-mentioned volatile oil and thick paste are added. 20 g of glycerol and 10 g of azone are added, and the mixture is stirred well. 60% ethanol is added to adjust the total volume to 1000 ml to obtain a film-forming agent.

[0043] Example 7 Preparation method

[0044] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0045] (2) Distillation extraction: Add 6 times the total amount of water of the medicinal materials, heat and distill for 2 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0046] (3) Enzymatic extraction: Add 4 times the amount of water to the medicinal material, and then add 1% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 50°C and pH 5.0 for 12 hours, heat and boil, and filter to obtain the enzymatic extract.

[0047] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal materials, add ethanol to make the alcohol content reach 50%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0048] (5) Ingredients: Take 40g of polyvinyl alcohol PVA-124, add an appropriate amount of 60% ethanol to dissolve it, add the above-mentioned volatile oil and thick paste, then add 10g of glycerol and 10g of azone, stir well, and add 60% ethanol to adjust the total amount to 1000ml to obtain a coating agent.

[0049] Example 8 Preparation method

[0050] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0051] (2) Distillation extraction: Add 10 times the total amount of water to the medicinal material, heat and distill for 4 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0052] (3) Enzymatic extraction: Add 8 times the amount of water to the medicinal material, and then add 3% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 42°C and pH 5.0 for 36 hours, heat and boil, and filter to obtain the enzymatic extract.

[0053] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, add ethanol to make the alcohol content reach 90%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0054] (5) Ingredients: 80 g of polyvinyl alcohol PVA-124 is dissolved in an appropriate amount of 60% ethanol, and the above-mentioned volatile oil and thick paste are added. 30 g of glycerol and 10 g of azone are added, and the mixture is stirred well. 60% ethanol is added to adjust the total volume to 1000 ml to obtain a film-forming agent.

[0055] Example 9 Preparation method

[0056] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0057] (2) Distillation extraction: Add 7 times the total amount of water of the medicinal materials, heat and distill for 3 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0058] (3) Enzymatic extraction: Add 5 times the amount of water to the medicinal material, and then add 2% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 45°C and pH 5.0 for 18 hours, heat and boil, and filter to obtain the enzymatic extract.

[0059] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, add ethanol to make the alcohol content reach 60%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0060] (5) Ingredients: 60 g of polyvinyl alcohol PVA-124 is dissolved in an appropriate amount of 60% ethanol, and the above-mentioned volatile oil and thick paste are added. Then, 10 g of glycerol and 10 g of azone are added, and the mixture is stirred well. The total amount is adjusted to 1000 ml by adding 60% ethanol to obtain a film-forming agent.

[0061] Example 10 Preparation method

[0062] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0063] (2) Distillation extraction: Add 7 times the total amount of water of the medicinal materials, heat and distill for 3 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0064] (3) Enzymatic extraction: Add 7 times the amount of water to the medicinal material, and then add 2% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 50°C and pH 5.0 for 28 hours, heat and boil, and filter to obtain the enzymatic extract.

[0065] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, add ethanol to make the alcohol content reach 70%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0066] (5) Ingredients: 60 g of polyvinyl alcohol PVA-124 is dissolved in an appropriate amount of 60% ethanol, and the above-mentioned volatile oil and thick paste are added. 20 g of glycerol and 10 g of azone are added, and the mixture is stirred well. 60% ethanol is added to adjust the total volume to 1000 ml to obtain a film-forming agent.

[0067] Example 11 Preparation method

[0068] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0069] (2) Distillation extraction: Add 6 times the total amount of water of the medicinal materials, heat and distill for 3 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0070] (3) Enzymatic extraction: Add 8 times the amount of water to the medicinal material, and then add 2% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 45°C and pH 5.0 for 32 hours, heat and boil, and filter to obtain the enzymatic extract.

[0071] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, add ethanol to make the alcohol content reach 60%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0072] (5) Ingredients: Take 40g of polyvinyl alcohol PVA-124, add an appropriate amount of 60% ethanol to dissolve it, add the above-mentioned volatile oil and thick paste, then add 30g of glycerol and 10g of azone, stir well, and add 60% ethanol to adjust the total amount to 1000ml to obtain a coating agent.

[0073] Example 12 Preparation method

[0074] (1) Coarse grinding of medicinal materials: Mix the Chinese medicinal materials and grind them into coarse powder with a mesh size of 10.

[0075] (2) Distillation extraction: Add 4 times the total amount of water of the medicinal materials, heat and distill for 2 hours, collect the volatile oil for later use, filter, and collect the filtrate for later use.

[0076] (3) Enzymatic extraction: Add 8 times the amount of water to the medicinal material, and then add 2% complex enzyme (cellulase: pectinase: papain = 3:1:1). Extract at 45°C and pH 5.0 for 12 hours, heat and boil, and filter to obtain the enzymatic extract.

[0077] (4) Purification: Combine the decoction and the enzymatic extract, concentrate to a clear paste with a ratio of 1:1 to the amount of the raw medicinal materials, add ethanol to make the alcohol content reach 80%, let it stand overnight, filter, and concentrate the filtrate to a thick paste.

[0078] (5) Ingredients: Take 50g of polyvinyl alcohol PVA-124, add an appropriate amount of 60% ethanol to dissolve it, add the above-mentioned volatile oil and thick paste, then add 20g of glycerol and 10g of azone, stir well, and add 60% ethanol to adjust the total amount to 1000ml to obtain a coating agent.

[0079] In order to further verify the feasibility of the present invention, the inventors conducted a series of experiments, as follows:

[0080] 1. Prescription composition and compatibility

[0081] 1.1 Prescription Medications

[0082] Touguxiang is the dried whole plant of Gaultheria leucocarpa Bl. var. crenulata (Kurz) TZHsu, a plant in the Ericaceae family. It has a pungent flavor and a neutral nature. It enters the lung and liver meridians. It has the effects of promoting blood circulation, removing blood stasis, and dispelling wind and dampness. It is used to treat swelling and pain caused by falls, as well as rheumatic pain.

[0083] Justicia ventricosa Wall.ex Hooker is the dried aerial part of the Acanthaceae family. It has a bitter and pungent flavor and a neutral nature. It enters the spleen and liver meridians. It has the effects of promoting blood circulation, dispersing blood stasis, dispelling wind and dampness, and strengthening tendons and bones. It is used to treat injuries from falls, fractures, rheumatoid arthritis, and swelling from trauma.

[0084] Red Hemp is the dried whole herb of Laportea bulbifera (Sieb et Zucc) Wedd, a plant of the Urticaceae family. It has a pungent flavor and warm properties. It enters the liver and kidney meridians. It dispels wind and dampness, and promotes blood circulation and removes blood stasis. It is used for rheumatic numbness, injuries from falls, and fractures.

[0085] Croton crassifolius Geisel is the dried root of Croton crassifolius Geisel, a plant of the Euphorbiaceae family. It has a pungent, bitter flavor and a warm nature. It enters the liver, stomach, and large intestine meridians. It promotes qi circulation, relieves pain, and dispels wind and dampness. It is used for rheumatic pain, lower back pain, leg pain, and sprains.

[0086] Acronychia pedunculata (L.) Miq. (Rutaceae) is a plant species that originates from the Rutaceae family. It has a pungent and bitter flavor and a neutral nature. It enters the liver, stomach, and lung meridians. It promotes qi circulation, relieves pain, resolves phlegm, and relieves cough, and activates blood circulation and removes blood stasis. It is used for rheumatic low back and leg pain, pain from falls and bruises, and bronchitis.

[0087] Cinnamon twigs are the dried young branches of Cinnamomum cassia (Cinnamomum cassia Presl), a plant of the Lauraceae family. They are pungent, sweet, and warm in nature. They enter the heart, lung, and bladder meridians. They have the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, promoting yang and transforming qi, and balancing and descending qi. They are used to treat colds, cold pain in the abdomen due to wind and cold in the blood, amenorrhea, joint pain, phlegm and fluid retention, edema, palpitations, and thrush.

[0088] Angelica sinensis (Danggui) is the dried root of Angelica sinensis (Oliv.) Diels, a plant in the Apiaceae family. It has a sweet and pungent flavor and a warm nature. It enters the liver, heart, and spleen meridians. It nourishes and invigorates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is used to treat sallow complexion caused by blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain caused by cold and deficiency, rheumatic pain, injuries from falls, carbuncles, ulcers, and constipation caused by dry intestines.

[0089] Ground brush is the dried whole herb of Lycopodium complanatum L., a plant of the Lycopodium family. It has a pungent and bitter taste and a warm nature. It enters the liver, spleen, and kidney meridians. It has the effects of dispelling wind and dampness, relaxing tendons and activating collaterals, and promoting urination and relieving stranguria. It is used for rheumatic pain, numbness of the limbs, pain in the tendons and bones, and injuries from falls.

[0090] Poplar is the dried branches of Populus davidiana Dode (Salixaceae). It has a bitter taste and cold properties. It enters the lung and large intestine meridians. It has the effects of dispelling wind and activating blood circulation, clearing heat and detoxifying, and removing phlegm. It is used to treat pain caused by bruises, blood stasis, rheumatism, and coughs caused by lung heat.

[0091] Adenium root is the dried root and rhizome of Adinia rubella Hance, a plant of the Rubiaceae family. It has a bitter and astringent taste and a cooling nature. It enters the lung, liver, and large intestine meridians. It clears heat and dampness, dissipates blood stasis, and relieves pain. It is used to treat pain caused by injuries, liver and gallbladder dampness, and fever caused by colds.

[0092] Ubena lobata (ground peach flower) is the dried whole herb of the Malvaceae plant Ubena lobata L. It has a sweet and pungent flavor and a cooling nature. It enters the lung and spleen meridians. It has the effects of clearing heat and detoxifying, promoting blood circulation and reducing swelling, and dispelling wind and dampness. It is used to treat swelling and pain caused by wounds, rheumatic pain, and snake bites.

[0093] Red peony root is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch, both plants of the Ranunculaceae family. It has a bitter taste and slightly cold properties. It enters the Liver meridian. It has the properties of clearing heat, cooling blood, dispersing blood stasis, and relieving pain. It is used to treat heat invading the blood, fever-induced rashes, hematemesis and epistaxis, red and swollen eyes, liver depression and flank pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, and carbuncles and ulcers.

[0094] 1.2 Formula

[0095] 20g of Touguxiang, 15g of Dabogu, 10g of Honghema, 15g of Jiguxiang, 10g of Shatangmu, 15g of Guizhi, 15g of Angelica, 15g of Dishuazi, 20g of Baiyang, 20g of Shuimeigen, 6g of Ditaohua, and 6g of Chishao.

[0096] 1.3 Compatibility

[0097] In this prescription, Dabogu, Tougushang, and Honghema promote blood circulation and dissolve blood stasis, reduce swelling, Jiguxiang and Shatangmu regulate qi and relieve pain, and Guizhi warms the meridians and dredges the collaterals. Combined with Angelica sinensis to replenish blood, this formula combines both dissipation and tonification. Stagnant blood leads to poor qi flow and the accumulation of phlegm and dampness, so Dishuazi and Baiyang are used to eliminate dampness and resolve phlegm. Stagnation leads to heat, so the addition of Amaranth root, Ditaohua, and Chishao clears heat and dampness, detoxifies, and resolves stagnation, promoting blood circulation and cooling. The entire formula combines cooling and heat, dissipating and tonifying, and emphasizes both local and overall health. Each drug acts on different aspects of the pathogenesis and treatment, synergizing and complementing each other. The combined use of these drugs has the effects of promoting blood circulation, removing stasis, regulating qi and relieving pain, cooling blood and reducing swelling, and is indicated for various acute soft tissue injuries.

[0098] 2 Preparation method research and test

[0099] The prescription of the present invention consists of 12 herbs, including radix tougaxiang, radix dabogu, radix hemp, radix jiguxiang, radix cinnamon, radix angelicae sinensis, radix scutellariae, white poplar, root of alfalfa, root of ground peach blossom, and red peony root. Among them, the herbs, including radix tougaxiang, radix dabogu, radix hemp, radix jiguxiang, radix cinnamon, and radix angelicae sinensis, all contain volatile oil, and the volatile oil is a key substance for the prescription to exert the effects of promoting blood circulation and dispersing blood stasis, so it is necessary to adopt a suitable method to extract the volatile oil. In addition, according to reference to data, the alkaloid components in the prescription are also the main effective components of the prescription, and they also need to be extracted and purified by a suitable method.

[0100] 2.1 Investigation of volatile oil extraction process

[0101] The extraction methods of volatile oils include organic solvent extraction, steam distillation and supercritical extraction. Relatively speaking, steam distillation is a simple, easy-to-operate and low-cost method. Therefore, this study decided to use this method as the extraction method for the volatile oil in this prescription, and optimized the optimal process parameters through experiments.

[0102] 2.1.1 Investigation of water addition amount

[0103] Three portions of the medicinal material were weighed according to the formula ratio in "1.2." After coarsely pulverizing (passing through a 10-mesh sieve), 6, 8, and 10 portions of water were added, respectively. The mixture was distilled for 3 hours. The volatile oil was collected, the extract was filtered, and the filtrate was concentrated and diluted to 500 ml. The alkaloid content was determined. The results are shown in Table 1.

[0104] Table 1 Results of investigation on water addition amount for volatile oil extraction

[0105]

[0106] The experimental results show that the amount of water added has little effect on the extraction effect of volatile oil, but the alkaloid extraction amount when adding 6 times water is significantly lower than that when adding 8 times and 10 times water, while the alkaloid content when adding 8 times and 10 times water is not much different. Taking all factors into consideration, adding 8 times water can be selected as the optimal parameter.

[0107] 2.1.2 Investigation of distillation time

[0108] Three portions of the medicinal material were weighed according to the formula ratio in "1.2." Coarsely pulverize (pass through a 10-mesh sieve), then add 8 times the amount of water. Distill for 2, 3, and 4 hours, respectively. The volatile oil was collected, the extract was filtered, and the filtrate was concentrated and diluted to 500 ml. The alkaloid content was determined. The results are shown in Table 2.

[0109] Table 2 Results of investigation on volatile oil extraction and distillation time

[0110]

[0111] The experimental results show that the distillation time has a great influence on the extraction of volatile oil and alkaloids. The volatile oil and alkaloid extraction amount after 2 hours of distillation is significantly lower than that after 3 and 4 hours of distillation, while the volatile oil and alkaloid content after 3 and 4 hours of distillation is not much different. Therefore, 3 hours of distillation can be selected as the optimal parameter.

[0112] 2.2 Investigation of secondary extraction process

[0113] 2.2.1 Selection of extraction method

[0114] After distillation, the volatile oils of the prescribed Chinese medicinal materials are completely extracted, but whether the alkaloids are completely extracted requires further investigation. This study conducted a secondary extraction on the medicinal residue after the volatile oil was extracted, examining both aqueous extraction and enzymatic extraction. The specific operation methods are as follows:

[0115] According to the formula ratio under "1.2", a total of 3 parts of medicinal materials were weighed, coarsely crushed (passed through a 10-mesh sieve), and then 8 parts of water were added. The mixture was distilled for 3 hours, and the volatile oil was collected. The extract was filtered and the filtrate was set aside. 6 parts of water were added to the residue. The first part was decocted for 1 hour and filtered. The two filtrates were combined, concentrated, and the volume was adjusted to 500 ml. 2.0% cellulase was added to the second part, and the mixture was extracted at 45°C and pH 5.0 for 24 hours. The mixture was boiled and filtered. The two filtrates were combined, concentrated, and the volume was adjusted to 500 ml. 2.0% complex enzyme (cellulase: pectinase: papain = 3:1:1) was added to the third part, and the mixture was extracted at 45°C and pH 5.0 for 24 hours. The mixture was boiled and filtered. The two filtrates were combined, concentrated, and the volume was adjusted to 500 ml. The alkaloid content was determined. The results are shown in Table 3.

[0116] Table 3 Results of secondary extraction method

[0117]

[0118] The test results show that the alkaloid content in the distillation enzymatic hydrolysis method (complex enzyme) extract is significantly higher than that in the distilled water extraction method. Therefore, the distillation enzymatic hydrolysis method (complex enzyme) is selected as the secondary extraction method for this prescription.

[0119] 2.2.2 Investigation of water addition for enzymatic hydrolysis

[0120] According to the formula ratio under "1.2", 3 parts of medicinal materials were weighed and coarsely ground (passed through a 10-mesh sieve), followed by addition of 8 parts water and distillation for 3 hours. The volatile oil was collected and the extract was filtered. The filtrate was reserved. The medicinal residue was added with 4 parts, 6 parts, and 8 parts water, respectively, and then 2.0% complex enzyme (cellulase:pectinase:papain = 3:1:1) was added. The mixture was extracted at 45°C and pH 5.0 for 24 hours. The mixture was boiled and filtered. The two filtrates were combined, concentrated, and the volume was made up to 500 ml. The alkaloid content was determined. The results are shown in Table 4.

[0121] Table 4 Results of water addition for enzymatic extraction

[0122]

[0123] The test results show that the amount of water added has little effect on the enzymatic extraction effect. Taking all factors into consideration, adding 6 times the amount of water is the best choice.

[0124] 2.2.3 Investigation of the dosage of complex enzymes

[0125] According to the formula ratio under "1.2", 3 parts of medicinal materials were weighed and coarsely ground (passed through a 10-mesh sieve), followed by addition of 8 parts water and distillation for 3 hours. The volatile oil was collected, and the extract was filtered and the filtrate was reserved. The medicinal residue was added with 6 parts water, and then 1.0%, 2.0%, and 3.0% of a complex enzyme (cellulase:pectinase:papain = 3:1:1) were added, respectively. The mixture was extracted at 45°C and pH 5.0 for 24 hours. The mixture was boiled and filtered. The two filtrates were combined, concentrated, and the volume was made up to 500 ml. The alkaloid content was determined. The results are shown in Table 5.

[0126] Table 5 Enzyme dosage investigation results

[0127]

[0128] The test results show that the effective ingredients in the extracts with enzyme dosage of 2.0% and 3.0% are not much different, but both are significantly higher than that with enzyme dosage of 1.0%. Therefore, the enzyme dosage of 2.0% can be selected as the optimal process parameter.

[0129] 2.2.4 Investigation of extraction time

[0130] According to the formula ratio under "1.2", 3 parts of medicinal materials were weighed and coarsely ground (passed through a 10-mesh sieve), followed by addition of 8 parts water and distillation for 3 hours. The volatile oil was collected, and the extract was filtered. The filtrate was reserved. The medicinal residue was added with 6 parts water, and then 2.0% complex enzyme (cellulase:pectinase:papain = 3:1:1) was added. The extract was extracted at 45°C and pH 5.0 for 12 hours, 24 hours, and 36 hours, respectively. The extract was boiled and filtered. The two filtrates were combined, concentrated, and the volume was made up to 500 ml. The alkaloid content was determined. The results are shown in Table 6.

[0131] Table 6 Extraction time investigation results

[0132]

[0133] The test results show that the effective ingredients in the extracts extracted for 24 hours and 36 hours are not much different, but both are higher than those extracted for 12 hours. Therefore, 24 hours of extraction can be selected as the optimal process parameter.

[0134] 2.3 Purification process investigation

[0135] This prescription has a lot of medicinal flavors. After distillation and enzymatic extraction, although the volatile oil and alkaloid components were extracted to the maximum extent, the amount of paste was large, so it was necessary to purify the extract. This study selected the classic alcohol precipitation method in traditional Chinese medicine preparation technology for purification and studied the key parameter affecting the alcohol precipitation effect, the alcohol precipitation concentration. The method is as follows:

[0136] According to the formula ratio under "1.2", a total of 5 parts of medicinal materials were weighed, coarsely ground (passed through a 10-mesh sieve), and then 8 parts water were added. The mixture was distilled for 3 hours, and the volatile oil was collected. The extract was filtered and the filtrate was reserved. The medicinal residue was added with 6 parts water, and then 2.0% complex enzyme (cellulase:pectinase:papain = 3:1:1) was added. The extracts were extracted at 45°C and pH 5.0 for 24 hours. The extracts were boiled and filtered. The two filtrates were combined and concentrated to an extract with a 1:1 ratio of the medicinal materials. The alkaloid content and solid content were determined. 95% ethanol was added to adjust the alcohol content to 50%, 60%, 70%, 80%, and 90%, respectively. The extract was allowed to stand overnight and filtered. The filtrate was concentrated and made up to 500 ml. The alkaloid content and solid content were determined. The alkaloid retention rate and impurity removal rate were calculated. The results are shown in Table 7.

[0137] Table 7 Alcohol precipitation concentration investigation results

[0138]

[0139]

[0140] The test results show that when the ethanol concentration is below 70%, the alkaloid retention rate is higher, reaching more than 90%, and the impurity removal effect can reach about 40%. The alcohol precipitation effect is ideal, so 70% can be selected as the optimal alcohol precipitation concentration.

[0141] 2.4 Preparation molding process research

[0142] 2.4.1 Coating agent matrix screening

[0143] The coating matrix usually consists of a film-forming material, a plasticizer and a transdermal absorption enhancer.

[0144] Film-forming materials are all polymer materials, and commonly used ones include polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), carbomer, and acrylic resin. Studies have shown that, in terms of film-forming properties (such as adhesion, flexibility, film-forming time, etc.), PVA is the best film-forming material. Among them, PVA-124 is a water-soluble polymer compound that is easily soluble in water. It has stable properties, good hygroscopicity, strong flexibility, and the drug can be evenly dispersed in the matrix. Therefore, the present invention selects PVA-124 as the film-forming material.

[0145] Commonly used plasticizers include propylene glycol, triacetin, glycerol, etc. Among them, glycerol as a plasticizer can not only increase the softness and tensile strength of the coating agent, but also has a certain effect of promoting transdermal absorption and moisturizing. Therefore, the present invention selects glycerol as the plasticizer of this preparation.

[0146] Commonly used transdermal absorption enhancer has borneol, azone, menthol etc. in film-coating.Add transdermal absorption enhancer in preparation, can play the effect that promotes other medicines transdermal absorption, enhances therapeutic effect.Wherein azone is better to the osmotic enhancement of hydrophilic compound, and it has the effect of high efficiency and low toxicity and is widely used, therefore, the present invention selects azone as the transdermal absorption enhancer of this preparation.

[0147] 2.4.2 Matrix ratio study

[0148] PVA-124 was weighed according to Table 8 and placed in a beaker. Six times the amount of 60% ethanol was added and soaked for 24 hours to fully swell. The mixture was heated in a water bath (85°C) and stirred continuously to fully dissolve into a gel. The mixture was cooled and the extract (1 / 10 times the prescribed amount) was added while stirring. Glycerol and azone were then added according to Table 8, stirred to disperse evenly, and 60% ethanol was added to adjust the volume to 100 mL. This gave film coatings with different matrix ratios. The properties of the film coatings with different matrix ratios were determined by the following method. The test results are shown in Table 9.

[0149] 2.4.2.1 Viscosity

[0150] Place the prepared coating agent in a constant temperature environment of 25℃, select a suitable rotor and speed, and use NDJ-5S viscometer to measure the viscosity of the film-forming solution, keep the torque within the range of 10% to 90%, and record the measured viscosity value.

[0151] 2.4.2.2 Film formation time

[0152] Take 0.2 mL of the prepared coating solution and evenly apply it on a 4 cm × 4 cm area on the back of the hand. Observe every 30 seconds. The evaluation index is that 95% of the solution is not sticky and can form a thin film. Record the film-forming time.

[0153] 2.4.2.3 Appearance

[0154] The color of the coating solution, drug dispersion and quality after film formation are used as indicators for evaluation and are divided into four levels: good, better, average and poor.

[0155] 2.4.2.4 Tensile strength and load-bearing capacity

[0156] Take 2mL of the obtained coating solution and evenly apply it on a 5cm×10cm glass plate. Place it in an oven and heat it to form a film. Cut the obtained film into long strips with a width of 1cm and a length of 10cm for later use. Take a glass rod and fix it on an iron stand. Hang the cut long strips of film on the glass rod in a folded manner, with the overlapping part at the top being 1cm and fixed by hand. Hang a hook with a bag that can hold weights at the bottom. Start adding weights from 100g and increase 50g every 2 minutes. Place a ruler next to it to measure the length. When the film breaks, record the length before the break. Its length minus the original length (4cm) is the tensile strength, and the weight of the weight is the load-bearing capacity.

[0157] Table 8 Matrix ratio table

[0158]

[0159]

[0160] Table 9 Matrix ratio test results

[0161]

[0162] The results in Table 9 show that the greater the amount of PVA-124 used, the stronger the viscosity of the preparation. When the amount of PVA-124 in each formulation reached 60g, the solution viscosity reached approximately 600 MPa·s. Although Test 8 showed relatively good film-forming time, appearance, strength, and load-bearing data, the high solution viscosity made clinical use inconvenient and not conducive to transdermal drug absorption. Taking all factors into consideration, the parameters of Test 5 were selected as the optimal matrix ratio, that is, 60g PVA-124, 20g glycerol, and 10g azone were added to each formulation.

[0163] 3 Clinical efficacy verification

[0164] In order to verify the efficacy of the preparation of the present invention, we further carried out clinical efficacy verification experiments.

[0165] 3.1 Materials and Methods

[0166] 3.1.1 Clinical data

[0167] A total of 150 patients with soft tissue injuries admitted to Guizhou Provincial People's Hospital between January 2022 and December 2023 were selected as research subjects. With informed consent, they were divided equally into a control group (Shangkeling spray, produced by Guizhou Hengba Pharmaceutical Co., Ltd.), a control group (Shangjin Waifu powder), and an observation group (film-coated preparation prepared by the present invention), each with 50 patients. Control group 1 consisted of 26 males and 24 females; control group 2 consisted of 25 males and 25 females, aged 19 to 58 years (mean age 37.51 years). The observation group consisted of 27 males and 23 females, aged 20 to 59 years (mean age 39.25 years).

[0168] 3.1.2 Inclusion and Exclusion Criteria

[0169] Inclusion criteria: ① Soft tissue injury confirmed by detailed examination; ② After consultation with the family, the patient agreed to the study and accepted treatment. Exclusion criteria: ① Allergy to the relevant medication; ② Withdrawal from the study midway or incomplete or lost data. No statistically significant differences in general data were found among the three groups (P > 0.05).

[0170] 3.1.3 Treatment methods

[0171] Control group 1 and control group 2 were given conventional treatment. Before treatment, 75% iodine tincture was prepared to disinfect the soft tissue injury site. Control group 1 was treated with Shangkeling spray, and control group 2 was treated with Shangjin Waifu powder, which was applied to the disinfected soft tissue injury site three times a day.

[0172] The observation group was disinfected in the same manner as the control group, with the coating of the present invention sprayed onto the disinfected soft tissue injury site 3 times a day. The treatment results of the three groups were observed after 5 consecutive days of use.

[0173] 3.1.4 Observation indicators and efficacy assessment

[0174] The scores and treatment effects of the three groups were observed before and after treatment. The scores included functional impairment and pain scores. Functional impairment primarily assessed functional motor status, with a total score of 10 points. The score was positively correlated with the degree of functional impairment; higher scores indicated more severe functional impairment. The pain score primarily assessed pain status, using a visual analog scale with a total score of 10 points. The score was positively correlated with the degree of pain; higher scores indicated more severe pain. Clinical efficacy evaluation criteria were as follows: ① Significantly effective: no functional impairment, no pain; ② Effective: minimal functional impairment, mild pain; ③ Ineffective: severe functional impairment, severe and unbearable pain.

[0175] Total effective rate = (markedly effective + effective) / total number of cases × 100%.

[0176] 3.2 Results

[0177] 3.2.1 Comparison of functional impairment and pain scores among the three groups before and after treatment

[0178] There was no statistically significant difference in the functional impairment and pain scores before treatment between the observation group, control group 1, and control group 2 (P>0.05), but there was a statistically significant difference between the three groups after treatment and before treatment (P<0.05). See Table 10.

[0179] Table 10 Comparison of functional impairment and pain scores among the three groups before and after treatment

[0180]

[0181] Note: Compared with the control group 1 after treatment *P<0.05

[0182] The test results show that after the tendon injury external application powder is prepared into a coating agent, the therapeutic effect is obviously better than that of the original use method.

[0183] 3.2.2 Improvement of clinical symptoms

[0184] There were statistically significant differences in treatment effects among the observation group, control group 1, and control group 2 (P < 0.05), see Table 11.

[0185] Table 11 Comparison of clinical efficacy among three groups of patients Group Number of cases Significantly effective Effective Ineffective Total effective rate (%)

[0186]

[0187] Note: *P<0.05 compared with control group 1;

[0188] Although the present invention has been described in detail above using general explanations, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made on the basis of the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention are within the scope of protection claimed by the present invention.

Claims

1. A pharmaceutical composition for treating traumatic injuries, characterized in that: The pharmaceutical composition comprises 20-30 parts of radix tougacensis, 15-20 parts of da bogu, 10-15 parts of red hemlock, 10-15 parts of jiguxiang, 10-15 parts of sandtangmu, 15-20 parts of cassia twig, 15-20 parts of angelica, 10-15 parts of ground brush, 15-20 parts of white poplar, 10-50 parts of avens root, 6-10 parts of ground peach flower and 6-10 parts of red peony root.

2. The pharmaceutical composition according to claim 1, characterized in that The medicine composition consists of 20 parts of radix polygoni multiflori, 15 parts of da bogu, 10 parts of red hemlock, 15 parts of radix jiguxiang, 10 parts of sandtangmu, 15 parts of cassia twig, 15 parts of angelica, 15 parts of ground brush, 20 parts of white poplar, 20 parts of root of alfalfa, 6 parts of ground peach flower and 6 parts of red peony root.

3. The method for preparing the pharmaceutical composition according to any one of claims 1 to 2, wherein: The preparation method comprises the following steps: coarse crushing of medicinal materials, distillation extraction, enzymatic extraction, purification and batching.

4. The preparation method according to claim 3, characterized in that The coarse grinding of the medicinal materials is specifically as follows: all the medicinal materials in the composition are mixed and then ground into coarse powder exceeding 10 mesh.

5. The preparation method according to claim 3, characterized in that The distillation extraction specifically comprises the following steps: adding 6-10 times the total amount of water of the medicinal materials, heating and distilling for 2-4 hours, collecting volatile oil for later use, filtering, and collecting the filtrate for later use.

6. The preparation method according to claim 5, characterized in that The distillation extraction is specifically as follows: adding water 8 times the total amount of the medicinal materials, heating and distilling for 3 hours, collecting volatile oil for later use, filtering, and collecting the filtrate for later use.

7. The preparation method according to claim 3, characterized in that The enzymatic extraction is specifically as follows: adding water 6 times the total amount of the medicinal material to the medicinal residue, then adding complex enzyme, extracting at 45° C. and pH 5.0 for 24 hours, heating and boiling, and then filtering to obtain the enzymatic extraction solution.

8. The preparation method according to claim 7, characterized in that The complex enzyme is cellulase: pectinase: papain = 3:1:

1.

9. The preparation method according to claim 3, characterized in that The purification is specifically as follows: combining the water decoction and the enzymatic extract, concentrating to a clear paste with a ratio of 1:1 to the amount of the raw medicinal material, adding ethanol to make the alcohol content reach 70%, leaving it overnight, filtering, and concentrating the filtrate to a thick paste.

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