Traditional Chinese medicine composition for treating infantile traumatic swelling and pain and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating infantile traumatic swelling and pain. The traditional Chinese medicine composition comprises the following raw material medicines: radix rehmanniae recen, radix paeoniae rubra, angelica sinensis, ligusticum wallichii, herba lycopi, pericarpium citri reticulatae viride, poria with hostwood, liquorice, Chinese starjasmine stem, fried malt and fried endothelium corneum gigeriae galli. The invention also provides a traditional Chinese medicine compound preparation and application thereof in preparation of a medicine for treating infantile traumatic swelling and pain. The composition disclosed by the invention has the effects of promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, relieving swelling and pain and promoting swelling fading, is high in effective rate and capable of accelerating the process of rehabilitation treatment or subsequent operative treatment, and has relatively high clinical value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating swelling and pain after trauma in children and its application. Background Technology

[0002] Swelling and pain in children's skin often occur after trauma, and the vast majority of cases are in children under 14 years old. Because children's limb muscles are not fully developed, they are prone to accidental falls, impacts, sprains, and even fractures, resulting in swelling and pain at the injured site. A small number of patients may also experience fractures, soft tissue contusions, and other problems, which fall under the category of "muscle and bone diseases" in traditional Chinese medicine.

[0003] Analysis of the pathogenesis of swelling and pain in children: The spleen governs the tendons and the kidneys govern the bones. The tendons and bones are located in the skin. Therefore, after an external injury, the tendons and veins in the affected area become obstructed, and the flow of qi and blood is blocked. This leads to qi stagnation and blood stasis, and blood coagulation, resulting in swelling and pain. If the disease persists and penetrates deeper, the spleen and kidneys become deficient, which can cause cold extremities and difficulty in movement, which is known as arthralgia.

[0004] Treatment of swelling and pain in children: In the early stages of the disease, it is a syndrome of qi stagnation and blood stasis. Clinically, most children's swelling is treated with acupoint application, elevation of the affected limb, and acupuncture and other rehabilitation techniques. Although these methods are simple and clear, children are difficult to cooperate with. If the child cries, the rehabilitation treatment may not be effective and may affect the recovery. For children with fractures who need surgery, the swelling at the affected area may affect the time of the operation. If the swelling takes too long to subside, it may affect the postoperative recovery and even lead to malunion.

[0005] Therefore, it is necessary to develop a traditional Chinese medicine for various swellings and pains after childhood injuries, which can be taken internally and applied externally to accelerate the reduction of swelling and alleviate pain. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the present invention provides a traditional Chinese medicine composition for treating swelling and pain after trauma in children, which solves the problems of poor treatment effect and poor patient compliance in the current treatment of swelling and pain in children.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for treating swelling and pain from childhood injuries, comprising the following raw materials: Rehmannia glutinosa, Paeonia lactiflora, Angelica sinensis, Ligusticum chuanxiong, Lycopus lucidus, Citrus reticulata peel, Poria cocos, Glycyrrhiza uralensis, Trachelospermum jasminoides, stir-fried malt, stir-fried chicken gizzard lining.

[0008] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-10 parts of Rehmannia glutinosa, 5-10 parts of Paeonia lactiflora, 5-10 parts of Angelica sinensis, 5-10 parts of Ligusticum chuanxiong, 5-10 parts of Lycopus lucidus, 5-10 parts of Citrus reticulata peel, 5-10 parts of Poria cocos, 1-5 parts of Glycyrrhiza uralensis, 8-15 parts of Trachelospermum jasminoides, 8-15 parts of stir-fried malt, and 8-15 parts of stir-fried chicken gizzard lining.

[0009] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: The composition by weight is as follows: 6 parts Rehmannia glutinosa, 6 parts Paeonia lactiflora, 6 parts Angelica sinensis, 6 parts Ligusticum chuanxiong, 6 parts Lycopus lucidus, 6 parts Citrus reticulata peel, 6 parts Poria cocos, 3 parts Glycyrrhiza uralensis, 10 parts Trachelospermum jasminoides, 10 parts stir-fried malt, and 10 parts stir-fried chicken gizzard lining.

[0010] Swelling and pain after childhood trauma is the most common and prominent group of symptoms of "childhood trauma". It specifically refers to the symptoms such as swelling, pain, bruising, tenderness, and limited movement that occur in the local area after a child is subjected to external force (fall, impact, compression, traction, twisting, etc.).

[0011] The present invention also provides a traditional Chinese medicine compound preparation for treating pediatric traumatic swelling and pain by preparing the traditional Chinese medicine composition for treating pediatric traumatic swelling and pain.

[0012] The dosage forms of the traditional Chinese medicine compound preparations include tablets, capsules, granules, oral liquids, drop pills, micro-pills, decoctions, or mixtures. Traditional Chinese medicine compound preparations can be prepared by adding human-acceptable pharmaceutical excipients to the traditional Chinese medicine composition and following conventional pharmaceutical processes.

[0013] As a further preferred technical solution of the present invention, the present invention also provides the application of the traditional Chinese medicine composition or traditional Chinese medicine compound preparation in the preparation of drugs for treating pediatric traumatic swelling and pain.

[0014] The pharmacological analysis of each raw material in the traditional Chinese medicine composition of the present invention is as follows: Rehmannia glutinosa: sweet in taste, cold in nature, enters the heart, liver, and kidney meridians; clears heat and detoxifies, cools blood and nourishes yin; Red peony root: bitter in taste, slightly cold in nature, enters the liver meridian; clears heat and cools the blood, softens hardness and dissipates nodules; Angelica sinensis: sweet and pungent in taste, warm in nature, enters the liver, heart, and spleen meridians; nourishes blood, promotes blood circulation, regulates menstruation, and relieves pain; Chuanxiong: It is pungent and warm in nature, and enters the liver, gallbladder and pericardium meridians; it invigorates blood and promotes qi circulation, dispels wind and relieves pain; Eupatorium fortunei: bitter and pungent in taste, slightly warm in nature, enters the liver and spleen meridians; it breaks up blood stasis, promotes qi circulation, reduces swelling and relieves pain. Stir-fried green tangerine peel: bitter and pungent in taste, warm in nature, and enters the liver, gallbladder, and stomach meridians; it regulates qi and eliminates dampness, promotes qi circulation and relieves pain; Poria cocos: sweet and bland in taste, neutral in nature; calms the mind and soothes the nerves; Licorice: Sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians; harmonizes the effects of other herbs; Trachelospermum jasminoides: Bitter and cool in nature, it enters the liver and kidney meridians; it invigorates blood circulation, unblocks collaterals, disperses nodules and reduces swelling; Roasted malt: neutral in nature, sweet in taste, enters the spleen and stomach meridians; aids digestion and harmonizes the stomach; Stir-fried chicken gizzard: sweet in taste, neutral in nature, and enters the spleen, stomach, small intestine, and bladder meridians; it softens hard masses, disperses nodules, reduces swelling, and relieves pain.

[0015] The traditional Chinese medicine composition of this invention uses Rehmannia glutinosa, Paeonia lactiflora, Angelica sinensis, and Ligusticum chuanxiong as the principal herbs, for their effects of reducing swelling, dispersing nodules, and relieving pain. Trachelospermum jasminoides, stir-fried malt, stir-fried chicken gizzard lining, and Lycopus lucidus are combined with Angelica sinensis to invigorate blood circulation and remove blood stasis; as blood circulation improves, swelling subsides. Stir-fried Citrus reticulata peel regulates qi and relieves pain, while Poria cocos calms the mind. Licorice root harmonizes the effects of all the herbs. This traditional Chinese medicine composition invigorates blood circulation, removes blood stasis, softens and disperses nodules, reduces swelling and relieves pain, and can promote the reduction of swelling from childhood injuries, thus accelerating the process of rehabilitation or subsequent surgical treatment. The overall effective rate is over 97%, making it of great value for widespread application. Detailed Implementation

[0016] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0017] Example 1 6g Rehmannia glutinosa, 6g Paeonia lactiflora, 6g Angelica sinensis, 6g Ligusticum chuanxiong, 6g Lycopus lucidus, 6g Citrus reticulata peel, 6g Poria cocos, 3g Glycyrrhiza uralensis, 10g Trachelospermum jasminoides, 10g stir-fried malt, 10g stir-fried chicken gizzard lining.

[0018] Preparation method: Weigh the medicinal materials according to the above formula, add water and soak for about 30 minutes. In winter, the soaking time can be extended to 1 hour. Decoction twice. For the first decoction, add water to a depth of more than one finger joint after placing the Chinese medicine in the decoction pot. After the first decoction is brought to a boil over high heat, simmer over low heat for 30 minutes. After the decoction is finished, immediately filter out the liquid. Add 400ml of water for the second decoction. After the second decoction is brought to a boil over high heat, simmer over low heat for 20 minutes. Mix the two decoctions to obtain the soup.

[0019] For general children, one application is given daily. Each application contains the following herbs: Rehmannia glutinosa (raw), Paeonia lactiflora (red), Angelica sinensis (angelica sinensis), Ligusticum chuanxiong (chuanxiong), Lycopus lucidus (zeolite), Citrus reticulata (green tangerine peel), Poria cocos (poria cocos), Glycyrrhiza uralensis (licorice root), Trachelospermum jasminoides (trachelospermum jasminoides), Hordeum vulgare (fried), and Gallus gallus domesticus (fried). Dosage: Decoction in water, taken orally, one dose per day. Mix the two decoctions and take half warm after breakfast and dinner.

[0020] The following description, based on clinical data and typical cases, further illustrates the beneficial effects of the present invention: 1. Clinical observation Clinical data: One hundred patients diagnosed with limb fractures between June 2019 and December 2023 were included. All patients presented with swelling, pain, and significant tenderness. Their ages ranged from 6 to 13 years, with a mean age of 11.2 years. The duration of treatment ranged from 7 to 30 days, with a mean duration of 20 days. The patients were divided into two non-randomized, concurrently controlled groups: a treatment group of 65 patients (mean age 10 years, mean duration of treatment 17 days) and a control group of 40 patients (mean age 10.6 years, mean duration of treatment 18.4 days). Statistical analysis showed no significant differences between the two groups in terms of age and disease duration, indicating comparability between the groups.

[0021] 2. Diagnostic criteria: Grading of swelling degree; Grade 0: No swelling at the affected area, and the local skin is normal; Grade 1: Mild swelling at the affected area, slight pitting upon finger pressure, slightly taut skin with remaining skin lines, and the difference in circumference between the affected and healthy sides at the same location is less than or equal to 0.5 cm; Grade II: The affected area is obviously swollen, with obvious pitting when pressed, the skin is tense, the skin lines are gone, the skin temperature is slightly higher, and the circumference difference is 0.5-1cm; Grade 3: The affected area is obviously swollen, the skin is obviously tense, the skin lines disappear, the skin temperature is significantly increased, blisters may appear, and the circumference difference exceeds 1cm; 3. Treatment method: The treatment group took the medicine described in this embodiment, one dose per day, decocted twice, the two decoctions were mixed, and half was taken warm after breakfast and dinner, and the treatment lasted for 7 days as one course of treatment. 4. The control group received no special treatment, only instructions to elevate the affected limb; 5. Efficacy evaluation criteria: Cured: Swelling score decreased by 2 levels or reached 0 after treatment; Improved: Swelling score decreased by 1 level and not reached 0; Ineffective: Swelling score showed no change or even increased; 6. Treatment results: There was a significant difference in the overall treatment level between the two groups (P<0.05), as shown in Table 1.

[0022] Table 1 Comparison of symptom improvement in the two groups of patients before and after treatment. total number cure improvement ineffectiveness total effective rate experimental group 60 30 28 2 96.7% control group 40 10 12 18 55% In summary, according to the table above, among the 60 patients in the treatment group, 30 were cured, 28 improved, and 2 showed no effect, with a total effective rate of 96.7%. In contrast, among the 40 patients in the control group, 10 were cured, 12 improved, and 18 showed no effect, with a total effective rate of 55%. Therefore, it is evident that the total effective rate of 97.1% in the treatment group using this traditional Chinese medicine is significantly higher than the 55% in the rehabilitation treatment group. Furthermore, the cure rate in the treatment group reached 66%, demonstrating the significant efficacy of this traditional Chinese medicine in treating pediatric swelling and pain.

[0023] Here are a few typical cases: Case 1, female, age 8 years old, diagnosed with distal radius fracture. The child was crying in pain and had significant swelling in the forearm. After manual reduction and plaster fixation, the child's mental state improved and the swelling subsided significantly after one week of oral administration of this medicine. After 3 weeks, the fracture was healed and the plaster cast was removed. The child now has no obvious discomfort in daily activities.

[0024] Case 2, male, age 4 years old, diagnosed with supracondylar fracture of the humerus. The child was crying in pain and had significant swelling in the upper arm. After manual reduction and plaster fixation, the child's mental state improved and the swelling subsided significantly after one week of oral administration of this prescription. The fracture healed well after 3 weeks, and the plaster cast was removed. The child now has no obvious discomfort in daily activities.

[0025] Case 3, female, age 9 years old, diagnosed with a right Monteggia fracture. After a fall, the child experienced pain, crying, swelling, and deformity in her right elbow and forearm, with limited elbow joint movement. X-ray confirmed anterior dislocation of the radial head combined with a fracture of the ulna (Monteggia fracture). Closed reduction of the radial head and closed reduction of the ulna were performed, followed by immobilization with a long arm cast at 110° elbow flexion. After one week of oral administration of this medication, the child's pain improved, and the swelling significantly subsided. Six weeks later, the fracture healed stably, and the cast was removed. Currently, the child has no significant discomfort in raising her hand, holding objects, or engaging in other daily activities.

[0026] Case 4, male, age 10 years old, diagnosed with a double fracture of the midshaft of the left radius and ulna. The child fell and landed on his palm, resulting in pain, crying, significant swelling and deformity of the left forearm, and loss of rotational function. X-ray showed a midshaft fracture of the radius and ulna. Closed reduction was performed followed by long arm immobilization with a plaster cast. After one week of oral administration of this medication, the child's pain improved, and the swelling subsided significantly. After 5 weeks, callus formation was good, and the plaster cast was removed. Currently, the child has no significant discomfort in daily activities such as turning doorknobs and tightening bottle caps.

[0027] Case 5: Male, age 7 years old, diagnosed with a greenstick fracture of the midshaft of the tibia. The child fell while running, resulting in pain and swelling in the right lower leg, inability to stand or walk, and restlessness. Physical examination revealed significant swelling in the midshaft of the right lower leg, severe local tenderness, and refusal to be touched or moved. X-ray showed a greenstick fracture of the midshaft of the right tibia, with acceptable alignment. Manual reduction was performed, followed by immobilization with a long leg cast. After one week of oral administration of this medication, the child's mood stabilized, his mental state improved, and the swelling in the right lower leg subsided significantly. A follow-up examination four weeks later showed a blurred fracture line and good clinical healing; the cast was removed. Progressive weight-bearing exercises and knee and ankle joint exercises were initiated. Currently, the child experiences no significant discomfort in daily walking, running, and jumping activities, has a normal gait, and satisfactory functional recovery.

[0028] Case 6, female, age 10, diagnosed with a midshaft fracture of the right clavicle. The child presented with pain and crying in her right shoulder, along with local swelling, after a fall. X-ray showed a clavicle fracture. Manual reduction was performed, followed by immobilization with a figure-of-eight bandage. After one week of oral administration of this medication, her mental state improved, and the swelling significantly subsided. Three weeks later, the fracture alignment stabilized, and the immobilization was removed. Currently, the child experiences no significant discomfort in right shoulder abduction or carrying a backpack.

[0029] Case 7, female, age 12, diagnosed with a fracture of the 5th metacarpal bone of the right hand. The child experienced swelling and pain in her right hand after punching a hard object, accompanied by crying and limited movement of the little finger. X-ray showed a metacarpal fracture. Manual reduction was performed followed by short-arm plaster cast immobilization. After one week of oral administration of this medication, her mental state improved, and the swelling significantly subsided. Three weeks later, the fracture line became blurred, and the plaster cast was removed. Currently, the child has no significant discomfort in daily hand activities such as holding a pen and grasping objects.

[0030] Case 8, Female, Age: 6 years old. Chief complaint: Swelling and pain in the right forearm with limited range of motion for 2 hours. Present illness: Fall from a 1-meter-high slide, landing on her right hand. Physical examination: Swelling in the mid-shaft of the right forearm, tenderness (+), longitudinal percussion tenderness (+), finger movement is normal. Imaging: X-ray shows a greenstick fracture of the mid-shaft of the right radius and ulna, with an angulation of approximately 15°. Diagnosis: Greenstick fracture of the right radius and ulna. Treatment: Manual reduction and plaster cast immobilization for 3 weeks. After one week of oral administration of this medication, the child's mental state improved, and the swelling subsided significantly. After 3 weeks, the fracture line became blurred, and the plaster cast was removed. The child currently has no significant discomfort.

[0031] Case 9, Male, Age: 4 years old. Chief complaint: Left elbow deformity accompanied by crying for 30 minutes. Present illness: Fell while running, landing on his left elbow. Physical examination: Abnormal posterior triangle relationship of the left elbow, crepitus palpable. Imaging: X-ray showed left supracondylar fracture of the humerus (extension type), posteriorly displaced. Treatment: Closed reduction and percutaneous Kirschner wire fixation, postoperative plaster cast immobilization. After one week of oral administration of this medication, the child's mental state improved, and swelling significantly subsided. Three weeks later, the fracture line became blurred, and the Kirschner wires and plaster cast were removed. The child currently has no significant discomfort.

[0032] Case 10, Female, Age: 5 years. Chief complaint: Swelling and limited range of motion in the right shoulder. Present illness: Fell from a children's tricycle, landing on her right shoulder. Physical examination: Squared shoulder deformity, Dugas sign (+). Imaging: X-ray showed a midshaft fracture of the right clavicle with an angulation of 30°. Treatment: Manual reduction followed by figure-of-eight bandage fixation. After one week of oral administration of this formula, her mental state improved and the swelling significantly subsided. Three weeks later, the fracture line became blurred, and the patient currently has no significant discomfort. Case 11, Male, Age: 9 years old. Chief complaint: Pain in the right wrist with wrist drop deformity. Present illness: Fell from a bicycle, landing on his right hand. Physical examination: Decreased sensation on the radial side of the dorsum of the hand, wrist drop. Imaging: X-ray showed distal radius fracture of the right hand (Colles type). Treatment: Manual reduction + cast immobilization. After one week of oral administration of this medicine, the patient's mental state improved, and the swelling subsided significantly. After 3 weeks, the fracture line became blurred, and the patient currently has no significant discomfort and his daily life is unrestricted.

[0033] Case 12, Female, Age: 6 years old. Chief complaint: Swelling and abnormal movement of the right thigh. Present illness: Right thigh deformity due to a car accident. Physical examination: Right lower limb shortened by 4 cm, crepitus (+). Imaging: X-ray showed spiral fracture of the right femoral shaft. Treatment: Flexible intramedullary nailing. During hospitalization, she took this medicine, and there was no obvious crying or agitation at night, and the swelling subsided significantly.

[0034] Case 13, Male, Age: 3 years old. Chief complaint: Swelling of the left ankle accompanied by crying. Present illness: Sprain during trampoline activity. Physical examination: Tenderness on the left lateral malleolus, drawer test (positive). Imaging: X-ray showed distal fibular epiphyseal fracture of the left side. Treatment: Closed reduction and plaster cast immobilization. After one week of oral administration of this treatment, the patient's mental state improved, and the swelling subsided significantly. After 3 weeks, the fracture line became blurred, and the patient currently has no significant discomfort.

[0035] Case 14, Female, Age: 7 years old. Chief complaint: Pain and limited range of motion in the right elbow. Present illness: Injury from a playground slide. Physical examination: Swelling on the lateral side of the elbow joint, with positive crepitus. Imaging: X-ray showed fracture of the right lateral condyle of the humerus. Treatment: Open reduction and Kirschner wire fixation. The swelling significantly subsided after taking this prescription during the perioperative period.

[0036] Case 15, Male, Age: 8 years old, Chief Complaint: Right shoulder pain with limited range of motion. Present Illness: Right shoulder impact with the ground during a fall. Physical Examination: Tenderness in the middle and outer third of the clavicle, limited abduction of the affected limb. Imaging: X-ray showed a right clavicle fracture with overlapping displacement. Treatment: Manual reduction + modified sling fixation. Outpatient follow-up: After one week of taking this treatment, the swelling significantly subsided. Currently, the fracture line is blurred, shoulder joint movement is unrestricted, and daily activities are unaffected.

[0037] Case 16, Female, Age: 7 years old. Chief complaint: Swelling and limited range of motion in the left dorsum of the foot. Present illness: Injury sustained while playing soccer. Physical examination: Tenderness at the base of the 5th metatarsal, eversion deformity of the foot. Imaging: X-ray showed fracture at the base of the left 5th metatarsal. Treatment: External fixation with a brace, outpatient follow-up, pain management. After 8 days of taking this medication, the swelling subsided significantly. The fracture line is now blurred, and there is no significant discomfort after the external fixation with the brace was removed.

[0038] Case 17, Male, Age: 5 years old. Chief complaint: Right elbow pain with limited forearm rotation. Present illness: Injury from a collision with an amusement park ride. Physical examination: Normal posterior triangle relationship of the elbow, limited forearm rotation. Imaging: X-ray showed fracture of the olecranon of the right ulna. Treatment: Kirschner wire tension band fixation. After 8 days of treatment, the swelling subsided significantly. The fracture line is now blurred, and there is no significant discomfort after the Kirschner wires were removed.

[0039] Case 18, Male, Age: 5 years old. Chief complaint: Pain in the mid-right lower leg accompanied by abnormal movement. Present illness: Hit by a bicycle while running. Physical examination: Swelling in the mid-right lower leg, angular deformity <15°. Imaging: X-ray showed greenstick fracture of the right tibia and fibula. Treatment: Manual reduction followed by long leg cast immobilization, and oral administration of this formula for 7 doses. Follow-up: The cast was removed after 4 weeks. Gait was normal, swelling was significantly reduced, and there was no significant discomfort.

[0040] Case 19, Female, Age: 7 years old. Chief complaint: Swelling and limited range of motion in the right ankle. Present illness: Sprain during soccer. Physical examination: Tenderness on the lateral side of the ankle joint, positive drawer test. Imaging: X-ray showed right lateral malleolar epiphyseal fracture. Treatment: Manual reduction followed by plaster cast immobilization, and oral administration of this formula for 7 doses. Follow-up: No discomfort when bearing weight and walking after 5 weeks.

[0041] Case 20, Female, Age: 6 years old. Chief complaint: Swelling and pain in the right elbow with limited range of motion for 2 hours. Present illness: Fall from a slide, landing on her right hand. Physical examination: Mild angular deformity of the right elbow, no neurovascular injury. Imaging: X-ray showed a supracondylar fracture of the right humerus (extension type), displacement <2mm. Treatment: Manual reduction followed by plaster cast immobilization with the elbow flexed at 90°. The patient was given this prescription orally during hospitalization, and the swelling significantly decreased. Follow-up: The plaster cast was removed after 4 weeks, and the elbow joint range of motion recovered to 95% of the healthy side.

[0042] Case 21, Male, Age: 5 years old. Diagnosed with left femoral shaft fracture. The child fell from a slide, resulting in severe pain, deformity, swelling, and inability to stand in his left thigh. X-ray showed a transverse fracture of the midshaft of the femur. Traction reduction was performed followed by hip spica cast immobilization. After one week of oral administration of this medication, the pain and swelling subsided. After 8 weeks, callus formation was good, and the cast was removed. The child can now walk independently with a basically normal gait.

[0043] Case 22, female, age 3 years. Diagnosed with a greenstick fracture of the surgical neck of the right humerus. The child fell and landed on her elbow, resulting in swelling, reluctance to move, and crying in her right shoulder. X-ray showed an incomplete fracture of the surgical neck of the humerus. A triangular bandage was used for sling fixation. Pain subsided after 3 days of oral administration of this medication, and swelling subsided after 1 week. The fracture stabilized after 2 weeks, and the fixation was removed. The child now has full range of motion in her right upper limb.

[0044] Case 23, male, age 6 years. Diagnosed with a distal fibular fracture of the left leg. The child twisted his left ankle while playing soccer, experiencing local swelling and tenderness, and refused to bear weight. X-ray showed a hairline fracture of the distal fibula. A short leg cast was applied for immobilization. After 5 days of oral administration of this medication, the swelling significantly decreased. The fracture healed after 4 weeks, and the cast was removed. He currently has no discomfort during running and jumping activities.

[0045] Case 24, female, age 7. Diagnosed with a fracture of the neck of the 5th metacarpal bone in the right hand (boxer's fracture). The child experienced swelling, pain, and deformity on the back of her right hand after striking a hard object. X-ray confirmed the diagnosis. Manual reduction was performed followed by fixation with an aluminum plate. The pain subsided after one week of oral administration of this medication. Three weeks later, callus formation occurred, and the fixation was removed. Currently, her pen-holding and object-holding functions are normal.

[0046] Case 25, male, age 9 years. Diagnosed with distal tibial epiphyseal injury of the left leg. The child suffered a skateboarding accident resulting in swelling, deformity, and inability to walk on the left ankle. X-ray showed epiphyseal separation with metaphyseal fracture. Closed reduction was performed followed by long leg cast immobilization. Symptoms improved after one week of oral administration of this medication. After 6 weeks, healing was good, and the cast was removed. Currently, ankle joint range of motion has recovered to 90%.

[0047] Case 26, female, age 4 years. Diagnosed with a fracture of the right olecranon. The child fell and landed on her elbow, resulting in swelling and limited elbow extension. X-ray showed a non-displaced hairline fracture. A long arm cast was applied to immobilize the elbow in a 90° flexion position. After 3 days of oral administration of this medication, crying decreased. Four weeks later, the fracture line became blurred, and the cast was removed. Elbow flexion and extension function is now normal.

[0048] Case 27, male, age 11 years. Diagnosed with a left radial neck fracture. The child fell and landed with his palm abducted, experiencing swelling and pain in his left elbow and limited forearm rotation. X-ray showed radial head tilt. Manual reduction was performed followed by plaster cast immobilization. Swelling subsided after one week of oral administration of this medication. The fracture healed after 5 weeks, and the cast was removed. Forearm rotation function has now fully recovered.

[0049] Case 28, female, age 5 years. Diagnosed with bilateral calcaneal fractures. The child jumped from a 1-meter-high platform, resulting in heel swelling and pain, and refusal to stand. CT scan showed bilateral extra-articular calcaneal fractures. Short leg casts were applied for immobilization. Pain was relieved after one week of oral administration of this medication. The casts were removed after 6 weeks, and weight-bearing training was gradually initiated. She can now walk without any sequelae.

[0050] Case 29, male, age 8 years. Diagnosed with a fracture of the medial epicondyle of the left humerus. The child suddenly experienced severe pain and swelling in his left elbow, along with weakness in wrist flexion, during a tug-of-war competition. X-ray showed epiphyseal avulsion and displacement. Manual reduction was performed followed by plaster cast immobilization. After 5 days of oral administration of this formula, the local ecchymosis subsided. The fracture healed after 4 weeks, and his grip strength is now normal after functional exercises.

[0051] Case 30, female, age 10. Diagnosed with a fracture of the base of the right metatarsal. The child sprained her right foot during dance practice, with swelling and tenderness in the midfoot. X-ray showed a fracture of the base of the 5th metatarsal. A walking boot was used for immobilization. Pain decreased after 3 days of oral administration of this medication. The fracture stabilized after 3 weeks, and an elastic bandage was applied. She is now participating in normal physical activities.

[0052] Comparative Example 1 The prescription of this invention was developed by the inventors through long-term clinical practice and experimentation. The absence or substitution of any component in the prescription will lead to a decrease in efficacy. Specific cases are provided below. These cases are all derived from real clinical practice and represent actual examples accumulated during the optimization of the prescription.

[0053] Case 31 Male, 5 years old. Diagnosed with a double fracture of the radius and ulna in the right forearm. The child experienced pain and limited movement in the right forearm after a fall. After manual reduction and plaster cast immobilization, X-ray showed acceptable alignment.

[0054] The prescription is as follows: Rehmannia glutinosa 6g, Paeonia lactiflora 6g, Angelica sinensis 6g, Ligusticum chuanxiong 6g, Lycopus lucidus 6g, Citrus reticulata peel 6g, Poria cocos 6g, Glycyrrhiza uralensis 3g, Trachelospermum jasminoides 10g, Hordeum vulgare 10g, and Raphanus sativus 10g.

[0055] The difference between this formula and Example 1 is that stir-fried chicken gizzard is replaced with stir-fried radish seeds. The preparation method and method of administration are the same as in Example 1.

[0056] Treatment status: After taking 7 doses, the child returned for a follow-up visit. The parents reported that the child's appetite had improved and the abdominal distension had lessened, but the swelling, stiffness, and functional activity of the affected limb had not improved significantly, and the child still cried frequently at night.

[0057] Given that the efficacy in promoting blood circulation, strengthening muscles and bones, and promoting functional recovery did not meet expectations, the prescription was adjusted during the follow-up visit, and "fried radish seeds" was changed to "fried chicken gizzard" (i.e., the original prescription of Example 1 was used).

[0058] After continuing the treatment with the prescription from Example 1 for 7 more doses, the child returned for a follow-up visit. The swelling in the affected limb had largely subsided, the skin temperature had returned to normal, muscle elasticity had improved, and appetite and sleep had significantly improved. The cast was removed 2 weeks later. The child's right forearm function is now normal.

[0059] Case 32 The patient is a 7-year-old female. She was diagnosed with a fracture of the left tibia shaft. She presented with left lower limb pain and swelling, and limited mobility, following a violent collision during exercise. She was treated with plaster cast immobilization. X-ray showed adequate fracture alignment.

[0060] The prescription is as follows: Rehmannia glutinosa 6g, Paeonia lactiflora 6g, Angelica sinensis 6g, Ligusticum chuanxiong 6g, Lycopus lucidus 6g, Citrus reticulata peel 6g, Polygala tenuifolia 6g, Glycyrrhiza uralensis 3g, Trachelospermum jasminoides 10g, Hordeum vulgare 10g, and Gizzard lining of chicken 10g.

[0061] The difference between this formula and Example 1 is that Poria cocos is replaced with processed Polygala tenuifolia. The preparation method and administration method are the same as in Example 1.

[0062] Treatment progress: After taking 7 doses, the child returned for a follow-up visit. The parents reported that the child's appetite had improved, the abdominal distension after meals had disappeared, and the child's overall condition had slightly improved. However, nighttime sleep did not improve significantly; the child still woke up frequently, reported pain in the affected limb, and had difficulty concentrating.

[0063] Given that the therapeutic effects on calming the mind, relieving soreness and discomfort in the affected limb, and promoting functional recovery did not meet expectations, the prescription was adjusted during the follow-up visit, and "Zhiyuanzhi" was changed to "Fushen" (i.e., the original prescription of Example 1 was used).

[0064] After the child continued taking the prescription from Example 1 for 7 more doses, the family happily reported that the child slept soundly at night, with a significant reduction in the number of times they woke up, improved daytime energy, and better concentration. The child also reported reduced pain in the affected limb and improved attention. The fracture healed well after 3 weeks, and the cast was removed. Functional recovery is now progressing well.

[0065] Case 32 Male, 4 years old. Diagnosed with a greenstick fracture of the right clavicle. Due to a fall, the right clavicle was swollen and painful, and was immobilized with a figure-eight bandage.

[0066] The prescription is as follows: Rehmannia glutinosa 6g, Paeonia lactiflora 6g, Angelica sinensis 6g, Ligusticum chuanxiong 6g, Lycopus lucidus 6g, Citrus reticulata peel 6g, Poria cocos 6g, Glycyrrhiza uralensis 3g, Trachelospermum jasminoides 10g, Crataegus pinnatifida 10g, and Gizzard lining of chicken 10g.

[0067] The difference between this formula and Example 1 is that roasted malt is replaced with roasted hawthorn. The preparation method and method of administration are the same as in Example 1.

[0068] Treatment progress: After taking 7 doses, the child returned for a follow-up visit. The parents reported that the child's appetite had improved, and the child was beginning to eat meat, with reduced abdominal distension. However, the child's stools remained loose and unformed, the improvement in shoulder mobility was slow, and mood and sleep problems persisted.

[0069] Given that the therapeutic effect in strengthening the spleen and drying dampness, regulating qi and relaxing muscles was not optimal, the prescription was adjusted during the follow-up visit, and "fried hawthorn" was replaced with "fried malt" (that is, the original prescription of Example 1 was used).

[0070] After the child continued taking the prescription from Example 1 for 7 more doses, the stool gradually became formed, the appetite steadily increased, and at the follow-up visit, the child was more cheerful than before, the active range of motion of the shoulder joint increased, and the sleep at night was more restful. The external fixation was removed 3 weeks later.

Claims

1. A traditional Chinese medicine composition for treating swelling and pain from childhood injuries, characterized in that... Including the following raw materials: Rehmannia glutinosa, Paeonia lactiflora, Angelica sinensis, Ligusticum chuanxiong, Lycopus lucidus, Citrus reticulata peel, Poria cocos, Glycyrrhiza uralensis, Trachelospermum jasminoides, stir-fried malt, stir-fried chicken gizzard lining.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that... The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-10 parts of Rehmannia glutinosa, 5-10 parts of Paeonia lactiflora, 5-10 parts of Angelica sinensis, 5-10 parts of Ligusticum chuanxiong, 5-10 parts of Lycopus lucidus, 5-10 parts of Citrus reticulata peel, 5-10 parts of Poria cocos, 1-5 parts of Glycyrrhiza uralensis, 8-15 parts of Trachelospermum jasminoides, 8-15 parts of stir-fried malt, and 8-15 parts of stir-fried chicken gizzard lining.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that... The traditional Chinese medicine composition comprises the following raw materials in parts by weight: The composition by weight is as follows: 6 parts Rehmannia glutinosa, 6 parts Paeonia lactiflora, 6 parts Angelica sinensis, 6 parts Ligusticum chuanxiong, 6 parts Lycopus lucidus, 6 parts Citrus reticulata peel, 6 parts Poria cocos, 3 parts Glycyrrhiza uralensis, 10 parts Trachelospermum jasminoides, 10 parts stir-fried malt, and 10 parts stir-fried chicken gizzard lining.

4. A traditional Chinese medicine compound preparation for treating pediatric traumatic swelling and pain, prepared from the traditional Chinese medicine composition for treating pediatric traumatic swelling and pain as described in any one of claims 1 to 3.

5. The traditional Chinese medicine compound preparation as described in claim 4, characterized in that... The dosage forms of the traditional Chinese medicine compound preparations include tablets, capsules, granules, oral liquids, drop pills, micro-pills, decoctions, or mixtures.

6. The use of the traditional Chinese medicine composition for treating pediatric traumatic swelling and pain as described in any one of claims 1 to 3, or the traditional Chinese medicine compound preparation as described in claim 4, in the preparation of a drug for treating pediatric traumatic swelling and pain.