A traditional Chinese medicine composition for treating musculoskeletal pain and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating musculoskeletal pain and a preparation method thereof, and belongs to the technical field of medicines. The raw medicine is prepared from the following components in parts by weight: 8-12 parts of rhubarb, 3-6 parts of honeysuckle, 8-10 parts of dandelion, 3-5 parts of red root of madder, 8-10 parts of camptodrome, 6-8 parts of cyperus, 3-5 parts of angelica, 5-7 parts of baizhi, 1-3 parts of mint, 2-5 parts of turmeric and 2-4 parts of notopterygium. The traditional Chinese medicine composition has the advantages of long-lasting efficacy, high safety, comfortable use and strong stability. Compared with traditional cream, the application realizes slow drug release through EC microcapsules, and the analgesic effect of single medication can last for 6-8 hours, so that the medication frequency can be reduced. The amount of hydroxyphenyl ethyl ester is low (0.05%), and the risk of preservative allergy can be reduced. The O / W type substrate has a refreshing texture, good spreadability and no greasy feeling. Nitrogen ketone promotes transdermal absorption of the medicine, and has a fast onset speed. The microcapsule embedding technology improves the stability of the medicine, and the finished product can be stably stored for 18 months under the condition of 40 DEG C and 75% humidity.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition and its preparation method, and more particularly to a traditional Chinese medicine composition for treating musculoskeletal pain and its preparation method. Background Technology

[0002] Musculoskeletal pain refers to pain in the muscles, bones, ligaments, tendons, and nerves. You may only feel pain in one part of your body, such as your back. If you have fibromyalgia, you may also experience this. The pain ranges in intensity from mild to severe, enough to affect your daily life. It can come on suddenly but last only a short time, which is called acute pain. Pain that lasts for more than 3 to 6 months is called chronic pain. Approximately 1.3 billion people worldwide suffer from musculoskeletal pain, with over 300 million patients in China. With the increasing aging of the population, it is becoming a serious public health problem in my country.

[0003] Currently, there are many traditional Chinese medicine preparations on the market for treating musculoskeletal pain, most of which are oral pills, tablets, and capsules. These medications are taken orally, requiring large doses, long treatment cycles, and a long onset of action. Furthermore, long-term use of traditional Chinese medicine can irritate the gastrointestinal tract. External applications include poultices and black plasters. Poultices contain rubber components, which have poor breathability, are prone to causing allergies, have poor absorption and permeability, and poor performance stability. Black plasters contain heavy metal components, tend to stick to the skin, are inconvenient to clean, and have unsatisfactory effects, generally having limited efficacy in treating musculoskeletal pain. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating musculoskeletal pain and its preparation method. The medicine is prepared using traditional Chinese medicine and modern pharmaceutical technology, which can conveniently treat patients' musculoskeletal pain.

[0005] To achieve the above objectives, the specific plan is as follows:

[0006] A traditional Chinese medicine composition for treating musculoskeletal pain, comprising the following raw materials by weight: rhubarb 8-12, honeysuckle 3-6, dandelion 8-10, red peony root 3-5, gardenia 8-10, cyperus rhizome 6-8, angelica root 3-5, angelica dahurica root 5-7, peppermint 1-3, turmeric 2-5, and notopterygium root 2-4.

[0007] Furthermore, by weight, the raw materials are: rhubarb 10, honeysuckle 5, dandelion 8, red peony root 4, gardenia 10, cyperus rhizome 8, angelica root 4, angelica dahurica root 5, peppermint 3, turmeric 4, and notopterygium root 2.

[0008] Furthermore, the traditional Chinese medicine composition is a traditional Chinese medicine preparation.

[0009] Furthermore, the traditional Chinese medicine preparation is an ointment.

[0010] The traditional Chinese medicine preparation of the present invention is preferably a paste, which is convenient for clinical use, allows for rapid absorption of the active ingredients, has a long shelf life, and has a simple production process. A preferred method for preparing the traditional Chinese medicine preparation includes the following steps:

[0011] S1: Extracting the effective components from traditional Chinese medicine compound formulas;

[0012] S2: Ethyl cellulose microcapsules were prepared using an emulsification-solvent evaporation method;

[0013] S3: Microcapsule cream molding.

[0014] Furthermore, step S1 includes the following sub-steps:

[0015] S11, Raw material pretreatment: Wash the 11 compound medicinal materials, dry them at 60℃ until the moisture content is ≤8%, and pulverize them through an 80-mesh sieve; store them in two groups: Group 1 contains peppermint, notopterygium root, and turmeric, and Group 2 contains the remaining 8 medicinal materials.

[0016] S12, volatile oil extraction: Take the medicinal material from group 1, add 8 times the amount of purified water, steam distill at 105℃ and 0.12MPa for 2.5h, collect the upper volatile oil using an oil-water separator, filter it through a 0.22μm filter membrane, refrigerate at 4℃ for later use, and retain the residue.

[0017] S13, Extraction of polar components: Take the medicinal materials from group 2 and the residue from group 1, add 8 times the amount of 70% ethanol, and reflux at 80℃ twice. Combine the extracts and filter them through a 0.45μm filter cloth. Concentrate the filtrate under reduced pressure at 50℃ to obtain an extract with a relative density of 1.20-1.25 (measured at 60℃). Vacuum dry at 60℃ until the moisture content is ≤5%, and pulverize it through an 80-mesh sieve to obtain a dry powder of polar components.

[0018] S14, Preparation of compound drugs: Mix the volatile oil and the dry powder of polar components at a mass ratio of 1:100, stir at 2000r / min for 10min to obtain a uniform compound drug mixture.

[0019] Furthermore, step S2 includes the following sub-steps:

[0020] S21, Oil phase preparation: Take EC according to the ratio, add a mixed solvent of dichloromethane and ethanol, stir at 800 r / min for 30 min until completely dissolved; add the compound drug mixture, continue stirring for 10 min to obtain the drug-EC oil phase;

[0021] S22, Aqueous phase preparation: Take an appropriate amount of purified water, add the required amount of Tween 80, and stir until dissolved to obtain the aqueous phase;

[0022] S23, Emulsification and Encapsulation: The oil phase is slowly injected into the aqueous phase, and high-speed shear emulsification is performed at 8000 r / min for 15 min to form an O / W emulsion; the solvent is removed by rotary evaporation under reduced pressure at 35℃ for 30 min, and microcapsules are precipitated.

[0023] S24, Microcapsule purification: Collect microcapsules by centrifugation at 3000 r / min for 10 min, wash twice with purified water, vacuum dry at 50℃ for 4 h, and pass through a 100-mesh sieve to obtain compound EC microcapsules.

[0024] Furthermore, step S3 includes the following sub-steps:

[0025] S31, Oil phase preparation: Take petrolatum, liquid paraffin and stearic acid in proportion, heat to 75-80℃ to melt, and stir evenly;

[0026] S32, Aqueous phase preparation: Take purified water, add the appropriate amounts of glycerol, triethanolamine, and ethylparaben, heat to 75-80℃ to dissolve, and stir until homogeneous;

[0027] S33, Matrix emulsification: Inject the aqueous phase into the oil phase and homogenize at 8000 r / min for 15 min to form a uniform O / W matrix;

[0028] S34, Microcapsule Dispersion: After the matrix cools down to below 40℃, add compound EC microcapsules and the required amount of azone, homogenize at 5000r / min for 5min, adjust the pH to 6.0-7.0, and cool to room temperature to obtain the finished product.

[0029] In summary, the present invention has the following advantages over the prior art:

[0030] (1) Long-lasting effect: EC microcapsules enable slow drug release, and the analgesic effect of a single application can last for 6-8 hours, reducing the frequency of application (3-4 times a day, which is less than the 5-6 times a day of traditional topical ointments).

[0031] (2) High safety: Topical administration avoids the gastrointestinal irritation of oral medications, and the dosage of ethylparaben is low (0.05%), reducing the risk of preservative allergy;

[0032] (3) Comfortable to use: The O / W type matrix has a refreshing texture, good spreadability, and no greasy feeling; azone promotes transdermal drug absorption and has a fast onset of action (acute pain can be relieved 15-30 minutes after medication).

[0033] (4) Strong stability: Microencapsulation technology improves drug stability, and the finished product can be stably stored for 18 months at 40℃ and 75% humidity (traditional topical ointments are generally 12 months). Attached Figure Description

[0034] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings:

[0035] Figure 1 This is a flowchart of the ointment preparation method. Detailed Implementation

[0036] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0037] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments of the present invention. As used herein, the singular form may also include the plural form unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0038] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the invention. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following figures denote similar items; therefore, once an item is defined in one figure, it need not be further discussed in subsequent figures.

[0039] The traditional Chinese medicine composition of this invention is a modern traditional Chinese medicine designed with reference to the principles of principal, assistant, adjuvant, and guide herbs in traditional Chinese medicine formulation. The efficacy of the raw materials used is as follows:

[0040] Rhubarb, also known as Huangliang, Jinwen, Shengjun, and Chuanjun, is the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., or Rheum officinale Baill., all belonging to the Polygonaceae family. It is harvested in late autumn when the stems and leaves wither, or in the following spring before sprouting. Fine roots are removed, the outer skin is scraped off, and it is cut into segments or sections, strung together and dried, or dried directly.

Functions and Indications

[0041] Honeysuckle, also known as Lonicera japonica Thunb., is a plant belonging to the Caprifoliaceae family. It is the dried flower bud or newly opened flower. Harvested in early summer before the flowers open and then dried; or dried after being fumigated with sulfur. [Functions and Indications] Clears heat and detoxifies, disperses wind-heat. Used for carbuncles, boils, sore throat, erysipelas, dysentery due to heat toxins, wind-heat colds, and febrile diseases.

[0042] Dandelion, also known as: None, is the dried whole herb of *Taraxacum mongolicum* Hand.-Mazz., *Taraxacum borealisinense* Kitam., or several other species of the same genus in the Asteraceae family. It is harvested from spring to autumn when the flowers are just beginning to bloom, impurities are removed, it is washed, and then sun-dried.

Functions and Indications

[0043] Red peony root, also known as wood peony, red peony, herbaceous peony, and red peony, is the dried root of Paeonia veitchii Lynch, a plant in the Ranunculaceae family. It is harvested in spring and autumn, with the rhizomes, fibrous roots, and soil removed before sun-drying.

Functions and Indications

[0044] Gardenia, also known as yellow gardenia or mountain gardenia, is the dried, ripe fruit of *Gardenia jasminoides* Ellis, a plant in the Rubiaceae family. It is harvested from September to November when the fruit is ripe and reddish-yellow. The fruit stalks and impurities are removed, and the fruit is steamed until steam rises or briefly blanched in boiling water, then removed and dried. [Functions and Indications] It clears heat and relieves irritability, promotes diuresis and eliminates dampness, cools the blood and detoxifies; externally, it reduces swelling and relieves pain. It is used for feverish irritability, damp-heat jaundice, painful urination, hematemesis and epistaxis due to blood heat, red and swollen eyes, and carbuncles caused by fire toxins; externally, it is used to treat sprains and contusions.

[0045] Cyperus rotundus L., also known as Xiangfu, is the dried rhizome of the sedge plant (Cyperus rotundus L.). It is harvested in autumn, the hairs are singed off, and it is then briefly boiled or steamed in boiling water before being sun-dried, or singed and then directly sun-dried.

Functions and Indications

[0046] Angelica sinensis, also known as Angelica sinensis (Oliv.) Diels, is the dried root of the plant Angelica sinensis (Oliv.) Diels, belonging to the Apiaceae family. It is harvested in late autumn, with the fibrous roots and soil removed. After the moisture has partially evaporated, it is bundled into small bunches, placed on a rack, and slowly dried using smoke. [Functions and Indications] It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness.

[0047] Angelica dahurica, also known as fragrant angelica, is the dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. or Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav. cv. Hangbaizhi Yuanet Shan, belonging to the Apiaceae family. It is harvested in summer and autumn when the leaves turn yellow. The fibrous roots and soil are removed, and it is sun-dried or dried at low temperature.

Functions and Indications

[0048] Peppermint, also known as: none, is the dried aerial part of *Mentha haplocalyx* Briq., a plant in the Lamiaceae family. Harvested in stages during the summer and autumn when the stems and leaves are lush or when the flowers have bloomed to the third whorl, on sunny days, and then sun-dried or shade-dried.

Functions and Indications

[0049] Turmeric, also known as: None, is the dried rhizome of *Curcuma longa* L., a plant in the ginger family. It is harvested in winter when the stems and leaves wither, washed, boiled or steamed until thoroughly cooked, sun-dried, and the fibrous roots removed.

Functions and Indications

[0050] Notopterygium incisum, also known as silkworm notopterygium, bamboo-joint notopterygium, and big-headed notopterygium, is the dried rhizome and root of *Notopterygium incisum* Ting ex HT Chang or *Notopterygium forbesii* de Boiss., belonging to the Apiaceae family. It is harvested in spring and autumn, with fibrous roots and soil removed before sun-drying.

Functions and Indications

[0051] See Figure 1 As shown, the traditional Chinese medicine preparation of the present invention is preferably a paste, and the preferred method for preparing the traditional Chinese medicine preparation includes the following steps:

[0052] S1: Extraction of effective components from traditional Chinese medicine compound formulas

[0053] S11, Raw material pretreatment: The 11 medicinal materials were quickly rinsed twice with purified water to remove surface mud and impurities; dried in a 60℃ forced-air drying oven until the moisture content was ≤8%; pulverized through an 80-mesh sieve using a universal pulverizer; grouped according to component characteristics: Group 1 consisted of peppermint, notopterygium root, and turmeric (containing volatile components); Group 2 consisted of rhubarb, honeysuckle, dandelion, red peony root, gardenia, cyperus rhizome, angelica root, and angelica dahurica (containing polar active components).

[0054] S12, volatile oil extraction: Take the medicinal material from group 1, add 8 times the amount of purified water, steam distill at 105℃ and 0.12MPa for 2.5h, collect the upper volatile oil using an oil-water separator, filter through a 0.22μm filter membrane, refrigerate at 4℃ for later use, and retain the residue.

[0055] S13, Extraction of polar components: Take the medicinal materials from group 2 and the residue from group 1, add 8 times the amount of 70% ethanol, and reflux at 80℃ twice (1.5h each time). Combine the extracts and filter them through a 0.45μm filter cloth. Concentrate the filtrate under reduced pressure at 50℃ to obtain an extract with a relative density of 1.20-1.25 (measured at 60℃). Vacuum dry at 60℃ until the moisture content is ≤5%, and pulverize it through an 80-mesh sieve to obtain a dry powder of polar components.

[0056] S14, Preparation of compound drugs: Mix the volatile oil and the dry powder of polar components at a mass ratio of 1:100, stir at 2000r / min for 10min to obtain a uniform compound drug mixture.

[0057] S2: Preparation of ethyl cellulose microcapsules (emulsification-solvent evaporation method)

[0058] S21, Oil phase preparation: Take EC according to the ratio, add a mixed solvent of dichloromethane and ethanol (3:1 volume ratio), stir at 800 r / min for 30 min until completely dissolved; add the compound drug mixture, and continue stirring for 10 min to obtain the drug-EC oil phase.

[0059] S22, Aqueous phase preparation: Take an appropriate amount of purified water (oil phase:water phase volume ratio 1:3), add the required amount of Tween 80, and stir until dissolved to obtain the aqueous phase.

[0060] S23, Emulsification and Encapsulation: The oil phase is slowly injected into the aqueous phase, and high-speed shear emulsification is performed at 8000 r / min for 15 min to form an O / W emulsion; the solvent is removed by rotary evaporation under reduced pressure at 35℃ for 30 min, and microcapsules are precipitated.

[0061] S24, Microcapsule purification: Collect microcapsules by centrifugation at 3000 r / min for 10 min, wash twice with purified water, vacuum dry at 50℃ for 4 h, and pass through a 100-mesh sieve to obtain compound EC microcapsules (particle size D50=5-8μm, encapsulation rate ≥75%).

[0062] S3: Microcapsule cream molding

[0063] S31, Oil phase preparation: Take petrolatum, liquid paraffin and stearic acid in proportion, heat to 75-80℃ to melt, and stir evenly.

[0064] S32, Aqueous phase preparation: Take purified water (to bring up to the total mass of the cream), add the appropriate amounts of glycerin, triethanolamine, and ethylparaben, heat to 75-80℃ to dissolve, and stir until homogeneous.

[0065] S33, Matrix Emulsification: Inject the aqueous phase into the oil phase and homogenize at 8000 r / min for 15 min to form a uniform O / W matrix.

[0066] S34, Microcapsule Dispersion: After the matrix cools down to below 40℃, add compound EC microcapsules and the required amount of azone, homogenize at 5000r / min for 5min, adjust the pH to 6.0-7.0, and cool to room temperature to obtain the finished product.

[0067] Core features of the process:

[0068] The volatile oil and polar components are extracted separately, then mixed and encapsulated to retain the synergistic effects of the compound.

[0069] EC, as the encapsulation material, allows for precise control of microcapsule particle size (5-8μm) by controlling the solvent ratio and emulsification speed, thus meeting transdermal requirements;

[0070] Microcapsules are added below 40°C to prevent membrane rupture and ensure sustained-release performance.

[0071] Example 1:

[0072] The traditional Chinese medicine preparation is prepared according to the above method. In step S1, the weight ratio of each raw material is as follows: rhubarb 10, honeysuckle 5, dandelion 8, red peony root 4, gardenia 10, cyperus rotundus 8, angelica sinensis 4, angelica dahurica 5, peppermint 3, turmeric 4, and notopterygium incisum 2.

[0073]

Characteristics

[0074]

Usage and Dosage

[0075] [Adverse Reactions] Not yet clear.

[0076] [Contraindications] Not yet clear.

[0077]

Precautions

[0078]

Specifications

[0079] [Packaging] Packed in plastic bottles, 1 bottle per box

[0080]

Storage

[0081]

Indications

[0082] Table 1 Raw material formula

[0083]

[0084] Example 2: Clinical Case

[0085] Case 1: Acute soft tissue contusion

[0086] Chief complaint: Pain and swelling on the front of the left thigh for 2 hours after an impact.

[0087] Present Illness: The patient is a sophomore at a university and a member of the school's basketball team. Two hours ago, during basketball practice, he collided violently with a teammate, bearing the impact on the front of his left thigh. He immediately experienced severe local pain, followed by swelling. The pain worsened with activity. There was no dizziness, nausea, or skin breakage and bleeding. Seeking treatment, he was accompanied by a classmate to the school hospital. Since the injury, his mental state has been good, and his appetite and bowel movements have been normal.

[0088] Physical examination: Temperature 36.8℃, pulse 82 bpm, respiratory rate 18 bpm, blood pressure 120 / 75 mmHg. The patient is alert and in good spirits. A 3cm × 4cm oval-shaped area of ​​redness and swelling is visible on the anterior left thigh, with indistinct borders. The local skin temperature is approximately 0.8℃ higher than the contralateral side. There is tenderness (+++), but no fluctuation or subcutaneous crepitus. Active flexion of the left knee can reach 90°, with increased pain at the affected area during flexion. Passive movement is not significantly restricted. Sensation and blood circulation in the lower extremities are normal, and the dorsalis pedis artery pulse is strong.

[0089] Auxiliary examination: X-ray of the left thigh (anteroposterior and lateral views) (University Hospital, 2025-10-15): No signs of fracture or joint dislocation were observed, but soft tissue swelling was present.

[0090] Diagnosis: Acute soft tissue contusion of the left anterior thigh.

[0091] Treatment plan: After evaluation by the school doctor, it is recommended to use this product externally (with informed consent from the patient and family). After cleaning the affected skin, apply an appropriate amount of this product evenly to the red and swollen area, about 0.5 mm thick, 4 times a day; instruct the patient to suspend basketball training, avoid pressure and strenuous activity on the affected area, wear loose clothing, and have a classmate assist in observing the skin reaction after medication.

[0092] Feedback on treatment efficacy: Follow-up visit after 1 day of medication: Pain at the affected area was relieved (tenderness reduced to ++), the area of ​​redness and swelling did not expand, and skin temperature was lower than before; After 3 days of medication: The red and swollen area shrank to 2.5cm × 4cm, tenderness was significantly reduced (+), the left knee joint could be flexed to 120°, and daily activities were not significantly restricted; After 5 days of medication: Redness and swelling had basically subsided, with only scattered light brown ecchymosis remaining, and no significant pain upon pressure; After 7 days of medication: The color of the ecchymosis lightened, and the appearance and function of the affected skin had basically recovered. Basic basketball dribbling training was attempted without discomfort. No allergic reactions such as skin redness or itching occurred throughout the entire course of treatment.

[0093] Case 2: Chronic soft tissue strain of the knee joint

[0094] Chief complaint: Recurrent pain in the right knee joint for 3 months, which worsened in the past 3 days.

[0095] Present Illness: The patient is a surgeon at a hospital. For the past three months, due to prolonged standing during surgeries (average 6-8 hours per day) and writing medical records, he gradually developed right knee pain, described as aching and swelling, which was relieved by rest. Three days ago, after performing two major surgeries (totaling 10 hours), the knee pain significantly worsened post-surgery. The pain was severe upon standing after prolonged sitting, and he experienced weakness when climbing stairs. There was no joint clicking, fever, or limitation of movement. The symptoms did not improve significantly after rest, so he consulted with colleagues in the orthopedics department of the same hospital. Since the onset of the illness, his sleep has been slightly affected, but his appetite and bowel movements are normal.

[0096] Physical examination: Temperature 36.5℃, pulse 78 bpm, respiratory rate 17 bpm, blood pressure 125 / 80 mmHg. The patient is alert and in good spirits. There is no obvious redness or swelling in the right knee joint, but tenderness (++) is present in the medial joint space. Patellar grinding test is negative, McMurray's sign is negative. Active knee flexion and extension range is 0°-140°, with no crepitus during movement. Muscle strength and tone are normal in both lower extremities, and sensation and blood circulation are good.

[0097] Auxiliary examinations: 1. Knee X-ray: No narrowing of the knee joint space was observed; the cortical bone was continuous, and no bone hyperplasia or destruction was seen. Diagnosis: Knee pain.

[0098] Medication regimen: Recommended by an orthopedic colleague, and after understanding the ingredients and mechanism of action of this product, I used it independently. After get off work each day, clean the skin of the knee joint, apply an appropriate amount of this product to the painful area and a 5cm radius around it, 3 times a day; combine with a 15-minute hot compress before bed, adjust the work rhythm, take a short break every 2 hours of standing for surgery, and reduce the time spent working at a desk at night.

[0099] Feedback on treatment efficacy: After 2 days of medication: knee joint soreness and swelling were relieved, and pain upon standing after prolonged sitting was reduced (tenderness decreased to +); After 1 week of medication: pain was tolerable after 4 hours of continuous standing surgery, requiring no immediate rest, and weakness when climbing stairs improved; After 2 weeks of medication: pain symptoms were significantly reduced during daily work, with only occasional mild soreness after 3 consecutive major surgeries, which could be relieved by 1-2 hours of rest. Close observation was maintained during medication, and no skin allergies or other adverse reactions were observed. It is believed that this product can relieve discomfort caused by occupational soft tissue strain.

[0100] Case 3: Acute wrist sprain

[0101] Chief complaint: Pain and limited range of motion in the right wrist for 30 minutes after being hit by an instrument.

[0102] Present Illness: The patient is a third-year science and engineering student at a university. Thirty minutes prior to the incident, while conducting an experiment in the lab, he accidentally knocked over a metal experimental stand. His right wrist was struck as he instinctively braced himself, experiencing immediate and severe pain followed by swelling. He was unable to perform actions such as gripping a pen or unscrewing a bottle cap. There was no skin breakage, bleeding, or numbness in his fingers. He was accompanied by his roommate to the university hospital's emergency room. Since the injury, he has been in a state of anxiety, and his diet and bowel movements have not been checked.

[0103] Physical examination: Temperature 36.7℃, pulse 85 bpm, respiratory rate 19 bpm, blood pressure 115 / 70 mmHg. The patient is alert but slightly nervous. A 2cm x 3cm area of ​​redness and swelling is visible on the radial side of the right wrist joint, with slightly elevated local skin temperature. Tenderness is present at the radial styloid process (+++). Dorsiflexion of the wrist joint reaches 30°, palmar flexion reaches 45°, and rotational movement is limited. Sensation and movement of all fingers are normal, peripheral blood supply is good, and capillary refill time is <2 seconds.

[0104] Auxiliary examination: X-ray of the right wrist (anteroposterior and lateral views) (University Hospital, 2025-10-28): The cortical bones of the carpal bones and distal radius and ulna are continuous, and no fracture lines or signs of joint dislocation are seen.

[0105] Diagnosis: Acute soft tissue sprain of the right wrist (Grade I)

[0106] Medication plan: After evaluation by the school hospital physician, it is recommended to try this product (the patient must sign an informed consent form). The roommate will assist in cleaning the affected area, and apply an appropriate amount of this product gently to the red, swollen, and tender area 4 times a day; the patient is advised to temporarily reduce right-hand experimental operations and prolonged writing, and if necessary, use an elastic bandage to lightly fix it (the tightness should be such that one finger can be inserted), avoid lifting heavy objects, and the roommate will assist in observing the skin condition daily.

[0107] Feedback on treatment efficacy: After 1 day of medication: Wrist pain was somewhat relieved (tenderness decreased to ++), and the patient could hold a pen to complete short experimental records, although pain was still felt when exerting force; After 3 days of medication: Redness and swelling significantly subsided, tenderness at the radial styloid process was present (±), and the patient could operate simple experimental equipment and write notes normally, with occasional discomfort when rotating the wrist; After 5 days of medication: Wrist joint movement basically returned to normal (dorsiflexion 70°, palmar flexion 85°), with no significant pain, and the patient could participate in experimental courses and club activities, although slight soreness was still felt when lifting heavy objects. No allergic reactions such as skin redness or itching occurred throughout the entire course.

[0108] Case 4: Acute ankle sprain with soft tissue swelling

[0109] Chief complaint: Pain and swelling in the left ankle for 4 hours after a sprain.

[0110] Present Illness: The patient is a resident physician in the internal medicine department of a hospital. Four hours prior to the incident, after working the night shift, due to a malfunction in the stairwell lights, he accidentally missed a step while descending the stairs, causing his left foot to roll inward and land on its own. He immediately experienced severe pain in his left ankle, which quickly became swollen. The pain worsened with walking. There was no skin breakage or bleeding, and he experienced no dizziness or altered consciousness. After applying ice for one hour without significant relief, he sought medical attention at the emergency department of this hospital to determine the cause. Since the injury, his mental state has been good, and his appetite and bowel movements have been normal.

[0111] Physical examination: Temperature 36.6℃, pulse 80 bpm, respiratory rate 18 bpm, blood pressure 122 / 78 mmHg. The patient is alert and in good spirits. A 3cm x 4cm area of ​​redness and swelling is visible on the medial aspect of the left ankle, with local skin temperature approximately 1℃ higher than the contralateral side. Tenderness (+++) is present at the tip of the medial malleolus, with pain worsening upon inversion of the ankle and limited eversion and flexion / extension movements. Sensation in the left foot is normal, and the dorsalis pedis artery pulse is strong, indicating good peripheral blood supply.

[0112] Auxiliary examination: X-ray of the left ankle joint (anteroposterior and lateral views) (Our hospital, 2025-11-02): The medial malleolus, lateral malleolus and talus cortex are continuous, with no signs of fracture or joint dislocation, and obvious soft tissue swelling.

[0113] Diagnosis: Acute sprain of the left ankle with soft tissue swelling

[0114] Medication regimen: After ruling out fractures in the emergency room, patients should use the product independently based on their own medical background and understanding of the efficacy data from the product's development phase. After cleaning the affected skin, apply an appropriate amount of the product evenly to the red and swollen area three times daily. After application, elevate the affected limb and rest for 30 minutes. Change into flat, non-slip shoes while working to reduce the frequency of walking within the ward. Observe changes in the condition and skin reaction during rest time.

[0115] Feedback on treatment efficacy: After 1 day of medication: ankle swelling had slightly subsided, and pain had lessened (tenderness reduced to ++), allowing for short, slow walking to complete ward rounds; After 4 days of medication: redness and swelling had largely subsided, tenderness was (±), there was no significant pain while walking, and the range of motion of the ankle joint had improved; After 6 days of medication: the function of the affected area had basically returned to normal, allowing for normal night shifts and daily clinical work, with occasional mild, dull pain after prolonged walking, which could be relieved by rest. Due to concerns about medication safety, close monitoring was maintained throughout the course, and no adverse reactions occurred.

[0116] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating musculoskeletal pain, characterized in that, The raw materials, by weight, are: rhubarb 8-12, honeysuckle 3-6, dandelion 8-10, red peony root 3-5, gardenia 8-10, cyperus rhizome 6-8, angelica root 3-5, angelica dahurica root 5-7, peppermint 1-3, turmeric 2-5, and notopterygium root 2-4.

2. The traditional Chinese medicine composition for treating musculoskeletal pain according to claim 1, characterized in that, The raw materials, by weight, are: rhubarb 10, honeysuckle 5, dandelion 8, red peony root 4, gardenia 10, cyperus rhizome 8, angelica root 4, angelica dahurica root 5, peppermint 3, turmeric 4, and notopterygium root 2.

3. The traditional Chinese medicine composition for treating musculoskeletal pain according to claim 1 or 2, characterized in that, The herbal composition is a traditional Chinese medicine preparation.

4. The traditional Chinese medicine composition for treating musculoskeletal pain according to claim 3, characterized in that, The traditional Chinese medicine preparation is an ointment.

5. The method for preparing the traditional Chinese medicine composition for treating musculoskeletal pain according to claim 4, characterized in that, The preparation steps of the traditional Chinese medicine preparation include: S1: Extracting the effective components from traditional Chinese medicine compound formulas; S2: Ethyl cellulose microcapsules were prepared using an emulsification-solvent evaporation method; S3: Microcapsule cream molding.

6. The method for preparing the traditional Chinese medicine composition for treating musculoskeletal pain according to claim 5, characterized in that, Step S1 includes the following sub-steps: S11, Raw material pretreatment: Wash the 11 compound medicinal materials, dry them at 60℃ until the moisture content is ≤8%, and pulverize them through an 80-mesh sieve; store them in two groups: Group 1 contains peppermint, notopterygium root, and turmeric, and Group 2 contains the remaining 8 medicinal materials. S12, volatile oil extraction: Take the medicinal material from group 1, add 8 times the amount of purified water, steam distill at 105℃ and 0.12MPa for 2.5h, collect the upper volatile oil using an oil-water separator, filter it through a 0.22μm filter membrane, refrigerate at 4℃ for later use, and retain the residue. S13, Extraction of polar components: Take the medicinal materials from group 2 and the residue from group 1, add 8 times the amount of 70% ethanol, and reflux at 80℃ twice. Combine the extracts and filter them through a 0.45μm filter cloth. Concentrate the filtrate under reduced pressure at 50℃ to obtain an extract with a relative density of 1.20-1.25 (measured at 60℃). Vacuum dry at 60℃ until the moisture content is ≤5%, and pulverize it through an 80-mesh sieve to obtain a dry powder of polar components. S14, Preparation of compound drugs: Mix the volatile oil and the dry powder of polar components at a mass ratio of 1:100, stir at 2000r / min for 10min to obtain a uniform compound drug mixture.

7. The method for preparing the traditional Chinese medicine composition for treating musculoskeletal pain according to claim 5, characterized in that, Step S2 includes the following sub-steps: S21, Oil phase preparation: Take EC according to the ratio, add a mixed solvent of dichloromethane and ethanol, stir at 800 r / min for 30 min until completely dissolved; add the compound drug mixture, continue stirring for 10 min to obtain the drug-EC oil phase; S22, Aqueous phase preparation: Take an appropriate amount of purified water, add the required amount of Tween 80, and stir until dissolved to obtain the aqueous phase; S23, Emulsification and Encapsulation: The oil phase is slowly injected into the aqueous phase, and high-speed shear emulsification is performed at 8000 r / min for 15 min to form an O / W emulsion; the solvent is removed by rotary evaporation under reduced pressure at 35℃ for 30 min, and microcapsules are precipitated. S24, Microcapsule purification: Collect microcapsules by centrifugation at 3000 r / min for 10 min, wash twice with purified water, vacuum dry at 50℃ for 4 h, and pass through a 100-mesh sieve to obtain compound EC microcapsules.

8. The method for preparing the traditional Chinese medicine composition for treating musculoskeletal pain according to claim 5, characterized in that, Step S3 includes the following sub-steps: S31, Oil phase preparation: Take petrolatum, liquid paraffin and stearic acid in proportion, heat to 75-80℃ to melt, and stir evenly; S32, Aqueous phase preparation: Take purified water, add the appropriate amounts of glycerol, triethanolamine, and ethylparaben, heat to 75-80℃ to dissolve, and stir until homogeneous; S33, Matrix emulsification: Inject the aqueous phase into the oil phase and homogenize at 8000 r / min for 15 min to form a uniform O / W matrix; S34, Microcapsule Dispersion: After the matrix cools down to below 40℃, add compound EC microcapsules and the required amount of azone, homogenize at 5000r / min for 5min, adjust the pH to 6.0-7.0, and cool to room temperature to obtain the finished product.

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