A pharmaceutical composition, preparation and its preparation method and application for assisting in treating chronic soft tissue injury disease

Abstract

The application provides a kind of drug composition, preparation and its preparation method and application for assisting treatment chronic soft tissue injury disease, the drug composition of the application is developed into Lifa paste by using Lijia such as descending true incense, centipede, etc., its preparation method is to process each raw material respectively, the composition can be made into external use gel ointment, the drug composition is stirred under pulsed electric field and is added to the matrix solvent containing olive oil, propylene glycol and various components.Treatment of chronic soft tissue injury, evaluation of clinical efficacy, evaluation of safety and side effects. Formulate Lifa paste standard preparation process. The technical problems to be solved include formula optimization, preparation process standardization, efficacy evaluation method, aiming at inheriting and developing Lizu medicine culture, improving the application value of Liju in modern medicine. To explore the mechanism of Lifa paste in treating chronic soft tissue injury and provide clinical data support for the next step, promote the development of Liju.

Description

Technical Field

[0001] The present invention relates to the technical field of drug preparation, and in particular to a drug composition and preparation for auxiliary treatment of chronic soft tissue injury diseases, as well as a preparation method and application thereof. Background Art

[0002] Chronic soft tissue injuries are common clinical conditions, often caused by factors such as long-term strain, prolonged trauma, or the invasion of wind, cold, and dampness, leading to localized blood stasis and meridian blockage, resulting in pain, swelling, and functional impairment. In modern society, the fast-paced pace of life and increasing work pressures lead to chronic soft tissue injuries such as neck, shoulder, waist, and leg pain. These conditions are often caused by factors such as prolonged sitting, lack of exercise, staying up late at work, craving for cool air, and improper diet.

[0003] Currently, there are various clinical approaches to treating chronic soft tissue injuries, with medication being a common approach. While Western medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) like Voltaren ointment, can alleviate pain and inflammation to a certain extent, they have limitations. These medications may cause adverse reactions such as gastrointestinal discomfort and liver and kidney damage. Long-term use can also lead to increased drug tolerance and a gradual decrease in efficacy. Furthermore, for some underlying issues caused by chronic injuries, such as tissue adhesions and muscle atrophy, Western medication alone is unlikely to fundamentally address them.

[0004] While traditional Chinese medicine offers advantages in treating chronic soft tissue injuries, existing TCM preparations also have shortcomings. Some formulations are relatively simple, failing to fully address the complex pathological mechanisms of chronic soft tissue injuries. Firstly, it's difficult to fully extract the active ingredients from the medicinal herbs, resulting in unstable efficacy. Secondly, they suffer from deficiencies such as poor transdermal absorption and uncontrollable drug release rates, making it difficult to meet the diverse clinical needs for treating chronic soft tissue injuries. Summary of the Invention

[0005] In view of this, the present invention proposes a pharmaceutical composition, a preparation, a preparation method and an application thereof for assisting in the treatment of chronic soft tissue injury diseases to solve the above problems.

[0006] The technical solution of the present invention is achieved as follows: a pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases, comprising the following raw materials in parts by weight: 1-2 parts of agarwood, 1-2 parts of centipede, 1-3 parts of smilax glabra, 2-4 parts of dragon palm blood, 1-3 parts of crocodile mouth flower, and 1-3 parts of golden coin.

[0007] Furthermore, a pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases comprises the following raw materials in parts by weight: 1 part of agarwood, 1 part of centipede, 2 parts of clematis, 3 parts of dragon palm blood, 2 parts of crocodile mouth flower, and 2 parts of golden coin.

[0008] Furthermore, a method for preparing a pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases comprises the following steps.

[0009] S1, remove centipede impurities, head and feet, wash with clean water, adopt low temperature drying, crush, pass through 80-100 mesh sieve, obtain centipede powder;

[0010] S2, collect the root or stem part of the dragon palm blood, wash, remove impurities, dry, dry at 40-50 ℃, crush through a 50-80 mesh sieve, add a mass concentration of 70-80% ethanol solution, the mass volume ratio g / ml is 1:8-10, reflux extraction 2-3 times, each time 1.5-2 hours, after the extraction is completed, filter and combine the extracts, concentrate to obtain the dragon palm blood extract, dry it, and set aside;

[0011] S3, grinding the agarwood into coarse powder, adding water, with a mass volume ratio of g / ml of 2-5:10, and performing microwave extraction for 15-25 minutes at a microwave power of 600-800 W. After the extraction, filtering and concentrating the extract to obtain the agarwood extract;

[0012] S4. Take the dried product of crocodile mouth flower, wash and dry it, grind it into coarse powder, put it into a percolation cylinder, slowly add ethanol solution with a mass concentration of 60-90, the mass volume ratio g / ml is 1-3:8, and the percolation rate is 1-3mL / min. The initial percolation liquid is continued to be poured into the percolation cylinder and circulated for 3-6 times. The percolation liquid is collected and concentrated to obtain the crocodile mouth flower percolate;

[0013] S5, drying the Herba Lycopodii flavescentis and grinding it into fine powder, loading it into a supercritical extraction kettle for supercritical carbon dioxide extraction, adding a 5-10% mass concentration of ethanol solution, extracting for 1-3 hours, and separating under reduced pressure to obtain the Herba Lycopodii flavescentis extract;

[0014] S6. After crushing the scutellaria baicalensis, adding a citric acid-sodium citrate buffer solution with a pH of 4.5-5.5 and soaking for 2-5 hours, adding 0.5-1% complex enzyme by weight of the powder, and performing enzymolysis at a temperature of 40-50° C. for 1-3 hours. After the enzymolysis is completed, heating the mixture to 80-90° C. to inactivate the enzyme to obtain an enzymatic solution, and continuing to add ethyl acetate with a mass concentration of 60-80%, and performing ultrasonic-assisted extraction at an ultrasonic power of 200-300 W for 30-40 min to obtain a scutellaria baicalensis extract;

[0015] S7. Mix the centipede powder, the dragon palm blood extract, the agarwood extract, the crocodile mouth flower percolate and the clematis extract to obtain a pharmaceutical composition.

[0016] Furthermore, the parameters of the supercritical carbon dioxide extraction in S5 are: temperature 40-60° C., pressure 20-30 MPa, and carbon dioxide flow rate 20-30 kg / h.

[0017] Furthermore, the S6 complex enzyme is cellulase and pectinase in a mass ratio of 1-3:5.

[0018] Furthermore, the Chinese medicine composition prepared by the above preparation method is added with acceptable excipients to prepare an external-use gel ointment, namely Li Gaotie.

[0019] Furthermore, the topical gel ointment is prepared by placing the pharmaceutical composition under a pulsed electric field and stirring at a stirring rate of 300-500 rpm, adding a matrix solvent during the stirring process until a paste is formed, and the mass volume ratio of the pharmaceutical composition to the matrix solvent g / mL is 1-5:10. The prepared paste is evenly coated on a non-woven fabric with a coating thickness of 1-3 mm, and then cut and packaged to obtain a topical gel ointment.

[0020] Furthermore, the matrix solvent is 10-20 parts of olive oil, 5-10 parts of propylene glycol, 3-6 parts of sodium polyacrylate, 1-3 parts of polylactic acid-glycolic acid copolymer, 10-20 parts of kaolin, 5-10 parts of micropowder silica gel, and 40-60 parts of water.

[0021] Furthermore, the pulse electric field strength is 30-80 kV / cm, and the pulse frequency is 50-200 Hz.

[0022] Furthermore, the pharmaceutical composition is used in the preparation of auxiliary treatments for chronic soft tissue injury diseases.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] The prescription of the present invention is demonstrated as follows: the prescription uses centipede as the main drug, which is warm in nature, pungent in taste, and toxic. Insect drugs can remove wind, dredge meridians, and relieve pain, attack toxins and disperse stagnation, and directly reach the affected area. It plays a key role in quickly relieving pain, reducing swelling and removing blood stasis for the symptoms of meridian blockage and blood stasis caused by chronic soft tissue injury. The auxiliary drug is Feilong Zhangxue, which is warm in nature, pungent and slightly bitter in taste, and has low toxicity. It can dispel wind, relieve pain, disperse blood stasis, stop bleeding, and remove toxins and reduce swelling. It cooperates with the main drug centipede to further enhance the effects of dredging meridians, relieving pain, promoting blood circulation, removing blood stasis, and removing toxins and reducing swelling, and has a good effect on the conditions of blood stasis, swelling and pain that are difficult to eliminate, etc. in the injured area. The formula is combined with Radix Achyranthis Bidentatae, which is slightly warm in nature and sweet in taste, and mainly dispels wind-dampness, strengthens the waist and knees, and helps to dredge the meridians. It mainly assists the monarch and ministerial herbs in dredging the meridians and regulating Qi and blood. At the same time, its effect of strengthening the waist and knees helps to improve the symptoms of soreness and weakness in the waist and knees, and poor mobility caused by chronic soft tissue injuries involving the tissues around the waist and lower limb joints, thereby enhancing the overall therapeutic effect. Agarwood is mild in nature and sweet in taste, and can dispel wind, activate blood circulation, regulate Qi and relieve pain. Crocodile mouth flower is cool in nature and slightly bitter in taste, and mainly promotes blood circulation, relaxes muscles, clears heat and removes dampness. Glehnia littoralis is cold in nature, bitter in taste, and slightly toxic, and mainly clears heat, detoxifies and relieves pain. These three herbs assist the monarch and ministerial herbs, on the one hand, further promoting the circulation and dredging of Qi and blood, and on the other hand, can clear heat and remove dampness, detoxify, prevent the heat and toxicity caused by the stagnation of Qi and blood in the injured area, avoid further development of inflammation, and relieve discomfort such as redness, swelling, heat and pain in the injured area, making the whole formula more comprehensive and balanced in the treatment of chronic soft tissue injuries. The whole formula has the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relieving pain.

[0025] In terms of preparation technology, by adopting targeted extraction methods for each medicinal material, including ethanol reflux extraction of Feilong Palm blood, microwave extraction of Aquilaria resina, percolation extraction of Crocodile Mouth Flower, supercritical carbon dioxide extraction of Tripterygium wilfordii, and enzymatic hydrolysis combined with ultrasound-assisted extraction of Artemisia selengensis, the effective ingredients in the medicinal materials can be efficiently extracted, the purity and concentration of the drugs can be improved, and thus the efficacy of the drugs can be enhanced.

[0026] The prepared external-use gel ointment adopts a process combining stirring under a pulsed electric field with a specific matrix solvent, which not only enables the drug composition to be evenly dispersed in the matrix, but also facilitates transdermal absorption of the drug, allowing the drug to continuously and stably act on the injured area, thereby improving the drug's bioavailability. Furthermore, the use of pure herbal plants has the characteristics of high safety and application value, no side effects, strong operability, low cost, and is suitable for the general public. In summary, the pharmaceutical composition and preparation of the present invention provide a new safe, effective, multi-target action option for the treatment of chronic soft tissue injuries, contribute to the formation of theories of prevention and treatment in Li medicine, and promote them to clinical application, with broad application prospects. DETAILED DESCRIPTION

[0027] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0028] Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods.

[0029] Unless otherwise specified, the materials, reagents, etc. used in the examples of the present invention can be obtained from commercial sources.

[0030] The following is an introduction to the basic information of the main raw materials based on the "Chinese Pharmacopoeia", "Chinese Materia Medica Dictionary", "Li Medicine and Li Medicine", and "Li Nationality Pharmacopoeia":

[0031] Agarwood: Pungent, warm in nature, enters the Liver and Spleen meridians. Functions: Removes blood stasis, stops bleeding, regulates Qi, and relieves pain.

[0032] Centipede: warm in nature, pungent in taste, enters the Liver Channel. Functions and indications: calms wind and calms spasms, dredges meridians and relieves pain, attacks toxins and disperses stagnation.

[0033] Qianjinba: slightly warm in nature, sweet and mild in taste, enters the lung and kidney meridians. Functions and indications: relaxes muscles and strengthens bones, astringes the lungs and clears the throat.

[0034] Feilong Zhangxue: Warm in nature, pungent and slightly bitter in taste, enters the spleen and stomach meridians. Functions and indications: dispels wind and relieves pain, disperses blood stasis and stops bleeding.

[0035] Crocodile Mouth Flower: Cool in nature, slightly bitter in taste, enters the Liver and Kidney meridians. Functions and indications: Clears heat and dampness, reduces swelling and relieves pain, disperses blood stasis and stops bleeding.

[0036] Golden Buds: Cold in nature, bitter in taste, enters the Liver and Stomach meridians. Functions and indications: Disperses blood stasis and stops bleeding, reduces swelling and relieves pain, nourishes and strengthens the body. Example 1

[0037] A pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases comprises the following raw materials in parts by weight: 1 part of agarwood, 1 part of centipede, 1 part of clematis, 2 parts of dragon palm blood, 1 part of crocodile mouth flower, and 1 part of golden coin. Example 2

[0038] A pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases comprises the following raw materials in parts by weight: 2 parts of agarwood, 2 parts of centipede, 3 parts of clematis, 4 parts of dragon palm blood, 3 parts of crocodile mouth flower, and 3 parts of golden coin. Example 3

[0039] A pharmaceutical composition for assisting in the treatment of chronic soft tissue injury diseases, comprising the following raw materials in parts by weight: 1 part of agarwood, 1 part of centipede, 2 parts of scutellaria baicalensis, 3 parts of dragon palm blood, 2 parts of crocodile mouth flower, and 2 parts of golden jewel;

[0040] The above examples 1-3 adopt the following preparation method:

[0041] S1, remove centipede impurities, head and feet, wash with clean water, adopt low temperature drying, crush, pass through 100 mesh sieve, obtain centipede powder;

[0042] S2. Collect the root or stem of the dragon palm blood, wash it, remove impurities, dry it, dry it at 45 ° C, crush it through an 80-mesh sieve, add a 75% ethanol solution with a mass volume ratio of g / ml of 1:9, and reflux extract it 3 times, each time for 2 hours. After the extraction is completed, filter and combine the extracts, concentrate them to obtain the dragon palm blood extract, and dry it for standby use;

[0043] S3, grinding the agarwood into coarse powder, adding water, the mass volume ratio g / ml is 3:10, using microwave extraction for 20 minutes, the microwave power is 800W, after the extraction is completed, filtering and concentrating the extract to obtain the agarwood extract;

[0044] S4. Take the dried product of crocodile mouth flower, wash and dry it, grind it into coarse powder, put it into a percolation cylinder, slowly add ethanol solution with a mass concentration of 80, the mass volume ratio g / ml is 2:8, and the percolation rate is 2mL / min. The initial percolate is continued to be poured into the percolation cylinder and percolated 5 times. The percolate is collected and concentrated to obtain the crocodile mouth flower percolate;

[0045] S5, after drying the Herba Lycopodii, crush it into fine powder, put it into a supercritical extraction kettle for supercritical carbon dioxide extraction, add 8% ethanol solution by mass concentration, supercritical carbon dioxide extraction temperature 50 ° C, pressure 25 MPa, carbon dioxide flow rate 25 kg / h, extraction for 2 h, and vacuum separation to obtain the Herba Lycopodii extract;

[0046] S6, after crushing the smilax chinaii, adding a citric acid-sodium citrate buffer solution of pH 5 and soaking for 3 hours, adding 0.8% complex enzyme of the powder mass, the complex enzyme is cellulase and pectinase in a mass ratio of 2: 5, the enzymatic hydrolysis temperature is 45 ° C, the enzymatic hydrolysis is 2h, after the enzymatic hydrolysis is completed, the temperature is raised to 85 ° C to inactivate the enzyme to obtain an enzymatic solution, and ethyl acetate with a mass concentration of 70% is continued to be added, and ultrasonic-assisted extraction is performed with an ultrasonic power of 250W and a time of 35min to obtain the smilax chinaii extract;

[0047] S7. Mix the centipede powder, the dragon palm blood extract, the agarwood extract, the crocodile mouth flower percolate and the clematis extract to obtain a pharmaceutical composition. Example 4

[0048] The pharmaceutical compositions of Examples 1-3 above were added with acceptable excipients respectively to prepare external-use gel ointments, wherein the pharmaceutical composition was placed under a pulsed electric field and stirred, with a pulsed electric field strength of 50 kV / cm, a pulse frequency of 100 Hz, and a stirring rate of 400 rpm. A matrix solvent was added during the stirring process until a paste was formed, and the mass volume ratio of the pharmaceutical composition to the matrix solvent (g / mL) was 3:10. The prepared paste was evenly coated on a non-woven fabric with a coating thickness of 2 mm, and the paste was cut and packaged to obtain an external-use gel ointment, namely "Li Gaotie".

[0049] The matrix solvent is 15 parts of olive oil, 8 parts of propylene glycol, 4 parts of sodium polyacrylate, 12 parts of polylactic acid-glycolic acid copolymer, 15 parts of kaolin, 8 parts of micropowder silica gel and 50 parts of water.

[0050] The external-use gel ointment prepared in the above embodiment is applied clinically:

[0051] 1. Study Cases

[0052] (1) Case source and collection time

[0053] From May to November 2024, a total of 132 patients with chronic soft tissue injuries who visited the Li Medicine Clinic and Orthopedic Clinic of Hainan Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine and were recruited into the group were included in strict accordance with the standards of this study.

[0054] (2) Sample size calculation

[0055] This study was a randomized controlled trial, with the efficacy of the subjects as the observed outcome measure. The estimated efficacy rates were 98.67% in the observation group and 85.33% in the control group. With a two-sided α of 0.05 and a power of 90%, the PASS21 software was used to calculate the sample size (N1) of 55 subjects in the observation group and N2 of 55 subjects in the control group. Taking into account the 20% loss to follow-up and refusal to follow-up, the final number of subjects required was 66 in each group, for a total of 132 subjects.

[0056] 2. Research Standards

[0057] (1) Traditional Chinese Medicine diagnostic criteria

[0058] Refer to the 2002 "Guiding Principles for Clinical Research of New Chinese Medicines" (Trial Implementation) and the diagnostic criteria for chronic soft tissue injuries in the national higher education textbook for the traditional Chinese medicine industry, "Training of Muscles and Muscles":

[0059] ① History of chronic continuous strain (long-term labor with bad posture, work or bad living habits causing excessive exertion of a certain part of the body for a long time);

[0060] ②Disease duration ≥ 14 days;

[0061] ③Local pain or swelling, dysfunction, muscle atrophy.

[0062] (2) Western medicine diagnostic criteria

[0063] Refer to the diagnosis standard of chronic injury of the motor system (chronic soft tissue injury) in the 9th edition of the textbook of surgery of national colleges and universities: ① long-term chronic pain at the site of onset, no clear history of trauma; ② there are tender points or lumps in the affected area, often accompanied by certain special signs; ③ no obvious acute inflammatory manifestations in the local area; ④ there is a history of overactivity related to the pain site in the recent period; ⑤ some patients have bad posture, work habits or occupation history.

[0064] (3) Inclusion criteria

[0065] ① Meet the above diagnostic criteria of traditional Chinese and Western medicine; ② Age 18-65 years old; ③ The subject is aware of the treatment plan of this study and voluntarily signs the informed consent form.

[0066] (4) Exclusion criteria

[0067] ① Not in line with the above diagnostic criteria of traditional Chinese and Western medicine; ② Within 2 weeks before entering the study, there are those who use blood-activating and collateral-dredging, Shujin pain-relieving drugs; ③ Fracture or open injury; ④ Infection, gouty arthritis and other acute attacks; ⑤ Lactation or pre-pregnancy women; ⑥ Allergic to external drugs; ⑤ Combined with other serious systemic diseases and patients with mental illness.

[0068] (5) Exclusion, dropout and termination criteria

[0069] ① Poor compliance, who arbitrarily use other drugs or receive other treatments during the study; ② Those who cannot cooperate with treatment and related examination due to their own reasons, affecting the determination of efficacy; ③ Those who have serious adverse reactions during treatment, such as severe allergy, symptom aggravation, etc.; ④ Those who have not received any treatment after entering this study or cannot obtain any clinical data after treatment.

[0070] 3. Research methods

[0071] (1) Design grouping

[0072] Using randomized controlled research method, 132 patients who meet the research criteria are divided into control group and observation group by simple random number table method, 66 cases in each group.

[0073] (2) Trial scheme

[0074] ① Control group: Apply Voltaren Ointment (National Medicine Standard No. H19990291) to the affected area three times daily for two weeks. Observation group: Apply "Li Gaotie," a Li medicine clinic's clinical formula, to the affected area five times a week, once daily, with one patch applied to each affected area (depending on the number and area of ​​affected areas). Each application lasts for six hours, for a total course of two weeks and ten treatments. "Li Gaotie" preparation: The topical gel ointment prepared according to the method of Example 4 in Example 3 of the present invention was used. 20,000 patches were prepared.

[0075] ② Efficacy and Safety Evaluation: Efficacy was evaluated at 7 and 14 days after the start of treatment. Adverse events during treatment were also observed. Efficacy evaluation indicators included the reduction in pain VAS score and the difference in Traditional Chinese Medicine (TCM) syndrome score. (The modified Wong-Baker facial expression pain assessment was used.) The reduction in pain VAS score was calculated as the post-treatment pain VAS score minus the pre-treatment pain VAS score. A TCM syndrome score scale was developed, using the 2002 "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (Trial Implementation). Symptoms and signs were graded using the Soft Tissue Injury Symptom Grading Scale. The difference in TCM syndrome score was calculated as the pre-treatment TCM syndrome score minus the post-treatment TCM syndrome score. Safety evaluation indicators included physical examination, vital signs, blood count, liver function tests, and renal function tests. Adverse events were also recorded throughout the treatment process.

[0076] ③ Efficacy Criteria: Referencing the 2002 "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (Trial Implementation), the criteria for cure, marked effect, effectiveness, and ineffectiveness were determined based on the reduction rate of TCM syndrome score (n). Cure: n ≥ 95%; marked effect: 70% ≤ n < 95%; effectiveness: 30% ≤ n < 70%; ineffectiveness: n < 30%. (n = [(pre-treatment score - post-treatment score) ÷ pre-treatment score]) × 100%). Total effective rate = cure rate + marked effective rate + effective rate.

[0077] ④ Statistical methods: SPSS 26.0 statistical software was used for data analysis. Count data were compared using the χ2 test; measurement data followed a normal distribution with homogeneous variance and were expressed as mean ± standard deviation ( ), independent sample t-tests were used for comparisons between groups, and paired t-tests were used for comparisons within groups. Measurement data that did not follow a normal distribution were expressed as [M(P25, P75)]. Nonparametric tests were used for comparisons within and between groups. P < 0.05 indicated statistical significance.

[0078] 4. Research results.

[0079] Table 1: Efficacy evaluation results

[0080] Control group (Voltaren ointment) Observation group (Li plaster) Reduction in pain VAS score after 7 days of treatment (points) 2.5±1.2 3.2±1.5 Reduction in pain VAS score after 14 days of treatment (points) 4.1±1.8 5.5±2.0 Difference in TCM syndrome scores after 7 days of treatment 3.0±1.3 4.0±1.6 Difference in TCM syndrome scores after 14 days of treatment 6.5±2.0 9.0±2.5

[0081] Table 2: Efficacy evaluation results

[0082] Number of cases Cured (case) Significantly effective (example) Valid (example) Invalid (Example) Total effective rate (%) control group 66 30 25 7 4 93.94 Observation Group 66 45 10 10 1 98.48

[0083] The observation group performed better in various efficacy evaluation indicators, with a total effective rate of 98.48%, further demonstrating that the Li Gaotie of the present invention has a better effect in treating chronic soft tissue injuries than the control group.

[0084] Table 3: Safety evaluation

[0085] Abnormal physical examination (cases) Abnormal vital signs (cases) Abnormal blood test results (cases) Abnormal liver function (cases) Abnormal renal function (cases) Adverse reaction events (cases) control group 3 0 1 1 0 5 Observation Group 0 0 0 0 0 0

[0086] During treatment in the observation group, no serious adverse events occurred. Blood routine, liver function, and kidney function tests were normal. Physical examination and vital sign indicators were all within normal ranges.

[0087] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A topical pharmaceutical composition for auxiliary treatment of chronic soft tissue injuries, characterized by: The invention is prepared from the following raw materials in parts by weight: 1-2 parts of agarwood, 1-2 parts of centipede, 1-3 parts of smilax glabra, 2-4 parts of dragon palm blood, 1-3 parts of crocodile mouth flower and 1-3 parts of golden basil.

2. The external-use pharmaceutical composition for assisting the treatment of chronic soft tissue injuries according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 1 part of agarwood, 1 part of centipede, 2 parts of clematis, 3 parts of dragon palm blood, 2 parts of crocodile mouth flower and 2 parts of golden basil.

3. The method for preparing the external-use pharmaceutical composition for assisting the treatment of chronic soft tissue injuries according to claim 1, wherein: The following steps are involved: S1, remove centipede impurities, head and feet, wash with clean water, adopt low temperature drying, crush, pass through 80-100 mesh sieve, obtain centipede powder; S2, collect the root or stem part of the dragon palm blood, wash, remove impurities, dry, dry at 40-50 ℃, crush through a 50-80 mesh sieve, add a mass concentration of 70-80% ethanol solution, the mass volume ratio g / ml is 1:8-10, reflux extraction 2-3 times, each time 1.5-2 hours, after the extraction is completed, filter and combine the extracts, concentrate to obtain the dragon palm blood extract, dry it, and set aside; S3, grinding the agarwood into coarse powder, adding water, with a mass volume ratio of g / ml of 2-5:10, and performing microwave extraction for 15-25 minutes at a microwave power of 600-800 W. After the extraction, filtering and concentrating the extract to obtain the agarwood extract; S4. Take the dried product of crocodile mouth flower, wash and dry it, grind it into coarse powder, put it into a percolation cylinder, slowly add ethanol solution with a mass concentration of 60-90, the mass volume ratio g / ml is 1-3:8, and the percolation rate is 1-3mL / min. The initial percolation liquid is continued to be poured into the percolation cylinder and circulated for 3-6 times. The percolation liquid is collected and concentrated to obtain the crocodile mouth flower percolate; S5, drying the Herba Lycopodii flavescentis and grinding it into fine powder, loading it into a supercritical extraction kettle for supercritical carbon dioxide extraction, adding a 5-10% mass concentration of ethanol solution, extracting for 1-3 hours, and separating under reduced pressure to obtain the Herba Lycopodii flavescentis extract; S6. After crushing the scutellaria baicalensis, adding a citric acid-sodium citrate buffer solution with a pH of 4.5-5.5 and soaking for 2-5 hours, adding 0.5-1% complex enzyme by weight of the powder, and performing enzymolysis at a temperature of 40-50° C. for 1-3 hours. After the enzymolysis is completed, heating the mixture to 80-90° C. to inactivate the enzyme to obtain an enzymatic solution, and continuing to add ethyl acetate with a mass concentration of 60-80%, and performing ultrasonic-assisted extraction at an ultrasonic power of 200-300 W for 30-40 min to obtain a scutellaria baicalensis extract; S7. Mix the centipede powder, the dragon palm blood extract, the agarwood extract, the crocodile mouth flower percolate and the clematis extract to obtain a pharmaceutical composition.

4. The method for preparing a topical pharmaceutical composition for auxiliary treatment of chronic soft tissue damage according to claim 3, characterized in that: The parameters of the supercritical carbon dioxide extraction in step S5 are: temperature 40-60° C., pressure 20-30 MPa, and carbon dioxide flow rate 20-30 kg / h.

5. The method for preparing the external-use pharmaceutical composition for assisting in the treatment of chronic soft tissue damage according to claim 3, wherein: The complex enzyme in step S6 is composed of cellulase and pectinase in a mass ratio of 1-3:

5.

6. A pharmaceutical preparation for the adjuvant treatment of chronic soft tissue injuries, characterized in that: The external-use Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 5 is added with acceptable excipients to prepare an external-use gel ointment.

7. The pharmaceutical preparation for assisting in the treatment of chronic soft tissue injuries according to claim 6, characterized in that: The topical gel ointment is prepared by placing a pharmaceutical composition under a pulsed electric field and stirring at a stirring rate of 300-500 rpm, adding a matrix solvent during the stirring process until a paste is formed, wherein the mass volume ratio of the pharmaceutical composition to the matrix solvent is 1-5:10 in g / mL, and evenly coating the prepared paste on a non-woven fabric with a coating thickness of 1-3 mm, cutting and packaging the paste to obtain the topical gel ointment.

8. The pharmaceutical preparation for assisting in the treatment of chronic soft tissue injuries according to claim 7, characterized in that: The matrix solvent comprises 10-20 parts of olive oil, 5-10 parts of propylene glycol, 3-6 parts of sodium polyacrylate, 1-3 parts of polylactic acid-glycolic acid copolymer, 10-20 parts of kaolin, 5-10 parts of micropowder silica gel and 40-60 parts of water.

9. The pharmaceutical preparation for assisting in the treatment of chronic soft tissue injuries according to claim 7, characterized in that: The pulse electric field strength is 30-80 kV / cm, and the pulse frequency is 50-200 Hz.

10. Use of the external-use pharmaceutical composition according to claim 1 or 2 in the preparation of an external-use medicament for auxiliary treatment of chronic soft tissue injuries.