Pharmaceutical composition and preparation for adjuvant treatment of chronic soft tissue injury disease as well as preparation method and application of pharmaceutical composition and preparation

Abstract

The invention provides a pharmaceutical composition and a preparation for adjuvant therapy of chronic soft tissue injury diseases, and a preparation method and application thereof, the pharmaceutical composition is prepared into a Li plaster by adopting Li medicines such as acronychia pedunculata and centipede, the preparation method comprises the following steps: respectively treating the raw materials, and the composition can be prepared into an external gel ointment, and can be used for treating the chronic soft tissue injury diseases. The pharmaceutical composition is stirred under a pulsed electric field, and a matrix solvent containing olive oil, propylene glycol and other components is added. Chronic soft tissue injury is treated, clinical curative effect is evaluated, and safety and side effects are evaluated. And formulating a standard preparation process of the mucuna plaster. The technical problems to be solved comprise formula optimization, preparation process standardization and a curative effect evaluation method, and aims at inheriting and developing Rieguan medicine culture and improving the application value of Li medicine in modern medicine. Clinical data support is provided for further exploring the mechanism of treating chronic soft tissue injury by the Li plaster, and exploration and development of Li medicine are promoted.

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 assisting in the treatment of chronic soft tissue injury diseases, and a preparation method and application thereof. Background Art

[0002] Chronic soft tissue injury is a common clinical disease, which is mostly caused by long-term strain, prolonged trauma or invasion of wind, cold and dampness, leading to local blood stasis and meridian obstruction, and then pain, swelling, functional impairment and other manifestations. In modern society, with the tense pace of life and increasing work pressure, people sit for a long time and do not exercise much, stay up late at work, crave coolness, improper diet and other reasons, leading to the occurrence of chronic soft tissue injury diseases such as neck, shoulder, waist and leg pain.

[0003] At present, there are various methods for treating chronic soft tissue injuries clinically, among which drug treatment is one of the commonly used methods. Western medicines such as non-steroidal anti-inflammatory drugs such as Voltaren ointment can relieve pain and inflammation to a certain extent, but they have some limitations. Such drugs may cause adverse reactions such as gastrointestinal discomfort and liver and kidney damage. Long-term use may also lead to increased drug tolerance and gradually reduced efficacy. Moreover, for some deep-seated problems such as tissue adhesion and muscle atrophy caused by chronic injuries, simple Western medicine treatment is difficult to fundamentally improve.

[0004] Traditional Chinese medicine has certain advantages in the treatment of chronic soft tissue injuries, but existing Chinese medicine preparations also have shortcomings. The formula composition of some Chinese medicine preparations is relatively simple and cannot fully play a role in the complex pathological mechanism of chronic soft tissue injuries. First, it is difficult to fully obtain the effective ingredients in the medicinal materials, resulting in unstable drug efficacy. Second, there are defects such as poor transdermal absorption and uncontrollable drug release rate, which makes it difficult to meet the diverse clinical needs for the treatment of 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 the treatment of chronic soft tissue injury diseases to solve the above-mentioned problems.

[0006] The technical solution of the present invention is achieved as follows: a pharmaceutical composition for assisting 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 clerocarpus scabra, 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 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 clerocaria rhynchophylla, 3 parts of dragon palm blood, 2 parts of crocodile mouth flower, and 2 parts of rubiaceae.

[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, dry at low temperature, crush, and pass through 80-100 mesh sieve to obtain centipede powder;

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

[0011] S3, grinding the agarwood into coarse powder, adding water, the mass volume ratio g / ml is 2-5:10, using microwave extraction for 15-25 minutes, the microwave power is 600-800W, after the extraction is completed, 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, the percolation speed is 1-3mL / min, and the initial percolated liquid is continuously poured into the percolation cylinder for 3-6 cycles, the percolated liquid is collected, and concentrated to obtain the crocodile mouth flower percolate;

[0013] S5, drying the radix spatholobi 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 1-3h, and separating under reduced pressure to obtain a radix spatholobi 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% of the weight of the powder as a composite enzyme, the enzymolysis temperature is 40-50 ° C, the enzymolysis is 1-3 hours, after the enzymolysis is completed, the temperature is raised to 80-90 ° C to inactivate the enzyme, and an enzymolysis solution is obtained, and ethyl acetate with a mass concentration of 60-80% is continuously added, and ultrasonic-assisted extraction is performed, the ultrasonic power is 200-300 W, and the time is 30-40 min to obtain a scutellaria baicalensis extract;

[0015] S7. Mix the centipede powder, the dragon palm blood extract, the agarwood extract, the alligator flower percolate and the smilax china extract to obtain a pharmaceutical composition.

[0016] Furthermore, the parameters of the supercritical carbon dioxide extraction of 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 obtained by the above preparation method is added with acceptable excipients to prepare an external gel ointment, namely Li Gaotie.

[0019] Furthermore, the topical gel ointment is prepared by placing the drug 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 drug 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 micro powder 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, relieve pain, attack toxins and disperse knots, and directly reach the diseased area. It plays a key role in quickly relieving pain, reducing swelling and removing blood stasis for the symptoms such as pain and swelling caused by meridian blockage and poor circulation of qi and blood caused by chronic soft tissue injury; the auxiliary drug is flying dragon palm blood, which is warm in nature, pungent in taste, slightly bitter, and slightly toxic, and can dispel wind and relieve pain, disperse blood stasis and stop bleeding, and remove toxins and reduce swelling; it cooperates with the main drug centipede to further enhance the effects of dredge meridians to relieve pain, promote blood circulation and remove blood stasis, and remove toxins and reduce swelling, and has a good effect on the local blood stasis, swelling and pain that are difficult to eliminate, etc. The effect of improving the condition of the body is to promote the repair and regeneration of damaged tissues; with the help of Radix Glehniae, it is slightly warm in nature, sweet and mild in taste, mainly dispelling rheumatism, strengthening the waist and knees, and helping to dredge the meridians; it mainly plays the role of assisting the main and auxiliary drugs to dredge the meridians and regulate qi and blood. At the same time, its effect of strengthening the waist and knees helps to improve the symptoms of soreness of the waist and knees, poor mobility, etc. caused by chronic soft tissue injuries involving the tissues around the waist and lower limb joints, and enhances the overall therapeutic effect; Aquilaria sinensis is mild in nature and sweet in taste, dispelling wind and activating blood circulation, regulating qi and relieving pain; Crocodile mouth flower is cool in nature and slightly bitter in taste, mainly activating blood circulation and relaxing muscles, clearing heat and removing dampness; Golden Buds are cold in nature, bitter in taste, and slightly toxic, mainly clearing heat, detoxifying, and relieving pain. These three herbs assist the main and auxiliary drugs, on the one hand, can further promote the circulation and dredging of qi and blood, on the other hand, can clear heat and remove dampness, detoxify, prevent heat and toxicity caused by local qi and blood stasis in the injury, avoid further development of inflammation, and relieve discomfort such as redness, swelling, heat and pain in the injured area, making the whole prescription 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 dragon palm blood, microwave extraction of agarwood, percolation extraction of crocodile mouth flower, supercritical carbon dioxide extraction of angelica dahurica, and enzymatic hydrolysis combined with ultrasound-assisted extraction of smilax china, the effective ingredients in the medicinal materials can be efficiently extracted, the purity and concentration of the drugs can be improved, thereby enhancing the efficacy of the drugs.

[0026] The prepared external 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 the transdermal absorption of the drug, so that the drug can act on the injured part continuously and stably, thereby improving the bioavailability of the drug. In addition, pure herbal plants are used, which have the characteristics of high safety and application value, no side effects, strong operability, low cost, and are suitable for the general public; in summary, the drug composition and preparation of the present invention provide a safe, effective, multi-target new choice for the treatment of chronic soft tissue injuries, which is helpful for the formation of theories of prevention and treatment of Li medicine, and is promoted to clinical applications, and has broad application prospects. DETAILED DESCRIPTION

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

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

[0029] Unless otherwise specified, the materials, reagents, etc. used in the embodiments 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, the Chinese Materia Medica Dictionary, the Li Medicine and Li Medicine, and the Li Nationality Pharmacopoeia:

[0031] Jiangzhenxiang: spicy, warm in nature, enters the liver and spleen meridians. Functions and indications: has the effects of removing blood stasis and stopping bleeding, regulating qi and relieving pain.

[0032] Centipede: warm in nature, pungent in taste, enters the liver meridian. Functions and indications: calming wind and relieving spasm, dredging meridians and relieving pain, attacking toxins and dispersing 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 meridian and stomach meridian. Functions and indications: dispel wind and relieve pain, disperse blood stasis and stop bleeding.

[0035] Crocodile mouth flower: cool in nature, slightly bitter in taste, enters the liver and kidney meridians. Functions and indications: clearing away heat and dampness, relieving swelling and pain, dispersing blood stasis and stopping bleeding.

[0036] Golden ginseng: cold in nature, bitter in taste, enters the liver and stomach meridians. Functions and indications: dispersing blood stasis and stopping bleeding, reducing swelling and relieving pain, nourishing and strengthening. 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 basil. 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 clerocaria rhynchophylla, 4 parts of dragon palm blood, 3 parts of crocodile mouth flower, and 3 parts of rubiaceae. Example 3

[0039] A pharmaceutical composition for assisting 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 basil;

[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, remove impurities, dry, dry at 45 ° C, crush through an 80 mesh sieve, add a 75% ethanol solution with a mass volume ratio of g / ml of 1:9, reflux extraction 3 times, each time for 2 hours, after the extraction is completed, filter and combine the extracts, concentrate to obtain the dragon palm blood extract, dry it, and set it aside;

[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, the percolation speed is 2mL / min, the initial percolate is continued to be poured into the percolation cylinder for 5 cycles, the percolate is collected, and concentrated to obtain the crocodile mouth flower percolate;

[0045] S5, drying the radix spatholobi and grinding it into fine powder, loading it into a supercritical extraction kettle for supercritical carbon dioxide extraction, adding 8% ethanol solution by mass concentration, supercritical carbon dioxide extraction temperature of 50 ° C, pressure of 25 MPa, carbon dioxide flow rate of 25 kg / h, extraction for 2h, and vacuum separation to obtain the radix spatholobi extract;

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

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

[0048] The pharmaceutical compositions of the above-mentioned Examples 1-3 were respectively added with acceptable excipients to prepare external gel ointments, wherein the pharmaceutical composition was stirred under a pulsed electric field with a 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 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 micro powder silica gel and 50 parts of water.

[0050] The external 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 is a randomized controlled trial. The effective rate of the subjects is the observed outcome indicator. The effective rate of the observation group is expected to be 98.67%, and the effective rate of the control group is 85.33%. The bilateral α=0.05 and the confidence level are 90%. The sample size of the observation group N1=55 cases and the sample size of the control group N2=55 cases were calculated using PASS21 software. Considering the loss of follow-up and refusal to visit 20%, 66 subjects in each observation group and control group were required, and a total of 132 subjects were included.

[0056] 2. Research standards

[0057] (1) TCM diagnostic criteria

[0058] Refer to the 2002 "Guidelines for Clinical Research of New Chinese Medicines" (Trial) and the diagnostic criteria for chronic soft tissue injuries in the national higher education textbook "Traditional Chinese Medicine Muscle Traumatology":

[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 human body for a long time);

[0060] ②Disease duration ≥ 14 days;

[0061] ③Local pain or swelling, functional impairment, and muscle atrophy.

[0062] (2) Western medicine diagnostic criteria

[0063] The diagnostic criteria for chronic injuries of the musculoskeletal system (chronic soft tissue injuries) in the 9th edition of the national college textbook "Surgery" were used for assessment: ① long-term chronic pain in the affected area without a clear history of trauma; ② tenderness or lumps in the affected area, often accompanied by some special physical signs; ③ no obvious local acute inflammatory manifestations; ④ recent history of excessive activity related to the painful area; ⑤ some patients have poor posture, work habits or occupational history.

[0064] (3) Inclusion criteria

[0065] ① Meet the above-mentioned Chinese and Western medicine diagnostic criteria; ② Aged between 18 and 65 years old; ③ The subjects are aware of the treatment plan of this study and voluntarily sign the informed consent.

[0066] (4) Exclusion criteria

[0067] ① Those who do not meet the above-mentioned Chinese and Western medical diagnostic criteria; ② Those who have used external or internal blood circulation, muscle relaxation and analgesic drugs within 2 weeks before entering the study; ③ Those with fractures or open injuries; ④ Acute attacks such as infections and gouty arthritis; ⑤ Women who are breastfeeding or preparing for pregnancy; ⑥ Those who are allergic to external drugs; ⑤ Patients with other serious systemic diseases and mental illnesses.

[0068] (5) Criteria for rejection, fall-off and termination of test

[0069] ① Those with poor compliance, who use other drugs or receive other treatments at the same time without authorization during the study; ② Those who are unable to cooperate with treatment and related examinations due to personal reasons, which affects the judgment of efficacy; ③ Those who have serious adverse reactions during the treatment, such as severe allergies, aggravated symptoms, etc.; ④ Those who have not received any treatment after entering this study or cannot obtain any clinical data after receiving treatment.

[0070] 3. Research Methods

[0071] (1) Design grouping

[0072] A randomized controlled study was conducted and 132 patients who met the study criteria were divided into a control group and an observation group using a simple random number table, with 66 patients in each group.

[0073] (2) Experimental plan

[0074] ① Control group: Voltaren ointment (National Medicine Standard H19990291) was applied to the affected area in an appropriate amount, 3 times a day, for 2 consecutive weeks. Observation group: The Li medicine clinic clinical experience prescription "Li Gaotie" was applied to the affected area, 5 times a week, once a day, 1 patch per affected part (depending on the number and area of ​​the affected parts), each application lasted 6 hours, the total course of treatment was 2 weeks, and the total number of treatments was 10 times. "Li Gaotie" drug preparation: Hainan Li nationality area drug: Example 3 of the present invention was prepared according to the method of Example 4 for external use gel paste, the patch specification was 6g (13cm*16cm), a total of 20,000 copies.

[0075] ②Efficacy evaluation index and safety evaluation: The efficacy evaluation was conducted at two time points, 7d and 14d after the start of treatment, and the occurrence of adverse events during treatment was observed. The efficacy evaluation indexes used were the reduction in pain VAS score and the difference in TCM syndrome score. (The revised version of Wong-Baker facial expression pain assessment method was used) The reduction in pain VAS score = pain VAS score after treatment - pain VAS score before treatment; referring to the 2002 "Guidelines for Clinical Research of New Chinese Medicines" (Trial), the symptoms and signs were graded according to the soft tissue injury symptom grading quantitative table, and a TCM syndrome score scale was developed. The difference in TCM syndrome score = TCM syndrome score before treatment - TCM syndrome score after treatment. Safety evaluation indicators include physical examination and vital sign observation indicators and blood routine, liver function, and kidney function tests, and whether adverse reactions occurred during the entire treatment process was recorded.

[0076] ③Efficacy judgment standard: refer to the 2002 "Guidelines for Clinical Research of New Chinese Medicines" (Trial Implementation), and formulate the judgment results of cure, marked effect, effectiveness, and ineffectiveness 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] ④Statistical methods: SPSS26.0 statistical software was used for data analysis. The chi-square test was used to compare the count data; the measurement data followed a normal distribution and had homogeneous variance, and were expressed as mean ± standard deviation ( ), independent sample t test was used for inter-group comparison, paired t test was used for intra-group comparison, measurement data did not follow normal distribution, expressed as [M (P25, P75)], and non-parametric tests were used for intra-group and inter-group comparisons. P < 0.05 indicated statistically significant differences.

[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 (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 the treatment period, no serious adverse events occurred in the observation group. No abnormalities were found in blood routine, liver function, and kidney function tests. Physical examination and vital signs observation indicators fluctuated within the normal range.

[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 principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A pharmaceutical composition for assisting the treatment of chronic soft tissue injury diseases, characterized in that: The invention comprises 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. A pharmaceutical composition for assisting the treatment of chronic soft tissue injury diseases according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 1 part of agarwood, 1 part of centipede, 2 parts of kelp, 3 parts of dragon palm blood, 2 parts of crocodile mouth flower and 2 parts of golden basil.

3. The method for preparing a pharmaceutical composition for assisting the treatment of chronic soft tissue injury diseases according to claim 1, characterized in that: The following steps are involved: S1, remove centipede impurities, head and feet, wash with clean water, dry at low temperature, crush, and pass through 80-100 mesh sieve to obtain centipede powder; S2, collect the root or stem of the dragon palm blood, wash, remove impurities, dry, dry at 40-50 ° C, crush through a 50-80 mesh sieve, add a 70-80% ethanol solution with a mass volume ratio of g / ml of 1: 8-10, reflux extraction 2-3 times, each time for 1.5-2 hours, after the extraction is completed, filter and combine the extracts, concentrate, obtain the dragon palm blood extract, dry it, and set it aside; S3, grinding the agarwood into coarse powder, adding water, the mass volume ratio g / ml is 2-5:10, using microwave extraction for 15-25 minutes, the microwave power is 600-800W, after the extraction is completed, 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, the percolation speed is 1-3mL / min, and the initial percolated liquid is continuously poured into the percolation cylinder for 3-6 cycles, the percolated liquid is collected, and concentrated to obtain the crocodile mouth flower percolate; S5, drying the radix spatholobi 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 1-3h, and separating under reduced pressure to obtain a radix spatholobi 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% of the weight of the powder as a composite enzyme, the enzymolysis temperature is 40-50 ° C, the enzymolysis is 1-3 hours, after the enzymolysis is completed, the temperature is raised to 80-90 ° C to inactivate the enzyme, and an enzymolysis solution is obtained, and ethyl acetate with a mass concentration of 60-80% is continuously added, and ultrasonic-assisted extraction is performed, the ultrasonic power is 200-300 W, and the time is 30-40 min to obtain a scutellaria baicalensis extract; S7. Mix the centipede powder, the dragon palm blood extract, the agarwood extract, the alligator flower percolate and the smilax china extract to obtain a pharmaceutical composition.

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

5. The method for preparing a pharmaceutical composition for assisting the treatment of chronic soft tissue injury diseases according to claim 3, characterized in that: The S6 complex enzyme is cellulase and pectinase in a mass ratio of 1-3:

5.

6. A pharmaceutical preparation for assisting the treatment of chronic soft tissue injury diseases, characterized in that: The traditional 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 gel ointment.

7. A pharmaceutical preparation for assisting the treatment of chronic soft tissue injury diseases according to claim 6, characterized in that: The topical gel ointment is prepared by placing the drug 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 drug composition to the matrix solvent (g / mL) is 1-5:10, and the prepared paste is evenly coated on a non-woven fabric with a coating thickness of 1-3 mm, and then shearing and packaging are performed to obtain the topical gel ointment.

8. A pharmaceutical preparation for assisting the treatment of chronic soft tissue injury diseases as claimed in claim 7, characterized in that: 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 micro powder silica gel and 40-60 parts of water.

9. The pharmaceutical preparation for assisting the treatment of chronic soft tissue injury diseases 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 pharmaceutical composition according to claim 1 or 2 in the preparation of an adjuvant therapy for chronic soft tissue injury diseases.