Traditional Chinese medicine preparation as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine preparation and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine preparation is prepared from the following raw materials: cortex phellodendri, rhizoma coptidis, radix scutellariae, radix angelicae, rhizoma bletillae, fructus forsythiae and a bacteriostatic agent. The traditional Chinese medicine preparation has the effects of antibiosis, anti-inflammation, antioxidation and immunoregulation, and has a good treatment effect on swelling, abscess, specific infection and the like caused by inflammatory reaction in clinical practice.

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine preparation and a preparation method and application thereof. Background Art

[0002] At present, modern medicine usually uses antibiotics, non-steroidal anti-inflammatory drugs and glucocorticoids to treat most inflammatory diseases. However, long-term use of these drugs may damage the skin's barrier function and is accompanied by a variety of potential toxic side effects. In addition, long-term or high-dose use of Western anti-inflammatory drugs may lead to dependence and drug resistance, and cannot guarantee the progression of the disease. Therefore, for patients with local and deep swelling of skin and soft tissues throughout the body, normal tissues around infected wounds, traumatic non-wound swelling, and inflammatory swelling caused by non-specific infections, while receiving Western anti-inflammatory drugs, they can also apply Chinese medicine topically to promote anti-inflammatory and detumescence, shorten the course of treatment, and reduce local spread of inflammation. Summary of the invention

[0003] In view of the above-mentioned prior art, the present invention discloses a Chinese medicine preparation to solve the technical problems that the existing drugs have poor therapeutic effects, cannot guarantee the progression of the disease after long-term use and are accompanied by multiple potential toxic and side effects.

[0004] In order to achieve the above purpose, the technical solution adopted by the present invention is: to provide a traditional Chinese medicine preparation, which includes the following raw materials: phellodendron, coptis, scutellaria, angelica dahurica, bletilla striata, forsythia, and antibacterial agent.

[0005] Based on the above technical solution, the present invention can also be improved as follows.

[0006] Furthermore, it comprises the following raw materials in parts by weight: 40-60 parts of Phellodendron amurense, 40-60 parts of Coptidis chinensis, 40-60 parts of Scutellaria baicalensis, 40-60 parts of Angelica dahurica, 40-60 parts of Bletilla striata, 40-60 parts of Forsythia suspensa and an antibacterial agent.

[0007] Furthermore, it comprises the following raw materials in parts by weight: 45-55 parts of Phellodendron amurense, 45-55 parts of Coptidis chinensis, 45-55 parts of Scutellaria baicalensis, 45-55 parts of Angelica dahurica, 45-55 parts of Bletilla striata, 45-55 parts of Forsythia suspensa and an antibacterial agent.

[0008] Furthermore, it comprises the following raw materials in parts by weight: 50 parts of Phellodendron amurense, 50 parts of Coptis chinensis, 50 parts of Scutellaria baicalensis, 50 parts of Angelica dahurica, 50 parts of Bletilla striata, 50 parts of Forsythia suspensa and an antibacterial agent.

[0009] Furthermore, the antibacterial agent is a 0.02wt% furacilin solution, egg white or physiological saline.

[0010] Furthermore, the dosage ratio of the antibacterial agent to Phellodendron amurense is 8-15 mL: 40-60 g.

[0011] Furthermore, the dosage form of this Chinese medicine preparation is a Chinese medicine dressing.

[0012] The invention also discloses a preparation method of the Chinese medicine preparation, which comprises the following steps: grinding a prescribed amount of Chinese medicine raw materials into powder, and then adjusting the powder into a paste state with an antibacterial agent to obtain the preparation.

[0013] The invention also discloses the use of the Chinese medicine preparation in preparing medicine for treating swelling, wherein the swelling includes local and deep swelling of skin and soft tissues throughout the body, swelling of normal tissues around infected wounds, traumatic non-wound swelling and inflammatory swelling caused by non-specific infection.

[0014] Usage: Apply the Chinese medicine dressing to the affected area, cover it with film or green vegetable leaves, and bandage it with gauze.

[0015] According to the guidance of the monarch, minister, assistant and envoy theory of traditional Chinese medicine, this preparation uses Coptis chinensis as the monarch drug, which can inhibit the inflammatory response pathway and reduce the inflammatory response, thereby inhibiting the release of inflammatory cytokines, regulating the cell cycle and inhibiting cell proliferation; Phellodendron chinense and Scutellaria baicalensis are ministerial drugs, and the flavonoids in Phellodendron chinense and Scutellaria baicalensis can inhibit the production of various inflammatory mediators, thereby reducing the inflammatory response; Bletilla striata, Angelica dahurica and Forsythia suspensa are adjuvant drugs, and Bletilla striata has the effects of astringent hemostasis, swelling and tissue regeneration; Angelica dahurica has the effects of aromatic dehumidification, pus discharge and tissue regeneration, and blood circulation and pain relief; Forsythia suspensa has the effects of clearing away heat and toxicity, reducing swelling and dispersing nodules; antibacterial agent is the envoy drug, and the antibacterial agent has antibacterial and bactericidal effects, and it is used as a solvent to blend the traditional Chinese medicine powder.

[0016] The beneficial effects of the present invention are:

[0017] 1. It has good therapeutic effects on swelling, abscesses, specific infections, etc. caused by inflammatory reactions.

[0018] 2. It can greatly reduce the patient's pain symptoms, promote anti-inflammatory and swelling reduction, shorten the treatment course, and reduce the local spread of inflammation.

[0019] 3. Reduce treatment costs and improve patient satisfaction with treatment. DETAILED DESCRIPTION

[0020] The specific implementation modes of the present invention are described in detail below with reference to the embodiments.

[0021] Example 1

[0022] A traditional Chinese medicine preparation comprises the following raw materials: 40g of Phellodendron chinense, 45g of Coptis chinensis, 60g of Scutellaria baicalensis, 40g of Angelica dahurica, 60g of Bletilla striata, 60g of Forsythia suspensa and a 0.02wt% furacilin solution.

[0023] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then use 8 mL of furacilin solution to adjust the powder to a paste state.

[0024] Example 2

[0025] A traditional Chinese medicine preparation comprises the following raw materials: 60g of Phellodendron chinense, 55g of Coptidis rhizome, 55g of Scutellaria baicalensis, 60g of Angelica dahurica, 55g of Bletilla striata, 45g of Forsythia suspensa and egg white.

[0026] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then use 10mL of egg white to adjust the powder to a paste.

[0027] Example 3

[0028] A traditional Chinese medicine preparation comprises the following raw materials: 55g of Phellodendron amurense, 60g of Coptis chinensis, 45g of Scutellaria baicalensis, 55g of Angelica dahurica, 40g of Bletilla striata, 55g of Forsythia suspensa and egg white.

[0029] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then use 15mL of egg white to adjust the powder to a paste.

[0030] Example 4

[0031] A traditional Chinese medicine preparation comprises the following raw materials: 45g of Phellodendron chinense, 40g of Coptidis rhizome, 40g of Scutellaria baicalensis, 45g of Angelica dahurica, 45g of Bletilla striata, 40g of Forsythia suspensa and normal saline.

[0032] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then use 8 mL of normal saline to adjust the powder to a paste.

[0033] Example 5

[0034] A traditional Chinese medicine preparation comprises the following raw materials: 50g of Phellodendron amurense, 50g of Coptidis chinensis, 50g of Scutellaria baicalensis, 50g of Angelica dahurica, 50g of Bletilla striata, 50g of Forsythia suspensa and normal saline.

[0035] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then grind it into powder, and use 10mL of physiological saline to adjust the powder to a paste.

[0036] Comparative Example 1

[0037] A traditional Chinese medicine preparation comprises the following raw materials: 50g of Phellodendron amurense, 50g of Scutellaria baicalensis, 50g of Angelica dahurica, 50g of Bletilla striata, 50g of Forsythia suspensa and a 0.02wt% furacilin solution.

[0038] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then grind it into powder, and use 8mL of furacilin solution to adjust the powder to a paste state.

[0039] Comparative Example 2

[0040] A traditional Chinese medicine preparation comprises the following raw materials: 55g of coptis root, 55g of scutellaria root, 60g of angelica root, 55g of bletilla striata, 45g of forsythia and egg white.

[0041] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then grind it into powder, and use 10mL of egg white to adjust the powder to a paste.

[0042] Comparative Example 3

[0043] A traditional Chinese medicine preparation comprises the following raw materials: 55g of Phellodendron amurense, 60g of Coptis chinensis, 55g of Angelica dahurica, 40g of Bletilla striata, 55g of Forsythia suspensa and egg white.

[0044] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then grind it into powder, and use 8 mL of egg white to adjust the powder to a paste.

[0045] Comparative Example 4

[0046] A traditional Chinese medicine preparation comprises the following raw materials: 45g of Phellodendron chinense, 40g of Coptidis rhizome, 40g of Scutellaria baicalensis, 45g of Angelica dahurica, 40g of Forsythia suspensa and normal saline.

[0047] Use a Chinese medicine crusher to crush the Chinese medicine raw materials in the formula into powder, the mesh size of the Chinese medicine powder is 250 mesh, and then grind it into powder, and use 8 mL of normal saline to adjust the powder to a paste.

[0048] Test example

[0049] Clinical research trials

[0050] 1. Case selection

[0051] 1. Diagnostic criteria

[0052] Western medicine diagnosis follows the standards established in the "Expert Consensus on the Diagnosis and Treatment of Oral and Maxillofacial Space Infections (2021)" and the "Guidelines for the Diagnosis and Treatment of Oral and Maxillofacial Space Infections (2022 Edition)": comprehensive judgment based on the cause of the disease, medical history, clinical manifestations, laboratory tests, and imaging examinations.

[0053] Clinical manifestations: 1. Systemic reaction: Mild cases have no obvious systemic reaction, while severe cases may have fever, chills, headache, general discomfort, etc. If serious complications occur, such as toxic shock and sepsis, corresponding symptoms will appear. 2. Local manifestations: pain, swelling, redness of the skin, high skin temperature, tight and shiny skin, hardness to touch, tenderness, pitting edema or fluctuation. Accompanied by functional disorders, such as difficulty opening the mouth or swallowing, respiratory obstruction, etc.

[0054] Specialist examination: The examination can reveal typical manifestations of infection: local redness, swelling, heat, pain and functional impairment. The central area of ​​infection may have pitting edema; if an abscess is formed, it may be palpable. Punctures can be performed at the most obvious site of swelling, and if pus is drawn out, the diagnosis can be confirmed.

[0055] Auxiliary examinations: 1. Imaging examinations: plain film examination, CT and MRI examinations, ultrasound examinations, etc., to clarify the scope, location, nature, etc. of infection. 2. Laboratory examinations: white blood cell (WBC) count, C-reactive protein (CRP) level and serum procalcitonin (PCT) level. Elevated erythrocyte sedimentation rate is suggestive of infection, but it is not specific. Pus smear and bacterial culture can determine the bacterial species. If necessary, bacterial drug sensitivity tests can be performed to select appropriate antibacterial drugs.

[0056] 2. Test case standards

[0057] Included cases: 200 inpatients and outpatients from the People's Hospital of Aba Tibetan and Qiang Autonomous Prefecture from November 2021 to December 2023. All patients met the diagnostic criteria for oral and maxillofacial space infection in the guidelines and consensus. All patients and their families were informed of the trial and signed the informed consent form, and their general information was complete.

[0058] Excluded cases: patients with mental disorders unable to cooperate with relevant diagnosis and treatment, patients with major organ dysfunction or unable to tolerate relevant diagnosis and treatment, patients with other genetic or congenital diseases that are tolerant to the raw materials or other Chinese medicines in the present invention, patients who are allergic to or have contraindications to antibiotics and the raw materials in the present invention.

[0059] 2. Treatment Methods

[0060] Treatment principles: Antibiotic treatment is used to target pathogens. Incision and drainage can be performed for pus and necrotic tissue produced by inflammation to remove infection factors and local lesions as early as possible.

[0061] Grouping method: 200 cases were randomly divided into a treatment group and a control group, including 153 people in the treatment group, randomly divided into 9 groups, and 47 people in the control group.

[0062] (1) Treatment group: The dressings obtained from Example 1, Example 2, Example 3, Example 4, Example 5, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4 were applied wet to the swollen area and normal tissues around the infection of patients in each treatment group, and covered with a film or green vegetable leaves to keep moisture, and fixed with gauze, once a day; the patients also received conventional symptomatic treatment with Western medicine antibiotics, and the usage and dosage of antibiotics could be adjusted according to the patient's condition; the treatment cycle was 5 to 7 days.

[0063] (2) Control group: Patients received routine symptomatic treatment with Western antibiotics. The dosage of antibiotics could be adjusted according to the patient's condition. The treatment period was 5 to 7 days.

[0064] 3. Clinical Observation

[0065] The clinical efficacy of the two groups after treatment was observed: swelling subsidence time, pain threshold, first limit of mouth opening, changes in inflammatory indicators, self-evaluation of efficacy, length of hospital stay, and hospitalization costs.

[0066] IV. Experimental Results

[0067] The postoperative pain of the patients in the treatment group was significantly relieved. Only 4 cases of external application of Sanhuang Powder after surgery added analgesics, while about 85% of the patients in the control group used analgesics after surgery; the local swelling of the patients in the treatment group was an average of 3 to 4 days, while the swelling of the patients in the control group subsided in about 10 days. Due to the different pain and anti-inflammatory and swelling time and medication, the average hospitalization days in the treatment group were significantly shorter than those in the control group by 4 days, and the cost was about 2,000 yuan less; in addition, the patients in the treatment group were more satisfied with the treatment than those in the control group. CRP is an acute phase protein synthesized by the liver to protect the body through cytokine mediation when the body is infected or tissue damaged. It can activate the complement and mononuclear phagocyte system, remove damaged, necrotic tissues and foreign pathogens to maintain the body's homeostasis; the increase in CRP is positively correlated with the degree of infection, and its normal reference range is 0 to 10 mg / L. Inflammatory stimulation, especially severe bacterial infection or sepsis, can cause various tissues and cell types in the body to produce PCT and release it into the blood circulation system. At this time, its level in plasma increases significantly, and its normal reference range is 0.0-0.5 ng / mL. At the same time, immune cells gather at the site of inflammation, and the number of WBC increases significantly. The normal reference range of WBC count is 3.5-9.5 (10^ 9 / L), as shown in Table 1, the inflammatory indexes of the patients in the treatment group were reduced to the normal range on the second day after surgery, while the inflammatory indexes of the patients in the control group were reduced to the normal range 4-5 days after surgery. Based on the experimental results, it can be seen that after applying the Chinese medicine dressing in the embodiment, the pain symptoms of the patients with oral and maxillofacial space infection can be greatly alleviated, the anti-inflammatory and swelling effects are significant, and the treatment period is significantly shortened.

[0068] Table 1

[0069]

[0070] Although the specific implementation of the present invention is described in detail in conjunction with the embodiments, it should not be understood as limiting the scope of protection of this patent. Within the scope described in the claims, various modifications and variations that can be made by those skilled in the art without creative work still fall within the scope of protection of this patent.

Claims

1. A Chinese medicine preparation, characterized in that: Its raw materials include: Phellodendron chinense, Coptis chinensis, Scutellaria baicalensis, Angelica dahurica, Bletilla striata, Forsythia suspensa and antibacterial agents.

2. The Chinese medicine preparation according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 40-60 parts of phellodendron, 40-60 parts of coptis root, 40-60 parts of scutellaria root, 40-60 parts of angelica root, 40-60 parts of bletilla striata, 40-60 parts of forsythia and an antibacterial agent.

3. The Chinese medicine preparation according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 45-55 parts of phellodendron, 45-55 parts of coptis root, 45-55 parts of scutellaria root, 45-55 parts of angelica dahurica, 45-55 parts of bletilla striata, 45-55 parts of forsythia and an antibacterial agent.

4. The Chinese medicine preparation according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 50 parts of phellodendron, 50 parts of coptis root, 50 parts of scutellaria root, 50 parts of angelica dahurica, 50 parts of bletilla striata, 50 parts of forsythia and an antibacterial agent.

5. The Chinese medicine preparation according to claim 1, characterized in that: The antibacterial agent is a 0.02wt% furacilin solution, egg white or physiological saline.

6. The Chinese medicine preparation according to claim 5, characterized in that: The dosage ratio of the antibacterial agent to the Phellodendron amurense is 8-15 mL: 40-60 g.

7. The Chinese medicine preparation according to any one of claims 1 to 6, characterized in that: The dosage form of the Chinese medicine preparation is a Chinese medicine dressing.

8. The method for preparing the Chinese medicine preparation according to any one of claims 1 to 6, characterized in that: The Chinese medicinal raw materials in a prescribed amount are ground into powder, and then the powder is adjusted to a paste state with the antibacterial agent to obtain the product.

9. Use of the Chinese medicine preparation according to any one of claims 1 to 7 in the preparation of a drug for treating swelling, wherein the swelling includes local and deep swelling of the skin and soft tissues of the whole body, swelling of normal tissues around infected wounds, traumatic non-wound swelling, and inflammatory swelling caused by nonspecific infection.

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