A Chinese medicine composition for wound repair

Abstract

The invention discloses a Chinese medicine composition for wound repair, which is prepared from the following raw materials in weight ratio: 1-5 parts of rhubarb, 1-5 parts of phellodendron, 1-5 parts of atractylodes, 1-5 parts of sophora flavescens, 1-8 parts of thorns of Gleditsia sinensis, and 1-5 parts of loquat leaves. The Chinese medicine composition of the invention has the effects of clearing away heat and detoxifying, drying dampness and discharging pus, and removing blood stasis and dredging collaterals. For acute infected wounds, the wounds are red, swollen, burning, purulent secretions, pain, etc.; chronic wounds have signs of infection, such as redness around the wound, increased skin temperature, purulent secretions, odor, pain, fragile granulation, etc.; traumatic eczema, common eczema in acute and subacute stages, and acute carbuncle (acute infection of skin and soft tissue), the skin of the affected area is flushed, swollen, fever, erosion, exudation, pain, etc., and has excellent therapeutic effects, and has practical promotion and application value.

Description

Technical Field

[0001] The invention specifically relates to a traditional Chinese medicine composition for wound repairing. Background Art

[0002] Infection is the most common complication of wounds, and the presence of infected wounds often affects wound healing. In clinical practice, bacterial culture of wounds is an important criterion for accurate clinical diagnosis of infection, while symptoms and wound redness, swelling, pain, necrotic tissue, secretions, odor, and morphology of granulation tissue are important factors for judging infection. Studies have shown that pathogens of infected wounds are diverse and have a high rate of drug resistance. Blind or empirical anti-infection treatment has lost its meaning and increases the risk of bacterial resistance.

[0003] The complexity and high drug resistance of infectious wounds emphasize wound bacterial culture, dynamically monitor bacterial changes according to the wound situation, and guide the use of antibacterial drugs, but this can easily lead to drug resistance to commonly used antibacterial drugs, and on the other hand, it also increases the economic burden on patients. At present, there are many studies on the treatment of infectious wounds with traditional Chinese medicine. For example, CN114569692A discloses an anti-infective Chinese medicine composition for wound treatment, which tends to warm and dredge, cool blood and detoxify, can reduce the accumulation of secretions, and improve the wound surface. However, the composition is guided by the theory of "simmering pus to generate muscle", and although it has astringent taste, its preparation form of mud or gel will accelerate wound liquefaction, increase pus secretion and exudation, and easily soak the dressing, thereby increasing the frequency of changing dressings, otherwise it is easy to cause wound maceration, increase the dressing cycle, and bring more pain to patients. At the same time, from the perspective of antibacterial effect, it can inhibit bacterial growth in the short term, but the effect is relatively weak and needs long-term use. Therefore, it is necessary to develop a Chinese medicine compound with better effect and shorter treatment course. Summary of the invention

[0004] In order to solve the above problems, the present invention provides a Chinese medicine composition for wound repair, which is prepared from raw materials containing the following weight ratio:

[0005] 1-5 parts of rhubarb, 1-5 parts of phellodendron, 1-5 parts of atractylodes, 1-5 parts of sophora flavescens, 1-8 parts of gleditsia thorn, and 1-5 parts of loquat leaf.

[0006] Furthermore, it is prepared from raw materials containing the following weight ratio:

[0007] 1 part of Rhubarb, 1 part of Phellodendron, 1 part of Atractylodes, 1 part of Sophora flavescens, 1.5 parts of Gleditsia sinensis, and 1 part of Eriobotrya japonica leaf.

[0008] Furthermore, it is a preparation prepared from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, and the addition of pharmaceutically acceptable excipients.

[0009] Furthermore, the preparation is an external preparation.

[0010] Furthermore, the external preparation is a solution, a spray, an ointment or an emulsion.

[0011] The present invention also provides a method for preparing the aforementioned Chinese medicine composition, which comprises the following steps:

[0012] (1) Weigh the raw materials according to the above ratio;

[0013] (2) The raw material drug is ground into powder, or the water or organic solvent extract of the raw material drug is added with excipients or auxiliary ingredients commonly used in pharmaceuticals to obtain the powder.

[0014] Finally, the present invention provides a use of the aforementioned traditional Chinese medicine composition in preparing a medicine for repairing wound surfaces.

[0015] Furthermore, the medicine is a medicine for repairing infected wounds.

[0016] Furthermore, the medicine is a medicine for repairing acute infectious wounds.

[0017] Furthermore, the drug is a drug for repairing acute infected wounds, chronic wounds with inflammation, acute or subacute traumatic eczema or common eczema, and / or acute skin and soft tissue infections.

[0018] Furthermore, the medicine is a medicine that relieves wound pain, reduces wound secretions and / or reduces the area of ​​wound redness and swelling.

[0019] The Chinese medicine composition for wound repair of the present invention has bitter, cold, turbid and thick smell, and is good at clearing away heat and dampness, purging fire and detoxifying. Atractylodes is pungent, dispersing, warming and dry, and can treat internal and external dampness. The two are combined, one is warm and the other is cold, and can clear heat without damaging yang, and the effect of drying dampness is greatly increased. They form the structure of two wonderful powders, and are both monarch drugs to resolve fire poison and dampness turbidity in acute wounds, and to cool without leaving blood stasis; Rhubarb is cold in nature, can detoxify and reduce swelling, promote blood circulation and relieve pain, can help Phellodendron clear heat and detoxify, and also has It has the effects of cooling blood, removing blood stasis and activating blood circulation, clearing blood stasis and heat, and promoting blood circulation. Sophora flavescens is cold in nature, dries dampness and relieves itching, which can enhance the heat-clearing and dampness-clearing effects of the main medicine. The two are together the ministers; Gleditsia sinensis is good at reducing swelling, expelling toxins and discharging pus, and can eliminate pus that has not yet formed, and can rupture pus that has already formed. "Bencao Huiyan" calls it the most important medicine for ulcers and toxins. Loquat leaves, with the meaning of "the lungs govern the skin and hair", are used as adjuvants together with Gleditsia sinensis, and together they play the role of carrying the medicine and leading the medicine directly to the lesion.

[0020] The Chinese medicine composition of the present invention has strong effects of clearing away heat and dampness, draining pus, removing blood stasis and unblocking meridians. When used on infected wounds, it can quickly reduce the redness, swelling, heat and pain around the wound and improve the exudation of the wound. It acts on the affected area in the form of rinsing and wet compressing, can clean the wound surface and remove filth. At the same time, through the penetration absorption and hydration of the medicine, it can play the role of local anti-inflammatory, promote the smooth flow of qi and blood, inhibit exudation and the like.

[0021] Clinical experiments have shown that the Chinese medicine composition of the present invention can significantly reduce wound pain, reduce wound secretions, inhibit wound bacteria, reduce the redness and swelling of the wound and the skin tissue around the wound, and promote wound healing. For acute infected wounds, the wound is red, swollen, burning, purulent secretions, pain, etc.; chronic wounds have signs of infection, such as: redness around the wound, increased skin temperature, purulent secretions, odor, pain, fragile granulation, etc.; traumatic eczema, common eczema in the acute and subacute stages, and acute carbuncle (acute infection of skin and soft tissue) with symptoms such as redness, swelling, fever, erosion, exudation, pain, etc. of the affected skin, it has excellent therapeutic effects and has practical application value.

[0022] Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

[0023] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 Male patient wound repair diagram

[0025] Figure 2 Female patient's wound repair diagram

[0026] Figure 3 Male patient wound repair diagram DETAILED DESCRIPTION

[0027] The raw materials and equipment used in the specific embodiments of the present invention are all known products and are obtained by purchasing commercially available products.

[0028] Example 1. Preparation of the composition of the present invention

[0029] Formula: 30g of rhubarb, 30g of phellodendron, 30g of atractylodes, 30g of sophora flavescens, 45g of sapodilla thorn, 30g of loquat;

[0030] Preparation method ①: Weigh each raw material according to the above weight ratio, add 900mL of water to soak for 30 minutes, and then boil for 30 minutes to obtain the filtrate; add 700mL of drinking water again, boil for 20 minutes and then obtain the filtrate; combine the two filtrates, concentrate and sterilize to obtain 300mL of liquid medicine.

[0031] Preparation method ②: Weigh each raw material according to the above weight ratio, dry and grind it through a 100-mesh sieve to obtain a powder.

[0032] Example 2: Preparation of the drug of the present invention

[0033] Formula: 40g of rhubarb, 60g of phellodendron, 60g of atractylodes, 40g of sophora flavescens, 30g of sapodilla thorn, and 10g of loquat;

[0034] Preparation method ①: Weigh each raw material according to the above weight ratio, add 800mL of water to soak for 30 minutes, and then boil for 30 minutes to obtain the filtrate; add 700mL of drinking water again, boil for 20 minutes and then obtain the filtrate; combine the two filtrates, concentrate and sterilize to obtain 400mL of liquid medicine.

[0035] Preparation method ②: Weigh each raw material according to the above weight ratio, dry and grind it through a 100-mesh sieve to obtain a powder.

[0036] Example 3, preparation of the drug of the present invention

[0037] Formula: 40g of rhubarb, 80g of phellodendron, 60g of atractylodes, 30g of sophora flavescens, 35g of sapodilla thorn, 20g of loquat;

[0038] Preparation method ①: Weigh each raw material according to the above weight ratio, add 1000mL of water to soak for 30 minutes, and then boil for 30 minutes to obtain the filtrate; add 900mL of drinking water again, boil for 20 minutes and then obtain the filtrate; combine the two filtrates, concentrate and sterilize to obtain 500mL of liquid medicine.

[0039] Preparation method ②: Weigh each raw material according to the above weight ratio, dry and grind it through a 100-mesh sieve to obtain a powder.

[0040] The beneficial effects of the present invention are further illustrated by test examples below.

[0041] Experimental Example 1 Clinical study on the repair of wound surface by the Chinese medicine composition of the present invention

[0042] 1. Medication

[0043] 1.1. Decoction

[0044] (1) API: 10g of Rhubarb, 10g of Phellodendron, 10g of Atractylodes, 10g of Sophora flavescens, 15g of Gleditsia sinensis, 10g of Loquat Leaf

[0045] (2) Preparation method: Weigh each raw material drug according to the above weight ratio; take 3 doses of raw material drug and put them into a disposable non-woven gauze decoction bag, and use 700 mL of drinking water that meets national health standards to fully soak the medicinal materials for 30 minutes; use a decoction machine (produced by Beijing Donghuayuan Medical Equipment Co., Ltd., model: YJD13-GL) to boil over high heat and then simmer over low heat, and decoct for a total of 30 minutes under normal pressure to obtain the filtrate; add 600 mL of drinking water again, decoct for 20 minutes, and then obtain the filtrate; combine the two filtrates, double filter, concentrate and sterilize to obtain 300 mL of liquid medicine, and use a Chinese medicine decoction packaging machine (produced by Beijing Donghuayuan Medical Equipment Co., Ltd., model: YB50-250) to pack the liquid medicine into a 100 mL vacuum packaging bag.

[0046] 1.2 Powder

[0047] (1) API: 10 g of Rhubarb, 10 g of Phellodendron amurense, 10 g of Atractylodes macrocephala, 10 g of Sophora flavescens, 15 g of Gleditsia sinensis, and 10 g of Loquat leaf;

[0048] (2) Preparation method: The raw materials are mixed evenly, dried at low temperature, crushed and passed through a 100-mesh sieve, and then divided into non-woven bags, 10 grams per bag, to obtain the powder of the pharmaceutical composition of the present invention. The powder can save the burden of boiling, is convenient to use, and does not need to be boiled at any time.

[0049] (3) When using, brew the powder with boiling water, filter the brewing water with gauze, and then rinse or apply it to the injured area.

[0050] 2. Usage

[0051] 1) Externally rinse the wound. Depending on the size of the wound, use a syringe to draw out the Chinese medicine solution under "1.1 Decoction" or "1.2 Powder" to rinse the wound.

[0052] 2) Apply wet compress to the wound, that is, soak gauze with the Chinese medicine liquid under "1.1 Decoction" or "1.2 Powder", apply it to the wound and the surrounding red and swollen skin area. After 15-20 minutes of wet compress, remove the Chinese medicine gauze and then perform regular bandage.

[0053] 3) If the wound is deep, a syringe or infusion hose can be inserted into the bottom of the wound for flushing.

[0054] Note: Flushing and wet compresses can be used separately or in combination according to the actual situation of the wound. When used together, it can increase the time that Chinese medicine acts on the skin. For example, if the wound has a lot of necrotic tissue and is covered with a thick layer, flushing can be used. If the wound has a lot of exudate and the area around the wound is red and swollen, wet compresses can be used.

[0055] 3. Data collection of clinical efficacy evaluation indicators

[0056] ① Wound pain: Visual Analogue Scale (VAS) was used. The specific method was to use a 10-cm-long line segment with 10 scales, with "0" and "10" at the two ends, "0" for no pain, and "10" for the most severe pain that was unbearable. The patient was asked to mark the corresponding position on the line segment that represented the degree of pain before and after treatment. The physician rated the pain degree based on the position marked by the patient. The pain was measured before treatment, 3 days after treatment, and 7 days after treatment.

[0057] ② Wound secretion: refer to the relevant literature [Cao Dongyang. Experimental and clinical study on promoting the healing of chronic infected wounds with collagen loaded with Chuangling liquid [D]. Nanjing: Nanjing University of Chinese Medicine, 2014.], and use the wound secretion scoring table to evaluate the shape, color, odor, properties, properties, and exudate volume of the secretion, with a score ranging from 0 to 28 points. The evaluation was conducted before treatment, 3 days after treatment, and 7 days after treatment.

[0058] ③ Redness and swelling around the wound: refer to the "Standards for Diagnosis and Therapeutic Effect of TCM Diseases and Syndromes" [State Administration of Traditional Chinese Medicine. Standards for Diagnosis and Therapeutic Effect of TCM Diseases and Syndromes [M]. Nanjing: Nanjing University Press, 1994.] and use a ruler to calculate the range of redness and swelling;

[0059] 0 points: no redness or swelling;

[0060] 1 point: redness and swelling are less than 0.5 cm from the wound edge;

[0061] 2 points: redness and swelling are 0.5 to 1 cm away from the wound edge;

[0062] 3 points: The redness and swelling are greater than 1 cm away from the wound edge.

[0063] ④ Bacterial growth: Bacterial culture method was used for detection, and samples were taken for culture before treatment and 7 days after treatment.

[0064] ⑤ Wound area: Use a wound (cm) ruler perpendicular to the wound edge (not in contact with the wound), with the length in the direction of the long axis of the body and the width in the direction perpendicular to the long axis, and record the maximum length and maximum width of the wound;

[0065] Wound area = maximum length * maximum width.

[0066] Wound area reduction rate = (original wound area - wound area on day n) / original wound area * 100%, measured before treatment and 7 days after treatment.

[0067] 4. Data statistics results

[0068] From October 2019 to December 2022, 35 patients with acute infected wounds and chronic wounds with signs of infection who were aged <70 years and had a wound diameter <10 cm and could undergo conservative dressing treatment or could not undergo surgical treatment for other reasons were collected. Among them, 21 males and 14 females with an average age of (55.80±14.13) years were caused by scrapes, contusions, falls, and compression injuries; 2 patients had a history of diabetes, 1 had a history of gout, and 1 had a history of lower limb vascular disease. After 7 days of external Chinese medicine dressing treatment, the patients were controlled before and after, and the statistical results of each observation index by SPSS19.0 were as follows:

[0069] (1) Wound pain

[0070] T-test was performed on the wound pain scores at different time points. The VAS scores of patients at 3d and 7d after treatment were statistically different from those before treatment, both P < 0.01, with statistically significant differences. In addition, during the observation period, the effect of improving wound pain increased with the extension of the use time, indicating that the effect of external Chinese medicine dressing change on improving wound pain is positive, see Table 1.

[0071] Table 1 Comparison of wound pain scores (mean ± standard deviation, points)

[0072]

[0073] (2) Comparison of wound secretions

[0074] The t-test was performed to compare the wound secretion scores at different time points. The results showed that the wound secretion scores of patients at 3d and 7d after treatment were significantly higher than those before treatment, both P < 0.01, which was statistically significant. In addition, the effect of improving wound secretion increased with the extension of the use time, indicating that the effect of external Chinese medicine dressing change on improving wound secretion was positive, as shown in Table 2.

[0075] Table 2 Comparison of wound secretion scores (mean ± standard deviation, points)

[0076]

[0077] (3) Periwound redness and swelling score

[0078] T-test was performed on the scores of periwound redness and swelling at different time points. The results showed that the scores of periwound redness and swelling of patients at 3d and 7d after treatment were significantly lower than those before treatment, both P < 0.01, with statistical significance, indicating that Chinese medicine dressing change has a positive effect on improving the redness and swelling of the skin around the wound, and the effect is strengthened with the extension of time, as shown in Table 3. Table 3 Comparison of the range of redness and swelling of the skin around the wound (mean ± standard deviation, points)

[0079]

[0080] (4) Bacterial growth in wounds

[0081] The bacterial growth of wound secretions before and 7 days after treatment was compared. At the time of enrollment, bacteria were cultured from the wound secretions of 35 patients, including 29 cases (82.86%) of Gram-positive bacteria and 6 cases (17.14%) of Gram-negative bacteria. After 7 days of treatment, no bacterial growth was found in the secretions of 25 patients (71.42%), and 10 patients (28.58%) still had bacterial infection.

[0082] (5) Reduction of wound area

[0083] The wound area before and after treatment for 7 days was compared by t-test. The statistical result showed that P<0.05, indicating that Chinese medicine dressing treatment can promote wound healing. The wound area was reduced by (2.56±3.79) cm before and after treatment. 2 The area reduction rate is (31.17±28.64)%. See Table 4.

[0084] Table 4 Comparison of wound area reduction rate (mean ± standard deviation, %)

[0085]

[0086] In summary, the Chinese medicine composition of the present invention can significantly reduce wound pain, inhibit wound bacterial growth, reduce wound secretions, reduce wound redness and swelling area, and accelerate wound repair.

[0087] Test Example 2 Typical Case

[0088] A 29-year-old male patient was injured by a heavy object 2 weeks ago. He had soft tissue defect in the left heel, local skin redness and swelling, fever, extremely foul odor, and yellow-white purulent secretion. The affected foot was obviously painful. Bacterial examination showed that it was Staphylococcus aureus. He was only given the liquid in Test Example 1 to rinse the wound and the powder to wet the red and swollen tissue around the wound. No local or systemic antibiotics or special dressings were used. The local inflammation was well controlled and the pain was significantly relieved. ( Figure 1 )

[0089] A 49-year-old female patient had skin and soft tissue ulceration in the middle of her left calf due to a motorcycle collision 16 days ago. When she was admitted to the hospital, the middle of her left calf was red and swollen, the skin temperature was significantly increased, and there was yellow viscous purulent secretion. The wound was covered with necrotic flesh. Bacterial examination showed Staphylococcus aureus. She was only given the liquid in Test Example 1 to rinse and wet compress the red and swollen tissue around the wound. The swelling and pain of the injured limb were relieved quickly, and the infection of the wound bed was well controlled.

[0090] ( Figure 2 )

[0091] A 48-year-old male patient had a wound on the inner side of the lower right leg that had not healed for nearly three months. The wound had a small amount of yellow purulent secretions, was covered with necrotic flesh, had fibrosis, had a small amount of granulation tissue growing inside the wound, was red in color, and easily bled when scraped. The skin edge was slightly aged, the surrounding skin was red and swollen, the skin temperature was elevated, and there were a few traumatic eczema-like changes. Bacterial examination indicated Staphylococcus aureus. Only the Chinese medicine solution in Test Example 1 was applied for wet compresses and dressing changes, and the redness and swelling of the wound were alleviated, and the wound area was reduced. ( Figure 3 ).

Claims

1. A Chinese medicine composition for wound repair, characterized in that: It is prepared from raw materials in the following weight ratio: 1-5 parts of rhubarb, 1-5 parts of phellodendron, 1-5 parts of atractylodes, 1-5 parts of sophora flavescens, 1-8 parts of gleditsia thorn, and 1-5 parts of loquat leaf.

2. The Chinese medicine composition according to claim 1, characterized in that: It is prepared from raw materials in the following weight ratio: 1 part of Rhubarb, 1 part of Phellodendron, 1 part of Atractylodes, 1 part of Sophora flavescens, 1.5 parts of Gleditsia sinensis, and 1 part of Eriobotrya japonica leaf.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: It is a preparation made from the powder of the raw material drug, or the water or organic solvent extract of the raw material drug as the active ingredient, plus pharmaceutically acceptable excipients.

4. The Chinese medicine composition according to claim 3, characterized in that: The preparation is an external preparation.

5. The Chinese medicine composition according to claim 4, characterized in that: The external preparation is a solution, a spray, an ointment or an emulsion.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: It includes the following steps: (1) Weigh the raw materials according to the ratio; (2) The raw material drug is ground into powder, or the water or organic solvent extract of the raw material drug is added with excipients or auxiliary ingredients commonly used in pharmaceuticals to obtain the powder.

7. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine composition prepared by the preparation method according to claim 6 in preparing a medicament for repairing wounds.

8. The use according to claim 7, characterized in that: The medicine is a medicine for repairing infected wounds.

9. The use according to claim 8, characterized in that: The medicine is used for repairing acute infected wounds, chronic wounds with inflammation, acute and subacute traumatic eczema or common eczema, and / or acute skin and soft tissue infections.

10. The use according to claim 9, characterized in that: The medicine is a medicine for relieving wound pain, reducing wound secretions and / or reducing the redness and swelling area of ​​the wound.

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