Chinese herbal medicine formula for treating burns and scalds through exposure method and preparation method

Abstract

The invention relates to the technical field of external Chinese herbal medicine preparations for treating burns and scalds, and discloses a Chinese herbal medicine formula for treating burns and scalds by an exposure method, the Chinese herbal medicine formula comprises a powder part and a tincture part, the powder part is prepared from the following raw materials in parts by weight: 1 part of honeysuckle, 1 part of radix angelicae, 1 part of polygonum cuspidatum, 1 part of sanguisorba officinalis, 1 part of salvia miltiorrhiza and 1 part of clove; and borneol accounting for 1-3% of the total weight of the six raw materials. The tincture part is prepared from mulberry bark and an ethanol solution. The volume fraction of the ethanol solution in the tincture is 45%-55%. A multi-target synergistic effect is realized by scientifically proportioning components such as honeysuckle and sanguisorba officinalis which have the effects of clearing away heat and toxic materials and cooling blood to heal sores in the powder and components such as salvia miltiorrhiza and polygonum cuspidatum which have the effects of promoting blood circulation to remove blood stasis and improving microcirculation. The formula can comprehensively cope with complicated pathological conditions of heat toxin, blood stasis and swelling and pain of the wound of the burn and scald.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of burn and scald external use Chinese herbal medicine preparation, in particular to a Chinese herbal medicine formula for treating burn and scald by exposure method and a preparation method thereof. BACKGROUND

[0002] Burn and scald is a common type of trauma in clinic, and the core of its treatment is to control infection, relieve pain and promote wound healing. Among various treatment methods for burn and scald, exposure therapy is an important clinical application. This therapy directly exposes the wound to the air, keeps the wound dry, forms a scab by relying on self or drug action, protects the wound by using the biological barrier function of the scab, and until it is naturally healed and falls off. This therapy has specific requirements for the performance of the external use drugs applied.

[0003] The existing technical solutions for burn and scald treatment still have several problems to be improved. At present, some external use drugs have relatively single function, or focus on anti-infection or pain relief, and it is difficult to comprehensively deal with the complex pathological changes of inflammation, exudation, pain and tissue repair of burn and scald wound by one preparation. In addition, the greasy base of conventional ointments, creams and other dosage forms may soak the wound when applied to exposure therapy, which is not conducive to dry scabbing. Although some powder-like preparations can keep the wound dry, they have poor adhesion on wounds with more exudation and are easily washed away. In terms of wound healing quality, many treatment methods cannot effectively intervene in the tissue repair process, and the wound healing is often accompanied by excessive fibrous tissue proliferation, with a high risk of scarring. At the same time, some chemical synthetic drugs may cause local irritation or allergic reactions, and systemic administration may be accompanied by potential systemic side effects. SUMMARY

[0004] In view of the deficiencies of the prior art, the present application provides a Chinese herbal medicine formula for treating burn and scald by exposure method and a preparation method thereof, which solves the problems of single function of external use drugs in the prior art, difficulty in comprehensively dealing with complex pathological changes of inflammation, pain and tissue repair of wound, and defects of the preparation in exposure therapy, such as poor dry scabbing or poor adhesion, high risk of scarring after healing, and insufficient safety of some drugs.

[0005] To achieve the above object, the present application is realized by the following technical scheme:

[0006] The present application provides a Chinese herbal medicine formula for treating burn and scald by exposure method, which comprises (a) a powder and (b) a tincture:

[0007] The powder part is made of the following raw materials by weight: two flowers 1 part, Bai Zhi 1 part, Hu Zhang 1 part, Dui Yu 1 part, Dan Shen 1 part, Ding Xiang 1 part, and 1% to 3% of the total weight of the above six kinds of raw materials of Bing Pian.

[0008] The tincture part is prepared from mulberry jujube bark and ethanol solution.

[0009] In a preferred technical solution, the volume fraction of the ethanol solution in the tincture is 45% to 55%.

[0010] The composition of the present application is compatible, and the components synergize. In the powder formula, Erhuang and Sanguisorba officinalis are the monarch drugs. Erhuang clears heat and resolves toxins, and disperses wind-heat. Sanguisorba officinalis cools blood, stops bleeding, resolves toxins, and astringes sores. Both of them directly reach the disease site and control the fire-heat toxin caused by burns and scalds. Polygonum cuspidatum, Angelica dahurica, and Salvia miltiorrhiza are the ministerial drugs. Polygonum cuspidatum promotes blood circulation to remove blood stasis, dispels wind and dredges collaterals, and can relieve swelling and pain. Angelica dahurica resolves the exterior and dispels wind, resolves swelling and pus, and dries dampness, which helps to clean the wound and repair the tissue. Salvia miltiorrhiza promotes blood circulation to remove blood stasis, cools blood to resolve abscess, and clears the heart to relieve distress, which can improve the local microcirculation of the wound and provide a foundation for tissue repair. Clove is the auxiliary drug, which is pungent and warm, and can warm the middle and descend adverse qi, dispel cold and relieve pain. Borneol is the ministerial drug, which is pungent and cool, and can clear heat and relieve swelling when used externally, relieve pain, and guide the drugs to the lesion to enhance the overall efficacy.

[0011] The tincture part uses mulberry jujube bark as raw material, which has the functions of astringing and astringing the wound, can form a protective film on the wound, reduce exudation, prevent external infection, and provide a favorable environment for the growth of new granulation tissue.

[0012] The innovation of the present application is that the compound powder with the effects of clearing heat and resolving toxins, promoting blood circulation to remove blood stasis, and relieving swelling and pain is combined with the single tincture with the functions of astringing and astringing the wound and protecting the wound. The powder directly acts on the wound and plays its core therapeutic function, and the tincture forms a physical and pharmacological barrier. The two have different dosage forms and complementary functions, and are used in combination in the exposure therapy, which can deal with a series of pathological changes of inflammation, exudation, infection, and tissue repair in the healing process of burns and scalds in stages and multiple targets.

[0013] The present application provides a preparation method of the Chinese herbal composition as described above, which comprises the following steps:

[0014] (a) preparing the powder: baking and drying Erhuang, Angelica dahurica, Polygonum cuspidatum, Sanguisorba officinalis, Salvia miltiorrhiza, and clove, crushing them into fine powder, adding borneol and mixing uniformly after the fine powder is cooled, to obtain the powder;

[0015] (b) preparing the tincture: placing mulberry jujube bark in ethanol solution for sealed soaking, and then filtering to obtain the tincture.

[0016] In a preferred technical solution, the baking and drying temperature in step (a) is 90°C to 110°C.

[0017] In a more preferred technical solution, the fine powder in step (a) can pass through a 100-mesh to 120-mesh screen.

[0018] In a further preferred technical solution, the cooling of the fine powder in step (a) refers to cooling to room temperature of 20-30°C.

[0019] In a preferred technical solution, in the step of preparing the tincture in step (b), the ratio of mulberry jujube bark to ethanol solution is 1:5 to 1:10 (g / mL).

[0020] In a more preferred technical solution, the sealing soaking time in step (b) is 7 to 14 days.

[0021] In a further preferred technical solution, during the sealing soaking in step (b), the soaking solution is shaken or stirred 1 to 2 times a day to promote the dissolution of the active ingredients.

[0022] In a preferred technical solution, step (b) further comprises, after filtration: letting the filtrate stand for clarification for 24 hours, and taking the supernatant as the final tincture product.

[0023] The present application provides a Chinese herbal medicine formula and preparation method for the treatment of burns and scalds by exposure method. It has the following beneficial effects:

[0024] 1. The present application realizes multi-target synergistic effect by scientifically matching the components of Erhua, Dui, which have the effects of clearing heat and detoxifying, cooling blood and closing wounds, with Danshen, Hujuan, which have the effects of promoting blood circulation and improving microcirculation, and Dingxiang, Bingpian, which have the effect of pain relief. The formula can comprehensively deal with the complex pathological conditions of heat and toxin, blood stasis, and swelling and pain of burn and scald wounds, thereby effectively controlling inflammatory response, relieving pain, and creating basic conditions for tissue repair.

[0025] 2. The present application innovatively uses two dosage forms of powder and tincture in combination. The powder directly acts on the wound surface, playing the core therapeutic functions of clearing heat, reducing swelling, and relieving pain; while the tincture prepared from mulberry jujube bark can form a protective film with astringent effect on the wound surface after application. This complementation of dosage forms not only protects the wound, reduces exudation, and prevents external environmental pollution, but also provides a stable environment for the sustained action of the active ingredients in the powder, promoting rapid scabbing of the wound.

[0026] 3. The composition of the present application is particularly suitable for the exposure therapy of burns and scalds. After combined application, the drug can adhere well to the wound surface without the need for gauze dressing covering. This makes the observation of wound changes more direct and convenient, while also increasing the comfort and freedom of movement of the patient, and fundamentally avoiding the secondary damage to the newly formed granulation tissue and the pain caused by traditional dressing change.

[0027] 4、The technical scheme of the present application effectively improves the blood circulation of the local wound surface through the components of Salviae Miltiorrhizae Radix et Rhizoma and Polygoni Cuspidati Rhizoma et Radix, and rapidly controls the inflammatory reaction through the components of Lonicerae Japonicae Flos and Sanguisorbae Radix, thereby creating favorable conditions for the orderly regeneration of skin tissue. This mechanism promotes the healthy migration and growth of epithelial cells, thereby inhibiting the excessive proliferation of fibrous tissue during the healing process and reducing the risk of scar formation after the healing of superficial second-degree and deep second-degree burns.

[0028] 5、The present application is a pure Chinese herbal external preparation, and the drug directly acts on the local wound surface, is absorbed through the skin, avoids the liver and kidney burden or other systemic side effects that may be caused by systemic administration, and improves the overall safety of treatment. At the same time, since the effect is direct and the effect is exact, it can accelerate the healing process of the wound, and therefore significantly shortens the overall treatment cycle of burns of different depths. DETAILED DESCRIPTION

[0029] The technical solutions in the embodiments of the present application will be described below in conjunction with the specification of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0030] Example 1: Preparation of Chinese herbal powder

[0031] Raw material weighing

[0032] Accurately weigh the following weight of each component raw material:

[0033] Lonicerae Japonicae Flos: 100.0g

[0034] Angelicae Dahuricae Radix: 100.0g

[0035] Polygoni Cuspidati Rhizoma et Radix: 100.0g

[0036] Sanguisorbae Radix: 100.0g

[0037] Salviae Miltiorrhizae Radix et Rhizoma: 100.0g

[0038] Caryophylli Flos: 100.0g

[0039] Borneolum Syntheticum: 12.0 g (2% of the total weight of the first six medicinal materials, 600.0 g)

[0040] Preparation step

[0041] (1) The weighed two-flowered, white peony root, giant knotweed, hawthorn, salvia miltiorrhiza and clove were placed in an electric hot air drying oven and baked at a constant temperature of 100°C for 2 hours.

[0042] (2) The mixture of the six medicinal materials after baking and drying was placed in a high-speed pulverizer and pulverized thoroughly, so that the obtained powder passed through a 120-mesh standard sieve to obtain fine powder.

[0043] (3) The obtained fine powder was placed in a clean container and naturally cooled at room temperature 25°C.

[0044] (4) After the fine powder was completely cooled, 12.0 g of borneolum syntheticum was added, and the two were stirred and mixed uniformly in a closed mixer.

[0045] (5) The finally prepared powder was divided into sterile and dry wide-mouth sealed bottles, labeled, and stored in a cool and dry place for standby.

[0046] Example 2: Preparation of Chinese herbal medicine tincture

[0047] Preparation of raw materials and solvents

[0048] (1) 100.0 g of Morus cortex et Ziziphi jujubae cortex which was preliminarily cleaned and sliced was weighed.

[0049] (2) A 50% ethanol solution was prepared: 800 mL of a 50% ethanol solution was prepared by diluting and making up to volume with purified water.

[0050] Preparation step

[0051] (1) 100.0 g of Morus cortex et Ziziphi jujubae cortex was placed in a clean soaking tank, and 800 mL of a 50% ethanol solution was added to ensure a solid-liquid ratio of 1:8 (g / mL).

[0052] (2) The tank was sealed and soaked at room temperature 25°C in the dark for 10 days.

[0053] (3) During the soaking period, the soaking tank was shaken twice a day to promote the dissolution of effective ingredients.

[0054] (4) After the soaking period, the filtrate was collected by using 4 layers of sterile gauze for primary filtration and filter paper for fine filtration.

[0055] (5) The obtained filtrate was placed in a clean container, sealed and allowed to stand for 24 hours for clarification.

[0056] (6) The supernatant was carefully decanted and divided into sterile, dry, brown, narrow-mouth, sealed bottles, labeled, and stored in a cool, dark place for later use.

[0057] Example 3: Chinese herbal composition of the present application

[0058] The Chinese herbal powder prepared in Example 1 and the Chinese herbal tincture prepared in Example 2 were used together to constitute the "composition of the present application" for the subsequent test examples. In use, the two were applied to the wound surface in combination.

[0059] Comparative Example 1

[0060] The difference compared with Example 1 was that no Sanguisorba officinalis was added when preparing the powder, and the remaining raw materials and preparation steps were the same as in Example 1.

[0061] Comparative Example 2

[0062] The Chinese herbal powder prepared in Example 1 was used alone, without being combined with the tincture, for the subsequent tests.

[0063] Comparative Example 3

[0064] The Chinese herbal tincture prepared in Example 2 was used alone, without being combined with the powder, for the subsequent tests.

[0065] Comparative Example 4

[0066] The physiological saline was used as a blank control group for the subsequent tests.

[0067] Test Example 1: Evaluation of the therapeutic effect on a deep II degree scald model on the back of a rat

[0068] 1. Experimental animals, grouping, and model preparation

[0069] Forty healthy adult SD rats, weighing 220 ± 20 g, half male and half female, were selected and randomly divided into 5 groups, 8 rats in each group: Example 3 group (composition of the present application), Comparative Example 1 group (no Sanguisorba officinalis powder + tincture), Comparative Example 2 group (only powder), Comparative Example 3 group (only tincture), and Comparative Example 4 group (physiological saline control). After the rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital (30 mg / kg), the back of the rat was shaved and prepared on both sides of the spine symmetrically. A custom-made copper block with a diameter of 2.5 cm was placed in a 100°C constant temperature water bath for 5 minutes, and then immediately placed vertically on the exposed skin of the rat back, lasting for 10 seconds, to cause a standardized deep II degree scald wound.

[0070] 2. Administration method

[0071] The administration was started immediately after modeling, once a day, for 14 days.

[0072] Example 3 group: First, evenly apply a layer of the tincture prepared in Example 2 to the wound surface, and then evenly sprinkle a thin layer of the powder prepared in Example 1 on the surface after it is dry.

[0073] Comparative Example 1 group: The administration method is the same as that of Example 3 group, but the powder of Comparative Example 1 is used.

[0074] Comparative Example 2 group: Only a thin layer of the powder prepared in Example 1 is evenly sprinkled on the wound surface.

[0075] Comparative Example 3 group: Only a layer of the tincture prepared in Example 2 is evenly applied to the wound surface.

[0076] Comparative Example 4 group: The wound surface is smeared with a sterile cotton swab soaked in normal saline.

[0077] All operations were carried out under sterile conditions, and the animals were single-caged after administration, with free access to food and water.

[0078] 3. Observation index and detection method

[0079] 3.1 Wound healing rate determination:

[0080] On the 0th, 7th, and 14th days after administration, a piece of transparent sulfuric acid paper of appropriate size was covered on the wound surface, and the outline of the wound margin was drawn with a marker pen. The wound area at each time point was calculated using image analysis software, and the wound healing rate was calculated according to the following formula:

[0081] Wound healing rate (%) = (initial wound area - wound area at a specific time point) / initial wound area x 100%

[0082] 3.2 Wound tissue inflammatory factor level detection:

[0083] On the 3rd day after administration, 4 rats were randomly selected from each group, and the full-thickness skin tissue at the center of the wound was aseptically cut under anesthesia. After accurate weighing, PBS buffer was added for tissue homogenization. The supernatant was centrifuged, and the protein expression levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in the tissue homogenate were detected according to the operation steps of the ELISA kit instruction manual, and the factor content per unit weight of tissue was calculated.

[0084] 4. Experimental data

[0085] The experimental data of each group is shown in Table 1 below.

[0086] Table 1: Wound healing rate and tissue inflammatory factor level determination results of each group of rats

[0087] Group Wound healing rate (7th day, %) Wound healing rate (14th day, %) TNF-α (pg / mg tissue) IL-6 (pg / mg tissue) Example 3 group 58.3±4.1 97.2±2.5 112.6±15.3 155.9±20.4 Comparative example 1 group 41.7±5.2 81.5±4.8 198.4±21.7 264.3±31.2 Comparative example 2 group 45.1±3.9 85.4±3.6 185.7±19.8 241.8±25.6 Comparative example 3 group 25.6±4.5 53.8±6.1 251.2±28.5 310.5±35.7 Comparative example 4 group 20.2±3.8 46.1±5.4 315.8±30.2 388.2±40.1

[0088] Experimental data show that the wound healing rate of the combination of powder and tincture used in Example 3 was significantly higher than that of all comparative groups on days 7 and 14. This result indicates that the powder and tincture combination provided by the present invention can more effectively promote the healing process of burn wounds compared to any single formulation or incomplete formulation. This effect is achieved through the synergistic and complementary functions of the powder and tincture.

[0089] From a mechanistic perspective, the levels of pro-inflammatory factors TNF-α and IL-6 in the wound tissue of Example 3 were the lowest among all groups, which corresponds to the heat-clearing, detoxifying, blood-cooling, and swelling-reducing functions of the principal herbs, honeysuckle and sanguisorba, in the formula. Simultaneously, the blood-activating and stasis-removing effects of the assistant herbs, salvia miltiorrhiza and polygonum cuspidatum, improved local microcirculation. Although the levels of inflammatory factors decreased in Comparative Example 1 (lacking sanguisorba) and Comparative Example 2 (powder only), the effect was limited, indicating that the integrity of the formula and its combination with the tincture are crucial for effectively regulating the inflammatory microenvironment of the wound.

[0090] Ultimately, the test results confirmed the completeness of the technical solution of this invention. The protective layer formed by the tincture prepared from mulberry bark on the wound surface provides a stable physical environment for the various Chinese herbal components in the powder to exert their effects, reducing external irritation and excessive moisture evaporation. On this basis, the carefully formulated powder can continuously and efficiently act on the deep layers of the wound, accelerating the repair and regeneration of skin tissue by controlling inflammation and improving blood supply. This combined application of the powder as the primary agent and the tincture as the external agent is the key to achieving the expected technical effect.

[0091] Test Example 2: Evaluation of analgesic effect in a mouse hot plate analgesia model

[0092] 1. Experimental animals, grouping, and model preparation

[0093] Forty healthy adult Kunming mice, weighing 20±2g each, with half males and half females, were selected. They were randomly divided into four groups of 10 mice each: Example 3 group (the composition of this invention), Comparative Example 2 group (powder only), Comparative Example 4 group (saline control), and a positive control group (lidocaine gel). The baseline pain threshold of the mice was determined using a hot plate test (temperature constant at 55±0.5℃), and the time it took for the mice to lick their hind paws was recorded as the pain threshold latency. Mice with a baseline pain threshold latency of 5-15 seconds were selected for subsequent experiments.

[0094] 2. Administration method

[0095] The skin of the right hind paw of each group of mice was prepared locally, and then the drug was applied.

[0096] Example 3 group: First, apply a layer of the tincture prepared in Example 2 evenly, and after it is dry on the surface, sprinkle a thin layer of the powder prepared in Example 1 evenly.

[0097] Comparative Example 2 Group: only a thin layer of the powder prepared in Example 1 was evenly spread.

[0098] Comparative Example 4 Group: an equal volume of normal saline was applied.

[0099] Positive Control Group: a commercially available 2% lidocaine gel was applied.

[0100] At 30, 60 and 120 minutes after administration, the mice were placed on the hot plate and their pain threshold latency was determined again. To avoid tissue damage, the maximum observation time for a single test was set to 45 seconds.

[0101] 3. Experimental data

[0102] The pain threshold latency data of the mice in each group at different time points is shown in Table 2.

[0103] Table 2: Hot plate pain threshold latency (s) of mice in each group at different time points

[0104] Group Before administration (0 min) 30 min after administration 60 min after administration 120 min after administration Example 3 group 9.8±2.1 25.3±3.4 28.1±4.2 22.5±3.8 Comparative example 2 group 10.1±1.9 17.4±2.8 19.6±3.1 15.7±2.5 Comparative example 4 group 9.5±2.3 10.2±2.5 9.9±2.2 9.7±2.4 Positive control group 10.3±2.0 35.8±4.5 32.4±4.9 18.9±3.3

[0105] The above hot plate test data show that the pain threshold latency of Example 3 group, which was administered with the composition of the present application, was significantly longer than that of Comparative Example 2 group (only powder) and Comparative Example 4 group (normal saline control) at each time point after administration. This result objectively confirms that the Chinese herbal medicine composition has a clear local analgesic effect and can effectively improve the body's tolerance to heat pain stimulation, thereby achieving the technical effect of relieving the early severe pain of burns and scalds.

[0106] The analgesic effect is directly related to the pharmacological functions of clove and borneol in the formula. Clove is pungent and warm, contains eugenol components, and has definite local anesthetic and analgesic functions; borneol is pungent and cool, can be used externally to clear heat, reduce swelling, and relieve pain, and its high permeability can also guide other drug components to act on the deep layers of the wound. The combined use of these two components in the formula constitutes the material basis for achieving analgesic effect, directly acting on the nerve endings in the local wound and blocking or weakening the transmission of pain signals.

[0107] Comparing the data of Example 3 group and Comparative Example 2 group, it can be seen that the analgesic effect of the combination of powder and tincture is better than that of powder alone. This indicates that the tincture prepared from mulberry jujube bark plays a synergistic effect here. The protective film layer formed by the tincture not only isolates the external environment, but also provides a stable attachment and action interface for the powder, reducing the rapid evaporation or loss of the drug, so that the analgesic active ingredients of clove and borneol can be continuously and stably released and permeated, thereby producing a stronger and more lasting analgesic effect.

[0108] While embodiments of the application have been shown and described, it is to be understood that the embodiments described are merely exemplary of the principles and application of the present application. Numerous modifications and adaptions can be effected without departing from the spirit and scope of the present application, which is not limited to the exact construction and arrangement described. It is intended, therefore, to cover all modifications and adaptions that fall within the scope of the claims and their equivalents.

Claims

1. A Chinese herbal formula for treating burn and scald by exposure method, characterized in that, Both a powder and a tincture are included: The powder is made of the following raw materials by weight: Two flowers 1 part, Bai Zhi 1 part, Giant Knotweed 1 part, White Elm 1 part, Salvia 1 part, Clove 1 part, and 1% to 3% of the total weight of the preceding six kinds of raw materials of Borneol; The tincture is prepared from mulberry jujube bark and ethanol solution.

2. The Chinese herbal formula for treating burn and scald according to claim 1, wherein the Chinese herbal formula is prepared in the form of a cream. The volume fraction of ethanol solution in the tincture is 45% to 55%.

3. A method of formulating the Chinese herbal formula of claim 1, characterized in that, The following steps are included: Preparation of the powder: Two flowers, Bai Zhi, Giant Knotweed, White Elm, Salvia and Clove are baked and dried, and then crushed into fine powder. After the fine powder is cooled, Borneol is added and mixed evenly to obtain the powder; Preparation of the tincture: mulberry jujube bark is sealed and soaked in ethanol solution, and then filtered to obtain the tincture.

4. The method of formulating according to claim 3, wherein, The temperature of the baking and drying is 90℃ to 110℃, and the fine powder can pass through a 100-120 mesh sieve.

5. The method of formulating according to claim 3, wherein, In the step of preparing the tincture, the solid-liquid ratio of mulberry jujube bark to ethanol solution is 1:5g / mL to 1:10g / mL, and the sealed soaking time is 7 to 14 days.

6. The method of formulating according to claim 3, wherein, Cooling the fine powder means cooling to room temperature of 20℃-30℃.

7. The method of formulating according to claim 3, wherein, During the sealed soaking, the soaking liquid is shaken or stirred 1 to 2 times a day.

8. The method of formulating according to claim 3, wherein, The step of preparing the tincture further includes, after filtering, standing the filtrate for clarification for 24 hours, and taking the supernatant as the tincture.