A pharmaceutical composition, a pharmaceutical preparation, a method for preparing the same and its application

Abstract

This invention relates to a pharmaceutical composition, a pharmaceutical preparation, a method for preparing the same, and its application. The composition, by weight, comprises: 10-20 parts honeysuckle, 20-30 parts hibiscus leaves, 10-20 parts prunella vulgaris, 10-20 parts fritillaria thunbergii, 10-20 parts trichosanthes kirilowii, 10-20 parts pinellia ternata, 10-20 parts gallnut, 5-10 parts turmeric, 5-10 parts rhubarb, 5-10 parts phellodendron chinense, 5-10 parts atractylodes lancea, 5-10 parts angelica dahurica, and 5-10 parts magnolia officinalis. This pharmaceutical composition uses hibiscus leaves and honeysuckle as the principal ingredients to clear heat and detoxify, inhibit bacteria and control infection; and prunella vulgaris, trichosanthes kirilowii, pinellia ternata, and fritillaria thunbergii as the assistant ingredients to invigorate blood circulation, dispel dampness, resolve phlegm and dissipate nodules, reduce swelling, and relieve pain. Turmeric, rhubarb, magnolia officinalis, phellodendron chinense, atractylodes lancea, and angelica dahurica are the adjuvant ingredients to enhance the effects of clearing heat while simultaneously promoting diuresis and reducing swelling. The medication acts on the wound periphery to clear heat and detoxify, promote blood circulation and remove dampness, reduce swelling and relieve pain, and acts on the wound surface to inhibit bacteria, reduce swelling and relieve pain.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition, a pharmaceutical preparation, a method for preparing the same, and its application. Background Technology

[0002] Domestic and international studies have shown that diabetic foot is extremely costly, accounting for about one-third of all diabetes medical expenses. Therefore, diabetic foot is one of the leading causes of disability and death among diabetic patients, and a major public health problem that places a heavy burden on society.

[0003] Diabetic foot, a typical example of infectious diseases of the skin, often manifests as ulceration of the wound surface, with redness, swelling, heat, and pain around the wound. Currently, most drugs or dressings used to treat infectious diseases of the skin are applied as sap to the wound surface, with fewer drugs applied around the wound. The marketed drug Ruyi Jinhuang San can be used as a topical medication, but its powder form is inconvenient for clinical application and is prone to causing allergies and staining clothing.

[0004] Therefore, it is essential to develop a new drug composition and drug formulation. Summary of the Invention

[0005] This invention provides pharmaceutical compositions, pharmaceutical preparations, their preparation methods, and applications. The pharmaceutical compositions and pharmaceutical preparations have anti-inflammatory, analgesic, and antibacterial effects, and are used to prepare drugs for treating skin inflammation or anti-infective drugs. The pharmaceutical preparations can be applied to the wound or the surrounding area, solving the clinical problem of treating only the wound while neglecting the surrounding area. Based on clinical practice, a preparation process has been designed to make the dosage form application more convenient and the efficacy better.

[0006] The technical solution adopted in this invention is:

[0007] One objective of this invention is to provide a pharmaceutical composition comprising, by weight, 10-20 parts of honeysuckle, 15-30 parts of hibiscus leaves, 10-20 parts of prunella vulgaris, 10-20 parts of fritillaria thunbergii, 10-20 parts of trichosanthes kirilowii, 10-20 parts of pinellia ternata, 10-20 parts of gallnut, 5-10 parts of turmeric, 5-10 parts of rhubarb, 5-10 parts of phellodendron chinense, 5-10 parts of atractylodes lancea, 5-10 parts of angelica dahurica, and 5-10 parts of magnolia officinalis.

[0008] As a preferred technical solution of this application, the composition comprises, by weight, 12-15 parts of honeysuckle, 15-24 parts of hibiscus leaves, 12-15 parts of prunella vulgaris, 12-15 parts of fritillaria thunbergii, 12-15 parts of trichosanthes kirilowii, 12-15 parts of pinellia ternata, 12-15 parts of gallnut, 6-9 parts of turmeric, 6-9 parts of rhubarb, 6-9 parts of phellodendron chinense, 6-9 parts of atractylodes lancea, 6-9 parts of angelica dahurica, and 6-9 parts of magnolia officinalis.

[0009] As a preferred technical solution of this application, the pharmaceutical composition comprises, by weight, 30 parts of Hibiscus mutabilis leaves, 20 parts of honeysuckle, 20 parts of prunella vulgaris, 20 parts of Fritillaria thunbergii, 20 parts of Trichosanthes kirilowii, 20 parts of Pinellia ternata, 20 parts of Galla chinensis, 10 parts of turmeric, 10 parts of rhubarb, 10 parts of Phellodendron chinense, 10 parts of Atractylodes lancea, 10 parts of Angelica dahurica, and 10 parts of Magnolia officinalis.

[0010] As a preferred technical solution of this application, the pharmaceutical composition comprises, by weight, 15 parts of Hibiscus mutabilis leaves, 10 parts of honeysuckle, 10 parts of prunella vulgaris, 10 parts of Fritillaria thunbergii, 10 parts of Trichosanthes kirilowii, 10 parts of Pinellia ternata, 10 parts of Galla chinensis, 5 parts of turmeric, 5 parts of rhubarb, 5 parts of Phellodendron chinense, 5 parts of Atractylodes lancea, 5 parts of Angelica dahurica, and 5 parts of Magnolia officinalis.

[0011] As a preferred technical solution of this application, the composition comprises, by weight, 20 parts of Hibiscus mutabilis leaves, 15 parts of honeysuckle, 15 parts of prunella vulgaris, 15 parts of Fritillaria thunbergii, 15 parts of Trichosanthes kirilowii, 15 parts of Pinellia ternata, 15 parts of Galla chinensis, 9 parts of turmeric, 9 parts of rhubarb, 9 parts of Phellodendron chinense, 9 parts of Atractylodes lancea, 9 parts of Angelica dahurica, and 9 parts of Magnolia officinalis.

[0012] A second objective of this invention is to provide a pharmaceutical preparation comprising the pharmaceutical composition described in the first objective; the dosage form of the pharmaceutical preparation is any one of a powder, tincture, or lotion.

[0013] A third objective of this invention is to provide a method for preparing a pharmaceutical preparation.

[0014] When the pharmaceutical preparation is a powder, the preparation method includes: crushing the pharmaceutical composition described in one of the objectives into powder, sieving it, and obtaining the powder.

[0015] As a preferred technical solution of this application, when the pharmaceutical preparation is a powder, the preparation method includes: crushing the pharmaceutical composition described in one of the objectives into powder, passing it through an 8-mesh sieve (150 mesh, 90 micrometers) to obtain a powder.

[0016] When the pharmaceutical preparation is a tincture, the preparation method includes: crushing the pharmaceutical composition of one of the purposes into powder, sieving it, dissolving it in alcohol, taking the supernatant, and obtaining the tincture.

[0017] As a preferred technical solution of this application, when the pharmaceutical preparation is a tincture, the preparation method includes: crushing the pharmaceutical composition described in one of the purposes into powder, passing it through an 8-mesh sieve (150 mesh, 90 micrometers), then taking 25 g and dissolving it in 250 mL of 75% alcohol, letting it stand for one week, taking the supernatant to obtain the tincture.

[0018] When the pharmaceutical preparation is a lotion, the preparation method includes: crushing the pharmaceutical composition of one of the purposes into powder, sieving it, dissolving it in alcohol, taking the supernatant, removing the alcohol, dissolving it in water, and obtaining the lotion.

[0019] As a preferred technical solution of this application, when the pharmaceutical preparation is a lotion, the preparation method includes: crushing the pharmaceutical composition described in one of the purposes into powder, passing it through an 8-mesh sieve (150 mesh, 90 micrometers), then taking 25 g and dissolving it in 250 mL of 75% alcohol, letting it stand for one week, taking the supernatant, then heating and evaporating to remove the alcohol, and dissolving it in water for injection to prepare a 10% solution to obtain the lotion.

[0020] A third objective of this invention is to provide a pharmaceutical composition as described in objective one, or a pharmaceutical preparation as described in objective two, for use in the preparation of anti-inflammatory or anti-infective drugs.

[0021] Preferably, the anti-infective drug is used for the treatment of postoperative wound infection or the prevention of wound infection.

[0022] Preferably, the inflammation or infection of the skin surface treated with anti-inflammatory or anti-infective drugs is caused by erysipelas, cellulitis, paronychia, lymphadenitis, thrombophlebitis, diabetic skin surface infection, etc.

[0023] Preferably, the skin infection is a diabetic foot ulcer infection.

[0024] The advantages and positive effects of this invention are:

[0025] This application utilizes Hibiscus mutabilis leaves, honeysuckle, Prunella vulgaris, and Trichosanthes kirilowii to clear heat and detoxify, inhibit bacteria and control inflammation; in addition, Pinellia ternata, turmeric, rhubarb, Phellodendron chinense, Atractylodes lancea, Magnolia officinalis, Angelica dahurica, and Fritillaria thunbergii to invigorate blood, remove dampness, resolve phlegm and dissipate nodules, reduce swelling and relieve pain; the drug composition or preparation is applied to the wound periphery to clear heat and detoxify, invigorate blood and remove dampness, reduce swelling and relieve pain, and applied to the wound surface to inhibit bacteria, reduce swelling and relieve pain.

[0026] External treatment methods involve applying medications, surgery, physical methods, or certain instruments directly to a specific part of the body surface or the site of a lesion to achieve therapeutic effects. Drug therapy is one of the commonly used methods of external treatment.

[0027] It should be noted that this application consists of a group of drugs for clearing heat and detoxifying, reducing swelling and relieving pain, a group of drugs for promoting blood circulation and removing dampness, reducing swelling and relieving pain, and a group of drugs for reducing swelling and relieving pain, resolving phlegm and dissipating nodules.

[0028] Heat-clearing, detoxifying, swelling-reducing and pain-relieving medicine group: Hibiscus mutabilis leaf is pungent and neutral in nature. Externally applied, it cools the blood, detoxifies, reduces swelling and relieves pain. Flos Lonicerae is sweet and cold in nature. Externally applied, it reduces swelling and relieves pain. It is recorded in the Chinese Pharmacopoeia that Hibiscus mutabilis leaf is neutral in nature, pungent in taste, and belongs to the lung and liver meridians. It can cool the blood, detoxify, reduce swelling and relieve pain. Hibiscus mutabilis is slippery and sticky with saliva. Its effect in treating carbuncles and sores is particularly miraculous. Surgeons secretly call it Qingliang Ointment, Qinglu Powder, Tiegu Powder, etc., all of which are this medicine. Its formula can treat all carbuncles, ulcers and boils on the back (surgical infectious diseases), breast abscesses and malignant sores, regardless of whether they are formed or not, whether they are perforated or not. Use hibiscus leaf, or root bark, or flower, either raw or ground into powder, and apply it around the swollen area with honey, leaving the center open. Hibiscus mutabilis leaf can be used as a surrounding medicine for the initial stage, suppuration stage and ulcer stage of traditional Chinese surgical diseases. Hibiscus mutabilis leaf cools the blood and detoxifies, improves capillary permeability, reduces soft tissue exudation, and plays an anti-inflammatory and analgesic effect, so it can reduce swelling and relieve pain. Flos Lonicerae is also called Flos Lonicerae Japonicae (abbreviated as Flos Lonicerae), commonly known as Jinhuahua, Yinhuahua, Erhuahua, Shuanghuahua, Jintenghua, Shuangbaohua, Lusihuahua, etc. Flos Lonicerae is sweet and cold in nature, known as the holy medicine for sores, with strong heat-clearing and detoxifying effects. It belongs to the lung, heart and stomach meridians and has various functions such as dispelling summer heat, clearing heat and detoxifying, reducing swelling and astringing. The combination of Flos Lonicerae and Hibiscus mutabilis leaf can significantly enhance their effects of clearing heat and detoxifying, reducing swelling and relieving pain. The two are used as the sovereign herbs. Cortex Phellodendri is bitter and cold. Externally applied, it clears damp-heat and purges fire-toxin. Radix Trichosanthis is slightly bitter and slightly cold. Externally applied, it clears heat and purges fire, reduces swelling and discharges pus. Prunella vulgaris is bitter, pungent and cold in nature, belongs to the liver and gallbladder meridians, clears heat and detoxifies, and dissipates nodules and reduces swelling. Cortex Phellodendri, Prunella vulgaris and Radix Trichosanthis are ministerial herbs, enhancing the effects of clearing heat and detoxifying, reducing swelling and relieving pain. Moreover, Prunella vulgaris can dissipate nodules and is suitable for the acute inflammation stage and its protracted stage.

[0029] Blood-activating, dampness-removing, swelling-reducing and pain-relieving medicine group: Galla Chinensis is cold in nature. Externally applied, it detoxifies, relieves itching, stops bleeding and relieves pain, astringes dampness and reduces swelling; Rheum palmatum is bitter and cold. Externally applied, it clears blood heat, breaks stasis, and eliminates swelling and toxin; Curcuma longa is pungent, bitter and warm. Externally applied, it promotes blood circulation, activates qi, dredges meridians and relieves pain, relieves itching and reduces swelling. These three herbs are important drugs in the surrounding medicine. Their combination can enhance the effect of clearing heat and detoxifying, and can also promote blood circulation and remove stasis. When blood circulates smoothly, the meridians are unobstructed. When blood circulates smoothly, swelling subsides. If there is obstruction, there is pain. If it is unobstructed, there is no pain, increasing the effect of reducing swelling and relieving pain.

[0030] Swelling-reducing, pain-relieving, phlegm-resolving and nodule-dissipating medicine group: Pinellia ternata is pungent and warm. Externally applied, it reduces swelling and relieves pain, resolves phlegm and dissipates nodules. It is best to use the raw product externally for treating carbuncles and sores. Pinellia ternata enters the spleen and stomach meridians. The spleen governs the four limbs and the muscles. Pinellia ternata is good at removing swelling of the skin and muscles when externally applied. When externally applied, appropriate amount of the raw product can be pounded and applied or applied with wine to the affected area. Atractylodes lancea is pungent, bitter and warm. Externally applied, it dries dampness, dispels foulness, and expels wind and water accumulation in the subcutaneous tissue. Atractylodes lancea is good at removing dampness and reducing swelling, and Atractylodes lancea has a certain effect of removing stasis. Angelica dahurica is pungent and warm. Externally applied, it dissipates nodules and relieves pain. Magnolia officinalis is pungent and warm. Externally applied, it dries dampness, dissipates nodules and reduces swelling and pain. Fritillaria thunbergii is bitter and cold, clears heat and detoxifies, dissipates nodules and eliminates carbuncles. The combination of Pinellia ternata, Atractylodes lancea, Angelica dahurica and Fritillaria thunbergii has a strong effect of resolving phlegm and dissipating nodules, enhancing the effect of reducing swelling and relieving pain.

[0031] The advantages and positive effects of this formula are as follows: Hibiscus mutabilis leaves and honeysuckle act as the principal ingredients to clear heat and detoxify, inhibit bacteria and control infection; while Prunella vulgaris, Trichosanthes kirilowii, Pinellia ternata, and Fritillaria thunbergii act as the assistant ingredients to invigorate blood circulation, dispel dampness, resolve phlegm and nodules, reduce swelling, and relieve pain. Curcuma longa, rhubarb, Magnolia officinalis, Phellodendron chinense, Atractylodes lancea, and Angelica dahurica act as adjuvant ingredients to enhance the effects of clearing heat while promoting diuresis and reducing swelling. The entire formula acts on the surrounding area to clear heat and detoxify, invigorate blood circulation, dispel dampness, reduce swelling and relieve pain, and on the wound surface to inhibit bacteria, reduce swelling and relieve pain.

[0032] This formula is composed of honeysuckle, hibiscus leaves, prunella vulgaris, fritillaria thunbergii, trichosanthes kirilowii, pinellia ternata, gallnut, turmeric, rhubarb, phellodendron chinense, angelica dahurica, and magnolia officinalis. Detailed Implementation

[0033] The embodiments of this application are described in detail below.

[0034] It should be understood that when an element or layer is referred to as "on," "adjacent to," "connected to," or "coupled to" other elements or layers, it may be directly on, adjacent to, connected to, or coupled to other elements or layers, or there may be intervening elements or layers. Conversely, when an element is referred to as "directly on," "directly adjacent to," "directly connected to," or "directly coupled to" other elements or layers, there are no intervening elements or layers. It should be understood that although the terms first, second, third, etc., may be used to describe various elements, components, areas, layers, and / or portions, these elements, components, areas, layers, and / or portions should not be limited by these terms. These terms are only used to distinguish one element, component, area, layer, or portion from another element, component, area, layer, or portion. Therefore, without departing from the teachings of this application, the first element, component, area, layer, or portion discussed below may be referred to as a second element, component, area, layer, or portion. And the discussion of a second element, component, area, layer, or portion does not imply that the first element, component, area, layer, or portion necessarily exists in this application.

[0035] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0036] In this application, when numerical intervals (i.e., numerical ranges) are involved, unless otherwise specified, the distribution of selectable numerical values ​​within the numerical interval is considered continuous, and includes the two endpoints of the numerical interval (i.e., the minimum and maximum values), as well as every numerical value between these two endpoints. Unless otherwise specified, when a numerical interval refers only to integers within that numerical interval, it includes the two endpoint integers of the numerical range, as well as every integer between the two endpoints, which is equivalent to directly listing every integer. When multiple numerical ranges are provided to describe features or characteristics, these numerical ranges can be merged. In other words, unless otherwise specified, the numerical ranges disclosed in this application should be understood to include any and all subranges included therein. The "numerical value" in the numerical interval can be any quantitative value, such as a number, percentage, ratio, etc. The term "numerical interval" can be broadly included to include percentage intervals, ratio intervals, proportion intervals, etc.

[0037] This application provides a technical solution for a pharmaceutical composition, a traditional Chinese medicine preparation, its preparation method, and its application. Details are provided below.

[0038] Exemplary embodiments according to this application will now be described in more detail. It should be understood that these exemplary embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein.

[0039] Example 1:

[0040] This embodiment provides an experimental study on the efficacy of an anti-inflammatory and swelling-reducing formula in treating skin abscesses in rats. The study includes: establishing a positive abscess model through subcutaneous injection of Staphylococcus aureus; investigating the effects and therapeutic efficacy of a tincture made from the drug composition; observing the time of abscess formation, changes in skin temperature around the abscess, changes in rat weight, and general behavior; and recording the extent of abscess spread.

[0041] This embodiment provides a pharmaceutical composition, which, by weight, includes: 10g of honeysuckle, 10g of hibiscus leaves, 5g of prunella vulgaris, 10g of fritillaria thunbergii, 10g of trichosanthes kirilowii, 10g of pinellia ternata, 10g of gallnut, 5g of turmeric, 5g of rhubarb, 5g of phellodendron bark, 5g of atractylodes lancea, 5g of angelica dahurica, and 5g of magnolia officinalis.

[0042] This embodiment also provides a pharmaceutical preparation, which is a powder. The preparation method includes: crushing the above-mentioned pharmaceutical composition into powder, passing it through an 8-mesh sieve (150 mesh, 90 μm) to make a powder.

[0043] This embodiment also provides a pharmaceutical preparation, which is a tincture. The preparation method includes: crushing the above-mentioned pharmaceutical composition into powder, passing it through an 8-mesh sieve (150 mesh, 90 μm) to make a powder; then dissolving 25g of the powder in 250ml (1:10) of 75% medical alcohol for one week, taking the supernatant to make a tincture.

[0044] This embodiment also provides a pharmaceutical preparation, which is a lotion. The preparation method includes: crushing the above-mentioned pharmaceutical composition into powder, passing it through an 8-mesh sieve (150 mesh, 90 μm) to make a powder; then, dissolving 25g of the powder in 250ml (1:10) of 75% medical alcohol for one week, and taking the supernatant; then, heating and evaporating to remove the alcohol, and then dissolving it in water for injection to make a 10% solution to form a lotion.

[0045] Funo (Compound Polymyxin B Ointment): National Drug Approval Number H20061269, Zhejiang Funo Pharmaceutical Co., Ltd. Used for the prevention of bacterial infection of skin wounds such as cuts, abrasions, burns, and surgical wounds, and for temporary relief of pain and discomfort. This product is a compound preparation. Component A is 3g / tube, containing 15,000 units of polymyxin B sulfate, 10,500 units of neomycin sulfate, 1,500 units of bacitracin, and 120mg of lidocaine hydrochloride; Component B is 10g / tube, containing 50,000 units of polymyxin B sulfate, 35,000 units of neomycin sulfate, 5,000 units of bacitracin, and 400mg of lidocaine hydrochloride; Component C is 20g / tube, containing 100,000 units of polymyxin B sulfate, 70,000 units of neomycin sulfate, 10,000 units of bacitracin, and 800mg of lidocaine hydrochloride.

[0046] Physiological saline: China Resources Double-Crane Pharmaceutical Co., Ltd.

[0047] The strains used in this embodiment are from the following sources:

[0048] Staphylococcus aureus: Staphylococcus aureus strain ATCC25923, with a Staphylococcus aureus concentration of 3-5 × 10⁻⁶ in the bacterial culture. 9 cfu / mL. Preparation of bacterial suspension: Staphylococcus aureus was cultured on nutrient agar medium at 37°C for 24 hours. After that, the colonies were collected and ground with an appropriate amount of sterile sodium chloride injection to prepare a bacterial suspension containing 300-500 million Staphylococcus aureus bacteria per milliliter.

[0049] The instruments used in this embodiment are as follows:

[0050] Omron MC-872 Infrared Skin Thermometer. License No. 20100058 issued by Jiangsu Food and Drug Administration, Omron Healthcare China Co., Ltd.

[0051] The experimental animals and their groups used in this embodiment are as follows:

[0052] Eighty SD rats, weighing 260±20g, were randomly divided into 5 groups of 16 each after 3 days of acclimatization. Forty rats (8 per group) were used for blood and tissue collection, and the remaining 40 rats (8 per group) were used for measuring body temperature, transcutaneous oxygen partial pressure, abscess area, wound area, and healing rate. The rats were purchased from the Experimental Animal Center of the Academy of Military Medical Sciences of the Chinese People's Liberation Army.

[0053] The experimental animals were grouped as follows:

[0054] (1) Blank control group: Rats were injected subcutaneously with physiological saline and fed normally without any treatment.

[0055] (2) Pretreatment group: rats were infected by subcutaneous injection of Staphylococcus aureus. Anti-inflammatory and swelling-reducing solution was applied immediately 4 hours after injection and the dressing was changed once a day.

[0056] (3) Treatment group: Rats were infected by subcutaneous injection of Staphylococcus aureus. After the appearance of induration, anti-inflammatory and swelling-reducing solution was applied and the dressing was changed immediately, once a day.

[0057] (4) Control group: rats were injected subcutaneously with Staphylococcus aureus. After scleroderma appeared, Furen was applied topically and changed once a day.

[0058] (5) Model group: rats were infected by subcutaneous injection of Staphylococcus aureus, and the dressing was changed with saline gauze once a day.

[0059] The modeling method provided in this embodiment is as follows:

[0060] The method of subcutaneous bacterial injection was employed. In determining the formation of infection foci, since the subcutaneous tissue of rats is primarily muscle and lacks loose connective tissue, but exhibits relative redness, swelling, and elevated skin temperature, abscesses can form. We considered the finger-sized abscess cavity that appears after the formation of a subcutaneous induration in rats as one of the important markers of infection foci, with secondary markers being skin redness and elevated skin temperature. Injection method: Staphylococcus aureus bacterial solution with a concentration of 3-5 × 10⁹ CFU / ml was injected subcutaneously into the skin using a 1 ml syringe, from the tail end to the head end, ensuring the wheal was centered within the circular observation area.

[0061] The experimental observation indicators provided in this embodiment are as follows:

[0062] (1) Observation of the general living behavior of animals

[0063] Observe and record the physiological and behavioral characteristics and weight changes of each group of animals daily.

[0064] (2) Record the swelling and healing of the rat wounds.

[0065] The extent of swelling, duration of swelling localization, skin temperature around the swelling (measured over four weeks and averaged), time to abscess formation, and wound healing time were assessed. Swelling extent was scored as follows: 1 point (swelling exceeding 4cm, diffuse swelling without a head); 2 points (swelling 2-4cm, localized swelling); 3 points (swelling less than 2cm, localized swelling); 4 points (no obvious swelling). A preliminary experiment was conducted to observe the wound healing time in rats after incision and drainage, and after disruption of the protective barrier.

[0066] (3) Experimental observation indicators

[0067] Blood samples of approximately 1.5 ml were collected from the heart on days 3, 7, 14, and 18 of treatment. The levels of rat bactericidal / permeability-increasing protein (BPI), regressor D1 (RvD1), high-mobility group box 1 (HMGB1), lipooxygenin A4 (LXA4), interleukin-10 (IL-10), and interleukin-1β (IL-1β) in the samples were determined using a double-antibody sandwich assay. The absorbance (OD value) was measured at 450 nm using a microplate reader, and the concentrations of rat BPI, RvD1, HMGB1, LXA4, IL-10, and IL-1β in the samples were calculated using a standard curve.

[0068] This embodiment provides a statistical method, as follows:

[0069] Experimental data were processed using SPSS 16.0 statistical software. Quantitative data were expressed as mean ± standard deviation. The numbers indicate that within-group comparisons were performed using paired t-tests. Comparisons among multiple groups were performed using one-way ANOVA with post-test multiple comparisons using LSD, and an α=0.05 significance level.

[0070] The experimental results obtained in this embodiment are as follows:

[0071] (1) Observation results of general living behavior of rats

[0072] Observations of the rats' living conditions, behavior, and general wound condition revealed that after modeling, the rats exhibited reduced activity, poor appetite, and decreased food intake. Except for the blank control group, all other groups showed varying degrees of lethargy. Induration appeared on day 1 after modeling in all groups, with congested and edematous skin around the induration. In some rats, the skin in the center of the induration was pale. The abscesses did not subside after intervention in any group, which was considered related to the amount of injected bacteria, failing to effectively dissipate the toxins. The swelling was localized in all groups from 4 to 13 days, and the wound ruptured after 7 to 13 days, with wound healing time ranging from 15 to 24 days. In the experiment, it was observed that rats whose abscess walls at the base were incised experienced infection spread and damage to the protective barrier, resulting in prolonged wound healing time of 29-33 days, and even poor appetite and significant weight loss.

[0073] (2) Comparison of the time for abscess localization and wound healing time in the four groups

[0074] The time it took for abscesses to localize and for wounds to heal in each of the four groups was observed. Compared with the model group, the time for abscess localization was significantly different among the pre-treatment group, treatment group, and control group. P <0.05 or P <0.01). There was no statistically significant difference in the duration of abscess localization among the pretreatment group, treatment group, and control group. P >0.05). The wound healing time in the model group was significantly different from that in the treatment group. P <0.05). There was no statistically significant difference in wound healing time among the pretreatment group, treatment group, and control group. P >0.05). The results are shown in Table 1.

[0075] Table 1 Comparison of abscess localization time and wound healing time in four groups ( ,sky)

[0076]

[0077] Note: Compared with the pre-treatment group, ** P <0.01, * P <0.05; compared with the treatment group, △△ P <0.01, △ P <0.05; compared with the control group, ▽▽ P <0.01, ▽ P <0.05.

[0078] This embodiment also provides a comparison of four groups of abscess extent scores, as follows:

[0079] After 3 days of treatment, there was no statistically significant difference in abscess extent scores among the groups. P >0.05), after 7 days of treatment, the pre-treatment group, treatment group, and control group were all higher than the model group, and the differences were statistically significant. P <0.05), while there was no statistically significant difference in abscess extent scores between the treatment group and the control group, and between the pre-treatment group ( P >0.05), after 14 days of treatment, the pre-treatment group, treatment group, and control group were all higher than the model group, and the differences were statistically significant. P <0.01), while there was no statistically significant difference in abscess extent scores between the treatment group and the control group, and between the pre-treatment group ( P >0.05). The results are shown in Table 2.

[0080] Table 2 Comparison of abscess extent scores among groups ( (cm2)

[0081]

[0082] Note: Compared to the model group, * P <0.05,** P <0.01.

[0083] (3) Changes in protein content due to increased bactericidal permeability in each group

[0084] The levels of bactericidal permeability-increasing protein (BPI) in each group showed an increased trend compared to the control group at all detection time points. Compared with the control group, the BPI levels in the model group, control group, pre-treatment group, and treatment group were statistically significant at 3d, 7d, 14d, and 18d of treatment. P <0.01). At 7 days of treatment, the BPI differences between the control group and the pretreatment group were statistically significant compared to the model group. P <0.01 or P <0.05). Compared with the control group and the pretreatment group, the BPI in the treatment group was significantly different at 7 days of treatment. P <0.01). At day 14 of treatment, the difference in BPI levels between the control group and the model group was statistically significant ( P <0.05), and the BPI levels in the pretreatment group and the treatment group were statistically significant compared with the control group. P <0.01 or P <0.05). At day 18 of treatment, the difference in BPI levels between the control group and the model group was statistically significant ( P <0.01), and the BPI levels in the pretreatment group and the treatment group were statistically significant compared with the control group. P <0.01 or P <0.05). The results are shown in Table 3.

[0085] Table 3. Changes in BPI levels in each group ( ,ng / L)

[0086]

[0087] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P<0.01; compared with the pre-treatment group, △ P <0.05, △△ P <0.01.

[0088] (4) Changes in the content of cyclophosphamide D1 in each group

[0089] Compared with the blank control group, the levels of regressor D1 in all groups showed a decreasing trend at all detection time points. The differences in plasma regressor D1 levels at each treatment time point and in each group (except for the treatment group at day 18) compared to the blank control group were statistically significant. P <0.01 or P <0.05). At 18 days, there was no statistically significant difference in regressor D1 levels between the treatment group and the control group. P >0.05). There were no statistically significant differences in the levels of regressor D1 among the control group, model group, and treatment group at any of the detection time points. P >0.05). At 7 days of treatment, the difference in regressor D1 levels between the control group and the model group was statistically significant. P <0.05). At 14 days of treatment, compared with the model group, the levels of regressive D1 in the pre-treatment group and the treatment group were statistically significant (…). P <0.01 or P <0.05). At day 18 of treatment, the differences in regressor D1 levels among the control group, model group, and treatment group compared to the model group were statistically significant. P <0.01). The results are shown in Table 4.

[0090] Table 4. Changes in the content of cyclophosphamide D1 in each group ( (ng / mL)

[0091]

[0092] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P <0.01; compared with the pre-treatment group, △ P <0.05, △△ P <0.01.

[0093] (5) Changes in HMGB1 content in each group

[0094] The changes in HMGB1 levels in each group at different time points. At 3 days of treatment, the HMGB1 levels in the pre-treatment group and the treatment group were statistically significantly different from those in the model group. P <0.01 or P <0.05). After 7 days of treatment, there was no statistically significant difference in HMGB1 levels among the groups. P >0.05). After 14 days of treatment, the HMGB1 level in the treatment group was significantly different from that in the pre-treatment group. P <0.05), there was no statistically significant difference in HMGB1 levels among the blank group, model group, and control group. P >0.05). After 18 days of treatment, there was no statistically significant difference in HMGB1 levels among the groups. P >0.05). The results are shown in Table 3.

[0095] Table 5. Changes in HMGB1 content in each group ( (μg / L)

[0096]

[0097] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P <0.01; compared with the pre-treatment group, △ P <0.05, △△ P <0.01.

[0098] (6) Changes in lipooxygenin A4 content in each group

[0099] After 3 days of treatment, the levels of lipooxygenin A4 in the model group, control group, and treatment group were statistically significant compared with the blank group. P <0.01 or P <0.05). Compared with pretreatment, the lipooxygenin A4 levels in the model group and the treatment group were statistically significant ( P <0.01 or P <0.05). There were no statistically significant differences in lipooxygenin A4 levels among the groups at 7 and 14 days of treatment. P>0.05). After 18 days of treatment, there was no statistically significant difference between the groups. P >0.05). The results are shown in Table 6.

[0100] Table 6. Changes in lipooxygen A4 content in each group ( (pg / ml)

[0101]

[0102] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P <0.01; compared with the pre-treatment group, △ P <0.05, △△ P <0.01.

[0103] (7) Changes in plasma IL-10 levels in each group

[0104] The results showed that the IL-10 levels in all groups on day 3 after treatment were increasing compared with the control group, and the differences in IL-10 levels between the control group and the treatment group were statistically significant. P <0.01 or P <0.05), there was no statistically significant difference in IL-10 levels between the treatment group and the blank group, pre-treatment group, and control group. P >0.05). This suggests that early intervention with Frenox and anti-inflammatory / swelling-reducing solutions can increase IL-10 levels. At 7 days of treatment, IL-10 levels in all groups showed a decreasing trend, with significant decreases in the control and pre-treatment groups. The IL-10 levels in the pre-treatment and treatment groups were statistically significantly different from those in the blank group, model group, and control group. P <0.01 or P <0.05), there was no statistically significant difference in IL-10 levels between the model group and the control group. P>0.05). This indicates that within the monitoring time points, the IL-10 levels in the control group, pre-treatment group, and treatment group were highest on day 3 after intervention with the anti-inflammatory and swelling-reducing solution, subsequently showing a decreasing trend. After intervention with both Fenox and the anti-inflammatory and swelling-reducing solution, the IL-10 levels showed a trend of first increasing and then decreasing, with the Fenox group showing a faster decrease in IL-10 levels. At days 14 and 18 of treatment, the IL-10 levels in the pre-treatment and treatment groups showed a decreasing trend, while the model group showed an increasing trend. There was no statistically significant difference in IL-10 levels among the groups. P >0.05). The results are shown in Table 7.

[0105] Table 7. Changes in IL-10 levels in each group ( (ng / L)

[0106]

[0107] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P <0.01.

[0108] (8) Changes in plasma IL-1β levels in each group

[0109] After 3 days of treatment, the IL-1β levels in all groups showed an increasing trend compared to the blank group. The differences in IL-1β levels between the model group, control group, pretreatment group, and treatment group compared to the blank group were statistically significant. P <0.01). Except for the control group, the IL-1β levels in all treatment groups increased to varying degrees after 3 days of intervention. At 7, 14, and 18 days of treatment, the changes in IL-1β levels in the model group were statistically significant compared to the control group. P <0.01); compared with the model group, the changes in IL-1β expression levels in the control group, pre-treatment group, and treatment group were statistically significant ( P <0.01). After 14 days of treatment, the change in IL-1β levels in the control group was statistically significant compared with the blank group. P <0.01); compared with the control group, the change in IL-1β level in the treatment group was statistically significant ( P <0.01). The results are shown in Table 8.

[0110] Table 8. Changes in IL-1β levels in each group ( ,ng / L)

[0111]

[0112] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, △ P <0.05, △△ P <0.01.

[0113] (9) Changes in PCT content in each group

[0114] At 3, 7, and 14 days of treatment, the plasma PCT levels in the model group, control group, pre-treatment group, and treatment group were statistically significant compared with the blank group. P <0.01), plasma PCT levels in all groups showed a decreasing trend. Compared with the model group, the differences in plasma PCT levels in the pretreatment group and the treatment group were statistically significant ( P <0.01) or ( P <0.05). At 3 and 7 days of treatment, the plasma PCT levels in the pre-treatment and treatment groups were statistically significantly different from those in the control group. P <0.01 or P <0.05). The results are shown in Table 9.

[0115] Table 9. Changes in plasma PCT levels in each group ( (pg / mL)

[0116]

[0117] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05.

[0118] (10) Changes in CRP content in each group

[0119] At 3 and 7 days of treatment, the plasma CRP levels in the model group, control group, pre-treatment group, and treatment group were statistically significant compared with the blank group. P <0.01), plasma CRP levels in all treatment groups showed a decreasing trend. At 3, 7, and 14 days of treatment, the differences in plasma CRP levels between the control group, pre-treatment group, and treatment group compared to the model group were statistically significant (…). P <0.01 or P <0.05). At 3 and 7 days of treatment, the plasma CRP levels in the pre-treatment and treatment groups were statistically significantly different from those in the control group. P <0.01 or P <0.05). At 14 days of treatment, the plasma CRP level in the model group was significantly different from that in the control group. P <0.01). The results are shown in Table 10.

[0120] Table 10. Changes in plasma CRP levels (ng / mL) in each group

[0121]

[0122] Note: Compared with the blank group, * P <0.05, ** P <0.01; compared with the model group, # P <0.05, ## P <0.01; compared with the control group, ▽ P <0.05, ▽▽ P <0.01; compared with the pre-treatment group, △ P <0.05, △△ P <0.01.

[0123] Conclusion: The application of anti-inflammatory and swelling-reducing solution to treat skin abscesses in rats can shorten the localization time of abscesses and the wound healing time. The mechanism may be related to increasing the levels of BPI, RvD1, and IL-10 in plasma or local tissues, and decreasing the levels of PCT, IL1β, and CRP, thereby playing analgesic, anti-inflammatory, and edema-inhibiting effects, promoting wound formation, and accelerating wound healing.

[0124] discuss:

[0125] External treatment methods involve applying medications, surgery, physical methods, or certain instruments directly to a specific part of the body surface or the site of a lesion to achieve therapeutic effects. Drug therapy is one of the commonly used methods of external treatment.

[0126] The "Li Yue Pian Wen" states: "The principles of external treatment are the same as those of internal treatment, and the medicines used in external treatment are the same as those used in internal treatment; the only difference is the method." Drug therapy is one of the characteristic treatment methods of traditional Chinese medicine surgery for sores, carbuncles, and boils. This formula consists of a group of medicines for clearing heat and detoxifying, reducing swelling and relieving pain, as well as a group of medicines for promoting blood circulation and removing dampness, reducing swelling and relieving pain, and reducing swelling, relieving pain, resolving phlegm, and dissipating nodules.

[0127] Honeysuckle is sweet and cold in nature, used externally to reduce swelling and relieve pain; Hibiscus mutabilis leaves are pungent and neutral, used externally to clear heat, relieve pain, reduce swelling, and drain pus; Phellodendron bark is bitter and cold, used externally to clear damp-heat and purge fire toxins; Trichosanthes root is slightly bitter and cold, used externally to clear heat, purge fire, reduce swelling, and drain pus; Prunella vulgaris is bitter and slightly cold, used externally to clear heat, detoxify, reduce swelling, and relieve pain. These herbs together constitute a group of herbs for clearing heat, detoxifying, reducing swelling, and relieving pain.

[0128] Schisandra chinensis is cold in nature and is used externally to detoxify, relieve itching, stop bleeding, relieve pain, and reduce swelling; rhubarb is bitter and cold and is used externally to clear blood heat, break up blood stasis, and reduce swelling and toxins; turmeric is bitter, pungent, and warm and is used externally to invigorate blood circulation, regulate qi, relieve pain, stop itching, and reduce swelling. The above-mentioned drugs together form a group of drugs for invigorating blood circulation, removing dampness, reducing swelling, and relieving pain.

[0129] Pinellia ternata is pungent and warm, used externally to reduce swelling, relieve pain, resolve phlegm, and dissipate nodules; Atractylodes lancea is bitter, pungent, and warm, used externally to dry dampness, dispel foulness, and expel wind-dampness and swelling between the skin; Angelica dahurica is pungent and warm, used externally to dissipate nodules and relieve pain; Magnolia officinalis is pungent and warm, used externally to dry dampness, dissipate nodules, reduce swelling, and relieve pain; Fritillaria thunbergii is bitter and cold, used to clear heat, detoxify, dissipate nodules, and eliminate carbuncles. The above-mentioned herbs together form a group for reducing swelling, relieving pain, resolving phlegm, and dissipating nodules. Swelling can only be reduced with pungent and warm herbs, and toxins can only be cleared with cold herbs. This formula uses both warm and cold herbs, clearing heat and detoxifying while reducing swelling and relieving pain. The cold herbs are warmed to prevent stagnation in the skin, and the addition of pungent and warm herbs prevents them from becoming too warm and aggravating the heat. The three herbs used together clear heat and toxins, eliminate damp swelling, relieve pain, and disperse stagnation, achieving the effects of detoxification, pain relief, and reducing swelling.

[0130] Honeysuckle, also known as Lonicera japonica (or simply honeysuckle), is commonly called golden flower, silver flower, two-flower, double flower, golden vine flower, double-bud flower, egret flower, etc. It is sweet and cold in nature, and enters the lung, heart, and stomach meridians. It has the effects of clearing heat and detoxifying, and dispelling wind and heat. Externally, it can reduce swelling and relieve pain, and is mainly used to treat febrile diseases, carbuncles, boils, and dysentery caused by heat toxins. Honeysuckle is a typical broad-spectrum antibacterial traditional Chinese medicine. Studies have shown that compound honeysuckle external wash and water extract have antibacterial activity against Staphylococcus aureus, Escherichia coli, Bacillus subtilis, and Pseudomonas aeruginosa. Tetraploid honeysuckle water extract has both antibacterial and bactericidal effects against Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Klebsiella pneumoniae.

[0131] Hibiscus mutabilis leaves, belonging to the Malvaceae family and the Hibiscus mutabilis plant, are also known as frost-resistant leaves. They have a pungent and neutral flavor, and enter the lung and liver meridians. They can clear lung heat, cool the blood, detoxify, and reduce swelling. Externally, they can treat boils, carbuncles, mastitis, erysipelas, etc. Hibiscus mutabilis leaves contain flavonoids, tannins, and other components, which can inhibit the release of inflammatory mediators to reduce inflammatory responses; this is the main reason for their detoxification and swelling-reducing effects. Related studies have shown that its extracts have antibacterial activity against Staphylococcus aureus, hemolytic streptococci, and Escherichia coli, and the active ingredients can also inhibit the growth and reproduction of Proteus mirabilis, thus exerting an antibacterial effect.

[0132] Prunella vulgaris is bitter, pungent, and cold in nature, and enters the liver and gallbladder meridians. Externally, Prunella vulgaris is mainly used for its antibacterial and anti-inflammatory effects, clearing heat and detoxifying, dispersing nodules and reducing swelling, and relieving pain.

[0133] Fritillaria thunbergii, also known as elephant fritillaria or large fritillaria, is bitter and cold in nature, and enters the lung and heart meridians. It has the functions of clearing heat and resolving phlegm, dispersing nodules and eliminating carbuncles. It is mainly used to treat wind-heat cough, phlegm-fire cough, lung abscess, mastitis, scrofula, etc. The alkaloids and other active ingredients in Fritillaria thunbergii act on the cough center to exert an antitussive effect. It also has inhibitory effects on Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Diplococcus pneumoniae, and can inhibit inflammatory responses and reduce tissue inflammatory damage.

[0134] Trichosanthes root, also known as Trichosanthes kirilowii root, is sweet, slightly bitter, and slightly cold in nature. It enters the lung and stomach meridians and can clear heat and purge fire, promote body fluid production and quench thirst, reduce swelling and drain pus. It is mainly used to treat feverish thirst, dry cough due to lung heat, internal heat and thirst, and carbuncles and boils. Trichosanthes root contains components such as trichosanthes pollen protein, which can regulate cell osmotic pressure, promote water absorption and retention, and interfere with bacterial metabolic processes or destroy bacterial structures. It has inhibitory effects on various bacteria such as Staphylococcus aureus and hemolytic streptococci, helping to reduce inflammatory responses and promote disease recovery.

[0135] Pinellia ternata, pungent, warm, and toxic in nature, enters the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and dissipating lumps and nodules. It is mainly used to treat damp phlegm, cold phlegm, vomiting, chest and abdominal fullness, and globus hystericus. Pinellia ternata has an inhibitory effect on Staphylococcus aureus and Candida albicans, derived from its alkaloids, volatile oils, and other active ingredients, which can destroy the bacterial cell wall or cell membrane structure or interfere with bacterial metabolic processes to exert antibacterial effects.

[0136] Gallnut, with its sour and astringent taste and cold nature, enters the lung, large intestine, and kidney meridians. It has the effects of astringing the lungs and reducing heat, astringing the intestines and stopping diarrhea, consolidating essence and stopping seminal emission, and astringing sweat and stopping bleeding. It is mainly used to treat chronic cough due to lung deficiency, chronic diarrhea and dysentery, seminal emission, spontaneous sweating, and night sweats. Gallnut contains a large amount of tannins, which can bind to bacterial proteins and denature them, thus inhibiting Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa.

[0137] Turmeric, also known as Baodingxiang, is bitter, pungent, and warm in nature, and enters the liver and spleen meridians. It can break up blood stasis, promote qi circulation, relieve pain, and is mainly used to treat chest and rib pain, amenorrhea, abdominal masses, and rheumatic pain caused by qi stagnation and blood stasis. The active ingredients in turmeric, such as curcumin, can destroy bacterial cell walls and cell membranes, interfere with bacterial metabolism, and inhibit their growth and reproduction. It has inhibitory effects on Staphylococcus aureus, hemolytic streptococci, and Escherichia coli, and can be used as an adjunct treatment for related diseases. Curcumin can also inhibit the production and release of inflammatory mediators, reducing inflammatory responses, inhibiting platelet aggregation, reducing blood viscosity to prevent thrombosis, and promoting fibrinolysis to dissolve existing thrombi.

[0138] Rhubarb, bitter and cold in nature, enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging accumulations, clearing heat and purging fire, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. It is mainly used to treat conditions such as heat accumulation, constipation and abdominal pain, hematemesis and epistaxis due to blood heat, and red, swollen, and painful eyes. Rhubarb contains anthraquinone compounds and other components, which can inhibit bacterial metabolic processes, destroy bacterial cell walls or cell membranes to exert antibacterial effects, and have inhibitory effects on Staphylococcus aureus, Escherichia coli, and Shigella dysenteriae. It can also affect blood circulation, reduce blood viscosity, and promote the dissipation of blood stasis to remove blood stasis and promote menstruation.

[0139] Phellodendron bark, bitter and cold in nature, enters the kidney and bladder meridians. It has the effects of clearing heat and drying dampness, purging fire and relieving irritability, detoxifying and healing sores, reducing fever and nourishing yin. It is mainly used to treat damp-heat diarrhea, jaundice with dark urine, leukorrhea with vaginal itching, and painful urination due to heat. Phellodendron bark contains alkaloids such as berberine, which have inhibitory effects on various bacteria such as Staphylococcus aureus, Candida albicans, and Escherichia coli. It can also inhibit the release of inflammatory mediators, reduce inflammatory responses, and relieve symptoms such as redness, swelling, heat, and pain.

[0140] Angelica dahurica, with its pungent and warm properties, enters the lung, stomach, and large intestine meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and draining pus. It is mainly used to treat colds due to wind-cold, headaches, toothaches, nasal congestion and runny nose, excessive leukorrhea, and sores and swellings. Angelica dahurica has an inhibitory effect on various bacteria such as Escherichia coli, Shigella, Proteus, and Salmonella typhi. Because it contains coumarins and volatile oils, it can destroy bacterial cell membranes or cell walls, or interfere with normal bacterial metabolism. Coumarins and other components can also inhibit the release of inflammatory mediators and reduce inflammatory responses, which is an important mechanism for its analgesic, nasal-clearing, swelling-reducing, and pus-draining effects. Angelica dahurica can regulate neurotransmitters to relieve pain, especially headaches and toothaches, and can promote local blood circulation, reducing tissue congestion and edema. It has a positive effect on treating rheumatic pain, sores, and swellings.

[0141] Magnolia officinalis, with a bitter and warm nature, enters the spleen, stomach, lung, and large intestine meridians. It has the effects of drying dampness and resolving phlegm, lowering qi and relieving fullness. It is mainly used to treat abdominal distension, vomiting, and diarrhea caused by dampness obstructing the middle jiao and stagnation of qi in the spleen and stomach. It is also used for cough and asthma caused by phlegm obstructing the lungs. Magnolia officinalis has inhibitory effects on Staphylococcus aureus, Shigella dysenteriae, and Escherichia coli. Its antibacterial mechanism mainly lies in the fact that components such as magnolol can destroy the bacterial cell wall and cell membrane, interfere with normal bacterial metabolism, inhibit bacterial reproduction, and thus reduce the inflammatory response.

[0142] Bactericidal / permeability-enhancing protein (BPI) is a cationic protein found in neutrophils, approximately 55 kDa. BPI binds to lipopolysaccharides on the outer membrane of Gram-negative bacteria, increasing the membrane's permeability to antimicrobial agents. It possesses specific biological functions in killing Gram-negative bacteria and binding / neutralizing endotoxins, showing promising potential in the treatment of Gram-negative bacterial infections. BPI has a clear anti-infective effect and can correct endotoxemia. High-mobility group box 1 (HMGB1), as a damage-associated molecule (DAMP), functions as an "alarm," initiating damage-related molecular patterns and triggering inflammatory responses for repair. It binds to receptors such as RAGE, TLR2, and TLR4, activating related signaling pathways and promoting the production of cytokines such as TNF and IL-6. HMGB1 is a key cytokine mediating infection, injury, and inflammatory responses, playing an important pro-inflammatory role in inflammatory diseases such as sepsis. IL-10 (interleukin-10) is a multifunctional cytokine with potent anti-inflammatory activity. IL-10, initially known as a "cytokine synthesis inhibitor," is primarily secreted by activated T cells, monocytes, B cells, and macrophages. IL-10 inhibits the synthesis of IFN-γ, IL-2, and other cytokines by T lymphocytes, and suppresses the production of TNF-α, IL-1α, IL-1β, IL-6, and IL-8 by monocytes and macrophages. PCT and CRP are clinically used factors reflecting inflammation levels. This study shows that the anti-inflammatory and swelling-reducing formula, by inhibiting the inflammatory response caused by infection, reducing exudation, and relieving swelling and pain, increases the expression levels of BPI, RvD1, and IL-10 in plasma or local tissues, while decreasing the levels of PCT, IL1β, and CRP. This results in analgesic, anti-inflammatory, and edema-inhibiting effects, promoting localized inflammation and accelerating wound healing.

[0143] The advantages and positive effects of this formula are as follows: Honeysuckle, hibiscus leaves, prunella vulgaris, and trichosanthes kirilowii serve as the principal herbs to clear heat and detoxify, inhibit bacteria, and control infection; Pinellia ternata, turmeric, rhubarb, magnolia bark, angelica dahurica, and fritillaria thunbergii serve as the assistant herbs to invigorate blood circulation, dispel dampness, resolve phlegm and nodules, reduce swelling, and relieve pain. Phellodendron amurense and atractylodes lancea serve as adjuvant herbs to enhance the effects of clearing heat while simultaneously promoting diuresis and reducing swelling. The entire formula acts on the surrounding area to clear heat and detoxify, invigorate blood circulation, dispel dampness, reduce swelling, and relieve pain, and acts on the wound surface to inhibit bacteria, reduce swelling, and relieve pain.

[0144] Example 2: In vitro antibacterial experiment.

[0145] This embodiment provides an in vitro antibacterial experiment study of an anti-inflammatory and swelling-reducing solution, as follows:

[0146] (1) LB medium

[0147] Liquid culture medium: Weigh 10g tryptone, 5g yeast powder and 10g sodium chloride, add deionized water to make up to 1L, and then autoclave at 121℃ for 30min for later use.

[0148] Solid culture medium: Weigh 10g tryptone, 5g yeast powder, 10g sodium chloride, and 15g agar powder, and bring the volume to 1L with deionized water. Then autoclave at 121℃ for 30 minutes and set aside. When the culture medium temperature drops to about 55℃ (to avoid the antibiotics becoming ineffective due to excessive temperature), add the corresponding antibiotics and pour the medium onto a plate, 3-5ml per plate. After pouring, open the lid and irradiate under ultraviolet light for 10-15 minutes.

[0149] (2) Bacterial species: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.

[0150] (3) Preparation of anti-inflammatory and swelling-reducing tinctures and decoctions:

[0151] This embodiment provides a pharmaceutical composition comprising, by weight: 20g of honeysuckle, 20g of hibiscus leaves, 10g of prunella vulgaris, 20g of fritillaria thunbergii, 20g of trichosanthes kirilowii, 20g of pinellia ternata, 20g of gallnut, 10g of turmeric, 10g of rhubarb, 10g of phellodendron bark, 10g of atractylodes lancea, 10g of angelica dahurica, and 10g of magnolia officinalis.

[0152] This embodiment also provides a pharmaceutical preparation, the preparation method of which includes: crushing the above-mentioned pharmaceutical composition into powder, passing it through an 8-mesh sieve (150 mesh, 90 micrometers) to obtain a powder; taking 50g of the powder, sterilizing it, soaking it in 500ml of 75% alcohol for 1 week, and taking the supernatant to make a tincture for later use.

[0153] Soak in 500ml of purified water for 30 minutes, decoct for 60 minutes, filter with a nylon mesh, add another 500ml of purified water to the dregs and decoct for 60 minutes, filter with a nylon mesh, combine the two decoction filtrates, centrifuge and concentrate to 200mL, which is an anti-inflammatory and swelling-reducing solution with a concentration of 205.00mg / mL.

[0154] After autoclaving the decoction at 121℃ for 15 minutes, store it in a glass bottle at 4℃.

[0155] (4) Western medicine:

[0156] Piperacillin sodium and sulbactam sodium (4:1) were purchased from Ruiyang Pharmaceutical Co., Ltd., and cefoperazone sodium and sulbactam sodium were purchased from Pfizer Pharmaceutical Co., Ltd.

[0157] (5) Experiment on the antibacterial effect of Western medicine finished products and traditional Chinese medicine compound liquid:

[0158] The antibacterial effects of two Western medicines and two anti-inflammatory and swelling-reducing compound preparations were tested using antibacterial experiments.

[0159] (6) Preparation of antibacterial tablets:

[0160] Two concentration gradient solutions (300 mg / mL and 150 mg / mL) of the anti-inflammatory and swelling-reducing tincture and decoction to be tested were prepared using a double dilution method and then sterilized by boiling. A round Xinhua No. 1 filter paper disc was autoclaved and dried. µL of the prepared herbal solution was added dropwise onto the filter paper disc, and then dried for later use. A filter paper disc of the same size was also prepared, with 20 µL of sterile physiological saline added dropwise and dried for later use as a negative control.

[0161] (7) Evaluation of the experimental effect:

[0162] The diameter of the inhibition zone on the bacterial plates was measured with vernier calipers and recorded in detail. An inhibition zone diameter ≥7mm had an inhibitory effect, while a diameter ≤7mm had no inhibitory effect. No inhibition zone was produced in the negative control group.

[0163] (8) Experimental results and analysis:

[0164] ① Western medicine antibacterial loop experiment:

[0165] Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa were used as test bacteria in the inhibition zone test to measure the antibacterial effect of each Western medicine on the three bacteria (Table 11).

[0166] Based on the screening results of the inhibition zone test of Western medicines against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, piperacillin sodium / sulbactam sodium (4:1), cefoperazone sodium / sulbactam sodium (150 mg / mL) showed inhibitory effects on these three bacteria. Furthermore, the diameter of the inhibition zone increased with increasing drug concentration to 300 mg / mL. These results indicate that piperacillin sodium / sulbactam sodium (4:1) and cefoperazone sodium / sulbactam sodium have significant inhibitory effects on Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, and the inhibition of these bacteria becomes increasingly pronounced with increasing drug concentration.

[0167] Table 11. In vitro inhibition diameter (mm) of different concentrations and drugs against three bacteria

[0168]

[0169] ② Antibacterial loop experiment of anti-inflammatory and analgesic solution:

[0170] Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa were used as test bacteria in the inhibition zone test to measure the antibacterial effects of the anti-inflammatory and analgesic tincture and decoction on the three bacteria (Table 11).

[0171] Based on the screening results of the inhibition zone test of anti-inflammatory and analgesic tinctures and decoctions against three types of bacteria, the results show that both tinctures and decoctions have inhibitory effects on the three bacteria at their initial prepared concentrations. However, the antibacterial effect of both tinctures and decoctions weakens to some extent when the concentration is halved. These results indicate that both tinctures and decoctions have significant inhibitory effects on the three bacteria, and the inhibition of the three bacteria decreases to some extent with decreasing drug concentration. The diameter of the inhibition zone of the tincture did not decrease significantly at its initial concentration or at half the concentration, therefore, the concentration of the tincture did not significantly affect the inhibitory effect on the three bacteria.

[0172] It should be noted that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," etc., are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. The directional terms "inner" and "outer" refer to the inside or outside relative to the outline of each component itself. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein are interpreted accordingly.

[0173] It should also be noted that the terms "one embodiment," "another embodiment," and "embodiment" used in this application refer to specific features, structures, or characteristics described in connection with that embodiment, which are included in at least one embodiment described in the general description of this application. The appearance of the same expression in multiple places in the specification does not necessarily refer to the same embodiment. Furthermore, when a specific feature, structure, or characteristic is described in connection with any embodiment, the intention is to suggest that implementing such a feature, structure, or characteristic in conjunction with other embodiments also falls within the scope of this application.

[0174] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0175] It should also be noted that the above are merely preferred embodiments of this application and do not limit the scope of patent protection of this application. Any equivalent structural or procedural changes made using the content of this application's specification, or any direct or indirect application in other related technical fields, are similarly included within the scope of patent protection of this application.

Claims

1. The use of a pharmaceutical composition in the preparation of an anti-inflammatory or anti-infective drug, characterized in that, The composition, by weight, consists of 10-20 parts of honeysuckle, 15-30 parts of hibiscus leaf, 10-20 parts of prunella vulgaris, 10-20 parts of fritillaria thunbergii, 10-20 parts of trichosanthes kirilowii, 10-20 parts of pinellia ternata, 10-20 parts of gallnut, 5-10 parts of turmeric, 5-10 parts of rhubarb, 5-10 parts of phellodendron chinense, 5-10 parts of atractylodes lancea, 5-10 parts of angelica dahurica, and 5-10 parts of magnolia officinalis.

2. The application according to claim 1, characterized in that, The composition comprises, by weight, 12-15 parts of honeysuckle, 15-24 parts of hibiscus leaves, 12-15 parts of prunella vulgaris, 12-15 parts of fritillaria thunbergii, 12-15 parts of trichosanthes kirilowii, 12-15 parts of pinellia ternata, 12-15 parts of gallnut, 6-9 parts of turmeric, 6-9 parts of rhubarb, 6-9 parts of phellodendron chinense, 6-9 parts of atractylodes lancea, 6-9 parts of angelica dahurica, and 6-9 parts of magnolia officinalis.

3. The application according to claim 1, characterized in that, The pharmaceutical composition comprises, by weight, 30 parts of Hibiscus mutabilis leaves, 20 parts of honeysuckle, 20 parts of prunella vulgaris, 20 parts of Fritillaria thunbergii, 20 parts of Trichosanthes kirilowii, 20 parts of Pinellia ternata, 20 parts of Galla chinensis, 10 parts of turmeric, 10 parts of rhubarb, 10 parts of Phellodendron chinense, 10 parts of Atractylodes lancea, 10 parts of Angelica dahurica, and 10 parts of Magnolia officinalis.

4. The application according to claim 1, characterized in that, The pharmaceutical composition comprises, by weight, 15 parts of Hibiscus mutabilis leaves, 10 parts of honeysuckle, 10 parts of prunella vulgaris, 10 parts of Fritillaria thunbergii, 10 parts of Trichosanthes kirilowii, 10 parts of Pinellia ternata, 10 parts of Galla chinensis, 5 parts of turmeric, 5 parts of rhubarb, 5 parts of Phellodendron chinense, 5 parts of Atractylodes lancea, 5 parts of Angelica dahurica, and 5 parts of Magnolia officinalis.

5. The application according to claim 1 or 2, characterized in that, The composition comprises, by weight, 20 parts of Hibiscus mutabilis leaves, 15 parts of honeysuckle, 15 parts of prunella vulgaris, 15 parts of Fritillaria thunbergii, 15 parts of Trichosanthes kirilowii, 15 parts of Pinellia ternata, 15 parts of Galla chinensis, 9 parts of turmeric, 9 parts of rhubarb, 9 parts of Phellodendron chinense, 9 parts of Atractylodes lancea, 9 parts of Angelica dahurica, and 9 parts of Magnolia officinalis.

6. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation comprises the pharmaceutical composition according to any one of claims 1-5; The dosage form of the pharmaceutical preparation is any one of powder, tincture, or lotion.

7. The method for preparing a pharmaceutical formulation according to claim 6, characterized in that, When the pharmaceutical preparation is a powder, the preparation method includes: crushing the pharmaceutical composition according to any one of claims 1-5 into powder, sieving it, and obtaining the powder.

8. The method for preparing a pharmaceutical formulation according to claim 6, characterized in that, When the pharmaceutical preparation is a tincture, the preparation method includes: crushing the pharmaceutical composition according to any one of claims 1-5 into powder, sieving it, dissolving it in alcohol, taking the supernatant, and obtaining the tincture.

9. The method for preparing a pharmaceutical formulation according to claim 6, characterized in that, When the pharmaceutical preparation is a lotion, the preparation method includes: crushing the pharmaceutical composition according to any one of claims 1-5 into powder, sieving, dissolving in alcohol, taking the supernatant, removing the alcohol, dissolving in water, and obtaining the lotion.

10. The use of the pharmaceutical preparation according to claim 6 in the preparation of anti-inflammatory drugs or anti-infective drugs.

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