A kind of skin antibacterial cream and its preparation process

Abstract

The present invention proposes a skin antibacterial cream and a preparation process thereof, comprising the following raw materials: angelica, sophora flavescens, rhubarb, phellodendron chinense, brucea brucea, herba aconitifolii, notoginseng, scutellaria baicalensis, angelica dahurica, ligusticum chuanxiong, salvia miltiorrhiza, saltpeter, white pearl and chlorhexidine acetate. The present invention has the beneficial effects that after the Chinese medicine extract is prepared into an ointment for transdermal administration, the content of the active ingredient of the drug per unit area of ​​the epidermis can be increased, which is beneficial to improving the drug efficacy; at the same time, by selecting a suitable ointment type, the activity of the active ingredient of the Chinese medicine extract can be protected to prevent it from being inactivated or ineffective during long-term placement, so it is superior to injection and oral therapy, as well as smearing drug powder, for skin diseases, and can be used for a variety of skin diseases, with good efficacy, quick effect and no side effects; the skin antibacterial cream prepared by the preparation process of the skin antibacterial cream of the present invention has good skin feel, heat and cold resistance and long-term stability.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, in particular to a skin antibacterial cream and a preparation process thereof. Background Art

[0002] Skin diseases are on the surface of the skin, but the root causes are mostly in the body. For example, acne can be caused by wind-heat fumigating the skin, but more often it is caused by overeating greasy and spicy foods, which causes dampness and heat in the spleen and stomach, and invades the skin; or Chong and Ren are not in harmony, such as endocrine disorders during menopause, which can also lead to the skin's dysfunction of drainage. Alcoholic nasal congestion is mostly caused by the heat of the stomach and intestines fumigating the lungs, or alcoholism and spicy food, which causes heat to fumigate the lungs, and then encounter wind and cold, resulting in blood stasis. The acute stage of eczema is mostly caused by wind, dampness, and heat invading the skin, and the chronic stage is mostly caused by blood deficiency or spleen deficiency with wind dryness. Eczema and dermatitis are especially common in the hot and humid summer. Although skin diseases are mostly limited to lesions on the surface of the skin, the ugly acne and pimples on the originally smooth skin will inevitably make people feel annoyed, and if there is itching and exudation, it will be even more miserable. At present, injection and oral therapies not only damage nerves, blood vessels, muscles and other tissues and cause intestinal reactions, making it difficult for patients to accept them, but these methods are also easy for drugs to pass through the blood circulation and intestinal destruction throughout the body, and there are very few drugs that can actually reach the local part of the disease, so there is a large dosage, but the treatment effect is poor. In addition, although there are many types of drugs for skin diseases, most of them have good therapeutic effects on a certain skin disease, and generally have certain side effects, and if no obvious treatment effect is obtained for a long time, it is easy to develop drug resistance. Finally, the preparation process also has an impact on the treatment effect and storage, etc., and needs to be further optimized. Summary of the invention

[0003] The present invention provides a skin antibacterial cream and a preparation process thereof, which solve the above-mentioned problems in the prior art.

[0004] The technical solution of the present invention is achieved in this way:

[0005] A skin antibacterial cream comprises the following raw materials: angelica sinensis, sophora flavescens, rhubarb, phellodendron chinense, brucea javanica, herba aconitifolia, notoginseng, scutellaria baicalensis, angelica dahurica, ligusticum chuanxiong, salvia miltiorrhiza, saltpeter, white pearl and chlorhexidine acetate.

[0006] Furthermore, the skin antibacterial cream described in the present invention comprises the following raw materials in parts by weight: 5-15 parts of angelica sinensis, 5-15 parts of sophora flavescens, 5-15 parts of rhubarb, 5-15 parts of phellodendron chinense, 3-12 parts of brucea javanica, 3-12 parts of herba atractylodes, 3-12 parts of notoginseng, 5-15 parts of scutellaria baicalensis, 2-10 parts of angelica dahurica, 2-10 parts of ligusticum chuanxiong, 3-12 parts of salvia miltiorrhiza, 3-12 parts of saltpeter, 2-10 parts of white pearls, and 1-2 parts of chlorhexidine acetate.

[0007] Preferably, the antibacterial skin cream described in the present invention comprises the following raw materials in parts by weight: 5 parts of Angelica sinensis, 15 parts of Sophora flavescens, 5 parts of Rhubarb, 15 parts of Phellodendron chinense, 3 parts of Brucea javanica, 3 parts of Herba Atractylodes macrocephalae, 12 parts of Panax notoginseng, 15 parts of Scutellaria baicalensis, 2 parts of Angelica dahurica, 2 parts of Ligusticum chuanxiong, 3 parts of Salvia miltiorrhiza, 12 parts of Saltpeter, 2 parts of White Pearl, and 1 part of chlorhexidine acetate.

[0008] Preferably, the antibacterial skin cream of the present invention comprises the following raw materials in parts by weight: 15 parts of angelica sinensis, 5 parts of sophora flavescens, 15 parts of rhubarb, 5 parts of phellodendron chinense, 12 parts of brucea javanica, 12 parts of herba atractylodes, 3 parts of notoginseng, 5 parts of scutellaria baicalensis, 10 parts of angelica dahurica, 10 parts of ligusticum chuanxiong, 12 parts of salvia miltiorrhiza, 3 parts of saltpeter, 10 parts of white pearls, and 2 parts of chlorhexidine acetate.

[0009] Preferably, the antibacterial skin cream of the present invention comprises the following raw materials in parts by weight: 10 parts of Angelica sinensis, 10 parts of Sophora flavescens, 10 parts of Rhubarb, 10 parts of Phellodendron chinense, 7 parts of Brucea javanica, 7 parts of Herba Atractylodes, 7 parts of Panax notoginseng, 10 parts of Scutellaria baicalensis, 6 parts of Angelica dahurica, 6 parts of Ligusticum chuanxiong, 7 parts of Salvia miltiorrhiza, 7 parts of Saltpeter, 6 parts of White Pearl, and 1.5 parts of chlorhexidine acetate.

[0010] A preparation process of the above-mentioned antibacterial skin cream comprises the following steps:

[0011] S1. Raw material selection: remove insect-eaten, rat-bitten, moldy, fake and inferior products, and use Chinese herbal medicine pieces that are free of mold and rot and dried to constant weight;

[0012] S2, high-speed crushing: After weighing the cleaned medicinal materials according to the formula ratio, crush them with a high-speed crusher, pass them through an 80-100 mesh sieve, discard the coarse residue, and keep the fine powder for later use;

[0013] S3, preparing extract: performing ultrasonic extraction on the fine powder under auxiliary heating conditions to obtain an extract, which is sealed and placed at 4-6°C for later use;

[0014] S4, preparing a matrix: weighing lanolin, vaseline, stearic acid, sorbitan monostearate and sorbitan monooleate polyoxyethylene ether according to a preset weight ratio, placing lanolin, vaseline and stearic acid in a preset container, heating them to a liquid state, adding sorbitan monostearate thereto as an oil phase, keeping the temperature under 80° C. water bath conditions, taking an appropriate amount of extract, placing it in an appropriate amount of distilled water, and adding sorbitan monooleate polyoxyethylene ether thereto, stirring until uniformly dispersed, as an aqueous phase;

[0015] S5. Formulation: In a water bath at 80°C, drop the oil phase into the water phase, stirring at a constant speed throughout the process. After the addition is completed, continue stirring at a constant speed for 10 to 20 minutes at room temperature, and let cool.

[0016] Further, S3, preparing an extract: performing ultrasonic extraction on the fine powder under auxiliary heating conditions to obtain an extract, and sealing and placing it at 4-6° C. for standby use, specifically comprises the following steps:

[0017] The fine powder was placed in a preset container, 5 times the volume fraction of 75% ethanol was added thereto, ultrasonic extraction was performed in a water bath at 80°C for 25 to 35 minutes, and after cooling, the powder was filtered with filter paper and the residue was discarded;

[0018] The filtrate was centrifuged at 4000 r / min for 15 min, and the supernatant was concentrated under reduced pressure to an extract concentration of 0.8-1.2 g / mL. The extract was sealed and placed at 4-6°C for later use.

[0019] Preferably, the weight ratio of lanolin, vaseline, stearic acid, sorbitan monostearate and sorbitan monooleate polyoxyethylene ether is 2:6:8:2:1.

[0020] The beneficial effects of the present invention are:

[0021] The skin antibacterial cream of the present invention can increase the content of effective ingredients of the medicine per unit area of ​​the epidermis after the Chinese medicine extract is prepared into an ointment for percutaneous administration, which is beneficial to improving the efficacy of the medicine; at the same time, by selecting a suitable type of ointment, the activity of the effective ingredients of the Chinese medicine extract can be protected to prevent them from being inactivated or ineffective during long-term storage. Therefore, it is superior to injection and oral therapy, as well as smearing of drug powder, for skin diseases, and can be used for a variety of skin diseases, with good efficacy, quick effect and no side effects; the skin antibacterial cream prepared by the preparation process of the skin antibacterial cream of the present invention has good skin feel when applied, heat and cold resistance and long-term stability. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] The skin antibacterial cream of the invention comprises the following raw materials: angelica sinensis, sophora flavescens, rhubarb, phellodendron chinense, brucea javanica, herba aconitifolia, notoginseng, scutellaria baicalensis, angelica dahurica, ligusticum chuanxiong, salvia miltiorrhiza, saltpeter, white pearl and chlorhexidine acetate.

[0024] Among them, the skin antibacterial ointment described in the present invention comprises the following raw materials in parts by weight: 5-15 parts of angelica sinensis, 5-15 parts of sophora flavescens, 5-15 parts of rhubarb, 5-15 parts of phellodendron chinense, 3-12 parts of brucea javanica, 3-12 parts of herba atractylodes, 3-12 parts of notoginseng, 5-15 parts of scutellaria baicalensis, 2-10 parts of angelica dahurica, 2-10 parts of ligusticum chuanxiong, 3-12 parts of salvia miltiorrhiza, 3-12 parts of saltpeter, 2-10 parts of white pearls, and 1-2 parts of chlorhexidine acetate.

[0025] Among them, preferably, the antibacterial skin cream described in the present invention comprises the following raw materials in parts by weight: 5 parts of Angelica sinensis, 15 parts of Sophora flavescens, 5 parts of Rhubarb, 15 parts of Phellodendron chinense, 3 parts of Brucea javanica, 3 parts of Herba Atractylodesii, 12 parts of Panax notoginseng, 15 parts of Scutellaria baicalensis, 2 parts of Angelica dahurica, 2 parts of Ligusticum chuanxiong, 3 parts of Salvia miltiorrhiza, 12 parts of Saltpeter, 2 parts of White Pearl, and 1 part of chlorhexidine acetate.

[0026] Among them, preferably, the antibacterial skin cream described in the present invention comprises the following raw materials in parts by weight: 15 parts of Angelica sinensis, 5 parts of Sophora flavescens, 15 parts of Rhubarb, 5 parts of Phellodendron chinense, 12 parts of Brucea javanica, 12 parts of Herba Atractylodesii, 3 parts of Panax notoginseng, 5 parts of Scutellaria baicalensis, 10 parts of Angelica dahurica, 10 parts of Ligusticum chuanxiong, 12 parts of Salvia miltiorrhiza, 3 parts of Saltpeter, 10 parts of White Pearl, and 2 parts of chlorhexidine acetate.

[0027] Among them, preferably, the antibacterial skin cream described in the present invention comprises the following raw materials in parts by weight: 10 parts of Angelica sinensis, 10 parts of Sophora flavescens, 10 parts of Rhubarb, 10 parts of Phellodendron chinense, 7 parts of Brucea javanica, 7 parts of Herba Atractylodes, 7 parts of Panax notoginseng, 10 parts of Scutellaria baicalensis, 6 parts of Angelica dahurica, 6 parts of Ligusticum chuanxiong, 7 parts of Salvia miltiorrhiza, 7 parts of Saltpeter, 6 parts of White Pearl, and 1.5 parts of chlorhexidine acetate.

[0028] A preparation process of the above-mentioned antibacterial skin cream comprises the following steps:

[0029] S1. Raw material selection: remove insect-eaten, rat-bitten, moldy, fake and inferior products, and use Chinese herbal medicine pieces that are free of mold and rot and dried to constant weight;

[0030] S2, high-speed crushing: After weighing the cleaned medicinal materials according to the formula ratio, crush them with a high-speed crusher, pass them through an 80-100 mesh sieve, discard the coarse residue, and keep the fine powder for later use;

[0031] S3, preparing extract: performing ultrasonic extraction on the fine powder under auxiliary heating conditions to obtain an extract, which is sealed and placed at 4-6°C for later use;

[0032] S4, preparing a matrix: weighing lanolin, vaseline, stearic acid, sorbitan monostearate and sorbitan monooleate polyoxyethylene ether according to a preset weight ratio, placing lanolin, vaseline and stearic acid in a preset container, heating them to a liquid state, adding sorbitan monostearate thereto as an oil phase, keeping the temperature under 80° C. water bath conditions, taking an appropriate amount of extract, placing it in an appropriate amount of distilled water, and adding sorbitan monooleate polyoxyethylene ether thereto, stirring until uniformly dispersed, as an aqueous phase;

[0033] S5. Formulation: In a water bath at 80°C, drop the oil phase into the water phase, stirring at a constant speed throughout the process. After the addition is completed, continue stirring at a constant speed for 10 to 20 minutes at room temperature, and let cool.

[0034] Among them, preferably, the cleaned medicinal materials are weighed according to the formula ratio, crushed by a high-speed crusher, passed through a 90-mesh sieve, and the coarse residue is discarded, leaving the fine powder for later use.

[0035] Preferably, the fine powder is subjected to ultrasonic extraction under auxiliary heating conditions to obtain an extract, which is then sealed and placed at 5° C. for later use.

[0036] Preferably, the oil phase is added dropwise into the water phase in a water bath at 80° C., and uniform stirring is maintained throughout the process. After the addition is completed, uniform stirring is continued at room temperature for 15 minutes, and the mixture is allowed to cool.

[0037] Among them, the steps of S3, preparing an extract: performing ultrasonic extraction on the fine powder under auxiliary heating conditions to obtain an extract, and sealing and placing it at 4-6° C. for standby use are specifically as follows:

[0038] The fine powder was placed in a preset container, 5 times the volume fraction of 75% ethanol was added thereto, ultrasonic extraction was performed in a water bath at 80°C for 25 to 35 minutes, and after cooling, the powder was filtered with filter paper and the residue was discarded;

[0039] The filtrate was centrifuged at 4000 r / min for 15 min, and the supernatant was concentrated under reduced pressure to an extract concentration of 0.8-1.2 g / mL. The extract was sealed and placed at 4-6°C for later use.

[0040] Preferably, the fine powder is placed in a preset container, 5 times the volume fraction of 75% ethanol is added thereto, ultrasonic extraction is performed in a water bath at 80° C. for 30 minutes, and after cooling, the powder is filtered using filter paper and the residue is discarded.

[0041] Among them, preferably, the weight ratio of lanolin, vaseline, stearic acid, sorbitan monostearate and sorbitan monooleate polyoxyethylene ether is 3:6:7:2:1.

[0042] Because the ingredients of traditional Chinese medicine prescriptions are complex and easily interact with the cream matrix, how to balance the drug loading and quality stability of traditional Chinese medicine creams requires in-depth research. The skin antibacterial cream prepared by the preparation process of the skin antibacterial cream of the present invention is evaluated to have good skin feel, heat and cold resistance and long-term stability. The evaluation standard is a total score of 30 points, including 10 points for skin feel test, 10 points for heat and cold resistance test, and 10 points for long-term stability test:

[0043] 1. Skin feel test:

[0044] Score 1-2 points: Spreadability, moisturizing and nourishing properties are poor, and the color of the paste is uneven;

[0045] Score 3-5 points: Two of the spreadability, moisturizing and nourishing properties are poor, and the color of the paste is uniform;

[0046] Score 6-8 points: one of the spreadability, moisturizing and nourishing properties is poor, and the color of the paste is uniform;

[0047] Score 9-10 points: good spreadability, moisturizing and nourishing properties, and uniform paste color;

[0048] The antibacterial skin cream prepared by the preparation process of the antibacterial skin cream described in the present invention scored 9 points in this item.

[0049] 2. Heat and cold resistance test:

[0050] Take the same amount of antibacterial skin cream and place it in three centrifuge tubes respectively, place it at room temperature 25℃ for 72 hours, in a 45℃ constant temperature box for 24 hours, and in a -20℃ refrigerator for 24 hours, and observe the appearance after taking it out;

[0051] Score 1-2 points: stratification, hardening, and color changes are obvious;

[0052] Score 3 to 5 points: Delamination, hardening, and two changes in color;

[0053] Score 6-8 points: delamination, hardening, or color change;

[0054] Score 9-10 points: no change in delamination, hardening, or color;

[0055] The antibacterial skin cream prepared by the preparation process of the antibacterial skin cream described in the present invention scored 9 points in this item.

[0056] 3. Long-term stability test:

[0057] Take the same amount of antibacterial cream and place it in two centrifuge tubes with scales, put them symmetrically into the centrifuge, centrifuge at room temperature 25℃ and speed 3000r / min for 30min, take them out and observe their appearance;

[0058] Score 1-2 points: Delamination, hardening, color and skin feel all change significantly;

[0059] Score 3 to 5 points: There are three changes in delamination, hardening, color and skin feel;

[0060] Score 6-8 points: one or two changes in delamination, hardening, color and skin feel;

[0061] Score 9-10: No changes in delamination, hardening, color, or skin feel;

[0062] The skin antibacterial cream prepared by the preparation process of the skin antibacterial cream described in the present invention is scored 10 points in this item.

[0063] The skin antibacterial cream prepared by the preparation process of the skin antibacterial cream of the present invention has good formability, high repeatability, good spreadability, moisturizing and moisturizing properties, and a comprehensive score of 28 points; 100 volunteer patients were selected for a 3-month trial investigation, and none of them had allergic or irritation reactions such as itching, pain, redness and swelling. Among them, 2 people reported that the cream was slightly sticky, 4 people reported that the cream was slightly greasy, and the remaining 94 people were relatively satisfied with the quality of the cream.

[0064] Generally, the ingredients of traditional Chinese medicine are complex, which brings certain interference to the molding and stability of traditional Chinese medicine creams. The preparation process of the skin antibacterial cream described in the present invention is to perform ultrasonic extraction by high-speed crushing and screening. When preparing the matrix, lanolin, vaseline and stearic acid are placed in a preset container, heated to a liquid state, and sorbitan monostearate is added thereto as an oil phase, and the mixture is kept warm in a water bath at 80°C. An appropriate amount of the extract is taken, placed in an appropriate amount of distilled water, and dehydrated sorbitan monooleate polyoxyethylene ether is added thereto, and stirred until uniformly dispersed. As the aqueous phase, the oil phase is dripped into the aqueous phase under the condition of 80°C water bath insulation, and uniform stirring is maintained throughout the process. After the addition is completed, the uniform stirring is continued at room temperature. After stirring for 10 to 20 minutes, the prepared antibacterial skin cream forms an emulsified structure in which the oil phase covers the water phase. The outer oil phase can isolate the inner water phase from the outside world, thereby preventing the inner active ingredients from reacting with oxygen in the air during storage to produce oxidation reactions, thereby better exerting their antioxidant effects. It can cover the skin surface with a layer of oil film, enhance the hydration of the skin, facilitate the transdermal delivery of active ingredients to exert their target effects, prevent bacterial invasion, and have bactericidal, anti-inflammatory, astringent and healing effects on diseased skin. It has no irritation, allergy or other adverse reactions, and can significantly improve the moisturizing, spreadability, consistency, moisturizing and transdermal absorption of the cream, and has good heat and cold resistance and long-term stability.

[0065] The antibacterial skin cream of the present invention can treat skin diseases such as impetigo, for example:

[0066] Impetigo, commonly known as yellow water sores, is a common acute suppurative skin disease. It is prone to occur in summer and autumn. Symptoms include yellow blisters that suddenly appear on the head, face, ears and neck, which burst and ooze fat and water, and spread in an instant, causing pain and itching. This is caused by sun exposure and wind blowing, heat and toxins stagnate in the skin and fur, and sudden exposure to damp heat; or eating damp and hot things, causing wind to move fire and cause it to occur. Sitz sores, also known as acne and prickly heat, were also common skin diseases in the past, especially in summer and autumn. Symptoms include red papules that grow on both thighs, densely like scattered millet, sharp like thorns, itchy and painful, with a thorny feeling all over the body, and even skin lesions that stain clothes. This is caused by damp heat and damp toxins in the spleen meridians for a long time, and it can also be caused by sitting in a wet place for a long time, or sitting on a stone in the hot sun, causing damp heat.

[0067] Elbow tinea is a condition in which tinea develops on both elbows and ankles in a scaly manner with white flakes and itching. It can be caused by internal injuries due to the seven emotions, stagnation of Qi, which turns into fire over time, leading to hyperactivity of heart fire and toxic heat hidden in the blood. It can also be caused by improper diet, excessive intake of fishy foods that stimulate wind, disharmony of the spleen and stomach, poor Qi movement, which turns into heat over time, and further exposure to wind-heat toxins, leading to the onset of the disease.

[0068] The skin antibacterial cream of the present invention has the functions of clearing away heat and dampness, purging fire, detoxifying and curing sores. It can be made into an ointment for external application to treat skin eczema and wet sores. It can be used to treat skin diseases because it can cool blood, detoxify, remove blood stasis and dredge menstruation, and can also clear the bowels and release heat to eliminate heat evil. It has obvious effects on treating skin diseases such as impetigo.

[0069] The antibacterial skin cream of the present invention can also treat eczema, for example, chronic eczema is a chronic skin disease with a high clinical incidence rate, which can appear in multiple parts of the body such as the anus, vulva, feet, hands, and calves. The cause of its occurrence may be related to allergic constitution, endocrine disorders, heredity, neurological dysfunction, scratching, wind and other factors, which will have a serious impact on the patient's normal work or study.

[0070] At present, there are many ways to clinically treat this disease. Among them, glucocorticoids are common drugs for clinically treating patients with this disease. Although the initial treatment effect is significant, once the drug is stopped, there is a high risk of recurrence or worsening of the disease. The skin antibacterial cream described in the present invention can promote the percutaneous penetration of the drug to further achieve the effects of lubrication, protection and treatment, and can effectively avoid the disadvantages of taking glucocorticoids.

[0071] In order to verify the therapeutic effect of the skin antibacterial cream of the present invention on eczema, clinical data of 110 patients with chronic eczema treated in a hospital were selected. According to the different clinical drug treatment methods of the above candidates, they were divided into a control group of 55 cases of mometasone furoate cream and an observation group of 55 cases of the skin antibacterial cream of the present invention. There were 28 males and 27 females in the control group, aged 22 to 60 years old, with an average age of 45 years old, and a course of 1 to 9 months, with an average of 5 months. There were 28 males and 27 females in the observation group, aged 22 to 61 years old, with an average age of 45 years old, and a course of 1 to 9 months, with an average of 5 months.

[0072] Exclusion criteria: 1. Drug addicts, alcoholics, and those with drug dependence; 2. Coagulation disorders; 3. Concurrent infection at the medication site; 4. Severe organ failure; 5. Patients with other active skin diseases such as psoriasis; 6. Expression disorders or mental illness; 7. Patients who have recently received ultraviolet light therapy, antihistamines, immunosuppressants, glucocorticoids and other drug treatments; 8. Congenital heart disease; 9. Severe immune dysfunction; 10. Patients with malignant tumors.

[0073] Patients in the control group: Take an appropriate amount of mometasone furoate cream (Shanghai General Pharmaceutical Co., Ltd., National Medicine Standard H20040853) and apply it to the affected skin of the patient, once a day, and apply it locally for 5 days in a week, and stop the drug for 2 days. Patients in the observation group: The topical application of mometasone furoate cream is the same as that of the control group, and the skin antibacterial cream of the present invention is used at the same time. According to the skin lesion area of ​​the patient, take an appropriate amount of medicine, that is, 3 palm area skin lesions can correspond to 1 fingertip unit of medicine, apply it to the affected skin of the patient, and gently rub the affected area for 1 to 2 minutes, 3 times a day. The treatment effect of both groups of patients was evaluated after receiving 4 weeks of treatment.

[0074] Evaluation indicators: 1. Before treatment and 4 weeks after treatment, the lesion area and pruritus of the two groups of patients were evaluated with reference to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)", including none (0 points), mild (1 point), moderate (2 points), and severe (3 points), and the target lesion area was measured at the same time; 2. Before treatment and 4 weeks after treatment, the skin oil was measured by oil test tape; the transepidermal water loss (TEWL) was measured by a skin water loss tester, and the stratum corneum water content (WCSC) was measured by a skin moisture tester; 3. Before treatment and 4 weeks after treatment, the eczema area and severity index (EASI) was used to evaluate the improvement of the condition of the two groups of patients. The total score = (erythema score + papule score + epidermal exfoliation score + lichenification score) × area × index. The specific indexes are as follows: 0.4 for lower limbs, 0.3 for trunk, 0.2 for upper limbs, and 0.1 for head and neck. Each clinical manifestation score can be divided into 0-3 points according to the severity. The lower the score, the more obvious the improvement of the patient's symptoms.

[0075] Statistical methods: SPSS18.0 software was used for data processing. Non-independent sample t-test was used between groups, and paired sample t-test was used within groups. P<0.05 was considered statistically significant.

[0076] Lesion area, lesion pruritus score and target lesion area: Before treatment, there was no significant difference in lesion area score, lesion pruritus score and target lesion area between the two groups (P>0.05); after 4 weeks of treatment, the lesion area score and lesion pruritus score of the observation group were lower than those of the control group, and the target lesion area was less than that of the control group, with a statistically significant difference (P<0.05), as shown in the following table:

[0077]

[0078] Skin physiological function: Before treatment, there was no significant difference in skin oil, WCSC and TEWL values ​​between the two groups (P>0.05). After 4 weeks of treatment, the skin oil and WCSC values ​​of the observation group were higher than those of the control group, and the TEWL value was lower than that of the control group, with statistically significant differences (P<0.05), as shown in the following table:

[0079]

[0080] EASI: Before treatment, there was no significant difference in EASI between the two groups (P>0.05); after 4 weeks of treatment, the EASI of the observation group was lower than that of the control group, and the difference was statistically significant (P<0.05), as shown in the following table:

[0081] Group n Before treatment After 4 weeks of treatment t P Control group 55 14.01 4.62 26.658 0 Observation Group 55 14.25 2.31 34.251 0 t 0.129 24.125 P 0.901 0

[0082] The cause of eczema is relatively complex. It is an inflammatory skin disease caused by the combined action of internal and external factors. Its prevalence is about 7.5%, and the 3-year recurrence rate is about 85%. In addition, the severe itching will have a serious impact on the patient's quality of life and physical and mental health.

[0083] Currently, hormone drugs are mostly used clinically to help patients relieve clinical symptoms such as itching. However, due to the long course and recurring symptoms of the disease, when patients use this type of drug for a long time, they are very likely to experience various adverse reactions such as pigmentation, skin atrophy and dry skin, resulting in unsatisfactory prognosis.

[0084] The skin antibacterial cream of the present invention is directly applied to the corresponding body surface part or skin affected part of the patient's disease, and promotes its percutaneous penetration to further produce the effect of treatment, lubrication and protection. It is also suitable for treating skin lesions such as nodules, scales, chapped skin, and lichenoid lesions in chronic skin diseases. The experimental control results show that after 4 weeks of treatment, the skin lesion area score and skin lesion itching score of the observation group patients are lower than those of the control group patients, the target skin lesion area is less than that of the control group patients, the skin oil and WCSC values ​​of the observation group patients are higher than those of the control group patients, the TEWL value is lower than that of the control group patients, and the EASI of the observation group patients is lower than that of the control group patients, indicating that chronic eczema patients can be treated by the skin antibacterial cream of the present invention and mometasone furoate cream, which can relieve the condition, reduce the skin lesion area, improve the skin lesion itching symptoms, and improve the positive effect of skin physiological function. Mometasone furoate cream belongs to hormone drugs, which have multiple effects such as immunosuppression, anti-inflammatory and anti-proliferation, and fast onset, good skin tolerance, and are conducive to patient acceptance. However, it is worth noting that after long-term use, this drug can easily cause a variety of adverse reactions such as skin atrophy, capillary dilation and folliculitis. Therefore, in actual clinical treatment, it is often used in combination with other drugs to further help patients improve symptoms such as skin itching and improve clinical cure rates.

[0085] The skin antibacterial cream of the present invention can dispel wind and kill insects, clear away heat and dry dampness. When made into an ointment preparation, it can moisturize the skin and relieve itching, detoxify and dispel wind, clear away heat and dry dampness. After being used on a large area, no adverse drug events such as toxicity, sensitization and irritation were found, and it has good effects in anti-allergic and anti-inflammatory aspects.

[0086] The skin antibacterial cream of the present invention can increase the content of the active ingredient of the drug per unit area of ​​the epidermis after the Chinese medicine extract is prepared into an ointment for percutaneous administration, which is beneficial to improving the drug efficacy. At the same time, by selecting a suitable ointment type, the activity of the active ingredient of the Chinese medicine extract can be protected to prevent it from being inactivated or ineffective during long-term storage. Therefore, it is superior to injection and oral therapy, as well as smearing drug powder, etc. for skin diseases, and can be used for a variety of skin diseases, with good efficacy, quick effect, and no side effects.

[0087] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A skin antibacterial cream, characterized in that: The invention is prepared from the following raw materials in parts by weight: 5-15 parts of angelica sinensis, 5-15 parts of sophora flavescens, 5-15 parts of rhubarb, 5-15 parts of phellodendron amurense, 3-12 parts of brucea javanica, 3-12 parts of atractylodes macrocephala, 3-12 parts of notoginseng, 5-15 parts of scutellaria baicalensis, 2-10 parts of angelica dahurica, 2-10 parts of ligusticum chuanxiong, 3-12 parts of salvia miltiorrhiza, 3-12 parts of saltpeter, 2-10 parts of white pearl and 1-2 parts of chlorhexidine acetate.

2. The skin antibacterial cream according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 5 parts of angelica sinensis, 15 parts of sophora flavescens, 5 parts of rhubarb, 15 parts of phellodendron amurense, 3 parts of brucea javanica, 3 parts of herba aconitifolia, 12 parts of notoginseng, 15 parts of scutellaria baicalensis, 2 parts of angelica dahurica, 2 parts of ligusticum chuanxiong, 3 parts of salvia miltiorrhiza, 12 parts of saltpeter, 2 parts of white pearl and 1 part of chlorhexidine acetate.

3. The skin antibacterial cream according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 15 parts of angelica sinensis, 5 parts of sophora flavescens, 15 parts of rhubarb, 5 parts of phellodendron amurense, 12 parts of brucea javanica, 12 parts of herba aconitifoliae, 3 parts of notoginseng, 5 parts of scutellaria baicalensis, 10 parts of angelica dahurica, 10 parts of ligusticum chuanxiong, 12 parts of salvia miltiorrhiza, 3 parts of saltpeter, 10 parts of white pearl and 2 parts of chlorhexidine acetate.

4. The skin antibacterial cream according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 10 parts of angelica sinensis, 10 parts of sophora flavescens, 10 parts of rhubarb, 10 parts of phellodendron amurense, 7 parts of brucea javanica, 7 parts of herba aconitifolii, 7 parts of notoginseng, 10 parts of scutellaria baicalensis, 6 parts of angelica dahurica, 6 parts of ligusticum chuanxiong, 7 parts of salvia miltiorrhiza, 7 parts of saltpeter, 6 parts of white pearls and 1.5 parts of chlorhexidine acetate.

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