Alligator oil eczema cream and preparation method thereof

Abstract

The invention discloses alligator oil eczema cream and a preparation method thereof, the alligator oil eczema cream is prepared from a Chinese herbal medicine extracting solution, alligator oil and vaseline, and the Chinese herbal medicine extracting solution comprises the following raw materials: radix sophorae flavescentis, fructus cnidii, honeysuckle, fructus kochiae, radix saposhnikoviae, pseudo-ginseng, borneol and mint. The alligator oil is used as a carrier of the eczema cream, the Chinese herbal medicine extract is further added into the alligator oil, recurrent inflammation and pigmentation after treatment are reduced, and the alligator oil eczema cream is more suitable for eczema treatment of infants and higher in safety.

Description

Technical Field

[0001] The present invention belongs to the technical fields of pharmaceuticals and skin care products, and particularly relates to an alligator oil eczema cream and a preparation method thereof. Background Art

[0002] Dermatosis is a general term for diseases occurring in the skin and skin appendages. The common inducements in dermatosis are allergic and infectious, and eczema is a skin inflammatory reaction with severe itching caused by various internal and external factors. Eczema is common in daily life and often occurs in infants and young children. It can be divided into acute, subacute, and chronic stages according to the collective manifestations of eczema. The common symptoms caused by eczema are characterized by polymorphic, symmetrical skin lesions, itching, and easy recurrence. Traditional Chinese medicine records that the onset of eczema is related to congenital deficiency, improper diet, overeating spicy and stimulating foods, or physical weakness, or emotional disorders. Traditional Chinese medicine believes that congenital intolerance, internal accumulation of dampness and heat, or improper diet leading to damage of the spleen and stomach, combined with exogenous wind, dampness and heat pathogens, result in the occurrence of eczema due to the combination of the two internal and external pathogens. The characteristics of endogenous or exogenous factors causing eczema are severe itching and high recurrence rate, accompanied by small blisters of different sizes. If the condition worsens, pustules will occur, the inflammation will intensify, and it will fester and even suppurate after scratching. Severe eczema will affect the normal life of patients. Therefore, in combination with the inducing factors and physical and chemical factors of eczema, it has quite a research value to develop drugs that are highly effective in treating eczema and have no side effects.

[0003] Compendium of Materia Medica states: "Alligator fat can treat skin diseases and malignant sores". Alligator oil has characteristics similar to those of deep-sea fish, is rich in polyunsaturated fatty acids, and has relatively high contents of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Studies by Zhang (ZHANG T-T, et al. Progress in Lipid Research, 2019, 75.) and others have found that oils containing EPA / DHA-PL can reduce the production and release of inflammatory factors to produce an anti-inflammatory effect and promote wound healing. Polyunsaturated fatty acids are important skin nutrients for the synthesis of cytokines, thus maintaining the health of the body's skin environment and the integrity of its structure. The above characteristics endow alligator oil with the effects of maintaining skin stability, enhancing skin tolerance, anti-inflammatory and antibacterial, and accelerating repair and healing. Therefore, the present invention designs to utilize the characteristics of alligator oil for the treatment of eczema skin diseases to prepare an eczema cream product with no side effects and good treatment effects. Summary of the Invention

[0004] One object of the present invention is to provide an alligator oil eczema cream, which is made of a Chinese herbal medicine extract, alligator oil, and petrolatum, and the mass ratio of the Chinese herbal medicine extract, alligator oil, and petrolatum is 1:0.5-5:0.5-5;

[0005] The raw materials of the Chinese herbal medicine extract include: Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol, and Mentha haplocalyx Briq.

[0006] Further, the raw materials of the Chinese herbal medicine extract, by mass, include: 50 - 300 g of Sophora flavescens, 50 - 300 g of Fructus Cnidii, 50 - 300 g of Flos Lonicerae, 50 - 300 g of Fructus Kochiae Scopariae, 50 - 300 g of Radix Saposhnikoviae, 10 - 200 g of Panax notoginseng, 50 - 200 g of Borneol, and 50 - 200 g of Mentha haplocalyx Briq.

[0007] Even further, the raw materials of the Chinese herbal medicine extract further include vegetable oil, and the mass of the vegetable oil is 500 - 2000 g.

[0008] The second object of the present invention is to provide a preparation method of the above-mentioned alligator oil eczema cream, including the following steps:

[0009] Step 1: Grind Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol, and Mentha haplocalyx Briq. respectively, add vegetable oil and mix, then add an ethanol solution, perform vacuum reflux extraction, collect the extracted Chinese medicine extract and residue after extraction, filter to obtain a preliminarily purified Chinese herbal medicine extract, and perform vacuum reflux extraction on it again until all the ethanol is evaporated to obtain the Chinese herbal medicine extract;

[0010] Step 2: Mix the Chinese herbal medicine extract, alligator oil, and petrolatum to obtain the alligator oil eczema cream.

[0011] Further, the dosage of the ethanol solution is 1.5 - 3 times the mass - volume ratio of the total mass of Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol, and Mentha haplocalyx Briq., and the concentration of the ethanol solution is 30% - 100%.

[0012] Further, the temperature of the vacuum reflux is 30 - 70 °C. In an embodiment of the present invention, the temperature of the vacuum reflux used is 45 - 55 °C.

[0013] The present invention uses crocodile oil as the carrier of the eczema cream, and also adds Chinese herbal extracts to it, making up for the side effects brought by hormones such as calcineurin inhibitors, vitamin D3 derivatives, and glucocorticoid ointments in Western medicine, reducing recurrent inflammation and post-treatment pigmentation, and being more suitable for the treatment of eczema in infants and young children, with stronger safety. This eczema cream relies on traditional Chinese medicine treatment, focusing on strengthening the spleen and removing dampness for the treatment of eczema. The external application of the plaster directly acts on the eczema surface, reducing the treatment time limit, not bringing an excessive burden to the body, and providing external protection for the eczema surface, avoiding contact with the external environment, preventing wound infection, and accelerating the treatment and recovery of eczema. The penetration of the crocodile oil eczema cream results in high product stability and fast absorption. The various Chinese herbal medicines such as Sophora flavescens and Panax notoginseng added to the eczema cream can improve epidermal damage, regulate the immune system and body inflammation, and provide support for skin tissue conditioning in the treatment of eczema. The compound Chinese herbal medicine combines the treatment effects in multiple aspects and cooperates with the characteristics of crocodile oil to achieve a double treatment effect on the basis of the single-action mechanisms of the two.

[0014] Through animal experiments, the present invention demonstrated the repair effect and inhibitory ability of crocodile oil on the eczema surface; and used multiple factors such as the eczema standard scoring index, epidermal repair status, and skin tissue pathological observation to prove the repair ability of crocodile oil. Relevant research shows that the main fatty acid components contained in crocodile oil, palmitic acid, linoleic acid, and oleic acid, have a certain promoting effect on wound repair. Among them, linoleic acid is an essential amino acid for the human body, which is related to heart diseases such as atherosclerosis and coronary heart disease; oleic acid can also reduce the body's blood lipid and loosen blood vessels. Research shows that crocodile oil can effectively reduce the content of TNF-α, IL-1β, and IL-6 proteins in the damaged epidermis, thereby reducing the phosphorylation level of p38-MAPK, inhibiting the p38-MAPK signaling pathway, and preventing the expression of IL-1β and IL-6 related proteins. Further inhibiting the expression of inducible nitric oxide synthase (iNOS), reducing the synthesis of NO, and being able to reduce edema and prevent epidermal blood vessel dilation in the body phenotype. Crocodile oil can also accelerate the synthesis of collagen by fibroblasts and promote the recovery of epidermal damage. Therefore, choosing crocodile oil as an ingredient of the eczema cream can repair eczema and other inflammations, and at the same time inhibit the recurrence of eczema.

[0015] The present invention establishes a mouse eczema model by DNCB, administers multi-component drugs to the mice, and records the treatment effects. Through horizontal comparison, the effects are compared with those of the commercially available Quimixin Cream for treating dermatitis. Secondly, in this experiment, a refined comparison is also made by comparing the crocodile oil eczema cream with the components of crocodile oil to verify the improvement of the treatment effect of crocodile oil on eczema. The compound of Chinese herbal medicine and crocodile oil greatly enhances the product efficacy. Eczema treatment is a process prone to recurrence. The present invention also conducts an inhibitory determination of the eczema cream, using the mass difference of the ears to reflect the ear swelling degree, so as to verify the degree of eczema inhibition of each component. Combining with the experimental demonstration of skin pathology, various factors indicate that the crocodile oil eczema cream can effectively reduce inflammation and relieve itching, inhibit the generation of redness and swelling, eliminate lichenification, inhibit scar residue and pigmentation in the repair of eczema. The crocodile oil eczema cream can inhibit various aspects of eczema inflammation and can be used in skin diseases such as allergic itching and wound repair. Description of the Drawings

[0016] Figure 1 It is the appearance of the crocodile oil eczema cream.

[0017] Figure 2 It is the diagram of mouse eczema modeling.

[0018] Figure 3 It is the result of the eczema repair time of mice in each group.

[0019] Figure 4 It is the eczema repair situation of mice in each group.

[0020] Figure 5 It is the hair growth situation of mice after repair in each group. Among them, A is the control group, B is the Quimixin Cream group, C is the crocodile oil group, and D is the eczema cream group.

[0021] Figure 6 It is the shaved epidermis situation of mice after repair in each group. Among them, A is the control group, B is the Quimixin Cream group, C is the crocodile oil group, and D is the eczema cream group.

[0022] Figure 7 It is the result of the ear swelling degree of mice in each group.

[0023] Figure 8 It is the result of the specific eczema standard score of mice in each group.

[0024] Figure 9 It is the clinical score data of each group. Detailed Embodiment

[0025] The preferred embodiments of the present invention will be described in detail below in conjunction with the embodiments. It should be understood that the following embodiments are given only for the purpose of illustration and are not used to limit the scope of the present invention. Those skilled in the art can make various modifications and substitutions to the present invention without departing from the purpose and spirit of the present invention.

[0026] Unless otherwise specified, the experimental methods used in the following embodiments are all conventional methods.

[0027] Unless otherwise specified, the materials, reagents, etc. used in the following embodiments can all be obtained from commercial channels.

[0028] Sophora flavescens, Cnidium monnieri, Lonicera japonica, Kochia scoparia, Saposhnikovia divaricata, Panax notoginseng, Borneol, Mentha haplocalyx, etc. were purchased from Shen'ao Chinese Herbal Medicine Company; Crocodile oil was provided by Tuolong (Xiamen) Biomedical Research Institute Co., Ltd.; Quimeixin Cream was purchased from Baiyunshan Pharmaceutical Holdings Co., Ltd.; 2,4-Dinitrochlorobenzene solution (DNCB) was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; Acetone, Ethanol, Ether, Vaseline were purchased from Sinopharm Chemical Reagent Co., Ltd.; Olive oil was purchased from Beijing Zhongqi Huaye Food Co., Ltd.; 4% Formaldehyde fixing solution was purchased from Shenzhen Xijing Biotechnology Co., Ltd.; Vegetable oil was purchased from Yihai Kerry Food Marketing Co., Ltd.

[0029] Example 1

[0030] In this example, the alcohol extraction and extraction method was selected to prepare crocodile oil eczema cream, and the preparation method was as follows:

[0031] 200 g of Chinese herbal medicine Sophora flavescens, 100 g of Cnidium monnieri, 100 g of Lonicera japonica, 100 g of Kochia scoparia, 100 g of Saposhnikovia divaricata, 50 g of Panax notoginseng, 100 g of Borneol, and 100 g of Mentha haplocalyx were respectively ground into powder. The ground raw materials were added to 850 g of vegetable oil according to their mass ratio, and after mixing evenly, they were transferred to a rotary evaporator, and 1500 ml of 90% ethanol solution was added, and left for 12 hours. The water bath temperature was set at 45 - 55 °C, and vacuum reflux was carried out, and extracted repeatedly for 7 - 8 times. The extracted Chinese herbal medicine extract and residue were collected and filtered through 4 layers of gauze to obtain a preliminarily purified Chinese herbal medicine extract. The preliminarily purified extract was extracted again in a rotary evaporator until all the ethanol was evaporated from the mixture to obtain a Chinese herbal medicine extract with a higher purity. The Chinese herbal medicine extract, crocodile oil, and vaseline were mixed evenly in a water bath at 90 °C according to a ratio of 1:1:3 to prepare crocodile oil eczema cream, and stored in the refrigerator.

[0032] In this embodiment, through the alcohol extraction method, vegetable oil and ethanol are used as extraction agents, and vacuum negative pressure is adopted to extract the fat-soluble and water-soluble active ingredients from various Chinese herbal medicines such as honeysuckle, sophora flavescens, and Kochia scoparia. Then, they are mixed with vaseline and crocodile oil in a water bath according to a certain ratio to prepare the crocodile oil eczema cream. This eczema cream is dark green, in a solid paste form, has the fragrance of Chinese herbal medicines, can be used for the treatment of eczema, and has a certain inhibitory effect on skin diseases such as relieving itching and eliminating swelling. The appearance of the crocodile oil eczema cream is as Figure 1 shown.

[0033] Example 2

[0034] This example is similar to Example 1, the difference is that in the crocodile oil eczema cream described in this example, the ratio of the Chinese herbal medicine extract, crocodile oil, and vaseline is 1:1:4. The raw material composition of the Chinese herbal medicine extract and its content by mass ratio are 1000 g of camellia oil or peanut oil, 60 g of sophora flavescens, 120 g of cnidium monnieri, 150 g of honeysuckle, 150 g of Kochia scoparia, 150 g of ledebouriella seseloides, 50 g of notoginseng, 60 g of borneol, and 60 g of mentha haplocalyx.

[0035] Example 3

[0036] This example is similar to Example 1, the difference is that in the crocodile oil eczema cream described in this example, the ratio of the Chinese herbal medicine extract, crocodile oil, and vaseline is 1:0.8:3. The raw material composition of the Chinese herbal medicine extract and its content by mass ratio are 1000 g of corn oil or soybean oil, 100 g of sophora flavescens, 60 g of cnidium monnieri, 60 g of honeysuckle, 100 g of Kochia scoparia, 100 g of ledebouriella seseloides, 30 g of notoginseng, 50 g of borneol, and 50 g of mentha haplocalyx.

[0037] Example 4

[0038] This example is similar to Example 1, the difference is that in the crocodile oil eczema cream described in this example, the ratio of the Chinese herbal medicine extract, crocodile oil, and vaseline is 1:1.5:5. The raw material composition of the Chinese herbal medicine extract and its content by mass ratio are 1000 g of sesame oil, 50 g of sophora flavescens, 50 g of cnidium monnieri, 50 g of honeysuckle, 100 g of Kochia scoparia, 100 g of ledebouriella seseloides, 40 g of notoginseng, 60 g of borneol, and 60 g of mentha haplocalyx.

[0039] Example 5

[0040] This example is similar to Example 1, the difference is that in the crocodile oil eczema cream described in this example, the ratio of the Chinese herbal medicine extract, crocodile oil, and vaseline is 0.8:1:3. The raw material composition of the Chinese herbal medicine extract and its content by mass ratio are 800 g of sesame oil, 100 g of sophora flavescens, 100 g of cnidium monnieri, 100 g of honeysuckle, 50 g of Kochia scoparia, 50 g of ledebouriella seseloides, 50 g of notoginseng, 100 g of borneol, and 100 g of mentha haplocalyx.

[0041] The treatment effect of alligator oil eczema cream in Example 1 on eczema is given below.

[0042] 1. Grouping of mice and establishment of eczema model

[0043] Forty SPF-grade male Kunming mice, weighing 25 - 30 g, were purchased from Shandong Pabeile White Rat Breeding Cooperative at 3 weeks of age and randomly divided into a control group, a triamcinolone acetonide cream group, an alligator oil group, and an eczema cream group, with 10 mice in each group. Breeding conditions: room temperature 18 - 25 °C, humidity 65 - 75%, providing sufficient food and water, allowing self-feeding, with 12 h of light and 12 h of darkness each day.

[0044] After 3 days of adaptive cultivation, on the day before eczema modeling, the hair on the backs of the mice was removed with an electric hair clipper and then depilated a second time. 3% and 1% 2,4-dinitrochlorobenzene solution (DNCB) were respectively prepared for eczema modeling of mice. Weighed 240 mg of DNCB solid with an electronic balance, added 6 ml of acetone and 2 ml of olive oil, and dissolved to obtain 3% DNCB solution for eczema modeling on the backs of mice. Weighed 80 mg of DNCB solid and dissolved it in 6 ml of acetone and 2 ml of olive oil to obtain 1% DNCB solution for later eczema modeling on the ears of mice. Pipetted 150 μl of 3% 2,4-dinitrochlorobenzene solution and evenly applied it to the backs of the mice once a day with the same steps for 3 consecutive days for eczema modeling. When the mice showed dry back skin, lichenification, erythema, thickening of the cortex, and the mice were restless and had increased scratching behavior, it indicated that the eczema modeling was successful. The eczema modeling of mice is as Figure 2 shown.

[0045] 2. Study on the repair process of alligator oil eczema cream

[0046] The triamcinolone acetonide cream group, the alligator oil group, and the eczema cream group were respectively applied with triamcinolone acetonide cream, alligator oil, and alligator oil eczema cream twice a day (at 10 am and 4 pm) for 9 consecutive days. The control group was not given any drug treatment and was only applied with water. The mice were photographed and tracked on the 1st, 3rd, 5th, 7th, and 9th days, and the recovery of the eczema area was observed and recorded every day. After the 9th day, drug treatment was no longer carried out, and the mice were allowed to self-repair until the eczema area of the mice was completely recovered. After fasting for 12 h, the mice were anesthetized with ether and then decapitated to death, and the back skin tissues and ear pieces of the mice were collected for subsequent research.

[0047] The experimental results found that the repair time of the eczema area of the mice is as Figure 3As shown, control group: 15.5 ± 3.62 d, Trimiconazole Cream group: 9.67 ± 1.86 d, Crocodile Oil group: 8.56 ± 2.40 d, Eczema Ointment group: 6.75 ± 1.36 d. Comparing these data, the recovery time of the crocodile oil eczema ointment is significantly shorter than that of the control group, and it has the best repair effect and the shortest time among the four groups. This shows that the mixture of Chinese herbal medicine and crocodile oil components in the crocodile oil eczema ointment has an obvious effect on the repair of eczema. The repair time of the eczema area in the Crocodile Oil group is shortened to a certain extent compared with the normal saline group and the Trimiconazole Cream group, indicating that the component of crocodile oil also has a corresponding effect on the repair of the eczema area.

[0048] This embodiment also photographed and recorded the repair of the eczema area of the mice in the four groups, as Figure 4 shown. Among them, the recovery of the eczema area in the control group was very slow, and the degree of epidermal repair was poor. At the 9th day, the lichenification and erythema on the epidermis of the mice were still obvious, and local edema was accompanied. After the wound surface recovered, the residual rate of scarring on the epidermis was high. The repair performance of the mice in the Trimiconazole Cream group showed that there were residual scales and erythema on the epidermis, the skin surface was uneven, there was obvious pigment residue, the eczema area was hard, and the growth of new hair was slow, but the recovery time was faster than that of the control group. After recovery, the eczema area in the Crocodile Oil group was relatively flat, the scabs had fallen off, and there was an obvious shrinking trend. The epidermis was light red, darker than the epidermis of normal mice, and there were certain scars and pigment residues. The mice in the Crocodile Oil Eczema Ointment group had the shortest recovery time and the best recovery effect. The residual erythema, scales, and edema in the eczema area were the least. The growth of new hair and new granulation tissue on the epidermis was faster. And after recovery, the epidermis was smooth, the pigment residue was less, the hair grew densely, tended to be normal, the scar residual rate was very low, and the overall skin repair was good.

[0049] After all mice had fully recovered (on the 25th day), the final recovery status of the epidermis and the degree of fur growth of the mice in each group were analyzed, as Figure 5 shown. After repair, some new hair grew in the control group mice, but it did not completely cover the shaved area. And under the hair, there were still residual red scars, and the scarring phenomenon was obvious. The epidermis was uneven, and there was a relatively obvious boundary between the eczema area and the surrounding skin, and its color was different from that of normal skin. The growth rate of new hair on the epidermis of the mice in the Trimiconazole Cream group was relatively slow, the epidermis hair was sparse, there were some residual scars, and there was a certain amount of pigment residue on the epidermis, with an obvious boundary from normal skin. The fur of the mice in the Crocodile Oil group grew vigorously, the residual scars on the epidermis were less, and the color of the epidermis in the eczema area was close to the skin color of normal mice. The epidermis hair of the mice in the Crocodile Oil group was thick, there were no phenomena such as erythema and swelling, the boundary between the eczema area and the surrounding skin tended to be blurred, and the skin color of the epidermis also tended to be that of normal mice, with very little scar residue.

[0050] After recording the degree of fur repair of the mice after complete recovery, the mice were depilated again to more clearly and intuitively observe the recovery of the epidermis of the mice. The results are asFigure 6 As shown. The control group mice had the worst repair condition because they were not treated with medication. There were residual erythema and pigment on the epidermis, and the scabs fell off and remained, with a clear boundary from the normal epidermis of the mice. The epidermis of the mice treated with Qumixin cream recovered better, but there were still residual erythema and redness, and the epidermis of the mice was hard. The epidermis of the mice in the crocodile oil group and the eczema cream group was smooth, light pink, close to the normal mouse epidermis, with no obvious boundary from the normal epidermis, and no residual eczema symptoms such as scars and lichenification.

[0051] From the above three aspects of the research and analysis on the recovery of eczema, it was found that the crocodile oil eczema cream had the best recovery effect, followed by the crocodile oil group. It was concluded that crocodile oil has a significant effect on the treatment and recovery of eczema. The compound plaster of crocodile oil and Chinese herbal ingredients can significantly improve the recovery effect of eczema surface by adding the effective ingredients of Chinese herbal medicine on the basis of crocodile oil alone. On the one hand, crocodile oil can repair the inflammation of eczema, and on the other hand, it can act as a penetrant to promote the Chinese herbal medicine ingredients to enter the skin surface, accelerate the absorption of drugs and the recovery of wounds.

[0052] 3. Determination of mouse ear swelling

[0053] After the first eczema modeling of mice and the completion of drug treatment, wait for the complete recovery of the eczema surface. 4 hours before the second sensitization induction, the ears of mice were treated with drugs, and tromexin cream, crocodile oil, and eczema cream were applied to the left ears of mice, respectively. Then 100 μl of 1% 2,4-dinitrochlorobenzene solution was taken with a pipette and applied to both ears of the mice for secondary sensitization. The left and right ears were compared to explore the inhibitory effect of this product on eczema. After killing the mice, use scissors to cut off the mouse ear pieces (about 8 to 9 mm) along the base of the ears, place them on an electronic analytical balance to weigh the weight of the left and right ears of the mice (environmental effects are negligible), and calculate the mass difference (right ear mass - left ear mass). The mass difference between the left and right ear pieces is the swelling degree of the mouse ear, reflecting the degree of inhibition of eczema by each component.

[0054] The ear tissue of mice swelled up due to 1% 2,4-dinitrochlorobenzene solution, which was different from the ear tissue without drug treatment. Figure 7As shown. According to the obtained mass difference, the swelling degree of the ears of the mice in the Triamcinolone Acetonide, Econazole Nitrate and Neomycin Sulfate Cream group was 0.04±0.016 g, that in the crocodile oil group was 0.08±0.015 g, and that in the eczema cream group was 0.13±0.028 g. The degree of eczema inhibition was represented by the swelling degree. The higher the swelling degree value, the greater the mass difference between the two ears, indicating that the inhibitory effect of the drug was better. The swelling degree of the Triamcinolone Acetonide, Econazole Nitrate and Neomycin Sulfate Cream was significantly lower than that of the crocodile oil group and the eczema cream group, indicating that the Triamcinolone Acetonide, Econazole Nitrate and Neomycin Sulfate Cream had a poor effect on the inhibition and recurrence of eczema. The inhibition degree of the crocodile oil group was lower than that of the eczema cream group in terms of the swelling degree value, indicating that the crocodile oil added with Chinese herbal medicines had a good therapeutic effect on the recurrence and inhibition of eczema on the basis of crocodile oil, and had a beneficial improvement in the treatment of eczema.

[0055] 4. Determination of the eczema score of mice

[0056] Referring to the standard eczema score determination, the eczema conditions of the mouse epidermis were observed on the 1st, 3rd, 5th, 7th, and 9th days of the experiment, including multiple factors such as skin erythema, scratches, and edema, and the scores were recorded for subsequent data analysis.

[0057] The eczema score criteria are as follows:

[0058] (1) Mouse epidermal erythema / bleeding: If the area is greater than 75% of the skin area of the shaved area, it is recorded as 4 points; if the area is between 40% and 75%, it is recorded as 3 points; if the area is between 10% and 40%, it is recorded as 2 points; if the area is less than 10%, it is recorded as 1 point; if there is no epidermal erythema or bleeding, it is recorded as 0 points.

[0059] (2) Mouse epidermal scratches / erosions: If the area is greater than 75% of the skin area of the shaved area, it is recorded as 4 points; if the area is between 40% and 75%, it is recorded as 3 points; if the area is between 10% and 40%, it is recorded as 2 points; if the area is less than 10%, it is recorded as 1 point; if there are no epidermal scratches or erosions, it is recorded as 0 points.

[0060] (3) Mouse epidermal edema: If the epidermal color is dark red, the surface is moist, there is obvious swelling, and there is no hair growth, it is recorded as 4 points; if the epidermal color is light red, the surface is relatively dry, it is relatively swollen, and there is no hair growth, it is recorded as 3 points; if the epidermal color is pink, darker than the normal skin color, the surface is slightly uneven, and there is new hair growth, it is recorded as 2 points; if the epidermis is similar to the normal skin color of the mouse, there is a large amount of new hair growth, and the skin is relatively smooth, it is recorded as 1 point, and if there is no such manifestation, it is recorded as 0 points.

[0061] (4) Mouse epidermal scales or lichenification: If the area is greater than 75% of the shaved area, it is recorded as 4 points; if the area is between 40% and 75%, it is recorded as 3 points; if the area is between 10% and 40%, it is recorded as 2 points; if the area is less than 10%, it is recorded as 1 point; if there are no epidermal scales or lichenification, it is recorded as 0 points.

[0062] Refer to the relevant eczema standard scores. A total of five score calculations were performed after modeling. The eczema area of the mice was evaluated using multiple factors to reflect the therapeutic effects of each component. The relevant score curves are as Figure 8 shown.

[0063] The eczema score curves of each group gradually decreased with the increase of time. Among them, the eczema score of the eczema cream group decreased most significantly. The scores of the control group mice remained in a relatively high range all the time, and the scores decreased slowly; the scores of the crocodile oil group and the clotrimazole and neomycin sulfate cream group were close, showing a certain decrease compared with the control group, and the decrease of the crocodile oil group was more significant in the later stage of the experiment, indicating that the inflammatory phenomena such as erythema and lichenification of eczema decreased, and the recovery effect of the mice was better. From the decrease in the score of the eczema cream group, it can be seen that the curative effect of the crocodile oil eczema cream is the best, specifically manifested in multiple factors such as reduced erythema, alleviated swelling, and reduced scratching times. It shows that the therapeutic effect of the crocodile oil eczema cream is significant, and the eczema inflammation is well inhibited. The crocodile oil group and the clotrimazole and neomycin sulfate cream group also have a certain inhibitory effect on the treatment of eczema.

[0064] 5. Clinical application of crocodile oil eczema cream

[0065] By tracking the clinical treatment of patients, 56 patient investigation reports were collected to provide clinical data support for the market launch of the crocodile oil eczema cream, and the formula was adjusted and improved on this basis.

[0066] In this example, referring to the content of the SCORAD (Scoring Atopic Dermatitis Index) eczema standard score table, the sampled data collected started from 7 aspects: itching degree, erythema degree, papule / edema degree, exudation / crusting degree, scratch degree, fissure / skin crack degree, and lichenification degree, to verify the specific effects of the crocodile oil eczema cream from multiple aspects. The obtained data are as Figure 9 shown. A total of 56 patient data were collected. Among them, 52 people thought the itching degree was significantly reduced, and 4 people thought it was slightly reduced; 51 people thought the erythema degree was significantly reduced, 4 people thought it was slightly reduced, and 1 person had no erythema; 48 people thought the papule or edema degree was significantly reduced, 7 people thought it was slightly reduced, and 1 person thought there was no effect; 50 people thought the exudation or crusting degree was significantly reduced, 5 people thought it was slightly reduced, and 1 person thought there was no effect; 51 people thought the scratch degree was significantly reduced, and 5 people thought it was slightly reduced; 50 people thought the fissure or skin crack degree was significantly improved, 4 people thought it was slightly reduced, and 1 person had no improvement; 51 people thought the lichenification was significantly reduced, and 5 people thought it was slightly reduced.

[0067] The following are the specific situations of several cases among 56 clinical samples:

[0068] Case 1:

[0069] Du Moumou, male, 26 years old, from Xiamen, Fujian. The inflammatory manifestations of eczema are obvious, with long-term itching and scratching behaviors, which even affect sleep. The degree of erythema and scratches is very obvious, accompanied by lichenification, fissures and swelling, belonging to severe eczema. The patient applied alligator oil eczema cream three times a day for 15 days. Most of the eczema inflammation was cured, with some residual skin fissures and no recurrence.

[0070] Case 2:

[0071] Xiong Moumou, female, 27 years old, from Xiamen, Fujian. She has persistent or intermittent itching behaviors, but it does not affect sleep. The degree of skin fissures is very serious, and the eczema inflammation signs such as erythema, swelling and scratches are relatively obvious, diagnosed as mild eczema. The patient applied the cream for 10 days, three times a day. The skin inflammations such as swelling, scratches and erythema were completely cured, the itching behavior improved significantly, and there were some residual skin fissures, but there was no recurrence of eczema. After treatment, there was no pigmentation or scar residue on the skin.

[0072] Case 3:

[0073] Xin Moumou, female, 48 years old, from Quanzhou, Fujian. She is prone to recurrence of eczema disease and allergic phenomena when the skin changes seasons, with persistent itching and scratching behaviors, which affect normal sleep. The scratches, swelling, erythema and other eczema-related inflammations of the patient are very obvious, and she is diagnosed with severe eczema. The patient used alligator oil eczema cream for treatment, three times a day for 30 days. The eczema was treated and inhibited to a certain extent, the erythema weakened, the swelling subsided, the anti-itching effect was significant, and the scratching behavior decreased. Without using the eczema cream, there were occasional recurrence behaviors. After treatment, there was some pigment residue on the skin, but no scarring.

[0074] Case 4:

[0075] Zhang Moumou, female, 31 years old, from Xi'an, Shaanxi. She occasionally has eczema in daily life, with mild scratching and itching behaviors, and the degrees of edema, erythema and fissures are relatively light, which do not affect normal life, and is confirmed as occasional mild eczema. When the eczema occurred, she applied alligator oil eczema cream, which effectively inhibited phenomena such as erythema and lichenification. After application, the itching behavior disappeared immediately, and the skin was smooth without pigmentation after treatment.

[0076] Case 5:

[0077] He Moumou, female, 52 years old, from Nanning, Guangxi. She usually eats spicy food. Intermittent eczema caused by maladjustment to the local climate and soil and discomfort in the spleen and stomach, with itching in the limbs, partial epidermal edema and chapping, and obvious erythema, which will affect the patient's sleep quality. The patient applied alligator oil eczema cream 3 times a day for 25 days. The itching was significantly reduced, the lichenification around the skin fell off, and it was completely cured on the 25th day. There were no obvious scars left on the skin, the swelling and redness subsided, the erythema dissipated, and the recurrence time increased until it no longer recurred.

[0078] To sum up, alligator oil eczema cream focuses on treating itching, erythema, exudation / crusting, scratch marks, chapping / skin cracks, and lichen. Most people think that alligator oil eczema cream has a good improvement effect on eczema, specifically treats eczema symptoms, and has a low scar residue rate after recovery, tending to normal skin. However, the change in papules / edema is not obvious enough, and the formula can be adjusted for this symptom.

[0079] The present invention relates to, but is not limited to, the compounding of alligator oil and Chinese herbal medicine extracts (such as sophora flavescens, fructus cnidii, honeysuckle, etc.) for applications such as the efficacy of skin eczema.

Claims

1. A crocodile oil eczema cream, characterized in that, It is made from the extract of Chinese herbal medicine, crocodile oil and vaseline, and the mass ratio of the extract of Chinese herbal medicine, crocodile oil and vaseline is 1: 0.5-5: 0.5-5; The raw materials of the extract of Chinese herbal medicine include: Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol, Mentha haplocalyx Briq.

2. The crocodile oil eczema cream according to claim 1, wherein The raw materials of the extract of Chinese herbal medicine include, by mass: 50-300 g of Sophora flavescens, 50-300 g of Fructus Cnidii, 50-300 g of Flos Lonicerae, 50-300 g of Fructus Kochiae Scopariae, 50-300 g of Radix Saposhnikoviae, 10-200 g of Panax notoginseng, 50-200 g of Borneol, 50-200 g of Mentha haplocalyx Briq.

3. The crocodile oil eczema cream according to claim 2, characterized in that, The raw materials of the extract of Chinese herbal medicine also include vegetable oil, and the mass of the vegetable oil is 500-2000 g.

4. The preparation method of the crocodile oil eczema cream according to claim 1, characterized in that, It includes the following steps: Step 1, grind Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol and Mentha haplocalyx Briq. respectively, mix them with vegetable oil, then add ethanol solution, carry out vacuum reflux extraction, collect the extracted Chinese herbal medicine extract and residue, filter to obtain the preliminarily purified extract of Chinese herbal medicine, and carry out vacuum reflux extraction again until all the ethanol is evaporated to obtain the extract of Chinese herbal medicine; Step 2, mix the extract of Chinese herbal medicine, crocodile oil and vaseline to obtain the crocodile oil eczema cream.

5. The preparation method of the crocodile oil eczema cream according to claim 4, characterized in that, The dosage of the ethanol solution is 1.5-3 times the mass volume ratio of the total mass of Sophora flavescens, Fructus Cnidii, Flos Lonicerae, Fructus Kochiae Scopariae, Radix Saposhnikoviae, Panax notoginseng, Borneol and Mentha haplocalyx Briq., and the concentration of the ethanol solution is 30%-100%.

6. The preparation method of the crocodile oil eczema cream according to claim 4, wherein The temperature of the vacuum reflux is 30-70 °C.

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