Cortex moutan extract emulsifiable paste for treating skin eczema as well as preparation method and application thereof

Abstract

The invention discloses moutan bark extract emulsifiable paste for treating skin eczema and a preparation method and application of the moutan bark extract emulsifiable paste, and belongs to the technical field of traditional Chinese medicine preparations and application of the traditional Chinese medicine preparations. The ointment is prepared from 1%-15% of stearic acid, 1%-15% of glycerin monostearate, 5%-10% of vaseline, 1%-5% of liquid paraffin, 2%-6% of triethanolamine, 2%-15% of humectant, 0.01%-0.1% of preservative, 0.01%-1% of stabilizer and the balance of water. The cream disclosed by the invention is simple in preparation process, easy to operate, good in product coating property and high in stability. The emulsifiable paste has good activity in treatment of eczema, and meanwhile, menthol is added into the preparation, so that transdermal absorption of the medicine can be better promoted, and the treatment effect of the medicine is improved.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine preparations and their applications, and specifically relates to a peony bark extract cream and a preparation method and application thereof. Background Art

[0002] Peony bark was first recorded in Shennong's Herbal Classic. It is the dried root bark of Paeonia suffruticosaAndr., a plant of the Ranunculaceae family. It has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and clearing away heat. Clinically, peony bark is often used to treat fever and rashes, vomiting blood and bleeding, night heat and morning coolness, no sweat and bone steaming, dysmenorrhea, swelling and sores, and pain caused by falls. Compendium of Materia Medica records that peony bark can treat sores and itching, which is consistent with the clinical manifestations of eczema. Medical books in the Qing Dynasty further emphasized the unique advantages of peony bark in the treatment of skin diseases. Modern pharmacological studies have revealed that peony bark is rich in a variety of bioactive ingredients, which have anti-inflammatory, antibacterial and anti-allergic effects. These ingredients can effectively inhibit the release of inflammatory mediators and reduce skin inflammatory reactions. Given the close connection between peony bark and eczema treatment, its development and research in the field of anti-eczema has great potential.

[0003] Eczema, often referred to as "wet sores" in traditional Chinese medicine, is a skin inflammation caused by the combined effects of internal and external factors. It is characterized by various forms of skin damage, symmetrical distribution, intense itching and easy recurrence. Its pathological mechanism is closely related to the internal accumulation of dampness and heat and the overflow of blood heat. The cause of eczema is complex. Mental stress, endocrine disorders and climate change can all lead to the occurrence of eczema. Traditional eczema treatment drugs such as antihistamines, antibiotics, glucocorticoids and immunomodulators are effective in the short term, but long-term use may cause local side effects such as skin atrophy and acne, and even systemic problems such as increased blood sugar. Considering that the global incidence of eczema is about 1.8%, accounting for 58.55% of allergic skin diseases, it is urgent to develop safer and more effective treatments.

[0004] In recent years, the application of Chinese herbal medicine in the treatment of eczema has attracted more and more attention. Practice has proved that Chinese medicine has shown significant efficacy in the treatment of eczema, and the risk of recurrence after cure is relatively low. The development of Chinese herbal preparations with stable and controllable quality has important practical significance and clinical value for the treatment of eczema.

[0005] At present, paeonol cream is used to treat eczema and other inflammatory skin diseases, but its actual efficacy has not met people's expectations. Many researchers use other drugs in combination with paeonol to improve its efficacy. Therefore, studying Chinese medicine external preparations that can treat eczema is an important issue that this field is committed to solving. Among them, cream refers to a uniform semisolid external preparation made by mixing a drug with an oily or water-soluble matrix. It is mainly used on the surface of the skin and mucous membranes in medicine to play a local protective and therapeutic role. Summary of the invention

[0006] The object of the present invention is to provide a peony bark extract cream for treating skin eczema, and a preparation method and application thereof. The peony bark extract cream has a reasonable prescription, a simple preparation process, easy operation, high product stability, good coating properties, and a significant therapeutic effect on eczema.

[0007] In order to achieve the above-mentioned object of the invention, the technical solution of the present invention is:

[0008] In the first aspect, the present invention claims protection for a peony bark extract cream, which comprises the following raw materials and auxiliary materials, calculated by mass percentage: peony bark extract 1%-25%, stearic acid 1%-15%, glyceryl monostearate 1%-15%, vaseline 5%-10%, liquid paraffin 1%-5%, triethanolamine 2%-6%, moisturizer 2%-15%, preservative 0.01%-0.1%, stabilizer 0.01%-1%, and the rest is water.

[0009] Further preferably, the peony bark extract cream contains the following raw materials and auxiliary materials: peony bark extract 5%-25%, stearic acid 2.5%-12.5%, glyceryl monostearate 1%-9%, vaseline 6%-8%, liquid paraffin 3%-5%, triethanolamine 3%-5%, moisturizer 5%-15%, preservative 0.05%, stabilizer 0.1%, and the rest is water.

[0010] Further preferably, the peony bark extract cream comprises the following raw materials and auxiliary materials: peony bark extract is 20%, stearic acid is 7.5%, glyceryl monostearate is 5%, vaseline is 7.5%, liquid paraffin is 4%, triethanolamine is 4%, moisturizer is 10%, preservative is 0.05%, stabilizer is 0.1%, and the rest is water.

[0011] As a preferred technical solution, the peony bark extract cream also contains a permeation enhancer (also known as an absorption enhancer). Further preferably, the permeation enhancer is at least one of borneol, menthol and azone. Further preferably, the mass percentage of the permeation enhancer in the peony bark extract cream is 1%-6%; preferably 5%.

[0012] More preferably, the moisturizing agent plays a role in retaining water in the cream and is at least one of glycerin, propylene glycol and sodium hyaluronate.

[0013] The preservative is at least one of sodium benzoate, ethylparaben, ethylhydroxybenzoate and potassium sorbate.

[0014] The stabilizer is at least one of sodium carboxymethyl cellulose, sodium alginate and xanthan gum.

[0015] In a specific embodiment of the present invention, the preparation method of the peony bark extract is: weigh the peony bark slices, add 8-15 times the amount of 75% (v / v) ethanol to reflux and extract for 0.5-2h, extract 1-3 times, filter, combine the filtrate, recover the ethanol under reduced pressure at 30-50°C, and then extract with ethyl acetate. After recovering the ethyl acetate, dry the extract to obtain a dry extract.

[0016] In a second aspect, the present invention claims a method for preparing a peony bark extract cream, comprising the following steps:

[0017] (1) heating and stirring the peony bark extract, triethanolamine, moisturizer, preservative, stabilizer and water according to the formula amount to dissolve them and prepare an aqueous phase;

[0018] (2) taking stearic acid, glyceryl monostearate, vaseline, and liquid paraffin according to the formula, heating and stirring to dissolve them, and preparing an oil phase;

[0019] (3) The oil phase is added to the water phase while hot, homogenized at a speed of 10000-15000 r / min for 4-7 min, and then stirred and cooled to room temperature to obtain a peony bark extract cream.

[0020] When the raw materials and auxiliary materials of the peony bark extract cream include a penetration enhancer, during the preparation process, the penetration enhancer, peony bark extract, triethanolamine, moisturizer, preservative, stabilizer and water are heated and stirred according to the formula amount to prepare an aqueous phase; the rest of the process is the same.

[0021] Furthermore, in step (1), the heating temperature is 75 to 85° C.; in step (2), the heating temperature is 75 to 85° C.;

[0022] In a third aspect, the present invention seeks to protect the use of the above-mentioned Paeonia suffruticosa root extract cream in the preparation of a medicament for treating eczema.

[0023] In the present invention, the room temperature is 0-40°C, more preferably 25°C.

[0024] Peony bark extract cream: referred to as MDP cream.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The peony bark extract cream of the present invention uses the peony bark extract of the traditional Chinese medicine extract as a raw material, has a mild medicinal property, has little skin irritation, and has little side effects;

[0027] The present invention separates peony bark extract, emulsifier, solvent (water-soluble matrix, oil-soluble matrix), penetration enhancer, moisturizer and preservative into oil phase and water phase, heats the water phase and oil phase to 75-85° C. respectively according to the formula amount, adds the oil phase into the water phase while hot and stirs, and cools under stirring at room temperature, thereby preparing the cream. The preparation method of the cream of the present invention is simple in process and easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Observation of pathological sections of the back skin of guinea pigs in each group (100х);

[0029] Among them: A: blank group; B: model group; C: dexamethasone acetate cream; D: paeonol ointment group; E: MDP cream-high concentration group; F: MDP cream-medium concentration group; G: MDP cream-low concentration group. DETAILED DESCRIPTION

[0030] In the present invention, unless otherwise specified, the proportion or weight of each component refers to dry weight.

[0031] In the present invention, unless otherwise specified, the embodiments and preferred embodiments can be combined with each other to form a new technical solution.

[0032] In the present invention, unless otherwise specified, the preparation steps may be performed sequentially or randomly, but are preferably performed sequentially.

[0033] Through the following examples, the subject matter of the present invention and the excellent results achieved by the invention can be better understood. The described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other implementation methods obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0034] Example 1

[0035] A peony bark extract cream comprises, by mass percentage, 20% of peony bark extract, 7.5% of stearic acid, 3% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 3% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethyl paraben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder being water.

[0036] The preparation method of the emulsifiable paste is:

[0037] (1) According to the formula, the peony bark extract, triethanolamine, moisturizer, preservative, stabilizer and water are heated and stirred at 85° C. to dissolve them to prepare an aqueous phase for later use.

[0038] (2) Heat and stir stearic acid, glyceryl monostearate, vaseline, and liquid paraffin at 85° C. to dissolve them according to the formula to prepare an oil phase for later use.

[0039] (3) The oil phase was added to the water phase while hot, and homogenized at a speed of 10000 r / min for 5 min. Then, the mixture was stirred with a glass rod and cooled to room temperature to obtain a peony bark extract cream.

[0040] Wherein, the peony bark extract is obtained by the following method:

[0041] Weigh the peony bark slices, add 10 times the amount of 75% (v / v) ethanol, reflux and extract for 1 hour, extract twice, filter, combine the filtrates of the two extractions, recover the ethanol under reduced pressure at 40°C, and then extract with ethyl acetate. After recovering the ethyl acetate, dry the extract for 72 hours to obtain a dry extract.

[0042] The peony bark extract cream prepared in this example can be used to treat eczema. Usage and dosage: Apply the cream evenly to the affected area twice a day.

[0043] Example 2

[0044] A peony bark extract cream, comprising, by weight percentage:

[0045] Peony bark extract 20%, stearic acid 7.5%, glyceryl monostearate 5%, vaseline 7.5%, liquid paraffin 4%, triethanolamine 4%, moisturizer glycerin 10%, preservative ethylparaben 0.05%, stabilizer xanthan gum 0.1%, and the rest is water.

[0046] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0047] Example 3

[0048] The invention discloses a peony bark extract cream, which comprises, by weight percentage, 20% of peony bark extract, 10% of stearic acid, 3% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 4% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethylparaben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder of water.

[0049] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0050] Example 4

[0051] A peony bark extract cream comprises, by mass percentage, 20% of peony bark extract, 10% of stearic acid, 5% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 5% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethyl paraben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder being water.

[0052] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0053] Example 5

[0054] The invention discloses a peony bark extract cream, which comprises, by weight percentage, 20% of peony bark extract, 10% of stearic acid, 7% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 3% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethyl paraben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder of water.

[0055] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0056] Example 6

[0057] The invention discloses a peony bark extract cream, which comprises, by weight percentage, 20% of peony bark extract, 12.5% ​​of stearic acid, 3% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 5% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethylparaben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder of water.

[0058] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0059] Example 7

[0060] The invention discloses a peony bark extract cream, which comprises, by weight percentage, 20% of peony bark extract, 12.5% ​​of stearic acid, 5% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 3% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethylparaben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder of water.

[0061] The preparation methods of the Paeonia suffruticosa Andrews extract and cream are the same as those in Example 1, and the Paeonia suffruticosa Andrews extract cream is obtained.

[0062] Example 8

[0063] The invention discloses a peony bark extract cream, which comprises, by weight percentage, 20% of peony bark extract, 12.5% ​​of stearic acid, 7% of glyceryl monostearate, 5% of vaseline, 4% of liquid paraffin, 4% of triethanolamine, 10% of glycerol as a moisturizer, 0.05% of ethylparaben as a preservative, 0.1% of xanthan gum as a stabilizer, and the remainder of water.

[0064] The preparation method of the cream is the same as that of Example 1, and the Paeonia suffruticosa root extract cream is obtained.

[0065] Example 9 Quality inspection of Paeonia suffruticosa extract cream

[0066] The characteristic evaluation indexes of the peony bark extract cream for external use for eczema prepared in the embodiment of the present invention, and the specific evaluation criteria are shown in Table 1.

[0067] Table 1 Scoring criteria for peony bark extract cream

[0068]

[0069] The characteristic inspection scores of the peony bark extract cream for external use on eczema prepared in Examples 1-8 are shown in Table 2:

[0070] Table 2 Scores of characteristics of different eczema topical creams

[0071]

[0072]

[0073] As shown in Table 2, the scores of the characteristic inspection of the eczema topical creams prepared in Example 1 and Example 2 are similar, the prepared creams are uniform, delicate and shiny, and have better spreadability and stability. Example 2 is better than Example 1.

[0074] Example 10 Investigation of in vitro transdermal behavior of different penetration enhancers of Paeonia suffruticosa extract cream

[0075] 1. Experimental instruments and materials

[0076] 1.1 Experimental Instruments

[0077] 1 / 100,000 electronic analytical balance (Mettler Toledo Technology Co., Ltd., model: CP225D); 1 / 10,000 electronic balance (Mettler Toledo Technology (China) Co., Ltd., model: YTJ-05-001); desktop CNC ultrasonic cleaner (Dongguan Keqiao Ultrasonic Equipment Co., Ltd., model: KQ-300DE); Agilent 1260 Infinity II high performance liquid chromatograph (Agilent Technologies Co., Ltd.); C0720 Franz diffusion cell (Shanghai Kaikai Technology and Trading Co., Ltd.); TK-12D transdermal diffusion instrument (Shanghai Kaikai Technology and Trading Co., Ltd.).

[0078] 1.2 Experimental Materials

[0079] Self-prepared preparation of Paeonia suffruticosa cream (MDP cream prepared in Example 2 (without penetration enhancer), MDP cream with 5% menthol added to the formula of Example 2 (5%-menthol), MDP cream with 5% borneol added to the formula of Example 2 (5%-borneol)); MDP extract (prepared in-house according to the preparation method of Paeonia suffruticosa extract in Example 1); ethanol (chromatographic grade, Merck, batch number: 20220531); sodium chloride (analytical grade, Guangdong Guanghua Technology Co., Ltd., batch number: 20200105); 0.45 μm nylon membrane (Shimadzu Laboratory Equipment Co., Ltd.).

[0080] 2. Methods and Results

[0081] Add pure water to the transdermal tester, heat to 32±0.5℃, and adjust the magnetic stirring speed to 200r / min. Spread the prepared abdominal mouse skin flat on the Franz diffusion cell and fix it so that the outer epidermis faces upward and the inner epidermis faces downward. Apply the sample to the epidermis, seal the port of the receiving cell with a sealing film to prevent the solvent from evaporating, fill the receiving cell with 30% (v / v) ethanol saline (pay attention to exhaust the bubbles in the receiving cell), take 7.0mL of the receiving solution at 2, 4, 6, 8, and 12, and then add 7.0mL of the receiving solution. Make 3 copies in parallel for each group, filter the receiving solution with a 0.45μm microporous filter membrane for liquid phase content determination, and calculate the cumulative transdermal amount (Q) and cumulative transdermal rate (L) of paeonol, paeoniflorin, and benzoylpeoniflorin. The calculation formula is as follows:

[0082] Cumulative transdermal volume

[0083] Cumulative transdermal rate L = Q / m × 100%

[0084] Cn is the measured concentration of the nth sample, V is the volume of the receiving medium in the receiving pool, Vi is the sampling volume, Ci is the measured concentration of the n-1th sample, S is the effective release area; m is the drug content in the sample.

[0085] Table 3 Effects of different ratios of penetration enhancers on the in vitro transdermal properties of paeonol cream (n=3)

[0086]

[0087]

[0088] Table 4 Effects of different ratios of penetration enhancers on the in vitro transdermal properties of paeoniflorin cream (n=3)

[0089]

[0090] Table 5 Effects of different ratios of penetration enhancers on the in vitro transdermal properties of benzoylpeonidin cream (n=3)

[0091]

[0092] It can be seen from Tables 3, 4 and 5 that the permeation rates of each group increased, indicating that menthol and borneol can promote the transdermal absorption of MDP to a certain extent. Compared with no permeation enhancer, different proportions of menthol and borneol have certain permeation-enhancing effects. The larger the proportion, the better the permeation-enhancing effect. Among them, 5%-menthol has the most obvious permeation-enhancing effect on MDP cream. After 12 hours of permeation, the cumulative permeation rates of benzoylpeonidin, paeoniflorin and paeonol in MDP cream are 33.29%, 15.49% and 15.17%, respectively. Therefore, 5% BHC is selected as the permeation enhancer of MDP cream.

[0093] Example 11 Determination of content of Paeonia suffruticosa extract cream

[0094] 1.0 g of the MDP cream prepared in Example 2 was taken from three batches and placed in a beaker. 10 mL of methanol was added and ultrasonically treated for 30 min. The supernatant was taken and filtered. The contents of paeonol, paeoniflorin, and benzoylpeoniflorin in the three batches of peony bark extract cream were determined. The experimental results are shown in Table 6:

[0095] Table 6 Determination results of paeonol, paeoniflorin and benzoylpeoniflorin in peony bark extract cream

[0096]

[0097]

[0098] The contents of paeonol, benzoylpeonidin and paeoniflorin in three batches of MDP cream were measured, and the results are shown in Table 6. The average content of paeonol in MDP cream was 4.23±0.06%, the average content of paeoniflorin was 1.84±0.01%, and the average content of benzoylpeoniflorin was 0.92±0.02%.

[0099] Example 12 Experimental Example

[0100] 42 healthy guinea pigs were selected and raised for 3 days to adapt to the environment. Six guinea pigs were randomly selected as blank groups (Blank), and the rest of the guinea pigs were used for modeling, including model group (Model), dexamethasone acetate group (Y1), paeonol ointment group (Y2), MDP cream-high concentration group (MDP cream prepared in Example 2, MDP-H), MDP cream-medium concentration group (the peony bark extract in the formula of Example 2 was adjusted to 10%, supplemented with water to 100%, and the contents of the other components remained unchanged, MDP-M), and MDP cream-low concentration group (the peony bark extract in the formula of Example 2 was adjusted to 5%, supplemented with water to 100%, and the contents of the other components remained unchanged, MDP-L). The backs of the guinea pigs were depilated 1 day before the experiment. On the 1st and 2nd days after the start of the experiment, except for the blank group, the backs of the guinea pigs in the other groups were sensitized with 100 μL 5% DNCB solution, and the blank group was treated with 100 μL acetone-olive oil (3:1, v:v) solution. On the 8th, 12th and 16th days after the start of the experiment, except for the blank group, the ears of the remaining guinea pigs were sensitized with 20 μL of 0.5% DNCB solution for three times. The guinea pigs were raised normally during this period. Starting from the 4th day, each group was treated with dexamethasone acetate cream, paeonol cream, and MDP cream of different concentrations, while the blank group was treated with blank matrix cream and the model group was not treated. This treatment process lasted for 13 days. Twelve hours after the last administration, the guinea pigs were killed for subsequent testing and analysis.

[0101] (I) Skin lesion scoring method

[0102] After each administration, the changes in the skin on the back of the guinea pigs were observed and recorded, and scored according to Table 7 below. Half a grade, i.e. 0.5, was recorded between the scores of various symptoms. The results of the skin lesion scoring experiment are shown in Table 8.

[0103] Table 7 Skin lesion scoring table

[0104]

[0105] Example 8 Skin lesion scoring experimental results

[0106]

[0107] Note: Blank: blank group; Model: model group; Y1: dexamethasone acetate cream; Y2: paeonol ointment group; MDP-H: MDP cream-high concentration group; MDP-M: MDP cream-medium concentration group; MDP-L: MDP cream-low concentration group; Compared with the blank group, the model group: ## p<0.01, # p<0.05; compared with the model group: **p<0.01, *p<0.05

[0108] In the initial stage of the experiment, except for the blank group, the skin lesions on the backs of all guinea pigs participating in the experiment showed similar severity, including redness and swelling, scabs, and visible scratches. After 4 days of drug treatment, the skin lesion scores of the guinea pigs on the backs of the drug-treated groups began to show a significant downward trend, which was in sharp contrast to the model group without drug treatment. After 8 days of medication, the skin lesion scores of the guinea pigs in the dexamethasone acetate cream group, the paeonol ointment group, the MDP cream-high concentration group, and the MDP cream-medium concentration group decreased significantly. After 13 days of medication, there were significant differences in the skin lesion scores between the dexamethasone acetate cream group and the MDP cream-medium concentration group and the paeonol ointment group (p<0.05), and there was no significant difference in the skin lesion scores between the dexamethasone acetate cream group and the MDP cream-high concentration group (p>0.05). In addition, Figure 1 It can be seen that the recovery effect of the dexamethasone acetate cream group and the MDP cream-high concentration group was better than that of the paeonol ointment group. It further shows that the MDP-high concentration cream and dexamethasone acetate cream have better therapeutic effects on eczema, while the paeonol ointment has a relatively poor therapeutic effect on eczema.

[0109] (II) Determination of guinea pig ear swelling

[0110] 12 hours after the last administration, the guinea pigs were killed, their ears were collected, and their left and right ears were weighed using an electronic balance to calculate the degree of swelling. The experimental results are shown in Table 9.

[0111] Ear swelling = right ear weight - left ear weight

[0112] Table 9 Guinea pig ear swelling test results

[0113]

[0114] As shown in Table 9, the swelling degree of the model group increased significantly compared with the blank group (p < 0.01), indicating that the model was successfully established. Compared with the model group, the MDP cream-high concentration group and the MDP cream-medium concentration group can significantly reduce the swelling degree of the guinea pig ears (p < 0.01), and the MDP cream-low concentration has a certain inhibitory effect on the swelling of the guinea pig ears. The results show that different concentrations of MDP cream have a good inhibitory effect on the swelling degree of the guinea pig ears and have a good anti-inflammatory effect. Among them, the MDP cream-high concentration group has the best inhibitory effect. As shown in Table 9, the dexamethasone acetate cream group and the MDP cream-high concentration group have the lowest ear swelling degree and the best effect. There was a significant difference between the dexamethasone acetate cream group and the paeonol ointment group (p<0.05), and there was no significant difference between the dexamethasone acetate cream group and the MDP cream-high concentration group (p>0.05), indicating that MDP-high concentration cream and dexamethasone acetate cream have better therapeutic effects on eczema, while paeonol ointment has a poorer therapeutic effect on eczema.

[0115] (III) Determination of thymus and spleen index

[0116] After the guinea pigs were killed, the thymus and spleen of the guinea pigs were completely separated, and the blood stains on the surface were removed. Their weights were recorded, and the thymus index and spleen index were calculated according to the following formula. The test results are shown in Table 10.

[0117]

[0118] Table 10 Thymus and spleen index determination experimental results

[0119]

[0120] As shown in Table 10, the spleen index and thymus index of the guinea pigs in the model group increased significantly compared with the blank group (p < 0.01), and the model was successfully established. At the same time, compared with the model group, the spleen index and thymus index of the guinea pigs in the drug-treated group decreased, indicating that the inflammation of the guinea pigs was effectively treated. In each drug-treated group, the dexamethasone acetate cream group, the paeonol ointment group, and the MDP cream-high concentration group can significantly reduce the spleen index (p < 0.01) and thymus index (p < 0.01) of the guinea pigs; the MDP cream-medium concentration group significantly reduced the spleen index (p < 0.05) and thymus index (p < 0.05) of the guinea pigs; the MDP cream-low concentration group had no significant difference compared with the model group (p > 0.05), but there was still a certain downward trend, indicating that different concentrations of MDP cream can reduce the organ index increased by eczema. As shown in Table 10, compared with the model group, the organ index of the dexamethasone acetate cream group and the MDP cream-high concentration group was the lowest, and there was a significant difference between the MDP cream-high concentration group and the paeonol ointment group (p<0.05), and there was no significant difference between the dexamethasone acetate cream group and the MDP cream-high concentration group (p>0.05), which showed that the MDP-high concentration cream and dexamethasone acetate cream had a better therapeutic effect on eczema, while the paeonol ointment had a relatively poor therapeutic effect on eczema. The experimental results revealed that DNCB caused damage to the immune organs of guinea pigs, and this damage was significantly improved when MDP cream was used for treatment.

[0121] (IV) HE staining

[0122] After removing excess water from the skin, the skin was weighed and then fixed with 4% paraformaldehyde (commercially available) for 24 hours. Then, after dehydration and paraffin embedding, 4 μm sections were made and HE staining was performed. Finally, the sections were observed under a microscope and photographed.

[0123] Experimental results: After the pathological sections of the guinea pig back skin tissue were stained with HE, the results were as follows: Figure 1As shown. Compared with the blank group, the epidermis of the back skin of the guinea pigs in the model group showed significant hyperplasia, and the epidermis was significantly thickened. Obvious cell edema was observed inside the cells and in the intercellular space, and a large number of inflammatory cells gathered around the blood vessels in the dermis, showing the typical pathological characteristics of acute eczema as a whole, and the model was successfully established. Compared with the model group, the dexamethasone acetate group and the paeonol ointment group showed significant improvements in epidermal thickening, skin edema, and dermal inflammatory cell infiltration. In addition, the epidermal thickness of the high and medium concentration groups of the peony bark extract cream was significantly lower than that of the model group, and the edema phenomenon and the infiltration of inflammatory cells were also significantly improved. The peony bark extract cream-low concentration group also had a certain inhibitory effect on the increase in the thickness of the epidermis and dermis. This shows that the peony bark extract cream has a significant alleviating effect on skin edema and inflammation caused by eczema.

[0124] It can be seen from the above experimental results that the Chinese medicine composition cream provided by the present invention has a good therapeutic effect on eczema.

[0125] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. A person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A peony bark extract cream, characterized in that: Calculated by mass percentage, the peony bark extract cream contains the following raw materials and auxiliary materials: peony bark extract 1%-25%, stearic acid 1%-15%, glyceryl monostearate 1%-15%, vaseline 5%-10%, liquid paraffin 1%-5%, triethanolamine 2%-6%, moisturizer 2%-15%, preservative 0.01%-0.1%, stabilizer 0.01%-1%, and the rest is water.

2. The peony bark extract cream according to claim 1, characterized in that Calculated by mass percentage, the peony bark extract cream contains the following raw materials and auxiliary materials: peony bark extract 5%-25%, stearic acid 2.5%-12.5%, glyceryl monostearate 1%-9%, vaseline 6%-8%, liquid paraffin 3%-5%, triethanolamine 3%-5%, moisturizer 5%-15%, preservative 0.05%, stabilizer 0.1%, and the rest is water.

3. The peony bark extract cream according to claim 2, characterized in that Calculated by mass percentage, the peony bark extract cream contains the following raw materials and auxiliary materials: 20% of peony bark extract, 7.5% of stearic acid, 5% of glyceryl monostearate, 7.5% of vaseline, 4% of liquid paraffin, 4% of triethanolamine, 10% of moisturizer, 0.05% of preservative, 0.1% of stabilizer, and the rest is water.

4. The Paeonia suffruticosa moutan extract cream according to claim 1, 2 or 3, characterized in that: The peony bark extract cream also contains a penetration enhancer.

5. The Paeonia suffruticosa Andrews extract cream according to claim 1, 2 or 3, characterized in that: The moisturizer is at least one of glycerin, propylene glycol and sodium hyaluronate; the preservative is at least one of sodium benzoate, ethylparaben, ethylparaben and potassium sorbate; and the stabilizer is at least one of sodium carboxymethylcellulose, sodium alginate and xanthan gum.

6. The Paeonia suffruticosa Andrews extract cream according to claim 4, characterized in that The penetration enhancer is at least one of borneol, menthol and azone.

7. The Paeonia suffruticosa Andrews extract cream according to claim 1, 2 or 3, characterized in that: The preparation method of the peony bark extract is as follows: weighing peony bark slices, adding 8-15 times the amount of 75% ethanol for reflux extraction for 0.5-2h, extracting 1-3 times, filtering, combining the filtrate, recovering ethanol under reduced pressure at 30-50°C, and then extracting with ethyl acetate, after recovering the ethyl acetate, drying the extract to obtain a dry extract.

8. The method for preparing the Paeonia suffruticosa Andrews extract cream according to any one of claims 1 to 7, characterized in that: The following steps are involved: (1) heating and stirring the peony bark extract, triethanolamine, a moisturizer, a preservative, a stabilizer, and water according to the formula amount to dissolve them to prepare an aqueous phase; (2) taking stearic acid, glyceryl monostearate, vaseline, and liquid paraffin according to the formula, heating and stirring to dissolve them, and preparing an oil phase; (3) The oil phase is added to the water phase while hot, homogenized at a speed of 10,000 to 15,000 r / min for 4 to 7 minutes, and then stirred and cooled to room temperature to obtain a peony bark extract cream.

9. The method according to claim 8, characterized in that In step (1), the heating temperature is 75-85°C; in step (2), the heating temperature is 75-85°C.

10. Use of the Paeonia suffruticosa Andrews extract cream according to any one of claims 1 to 7 in the preparation of a medicament for treating eczema.

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