Cream for treating eczema and preparation method thereof

Abstract

The invention discloses emulsifiable paste for treating eczema and a preparation method thereof, and belongs to the technical field of medical application. The preparation method of the emulsifiable paste for treating eczema comprises the following steps: preparing an oil phase: melting caprylic / capric triglyceride, olive oil, beewax and polyglycerol to obtain the oil phase; preparing a water phase: dissolving glycerol, phloretin, acorus calamus extract and zinc acetate in a solvent to obtain the water phase; emulsifying: adding the preheated water phase into the oil phase to form primary emulsion, and then adding beewax for thickening to obtain the cream for treating eczema. The purpose of treating eczema is achieved through transdermal drug delivery of the medicine, the main components are extracted from plants, hormones are not added, toxic and side effects are avoided, and a new choice is provided for clinically treating eczema and relieving various symptoms caused by eczema.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical application, and more particularly to a cream for treating eczema and a preparation method thereof. BACKGROUND

[0002] Eczema is a common inflammatory skin disease of epidermis and superficial dermis caused by various internal and external factors, and is generally believed to have certain relationship with allergy. The skin rash is polymorphic, symmetrically distributed, and has obvious itching and chronic course. Eczema is prone to recurrence, which seriously affects the quality of life of patients. Patients often have allergic diseases such as allergic rhinitis and asthma. The cause of eczema is not clear, and it is related to internal and external factors, social psychological factors, etc. Heredity is the most important factor in determining whether a person is allergic, and many eczema patients have varying degrees of genetic factors, of which the most typical is atopic eczema (genetically allergic dermatitis or atopic dermatitis). Studies have found that 70% of children born to parents with atopic (genetically allergic) constitution will have atopic eczema, and if one party has atopic constitution, 50% of the children will be affected. The prevalence rate of the general population in China is about 3-5%, and that of children can be as high as 10-20%.

[0003] The common eczema treatment drugs on the market at present include calcineurin inhibitors, glucocorticoids and antihistamines, etc., but all have certain side effects and are prone to drug resistance. Therefore, for some chronic disease patients, traditional Chinese medicine may have better advantages in long-term disease control and prevention of disease aggravation. SUMMARY

[0004] The purpose of the present application is to provide a cream for treating eczema and a preparation method thereof to solve the problems existing in the prior art.

[0005] To achieve the above purpose, the present application provides the following solutions.

[0006] One of the technical solutions of the present application provides a preparation method of a cream for treating eczema, comprising the following steps:

[0007] Oil phase preparation: melt treating caprylic acid / capric acid triglyceride, olive oil, beeswax and polyglycerol to obtain the oil phase;

[0008] Water phase preparation: dissolving glycerol, phloretin and zinc acetate in a solvent to obtain the water phase;

[0009] Emulsification: adding the preheated water phase into the oil phase to form a primary emulsion, then adding beeswax thickening to obtain the cream for treating eczema.

[0010] Preferably, the water phase preparation process further comprises the addition of the Acorus calamus extract, specifically comprising: dissolving glycerol, phloretin, Acorus calamus extract and zinc acetate in a solvent to obtain the water phase.

[0011] Preferably, the octanoic acid / decanoic acid triglyceride, olive oil, beeswax and polyglycerol are used in a ratio of 7.5-10 mL:22.5-27 mL:0.4-0.6 g:0.5-2.5 mL.

[0012] Preferably, the temperature of the melting treatment is 74-76℃.

[0013] Preferably, the solvent is composed of propylene glycol and water in a volume ratio of 1-2.5:7.5-9.

[0014] Preferably, the glycerol, phloretin, Acorus calamus extract, zinc acetate and solvent are used in a ratio of 1-5 mL:0.1-0.5 g:0.5-1.25 g:0.25-1 g:10 mL.

[0015] Preferably, the temperature of the dissolving in the solvent is 74-76℃.

[0016] Preferably, the temperature of the preheating is 74-76℃.

[0017] Preferably, the emulsification comprises: adding the preheated water phase into the stirred oil phase to form a primary emulsion, and then adding beeswax thickening to obtain the eczema treatment cream; the stirring speed is 800 rpm.

[0018] Preferably, the total mass of the phloretin and Acorus calamus extract and the mass of the beeswax are in a ratio of 0.6-1.75:5.5-9.5.

[0019] The second technical solution of the present application provides the eczema treatment cream prepared by the preparation method.

[0020] The characteristics and effects of the raw materials in the present application are as follows:

[0021] Acorus calamus: pungent and bitter in nature, warm. It belongs to the heart and stomach channels. It has good therapeutic effect on rheumatoid arthritis, eczema, skin itching and other diseases, can drive wind and relieve itching, and relieve symptoms. It has the effect of detumescence and analgesia, and can promote local blood circulation, accelerate blood stasis and swelling subsides. The volatile oil contained in Acorus calamus has antibacterial and anti-inflammatory effects, can inhibit the growth of various bacteria, and has certain therapeutic effect on oral inflammation and skin diseases.

[0022] Zinc acetate: Zinc is one of the important trace elements in the human body, participating in the activity of more than 300 enzymes and playing an important role in skin metabolism, repair, and immune function. Zinc deficiency in the body can lead to dry, rough skin, and even skin problems such as eczema. Clinically, zinc oxide is only used as an adjunct treatment for eczema, but zinc acetate is simpler to prepare, cheaper, and can achieve the same effect of zinc supplementation.

[0023] Phloretin: Phloretin possesses extremely strong antioxidant properties, with an antioxidant concentration of 10-30 ppm in oils. It can scavenge free radicals in the skin. Free radicals are harmful substances produced by oxidation reactions and are associated with degenerative diseases. Topical application can prevent sugar components from entering epidermal cells, thereby inhibiting excessive secretion from sebaceous glands and treating acne caused by excessive secretion. Studies have shown that under the action of phloretin, the release of NO from macrophages significantly decreases under the stimulation of lipopolysaccharide and IFN-γ; the phagocytic rate of macrophages also significantly decreases under the action of phloretin. Therefore, phloretin has potential anti-inflammatory effects.

[0024] Olive oil is a natural skincare product that provides deep hydration, especially effective for dry skin. It can prevent symptoms such as redness, stinging, dryness, and flaking. Furthermore, olive oil is rich in vitamins, natural and without side effects, and can quickly make the skin soft and supple. Olive oil helps repair damaged skin, promotes wound healing, and can form a protective film on the skin's surface to prevent moisture loss and protect the skin from environmental damage.

[0025] Furthermore, glycerin is primarily used to absorb moisture from the air, maintaining skin hydration. Due to its hydrophilic nature, glycerin acts as a moisturizer to help the skin retain moisture and prevent dryness. Glycerin is absorbed extremely quickly, acting as a solubilizer to rapidly help medications penetrate the skin. In addition, glycerin has good breathability and will not form an overly greasy film on the skin surface, so it will not feel stuffy or suffocating after use. In contrast, petrolatum, commonly used in clinical practice, has high occlusive properties, feels greasy and suffocating when used, and has slow drug absorption efficiency.

[0026] The present invention discloses the following technical effects:

[0027] 1. This invention does not contain any hormones, has no toxic side effects, and there is no need to worry about developing drug resistance.

[0028] 2. The formula of this invention is simple, the raw materials are widely available, the production cost is low, and it is easy to promote.

[0029] 3. This invention has a significant moisturizing effect on various skin types, and it is absorbed faster and feels better on the skin compared to traditional skin medications. Attached Figure Description

[0030] Figure 1 The dorsal morphology of mice in different treatment groups in the experimental case;

[0031] Figure 2 The ear morphology of mice in different treatment groups in the experimental case;

[0032] Figure 3 HE staining results of the backs of mice in different treatment groups in the experimental case;

[0033] Figure 4 HE staining results of mice ears from different treatment groups in the experimental case. Detailed Implementation

[0034] This invention provides a method for preparing a cream for treating eczema, comprising the following steps:

[0035] Oil phase preparation: Caprylic / capric triglyceride, olive oil, beeswax and polyglycerol are melt-treated to obtain the oil phase;

[0036] Aqueous phase preparation: Glycerol, phloretin, and zinc acetate were dissolved in a solvent to obtain the aqueous phase;

[0037] Emulsification: The preheated aqueous phase is added to the oil phase to form a primary emulsion, and then beeswax is added to thicken it to obtain the cream for treating eczema.

[0038] In this invention, the aqueous phase preparation process also includes the addition of calamus extract, specifically including: dissolving glycerol, phloretin, calamus extract and zinc acetate in a solvent to obtain the aqueous phase.

[0039] In this invention, the preferred ratio of caprylic / capric triglyceride, olive oil, beeswax and polyglycerol is 7.5~10mL:22.5~27mL:0.4~0.6g:0.5~2.5mL, and more preferably 10mL:23mL:0.5g:2mL.

[0040] In this invention, the temperature of the melting treatment is preferably 74~76°C, and more preferably 74°C.

[0041] In this invention, the solvent is preferably composed of propylene glycol and water in a volume ratio of 1~2.5:7.5~9, and more preferably composed of propylene glycol and water in a volume ratio of 2.5:7.5.

[0042] In this invention, the preferred ratio of glycerol, phloretin, calamus extract, zinc acetate and solvent is 1~5mL:0.1~0.5g:0.5~1.25g:0.25~1g:10mL, and more preferably 5mL:0.5g:1.25g:1g:10mL.

[0043] In this invention, the dissolution temperature in the solvent is preferably 74~76°C, and more preferably 74°C.

[0044] In this invention, the preheating temperature is preferably 74~76℃, and more preferably 74℃.

[0045] In this invention, the emulsification includes: adding a preheated aqueous phase to a stirred oil phase to form a primary emulsion, then adding beeswax to thicken it, to obtain the cream for treating eczema; the stirring speed is 800 rpm.

[0046] In this invention, the preferred mass ratio of the total mass of phloretin and calamus extract to beeswax is 0.6~1.75:5.5~9.5.

[0047] The present invention also provides a cream for treating eczema prepared by the above preparation method.

[0048] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0049] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0050] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0051] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0052] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0053] It should be noted that any aspects not described in detail in this invention are conventional practices in the field and are not the focus of this invention.

[0054] Unless otherwise specified, all raw materials used in the following embodiments of the present invention are commercially available products, and the source of commercially available products does not affect the technical effect of the present invention.

[0055] Example 1

[0056] This embodiment provides a method for preparing a cream for treating eczema:

[0057] 1. Preparation of the oil phase:

[0058] Add 9 mL of GTCC (caprylic / capric triglyceride), 25 mL of olive oil, 0.5 g of beeswax, and 2 mL of polyglycerol to a clean beaker and melt them completely and evenly at 74°C.

[0059] 2. Preparation of the aqueous phase:

[0060] Add 4 mL of glycerin, 0.1 g of phloretin, 1.25 g of calamus extract, and 0.5 g of zinc acetate to a clean beaker, stir well, then add 2.5 mL of propylene glycol and 7.5 mL of distilled water, and cook at 74 °C until completely dissolved and clear.

[0061] 3. Mixing and emulsification:

[0062] The preheated aqueous phase (74°C) is slowly added to the oil phase, which is stirred at a high speed of 800 rpm. The addition of the aqueous phase should be slow to maintain high shear force, forming a primary emulsion. Finally, a clear water-in-oil emulsion is obtained. Then, 6g of beeswax is added and stirred to thicken it, resulting in a cream for treating eczema.

[0063] Example 2

[0064] This embodiment provides a method for preparing a cream for treating eczema:

[0065] 1. Preparation of the oil phase:

[0066] Add 10 mL of GTCC (caprylic / capric triglyceride), 23 mL of olive oil, 0.5 g of beeswax, and 2 mL of polyglycerol to a clean beaker and melt them completely and evenly at 75°C.

[0067] 2. Preparation of the aqueous phase:

[0068] Add 5 mL of glycerin, 0.25 g of phloretin, 1.25 g of calamus extract, and 0.5 g of zinc acetate to a clean beaker, stir well, then add 2.5 mL of propylene glycol and 7.5 mL of distilled water, and cook at 74 °C until completely dissolved and clear.

[0069] 3. Mixing and emulsification:

[0070] The preheated aqueous phase (74°C) is slowly added to the oil phase, which is stirred at a high speed of 800 rpm. The addition of the aqueous phase should be slow to maintain high shear force, forming a primary emulsion. Finally, a clear water-in-oil emulsion is obtained. Then, 6g of beeswax is added and stirred to thicken it, resulting in a cream for treating eczema.

[0071] Example 3

[0072] This embodiment provides a method for preparing a cream for treating eczema:

[0073] 1. Preparation of the oil phase:

[0074] Add 10 mL of GTCC (caprylic / capric triglyceride), 23 mL of olive oil, 0.4 g of beeswax, and 2 mL of polyglycerol to a clean beaker and melt them completely and evenly at 74 °C.

[0075] 2. Preparation of the aqueous phase:

[0076] Add 5 mL of glycerin, 0.5 g of phloretin, 1.25 g of calamus extract, and 0.5 g of zinc acetate to a clean beaker, stir well, then add 2.5 mL of propylene glycol and 7.5 mL of distilled water, and cook at 75 °C until completely dissolved and clear.

[0077] 3. Mixing and emulsification:

[0078] The preheated aqueous phase (75°C) is slowly added to the oil phase, which is stirred at a high speed of 800 rpm. The addition of the aqueous phase should be slow to maintain high shear force, forming a primary emulsion. Finally, a clear water-in-oil emulsion is obtained. Then, 6g of beeswax is added and stirred to thicken it, resulting in a cream for treating eczema.

[0079] Comparative Example 1

[0080] Same as Example 3, except that the addition of zinc acetate is omitted.

[0081] Comparative Example 2

[0082] Same as Example 3, except that the addition of calamus extract was omitted.

[0083] Comparative Example 3

[0084] Same as Example 3, except that the addition of phloretin is omitted.

[0085] Comparative Example 4

[0086] Same as Example 3, except that the addition of olive oil is omitted.

[0087] Experimental Example

[0088] 1. Experimental Materials

[0089] 1.1 Experimental Subjects

[0090] Eight-week-old female bal / BC mice, weighing 18-22g.

[0091] Husbandry conditions: After arriving at the laboratory, males and females were separated, with 5 mice per cage. Mice were put into service after 3 days and managed by designated personnel. The laboratory had ample lighting, good ventilation and air conditioning, with the room temperature controlled at 20-25℃ and humidity at 55-65%.

[0092] The laboratory is disinfected regularly according to standard procedures.

[0093] 1.2 Drugs

[0094] Take the creams prepared in Example 3 and Comparative Examples 1-4.

[0095] 2. Methods and Results

[0096] Effects of cream on experimental eczema model:

[0097] Twenty-four healthy mice, weighing 18-22g, were selected and randomly divided into eight groups of four mice each.

[0098] The negative control group was given excipients at a dose of 20 μg / cm³. 2 Once daily;

[0099] The model control group was given excipients at a dosage of 20 μg / cm³. 2 Once daily;

[0100] The positive control group received dexamethasone cream at a dosage of 20 μg / cm³. 2 Once daily;

[0101] Comparative Example 1: The cream prepared in Comparative Example 1 was applied at a rate of 20 μg / cm³. 2 Once daily;

[0102] Comparative Example 2: The cream prepared in Comparative Example 2 was applied at a rate of 20 μg / cm³. 2 Once daily;

[0103] In Example 3, the cream prepared in Example 3 was used at a dosage of 20 μg / cm³. 2 Once daily;

[0104] Comparative Example 3: The cream prepared in Comparative Example 3 was applied at a rate of 20 μg / cm³. 2 Once daily;

[0105] Comparative Example 4: The cream prepared in Comparative Example 4 was applied at a rate of 20 μg / cm³. 2 Once daily.

[0106] Except for the negative control group, the backs and ears of mice in the other groups were shaved, and the hair was applied at 20 μg / cm². 2 The mice were sensitized by topical application of 5% phthalic anhydride, and administration was initiated on the back of the mice 7 days later at a dose of 20 μg / cm². 2 The medication was administered once daily for 7 days. Phenotypic changes were observed visually 24 hours after the last administration. Results Figure 1 and Figure 2 As shown.

[0107] Depend on Figure 1 It was observed that in the model group, erythema and edema gradually appeared on the backs of mice, vasodilation was obvious in both ears, the average thickness increased significantly, and dryness and crusting phenotypes appeared on both backs and ears. After 7 days of use of the compound cream of this invention, the damage and ear thickness in the phthalic anhydride-induced eczema model were significantly reduced.

[0108] Depend on Figure 2 It was observed that in the model group, erythema and edema gradually appeared on the backs of mice, vasodilation was obvious in both ears, the average thickness increased significantly, and dryness and crusting phenotypes appeared on both backs and ears. After 7 days of use of the compound cream of this invention, the damage and ear thickness in the phthalic anhydride-induced eczema model were significantly reduced.

[0109] Back tissue samples were taken and prepared for pathological examination. The results of hematoxylin-eosin staining (HE staining) are as follows: Figure 3 and Figure 4 As shown.

[0110] Depend on Figure 3 and Figure 4 It is known that keratinocytes in normal skin are densely packed, regularly shaped, and have clear lines. After the application of phthalic anhydride, keratinocytes shed significantly, the stratum corneum lines become blurred, and mast cell infiltration increases. Compared with the model control group, the compound cream of this invention inhibited the occurrence and development of experimental eczema in mice, reduced swelling on the back and ears, decreased abnormal proliferation of epidermal cells, and significantly improved epidermal thickness and mast cell infiltration. The keratinocyte shedding phenomenon was inhibited, suggesting that the compound cream of this invention has an anti-experimental eczema effect in mice. Dexamethasone, a commonly used positive control drug in clinical practice, can also inhibit the occurrence and development of experimental eczema in mice. However, dexamethasone is a steroid drug, and long-term use can lead to drug resistance and has certain side effects on patients.

[0111] This invention treats eczema through transdermal drug absorption, rapidly eliminating various symptoms such as itching, pain, and rashes. The addition of phloretin repairs the damaged immune system and enhances antioxidant and anti-inflammatory capabilities. Olive oil moisturizes and increases drug absorption efficiency, treating eczema at its root. The addition of zinc ions repairs the damaged immune system and strengthens the body's resistance. Glycerin increases breathability and drug absorption efficiency, treating eczema fundamentally and acting directly on the skin without toxic side effects. This provides a new option for clinical treatment of eczema and relief of its various symptoms.

[0112] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0113] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A method of preparing a cream for treating eczema, characterized by, The preparation method comprises the following steps: Oil phase preparation: melt treating caprylic triglyceride, olive oil, beeswax and polyglycerol to obtain the oil phase; Water phase preparation: dissolving glycerol, phloretin and zinc acetate in a solvent to obtain the water phase; Emulsification: adding the preheated water phase into the oil phase to form a primary emulsion, and then adding beeswax thickening to obtain the eczema treatment cream.

2. The production method according to claim 1, characterized by, The water phase preparation process further comprises adding acorus calamus extract, specifically comprising: dissolving glycerol, phloretin, acorus calamus extract and zinc acetate in a solvent to obtain the water phase.

3. The production method according to claim 2, characterized by, The caprylic triglyceride, olive oil, beeswax and polyglycerol are used in a ratio of 7.5-10 mL:22.5-27 mL:0.4-0.6 g:0.5-2.5 mL; and the melt treating temperature is 74-76℃.

4. The production method according to claim 2, characterized by, The solvent is composed of propylene glycol and water in a volume ratio of 1-2.5:7.5-9.

5. The preparation method according to claim 2, characterized in that, The glycerol, phloretin, acorus calamus extract, zinc acetate and solvent are used in a ratio of 1-5 mL:0.1-0.5 g:0.5-1.25 g:0.25-1 g:10 mL.

6. The preparation method according to claim 2, characterized in that, The temperature for dissolving in the solvent is 74-76℃.

7. The preparation method according to claim 2, characterized in that, The preheating temperature is 74-76℃.

8. The method of claim 2, wherein, The emulsification comprises: adding the preheated water phase into the stirring oil phase to form a primary emulsion, and then adding beeswax thickening to obtain the eczema treatment cream; and the stirring speed is 800 rpm.

9. The preparation method according to claim 2, characterized in that, The mass ratio of the total mass of phloretin and acorus calamus extract to the mass of beeswax is 0.6-1.75:5.5-9.

5.

10. The eczema treatment cream prepared by the preparation method of any one of claims 1-9.

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