CN116672352B - Pharmaceutical composition for eczema and application thereof - Google Patents

Pharmaceutical composition for eczema and application thereof Download PDF

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Publication number
CN116672352B
CN116672352B CN202310764358.0A CN202310764358A CN116672352B CN 116672352 B CN116672352 B CN 116672352B CN 202310764358 A CN202310764358 A CN 202310764358A CN 116672352 B CN116672352 B CN 116672352B
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eczema
percent
pharmaceutical composition
pharmaceutical
skin
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CN116672352A (en
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李慧贤
李炜俊
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Zhenkaer Cosmetics Co ltd
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Zhenkaer Cosmetics Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/886Aloeaceae (Aloe family), e.g. aloe vera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses a pharmaceutical composition for eczema and application thereof, and the pharmaceutical composition for eczema comprises the following components in percentage by mass: 1 to 6 percent of cetostearyl olive oleate, 1 to 6 percent of stearic acid, 1.01 to 10 percent of ginsenoside Rg, 0.01 to 5 percent of epigallocatechin gallate, 0.01 to 1 percent of quercetin, 0.5 to 6 percent of egg yolk oil, 0.5 to 8 percent of soybean oil, 0.5 to 8 percent of caprylic/capric triglyceride, 0.1 to 4 percent of evening primrose oil, 0.1 to 5 percent of shea butter, 0.1 to 6 percent of glycerol, 0.05 to 2 percent of carbomer, 0.5 to 8 percent of grapefruit seed extract, 0.1 to 5 percent of aloe extract, 0.1 to 5 percent of centella asiatica extract and the balance of pure water. The invention has obvious curative effect, no toxic or side effect, mild skin and no stimulation, and does not generate drug dependence.

Description

Pharmaceutical composition for eczema and application thereof
Technical Field
The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for eczema and application thereof.
Background
Subacute eczema and chronic eczema are common skin diseases, and belong to common inflammatory skin diseases of epidermis and dermis shallow layers caused by various internal and external factors. It features severe itching, polymorphic skin damage, symmetrical distribution, exudative tendency, chronic disease course and easy repeated attack, and can occur at any age, at any location and in any season, but often recurs or aggravates after winter. In recent years, the incidence of eczema is in an ascending trend, which is possibly related to climate environment change, application of a large number of quantitative products in life, mental stress, quickened life rhythm and dietary structure change. The symptoms of the eczema part can be classified into lower leg eczema, scrotum eczema, breast eczema, hand eczema, anus eczema, infantile facial eczema and the like according to the different symptoms of the eczema part.
The traditional Chinese medicine considers that the cause of eczema is the combination of internal dampness and external dampness, wherein the internal dampness is caused by diet loss, drinking or excessive eating of fishy and wind-driven products, the spleen and the stomach are injured, the spleen is not healthy and moves, and damp-heat is accumulated in the body; external dampness is exogenous wind-damp-heat evil, and internal and external evil are mutually paced and filled in the striae and striae, and the skin is immersed to cause acute eczema. Or the symptoms of weakness, spleen and stomach dampness, skin malnutrition, damp-heat accumulation for a long time, yin and blood consumption, dryness and wind generation, blood deficiency and wind dryness, skin misnail and lasting and non-healing, and subacute eczema or chronic eczema.
Epigallocatechin gallate EGCG is the most effective active ingredient in tea polyphenols, belonging to catechin. EGCG has antibacterial, antiviral, antioxidant, arteriosclerosis resisting, thrombosis resisting, vascular proliferation resisting, antiinflammatory, and antitumor effects.
Several studies have shown that EGCG and quercetin have synergistic antidiabetic effects on pancreatic β cells (Liu, et al, 2021), synergistic antiproliferative effects on prostate cancer cells (Wang, et al, 2012), and synergistic protective effects on periodontal connective tissue destruction in rats. (Yelins' ka & Kostenko, 2019) a study showed that multiple combinations of green tea extract, quercetin and folic acid appeared to prevent cell damage in a synergistic manner (Jeong, et al, 2005).
Studies have shown that quercetin and ginsenoside Rg1 independently and synergistically increase cell viability (Xu, et al, 2022), ginseng (containing ginsenoside Rg 1), quercetin and tea (containing EGCG) synergistically increase the chemotherapeutic efficacy of colorectal cancer.
Eczema patients have symptoms of itching, skin ulceration, red swelling, erosion and the like, and the eczema patients are very uncomfortable in occurrence. Western medicines are commonly used for treating eczema, steroid and other hormones are added, dependence can be generated on patients, and different side effects can be generated after long-term use. Some traditional Chinese medicine lotions claim to have the effect of treating eczema, but the effect is not ideal, and the problems of inconvenient administration and the like exist. Most of these herbs can only temporarily relieve itching and cannot be treated fundamentally.
At present, a medicinal composition with obvious curative effect for eczema and application thereof are lacking.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and aims to provide a medicinal composition for eczema based on ginsenoside, epigallocatechin gallate (EGCG) and quercetin with obvious curative effect and application thereof.
In order to achieve the purposes of the application, the technical scheme adopted by the invention is as follows: in a first aspect, the present invention provides a pharmaceutical composition for eczema; in a second aspect, the invention provides an application of a pharmaceutical composition for eczema in preparing a pharmaceutical preparation for eczema; in a third aspect, the invention provides a method for preparing a pharmaceutical preparation for eczema.
The first aspect of the invention provides a pharmaceutical composition for eczema, which comprises an oily component and an aqueous component, wherein the pharmaceutical composition for eczema comprises the following components in percentage by mass based on 100% of the total mass of the pharmaceutical composition for eczema:
The oily component comprises:
The aqueous component comprises:
further, the pharmaceutical composition for eczema consists of the following components in percentage by mass:
The oily component comprises:
The aqueous component comprises:
further, the mass ratio of the ginsenoside Rg1, the epigallocatechin gallate and the quercetin is 6:1:0.3.
Further, the mass ratio of ginsenoside Rg1, epigallocatechin gallate, quercetin, grapefruit seed extract and centella asiatica extract is 6:1:0.3:6:3.
The invention provides an application of a pharmaceutical composition for eczema in preparing a pharmaceutical preparation for eczema.
Further, the eczema pharmaceutical preparation comprises at least one of a solution, an emulsion or a paste.
The invention relates to an eczema pharmaceutical preparation, which comprises a pharmaceutical composition for eczema.
Further, the eczema pharmaceutical preparation comprises at least one of eczema emulsion, eczema emulsion or eczema ointment.
The preparation method of the eczema pharmaceutical preparation provided by the third aspect of the invention comprises the following steps:
Weighing the components of the pharmaceutical composition for eczema;
Heating the oily component to 65-75 ℃;
heating the aqueous component to 65-75 ℃;
Mixing the heated oily component and the heated aqueous component, and cooling to obtain the eczema medicinal preparation.
Further, the mixture of the heated oily component and the heated aqueous component is stirred at a speed of 25-100rpm and homogenized at a speed of 2000-3000rpm for 25-35 minutes.
The beneficial effects are that: the eczema medicinal preparation has the advantages of remarkable curative effect, no toxic or side effect, mild and non-irritating skin, and no medicinal dependence. After the skin cream is used by a patient, the itching feeling can be resolved in a very short time, the drying effect of the skin can be moistened for a long time, and the damaged skin can be quickly repaired.
Compared with the prior art, the invention has the following advantages: (1) The eczema ointment provided by the invention contains rich natural nourishing components, supplements nutrition required by skin, balances damaged skin, is antibacterial, eliminates eczema red spots, does not contain hormone, has the effects of stopping scars, repairing, resisting inflammation and relieving redness and swelling for people suffering from skin problems such as eczema and dermatitis, and reduces discomfort of patients. The present invention can help reduce the use of steroids and thus reduce adverse effects on the skin.
(2) The active ingredients ginsenoside Rg1, quercetin and epigallocatechin gallate contained in the eczema ointment have good synergistic effect, and the use effect of the eczema ointment can be influenced in the absence of the active ingredients.
(3) The invention can treat chronic dermatitis such as eczema and contact dermatitis caused by external stimulus.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments or the description of the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a graph showing the comparative effect of the pharmaceutical composition for eczema according to the present invention on the expression of inflammatory factor genes and barrier protein genes in keratinocytes (HaCat).
Fig. 2 is a graph of the skin improvement effect of patients (based on EASI score) before and after the use of the pharmaceutical composition for eczema according to the present invention.
FIG. 3 is a state diagram of the patient A's foot eczema before and after the eczema ointment prepared in example 1 of the present invention is used; FIG. 3A is a state diagram of eczema of foot of patient A before using the eczema ointment prepared in example 1 of the present invention; fig. 3B is a state diagram of eczema of foot of patient a according to the present invention before using the eczema ointment prepared in example 1 according to the present invention.
FIG. 4 is a state diagram of the patient B leg eczema of the present invention before and after the eczema ointment prepared in example 1 of the present invention is used; fig. 4A is a state diagram of the eczema of the leg of the patient B before the eczema paste prepared in example 1 of the present invention is used, and fig. 4B is a state diagram of the eczema of the leg of the patient B after the eczema paste prepared in example 1 of the present invention is used.
Fig. 5 is a state diagram of the eczema of the hand of the patient C before and after the eczema of the patient C prepared by using the embodiment 1 of the present invention, fig. 5A is a state diagram of the eczema of the hand of the patient C before and after the eczema of the patient C prepared by using the embodiment 1 of the present invention, and fig. 5B is a state diagram of the eczema of the hand of the patient C before and after the eczema of the patient C prepared by using the embodiment 1 of the present invention.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved more clear, the application is further described in detail below with reference to the embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.
In the present application, the term "and/or" describes an association relationship of an association object, which means that three relationships may exist, for example, a and/or B may mean: a alone, a and B together, and B alone. Wherein A, B may be singular or plural. The character "/" generally indicates that the context-dependent object is an "or" relationship.
In the present application, "at least one" means one or more, and "a plurality" means two or more. "at least one of" or the like means any combination of these items, including any combination of single item(s) or plural items(s). For example, "at least one (individual) of a, b, or c," or "at least one (individual) of a, b, and c," may each represent: a, b, c, a-b (i.e., a and b), a-c, b-c, or a-b-c, wherein a, b, c may be single or multiple, respectively.
It should be understood that, in various embodiments of the present application, the sequence number of each process described above does not mean that the execution sequence of some or all of the steps may be executed in parallel or executed sequentially, and the execution sequence of each process should be determined by its functions and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.
The terminology used in the embodiments of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.
The weights of the relevant components mentioned in the description of the embodiments of the present application may refer not only to the specific contents of the components, but also to the proportional relationship between the weights of the components, so long as the contents of the relevant components in the description of the embodiments of the present application are scaled up or down within the scope of the disclosure of the embodiments of the present application. Specifically, in the description of the embodiment of the application, the mass can be a mass unit which is known in the chemical industry field such as mu g, mg, g, kg.
The terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated for distinguishing between objects such as substances from each other. For example, a first XX may also be referred to as a second XX, and similarly, a second XX may also be referred to as a first XX, without departing from the scope of embodiments of the application. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature.
The term "EGCG" is an abbreviation for "Epigallocatechin gallate" and represents epigallocatechin gallate.
The first aspect of the embodiment of the application provides a pharmaceutical composition for eczema, which comprises an oily component and an aqueous component, wherein the pharmaceutical composition for eczema comprises the following components in percentage by mass based on 100% of the total mass of the pharmaceutical composition for eczema:
The oily component comprises:
The aqueous component comprises:
The embodiment of the application provides a pharmaceutical composition for eczema, which takes ginsenoside Rg1, epigallocatechin gallate and quercetin as main components, and has better synergistic effect, so that the ginsenoside Rg1, the quercetin and the epigallocatechin gallate are indispensable. Meanwhile, the eczema medicinal preparation is mixed with components of cetostearyl olive oleate, stearic acid, evening primrose oil, shea butter, egg yolk oil, soybean oil, glycerol, carbomer, grapefruit seed extract, aloe extract and pure water, so that the eczema medicinal preparation has obvious curative effect, no toxic or side effect, is mild and has no stimulation to skin, and no medicament dependence. After the skin cream is used by a patient, the itching feeling can be resolved in a very short time, the drying effect of the skin can be moistened for a long time, and the damaged skin can be quickly repaired.
Many studies have shown that EGCG has the effects of protecting against free radical DNA damage, protecting against radiation and uv, preventing lipid peroxidation, reducing serum low-density cholesterol, ultra-low density cholesterol and triglycerides, interfering with the signaling required for cancer cell survival, inhibiting carcinogens in the diet, preventing the viability of certain carcinogens in combination with other enzymes and antioxidants in the intestines, liver, and lungs, scavenging free radicals, protecting against the effects of pollution, sun exposure and smoking, and preventing skin aging and wrinkling.
The centella asiatica extract can tighten the connection part of epidermis and dermis, can soften skin, is helpful for solving the skin relaxation phenomenon, and makes the skin smooth and elastic; helps promote collagen formation in dermis layers, regenerates fibrin, connects the dermis layers again, fundamentally eliminates mom lines, and achieves the effect of tightening and smoothing skin. Can also help the healing of damaged tissues and tighten the skin. Can promote the close connection between epidermis and dermis, inhibit the increase of fat cells, and prevent skin edema and obesity. Dicotyledonous plants of Umbelliferae family with repercussive, toxic materials removing, and abscess removing effects. The centella asiatica extract can tighten the connection part of epidermis and dermis, soften skin, promote collagen formation in dermis, and tighten skin.
The grapefruit seed extract has antioxidant, skin astringing, softening, moisturizing, and antiinflammatory effects.
The aloe extract contains aloin and aloesin, has effects of beautifying skin in various aspects, and has certain effects in keeping moisture, diminishing inflammation, inhibiting bacteria, relieving itching, resisting allergy, softening skin, preventing acne, inhibiting sweat and deodorizing, and has strong absorption effect on ultraviolet rays, and preventing skin burn. Aloe contains multiple components for scavenging superoxide radicals, such as superoxide dismutase and catalase, and has effects in caring skin, resisting aging, and protecting skin. The aloe gel is a natural sun-screening component, and can effectively inhibit ultraviolet rays in sunlight, prevent pigmentation and keep skin fair. It has been found that aloe has the effects of astringing skin, softening skin, moisturizing skin, diminishing inflammation, relieving sclerosis, keratinization, and improving wound.
In some embodiments, the pharmaceutical composition for eczema consists of the following components in percentage by mass:
The oily component comprises:
The aqueous component comprises:
In some embodiments, the mass ratio of ginsenoside Rg1, epigallocatechin gallate and quercetin is 6:1:0.3.
In some embodiments, the mass ratio of ginsenoside Rg1, epigallocatechin gallate, quercetin, grapefruit seed extract, and centella asiatica extract is 6:1:0.3:6:3.
The second aspect of the embodiment of the application provides application of a pharmaceutical composition for eczema in preparation of a pharmaceutical preparation for eczema.
In a third aspect, embodiments of the present application provide a pharmaceutical formulation for eczema, the pharmaceutical formulation for eczema including at least one of a solution, an emulsion or a paste.
In some embodiments, the eczema pharmaceutical formulation is a solution.
In some embodiments, the eczema pharmaceutical formulation is a solution.
In some embodiments, the eczema pharmaceutical formulation is a paste.
In some embodiments, the eczema pharmaceutical formulation is a mixture of solutions, emulsions and ointments.
The fourth aspect of the embodiment of the application provides a preparation method of a pharmaceutical preparation for eczema, which comprises the following steps:
Weighing the components of the pharmaceutical composition for eczema;
Heating the oily component to 65-75 ℃;
heating the aqueous component to 65-75 ℃;
Mixing the heated oily component and the heated aqueous component, and cooling to obtain the eczema medicinal preparation.
In some embodiments, the mixture of heated oily component and heated aqueous component is stirred at a rate of 100rpm and homogenized at a rate of 2500rpm for 30 minutes.
In some embodiments, the mixture of the heated oily component and the heated aqueous component is homogenized at a rate of 80rpm and at a rate of 2800rpm for 26 minutes.
The eczema ointment provided by the invention contains rich natural nourishing components, supplements nutrition required by skin, balances damaged skin, is antibacterial, eliminates eczema red spots, does not contain hormone, has the effects of stopping scars, repairing, resisting inflammation and relieving redness and swelling for people suffering from skin problems such as eczema and dermatitis, and reduces discomfort of patients.
Example 1
The invention relates to a pharmaceutical composition for eczema, which comprises an oily component and an aqueous component, wherein the pharmaceutical composition for eczema comprises the following components in percentage by mass based on 100% of the total mass of the pharmaceutical composition for eczema:
The oily component comprises:
The aqueous component comprises:
the invention relates to application of a pharmaceutical composition for eczema in preparation of a pharmaceutical preparation for eczema.
The invention relates to an eczema pharmaceutical preparation, which comprises a pharmaceutical composition for eczema.
The preparation method of the eczema ointment provided by the invention comprises the following steps:
Weighing the components of the pharmaceutical composition for eczema;
heating the oily component to 65 ℃; heating the aqueous component to 70 ℃;
Mixing the heated oily component and the heated aqueous component to form a paste, stirring the mixture of the heated oily component and the heated aqueous component at a speed of 25rpm and homogenizing at a speed of 3000rpm for 32 minutes, and cooling to obtain the eczema ointment.
Example 2
Example 2 differs from example 1 in that:
the invention relates to a pharmaceutical composition for eczema, which comprises the following components in percentage by mass: the oily component comprises:
The aqueous component comprises:
the preparation method of the eczema ointment provided by the invention comprises the following steps:
Weighing the components of the pharmaceutical composition for eczema;
heating the oily component to 75 ℃; heating the aqueous component to 65 ℃;
mixing the heated oily component and the heated aqueous component to form a paste, stirring the mixture of the heated oily component and the heated aqueous component at a speed of 100rpm and homogenizing at a speed of 2000rpm for 35 minutes, and cooling to obtain the eczema ointment.
Example 3
Example 3 differs from example 1 in that:
The invention relates to a pharmaceutical composition for eczema, which comprises the following components in percentage by mass:
The oily component comprises:
The aqueous component comprises:
the preparation method of the eczema ointment provided by the invention comprises the following steps:
Weighing the components of the pharmaceutical composition for eczema;
Heating the oily component to 68 ℃; heating the aqueous component to 75 ℃;
mixing the heated oily component and the heated aqueous component to form a paste, stirring the mixture of the heated oily component and the heated aqueous component at a speed of 70rpm and homogenizing at a speed of 2600rpm for 25 minutes, and cooling to obtain the eczema ointment.
Example 4
Example 4 differs from example 1 in that:
The invention relates to a pharmaceutical composition for eczema, which comprises the following components in percentage by mass:
The oily component comprises:
The aqueous component comprises:
example 5
Example 5 differs from example 1 in that:
The invention relates to a pharmaceutical composition for eczema, which comprises the following components in percentage by mass:
The oily component comprises:
The aqueous component comprises:
Example 6
Example 6 differs from example 1 in that:
The invention relates to a pharmaceutical composition for eczema, which comprises the following components in percentage by mass:
/>
the aqueous component comprises:
The preparation method of the eczema emulsion provided by the invention comprises the following steps:
weighing the components of the pharmaceutical composition for eczema;
Heating the oily component to 65 ℃;
Heating the aqueous component to 75 ℃;
Mixing the heated oily component and the heated aqueous component to form an emulsion, stirring the mixture of the heated oily component and the heated aqueous component at a speed of 25rpm and homogenizing at a speed of 2600rpm for 35 minutes, and cooling to obtain the eczema milk.
Comparative example 1
The difference from example 1 is that: no quercetin was added.
Comparative example 2
The difference from example 1 is that: no epigallocatechin gallate was added.
Comparative example 3
The difference from example 1 is that: no epigallocatechin gallate and quercetin were added.
Test example 1
Clinical efficacy tests were performed on the eczema drugs of examples 1-3 and comparative examples 1-3.
1. Test sample and method of use
Test article: eczema cream prepared in examples 1 to 3 and comparative examples 1 to 3;
number of human subjects: 120 eczema patients are selected, and are equally divided into 6 groups, each group has different male and female halves, and each group has no obvious difference in age, sex and disease course.
The using method comprises the following steps: the eczema ointment is applied to the affected part for 3 times a day, one course of treatment is a week, two courses of treatment are continuously treated, and other medicines are stopped during the treatment period. Return visit after 3 months and 6 months of use, respectively.
2. Clinical efficacy evaluation criteria
1. And (3) curing: clinical symptoms such as rash, red pimple, erythema, small scar, yellow scale, scab, exudation, erosion and the like all disappear, and the body is recovered;
2. the method is effective: the clinical symptoms are reduced and improved;
3. invalidation: the symptoms were not improved compared to before treatment.
3. Trial result analysis
The test results obtained are shown in Table 1.
TABLE 1
Grouping Healing/example Effectiveness/example Invalidation/instance Adverse reactions/examples
Example 1 16 4 0 0
Example 2 13 4 3 0
Example 3 14 4 2 0
Comparative example 1 10 5 5 0
Comparative example 2 12 4 4 0
Comparative example 3 9 5 6 0
As shown in Table 1, no adverse reaction occurred during the trial of the eczema cream of examples 1 to 3 and comparative examples 1 to 3 by the human subject. The eczema ointment prepared in the embodiment 1-3 of the invention contains the active ingredients of ginsenoside Rg1, quercetin, epigallocatechin gallate, centella asiatica extract and the like, has good synergistic effect, and has high cure rate, which is far higher than that of the eczema ointment prepared in the comparative example 1-3, and the defect that the defect of ginsenoside Rg1, quercetin and epigallocatechin gallate can affect the use effect of the eczema ointment. Wherein, the effect of the example 1 is best, and the cure rate reaches 100% after 2 treatment courses are tried out. The patients cured in examples 1-5 were given a return visit after 3 months and 6 months, respectively, with no recurrence.
Test example 2
HaCaT keratinocytes were cultured in DMEM supplemented with 10% FBS and antibiotics. Cells were grown in a 100mm dish at 37℃in a humid environment containing 5% carbon dioxide. Briefly, haCaT cells were seeded in 96-well plates and grown for 24 hours. TNF- α/IFN- γ was used to induce inflammation in HaCaT cells, which is representative of inflammatory skin diseases in an in vitro model. REAL TIME PCR was performed to confirm the inhibition of TNF- α/IFN- γ induced cytokine and chemokine expression levels in HaCaT keratinocytes and the improvement of skin barrier damage levels, including Il-1 β, thymus and activation regulating chemokines (Tarc) and filagg (Flg), by GEQ (0.1%) and dexamethasone (10 μm).
The invention can have the following mechanism for eczema patients: (1) repair skin barrier function by stimulating Filaggrin production, (2) reduce skin superficial inflammation by inhibiting growth of Staphylococcus aureus and its proteases that can cause exacerbation of eczema, (3) relieve itching by inhibiting itch inducers (e.g., PGE2, IL-4, IL-31, etc.), and (4) improve skin immune function by inhibiting pro-inflammatory cytokines (e.g., IL-13, IL-31, TSLP, etc.).
As shown in FIG. 1, the pharmaceutical composition for eczema of the present invention is a graph showing the comparative effect of the expression of the inflammatory factor gene and the barrier protein gene in keratinocytes (HaCat). Wherein Control is a Control group; AD is a model of eczema; ad+geq is the eczema model+the pharmaceutical composition for eczema of the present invention; ad+dex is eczema model+steroid.
In normal keratinocytes, the relative gene expression indices of inflammatory indices such as Il-1 beta and thymus and activation-modulating chemokines Tarc are low, whereas eczema models are high, with higher indices representing more severe inflammation and worse skin conditions. Under the same eczema model, the medicinal composition group of AD+GEQ for eczema has obvious effect on reducing the gene expression of inflammatory factors, and has similar effect to steroid, so that the medicinal composition for eczema can effectively inhibit the expression of inflammatory factors and reduce the discomfort of patients.
In addition, in normal keratinocytes, the gene expression index of the barrier protein Flg is high, whereas the eczema model is low, the lower the index is, the lower the barrier protein expression of the skin is, and the worse the skin condition is. Under the same eczema model, the AD+GEQ medicinal composition group for eczema has obvious effects on repairing skin and maintaining skin barrier energy, and is superior to steroid group, and the medicinal composition for eczema can be proved to be capable of effectively repairing skin.
Test example 3
Pharmaceutical composition for eczema prepared in example 1
The trial recruited 16 participants. The participants are mainly corporate employees and fixed clients. Inclusion criteria included: (a) men or women over 18 years of age, (b) clinically diagnosed Atopic Dermatitis (AD) for at least 1 year, (c) no dermatological or systemic diseases that might interfere with the outcome, and (d) no acute or chronic diseases that might interfere with or increase the risk of trial participation. The participants were informed that they did not use their usual topical cream/medication during the first 1 week of participation or during the study, and were informed that GEQ was applied twice daily to the affected area (or eczema-prone area) for 14 days in the morning and evening. EASI scores were evaluated before and after the trial.
EASI combines the severity of the four symptoms of eczema (redness, thickening/swelling, itching, lichenification) with the skin involvement of four body areas (head/neck, upper limb, trunk and lower limb), with a composite score ranging from 0 to 72.
Case 1: fig. 3 is a state diagram of the eczema of foot of patient a before and after using the eczema cream prepared in example 1 of the present invention. The foot of the patient A has serious eczema, and after the invention is used for one month, the itching degree and the dry bursting condition of the patient are reduced, and the damage bleeding condition is greatly improved.
Case 2: fig. 4 is a state diagram of the eczema of leg of patient B before and after using the eczema cream prepared in example 1 of the present invention. Patient B had a long-term red rash on his leg and after 14 days of use of the present invention, there was a marked regression of the rash.
Case 3: fig. 5 is a state diagram of the eczema of hand of patient C before and after using the eczema cream prepared in example 1 of the present invention. The invention has the advantages that the problem of slight eczema is solved, and the red swelling of hands of patients is resolved after 13 days of using the invention, and the itching degree and the dry hands are also improved greatly.
After the medicine composition is applied to a patient for 14 days, whether the eczema is serious (shown in figure 3), moderate (shown in figure 4) or slight (shown in figure 5), the score of the Eczema Area and Severity Index (EASI) is obviously reduced (shown in figure 2), and the result proves that the medicine composition of the active ingredients of the eczema ointment has better synergistic effect, has high cure rate and can effectively improve the eczema symptom.
The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the foregoing embodiments, which have been described in the foregoing embodiments and description merely illustrates the principles of the invention, and various changes and modifications may be made therein without departing from the spirit and scope of the invention, the scope of which is defined in the appended claims, specification and their equivalents.

Claims (7)

1. A pharmaceutical composition for eczema, which is characterized in that: the pharmaceutical composition for eczema comprises an oily component and an aqueous component, and comprises the following components in percentage by mass based on 100% of the total mass of the pharmaceutical composition for eczema:
the oily component comprises:
3% of cetostearyl olive oleate,
3% Of stearic acid,
Ginsenoside Rg16%,
1% Of epigallocatechin gallate,
0.3 Percent of quercetin,
3% Of egg oil,
5 Percent of soybean oil,
Caprylic/capric triglyceride 4%,
2 Percent of evening primrose oil,
1% Of shea butter;
The aqueous component comprises:
3% of glycerol,
0.5 Percent of carbomer,
6% Of grapefruit seed extract,
3% Of aloe extract,
3% Of centella asiatica extract,
The balance being pure water.
2. Use of the pharmaceutical composition for eczema according to claim 1 for the preparation of a pharmaceutical formulation for eczema.
3. The use according to claim 2, characterized in that: the eczema pharmaceutical preparation comprises at least one of emulsion or ointment.
4.A pharmaceutical formulation for eczema, characterized in that: the eczema pharmaceutical preparation comprises the pharmaceutical composition for eczema according to claim 1.
5. The eczema pharmaceutical formulation as claimed in claim 4, wherein: the eczema pharmaceutical preparation comprises at least one of eczema milk or eczema ointment.
6. The preparation method of the eczema pharmaceutical preparation is characterized by comprising the following steps:
weighing the components of the pharmaceutical composition for eczema according to claim 1;
heating the oily component to 65-75 ℃;
heating the aqueous component to 65-75 ℃;
Mixing the heated oily component and the heated aqueous component, and cooling to obtain the eczema medicinal preparation.
7. The method of manufacturing according to claim 6, wherein: and (3) homogenizing the heated mixture of the oily component and the heated aqueous component according to the speed of 25-100rpm and the speed of 2000-3000rpm, wherein the stirring and homogenizing time is 25-35 minutes.
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160117015A (en) * 2015-03-31 2016-10-10 (주)아모레퍼시픽 SKIN EXTERNAL PREPARATION COMPRISING GINSENOSIDE Rg1
CN112423726A (en) * 2018-07-10 2021-02-26 努其杜有限公司 Compositions for protecting cells from oxidative and mitochondrial stress
CN113230172A (en) * 2021-05-24 2021-08-10 泉州达浔生物科技有限公司 Cosmetic or dermatological composition, preparation method and application thereof
DE102021122753A1 (en) * 2021-09-02 2023-03-02 DR. HERMANS UG (haftungsbeschränkt) DERMATOLOGICAL AGENT

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160117015A (en) * 2015-03-31 2016-10-10 (주)아모레퍼시픽 SKIN EXTERNAL PREPARATION COMPRISING GINSENOSIDE Rg1
CN112423726A (en) * 2018-07-10 2021-02-26 努其杜有限公司 Compositions for protecting cells from oxidative and mitochondrial stress
CN113230172A (en) * 2021-05-24 2021-08-10 泉州达浔生物科技有限公司 Cosmetic or dermatological composition, preparation method and application thereof
DE102021122753A1 (en) * 2021-09-02 2023-03-02 DR. HERMANS UG (haftungsbeschränkt) DERMATOLOGICAL AGENT

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