A pharmaceutical composition for redness reduction and repair and preparation method thereof
Through a paste made of a variety of traditional Chinese medicine ingredients, the treatment problems of persistent flushing on the face and capillary dilation are solved by using nanostructured lipid carrier technology, and the treatment problems of continuous facial flushing and capillary dilation are achieved, which has achieved improvements in the thickening of the stratum corneum and skin barrier function, significantly improving the treatment effect.
Patent Information
- Application Number
- CN202411228044.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-03
- Publication Date
- 2025-03-07
- Estimated Expiration
- 2044-09-03
AI Technical Summary
The prior art is difficult to effectively treat persistent flushing on the face and the already formed capillary dilation. Existing skin care products mainly relieve mild paroxysmal flushing through moisturizing, but are ineffective against persistent flushing.
It uses a paste made of chamomile, Alisma, Sophora pilosula, Snake, Snake, Snake, Small Molecular Sodium Hyaluronate, Ektoin, Safflower, Ophiopogon japonicus, Peony, and White Peony. It is absorbed by the facial skin through a nanostructured lipid carrier, slowly releases Chinese medicine extracts, thickens the stratum corneum, improves the function of the skin barrier, and reduces capillary dilation and vascular congestion.
This pharmaceutical composition can significantly increase the thickness of the stratum corneum, effectively improve the persistent flushing of the face and capillary dilation, improve the therapeutic effect, and reduce the recurring attack of facial flushing.
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Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of skin disease treatment, and in particular to a pharmaceutical composition for redness removal and repair and a preparation method thereof. Background Art
[0002] Facial flushing is a very common symptom in dermatology. It is caused by the dilation of facial capillaries and manifests as diffuse and persistent facial redness and burning. It recurs over a long period of time and has a serious impact on the patient's daily life and treatment. The characteristics of facial flushing are as follows: (1) Predisposing sites: the entire face or the cheekbones. (2) Characteristics of skin lesions: paroxysmal facial flushing and burning sensation will occur when the patient is emotionally excited or exposed to heat. Some patients also sweat and feel upset. The flushing will gradually subside or even disappear after quieting down. (3) Characteristics of the course of disease: recurrent attacks can last for several months, several years or even more than 10 years, generally 2 to 5 years.
[0003] At present, there is a relative lack of drugs for repairing and treating facial flushing in the market. Some soothing and repairing skin care products, such as Winona Special Cream, are mainly soothing and moisturizing, but they do not directly thicken the stratum corneum. They mainly moisturize the skin by attracting and retaining moisture to prevent moisture evaporation, thereby helping to strengthen the skin barrier. They only have a temporary relief effect on mild paroxysmal flushing, and are ineffective for persistent facial flushing and already formed capillary dilation. Therefore, it is of great research significance to develop safe and effective drugs for persistent facial flushing and already formed capillary dilation. Summary of the invention
[0004] In order to overcome the shortcomings of the prior art, one of the objects of the present invention is to provide a pharmaceutical composition for redness reduction and repair, which can increase the thickness of the stratum corneum, has a good therapeutic effect on patients with persistent facial flushing and already formed capillary dilation, and can reduce facial redness.
[0005] The second object of the present invention is to provide a method for preparing a pharmaceutical composition for redness reduction and repair, which has simple steps and low cost.
[0006] One of the purposes of the present invention is achieved by the following technical solution:
[0007] A pharmaceutical composition for redness removal and repairing is an ointment prepared from raw materials according to the following weight ratio: 8-10 parts of chamomile, 6-12 parts of oriental rhizome, 5-10 parts of sophora flavescens, 6-12 parts of cnidium monnieri, 6-15 parts of kochia scoparia, 1-5 parts of small molecule sodium hyaluronate, 9-15 parts of ectoine, 3-10 parts of safflower, 6-12 parts of ophiopogon japonicus, 9-12 parts of mountain peony root, and 9-12 parts of white peony root; the ointment is composed of an ointment matrix, a nanostructured lipid carrier of a traditional Chinese medicine extract, and glycerol, and the ointment matrix is honey.
[0008] Chamomile: The terpenoids in chamomile, such as α-bisabolol and its oxides, matricariacene and β-farnesene, have anti-inflammatory effects and can reduce inflammatory reactions in allergic reactions; the antioxidant components of chamomile help protect cells from oxidative stress and reduce oxidative damage in allergic reactions; chamomile may reduce allergic symptoms by inhibiting the release of histamine or its effects; it is rich in flavonoid active ingredients and has good effects of soothing, repairing sensitive skin, reducing fine red blood streaks, reducing redness, and adjusting uneven skin color. It helps to reduce inflammation and relieve pain, and can help relieve headaches, back pain, muscle pain and other discomforts.
[0009] Ecdoin: It is a very hydrophilic substance that can form a stable protective film around skin cells by regulating osmotic pressure, which can calm and soothe irritated and damaged skin; it also has long-lasting hydration and moisturizing effects, increases skin water content, repairs the skin barrier, and protects the skin from damage caused by rapid dehydration.
[0010] Alisma: cold; sweet, light. Enters the kidney and bladder meridians. Promotes urination and clears dampness and heat. Used for urinary incontinence, edema, diarrhea, oliguria, phlegm and dizziness, hot stranguria and pain; high blood lipids. It has the effect of promoting water and removing dampness, and helps eliminate facial edema.
[0011] Cnidium monnieri: pungent, bitter; warm. Slightly toxic, enters the kidney meridian. It dries dampness and dispels wind, kills insects and relieves itching, warms the kidney and strengthens yang. It is used for vaginal itching and leucorrhea, eczema and itching, dampness and low back pain, kidney deficiency and yang paralysis, uterine cold and infertility. The kidney governs water, and warming the kidney can enhance the kidney's gasification function, which plays an important role in maintaining the production and excretion of urine in the human body, and can also reduce the chance of edema.
[0012] Sophora flavescens: bitter, cold. Entries to the heart, liver, stomach, large intestine, bladder meridians. Clears away heat and dampness, kills insects, and is a diuretic. Used for heat dysentery, blood in stool, jaundice, urine retention, leucorrhea, itchy skin, eczema, wet sores, scabies and leprosy; external treatment of trichomonas vaginitis. Damp heat in the body may cause facial blood vessels to dilate and facial flushing. Sophora flavescens can help clear the heat and dampness in the body, thereby alleviating or eliminating the symptoms of facial flushing.
[0013] Kochia scoparia: pungent, bitter, cold. Enters the kidney and bladder meridians. Clears away heat and dampness, dispels wind and relieves itching. Used for painful urination, vaginal itching, leucorrhea, urticaria, eczema, and skin itching.
[0014] Small molecule sodium hyaluronate: It can replenish water and moisturize the skin, relieve dry or peeling skin; small molecule sodium hyaluronate is easily absorbed by the human body, can penetrate into the dermis of the skin, promote blood microcirculation, help the skin absorb nutrients, and make the skin smoother; it can also achieve a filling effect, making the face fuller.
[0015] Safflower: warm; pungent; accords to the heart and liver meridians. Promotes blood circulation and menstruation, dissipates blood stasis and relieves pain. Used for amenorrhea, dysmenorrhea, lochia retention, vitiligo, lumps, injuries from falls, sores, swelling and pain.
[0016] Peony root: has anti-inflammatory effects and may help inhibit the increase in capillary permeability caused by inflammation.
[0017] White peony root: slightly cold; bitter, sour, sweet; enters the liver and spleen meridians. It soothes the liver and relieves pain, nourishes blood and regulates menstruation, and restrains yin and stops sweating. It is used for headache, dizziness, flank pain, abdominal pain, cramps in the limbs, blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, and night sweats. It soothes the liver and relieves depression, and harmonizes qi and blood.
[0018] Ophiopogon japonicus: slightly cold; sweet, slightly bitter; enters the heart, lung, and stomach meridians. Nourishes yin and produces body fluid, moistens the lungs and clears the heart. Used for dry cough due to lung dryness, consumptive cough, thirst due to loss of body fluid, restlessness and insomnia, internal heat and thirst, dry intestines and constipation; diphtheria. Nourishes yin fluid, restrains virtual fire, excessive yang heat in the human body, and virtual fire inflammation.
[0019] Furthermore, it is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 10 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of peony root, and 12 parts of white peony root.
[0020] Furthermore, the ointment is a skin plaster.
[0021] The second object of the present invention is achieved by adopting the following technical solution:
[0022] A method for preparing a pharmaceutical composition for redness reduction and repairing, comprising the following steps:
[0023] S1. Weigh 6-12 parts of Rhizoma Alismatis, 5-10 parts of Sophora flavescens, 6-12 parts of Fructus Cnidii, 6-15 parts of Fructus Kochiae, 6-12 parts of Ophiopogon japonicus, 9-12 parts of Rhizoma Paeoniae Alba, and 9-12 parts of Radix Paeoniae Alba by weight, and soak them in water for 30-60 minutes;
[0024] S2, prepare Chinese medicine extract: after soaking, mix together oriental rhizome, sophora flavescens, cnidium monnieri, kochia scoparia, ophiopogon japonicus, peony root and white peony root, add water and boil, boil quickly with high heat, switch to slow fire and simmer for 15 to 20 minutes, weigh 8 to 10 parts of chamomile and 3 to 10 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 1 to 5 parts of small molecule sodium hyaluronate and 9 to 15 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0025] S3. Preparation of nanostructured lipid carriers of Chinese herbal medicine extracts: weigh lipids, dissolve the nano-TCM extracts and lipids in a mass ratio of 1:1 in 15 mL of 85°C ethanol, and obtain a lipid phase after rotary evaporation of the ethanol; dissolve a surfactant in 10 mL of 85°C distilled water to obtain an aqueous phase; then quickly add the aqueous phase to the lipid phase to obtain a mixture; homogenize the mixture in an 85°C rotator for 10 minutes to obtain a pre-emulsion; and quickly cool the pre-emulsion in an ice-water mixture to obtain the nanostructured lipid carrier of Chinese herbal medicine extracts;
[0026] S4. Preparing an ointment: mixing the nanostructured lipid carrier of the Chinese herbal extract, the ointment base and glycerol, stirring them evenly to prepare an ointment, which is the pharmaceutical composition for redness removal and repairing.
[0027] Further, the paste base is honey;
[0028] Further, the lipid is ceramide;
[0029] Furthermore, the surfactant is selected from surfactants with little irritation to the skin, and the surfactant is glucoside.
[0030] The third object of the present invention is to provide a pharmaceutical composition for redness removal and repairing for use in the preparation of a drug for redness removal and repairing.
[0031] Compared with the prior art, the present invention has the following beneficial effects:
[0032] (1) The present invention provides a pharmaceutical composition for redness removal and repairing. Chamomile has an anti-allergic and soothing effect. Ecdoin can form a stable protective film around skin cells by regulating osmotic pressure, which can calm and soothe irritated and damaged skin, promote the soothing effect of chamomile, and also has the effects of long-term hydration and moisturizing, increasing skin water content, and repairing skin barrier. Alisma has the effect of promoting water and removing dampness, which helps to eliminate facial edema, is beneficial to smooth circulation of facial skin, and reduces symptoms of skin fever and itching. Kochia scoparia can also clear away heat and dampness, dispel wind and relieve itching, and also help to eliminate facial edema. Kochia scoparia and Alisma both have the effect of clearing away heat and dampness, and the synergistic effect of the two can enhance the effect of eliminating facial edema. The heat-clearing and dampness-drying effects of Cnidium monnieri and Sophora flavescens are utilized to make the dampness go out through urination, and the swelling disappears when the dampness is gone. Moreover, Cnidium monnieri can warm the kidneys Aphrodisiac can enhance the kidney's gasification function, nourish the liver, and inhibit facial flushing caused by hyperactivity of liver yang; safflower has the effect of promoting blood circulation and removing blood stasis, and blood circulation is unobstructed; mountain peony has an anti-inflammatory effect, which can inhibit the increase in capillary permeability caused by inflammation, maintain vascular elasticity, thereby inhibiting capillary dilation and eliminating facial flushing. Safflower promotes blood circulation and removes blood stasis, and mountain peony has an anti-inflammatory effect. The combination of the two can promote blood circulation, reduce inflammation, and jointly inhibit capillary dilation and reduce facial flushing; white peony is used to soothe the liver and relieve depression, harmonize qi and blood, so that qi and blood circulation is unobstructed, which is beneficial to clearing away heat and drying dampness; ophiopogon is used to nourish yin and produce fluid, moisten the lungs and clear the heart, so as to nourish yin fluid and restrain virtual fire. Excessive yang heat in the human body and virtual fire inflammation are manifested as facial flushing. White peony soothes the liver and relieves depression, harmonizes qi and blood, and ophiopogon nourishes yin and produces fluid, moistens the lungs and clears the heart. The combination of the two can regulate the body's water balance and qi and blood circulation, and reduce facial flushing caused by internal heat. Small molecule sodium hyaluronate is easily absorbed by the human body and can penetrate into the dermis of the skin to promote blood microcirculation. While penetrating, it can bring the above ingredients into the dermis to give full play to the efficacy of the medicine. Ectoin forms a protective film, and small molecule sodium hyaluronate penetrates deeply into the skin to provide moisturizing and repair. The two work synergistically to strengthen the skin barrier function and reduce external stimulation. In addition, small molecule sodium hyaluronate can also fill the extracellular matrix of the dermis, have a squeezing effect on the capillaries, and reduce facial flushing caused by capillary dilation and vascular congestion.
[0033] (2) The pharmaceutical composition for redness reduction and repair provided by the present invention is absorbed by facial skin in the form of a nanostructured lipid carrier. The nanostructured lipid carrier has a sustained release effect and slowly releases the components of the Chinese medicine extract. The facial redness treatment effect is long-lasting and the treatment effect is improved. The drug is dispersed in the Chinese medicine decoction by high shear force, and after concentration, a nano Chinese medicine extract is obtained. The Chinese medicine extract is more easily encapsulated by the nanostructured lipid carrier, thereby reducing the side effects of the Chinese medicine extract. Glycerol is a skin-mild skin penetrant, which is safe and non-allergenic. It can form hydrogen bonds with the lipid head groups of the skin, so that the nanostructured lipid carrier can easily penetrate the stratum corneum surface into the dermis to release the drug and exert its effect. The nanostructured lipid carrier is composed of lipids, which play a role in repairing the stratum corneum on the surface of the skin. After being absorbed by the skin, it can increase the thickness of the stratum corneum of the skin, so that the skin has the stratum corneum repair effect that sodium hyaluronate does not have. The skin is resistant to allergies when exposed to external stimuli, and facial redness will not recur. DETAILED DESCRIPTION
[0034] The present invention is further described below in conjunction with specific embodiments. It should be noted that, under the premise of no conflict, the embodiments or technical features described below can be arbitrarily combined to form a new embodiment.
[0035] As used herein, "treatment" is any action taken to prevent or delay the onset of a disease, to ameliorate one or more symptoms or complications, to induce or prolong remission, to delay relapse, recurrence or exacerbation, or to otherwise improve or stabilize the subject's disease state or risk of disease. Typically, treatment is prophylactic treatment intended to delay or prevent the onset of a disease or any symptom or complication associated with the disease.
[0036] Ceramide was purchased from Wuhan Kemik Biopharmaceutical Technology Co., Ltd.
[0037] Glucoside was purchased from Nanjing Dulai Biotechnology Co., Ltd.
[0038] The stratum corneum (Latin for 'horny layer') is the outermost layer of the epidermis, mainly composed of 10 to 20 layers of flat, dead cells without nuclei. When these cells fall off, the cells in the basal layer underneath are pushed up to form a new stratum corneum. The stratum corneum is the outermost layer of the epidermis, composed of dead, anucleated keratinocytes. The main function of the stratum corneum is to protect the subcutaneous tissue, prevent the subcutaneous tissue from infection, dehydration, and resist the pressure caused by chemicals and external forces. The cells in the stratum corneum contain keratin. It helps reduce water evaporation and can even absorb water to keep the skin moisturized.
[0039] The possibility of nanocarriers completely passing through the stratum corneum barrier is very low. On the one hand, these nanocarriers can accumulate in the outermost layer of the stratum corneum to form a drug reservoir and slowly release it into the skin layer. On the other hand, the drug can accumulate in the skin, hair follicle folds and hair follicle openings to form a drug reservoir, which will ensure the effective load and provide power for the passive penetration of drug molecules in the skin, achieving continuous and controllable slow release of drugs, thereby reducing side effects and improving therapeutic effects.
[0040] The extracts of Chinese herbal medicines after decoction are the products obtained by the traditional preparation methods of Chinese herbal medicines. They are usually macroscopic liquids containing various water-soluble components extracted from herbs. These extracts are not nanoscale, and their size and morphology depend on the type of herbs used, the extraction method and conditions.
[0041] Example 1
[0042] The present embodiment provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 10 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 12 parts of white peony root.
[0043] The present embodiment provides a method for preparing a pharmaceutical composition for redness removal and repair, comprising the following steps:
[0044] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 10 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight, and soak them in water for 50 minutes;
[0045] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0046] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and evaporate the ethanol by rotary evaporation to obtain a lipid ceramide phase; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain an aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion, and disperse the pre-emulsion into a nanophase by high shear force to obtain a pre-emulsion with a nanoscale lipid carrier; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0047] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0048] High shear forces are usually achieved using high shear emulsifiers or homogenizers. These devices can generate high-speed rotation or vibration, thereby generating strong shearing effects between the drug and the medium.
[0049] Example 2
[0050] The present embodiment provides a pharmaceutical composition for redness reduction and repair, which is an ointment prepared from raw materials according to the following weight ratio: 9 parts of chamomile, 6 parts of oriental rhizome, 8 parts of sophora flavescens, 12 parts of cnidium monnieri, 10 parts of kochia scoparia, 1 part of small molecule sodium hyaluronate, 9 parts of ectoine, 10 parts of safflower, 6 parts of ophiopogon japonicus, 10 parts of paeonia lactiflora, and 10 parts of white peony root.
[0051] This embodiment provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0052] S1. Weigh 6 parts of Rhizoma Alismatis, 8 parts of Sophora flavescens, 12 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 6 parts of Ophiopogon japonicus, 10 parts of Rhizoma Paeoniae Alba, and soak them in water for 30 minutes;
[0053] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Cnidium monnieri, Kochia scoparia, Ophiopogon japonicus, Paeonia lactiflora and Paeonia lactiflora together, add water and boil, boil quickly with high heat, switch to slow fire and simmer for 20 minutes, weigh 9 parts of chamomile and 10 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 1 part of small molecule sodium hyaluronate and 9 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and concentrate to obtain a nano Chinese medicine extract;
[0054] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and evaporate the ethanol by rotary evaporation to obtain a lipid ceramide phase; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain an aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion, and disperse the pre-emulsion into a nanophase by high shear force to obtain a pre-emulsion with a nanoscale lipid carrier; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0055] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0056] Example 3
[0057] The present embodiment provides a pharmaceutical composition for redness reduction and repair, which is an ointment prepared from raw materials according to the following weight ratio: 8 parts of chamomile, 12 parts of oriental rhizome, 10 parts of sophora flavescens, 6 parts of cnidium monnieri, 15 parts of kochia scoparia, 3 parts of small molecule sodium hyaluronate, 15 parts of ectoine, 3 parts of safflower, 9 parts of ophiopogon japonicus, 12 parts of paeonia lactiflora, and 9 parts of white peony root.
[0058] This embodiment provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0059] S1. Weigh 12 parts of Rhizoma Alismatis, 10 parts of Sophora flavescens, 6 parts of Fructus Cnidii, 15 parts of Fructus Kochiae, 9 parts of Ophiopogon japonicus, 12 parts of Rhizoma Paeoniae Alba, and 9 parts of Radix Paeoniae Alba in proportion to weight, and soak them in water for 60 minutes.
[0060] S2, prepare Chinese medicine extract: after soaking, mix oriental rhizome, sophora flavescens, cnidium monnieri, kochia scoparia, ophiopogon japonicus, peony root and white peony root together, add water to decoct, boil quickly with high heat, switch to slow fire and simmer for 18 minutes, weigh 8 parts of chamomile and 3 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 3 parts of small molecule sodium hyaluronate and 15 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and concentrate to obtain a nano Chinese medicine extract;
[0061] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and evaporate the ethanol by rotary evaporation to obtain a lipid ceramide phase; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain an aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion, and disperse the pre-emulsion into a nanophase by high shear force to obtain a pre-emulsion with a nanoscale lipid carrier; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0062] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0063] Comparative Example 1
[0064] The present comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 20 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 10 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 12 parts of white peony root.
[0065] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0066] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 10 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight, and soak them in water for 50 minutes;
[0067] S2, prepare Chinese medicine extract: after soaking, mix oriental rhizome, sophora flavescens, cnidium monnieri, kochia scoparia, ophiopogon japonicus, peony root and white peony root together, add water to decoct, boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 20 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and concentrate to obtain a nano Chinese medicine extract;
[0068] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0069] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0070] Comparative Example 2
[0071] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 8 parts of Alisma orientalis, 5 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 6 parts of Kochia scoparia, 5 parts of small molecule sodium hyaluronate, 20 parts of Ectoin, 8 parts of Carthamus tinctorius, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora, and 12 parts of White Peony Root.
[0072] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0073] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 10 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight, and soak them in water for 50 minutes;
[0074] S2, prepare Chinese medicine extract: after soaking, mix oriental rhizome, sophora flavescens, cnidium monnieri, kochia scoparia, ophiopogon japonicus, peony root and white peony root together, add water to decoct, boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 8 parts of safflower by weight, add it to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 20 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and concentrate to obtain a nano Chinese medicine extract;
[0075] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0076] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0077] Comparative Example 3
[0078] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 15 parts of sophora flavescens, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 12 parts of white peony root.
[0079] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0080] S1. Weigh 8 parts of Rhizoma Alismatis, 15 parts of Sophora flavescens, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight and soak them in water for 50 minutes;
[0081] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0082] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0083] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0084] Comparative Example 4
[0085] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental water chestnuts, 15 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 12 parts of white peony.
[0086] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0087] S1. Weigh 8 parts of Rhizoma Alismatis, 15 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Rhizoma Paeoniae Alba, and 12 parts of Radix Paeoniae Alba in proportion to weight, and soak them in water for 50 minutes.
[0088] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0089] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0090] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0091] Comparative Example 5
[0092] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 22 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, and 9 parts of paeonia lactiflora.
[0093] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0094] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 10 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, and 9 parts of Paeonia lactiflora according to weight, and soak them in water for 50 minutes;
[0095] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0096] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0097] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0098] Comparative Example 6
[0099] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 22 parts of white peony root.
[0100] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0101] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight, and soak them in water for 50 minutes;
[0102] S2, prepare Chinese medicine extract: after soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, switch to slow fire and simmer for 15 minutes, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration;
[0103] S3. Preparation of nanostructured lipid carrier of Chinese herbal medicine extract: weigh lipid ceramide, dissolve 25 mg of nano Chinese herbal medicine extract and 25 mg of lipid ceramide in 15 mL of 85°C ethanol, and obtain lipid ceramide phase after rotary evaporation of ethanol; dissolve surfactant glucoside in 10 mL of 85°C distilled water to obtain aqueous phase; then quickly add the aqueous phase to the lipid ceramide phase to obtain a mixture; put the mixture into an 85°C rotator for homogenization for 10 minutes to obtain a pre-emulsion; quickly cool the pre-emulsion in an ice-water mixture to obtain a nanostructured lipid carrier of Chinese herbal medicine extract;
[0104] S4. Prepare the ointment: mix the nanostructured lipid carrier of the Chinese herbal medicine extract, the ointment matrix honey and glycerol, stir evenly to prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0105] Comparative Example 7
[0106] This comparative example provides a pharmaceutical composition for redness reduction and repair and a preparation method thereof, which is an ointment prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 10 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora, and 12 parts of white peony root.
[0107] The present comparative example provides a method for preparing a pharmaceutical composition for redness reduction and repair, comprising the following steps:
[0108] S1. Weigh 8 parts of Rhizoma Alismatis, 5 parts of Sophora flavescens, 10 parts of Fructus Cnidii, 6 parts of Fructus Kochiae, 12 parts of Ophiopogon japonicus, 9 parts of Paeonia lactiflora and 12 parts of Paeonia lactiflora in parts by weight, and soak them in water for 50 minutes;
[0109] S2. Preparation of Chinese herbal medicine extract: After soaking, mix Rhizoma Alismatis, Sophora flavescens, Fructus Cnidium, Fructus Kochiae, Ophiopogon japonicus, Rhizoma Paeoniae Alba and Radix Paeoniae Alba together, add water and boil quickly with high heat, then simmer for another 15 minutes with low heat, weigh 10 parts of chamomile and 8 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese herbal medicine decoction,
[0110] Weigh 5 parts of small molecule sodium hyaluronate and 10 parts of ectoine according to weight, add them to the Chinese medicine decoction, use high shear to disperse the drugs in the Chinese medicine decoction through high shear force, and obtain nano Chinese medicine extract after concentration;
[0111] S3. Preparing an ointment: Mix the nano-TCM extract, the ointment matrix honey and glycerol, stir evenly, and prepare an ointment, which is a pharmaceutical composition for redness removal and repair.
[0112] Experimental example
[0113] Recruiting patients with facial flushing
[0114] Recruitment posters were posted in the hospital and recruitment information was published on the hospital's social media to recruit participants. Patients with facial flushing were recruited starting on June 8, 2023, and the required sample size was reached by October 12, 2023. All subjects should meet the diagnostic criteria of TCM syndromes for facial flushing. Patients who meet the diagnostic criteria will be studied in the Department of Dermatology, Affiliated Hospital of Guangdong Medical University. After obtaining informed consent from patients with facial flushing, a total of 100 patients with facial flushing were included in this study, including 62 males and 38 females, aged 22 to 45 years, with an average age of (35.12±2.53) years.
[0115] Diagnostic criteria
[0116] (1) Predisposing sites: the entire face or the cheekbones. (2) Characteristics of skin lesions: paroxysmal facial flushing and burning sensation may occur when the patient is emotionally excited or exposed to heat. Some patients also experience sweating and irritability. The flushing will gradually subside or even disappear after a period of rest. (3) Characteristics of the course of disease: recurrent attacks may last for several months, several years, or even more than 10 years, but generally lasts for 2 to 5 years. (4) Identification characteristics: Facial capillaries in telangiectasia continue to dilate, causing facial flushing. Strips or reticular dilated capillaries can be seen on the face, which are not easy to subside.
[0117] Inclusion criteria
[0118] (a) Pathological facial flushing caused by menopausal syndrome, carcinoid syndrome, contact dermatitis, diabetes, rosacea and other disease factors; (b) The treatment area is not complicated by other skin diseases; (c) Meet the diagnostic criteria for facial flushing.
[0119] Exclusion criteria
[0120] (a) Patients who have received treatment for facial flushing in the past month; (b) Pregnant or lactating women; (c) Patients whose facial flushing is caused by non-disease factors, such as emotional excitement, light, drinking, cold, taking anti-erectile dysfunction drugs, anti-anginal drugs, antihypertensive drugs, and long-term use of glucocorticoids; (d) Patients whose facial flushing is caused by non-pathological factors such as seborrheic dermatitis, perioral dermatitis, periocular dermatitis, seasonal facial dermatitis, solar dermatitis, cosmetic dermatitis, and hormone-dependent dermatitis, which are excluded through clinical manifestations and laboratory tests when necessary.
[0121] Treatment method: Patients with facial flushing who met the diagnostic criteria were randomly divided into 10 groups, with 10 patients in each group, namely Example 1-3 groups and Comparative Example 1-7 groups. Example 1-3 groups and Comparative Example 1-7 groups were provided with corresponding pharmaceutical compositions for redness reduction and repair, respectively. The treatment lasted for 4 weeks, and relevant efficacy indicators were evaluated at the end of the treatment.
[0122] Before treatment, the patient is advised to cleanse the face with a facial cleanser in warm water, and after drying the face, apply an appropriate amount of the medicinal composition for redness reduction and repairing as an ointment evenly to the treatment area, twice a day.
[0123] Efficacy criteria
[0124] Cure: The patient's original appearance is restored, and capillary dilation, skin flushing, etc. disappear;
[0125] Improvement: Skin color becomes lighter, capillary dilation, skin flushing, etc. are significantly reduced;
[0126] Ineffective: No significant changes were observed.
[0127] Total effective rate = (number of cured cases + number of improved cases) / total number of cases.
[0128] Observation indicators
[0129] The patients' skin flushing (none, mild, obvious, severe, 0-3 points) and capillary dilation (none, mild, obvious, severe, 0-3 points) were scored before treatment and 4 weeks after treatment. The higher the score, the more severe the skin flushing.
[0130] Determination method
[0131] The transepidermal water loss (TEWL) of the patients was measured using TM300-skin water loss meter (CK, Germany), and the thickness of the stratum corneum was measured using optical coherence tomography.
[0132] Optical coherence tomography (OCT) was performed using a SkinDex 300 instrument (ISIS Optronics GmbH, Mannheim, Germany). It uses a 1300 nm laser with a power of less than 20 mW to produce cross-sectional images of 1 mm wide and 0.9 mm deep on the skin. The spatial resolution is 3 μm (lateral) · 5 μm (depth), and images are collected in a three-dimensional enhanced mode and exported as bmp files. The images were acquired using the Optimas TM The thickness of the stratum corneum was determined using a custom image analysis algorithm written in 6.5 (Media Cybernetics LP, Silver Spring, MD, USA). Three images were taken at three locations of facial flushing, and the thickness of the stratum corneum of the skin at the facial flushing site was calculated after the distinct upper and lower SC edges were determined.
[0133] Examples 1 to 3, Comparative Examples 1-7, the results of observation of the therapeutic effects of Examples 1 to 3 are shown in Table 1; the results of observation of skin flushing, capillary dilation, transepidermal water loss (TEWL), and the average thickness of the stratum corneum are shown in Table 2.
[0134] Table 1
[0135]
[0136]
[0137] As shown in Table 1, the total effective rates of Examples 1 to 3 and Comparative Examples 1 to 7 are the same, and both can effectively improve the symptoms of facial flushing. However, the cure effects of Examples 1 to 3 are significantly better than those of Comparative Examples 1 to 6, indicating that in terms of cure, there is a synergistic effect between chamomile and ectoine, between Sophora flavescens and Cnidium monnieri, and between Cnidium monnieri and Paeonia lactiflora. The total effective rate of Comparative Example 7 is significantly low, indicating that the pharmaceutical composition for redness reduction and repair is absorbed by the facial skin in the form of a nanostructured lipid carrier, and the cure rate of facial flushing is good.
[0138] Table 2
[0139]
[0140]
[0141] As shown in Table 2, compared with before treatment, it was observed that after treatment, the scores of skin flushing and telangiectasia of patients in Example 1 to 3 groups and Comparative Example 1-6 groups were significantly reduced; the scores of skin flushing and telangiectasia of patients in Example 1 to 3 groups were significantly lower than those in Comparative Example 1-6 groups, indicating that in the treatment of skin flushing and telangiectasia, there is a synergistic effect between chamomile and ectoine, between Sophora flavescens and Cnidium monnieri, and between Cnidium monnieri and Paeonia lactiflora. After treatment, the difference in the scores of skin flushing and telangiectasia of patients in Comparative Example 7 group was small, indicating that the pharmaceutical composition for redness removal and repair is absorbed by the facial skin in the form of a nanostructured lipid carrier, the thickness of the stratum corneum is increased, and the improvement of skin flushing and telangiectasia is relatively obvious. From the measurement results of transepidermal water loss (TEWL), compared with before treatment, the transepidermal water loss (TEWL) of patients in Example 1 to 3 groups and Comparative Example 2-6 groups after treatment was significantly reduced, indicating that the pharmaceutical composition for redness removal and repair of the present invention has a repairing effect on the skin barrier function. Since Comparative Example 1 does not contain ectoine, it has no improvement effect on the repair of barrier function, so the transepidermal water loss (TEWL) does not change much, while the transepidermal water loss (TEWL) of patients in Comparative Example 7 group is significantly increased, indicating that increasing the thickness of the stratum corneum is very important for improving skin flushing and capillary dilation; from the measurement results of the thickness of the stratum corneum, the stratum corneum of the skin of patients in Example 1 to 3 groups and Comparative Example 1-6 groups is significantly increased, while the thickness of the stratum corneum of the skin of patients in Comparative Example 7 group is slightly reduced, indicating that the pharmaceutical composition for redness removal and repair is absorbed by the facial skin in the form of a nanostructured lipid carrier, thereby increasing the thickness of the stratum corneum.
[0142] Conclusion: The pharmaceutical composition for redness reduction and repair provided by the present invention can increase the thickness of the stratum corneum, has a good curative effect on patients with persistent facial flushing and established capillary dilation, and can reduce facial redness.
[0143] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.
Claims
1. A pharmaceutical composition for redness reduction and repair, characterized in that: The ointment is prepared from raw materials according to the following weight ratio: 8-10 parts of chamomile, 6-12 parts of oriental rhizome, 5-10 parts of sophora flavescens, 6-12 parts of cnidium monnieri, 6-15 parts of kochia scoparia, 1-5 parts of small molecule sodium hyaluronate, 9-15 parts of ectoine, 3-10 parts of safflower, 6-12 parts of ophiopogon japonicus, 9-12 parts of mountain peony root, and 9-12 parts of white peony root; the ointment is composed of an ointment matrix, a nanostructured lipid carrier of a traditional Chinese medicine extract, and glycerol, and the ointment matrix is honey.
2. A pharmaceutical composition for redness reduction and repair according to claim 1, characterized in that: The ointment is prepared from raw materials according to the following weight ratio: 10 parts of chamomile, 8 parts of oriental rhizome, 5 parts of sophora flavescens, 10 parts of cnidium monnieri, 6 parts of kochia scoparia, 5 parts of small molecule sodium hyaluronate, 10 parts of ectoine, 8 parts of safflower, 12 parts of ophiopogon japonicus, 9 parts of paeonia lactiflora and 12 parts of white peony root.
3. A pharmaceutical composition for redness reduction and repair according to claim 1, characterized in that: The ointment is a skin ointment.
4. A method for preparing a pharmaceutical composition for redness removal and repair according to any one of claims 1 to 3, characterized in that: The following steps are involved: S1. Weigh 6-12 parts of Rhizoma Alismatis, 5-10 parts of Sophora flavescens, 6-12 parts of Fructus Cnidii, 6-15 parts of Fructus Kochiae, 6-12 parts of Ophiopogon japonicus, 9-12 parts of Rhizoma Paeoniae Alba, and 9-12 parts of Radix Paeoniae Alba by weight, and soak them in water for 30-60 minutes; S2, prepare Chinese medicine extract: after soaking, mix together oriental rhizome, sophora flavescens, cnidium monnieri, kochia scoparia, ophiopogon japonicus, peony root and white peony root, add water and boil, boil quickly with high heat, switch to slow fire and simmer for 15 to 20 minutes, weigh 8 to 10 parts of chamomile and 3 to 10 parts of safflower by weight, add them to the decoction, continue to simmer for 10 minutes, filter out the residue, collect the Chinese medicine decoction, weigh 1 to 5 parts of small molecule sodium hyaluronate and 9 to 15 parts of ectoine by weight, add them to the Chinese medicine decoction, use high shear to disperse the drug in the Chinese medicine decoction by high shear force, and obtain nano Chinese medicine extract after concentration; S3. Preparation of nanostructured lipid carriers of Chinese herbal medicine extracts: weigh lipids, dissolve the nano-TCM extracts and lipids in a mass ratio of 1:1 in 15 mL of 85°C ethanol, and obtain a lipid phase after rotary evaporation of the ethanol; dissolve a surfactant in 10 mL of 85°C distilled water to obtain an aqueous phase; then quickly add the aqueous phase to the lipid phase to obtain a mixture; homogenize the mixture in an 85°C rotator for 10 minutes to obtain a pre-emulsion; and quickly cool the pre-emulsion in an ice-water mixture to obtain the nanostructured lipid carrier of Chinese herbal medicine extracts; S4. Preparing an ointment: mixing the nanostructured lipid carrier of the Chinese herbal extract, the ointment base and glycerol, stirring them evenly to prepare an ointment, which is the pharmaceutical composition for redness removal and repairing.
5. The method for preparing a pharmaceutical composition for redness removal and repairing according to claim 4, characterized in that: The ointment base is honey.
6. The method for preparing a pharmaceutical composition for redness removal and repairing according to claim 4, characterized in that: The lipid is ceramide.
7. The method for preparing a pharmaceutical composition for redness removal and repairing according to claim 4, characterized in that: The surfactant is selected from surfactants with little irritation to the skin, and the surfactant is glucoside.
8. Use of the pharmaceutical composition for redness removal and repairing according to any one of claims 1 to 3 in the preparation of a drug for redness removal and repairing.
Citation Information
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