JP5622775B2 - Composition for treating dermatosis, formulation using the same, and preparation method thereof - Google Patents

Description

  The present invention belongs to the field of cosmetics for skin or medicine, and specifically, it is used directly for the improvement and treatment of dermatoses or used on a part of skin in the form of cosmetics or medicines. The present invention relates to a composition for treating skin diseases. Furthermore, it is related with the formulation using the same and its control method.

  At present, with the development of society and the improvement of people's living standards, the pursuit of quality of life and the awareness of body health and skin health / beauty are getting stronger, so various new cosmetics are being introduced one after another. It is on the market. Currently, domestic and foreign cosmetics have the following problems: many cosmetics have only a moisturizing function that does not fundamentally change the physiological state of the skin, and some cosmetics are expensive to refine and process However, since the raw materials are likely to be altered or have a strange odor, it is necessary to use chemical components such as special preservatives. At the same time, it damages the skin. This product mainly prevents the product from being altered by using natural antioxidants.

  The skin that opposes the external environment as the outermost protective layer of the human body has a scaly shape because the epidermis proliferates against the instinct in the case of metabolic defects, friction or compression by external forces, and bacterial invasion. Causes skin lesions such as proliferation (psoriasis), octopus, crack-like proliferation (crested limbs), and chicken eyes. Human body cells must ingest many nutrient components such as, for example, unsaturated fatty acids essential to the human body and essential amino acids. The human body absorbs and uses these nutrients through various routes and transports them to skin cells as a primary barrier against the external environment. Insufficient nutritional components cause skin cell aging or lesions due to reduced immunity.

  In clinical practice and daily life, many patients suffering from the above-mentioned dermatoses have used medicines or cosmetics to improve the skin surface lesions, but conversely, due to inappropriate use, The balance of sebum is lost. In addition, when such drugs or cosmetics are used over the long term, the skin sebaceous glands are stimulated with feedback and abnormal secretion, and the skin becomes more sensitive to external stimuli, causing the skin to rupture and proliferate. Or cause spots or abscesses on the skin.

  Searching the disclosed patent literature, it was found that all patents relating to the treatment of skin diseases contain stimulating ingredients. Clinical experience has shown that long-term use of such drugs or cosmetics increases skin drug resistance and irritation, reduces skin self-healing power, and causes more side effects.

  Therefore, it is necessary to develop an external skin preparation that does not irritate the skin and has effects such as treatment or prevention of skin diseases, delay of skin aging and restoration of skin function.

  The object of the present invention is to prevent, ameliorate or treat skin-related diseases and skin functions that do not irritate the skin and can be used directly or on a part of the skin in the form of a cosmetic or pharmaceutical preparation It is intended to provide a composition for use in the repair of a drug, a preparation comprising the same, and a method for preparing the same.

  The present invention provides a composition for the treatment of skin diseases containing unsaturated fatty acids, collagen, amino acids, vitamins and inorganic salts. Among them, the unsaturated fatty acid may be one or more selected from unsaturated fatty acids essential to the human body such as oleic acid, linoleic acid, linolenic acid, and arachidonic acid. The unsaturated fatty acid used in the present invention is preferably a vegetable unsaturated fatty acid after purification, and a method such as solubilization, supercritical fluid extraction, or ultrasonic extraction can be used for the purification step. As the raw material of the vegetable unsaturated fatty acid, for example, various types of vegetable oils such as olive oil, rapeseed oil, sunflower oil and tea oil may be used. Collagen is a general term for a kind of protein, and may be extracted from animal raw materials such as fish, pigs and cows. The collagen may be collagen extracted by biotechnology, or may be collagen extracted by a chemical extraction method. The amino acids are one or more essential amino acids in the human body. Among them, the essential amino acids include eight amino acids such as lysine, tryptophan, phenylalanine, methionine, threonine, isoleucine, leucine, and valine. , Histidine, and arginine. As said vitamin, vitamin E and / or vitamin A are preferable. As the inorganic salt, a sodium salt and / or a potassium salt is preferable.

  In the above composition, the content of unsaturated fatty acid is 65% to 90% by weight, and the content of other components is 0.1% to 15% for collagen and 0.1% for amino acid. -10%, vitamins 0.1% to 10%, and inorganic salts 0.05% to 1%. Here, the unsaturated fatty acid may be one or more selected from the group consisting of oleic acid, linoleic acid, linolenic acid, arachidonic acid, and the like, and various unsaturated fatty acids can be mixed at different ratios. The amino acid may be one or more of amino acids essential for the human body, and the selection of the type of amino acid and the composition ratio thereof are determined according to the specific situation. As vitamins, vitamin E and vitamin A are preferable, and the contents thereof are preferably 0.1% to 1% for vitamin E and 0.1% to 1% for vitamin A. As the inorganic salt, sodium salt and potassium salt are preferable, and the content is preferably 0.05% to 0.9% for sodium salt and 0.05% to 0.1% for potassium salt. Among them, the sodium salt may exist in the form of sodium chloride, and the potassium salt may exist in the form of potassium chloride.

  The present invention further provides formulations comprising the composition prepared in various dosage forms suitable for use by adding excipients to the composition. For example, an ointment may be prepared by adding pharmaceutically acceptable excipients that can be creamed, and the efficacy of the formulation can be further improved with pharmaceutically acceptable surfactants as required. Alternatively, by adding an excipient that can be made into a pharmaceutically acceptable liquid, a mask prepared by further processing the liquid, the spray, and the above preparation may be prepared. In addition, although a formulation is prepared in order to use the composition of this invention more conveniently, an excipient | filler (and / or surfactant) and a fragrance | flavor are put into the composition of this invention in the concrete clinical application field. You may apply to the affected part of a patient's skin as it is, without adding.

  The content of each component in the preparation is 50% to 70% of unsaturated fatty acid, 0.1% to 10% of collagen, 0.1% to 6% of amino acid, 0.1% to 7% of vitamin, The inorganic salt is 0.05% to 1%, the excipient is 10% to 25%, and the vegetable flavor is 1% to 5%. Among them, 0.1% to 1% vitamin E and 0.1% to 1% vitamin A are preferable as vitamins. As the inorganic salt, 0.05% to 0.9% sodium salt and 0.05% to 0.1% potassium salt are preferable. The excipient may be each type of pharmaceutically acceptable adjuvant or surfactant, or may include natural vegetable flavors as required.

The present invention further provides a method for preparing the above preparation comprising the following steps.
(1) Taking raw materials according to the composition of the above preparation,
(2) A collagen and a water-soluble raw material are dissolved to obtain a water-soluble gel matrix. Here, the water-soluble raw materials are amino acids, vitamins and inorganic salts,
(3) After adding an excipient and an appropriate amount of a surfactant to the unsaturated fatty acid and mixing them uniformly, the water-soluble gel matrix obtained in step (2) is gradually added and uniformly emulsified. Obtain an ointment or solution,
(4) Finish the final product and package it.

  Here, the unsaturated fatty acid may be one or more selected from the group consisting of oleic acid, linoleic acid, linolenic acid, arachidonic acid, and the like, and is extracted from a plant unsaturated fatty acid. The purification step may employ methods such as solubilization, supercritical fluid extraction, and ultrasonic extraction, but a method of purifying unsaturated fatty acids by condensing plant unsaturated fatty acids and then performing high-speed centrifugation is preferred. Uses the difference in freezing point between saturated and unsaturated fatty acids for separation and purification. As the raw material of the plant unsaturated fatty acid, various types of vegetable oils such as olive oil, rapeseed oil, sunflower oil, tea oil may be used. The collagen may be collagen extracted by biotechnology, or may be collagen extracted by a chemical extraction method.

  The composition according to the present invention may be used directly on the skin, or may be used on a part of the skin in the form of a cosmetic or pharmaceutical preparation. The above preparation may be various skin dosage forms, and examples thereof include an ointment, a liquid, and a spray. In addition, it may be combined with other materials. For example, an ointment or liquid is applied to a single-layer thin film base, processed into a mask, and then packaged. The thin film base is made of pure cotton, non-woven fabric or synthetic fiber material.

  Hereinafter, pharmacological analysis of the composition according to the present invention is performed. All the components in the composition of the present invention are essential nutrients for the human body, and many of them must be supplemented from the outside world. All the ingredients are safe to eat. All nutritional components are absorbed through the skin and supplied to the skin cells without the need for systemic circulation, ensuring the nutrition of the skin cells, improving immunity, restoring their own ability to the skin, Resist intrusion and virus infringement.

  Based on the Chinese medicine skin osmotic therapy theory, this product is rich in active nutrients and nutrients, and can quickly penetrate the skin and quickly replenish the nutrients lacking skin cells, enhancing the cell's regenerative function In addition to removing stratum corneum, heavy metals and chemical contaminants that block pores, and reducing pore size, it also contributes to the treatment of diseases such as acne, pustules, cysts and ulcers on the skin surface.

  The product according to the present invention supplements the skin with the necessary nutrients, improves the microcirculation of the skin, improves the immunity of the cells themselves, and maintains the normal physiological elements necessary for skin growth and repair In addition, the normal form and function of the skin tissue can be maintained, the ability of the skin tissue to resist the invasion from the outside world can be enhanced, and the health of the skin tissue surface can be maintained.

  The composition according to the present invention and a preparation using the composition have remarkable effects in clinical experiments, and also have skin diseases such as neurodermatitis (psoriasis), acne, tinea pedis, onychomycosis, chicken eye, and onychomyelitis. Immediate effects appear.

  Hereinafter, the present invention will be further described with reference to examples. The following examples are intended to allow those skilled in the art to further understand the present invention, but the present invention is not limited to these examples.

Example 1: Ointment The raw material was taken according to the following composition and ratio. First, after condensing olive oil, the unsaturated fatty acid was purified by high-speed centrifugation. 65 g of purified unsaturated fatty acid, 2 g of a mixture of lysine, tryptophan, phenylalanine, methionine, threonine, isoleucine, leucine, and valine, 5 g of purified fish scale collagen peptide, 0.9 g of sodium chloride, and 0.1 g of potassium chloride In addition, 0.1 g of vitamin E and 0.1 g of vitamin A were used, and 25 g of propolis and 1.8 g of vegetable flavor were added thereto. Next, a water-soluble gel matrix was obtained by dissolving collagen, amino acids and inorganic salts in water. Next, 25 g of propolis is added to the unsaturated fatty acid in which the vitamin is dissolved, and the mixture is mixed until uniform, and then the water-soluble gel matrix is gradually added to the mixture and uniformly emulsified to obtain an ointment. It was. Finished product and packaged.

Example 2: Ointment The same preparation method as in Example 1 was used. Here, the raw materials were taken according to the following composition and ratio. 70 g of purified olive oil, 0.1 g of fish scale collagen peptide, 0.1 g of a mixture of 8 amino acids such as lysine, 0.05 g of vitamin A, 0.05 g of vitamin E, 0.05 g of NaCl, propolis 25 g and 4.65 g of vegetable flavor were used.

Example 3: Ointment The same preparation method as in Example 1 was used. Here, the raw materials were taken according to the following composition and ratio. 65 g of purified rapeseed oil, 10 g of fish scale collagen peptide, 6 g of a mixture of 8 amino acids such as lysine, 3.5 g of vitamin A, 3.5 g of vitamin E, 0.5 g of NaCl, 0.1 g of KCl, Propolis was 10 g and vegetable flavor was 1.4 g.

Example 4: Ointment The same preparation method as in Example 1 was used. Here, the raw materials were taken according to the following composition and ratio. 60 g of purified sunflower oil, 5.5 g of fish scale collagen peptide, 1.5 g of a mixture of 8 amino acids such as lysine, 2.0 g of vitamin A, 1.5 g of vitamin E, 0.4 g of NaCl, KCl 0.1 g, 24 g of petrolatum, and 5 g of vegetable fragrance were used.

Example 5: Ointment The same preparation method as in Example 1 was used. Here, the raw materials were taken according to the following composition and ratio. 55 g of purified tea oil, 8 g of fish scale collagen peptide, 3 g of a mixture of 8 amino acids such as lysine, 3.0 g of vitamin A, 2.0 g of vitamin E, 0.9 g of NaCl, 0.1 g of KCl , 25 g of petroleum jelly and 3 g of vegetable flavor were used.

Example 6: Ointment The same preparation method as in Example 1 was used. Here, the raw materials were taken according to the following composition and ratio. 50 g of purified olive oil, 10 g of fish scale collagen peptide, 6 g of a mixture of 8 amino acids such as lysine, 3.5 g of vitamin A, 3.5 g of vitamin E, 0.9 g of NaCl, 0.1 g of KCl, Vaseline was 22 g, and vegetable flavor was 4.0 g.

Example 7: Solution The raw material was taken according to the following composition and ratio. First, after condensing olive oil, the unsaturated fatty acid was purified by high-speed centrifugation. 80 g of purified unsaturated fatty acid, 6 g of lysine, tryptophan, phenylalanine, methionine, threonine, isoleucine, leucine, valine mixture, 10 g of fish scale collagen peptide, 0.9 g of sodium chloride, 0.1 g of potassium chloride, vitamin 1.5 g of E and 1.5 g of vitamin A were used. Next, a water-soluble gel matrix was obtained by dissolving collagen, amino acids and inorganic salts in water. Subsequently, the water-soluble gel matrix was gradually added to the unsaturated fatty acid in which the vitamin was dissolved, and the mixture was uniformly emulsified to obtain a solution. Thus, the final product was finished and packaged.

Example 8: Mask The product described in Example 1 or Example 7 is applied to a single-layer thin film substrate, processed into a mask, and then packaged. The thin film base is made of pure cotton, non-woven fabric or synthetic fiber material.

Clinical Experimental Example The preparation according to the present invention was greatly applied to clinical practice, and effective feedback was obtained. That is, in clinical application, it has the role of improving skin blood circulation, strengthening skin immunity and skin nutrition, softening stratum corneum, improving facial color and promoting pigment absorption, and stratum corneum that blocks pores It can remove heavy metals and chemical contaminants, prevent radiation, and supply nutrients to the skin. In addition, it is rich in active nutrients and nutrients, can quickly penetrate the skin and quickly replenish the nutrients lacking skin cells, and has immediate effect. In addition, the pores can be shortened, the cell regeneration can be enhanced, the nutrients necessary for the skin can be supplemented, and the immunity of the cells themselves can be improved. A clinical observation experiment in which skin diseases are treated using the preparation according to the present invention is shown below.

  Clinical observational experiment 1: Treatment of psoriasis.

1. Basic materials:
There are a total of 40 psoriasis patients, and all cases are randomly divided into a control group and an experimental group, and one group is 20 cases.

2. Experimental method:
A clinically used glucocorticoid was applied once a day and night to the skin of a control group patient, and after 7 days, azithromycin cream was applied three times a day. The ointment of Example 1 of the present invention was applied once each day and night to the onset sites of the experimental group patients. Then, on the seventh day, the first month, and the second month after the start of the experiment, the skin recovery conditions of the two groups of patients were observed.

3. Treatment effect:
The control group patients began to feel better and smoother after 7 days of using glucocorticoids. After 7 days, azithromycin ointment was used instead of glucocorticoid and treatment was continued for 3 weeks. One month after the start of treatment, some scales of psoriasis began to soften and peel off. Two months after the start of treatment, the treatment situation is not much different compared to one month after the start of treatment, and the patient's psoriasis improved, but no patients were completely cured.

  Patients in the experimental group began to feel better and smoother after 7 days using the formulation according to the present invention, but the control group is more effective. One month after the start of use, some scales of psoriasis began to soften and peel off, but there is not much difference compared to the control group. Two months after the start of use, of the 20 patients, 18 patients were almost completely cured, one patient improved greatly, and one patient did not improve.

  At the beginning of use, the therapeutic effect of the preparation according to the present invention on psoriasis is less immediate than that of hormones and antibiotics, but two months after the start of use, the preparation according to the present invention has clinically effective hormones and antibiotics. It has been clinically demonstrated that it has a better therapeutic effect on psoriasis than substance drugs. From the above results, it was found that the preparation according to the present invention is effective in treating skin diseases such as psoriasis, shortening the time for skin regeneration, and reducing side effects.

  Clinical observation experiment 2: Treatment of acne.

1. Basic materials:
There are a total of 50 acne patients, and all cases are randomly divided into a control group and an experimental group, and one group is 25 cases.

2. Experimental method:
The control group patients were orally administered with isotretinoin, which is a commonly used drug, twice a day, and the ointment of the present invention was applied once a day and night to the onset site of the experimental group patients. Then, on the second day, the seventh day, and the second week from the start of the experiment, the skin recovery status of the two groups of patients was observed.

3. Treatment effect:
The control group patients had improved skin 2 days after oral administration of isotretinoin. Seven days after oral administration, the skin was less effective than before. Two weeks after oral administration, the treatment status is not much different from that of one week after the start of treatment, and the patient's acne improved, but no patient was completely cured.

  The patients in the experimental group were superior to the control group since the skin started to become smooth and smooth after 2 days of using the preparation according to the present invention, and the acne pustules formed one day ago began to disappear. Seven days after use, 9 patients were completely better than the control group because acne pustules disappeared completely, 13 patients lost some pustules and 3 patients did not improve significantly. Two weeks after use, of 25 patients, 22 patients were completely cured, 2 patients improved significantly, and 1 patient did not improve.

  Two days after using the preparation according to the present invention, the therapeutic effect is superior to the control group, seven days after use, the therapeutic effect is remarkably superior to the control group, and two weeks after using the preparation according to the present invention, It has been clinically demonstrated that such a preparation has a significant therapeutic effect on acne compared to the control group. From the above results, it was found that when acne is treated using the preparation according to the present invention, skin regeneration time can be significantly shortened and side effects can be reduced.

In the following, typical clinical cases will be shown and their effects will be specifically explained.
Clinical Case 1: Lee XX, male, 61 years old, driving all year round so that the eyes are visible, but two weeks after using this product, the eyes start to become flexible and two months later It peeled off and was completely cured. At the same time, this product was used to treat senile plaques. After one month, most of the senile plaques became shallow and some disappeared.

  Clinical Case 2: White xx, male, 60 years old, working hard when young, thick foot octopus, needed to remove stratum corneum every two days, one week using this product After that, the stratum corneum becomes soft and it is no longer necessary to remove the stratum corneum with a sword. After one month, the octopus becomes thin and becomes the same as normal skin. At the same time, the skin of the foot becomes smooth and turns pink. It was.

  Clinical Case 3: Always xx, female, 58 years old, suffered from eczema, but was completely cured one week after using this product.

  Clinical Case 4: Wang xx, female, 21 years old, acne was severe, but using this product, thinly applied 2-3 times a day on the onset site, two days after the start of use, a new acne red swelling 2 weeks after the start of use, the red swollen part of the acne that was made long ago disappears, the pus bulb in the hair follicle disappears, the site of onset becomes smooth, and one month of start of use Later, the remaining pigment disappeared.

  Clinical Case 5: Goxx, male, 35 years old, psoriasis in winter, did not improve even after taking medicines or receiving injections. -3 times, itch was stopped immediately, and after 2 weeks from the start of use, the scales were peeled off and the onset site became smooth, and one month after the start of use, the remaining red New Skin and pigment were deposited and disappeared.

  Clinical Case 6: Acupuncture xx, male, 36 years old, suffered from periodontitis, but improved immediately after one month of using this product.

  From the above cases, it was found that the composition of the present invention and the preparation using the composition were excellent in the therapeutic effect on clinically normal skin diseases.

Claims (9)

A composition for the treatment of acne ,
The composition comprises unsaturated fatty acids, collagen, amino acids, vitamins and inorganic salts;
In the composition, the unsaturated fatty acid content is 65% to 90%, the collagen content is 0.1% to 15%, and the amino acid content is 0.1% by weight. % is 10%, 0.1% to 10% content of the vitamin, Ri 0.05% to 1% der content of the inorganic salt,
Vitamin A is included as the vitamin,
A composition for the treatment of acne characterized by the above. The composition for treating acne according to claim 1, wherein the unsaturated fatty acid is at least one selected from the group consisting of arachidonic acid, oleic acid, linolenic acid, and linoleic acid. The acne treatment according to claim 1, wherein the amino acid is one or more selected from the group consisting of glutamic acid, lysine, tryptophan, phenylalanine, methionine, threonine, isoleucine, leucine, valine, histidine, and arginine. Composition. The composition for treating acne according to claim 1, further comprising vitamin E as the vitamin . The composition for treating acne according to claim 1, wherein the inorganic salt is a sodium salt and / or a potassium salt. The content of each component is% by weight, 65% to 70% of unsaturated fatty acid, 0.1% to 10% of collagen, 0.1% to 6% of amino acid, and 0.1% to 7% of vitamin. , inorganic salts 0.05% to 1%, excipient 10% to 25%, and Ri 1% to 5% der vegetable flavor,
A preparation for the treatment of acne , which comprises vitamin A as the vitamin . The preparation for acne treatment according to claim 6, wherein the vitamin comprises 0.1% to 1% vitamin E and 0.1% to 1% vitamin A. The preparation for treating acne according to claim 6, wherein the inorganic salt comprises 0.05% to 0.9% sodium salt and 0.05% to 0.1% potassium salt. Taking the raw material according to the composition of the formulation;
Dissolving collagen and a water-soluble raw material to obtain a water-soluble gel matrix;
Adding an excipient to the unsaturated fatty acid and mixing uniformly, then gradually adding other ingredients and uniformly emulsifying to obtain a formulation; and
The method for preparing a therapeutic formulation for acne according to claim 6, comprising finishing and packaging into a final product.