Antibacterial and antipruritic ointment for senile cutaneous pruritus and preparation method of antibacterial and antipruritic ointment

Abstract

The invention discloses a bacteriostatic and antipruritic ointment for senile cutaneous pruritus and a preparation method of the bacteriostatic and antipruritic ointment. The antibacterial and antipruritic ointment is prepared from the following raw materials: 1 to 10 parts of antipruritic traditional Chinese medicine composition, 0.1 to 1 part of benzalkonium chloride, 1 to 5 parts of sulfur, 0.1 to 1 part of vitamin E, 1 to 20 parts of yellow vaseline, 1 to 20 parts of cetostearyl alcohol, 1 to 15 parts of liquid paraffin, 1 to 5 parts of glycerol polyethylene glycol-75-stearate, 1 to 5 parts of polyoxyethylene lauryl ether, 5 to 20 parts of glycerol, 0.1 to 1 part of xanthan gum and 20 to 100 parts of water. The ointment provided by the invention selects the traditional Chinese medicine extract extracted by a specific method, and has the advantages of definite curative effect, small side effect and high safety. Meanwhile, the preparation method provided by the invention is simple and feasible, and is easy for large-scale production.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an antibacterial and antipruritic ointment for elderly skin itching and a preparation method thereof. Background Art

[0002] Skin itching is one of the common skin symptoms in the elderly over 65 years old. It has a long course and is not cured. It affects the sleep of the elderly, has a negative impact on the patient's mood, and seriously affects the patient's quality of life. Senile skin itching has its special reasons. The skin of the elderly is aging, the functions of various glands are reduced, the hydration capacity of the stratum corneum is reduced, the skin is dry, the protection is reduced, and it is easy to be stimulated by the outside world. The epidermis and dermis of the elderly skin are thinner, the number of melanocytes and Langerhans cells is reduced, and the structure and function of the skin appendages are changed, resulting in slower epidermal replacement and repair rates, and a decrease in the response to damage, barrier function, chemical clearance rate, sensory function, vascular reactivity, and body temperature regulation ability. Elderly skin itching has the characteristics of multiple, recurrent, lingering course, and is more likely to cause secondary skin lesions.

[0003] In the clinical treatment of skin itching in the elderly, Western medicine mainly uses topical glucocorticoids, and internal antihistamines and antibiotics as the main treatment methods. They are fast-acting, effective, and have desirable short-term effects, but they have shortcomings such as high recurrence rate, more side effects and adverse reactions, and limited populations. The efficacy of antihistamines is often poor, and itching is difficult to control and completely cure. Long-term use produces drug resistance, which reduces the efficacy and makes it difficult to achieve satisfactory results.

[0004] Pruritus is referred to as "itchy wind" or "wind pruritus" or "blood-wind sore" in traditional Chinese medicine. Traditional Chinese medicine has strong pertinence and various means in treating pruritus, which can achieve the effects of strengthening the body and eliminating evil, treating both the symptoms and the root causes, and taking both internal and external factors into consideration. In the prior art, patent documents such as CN105687614A, CN105213608A, CN105920181A, and CN118078917A all provide Chinese medicine compositions for treating skin itching, and their efficacy or extraction methods need to be further optimized. Generally speaking, the extraction efficiency of the effective ingredients in Chinese medicine extracts has an important influence on the stability of the extracts and the efficacy of the medicines. Commonly used extraction methods include water extraction, alcohol precipitation, ultrasonic extraction, microwave extraction, supercritical extraction, etc., such as water extraction and alcohol precipitation, which are simple to operate, but the extraction efficiency is general; supercritical extraction has high efficiency, but the operation is not easy to control. How to optimize the extraction method of the Chinese medicine composition is also worth exploring for the efficacy of the Chinese medicine composition.

[0005] In summary, as the aging process in my country continues to intensify, there is an urgent need to develop a traditional Chinese medicine product suitable for elderly skin itching that has a definite efficacy, good safety, no dependence, and is easy to use. In view of this, the present invention is proposed. Summary of the invention

[0006] In view of the above technical problems, the primary purpose of the present invention is to provide an antibacterial and antipruritic ointment for elderly skin itching. The ointment is made of a Chinese herbal extract extracted by a specific method, has a definite therapeutic effect, few side effects and high safety.

[0007] The second object of the present invention is to provide a method for preparing the antibacterial and antipruritic ointment, which is simple, feasible and easy to mass produce.

[0008] In order to achieve the above object, the present invention adopts the following technical solution:

[0009] In a first aspect, the present invention provides an antibacterial and antipruritic ointment for senile skin itching, which is prepared from the following raw materials: 1 to 10 parts of an antipruritic Chinese medicine composition, 0.1 to 1 parts of benzalkonium chloride, 1 to 5 parts of sulfur, 0.1 to 1 parts of vitamin E, 1 to 20 parts of vaseline, 1 to 20 parts of cetostearyl alcohol, 1 to 15 parts of liquid paraffin, 1 to 5 parts of glycerol polyethylene glycol-75-stearate, 1 to 5 parts of lauryl alcohol polyoxyethylene ether, 5 to 20 parts of glycerol, 0.1 to 1 part of xanthan gum, and 20 to 100 parts of water.

[0010] In the above technical scheme, the antipruritic Chinese herbal composition is screened by the inventor, and the specific antipruritic Chinese herbal composition is used in combination with sulfur, which can break the disulfide bonds of skin keratin molecules and produce a keratin loosening effect. The combination of the two not only has a good bactericidal and insecticidal effect, but also has a good antipruritic effect, and the prepared product has low irritation, high safety and good stability.

[0011] As a preferred embodiment of the technical solution of the present invention, the antibacterial and antipruritic ointment is prepared from the following raw materials: 5 parts of antipruritic Chinese medicine composition, 0.5 parts of benzalkonium chloride, 1.5 parts of sulfur, 0.2 parts of vitamin E, 7 parts of vaseline, 9 parts of cetostearyl alcohol, 6 parts of liquid paraffin, 2 parts of glycerol polyethylene glycol-75-stearate, 3 parts of lauryl alcohol polyoxyethylene ether, 10 parts of glycerol, 0.3 parts of xanthan gum, and 55 parts of water.

[0012] As a preferred embodiment of the technical solution of the present invention, the antipruritic Chinese medicine composition is prepared from the following raw materials: 20 to 300 parts of Portulaca Oleracea, 30 to 300 parts of Dictamni Cortex, 30 to 300 parts of Kochia scoparia, 30 to 300 parts of Sophora flavescens, 20 to 200 parts of Cnidium monnieri, 10 to 300 parts of Cyclocarya paliurus leaves, and 7 to 300 parts of Citrus aurantium.

[0013] In the above technical scheme, the antipruritic Chinese medicine composition used has been obtained by repeated screening by the inventor. In the square, Sophora flavescens is the main drug, bitter and cold in nature, and is the main drug for clinical treatment of pruritus. It has outstanding insecticidal and antipruritic effects, and is safe for external use without adverse reactions. In the square, Dictamni is bitter, slightly pungent, cold in nature, clears away heat and dampness, detoxifies, dispels wind and stops itching, and is commonly used to treat skin itching; In the square, Kochia scoparia removes skin heat accumulation, removes skin itching, and is used with Dictamni to strengthen the effect; In the square, Fructus Aurantii Immaturus is bitter and fragrant in nature, sour and cool, and can remove wind itching formed by the mutual binding of evil qi such as cold evil, heat evil and tangible evil such as phlegm and blood stasis, and numbness and pain in the skin; In the square, Fructus lilii chinensis is externally used for antibacterial, anti-inflammatory, and dampness removal, and is used to treat stubborn moss; In the square, Fructus cnidii dispels wind and dampness and stops itching, and the above are used together to clear away heat and dampness, and dispel wind and stop itching as ministerial drugs. Purslane can clear away heat and detoxify, relieve swelling and relieve pain, and has a good effect on non-healing sores, contact dermatitis, and suppurative diseases, and is an adjuvant. The six medicines of the Chinese medicine composition of the present invention help each other to play the functions of clearing away heat and detoxifying, cooling blood and removing dampness, and killing insects and relieving itching.

[0014] The unique feature of the prescription is the use of Citrus aurantium and Cyclocarya paliurus leaves. Citrus aurantium is good at relieving itching. Although it was recorded in the Shennong's Herbal Classic, it was rarely recorded in later herbal books. It can relieve itching and treat itching caused by urticaria and other reasons. In clinical application, Citrus aurantium can be added to all cases of skin itching, especially those with obvious symptoms on the upper body. For more stubborn itching symptoms, Citrus aurantium is generally added to promote the flow of wind and dispel wind, while promoting the circulation of qi and blood. This is called "treating wind first treats blood, and blood circulation eliminates wind by itself". Cyclocarya paliurus leaves are bitter and warm in nature, and have the effects of dispelling wind and dampness, killing insects and relieving itching, and reducing swelling and relieving pain. Current research mainly focuses on the effects of Cyclocarya paliurus leaves in lowering blood sugar and lipids, losing weight, anti-aging, and anti-tumor. It can be used to relieve stubborn ringworm, that is, chronic stubborn skin diseases, which are mostly caused by wind, dampness, heat, and insects. It can also relieve eczema, urticaria, sores, swelling and pain.

[0015] As a further preferred embodiment of the technical solution of the present invention, the antipruritic Chinese medicine composition is prepared from the following raw materials: 100 parts of Portulaca Oleracea, 150 parts of Dictamni Cortex, 150 parts of Kochia Fruit, 200 parts of Sophora Flavescentis, 100 parts of Cnidium monnieri, 200 parts of Cyclocarya paliurus leaves, and 150 parts of Citrus aurantium.

[0016] In a second aspect, the present invention provides a method for preparing the antibacterial and antipruritic ointment, comprising the following steps:

[0017] (1) Pretreatment of the antipruritic Chinese medicine composition: firstly weigh each substance in the antipruritic Chinese medicine composition according to weight, and then extract it to obtain a Chinese medicine extract; then mix the obtained Chinese medicine extract, the first part of water, the first part of glycerol and sulfur, stir evenly and then perform homogenization to obtain a pretreated dispersion;

[0018] (2) Treatment of the aqueous phase: Add the second portion of water to the emulsification tank, add the pre-treated dispersion, stir evenly, then add the second portion of glycerin and xanthan gum, stir evenly, then add benzalkonium chloride, heat to 80-85° C., stir evenly, and keep warm for later use;

[0019] (3) Treatment of the oil phase: Add liquid paraffin to the oil phase tank, then add vitamin E, cetostearyl alcohol, yellow vaseline, glyceryl polyethylene glycol-75-stearate, and lauryl alcohol polyoxyethylene ether, heat to 75-80° C., stir evenly, and keep warm for later use;

[0020] (4) Emulsification: The insulated material in step (3) is cooled, sieved and added to the insulated water phase in step (2), stirred homogeneously, and then cooled to 40-48° C.; then, the pre-treated dispersion obtained in step (1) is added and stirred homogeneously again.

[0021] As a preferred embodiment of the technical solution of the present invention, in step (1), the extraction of the Chinese medicine extract comprises the following steps:

[0022] S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment, and release the pressure quickly after the treatment is completed to obtain a pretreated material;

[0023] S2, countercurrent extraction: adding an aqueous solvent containing a surfactant to a countercurrent extractor, and then adding the pretreated material obtained in step S1, and then performing a countercurrent extraction treatment; after the treatment is completed, an extract is obtained;

[0024] S3, centrifugal filtration: the extract obtained in step S2 is filtered under pressure to obtain a filtrate; the obtained filtrate is heated and concentrated, and the filtrate is centrifuged twice to remove the precipitate to obtain the product.

[0025] As a further preferred embodiment of the technical solution of the present invention, in step S1, saturated water vapor is used for steam explosion treatment, the steam explosion pressure is 1.1-1.25 MPa, and the pressure maintenance time is 30-90 s.

[0026] As a further preferred embodiment of the technical solution of the present invention, in step S2, the surfactant is cocamidopropyl betaine with a concentration of 0.04-0.1 wt%.

[0027] As a further preferred embodiment of the technical solution of the present invention, in step S2, the mass ratio of the water solvent to the pretreated material is 6 to 12:1; the countercurrent extraction temperature is 30 to 35°C, and the extraction time is 0.5 to 5h.

[0028] As a further preferred embodiment of the technical solution of the present invention, in step S3, the first centrifugal treatment time is 10 to 30 minutes; the second centrifugal treatment time is 15 to 35 minutes.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] (1) The antibacterial and antipruritic ointment provided by the present invention uses a specific antipruritic Chinese medicine composition in combination with sulfur, which can break the disulfide bonds of skin keratin molecules and produce a keratin loosening effect. The combination of the two not only has a good bactericidal and insecticidal effect, but also has a good antipruritic effect. The obtained product has low irritation, high safety and good stability.

[0031] (2) The antibacterial and antipruritic ointment provided by the present invention uses an antipruritic Chinese medicine composition obtained through repeated screening by the applicant. The various drugs in the prescription are combined to play the effects of clearing away heat and detoxifying, cooling blood and removing dampness, killing insects and relieving itching, and can treat both the symptoms and the root causes of senile skin pruritus. Studies have confirmed that the Chinese medicine composition of the present invention has a reliable and real effect on senile skin pruritus, and has a good effect on mild, moderate and even severe pruritus. The Chinese medicine composition of the present invention is non-toxic and harmless, safe and reliable, has no adverse reactions after use, and is safe to use.

[0032] (3) The preparation method of the antipruritic Chinese medicine composition provided by the present invention, combined with the advantages of steam explosion and countercurrent extraction, first performs steam explosion treatment, fully releases the effective substance, and facilitates the subsequent countercurrent leaching for short-term and efficient extraction; countercurrent leaching uses a water solvent, and a small amount of cocamidopropyl betaine is added as an extraction aid, which is a surfactant commonly used in cosmetics, and the ingredients are safe to use. By using cocamidopropyl betaine, the interfacial tension between the active substance of traditional Chinese medicine and the solvent can be reduced, and the extraction efficiency can be further improved. Compared with the existing commonly used flash extraction centrifugation, water extraction and alcohol precipitation methods, the extract obtained by the method provided by the present invention has good stability and high extraction efficiency.

[0033] (4) The present invention compares various extraction methods of Chinese medicine compositions and finds that the preparation method of the present invention is the best. Specifically, the freezing and standing process of the percolation method in the traditional process is the process of destroying the colloidal solution, so that the high-molecular impurities are precipitated; the alcohol precipitation method changes the hydrophilicity of the high-molecular impurities by adding ethanol to cause them to precipitate. The higher the ethanol concentration, the more times the precipitation is performed, the more complete the impurities are removed, but the loss of effective ingredients is greater; the preparation method provided by the present invention, the steam explosion + countercurrent extraction + membrane filtration method, on the basis of fully extracting the effective ingredients, finally uses a high-molecular filtration membrane (such as a porous semipermeable membrane, etc.) as the medium, and utilizes the selective screening effect of the membrane pores to intercept the substances, so that the solvent and low-molecular substances pass through, while the high-molecular substances cannot pass through, thereby achieving the purpose of separation and purification, so that the final extract obtained by the present invention has good stability, and no flocculation precipitation occurs during the stability investigation period as in other extraction methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is a photo of the composition extract obtained in Example 1 after being left for one month.

[0035] Figure 2 This is a photograph of the extract of the composition prepared in Comparative Example 1 after being left for one month.

[0036] Figure 3 This is a photo of the extract of the composition prepared in Comparative Example 2 after being left for one month.

[0037] Figure 4 This is a photo of the extract of the composition prepared in Comparative Example 3 after being left for one month. DETAILED DESCRIPTION

[0038] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0039] Unless otherwise specified, the raw materials used in the present invention can be purchased from ordinary pharmacies or markets, and their specifications meet national pharmaceutical standards. The purchase information of some raw materials is as follows: cetostearyl alcohol was purchased from Shanghai Jinjinle Industrial Co., Ltd.; glycerol polyethylene glycol-75-stearate is available under the trade name of Gelot TM 64, purchased from Gattefossé (Shanghai) Trading Co., Ltd.; the trade name of lauryl alcohol polyoxyethylene ether is Brij L4, purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; the brand name of cocamidopropyl betaine is CAB-35, purchased from Qingdao Huayuan Polymer Co., Ltd. The polymer filtration membrane can be selected from common products on the market, such as filtration membrane products that can retain 3000 molecular weight.

[0040] In the present invention, the steam explosion equipment and countercurrent extractor used are common equipment, which are obtained from the market.

[0041] Example 1

[0042] An antipruritic Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0043] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0044] In this embodiment, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0045] S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment (saturated water vapor, explosion pressure 1.15 MPa, pressure maintenance time 60 s), and release the pressure quickly after the treatment is completed to obtain the pretreated material;

[0046] S2, countercurrent extraction: add an aqueous solvent containing cocamidopropyl betaine (concentration 0.06wt%) to a countercurrent extractor, then add the pretreated material obtained in step S1 according to a mass ratio of aqueous solvent to pretreated material of 8:1, and then perform countercurrent extraction treatment (extraction temperature 30°C, time 1.5h); after the treatment is completed, an extract is obtained;

[0047] S3, centrifugal filtration: the extract obtained in step S2 is filtered by a suction machine with a polymer filter membrane to obtain a filtrate; the filtrate is heated and concentrated to a relative density of 0.125 g / mL, centrifuged for 20 min, and the precipitate is discarded and then heated and concentrated to a relative density of 1.0 g / mL, and then adjusted to a relative density of 0.8 g / mL, centrifuged for 20 min, the precipitate is removed, and the volume is weighed to 1.0 kg.

[0048] Example 2

[0049] An antipruritic Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0050] 80g of Portulaca Oleracea, 160g of Dictamni Cortex, 120g of Kochia scoparia, 180g of Sophora flavescens, 120g of Cnidium monnieri, 220g of Cyclocarya paliurus leaves, and 130g of Citrus aurantium.

[0051] In this embodiment, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0052] S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment (saturated water vapor, explosion pressure 1.15 MPa, pressure maintenance time 60 s), and release the pressure quickly after the treatment is completed to obtain the pretreated material;

[0053] S2, countercurrent extraction: add an aqueous solvent containing cocamidopropyl betaine (concentration 0.06wt%) to a countercurrent extractor, then add the pretreated material obtained in step S1 according to a mass ratio of aqueous solvent to pretreated material of 8:1, and then perform countercurrent extraction treatment (extraction temperature 30°C, time 1.5h); after the treatment is completed, an extract is obtained;

[0054] S3, centrifugal filtration: the extract obtained in step S2 is filtered by a suction machine with a polymer filter membrane to obtain a filtrate; the filtrate is heated and concentrated to a relative density of 0.125 g / mL, centrifuged for 20 min, and the precipitate is discarded and then heated and concentrated to a relative density of 1.0 g / mL, and then adjusted to a relative density of 0.8 g / mL, centrifuged for 20 min, the precipitate is removed, and the volume is weighed to 1.0 kg.

[0055] Example 3

[0056] An antipruritic Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0057] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0058] In this embodiment, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0059] S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment (saturated water vapor, explosion pressure 1.2 MPa, pressure maintenance time 50 s), and release the pressure quickly after the treatment is completed to obtain the pretreated material;

[0060] S2, countercurrent extraction: add an aqueous solvent containing cocamidopropyl betaine (concentration 0.05wt%) to a countercurrent extractor, then add the pretreated material obtained in step S1 according to a mass ratio of the aqueous solvent to the pretreated material of 9:1, and then perform a countercurrent extraction treatment (extraction temperature 30°C, time 1h); after the treatment is completed, an extract is obtained;

[0061] S3, centrifugal filtration: the extract obtained in step S2 is filtered by a suction machine with a polymer filter membrane to obtain a filtrate; the filtrate is heated and concentrated to a relative density of 0.125 g / mL, centrifuged for 20 min, and the precipitate is discarded and then heated and concentrated to a relative density of 1.0 g / mL, and then adjusted to a relative density of 0.8 g / mL, centrifuged for 20 min, the precipitate is removed, and the volume is weighed to 1.0 kg.

[0062] Example 4

[0063] The extract obtained in Example 1 was used to prepare an antibacterial and antipruritic ointment. In terms of components, the antibacterial and antipruritic ointment was prepared from the following raw materials: 5 g of an antipruritic Chinese medicine composition (the extract obtained in Example 1), 0.5 g of benzalkonium chloride, 1.5 g of sulfur, 0.2 g of vitamin E, 7 g of vaseline, 9 g of cetostearyl alcohol, 6 g of liquid paraffin, 2 g of glycerol polyethylene glycol-75-stearate, 3 g of lauryl alcohol polyoxyethylene ether, 10 g of glycerol, 0.3 g of xanthan gum, and 55 g of water.

[0064] In this embodiment, a method for preparing the above-mentioned antibacterial and antipruritic ointment is also provided, comprising the following steps:

[0065] (1) Pretreatment of the antipruritic Chinese medicine composition: The Chinese medicine extract obtained in Example 1, 4% water, 2% glycerol and sulfur were mixed, stirred evenly and then homogenized (about 10 minutes) to obtain a pretreated dispersion;

[0066] (2) Treatment of the aqueous phase: Add the remaining water to the emulsification tank, add the pre-treated dispersion, stir evenly, then add the remaining glycerin and xanthan gum, stir evenly, then add benzalkonium chloride, heat to 80°C, stir evenly, and keep warm for later use;

[0067] (3) Treatment of the oil phase: Add liquid paraffin to the oil phase tank, then add vitamin E, cetostearyl alcohol, yellow vaseline, glyceryl polyethylene glycol-75-stearate, and lauryl alcohol polyoxyethylene ether, heat to 80° C., stir evenly, and keep warm for later use;

[0068] (4) Emulsification: After cooling, the insulated material in step (3) is sieved and added to the insulated water phase in step (2), and homogenized and stirred for about 30 minutes (homogenization speed 3000 rpm, stirring speed 45 rpm), and then cooled to 45° C.; then, the pre-treated dispersion obtained in step (1) is added and homogenized and stirred again.

[0069] Comparative Example 1

[0070] Compared with Example 1, the difference between this comparative example and Example 1 is that the preparation method of the composition in this comparative example adopts the water extraction and alcohol precipitation method. Specifically, an antipruritic Chinese medicine composition for elderly skin itching is composed of the following raw materials by weight:

[0071] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0072] In this comparative example, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0073] S1, decoction extraction: weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, Fructus aurantii by weight, add 8 times the amount of water, heat and decoct for 1.0 hour each time, decoct 3 times, combine the decoctions, filter through 200 mesh, and obtain the pretreated material;

[0074] S2, concentration: the pre-treated material is concentrated under reduced pressure (temperature 75°C, vacuum degree -0.06~-0.08MPa) until the liquid concentration specific gravity is 1.05-1.10 (60°C~70°C) to obtain a concentrated solution;

[0075] S3, alcohol precipitation: the concentrated solution is transported to a stainless steel barrel, 95% ethanol is slowly added to make the alcohol content of the liquid reach 60%, refrigerated and allowed to stand for 36 hours, the supernatant is filtered through 200 mesh to a reflux extraction concentration tank, the filtrate is concentrated under reduced pressure to a relative density of 1.15-1.25 (60°C-70°C), the concentration temperature is 75°C, the vacuum degree is ≤-0.08Mpa, and the ethanol in the supernatant is recovered under reduced pressure until there is no alcohol taste;

[0076] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0077] Comparative Example 2

[0078] Compared with Example 1, the difference between this comparative example and Example 1 is that the preparation method of the composition in this comparative example adopts the percolation method. Specifically, an antipruritic Chinese medicine composition for elderly skin itching is composed of the following raw materials by weight:

[0079] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0080] In this comparative example, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0081] S1. Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus Aurantii Immaturus by weight, grind them with a grinder, and pass through a 40-mesh sieve to obtain Chinese medicine powder for later use;

[0082] S2, divided into percolation cylinders (put cotton balls in the percolation barrel), cover with filter paper, and press with small stones; soak with 1 times the amount of 70% ethanol for 30 minutes and then start percolation, the flow rate is controlled at about 4mL / min, add 3 times the amount of solvent at any time, and collect the percolation liquid below;

[0083] S3. Collect the percolate, filter through 200 mesh to a reflux extraction concentration tank; concentrate the filtrate under reduced pressure to a relative density of 1.15-1.25 (60°C-70°C), a concentration temperature of 75°C, and a vacuum degree of ≤-0.08Mpa; recover ethanol in the supernatant under reduced pressure until there is no alcohol taste.

[0084] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0085] Comparative Example 3

[0086] Compared with Example 1, the difference between this comparative example and Example 1 is that the preparation method of the composition in this comparative example adopts the reflux extraction method. Specifically, an antipruritic Chinese medicine composition for elderly skin itching is composed of the following raw materials by weight:

[0087] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0088] In this comparative example, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0089] S1. Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus Aurantii Immaturus by weight, grind them with a grinder, and pass through a 40-mesh sieve to obtain Chinese medicine powder for later use;

[0090] S2. Place the above Chinese medicine powder in a reflux pot, add 1 times the amount of 70% ethanol to soak for 25 minutes, then add 3 times the amount of ethanol to start heating reflux extraction, control the flow rate at 5mL / min, and continue to extract for 5 hours until it is exhausted;

[0091] S3, collecting the extract, filtering through 200 mesh to a reflux extraction concentration tank; concentrating the filtrate under reduced pressure to a relative density of 1.15-1.25 (60°C-70°C), a concentration temperature of 75°C, and a vacuum degree of ≤-0.08Mpa; recovering ethanol in the supernatant under reduced pressure until there is no alcohol taste;

[0092] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0093] Comparative Example 4

[0094] Compared with Example 1, the difference between this comparative example and Example 1 is that in step S2 of this comparative example, cocamidopropyl betaine is not added to the aqueous solvent. Specifically, a Chinese medicine composition for relieving itching of elderly skin is composed of the following raw materials by weight:

[0095] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0096] In this comparative example, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0097] S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment (saturated water vapor, explosion pressure 1.15 MPa, pressure maintenance time 60 s), and release the pressure quickly after the treatment is completed to obtain the pretreated material;

[0098] S2, countercurrent extraction: add water solvent to the countercurrent extractor, then add the pretreated material obtained in step S1 according to the mass ratio of water solvent to pretreated material of 8:1, and then perform countercurrent extraction treatment (extraction temperature 30°C, time 1.5h); after the treatment is completed, an extract is obtained;

[0099] S3, centrifugal filtration: the extract obtained in step S2 is filtered by a suction machine with a polymer filter membrane to obtain a filtrate; the filtrate is heated and concentrated to a relative density of 0.125 g / mL, centrifuged for 20 min, and the precipitate is discarded and then heated and concentrated to a relative density of 1.0 g / mL, and then adjusted to a relative density of 0.8 g / mL, centrifuged for 20 min, the precipitate is removed, and the volume is weighed to 1.0 kg.

[0100] Comparative Example 5

[0101] Compared with Example 1, this comparative example does not include step S1. Specifically, an antipruritic Chinese medicine composition for elderly skin itching is composed of the following raw materials by weight:

[0102] 100g of Portulaca Oleracea, 150g of Dictamni Cortex, 150g of Kochia scoparia, 200g of Sophora flavescens, 100g of Cnidium monnieri, 200g of Cyclocarya paliurus leaves, and 150g of Citrus aurantium.

[0103] In this comparative example, a method for preparing the above antipruritic Chinese medicine composition is also provided, comprising the following steps:

[0104] S1, countercurrent extraction: add an aqueous solvent containing cocamidopropyl betaine (concentration 0.06wt%) into a countercurrent extractor, then add the pretreated material obtained in step S1 according to the total mass ratio of the aqueous solvent to the antipruritic Chinese medicine composition of 8:1, and then perform countercurrent extraction treatment (extraction temperature 30°C, time 1.5h); after the treatment is completed, an extract is obtained;

[0105] S2, centrifugal filtration: the extract obtained in step S1 is filtered by a suction filter with a polymer filter membrane to obtain a filtrate; the filtrate is heated and concentrated to a relative density of 0.125 g / mL, centrifuged for 20 min, and the precipitate is discarded and then heated and concentrated to a relative density of 1.0 g / mL, and then adjusted to a relative density of 0.8 g / mL, centrifuged for a second time for 20 min, the precipitate is removed, and the volume is weighed to 1.0 kg.

[0106] Test Example 1

[0107] The Chinese medicine extract was prepared by using Example 1 and Comparative Examples 1 to 5, and the dry extract was obtained after further drying. The quality of the dry extract was measured, and the measurement results are shown in Table 1.

[0108] Table 1 Dry extract quality determination results

[0109] Test example Dry extract mass / g Example 1 210.4g Comparative Example 1 135.5 Comparative Example 2 124.9 Comparative Example 3 110.8 Comparative Example 4 163.5 Comparative Example 5 128.6

[0110] The present invention screens a large number of traditional Chinese medicine extraction methods and finds that the extraction method of the present invention can effectively extract the effective components of medicinal materials with the highest extraction efficiency, and ultimately achieves the ideal effect of good stability without flocculation and precipitation, and greatly retaining the effective components.

[0111] Test Example 2

[0112] The precipitation of Chinese medicine extract for external use is a thorny issue in Chinese medicine liquid preparations and an important indicator for judging quality. In view of this, the applicant conducted a test comparison of the storage precipitation of different processes. The results are shown in Table 2.

[0113] Table 2 Stability test results

[0114]

[0115] Note: ++ precipitation, + a small amount of precipitation, - no precipitation.

[0116] The stability test shows that the properties and clarity of the product of the embodiment of the present invention do not change much after being exposed to high temperature for one month, and the Chinese medicine composition of the present invention has good stability.

[0117] Test Example 3

[0118] 3.1 Test methods

[0119] Thirty ordinary guinea pigs that passed the quarantine were selected, half of which were male and half were female, with a body weight of 232.1-305.1 g. They were randomly divided into three groups according to their body weight: a blank control group, an experimental group 1, and an experimental group 2, with 10 guinea pigs in each group, half of which were male and half were female. Before drug administration, the hair on the back of the right hind paw of each group was shaved (about 1 cm 2), the back of the right foot of the guinea pigs in the blank control group was smeared with 0.9% sodium chloride injection, the back of the right foot of the guinea pigs in the test group 1 was smeared with the Chinese medicine extract prepared in Example 1, and the back of the right foot of the guinea pigs in the test group 2 was smeared with the Chinese medicine extract prepared in Comparative Example 1. The guinea pigs were given the drug twice a day, each time with an interval of 6 hours, for 7 consecutive days. After the last administration, the dorsal part of the right hind foot of the guinea pigs in each group was scratched with coarse sandpaper, and then the right hind foot of the guinea pigs was coated with 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.1%, 0.2%, and 0.3% histamine solutions of different concentrations were applied in sequence, 50 μL / guinea pig each time, once every 3 minutes, until the guinea pig licked its right foot for the first time, and the itch threshold of the guinea pig licking the foot was recorded.

[0120] 3.2 Detection indicators

[0121] Itch threshold: After the last application, the dorsal part of the right hind paw of each group of guinea pigs was scratched with coarse sandpaper, and then the patch was applied for 1 minute. The dorsal part of the right hind paw of the guinea pigs was coated with histamine solutions of different concentrations, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.1%, 0.2%, and 0.3%, 50 μL per guinea pig each time, every 3 minutes, until the guinea pig licked its right paw. The total amount of histamine used, i.e., the antipruritic threshold, was recorded.

[0122] 3.3 Data processing and statistical analysis

[0123] The significant figures of the experimental data were rounded off and statistical analysis was performed in accordance with SOP regulations. The statistical software used was SPSS23.0.

[0124] 3.4 Experimental Results

[0125] As shown in Table 3, compared with the blank control group, the antipruritic threshold of guinea pigs in the calamine lotion group showed an upward trend, but there was no significant difference, and the antipruritic threshold of guinea pigs in the antipruritic composition group was significantly increased (P≤0.01). Compared with the experimental group 2, the antipruritic threshold of guinea pigs in the experimental group 1 was significantly increased (P≤0.05).

[0126] Table 3 Effects on the itch threshold of the guinea pig itch model (X±S, n=10)

[0127] Group Itch threshold (mg) Blank control group 0.04±0.03 Test Group 1 <![CDATA[0.27±0.05 ++* ]]> Test Group 2 0.13±0.03

[0128] Note: Compared with the blank control group, ++P≤0.05; compared with the experimental group 1, *P≤0.05.

[0129] Test Example 4: Antibacterial Test

[0130] 4.1 Test conditions

[0131] Test sample: Antibacterial and antipruritic ointment prepared in Example 4

[0132] Test strains: Staphylococcus aureus (ATCC6538) and Escherichia coli (8099), provided by the Food Safety Strain Preservation Center of Guangdong Food Microbiological Safety Engineering Technology Research and Development Center, and the fifth generation fresh slant culture was used for the test.

[0133] 4.2 Test methods

[0134] The test is based on 2.1.8.2 of the Technical Specification for Disinfection (2002 Edition), and the antibacterial tablets are prepared (sterile and dry filter paper is taken, each piece is smeared with 20 mg of the original sample, and then the filter paper is placed flat in a clean sterile plate, and naturally dried at room temperature for use.) The incubation temperature is 37°C, and the time is 16-18 hours. Repeat 4 times.

[0135] 4.3 Test results

[0136] The average antibacterial ring diameter and diameter range when the concentration of the test product is the original sample are listed in the following Tables 4 and 5 respectively:

[0137] Table 4 Antibacterial effect of test samples on Staphylococcus aureus

[0138]

[0139] Note: Test bacterial solution 5×10 5～ 5×10 6 CFU / mL

[0140] Table 5 Antibacterial effect of test samples on Escherichia coli

[0141]

[0142] Note: Test bacterial solution 5×10 5～ 5×10 6 CFU / mL

[0143] It can be seen from Table 4 and Table 5 that the antibacterial and antipruritic ointment obtained by the present invention has a good antibacterial effect.

[0144] Test Example 5: Human Trial

[0145] 5.1 Trial Purpose

[0146] A trial investigation was conducted on the antibacterial and antipruritic ointment prepared in Example 4 of the present invention, so as to make a correct, objective and true evaluation of the effectiveness and safety of the product in treating senile skin pruritus.

[0147] 5.2 Trial Method

[0148] Trial population: The trial population is selected with senile pruritus. The sample size of the trial population is 30 people, with an age range of 60-80 years old, regardless of gender.

[0149] Trial method and dosage: Take twice a day, once in the morning and once in the evening, for 2 consecutive weeks.

[0150] 5.3 Efficacy observation indicators

[0151] The pruritus severity score is based on the modified pruritus grading standard developed abroad, and the pruritus is evaluated based on the severity of the pruritus, the cumulative location of the attack, and the frequency. The total score is the sum of the severity of the pruritus, the location, and the frequency. The pruritus score ranges from 1 to 10 points, with <3 points for mild pruritus, 4 to 6 points for moderate pruritus, and 7 to 10 points for severe pruritus. The purpose of the study was explained in detail to all patients, and the patients were informed. The evaluation was given to the patients on a voluntary basis, and the patients filled in the questionnaires by themselves. For those who had difficulty completing the questionnaires by themselves, the same physician assisted the patients in completing the questionnaires.

[0152] Therapeutic evaluation criteria: cured: itching completely disappeared without any skin lesions; markedly effective: itching was significantly relieved, and secondary skin lesions almost disappeared. Effective: itching was relieved to a certain extent, and skin lesions were also reduced. Ineffective: there was no significant change in itching and related symptoms. Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%.

[0153] 5.4 Trial Results

[0154] (1) Product effectiveness

[0155] After the trial, 15 people (50%) were cured, 9 people (30%) showed marked effects, 6 people (20%) were effective, and 0 people were ineffective. The total effective rate of the antibacterial and antipruritic ointment for senile skin pruritus was as high as 100%, and the clinical effectiveness was relatively high.

[0156] (2) Product safety

[0157] Among the trial population, 30 people (100%) reported that they did not experience any irritation or discomfort after the trial. In summary, the antibacterial and antipruritic ointment of the present invention does not have any local irritation or allergic reaction, and has high safety in clinical trials.

[0158] The applicant declares that the present invention illustrates the technical solution of the present invention through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of individual raw materials of the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. An antibacterial and antipruritic ointment for senile skin itching, It is characterized in that The antibacterial and antipruritic ointment is prepared from the following raw materials: 1-10 parts of an antipruritic traditional Chinese medicine composition, 0.1-1 parts of benzalkonium chloride, 1-5 parts of sulfur, 0.1-1 parts of vitamin E, 1-20 parts of yellow vaseline, 1-20 parts of cetostearyl alcohol, 1-15 parts of liquid paraffin, 1-5 parts of glycerol polyethylene glycol-75-stearate, 1-5 parts of lauryl alcohol polyoxyethylene ether, 5-20 parts of glycerol, 0.1-1 parts of xanthan gum and 20-100 parts of water.

2. An antibacterial and antipruritic ointment for elderly skin itching according to claim 1, It is characterized in that The antibacterial and antipruritic ointment is prepared from the following raw materials: 5 parts of antipruritic Chinese medicine composition, 0.5 parts of benzalkonium chloride, 1.5 parts of sulfur, 0.2 parts of vitamin E, 7 parts of yellow vaseline, 9 parts of cetostearyl alcohol, 6 parts of liquid paraffin, 2 parts of glycerol polyethylene glycol-75-stearate, 3 parts of lauryl alcohol polyoxyethylene ether, 10 parts of glycerol, 0.3 parts of xanthan gum, and 55 parts of water.

3. An antibacterial and antipruritic ointment for senile skin pruritus according to claim 1 or 2, It is characterized in that The antipruritic Chinese medicine composition is prepared from the following raw materials: 20-300 parts of purslane, 30-300 parts of difficile cortex, 30-300 parts of kochia scoparia, 30-300 parts of sophora flavescens, 20-200 parts of cnidium monnieri, 10-300 parts of cyclocarya paliurus leaves and 7-300 parts of fructus aurantii.

4. The antibacterial and antipruritic ointment for elderly skin itching according to claim 3, It is characterized in that The antipruritic Chinese medicine composition is prepared from the following raw materials: 100 parts of purslane, 150 parts of dittany, 150 parts of kochia scoparia, 200 parts of sophora flavescens, 100 parts of cnidium monnieri, 200 parts of cyclocarya paliurus leaves and 150 parts of fructus aurantii.

5. A method for preparing the antibacterial and antipruritic ointment according to any one of claims 1 to 4, It is characterized in that The steps include: (1) Pretreatment of the antipruritic Chinese medicine composition: firstly weigh each substance in the antipruritic Chinese medicine composition according to weight, and then extract it to obtain a Chinese medicine extract; then mix the obtained Chinese medicine extract, the first part of water, the first part of glycerol and sulfur, stir evenly and then perform homogenization to obtain a pretreated dispersion; (2) Treatment of the aqueous phase: Add the second portion of water to the emulsification tank, add the pre-treated dispersion, stir evenly, then add the second portion of glycerin and xanthan gum, stir evenly, then add benzalkonium chloride, heat to 80-85° C., stir evenly, and keep warm for later use; (3) Treatment of the oil phase: Add liquid paraffin to the oil phase tank, then add vitamin E, cetostearyl alcohol, yellow vaseline, glyceryl polyethylene glycol-75-stearate, and lauryl alcohol polyoxyethylene ether, heat to 75-80° C., stir evenly, and keep warm for later use; (4) Emulsification: The insulated material in step (3) is cooled, sieved and added to the insulated water phase in step (2), stirred homogeneously, and then cooled to 40-48° C.; then, the pre-treated dispersion obtained in step (1) is added and stirred homogeneously again.

6. The preparation method according to claim 5, It is characterized in that In step (1), the extraction of the Chinese medicine extract comprises the following steps: S1. Steam explosion: Weigh purslane, Dictamni cortex, Kochia scoparia, Sophora flavescens, Cnidium monnieri, Cyclocarya paliurus leaves, and Fructus aurantii by weight, add them into a steam explosion machine for steam explosion treatment, and release the pressure quickly after the treatment is completed to obtain a pretreated material; S2, countercurrent extraction: adding an aqueous solvent containing a surfactant to a countercurrent extractor, and then adding the pretreated material obtained in step S1, and then performing a countercurrent extraction process; After the treatment is completed, an extract is obtained; S3, centrifugal filtration: the extract obtained in step S2 is filtered under pressure to obtain a filtrate; the obtained filtrate is heated and concentrated, and the filtrate is centrifuged twice to remove the precipitate to obtain the product.

7. The preparation method according to claim 6, It is characterized in that In step S1, saturated water vapor is used for steam explosion treatment, the steam explosion pressure is 1.1-1.25 MPa, and the pressure maintenance time is 30-90 seconds.

8. The preparation method according to claim 6, It is characterized in that In step S2, the surfactant is cocamidopropyl betaine with a concentration of 0.04-0.1 wt%.

9. The preparation method according to claim 6, It is characterized in that In step S2, the mass ratio of water solvent to pretreated material is 6-12:1; the countercurrent extraction temperature is 30-35°C, and the extraction time is 0.5-5h.

10. The preparation method according to claim 6, It is characterized in that In step S3, the first centrifugal treatment time is 10 to 30 minutes; the second centrifugal treatment time is 15 to 35 minutes.

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