External traditional Chinese medicine composition for senile cutaneous pruritus as well as preparation method and application of external traditional Chinese medicine composition

Abstract

The invention discloses an external traditional Chinese medicine composition for senile cutaneous pruritus as well as a preparation method and application of the external traditional Chinese medicine composition. The external traditional Chinese medicine composition is prepared from the following raw materials: 20-300 parts of herba portulacae, 30-300 parts of cortex dictamni, 30-300 parts of fructus kochiae, 30-300 parts of radix sophorae flavescentis, 20-200 parts of fructus cnidii, 10-300 parts of cyclocarya paliurus leaves and 7-300 parts of fructus aurantii. The external traditional Chinese medicine composition provided by the invention is definite in curative effect, small in side effect and high in safety; meanwhile, the preparation method provided by the invention combines the advantages of steam explosion and countercurrent extraction, the extracted effective components are high in content, the extraction efficiency is high, and the product stability is good.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an external Chinese medicine composition for elderly skin itching, and a preparation method and application 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, it is currently urgent to develop a Chinese medicine composition suitable for treating senile skin pruritus with definite efficacy, good safety and no dependence. 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 a topical Chinese medicine composition for elderly skin itching, which has definite efficacy, few side effects and high safety.

[0007] The second object of the present invention is to provide a method for preparing the above-mentioned external Chinese medicine composition, which has high effective ingredients and high extraction efficiency.

[0008] The third object of the present invention is to provide an application of the above-mentioned external Chinese medicine composition in the preparation of external medicines, cosmetics or daily necessities.

[0009] In order to achieve the above object, the present invention adopts the following technical solution:

[0010] In a first aspect, the present invention provides an external Chinese medicine composition for senile skin itching, wherein the external 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.

[0011] In the above technical scheme, Radix Sophorae Flavescentis is the main drug in the prescription, and its nature and flavor are bitter and cold. It is the main drug for clinical treatment of pruritus, and its insecticidal and antipruritic effects are prominent, and it is safe for external use without adverse reactions. In the prescription, Radix 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 prescription, Fructus Kochiae removes skin heat accumulation, removes skin itching, and is used together with Fructus Dictamni to strengthen the effect; In the prescription, Fructus Aurantii Immaturus is both bitter and fragrant, 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 of the skin; In the prescription, Fructus Citri Reticulatae is externally used for antibacterial, anti-inflammatory, and dampness removal, and treats stubborn moss; In the prescription, Fructus Cnidium monnieri 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. Herba Portulacae clears heat and detoxifies, relieves swelling and stops pain, and has a good effect on non-healing of carbuncle, contact dermatitis, and suppurative diseases, and is an adjuvant. The six medicinal materials of the Chinese medicine composition of the present invention help each other to play the functions of clearing away heat and detoxicating, cooling blood and removing dampness, killing insects and relieving itching.

[0012] 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.

[0013] As a preferred embodiment of the technical solution of the present invention, the external Chinese medicine composition is prepared from the following raw materials: 20 to 200 parts of Portulaca Oleracea, 20 to 200 parts of Dictamni Cortex, 50 to 200 parts of Kochia scoparia, 50 to 200 parts of Sophora flavescens, 30 to 150 parts of Cnidium monnieri, 10 to 200 parts of Cyclocarya paliurus leaves, and 20 to 200 parts of Citrus aurantium.

[0014] As a further preferred embodiment of the technical solution of the present invention, the external 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.

[0015] In a second aspect, the present invention provides a method for preparing the above-mentioned external Chinese medicine composition, comprising the following steps:

[0016] 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;

[0017] 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;

[0018] 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.

[0019] As a 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.

[0020] As a 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%.

[0021] As a 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.

[0022] As a 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.

[0023] In a third aspect, the application of the external Chinese medicine composition provided by the present invention can be to use the composition for preparing medicines, cosmetics, daily necessities or disinfection products, etc. Exemplarily, the external medicines include but are not limited to common lotions, gels, ointments, suppositories, etc. Preferably, the preparation method of the external lotion is as follows: after centrifuging the Chinese medicine extract, 5% 1,2-hexanediol and 5% pentanediol are added, and the lotion is divided and filled.

[0024] Exemplarily, the cosmetics include various common preparations, such as creams, essences, lotions, gels, etc., but are not limited to the above dosage forms, and can be made according to methods known in the skin care industry.

[0025] Exemplarily, the daily necessities or disinfection products include, but are not limited to, common antipruritic sprays, sanitary wipes, and the like.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The Chinese medicine composition for external use provided by the present invention has 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 shown that the Chinese medicine composition of the present invention has a reliable and effective 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.

[0028] (2) The preparation method of the external Chinese medicine composition provided by the present invention, combined with the advantages of steam explosion and countercurrent extraction, first steam explosion treatment is carried out, the effective substance is fully released, and it is convenient for subsequent countercurrent leaching to extract in a short time and efficiently (extraction time 1.5 or so); countercurrent leaching is with water solvent, and a small amount of cocamidopropyl betaine is added as an extraction aid, cocamidopropyl betaine is a surfactant commonly used in cosmetics, and the ingredients are safe to use. By the use of cocamidopropyl betaine, the interfacial tension between the active substance of 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 alcohol precipitation and other methods, the extract obtained by the method provided by the present invention has good stability and high extraction efficiency.

[0029] (3) 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 occurs, and 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

[0030] Figure 1 This is a photo of the composition extract obtained in Example 1 after being left for one month.

[0031] Figure 2 This is a photo of the extract of the composition prepared in Comparative Example 1 after being left for one month.

[0032] Figure 3 This is a photo of the extract of the composition prepared in Comparative Example 2 after being left for one month.

[0033] 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

[0034] 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.

[0035] Unless otherwise specified, the raw materials used in the present invention can be purchased from ordinary medical stores, and their specifications meet national medical standards. The brand of cocamidopropyl betaine is CAB-35, purchased from Qingdao Huayuan Polymer Co., Ltd. The polymer filter membrane can be selected from common products on the market, such as filter membrane products that can intercept 3000 molecular weights.

[0036] In the present invention, the steam explosion equipment and countercurrent extractor used are common equipment, which are obtained from the market.

[0037] Example 1

[0038] An external Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0039] 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.

[0040] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0041] 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;

[0042] 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;

[0043] 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.

[0044] Example 2

[0045] An external Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0046] 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.

[0047] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0048] 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;

[0049] 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;

[0050] 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.

[0051] Example 3

[0052] An external Chinese medicine composition for treating senile skin pruritus, comprising the following raw materials by weight:

[0053] 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.

[0054] In this embodiment, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0055] 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;

[0056] 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;

[0057] 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.

[0058] Comparative Example 1

[0059] 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, a Chinese medicine composition for external use for senile skin itching is composed of the following raw materials by weight:

[0060] 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.

[0061] In this comparative example, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0062] 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;

[0063] 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;

[0064] 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;

[0065] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0066] Comparative Example 2

[0067] 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, a Chinese medicine composition for external use for senile skin itching is composed of the following raw materials by weight:

[0068] 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.

[0069] In this comparative example, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0070] 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;

[0071] 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;

[0072] S3, collect the percolate, filter through 200 mesh to reflux extraction concentration tank; concentrate the filtrate under reduced pressure to a relative density of 1.15-1.25 (60°C-70°C), concentration temperature 75°C, vacuum degree ≤-0.08Mpa; recover ethanol in the supernatant under reduced pressure until there is no alcohol taste;

[0073] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0074] Comparative Example 3

[0075] 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, a Chinese medicine composition for external use for senile skin itching is composed of the following raw materials by weight:

[0076] 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.

[0077] In this comparative example, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0078] 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;

[0079] 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;

[0080] 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;

[0081] S4. Mixing: Take the concentrated extract of medicinal materials and stir it, then slowly add water to 1.0 kg (weigh to volume).

[0082] Comparative Example 4

[0083] Compared with Example 1, the difference between this comparative example is that no cocamidopropyl betaine is added to the aqueous solvent in step S2 of this comparative example. Specifically, a Chinese medicine composition for external use for senile skin itching is composed of the following raw materials by weight:

[0084] 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.

[0085] In this comparative example, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0086] 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;

[0087] 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;

[0088] 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.

[0089] Comparative Example 5

[0090] Compared with Example 1, this comparative example does not include step S1. Specifically, a Chinese medicine composition for external use for treating senile skin pruritus is composed of the following raw materials by weight:

[0091] 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.

[0092] In this comparative example, a method for preparing the above-mentioned external Chinese medicine composition is also provided, comprising the following steps:

[0093] 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 external 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;

[0094] 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.

[0095] Application Example 1

[0096] After centrifuging the traditional Chinese medicine extract obtained in Example 1, 5% 1,2-hexanediol and 5% pentanediol were added, and the mixture was divided and filled to obtain the traditional Chinese medicine lotion.

[0097] Test Example 1

[0098] 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.

[0099] Table 1 Dry extract quality determination results

[0100]

[0101]

[0102] 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.

[0103] Test Example 2

[0104] 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.

[0105] Table 2 Stability test results

[0106]

[0107] Note: ++ precipitation, + a small amount of precipitation, - no precipitation.

[0108] 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.

[0109] Test Example 3

[0110] 3.1 Test methods

[0111] 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.

[0112] 3.2 Detection indicators

[0113] 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.

[0114] 3.3 Data processing and statistical analysis

[0115] 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.

[0116] 3.4 Experimental Results

[0117] 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).

[0118] Table 3 Effects on the itch threshold of the guinea pig itch model (X±S, n=10)

[0119] 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

[0120] Note: Compared with the blank control group, ++P≤0.05; compared with the experimental group 1, *P≤0.05.

[0121] Test Example 4

[0122] A total of 60 patients with senile pruritus aged 60 to 80 years were selected and divided into an observation group and a control group. The control group (30 cases) was given calamine lotion once a day for 4 weeks; the observation group (30 cases) was given the Chinese medicine lotion prepared in Application Example 1 once a day for 4 weeks. The pruritus degree score and efficacy evaluation were performed respectively.

[0123] 4.1 Efficacy evaluation criteria

[0124] 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.

[0125] 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%.

[0126] 4.2 Test results

[0127] 4.2.1 Comparison of pruritus scores between the two groups before and after treatment

[0128] The pruritus scores of the two groups of patients after treatment were compared. The pruritus scores of the observation group were lower than those of the control group, and the difference was statistically significant (P < 0.05), as shown in Table 4.

[0129] Table 4 Comparison of pruritus scores between the two groups before and after treatment

[0130] Group Before treatment After treatment Control group 6.58±1.28 5.87±2.11 Observation Group 7.05±1.85 3.56±2.56*

[0131] Note: Compared with the control group after treatment, P*<0.05.

[0132] 4.2.2 Comparison of the total effective rate of treatment between the two groups of patients

[0133] The total effective rate of the observation group was 90%, which was higher than 60% in the control group. The difference was statistically significant (P < 0.05).

[0134] Table 5 Comparison of total effective rate of treatment between the two groups of patients

[0135] Group Total number of cases Number of cured cases Number of effective cases Number of effective cases Invalid cases Efficiency Control group 30 6 8 4 12 60％ Observation Group 30 14 7 6 3 90％

[0136] It can be seen from the above test results that the Chinese medicine lotion prepared by the present invention has a very obvious effect in treating skin itching.

[0137] 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. A Chinese medicine composition for external use for treating senile skin pruritus, characterized in that: The external 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.

2. A Chinese medicine composition for external use for treating senile skin pruritus according to claim 1, characterized in that: The external Chinese medicine composition is prepared from the following raw materials: 20-200 parts of purslane, 20-200 parts of difficile cortex, 50-200 parts of kochia scoparia, 50-200 parts of sophora flavescens, 30-150 parts of cnidium monnieri, 10-200 parts of cyclocarya paliurus leaves, and 20-200 parts of fructus aurantii.

3. A Chinese medicine composition for external use for treating senile skin pruritus according to claim 1, characterized in that: The external Chinese medicine composition is prepared from the following raw materials: 100 parts of purslane, 150 parts of difficile cortex, 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.

4. A method for preparing the external Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: 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 filtrate is heated and concentrated, and the filtrate is centrifuged twice to remove the precipitate to obtain the product.

5. The preparation method according to claim 4, 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.

6. The preparation method according to claim 4, characterized in that: In step S2, the surfactant is cocamidopropyl betaine with a concentration of 0.04-0.1 wt%.

7. The preparation method according to claim 4, 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.

8. The preparation method according to claim 4, 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.

9. Use of the external Chinese medicine composition according to any one of claims 1 to 3 in the preparation of external medicines, cosmetics or daily necessities.

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