A kind of wet itching soothing lotion and its preparation method

Abstract

The present application relates to the technical field of traditional Chinese medicine, and specifically discloses a wet itching soothing lotion and a preparation method thereof, comprising a lotion main ingredient and a decoction promoter, wherein the lotion main ingredient is prepared from the following raw materials in parts by weight: 30-50 parts of Kochia scoparia, 26-30 parts of Smilax glabra, 26-34 parts of Lysimachia chinensis, 16-28 parts of Cnidium monnieri, 12-18 parts of Stemona officinalis, 15-21 parts of Sophora flavescens, 28-32 parts of Alumen, 28-40 parts of Dictamni cortex, 12-16 parts of Polygonum multiflorum and 8-10 parts of Phellodendron chinense; the decoction promoter of the present application contains sinomenine, which can not only exert its anti-inflammatory and analgesic effects by itself, but also work together with cocamidopropyl betaine as a surfactant to promote the extraction of active ingredients such as flavonoids and phytosterols in the raw materials. At the same time, the preparation method of the present application is simple, improves the bioavailability of active ingredients of the drug, does not need to be combined with other treatment methods, and improves the healing effect of inflammation caused by perianal eczema.

Description

Technical Field

[0001] The present application relates to the technical field of traditional Chinese medicine, and more specifically, to a wet itching soothing lotion and a preparation method thereof. Background Art

[0002] Anal eczema is a chronic, non-specific inflammatory skin disease that is persistent and recurrent. Traditional Chinese medicine believes that it is mostly caused by unclean anus or improper diet, which leads to spleen dysfunction, internal dampness and heat, causing exogenous toxic evils to flow into the anus and damage the yin fluid. Western medicine believes that anal eczema is caused by damaged epidermal barrier function, which can be caused by one's own constitution or by exogenous factors.

[0003] Although the incidence of perianal eczema is not very high, the discomfort such as itching after suffering from perianal eczema will seriously reduce the patient's quality of life and work status. In addition to internal treatment methods, there are many reports on external treatment methods of traditional Chinese medicine such as Chinese medicine sitz bath prescriptions and Chinese medicine external application. The applicant's previously published document "Clinical Observation on 100 Cases of Perianal Eczema with Damp-Heat Injection Type Treated with Oral Chinese Medicine Combined Sitz Bath, Zhang Xiaolong et al., November 2023" discloses the preparation of Chinese medicine sitz bath prescriptions, using rhubarb, sophora flavescens, Kochia scoparia, Phellodendron, Stemona, Cnidium monnieri, Atractylodes, Sanguisorba officinalis, Dictamni, and Smilax glabra as raw materials, and water decoction is used to prepare Chinese medicine sitz bath prescriptions. The Chinese medicine sitz bath prescription can make the active ingredients of the drug absorb inflammation through the wound tissue, reduce irritation, promote the repair and healing of wounds, and keep local cleanliness. At the same time, it can promote local blood circulation and restore tissue function, but the preparation method has low extraction efficiency of the active ingredients in the Chinese medicine ingredients, which affects the efficacy of the active ingredients. There is a weak anti-inflammatory effect, and it needs to be combined with oral Chinese medicine to achieve a good effect. Based on the above statements, the present application provides an itch-relieving lotion and a method for making the same. Summary of the invention

[0004] In order to solve the defects of the prior art in the preparation of itching soothing lotions, such as poor targetedness, poor effectiveness, weak anti-inflammatory effect, and the need to be taken orally with Chinese medicine to exert good effects, the present application provides a itching soothing lotion and a preparation method thereof.

[0005] A wet itching soothing lotion comprises a lotion main ingredient and a decoction accelerator, wherein the mass ratio of the lotion main ingredient to the decoction accelerator is 200:5-6, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30-50 parts of Kochia scoparia, 26-30 parts of Smilax glabra, 26-34 parts of Lysimachia sibiricum, 16-28 parts of Cnidium monnieri, 12-18 parts of Stemona tuber, 15-21 parts of Sophora flavescens, 28-32 parts of Alumen, 28-40 parts of Dictamni cortex, 12-16 parts of Polygonum multiflorum and 8-10 parts of Phellodendron amurense.

[0006] Preferably, the main ingredients of the lotion are composed of the following raw materials in parts by mass: 35-45 parts of Kochia scoparia, 27-29 parts of Smilax glabra, 28-32 parts of Lysimachia chinensis, 20-24 parts of Cnidium monnieri, 14-16 parts of Stemona japonica, 17-19 parts of Sophora flavescens, 29-31 parts of Alumen, 32-36 parts of Dictamni cortex, 13-15 parts of Polygonum multiflorum and 8.5-9.5 parts of Phellodendron chinense.

[0007] Preferably, the main ingredients of the lotion are composed of the following raw materials in parts by mass: 40 parts of Kochia scoparia, 28 parts of Smilax glabra, 30 parts of Lysimachia chinensis, 22 parts of Cnidium monnieri, 15 parts of Stemona japonica, 18 parts of Sophora flavescens, 30 parts of Alumen, 34 parts of Dictamni cortex, 14 parts of Polygonum multiflorum and 9 parts of Phellodendron chinense.

[0008] A method for preparing an itch-relieving lotion comprises the following steps:

[0009] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis, add 7-10 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8-2.6h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0010] Step A2: add 4-5 times the weight of water and a decoction promoter to the residue obtained by filtering in step A1, decoct over low heat for 0.6-0.8h, filter to obtain a second filtrate, combine the two filtrates, and obtain a wet itching soothing lotion.

[0011] Preferably, in step A1 and step A2, the mass of the decoction promoter added each time is equal.

[0012] Preferably, the decoction promoter is prepared by the following steps:

[0013] Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine to a Tris-HCl buffer, heat the mixture to 52-56°C, and stir for 12-16 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine, and the Tris-HCl buffer is 1.6-2.4:0.04-0.12:42-56, and the pH value of the Tris-HCl buffer is 8.4-9.2.

[0014] In summary, this application has the following beneficial effects:

[0015] The wet and itchy lotion proposed in the present application uses Kochia scoparia, Smilax glabra, Lysimachia chinensis, Cnidium monnieri, Stemona japonica, Sophora flavescens, Alumen, Dictamni cortex, Polygonum multiflorum and Phellodendron chinense as raw materials, and a decoction promoter containing Caulis oxyphylla extract, cocamidopropyl betaine and Tris-HCl buffer is added during the preparation process. The formula ingredients are simple and the mechanism of action is clear. First, Kochia scoparia, Dictamni cortex, Smilax glabra and Lysimachia chinensis are added to water and the decoction promoter, and boiled over high heat, and then Cnidium monnieri, Stemona japonica, Sophora flavescens, Alumen, Polygonum multiflorum and Phellodendron chinense are added, and the mixture is boiled over low heat, filtered, and the residue is added to water and the decoction promoter again, boiled over low heat, filtered, and the two filtrates are combined. The preparation method is simple, can significantly improve the solubility of the active ingredients of the medicine, and improve the bioavailability of the active ingredients of the medicine, and does not need to be combined with other treatment methods. It has a significant effect on the healing of inflammation caused by perianal eczema.

[0016] The wet and itchy lotion proposed in the present application uses Kochia scoparia, Smilax glabra and Herba Lysimachiae as the main medicines. Kochia scoparia has the effects of clearing away heat and dampness, dispelling wind and relieving itching, and having antibacterial and anti-inflammatory effects, and can improve the erythema and papules caused by eczema around the anus; while Herba Lysimachiae has the effects of clearing away heat and detoxifying, promoting dampness and relieving jaundice, and can play the effects of clearing heat and detoxifying, drying dampness and relieving itching, and further promote the healing of inflammation caused by perianal eczema; Herba Lysimachiae has the effects of detoxifying, dispersing blood stasis, reducing swelling and relieving pain, and can accelerate the recovery of inflammation caused by perianal eczema; using Fructus Cnidii, Radix Stemonae, Radix Sophorae Flavescentis and Alum as the assistant medicines, Fructus Cnidii has the effects of dispelling wind and relieving exterior symptoms, promoting dampness and relieving nebula, Radix Stemonae has the effects of killing insects and killing lice, Radix Sophorae Flavescentis has the effects of clearing away heat and detoxifying and anti-inflammatory effects, and Alumae Flavescentis has the effects of drying dampness and astringing sores, promoting tissue regeneration and stopping bleeding, and is helpful to astringe sores and promote healing. The four are used together to reduce discomfort symptoms such as redness, swelling and itching, and can enhance the effect of the main medicine and promote the healing of inflammation caused by perianal eczema. With Dictamni as the adjuvant, Dictamni has the effects of dispelling wind, relieving pain and removing dampness, which can relieve the anal itching and discomfort caused by dampness, and support the effect of the main drug; with Polygonum multiflorum and Phellodendron chinense as the guiding drugs, Polygonum multiflorum has the effects of killing insects, removing dampness and relieving itching, can inhibit the growth of pathogenic microorganisms, reduce inflammatory response, and help reduce exudate; Phellodendron chinense has the effects of reducing swelling, relieving itching and astringing, can effectively control wound exudation, and provide a healing environment; in addition, the two complement each other in terms of the mechanism of action, Polygonum multiflorum can inhibit bacterial growth and reduce inflammation, and Phellodendron chinense helps relieve symptoms such as skin redness, swelling, and itching. The multiple effects can guide and enhance the overall efficacy, so that the formula components can synergistically enhance the synergy, which not only ensures the pertinence and effectiveness of the drug and accelerates the healing process, but also compared with the first-generation product mentioned in the background technology of the present application, the product prepared in the present application can be used systemically, which greatly improves its application range.

[0017] The wet and itch-relieving lotion proposed in the present application is added with a decoction promoter three times during the preparation process. The decoction promoter contains Caulis Sinensis extract and cocamidopropyl betaine. The Caulis Sinensis extract is rich in sinomenine, which can not only exert its anti-inflammatory and analgesic effects by itself, but also work together with cocamidopropyl betaine as a surfactant to promote the extraction of active ingredients such as flavonoids and phytosterols in traditional Chinese medicine ingredients, thereby further improving the healing effect of inflammation caused by perianal eczema. DETAILED DESCRIPTION

[0018] In order to make the implementation methods of the present application easier to understand, the present application will be described in detail below in conjunction with specific examples. These examples are only for illustration and are not limited to the scope of application of the present application.

[0019] Preparation Examples 1-3 and Comparative Preparation Examples 1-3 provide a decoction accelerator.

[0020] Preparation Example 1

[0021] This preparation example provides a decoction promoter, which is prepared by the following steps:

[0022] Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine to Tris-HCl buffer, heat to 52°C, and stir at 500 rpm for 12 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine and Tris-HCl buffer is 1.6:0.04:42, and the pH value of the Tris-HCl buffer is 8.4.

[0023] Preparation Example 2

[0024] This preparation example provides a decoction promoter, which is prepared by the following steps:

[0025] Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine to Tris-HCl buffer, heat to 54°C, and stir at 550 rpm for 14 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine and Tris-HCl buffer is 2.0:0.08:49, and the pH value of the Tris-HCl buffer is 8.8.

[0026] Preparation Example 3

[0027] This preparation example provides a decoction promoter, which is prepared by the following steps:

[0028] Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine to Tris-HCl buffer, heat to 56°C, and stir at 600 rpm for 16 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine and Tris-HCl buffer is 2.4:0.12:56, and the pH value of the Tris-HCl buffer is 9.2.

[0029] Comparative Preparation Example 1

[0030] This comparative preparation example provides a decoction promoter, which is prepared by the following steps:

[0031] The knotweed extract and cocamidopropyl betaine were added to a Tris-HCl buffer, the temperature was raised to 52°C, and the mixture was stirred at 500 rpm for 12 minutes to obtain a decoction promoter, wherein the mass ratio of the knotweed extract, cocamidopropyl betaine and the Tris-HCl buffer was 1.6:0.04:42, and the pH value of the Tris-HCl buffer was 8.4.

[0032] Comparative Preparation Example 2

[0033] This comparative preparation example provides a decoction promoter, which is prepared by the following steps:

[0034] Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine into deionized water, heat to 52°C, and stir at 500 rpm for 12 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine and deionized water is 1.6:0.04:42.

[0035] Comparative Preparation Example 3

[0036] This comparative preparation example provides a decoction promoter, which is prepared by the following steps:

[0037] Cocamidopropyl betaine was added into Tris-HCl buffer, the temperature was raised to 52° C., and the mixture was stirred at a rotation speed of 500 rpm for 12 minutes to obtain a decoction promoter, wherein the mass ratio of cocamidopropyl betaine to Tris-HCl buffer was 0.04:42, and the pH value of the Tris-HCl buffer was 8.4.

[0038] Examples 1-3 and Comparative Examples 1-8 provide an anti-itch lotion and a preparation method thereof.

[0039] Example 1

[0040] The present embodiment provides a wet itching soothing lotion and a preparation method thereof. The wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 1, wherein the mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 1 is 200:5, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuberosa, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron amurense;

[0041] The preparation method of the wet itching soothing lotion comprises the following steps:

[0042] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0043] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0044] Example 2

[0045] The present embodiment provides a wet itching soothing lotion and a preparation method thereof. The wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 2. The mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 2 is 200:5.5. The lotion main ingredient is composed of the following raw materials in parts by mass: 40 parts of Kochia scoparia, 28 parts of Smilax glabra, 30 parts of Lysimachia sibiricum, 22 parts of Cnidium monnieri, 15 parts of Stemona tuberosa, 18 parts of Sophora flavescens, 30 parts of Alumen, 34 parts of Dictamni cortex, 14 parts of Polygonum multiflorum and 9 parts of Phellodendron chinense.

[0046] The preparation method of the wet itching soothing lotion comprises the following steps:

[0047] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis, add 8.5 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 2.2h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0048] Step A2: add 4.5 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.7 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0049] Example 3

[0050] The present embodiment provides a wet itching soothing lotion and a preparation method thereof. The wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 3. The mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 3 is 200:6. The lotion main ingredient is composed of the following raw materials in parts by mass: 50 parts of Kochia scoparia, 30 parts of Smilax glabra, 34 parts of Lysimachia chinensis, 28 parts of Cnidium monnieri, 18 parts of Stemona tuberosa, 21 parts of Sophora flavescens, 32 parts of Alumen, 40 parts of Dictamni cortex, 16 parts of Polygonum multiflorum and 10 parts of Phellodendron chinense.

[0051] The preparation method of the wet itching soothing lotion comprises the following steps:

[0052] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis, add 10 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 2.6h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0053] Step A2: add 5 times the weight of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.8 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the weight of the decoction promoter added each time is equal.

[0054] Comparative Example 1

[0055] The comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the Kochia scoparia in Example 1 is removed. The wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 1. The mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 1 is 200:5. The lotion main ingredient is composed of the following raw materials in parts by mass: 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Fructus Cnidium, 12 parts of Radix Stemonae, 15 parts of Sophorae Flavescentis, 28 parts of Alumen, 28 parts of Cortex Dictamni, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron amurense.

[0056] The preparation method of the wet itching soothing lotion comprises the following steps:

[0057] Step A1, according to the weight ratio as described above, take the raw materials: Dictamni, Smilax glabra and Lysimachia add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0058] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0059] Comparative Example 2

[0060] The comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the Kochia seeds in Example 1 are replaced with an equal mass of Smilax glabra. The wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 1. The mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 1 is 200:5. The lotion main ingredient is composed of the following raw materials in parts by mass: 56 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuberosa, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron chinense.

[0061] The preparation method of the wet itching soothing lotion comprises the following steps:

[0062] Step A1, according to the weight ratio as described above, take the raw materials: Dictamni, Smilax glabra and Lysimachia add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0063] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0064] Comparative Example 3

[0065] This comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the Herba Polygoni Multiflori in Example 1 is replaced with Phellodendron amurense of equal mass; the wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 1, wherein the mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 1 is 200:5, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia chinensis, 16 parts of Cnidium monnieri, 12 parts of Stemona tuber, 15 parts of Sophora flavescens, 28 parts of Alum, 28 parts of Dictamni cortex and 20 parts of Phellodendron amurense;

[0066] The preparation method of the wet itching soothing lotion comprises the following steps:

[0067] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis, add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Phellodendron and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0068] Step A2: add 4 times the mass of water and the decoction promoter prepared in Preparation Example 1 to the residue obtained by filtering in Step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain the wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0069] Comparative Example 4

[0070] This comparison provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the Phellodendron chinense in Example 1 is replaced with an equal amount of Polygonum multiflorum; the wet itching soothing lotion comprises a lotion main ingredient and a decoction promoter prepared in Preparation Example 1, the mass ratio of the lotion main ingredient to the decoction promoter prepared in Preparation Example 1 is 200:5, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuber, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex and 20 parts of Polygonum multiflorum;

[0071] The preparation method of the wet itching soothing lotion comprises the following steps:

[0072] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alumen, Polygonum multiflorum and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0073] Step A2: add 4 times the mass of water and the decoction promoter prepared in Preparation Example 1 to the residue obtained by filtering in Step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain the wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0074] Comparative Example 5

[0075] This comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the decoction promoter in Example 1 is replaced by the decoction promoter prepared in Comparative Preparation Example 1. The wet itching soothing lotion comprises a lotion main ingredient and the decoction promoter prepared in Comparative Preparation Example 1. The mass ratio of the lotion main ingredient to the decoction promoter prepared in Comparative Preparation Example 1 is 200:5. The lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuberosa, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron chinense.

[0076] The preparation method of the wet itching soothing lotion comprises the following steps:

[0077] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0078] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0079] Comparative Example 6

[0080] This comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the decoction promoter in Example 1 is replaced with the decoction promoter prepared in Comparative Preparation Example 2.

[0081] The wet itching soothing lotion comprises a lotion main ingredient and a decoction accelerator prepared in comparative preparation example 2, wherein the mass ratio of the lotion main ingredient to the decoction accelerator prepared in comparative preparation example 2 is 200:5, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuber, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron chinense;

[0082] The preparation method of the wet itching soothing lotion comprises the following steps:

[0083] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0084] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0085] Comparative Example 7

[0086] This comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the order of adding the decoction promoter is adjusted, and the decoction promoter added only in step A2 is specifically:

[0087] The wet itching soothing lotion comprises a lotion main ingredient and a decoction accelerator prepared in Preparation Example 1, wherein the mass ratio of the lotion main ingredient to the decoction accelerator prepared in Preparation Example 1 is 200:5, and the lotion main ingredient is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia chinensis, 16 parts of Cnidium monnieri, 12 parts of Stemona tuber, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum and 8 parts of Phellodendron chinense;

[0088] The preparation method of the wet itching soothing lotion comprises the following steps:

[0089] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra and Lysimachia chinensis add 7 times the mass of water, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum and Phellodendron chinense, turn to low heat and boil for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0090] Step A2: add 4 times the weight of water and a decoction promoter to the residue obtained by filtering in step A1, decoct over low heat for 0.6 h, filter to obtain a second filtrate, combine the two filtrates, and obtain the wet itching soothing lotion.

[0091] Comparative Example 8

[0092] This comparative example provides a wet itching soothing lotion and a preparation method thereof. Compared with Example 1, the decoction promoter in Example 1 is replaced by the decoction promoter prepared in Comparative Preparation Example 3, and Qingfengteng is added as the main ingredient of the lotion. The wet itching soothing lotion comprises the main ingredient of the lotion and the decoction promoter prepared in Comparative Preparation Example 3. The mass ratio of the main ingredient of the lotion to the decoction promoter prepared in Preparation Example 1 is 200:5. The main ingredient of the lotion is composed of the following raw materials in parts by mass: 30 parts of Kochia scoparia, 26 parts of Smilax glabra, 26 parts of Lysimachia sibiricum, 16 parts of Cnidium monnieri, 12 parts of Stemona tuberosa, 15 parts of Sophora flavescens, 28 parts of Alumen, 28 parts of Dictamni cortex, 12 parts of Polygonum multiflorum, 8 parts of Phellodendron amurense, and 5 parts of Qingfengteng;

[0093] The preparation method of the wet itching soothing lotion comprises the following steps:

[0094] Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Smilax glabra, Lysimachia chinensis and Caulis quinata, add 7 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8h, filter to obtain the first filtrate and the residue respectively, and set aside;

[0095] Step A2: add 4 times the mass of water and a decoction promoter to the residue obtained by filtering in step A1, simmer for 0.6 h, filter to obtain a second filtrate, combine the two filtrates to obtain a wet itching soothing lotion, wherein the mass of the decoction promoter added each time is equal.

[0096] Performance Testing

[0097] Wound damage and drug anti-inflammatory effect testing

[0098] The therapeutic effect tests were performed on the drug components prepared in Examples 1-3 of the present application and Comparative Examples 1-8, respectively.

[0099] Experimental animals

[0100] 140 specific pathogen-free SD rats, weighing (200±20.0) g, all male, were housed in single cages, illuminated with light, with room temperature controlled at 23°C, relative humidity 50%, and well-ventilated. During the experiment, the animals had free access to water and food, and were fed with normal feed.

[0101] Model preparation

[0102] All rats were fed adaptively for 3 days, with normal food and water intake, and the animal room environment was kept suitable and stable. On the fourth day, the rats were randomly divided into 14 groups, with 10 rats in each group. Except for the blank control group, the remaining rats were prepared with anal eczema models.

[0103] Preparation of rat perianal eczema model: Skin preparation began 2 days before modeling, and two marks were made around the rat anus, with the area of ​​A being about 1 cm × 1 cm and located about 5 cm from the anus on the abdomen, and the area of ​​B being about 2 cm × 2 cm and located near the anus. The hair of the marked area was shaved off with electric clippers, and then the depilatory cream was applied to the marked area. After the depilation, the depilated area was cleaned with clean water to observe whether it was allergic or damaged. On the first day of the experiment, 130 rats were taken and sensitized for the first time at the rat A mark. By using a pipette to apply 30L of 7% DNCB acetone solution to the A mark, it was observed that the rats were restless, emotionally unstable and irritable, and scratching behavior occurred many times. On the third day of the experiment, 100L of 5% DNCB acetone solution was applied to the B mark, and then the B mark was repeatedly stimulated once every 3 days, for a total of 5 times. On the 17th day of the experiment, the perianal skin of each rat was observed, and skin lesions such as erythema, papules, scabs, and exudation were clearly visible, indicating that the model had been successfully established, and the intervention stimulation was stopped.

[0104] Experimental groups and wound treatment

[0105] The 130 rats with successful modeling except the blank group were randomly divided into Example 1-3 groups, Comparative Example 1-8 groups, model group and positive control group, with an average of 10 rats in each group. The drug was administered on the second day after successful modeling (the 18th day of the experiment).

[0106] The rats in groups 1 to 3 of Examples and 1 to 8 of Comparative Examples were respectively washed with 50°C deionized water and the lotions prepared in Examples 1 to 3 and Comparative Examples 1 to 8 at a mass ratio of 1:5 to obtain the lotions. 1 mL of fecal supernatant was added dropwise 30 minutes before washing to simulate the fecal contamination of patients with perianal abscesses. The wounds were then rinsed with physiological saline and disinfected with iodine tincture. The administration frequency was controlled to 15 minutes / time. After the administration, the affected area was wiped dry.

[0107] The rats in the model group were dripped with 1 mL of fecal supernatant 30 minutes before dressing change to simulate the fecal contamination of patients with perianal abscess. The rats were then rinsed with normal saline and disinfected with iodine tincture, but no drug treatment was given.

[0108] The rat model group in the positive control group used 50°C deionized water and the Chinese medicine bathing recipe mentioned in the background technology to dilute the lotion at a mass ratio of 1:5 to soak the wound surface. 1 mL of fecal supernatant was added 30 minutes before soaking to simulate the fecal contamination of patients with perianal abscesses. Then it was rinsed with normal saline and disinfected with iodine tincture. The number of administrations was controlled to 15 minutes / time, and the affected area was wiped dry after the administration.

[0109] Observation indicators and detection methods

[0110] 1. Scoring of perianal skin lesions in rats

[0111] The scoring standard for the degree of perianal skin damage in rats was evaluated with reference to the eczema area and severity index (EASI) score, with slight modifications. The specific scoring standards are as follows:

[0112] The severity of eczema is mainly observed in terms of erythema, papules / edema, epidermal exfoliation, exudation / crust, lichenification, and scratches. The severity is scored from 0 to 3 points, with 0 points for none, 1 point for mild, 2 points for moderate, and 3 points for severe. Scratches: 0 points for none and 1 point for presence. The sum of the scores is the perianal skin lesion score.

[0113] ① Erythema: pink, dark red, purple inflammatory spots, which change color when pressed;

[0114] ② Papules / edema: papules, papulovesicles, or erythematous edema that are higher than the skin;

[0115] ③ Epidermal exfoliation: cracks or linear erosions on keratinized skin lesions;

[0116] ④ Exudation / scabbing: moist exudation at the skin lesion, including scabs formed after the exudate dries;

[0117] ⑤ Lichenification: excessive keratinization, dryness and desquamation, infiltration and hypertrophy of the lesions:

[0118] ⑥ Scratches: damage to the epidermis caused by claws.

[0119] Table 1 Comparison of EASI scores of perianal skin lesions in rats in each group (n=10, x̄±s,%)

[0120]

[0121] Note: In Table 1, a was compared with the model control group, P<0.05; b was compared with the comparative groups 1-8 and the positive control group, P<0.05.

[0122] As can be seen from Table 1, compared with Comparative Examples 1-8, the skin lesions of rats treated with the wet itching lotion prepared by Examples 1-3 were significantly improved (P<0.05), and the EASI score was significantly reduced, indicating that the wet itching lotion prepared by the present application has a more significant therapeutic effect on inflammation caused by perianal eczema.

[0123] 2. Count the number of scratches

[0124] The method for counting the number of times rats scratched was as follows: 30 minutes after the last drug administration, three rats without obvious irritation during the drug administration were randomly selected from each group, and they were placed in transparent observation cages for 30 minutes to adapt to the environment. Then, the video was recorded for 60 minutes, and the number of scratching was counted by replaying the video. The counting time was selected from 15-45 minutes (to avoid the influence of the rats' discomfort to the unfamiliar environment on the results).

[0125] Table 2 Comparison of scratching frequency in rats of each group (n=10, x̄±s,%)

[0126]

[0127] Note: In Table 2, a was compared with the model control group, P<0.05; b was compared with the comparative groups 1-8 and the positive control group, P<0.05.

[0128] It can be seen from Table 2 that compared with Comparative Examples 1-8, the number of scratching times of rats treated with the wet itching lotion prepared by Examples 1-3 was significantly reduced (P<0.05), indicating that the wet itching lotion prepared by the present application has a more significant therapeutic effect on skin itching caused by perianal eczema.

[0129] 3.ELISA method was used to detect the levels of TNF-α, IL-6, IL-1β and IL-13 in the serum of rats in each group

[0130] The ELISA method was used to detect the levels of TNF-α, IL-6, IL-1β and IL-13 in the serum of rats in each group. The operation was strictly in accordance with the instructions of the kit. The specific steps are as follows:

[0131] (1) Take out the serum to be tested, thaw it, centrifuge it, and take out the supernatant; take out the test kit 30 minutes in advance and equilibrate it to room temperature;

[0132] (2) Prepare reagents: dilute the standard and prepare various working solutions according to the operating instructions;

[0133] (3) Sample addition: Take out the ELISA plate, set up standard wells and sample wells, add samples, cover with plate film, and incubate at 37°C for 2 hours;

[0134] (4) Discard the liquid in the wells, spin dry, and do not wash; add biotin-labeled antibody working solution, cover with plate membrane, incubate at 37°C for 2 h, discard the liquid in the wells, and spin dry;

[0135] (5) Wash the plate 3 times (soak for 2 min / time, spin dry);

[0136] (6) Add horseradish peroxidase-labeled avidin working solution, cover with plate membrane, incubate at 37°C for 1 h, discard the liquid in the wells, and spin dry;

[0137] (7) Wash the plate 5 times, same as step (5);

[0138] (8) Color development: Add substrate solutions in sequence and develop color at 37°C in the dark for 15–30 min;

[0139] (9) Termination: Add the stop solution in sequence to terminate the reaction;

[0140] (10) Determination: Within 5 minutes after the reaction is terminated, the OD value of each well is measured at a wavelength of 450 nm using an ELISA reader:

[0141] (11) Calculation: Draw a standard curve and calculate the concentration of the sample to be tested.

[0142] Table 3 TNF-α, IL-6, IL-1β and IL-13 levels in the serum of rats in each group (n=10, x̄±s,%)

[0143]

[0144] Note: In Table 3, a was compared with the model control group, P<0.05; b was compared with the comparative example 1-8 groups and the positive control group, P<0.05.

[0145] It can be seen from Table 3 that, compared with Comparative Examples 1-8, after the wet itching lotion prepared in Examples 1-3 was used to treat rats, the levels of TNF-α, IL-6, IL-1β and IL-13 were significantly reduced, indicating that the wet itching lotion prepared in the present application has a more significant therapeutic effect on the inflammation caused by perianal eczema. In summary, the wet itching lotion prepared in the present application and the first-generation Chinese medicine sitz bath recipe mentioned in the background technology can both promote wound healing, but the wet itching lotion prepared in the present application is more significant.

[0146] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A wet itching soothing lotion, characterized in that The invention comprises a lotion main ingredient and a decoction accelerator, wherein the lotion main ingredient is composed of the following raw materials in parts by weight: 30-50 parts of Kochia scoparia, 26-30 parts of Smilax glabra, 26-34 parts of Lysimachia chinensis, 16-28 parts of Cnidium monnieri, 12-18 parts of Stemona officinalis, 15-21 parts of Sophora flavescens, 28-32 parts of Alumen, 28-40 parts of Dictamni cortex, 12-16 parts of Polygonum multiflorum and 8-10 parts of Phellodendron chinense; The decoction promoter is prepared by the following steps: Add the Herba Lycopersicon esculentum extract and cocamidopropyl betaine to a Tris-HCl buffer, heat the mixture to 52-56°C, and stir for 12-16 minutes to obtain a decoction promoter, wherein the mass ratio of the Herba Lycopersicon esculentum extract, cocamidopropyl betaine, and the Tris-HCl buffer is 1.6-2.4:0.04-0.12:42-56, and the pH value of the Tris-HCl buffer is 8.4-9.

2.

2. The itching soothing lotion according to claim 1, characterized in that: The main ingredients of the lotion are composed of the following raw materials in parts by weight: 35-45 parts of Kochia scoparia, 27-29 parts of Smilax glabra, 28-32 parts of Lysimachia chinensis, 20-24 parts of Cnidium monnieri, 14-16 parts of Stemona officinalis, 17-19 parts of Sophora flavescens, 29-31 parts of Alumen, 32-36 parts of Dictamni cortex, 13-15 parts of Polygonum multiflorum and 8.5-9.5 parts of Phellodendron chinense.

3. The itching soothing lotion according to claim 1, characterized in that: The main ingredients of the lotion are composed of the following raw materials in parts by weight: 40 parts of Kochia scoparia, 28 parts of Smilax glabra, 30 parts of Lysimachia chinensis, 22 parts of Cnidium monnieri, 15 parts of Stemona officinalis, 18 parts of Sophora flavescens, 30 parts of Alumen, 34 parts of Dictamni cortex, 14 parts of Polygonum multiflorum and 9 parts of Phellodendron amurense.

4. The itching soothing lotion according to claim 1, characterized in that: The mass ratio of the lotion main ingredient to the decoction accelerator is 200:5-6.

5. A method for preparing the wet itching soothing lotion according to any one of claims 1 to 4, characterized in that: The following steps are involved: Step A1, according to the weight ratio as described above, take the raw materials: Kochia scoparia, Dictamni, Lysimachia chinensis, Smilax glabra, add 7-10 times the mass of water and decoction promoter, first boil the water with high heat, then add Cnidium monnieri, Stemona, Sophora flavescens, Alum, Polygonum multiflorum, Phellodendron chinense and decoction promoter, switch to slow fire and decoct for 1.8-2.6h, filter to obtain the first filtrate and the residue respectively, and set aside; Step A2: add 4-5 times the weight of water and a decoction promoter to the residue obtained by filtering in step A1, decoct over low heat for 0.6-0.8h, filter to obtain a second filtrate, combine the two filtrates, and obtain a wet itching soothing lotion.

6. The method for preparing the itching soothing lotion according to claim 5, characterized in that: The mass of the decoction promoter added each time is equal.

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