A traditional Chinese medicine composition for treating pruritus and its preparation method

Abstract

This application belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition for treating pruritus and its preparation method. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of peach kernel, 10-20 parts of forsythia, 12-18 parts of hibiscus bark, 5-15 parts of notopterygium root, 8-13 parts of cinnamon twig, 4-15 parts of scutellaria root, 6-12 parts of pine needle, 1-5 parts of red peony root, 3-8 parts of lily bulb, 7-14 parts of honeysuckle flower, and 2-10 parts of kochia fruit. The preparation method of the traditional Chinese medicine composition includes the following steps: enzymatically hydrolyzing peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, and distilling to obtain volatile oil; pulverizing pine needle, red peony root, lily bulb, honeysuckle flower, and kochia fruit, and sieving to obtain traditional Chinese medicine powder; mixing the traditional Chinese medicine powder, volatile oil, and excipients to obtain the final product. The preparation method of this invention is simple, low-cost, and the obtained traditional Chinese medicine composition has significant therapeutic effects on pruritus, few side effects, and broad market prospects.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition for treating pruritus skin diseases and its preparation method. Background Technology

[0002] Pruritus is a complex, multifactorial skin condition caused by various acute or chronic skin diseases. When the itching becomes unbearable, people may unconsciously scratch their skin, leading to visible marks and pigmentation; as the condition progresses, secondary skin breakdown may also occur. Furthermore, pruritus can sometimes be a precursor to other health problems, such as cholestasis, end-stage renal disease, neurological disorders, and mental illnesses. This symptom not only directly impacts a patient's life but can also cause distress in social activities. Clinically, it has been found that people who suffer from chronic pruritus are more prone to mental health problems such as depression, anxiety, and insomnia. Suicidal tendencies may even occur, further emphasizing the importance of timely diagnosis and treatment of pruritus.

[0003] Currently, there are various methods for treating pruritus in clinical practice, mainly including oral medications and topical medications. Oral medications include antihistamines, pain modulators, opioid receptor antagonists, and antidepressants; while topical medications include calcium supplements, moisturizers, antipruritics, and corticosteroids. However, these drug treatments have some problems in clinical application: First, the efficacy is not always as ideal as expected, and some patients may not achieve sufficient relief; second, these drugs may cause varying degrees of side effects, such as drowsiness, dizziness, nausea, arrhythmia, dependence, and drug tolerance, seriously affecting patients' quality of life and increasing the complexity and uncertainty of treatment.

[0004] Therefore, there is an urgent need to develop a traditional Chinese medicine composition that has good efficacy and few side effects for treating pruritus skin diseases, which has important application value. Summary of the Invention

[0005] To address the problems of poor efficacy and significant side effects in existing drug treatments for pruritus, this application provides a traditional Chinese medicine composition for treating pruritus and its preparation method.

[0006] In a first aspect, this application provides a traditional Chinese medicine composition for treating pruritus skin diseases, employing the following technical solution:

[0007] A traditional Chinese medicine composition for treating pruritus skin diseases comprises the following raw materials in parts by weight: 10-20 parts of peach kernel, 10-20 parts of forsythia, 12-18 parts of hibiscus bark, 5-15 parts of notopterygium root, 8-13 parts of cinnamon twig, 6-12 parts of pine needle, 1-5 parts of red peony root, 3-8 parts of lily bulb, 4-15 parts of scutellaria root, 7-14 parts of honeysuckle flower, and 2-10 parts of kochia fruit.

[0008] Preferably, the traditional Chinese medicine composition for treating pruritus skin diseases comprises the following raw materials in parts by weight: 12-18 parts of peach kernel, 14-17 parts of forsythia, 13-16 parts of hibiscus bark, 8-12 parts of notopterygium root, 9-12 parts of cinnamon twig, 6-12 parts of scutellaria root, 8-10 parts of pine needle, 2-4 parts of red peony root, 5-7 parts of lily bulb, 9-12 parts of honeysuckle flower, and 5-8 parts of kochia fruit.

[0009] Furthermore, preferably, the traditional Chinese medicine composition for treating pruritus skin diseases comprises the following raw materials in parts by weight: 15 parts peach kernel, 15 parts forsythia, 14 parts hibiscus bark, 10 parts notopterygium root, 10 parts cinnamon twig, 8 parts scutellaria root, 9 parts pine needle, 3 parts red peony root, 6 parts lily bulb, 10 parts honeysuckle, and 7 parts kochia fruit.

[0010] Preferably, the traditional Chinese medicine composition for treating pruritus skin diseases further comprises pharmaceutically acceptable excipients.

[0011] Preferably, the excipient is at least one of surfactant, flow aid, lubricant and adhesive.

[0012] Preferably, the surfactant is at least one of lecithin, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, and rhamnose.

[0013] Secondly, this application provides a method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases, using the following technical solution:

[0014] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0015] Peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root were enzymatically hydrolyzed and distilled to obtain volatile oil;

[0016] Pine needles, red peony root, lily bulb, honeysuckle, and kochia fruit were freeze-dried, pulverized, and sieved to obtain Chinese medicine powder.

[0017] The Chinese herbal powder, volatile oil, and excipients are mixed evenly to obtain the Chinese herbal composition.

[0018] Preferably, the volatile oil is prepared by the following method:

[0019] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, wash, sterilize, grind, and obtain powder;

[0020] S12. Add the powder obtained in step S11 to water, sonicate it, add the compound enzyme preparation for enzymatic hydrolysis, and obtain the enzyme-treated slurry.

[0021] S13. Distill the enzyme-treated slurry obtained in step S12, collect the distillate, and obtain volatile oil.

[0022] Preferably, in step S2, the mass ratio of powder, water, and compound enzyme preparation is 1:100:0.01-0.02.

[0023] Preferably, the compound enzyme preparation is obtained by mixing cellulase, xylanase, pectinase and modified kaolin in a mass ratio of 2-8:4-5:1-6:20.

[0024] Preferably, the modified kaolin is prepared by the following method:

[0025] Acidified kaolin, polyethylene glycol, and ionic liquid were added to n-butanol, heated to 70-80℃, and stirred under reflux for 12-24 hours. The mixture was then filtered, washed, and dried to obtain modified kaolin.

[0026] Preferably, the mass ratio of acidified kaolin, polyethylene glycol, ionic liquid, and n-butanol is 10-20:0.1-0.5:6-10:50.

[0027] Preferably, the ionic liquid is obtained by mixing salicylate-choline ionic liquid and glycine-choline ionic liquid in a mass ratio of 3-8:5.

[0028] Preferably, the acidified kaolin is prepared by the following method:

[0029] Succinic acid, malic acid, and kaolin are added to water, and the mixture is reacted at 60-90℃ for 8-12 hours. After filtration, washing, and drying, acidified kaolin is obtained.

[0030] Preferably, the mass ratio of succinic acid, malic acid, kaolin, and water is 2-4:1-3:20:50.

[0031] Preferably, the freeze-drying temperature is -30 to -40°C and the time is 20 to 30 hours.

[0032] Preferably, the pulverization is a low-temperature pulverization, with a temperature of -5 to -10°C and a time of 30-60 minutes.

[0033] In summary, this application has the following beneficial effects:

[0034] This application uses a combination of medicinal materials according to the principles of principal, assistant, adjuvant, and guide herbs. Peach kernel, forsythia, and hibiscus bark are the principal herbs, notopterygium root, cinnamon twig, and scutellaria barbata are the assistant herbs, pine needle and red peony root are the adjuvant herbs, and lily bulb, honeysuckle, and kochia fruit are the guide herbs. The formula is reasonable, has few side effects, and can effectively relieve skin itching.

[0035] The method for preparing the traditional Chinese medicine composition of this application involves extracting volatile oil from a portion of the traditional Chinese medicine and making powder from another portion. Mixing the volatile oil, powder, and excipients helps to enhance the interaction between various medicinal materials, improves the medicinal value, greatly enhances the efficacy, and achieves anti-inflammatory and antipruritic effects, helping to relieve patients' skin itching symptoms. At the same time, it can be applied topically to the skin surface, reducing side effects on the human body.

[0036] The volatile oil in this application is extracted by enzymatic hydrolysis and a compound enzyme preparation is added. The compound enzyme preparation is a mixture of cellulase, xylanase, pectinase and modified kaolin. The interaction between the three enzymes and the modified kaolin greatly extracts the effective components in the traditional Chinese medicine and significantly improves the efficacy of the traditional Chinese medicine composition.

[0037] The modified kaolin of this application is grafted with ionic liquids on its surface, and the ionic liquids are obtained by mixing salicylate-choline ionic liquids and glycine-choline ionic liquids. During the enzymatic hydrolysis process, under the strong hydrogen bond force of the ionic liquids, the effective components of traditional Chinese medicine are released and dissolved in water along with the ionic liquids, which increases the content of effective components in the volatile oils and thus improves the efficacy of the traditional Chinese medicine composition. Detailed Implementation

[0038] The present application will be further described in detail below with reference to the embodiments.

[0039] Preparation Examples 1-5 provide methods for preparing modified kaolin.

[0040] Preparation Example 1

[0041] Modified kaolin is prepared by the following method:

[0042] Step 1) Add 2g succinic acid, 1g malic acid and 20g kaolin to 50g water, react at 60℃ for 8h, filter, wash and dry to obtain acidified kaolin.

[0043] Step 2) Add 10g of acidified kaolin, 0.1g of surfactant and 6g of ionic liquid to 50g of n-butanol, heat to 70℃, stir and reflux at 400r / min for 12h, filter, wash and dry to obtain modified kaolin.

[0044] The ionic liquid is obtained by mixing salicylic acid-choline ionic liquid and glycine-choline ionic liquid in a mass ratio of 3:5; the surfactant is polyethylene glycol.

[0045] Preparation Example 2

[0046] Modified kaolin is prepared by the following method:

[0047] Step 1) Add 3g succinic acid, 2g malic acid and 20g kaolin to 50g water, react at 80℃ for 10h, filter, wash and dry to obtain acidified kaolin.

[0048] Step 2) Add 15g of acidified kaolin, 0.3g of surfactant and 8g of ionic liquid to 50g of n-butanol, heat to 75℃, stir and reflux at 600r / min for 18h, filter, wash and dry to obtain modified kaolin.

[0049] The ionic liquid is obtained by mixing salicylate-choline ionic liquid and glycine-choline ionic liquid in a mass ratio of 1:1; the surfactant is polyethylene glycol.

[0050] Preparation Example 3

[0051] Modified kaolin is prepared by the following method:

[0052] Step 1) Add 4g succinic acid, 3g malic acid and 20g kaolin to 50g water, react at 90℃ for 12h, filter, wash and dry to obtain acidified kaolin.

[0053] Step 2) Add 20g of acidified kaolin, 0.5g of surfactant and 10g of ionic liquid to 50g of n-butanol, heat to 80℃, stir and reflux at 800r / min for 24h, filter, wash and dry to obtain modified kaolin.

[0054] The ionic liquid is obtained by mixing salicylic acid-choline ionic liquid and glycine-choline ionic liquid in a mass ratio of 8:5; the surfactant is polyethylene glycol.

[0055] Preparation Example 4

[0056] Preparation Example 4 differs from Preparation Example 1 only in that the ionic liquid is a salicylate-choline ionic liquid.

[0057] Preparation Example 5

[0058] Preparation Example 5 differs from Preparation Example 1 only in that the ionic liquid is a glycinecholine ionic liquid.

[0059] Examples 1-11 provide a traditional Chinese medicine composition for treating pruritus and its preparation method.

[0060] Example 1

[0061] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 10g peach kernel, 10g forsythia, 12g hibiscus bark, 5g notopterygium root, 8g cinnamon twig, 4g scutellaria root, 6g pine needle, 1g red peony root, 3g lily bulb, 5g honeysuckle flower, and 2g kochia fruit.

[0062] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0063] S1. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, and perform enzymatic hydrolysis and distillation to obtain volatile oil. The specific steps are as follows:

[0064] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, wash, sterilize, grind, and obtain powder;

[0065] S12. Take the powder obtained in step S11, add it to water with a mass of 100 times the powder, sonicate for 10 minutes, add compound enzyme preparation with a mass of 0.01 times the powder for enzymatic hydrolysis, adjust the pH to 5, and hydrolyze at 40℃ for 3 hours to obtain enzyme-treated slurry.

[0066] S13. The enzyme-treated slurry obtained in step S12 is distilled. The slurry is heated at 90°C for 3 hours and the distillate is collected to obtain volatile oil.

[0067] The compound enzyme preparation is obtained by mixing cellulase, xylanase, pectinase and modified kaolin in a mass ratio of 2:4:1:20, and the modified kaolin is prepared by Preparation Example 1.

[0068] S2. Take pine needles, red peony root, lily bulb, honeysuckle, and kochia fruit, wash and sterilize them, freeze-dry them at -30℃ for 20 hours, then pulverize them at -5℃ for 30 minutes, and pass them through a 400-mesh sieve to obtain Chinese medicine powder.

[0069] S3. Mix the Chinese herbal powder, volatile oil, and excipients evenly to obtain the Chinese herbal composition;

[0070] The excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the total mass of the Chinese herbal powder and volatile oil.

[0071] Example 2

[0072] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 16g of peach kernel, 15g of forsythia, 16g of hibiscus bark, 10g of notopterygium root, 11g of cinnamon twig, 13g of scutellaria root, 9g of pine needle, 4g of red peony root, 5g of lily bulb, 10g of honeysuckle flower, and 6g of kochia fruit.

[0073] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0074] S1. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, and perform enzymatic hydrolysis and distillation to obtain volatile oil. The specific steps are as follows:

[0075] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, wash, sterilize, grind, and obtain powder;

[0076] S12. Take the powder obtained in step S11, add it to water with a weight of 100 times the powder, sonicate for 15 minutes, add compound enzyme preparation with a weight of 0.015 times the powder for enzymatic hydrolysis, adjust the pH to 5.25, and hydrolyze at 45℃ for 3.5 hours to obtain enzyme-treated slurry.

[0077] S13. The enzyme-treated slurry obtained in step S12 is distilled. The slurry is heated at 94°C for 2 hours and the distillate is collected to obtain volatile oil.

[0078] The compound enzyme preparation is obtained by mixing cellulase, xylanase, pectinase and modified kaolin in a mass ratio of 5:4.5:3:20, and the modified kaolin is prepared by Preparation Example 2.

[0079] S2. Take pine needles, red peony root, lily bulb, honeysuckle, and kochia fruit, wash and sterilize them, freeze-dry them at -35℃ for 25 hours, then pulverize them at -8℃ for 40 minutes, and pass them through a 500-mesh sieve to obtain Chinese medicine powder.

[0080] S3. Mix the Chinese herbal powder, volatile oil, and excipients evenly to obtain the Chinese herbal composition;

[0081] The excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the total mass of the Chinese herbal powder and volatile oil.

[0082] Example 3

[0083] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 20g peach kernel, 20g forsythia, 18g hibiscus bark, 15g notopterygium root, 13g cinnamon twig, 15g scutellaria root, 12g pine needle, 5g red peony root, 8g lily bulb, 14g honeysuckle flower, and 10g kochia fruit.

[0084] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0085] S1. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, and perform enzymatic hydrolysis and distillation to obtain volatile oil. The specific steps are as follows:

[0086] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, wash, sterilize, grind, and obtain powder;

[0087] S12. Take the powder obtained in step S11, add it to water with a weight of 100 times the powder, sonicate for 20 minutes, add compound enzyme preparation with a weight of 0.02 times the powder for enzymatic hydrolysis, adjust the pH to 5.5, and enzymatically hydrolyze for 4 hours at 50℃ to obtain enzyme-treated slurry.

[0088] S13. The enzyme-treated slurry obtained in step S12 is distilled. The slurry is heated and distilled at 96°C for 1 hour. The distillate is collected to obtain volatile oil.

[0089] The compound enzyme preparation is obtained by mixing cellulase, xylanase, pectinase and modified kaolin in a mass ratio of 8:5:6:20, and the modified kaolin is prepared by Preparation Example 3.

[0090] S2. Take pine needles, red peony root, lily bulb, honeysuckle, and kochia fruit, wash and sterilize them, freeze-dry them at -40℃ for 30 hours, then pulverize them at -10℃ for 60 minutes, and pass them through a 600-mesh sieve to obtain Chinese medicine powder.

[0091] S3. Mix the Chinese herbal powder, volatile oil, and excipients evenly to obtain the Chinese herbal composition;

[0092] The excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the total mass of the Chinese herbal powder and volatile oil.

[0093] Example 4

[0094] Example 4 differs from Example 1 only in that the modified kaolin was prepared by Example 4.

[0095] Example 5

[0096] Example 5 differs from Example 1 only in that the modified kaolin was prepared from Preparation Example 5.

[0097] Example 6

[0098] Example 6 differs from Example 1 only in that the modified kaolin is replaced with an equal mass of kaolin.

[0099] Example 7

[0100] Example 7 differs from Example 1 only in that an ionic liquid of equal mass is used to replace the modified kaolin, and the ionic liquid is obtained by mixing salicylic acid choline ionic liquid and glycine choline ionic liquid in a mass ratio of 3:5.

[0101] Example 8

[0102] Example 8 differs from Example 1 only in that modified kaolin is not added to the compound enzyme preparation, and the compound enzyme preparation is obtained by mixing cellulase, xylanase and pectinase in a mass ratio of 2:4:1.

[0103] Example 9

[0104] Example 9 differs from Example 1 only in that cellulase is not added to the compound enzyme preparation, and the compound enzyme preparation is obtained by mixing xylanase, pectinase and modified kaolin in a mass ratio of 4:1:20.

[0105] Example 10

[0106] Example 10 differs from Example 1 only in that xylanase is not added to the compound enzyme preparation, and the compound enzyme preparation is obtained by mixing cellulase, pectinase and modified kaolin in a mass ratio of 2:1:20.

[0107] Example 11

[0108] Example 11 differs from Example 1 only in that pectinase is not added to the compound enzyme preparation, and the compound enzyme preparation is obtained by mixing cellulase, xylanase and modified kaolin in a mass ratio of 1:2:10.

[0109] To verify the comprehensive performance of the treatments for pruritus skin diseases prepared in Examples 1-11 of this application, the applicant has set up Comparative Examples 1-3, as follows:

[0110] Comparative Example 1

[0111] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 10g peach kernel, 10g forsythia, 12g hibiscus bark, 5g notopterygium root, 8g cinnamon twig, 4g scutellaria root, 6g pine needle, 1g red peony root, 3g lily bulb, 5g honeysuckle flower, and 2g kochia fruit.

[0112] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0113] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, scutellaria root, pine needle, red peony root, lily bulb, honeysuckle flower, and kochia fruit; wash, sterilize, and grind to obtain powder.

[0114] S12. Take the powder obtained in step S11, add it to water with a mass of 100 times the powder, sonicate for 10 minutes, add compound enzyme preparation with a mass of 0.01 times the powder for enzymatic hydrolysis, adjust the pH to 5, and hydrolyze at 40℃ for 3 hours to obtain enzyme-treated slurry.

[0115] S13. The enzyme-treated slurry obtained in step S12 is distilled. The slurry is heated at 90°C for 3 hours and the distillate is collected to obtain volatile oil.

[0116] S14. Mix the volatile oil and excipients evenly to obtain the traditional Chinese medicine composition;

[0117] The compound enzyme preparation is obtained by mixing cellulase, xylanase, pectinase and modified kaolin in a mass ratio of 2:4:1:20, and the modified kaolin is prepared by Preparation Example 1; the excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the volatile oil.

[0118] Comparative Example 2

[0119] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 10g peach kernel, 10g forsythia, 12g hibiscus bark, 5g notopterygium root, 8g cinnamon twig, 4g scutellaria root, 6g pine needle, 1g red peony root, 3g lily bulb, 5g honeysuckle flower, and 2g kochia fruit.

[0120] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0121] Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, scutellaria root, pine needle, red peony root, lily bulb, honeysuckle flower, and kochia fruit. Wash and sterilize them. First, freeze-dry them at -30℃ for 20 hours, then pulverize them at -5℃ for 30 minutes. Finally, pass them through a 400-mesh sieve to obtain Chinese medicine powder.

[0122] The Chinese herbal powder and excipients are mixed evenly to obtain the Chinese herbal composition;

[0123] The excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the Chinese medicine powder.

[0124] Comparative Example 3

[0125] A traditional Chinese medicine composition for treating pruritus skin diseases is made from the following raw materials: 10g peach kernel, 10g forsythia, 12g hibiscus bark, 5g notopterygium root, 8g cinnamon twig, 4g scutellaria root, 6g pine needle, 1g red peony root, 3g lily bulb, 5g honeysuckle flower, and 2g kochia fruit.

[0126] A method for preparing a traditional Chinese medicine composition for treating pruritus skin diseases includes the following steps:

[0127] S1. Extract the volatile oil from peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root using water. The specific steps are as follows:

[0128] S11. Take peach kernel, forsythia, hibiscus bark, notopterygium root, cinnamon twig, and scutellaria root, wash, sterilize, grind, and obtain powder;

[0129] S12. Take the powder obtained in step S11, add it to water with a mass of 100 times the powder, sonicate for 10 minutes, then distill it. Heat the distillate at 90°C for 3 hours, collect the distillate, and obtain the volatile oil.

[0130] S2. Take pine needles, red peony root, lily bulb, honeysuckle, and kochia fruit, wash and sterilize them, freeze-dry them at -30℃ for 20 hours, then pulverize them at -5℃ for 30 minutes, and pass them through a 400-mesh sieve to obtain Chinese medicine powder.

[0131] S3. Mix the Chinese herbal powder, volatile oil, and excipients evenly to obtain the Chinese herbal composition;

[0132] The excipient is polyoxyethylene castor oil, and the mass of the excipient is 10% of the total mass of the Chinese herbal powder and volatile oil.

[0133] Performance testing

[0134] The overall performance of the treatments for pruritus skin diseases prepared in Examples 1-11 and Comparative Examples 1-3 of this application was tested respectively.

[0135] 1. Animal activity evaluation

[0136] One hundred and seventy male ICR mice (purchased from Liaoning Changsheng Biotechnology Co., Ltd.), weighing 18-22g, were randomly selected and fed for one week of acclimatization. They were then randomly divided into a blank control group, a model group, a hydrocortisone acetate group (40mg / kg), and a group receiving the traditional Chinese medicine combination of Examples 1-11 and Comparative Examples 1-3 (40mg / kg), with ten mice in each group. The drugs in the treatment groups were applied to the skin of the back of the neck of the mice. Thirty minutes later, except for the blank control group, all other mice were injected intradermally with 500μg (50μL) of histamine in the right shoulder. The number of scratches within 30 minutes after the injection was recorded immediately by video. One scratch was defined as the mouse raising its hind paw to scratch the injection site once or more until the hind paw touched the ground or the mouse retracted its paw and paused. After applying the medication three times daily for one week, blood was collected from the eyeballs of mice to detect the levels of cytokines TNF-α, IL-6, and IL-4 in the serum. Data are expressed as mean ± standard deviation. One-way ANOVA was used for comparisons among multiple groups, and LSD was used for post-hoc comparisons. P < 0.05 was considered statistically significant. The specific results are shown in Table 1.

[0137] Table 1:

[0138]

[0139] Note: Lowercase letters indicate statistical significance between each treatment group and the model group: a: P < 0.0001; b: P < 0.001; c: P < 0.01; d: P < 0.05; Uppercase letters indicate statistical difference between the model group and the blank control group: A: P < 0.0001; B: P < 0.001.

[0140] Compared with the control group, the number of itching episodes in the model group mice was significantly increased, indicating successful model establishment. Compared with the model group, the number of itching episodes in Examples 1-11, Comparative Examples 1-3, and hydrocortisone acetate propyl ester was significantly reduced; the number of itching episodes in Examples 1-11, Comparative Examples 1-3, and hydrocortisone acetate propyl ester was even lower; further comparison of Examples 1-11 with Comparative Examples 1-3 revealed that the traditional Chinese medicine composition of this application can significantly improve the itching symptoms in mice; and comparison of Examples 1 with Examples 4 and 5 revealed that dual ionic liquids are more conducive to the extraction of volatile oils than single ionic liquids; comparison of Examples 1 with Examples 6 and 7 revealed that the chemical combination of kaolin and ionic liquid helps to improve the efficacy of the drug; comparison of Examples 1 with Examples 8-9 revealed that the interaction between enzymes and modified kaolin can effectively enhance the efficacy of the drug.

[0141] Compared with the blank group, the serum levels of TNF-α, IL-6, and IL-4 in the model group mice were significantly increased; compared with the model group, the serum levels of TNF-α, IL-6, and IL-4 in the mice in Examples 1-11, Comparative Examples 1-3, and Hydrocortisone Acetate propyl ester groups were significantly reduced, and the reduction in Examples 1-11 was greater, which fully demonstrates that the traditional Chinese medicine composition of this application has significant efficacy in treating pruritus skin diseases.

[0142] 2. Clinical efficacy

[0143] Sixty patients with chronic pruritus (excluding those with primary diseases such as diabetes, lymphoma, kidney disease, hepatobiliary disease, and autoimmune diseases accompanied by pruritus) were selected for observation. The main symptom was generalized pruritus. There were 30 males and 30 females, aged 21-78 years (mean 45 years), with a disease duration of 3 months-10 years (mean 3.3 years). All patients presented with varying degrees of skin lesions, including papules, scratch marks, scabs, and lichenification. They were randomly divided into a treatment group (n=30) and a control group (n=30), with an equal number of males and females. The treatment group received the herbal composition obtained in Example 1 of this application applied to the itchy areas (3 times / day, 9g / time). The control group received compound dexamethasone (3 times / day, 9g / time). Both groups had weekly follow-up visits, with 4 weeks constituting one course of treatment.

[0144] (1) Assessment of itching severity: Patients assessed their own itching using a visual analog scale (VAS), with a scale of 0-10. 0 indicates no itching, and 10 indicates extremely severe itching. Patients scored their itching based on their own experience, considering factors such as the severity, duration, extent, impact on sleep, and degree of scratching (secondary skin lesions such as scratch marks). Scoring was conducted at the initial consultation, at week 2 after treatment, and at week 4. Based on the scores, the doctor established the following criteria for assessing the severity of itching: 0 indicates itching has disappeared (level 1), 1-3 indicates mild itching (level 2), 4-6 indicates moderate itching (level 3), and ≥7 indicates severe itching (level 4).

[0145] (2) The severity of skin lesions was assessed by the physician using a visual analog scale (VAS). A scale of 0-10 was used, with 0 indicating complete resolution of the lesions and 10 indicating lesions covering more than 85% of the body surface area, indicating very severe lesions. The physician assessed and scored the lesions based on their area, thickening, scaling, lichenification, color, and crusting. Scoring was conducted at the initial consultation, at the second week after treatment, and at the fourth week. Based on the scoring results, the physician established the following criteria for assessing the severity of skin lesions: 0 indicating lesion disappearance (Grade 1), 1-3 indicating mild lesions (Grade 2), 4-6 indicating moderate lesions (Grade 3), and ≥7 indicating severe lesions (Grade 4).

[0146] (3) Efficacy assessment: Cured: The degree of itching and the degree of skin lesion are both judged to be at level 1; Significantly effective: The degree of itching and the degree of skin lesion do not increase and one of them reaches level 1 or the degree difference decreases by more than 2 levels; Effective: The degree of itching and the degree of skin lesion do not increase and one or more of the degree difference decreases by more than 1 level; Ineffective: The degree of itching and / or the degree of skin lesion do not decrease or increase.

[0147] After 4 weeks of treatment, 3 patients were excluded from the treatment group, leaving 27 patients; 5 patients were excluded from the control group, leaving 25 patients. Exclusion criteria: patients who did not complete the course of treatment as required or who received other Chinese or Western medicine treatments during the observation period. The specific results are shown in Table 2.

[0148] Table 2:

[0149]

[0150] As shown in the table above, the traditional Chinese medicine composition of this application has a definite curative effect in treating generalized pruritus, can significantly relieve pruritus, reduce the frequency and duration of pruritus, improve the condition of the local skin, and has few adverse drug reactions, high drug safety, and good clinical reusability.

[0151] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for treating pruritic skin diseases, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials by weight: peach kernel 10-20 parts, forsythia 10-20 parts, radix kochiae 12-18 parts, nardoo 5-15 parts, cassia twig 8-13 parts, pine needle 6-12 parts, red peony root 1-5 parts, lily 3-8 parts, radix scrophulariae 4-15 parts, honeysuckle 7-14 parts, and groundcherry 2-10 parts; The traditional Chinese medicine composition for treating skin pruritic diseases is prepared by the following method: Peach kernel, forsythia, radix kochiae, nardoo, cassia twig, and radix scrophulariae are subjected to enzymolysis and distillation to obtain volatile oil; Pine needle, red peony root, lily, honeysuckle, and groundcherry are subjected to freeze-drying treatment, pulverization, and sieving to obtain traditional Chinese medicine powder; The traditional Chinese medicine powder, volatile oil, and auxiliary materials are uniformly mixed to obtain the traditional Chinese medicine composition; The volatile oil is prepared by the following method: S11. Peach kernel, forsythia, radix kochiae, nardoo, cassia twig, and radix scrophulariae are washed, sterilized, and ground to obtain powder; S12. The powder obtained in step S11 is added to water, subjected to ultrasonic treatment, and then added to a composite enzyme preparation for enzymolysis to obtain enzyme treatment slurry; S13. The enzyme treatment slurry obtained in step S12 is subjected to distillation, and the distillation liquid is collected to obtain volatile oil; The composite enzyme preparation is obtained by mixing cellulase, xylanase, pectinase, and modified kaolin; The mass ratio of the cellulase, xylanase, pectinase, and modified kaolin is 2-8:4-5:1-6:20; The modified kaolin is prepared by the following method: Acidified kaolin, polyethylene glycol, and ionic liquid are added to n-butanol, subjected to stirring and reflux reaction, filtered, washed, and dried to obtain modified kaolin; The ionic liquid is obtained by mixing choline salicylate ionic liquid and choline glycine ionic liquid.

2. The traditional Chinese medicine composition for treating pruritic skin diseases according to claim 1, characterized in that, The stirring and reflux reaction in the preparation process of the modified kaolin refers to stirring and reflux reaction at 70-80°C for 12-24 h.

3. The traditional Chinese medicine composition for treating pruritic skin diseases according to claim 1, characterized in that, The mass ratio of the acidified kaolin, polyethylene glycol, ionic liquid, and n-butanol is 10-20:0.1-0.5:6-10:

50.

4. The traditional Chinese medicine composition for treating pruritic skin diseases according to claim 1, characterized in that, The mass ratio of the choline salicylate ionic liquid and choline glycine ionic liquid is 3-8:

5.

5. The Chinese medicine composition for treating pruritic skin diseases according to claim 1, characterized in that, The temperature of the freeze-drying is -30 to -40°C, and the time is 20-30 h.

6. The Chinese medicine composition for treating pruritic skin diseases according to claim 1, characterized in that, The pulverization is low-temperature pulverization, and the temperature is -5 to -10°C, and the time is 30-60 min.

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