External preparation for treating skin itch of patient with jaundice and preparation method of external preparation

Abstract

The invention relates to an external preparation for treating skin itch of a patient with jaundice and a preparation method of the external preparation, and relates to the technical field of traditional Chinese medicine. The traditional Chinese medicine extract comprises the following raw materials in parts by weight: 25-35 parts of humulus lupulus, 10-20 parts of chionanthus retusus leaves and 10-20 parts of rhizoma tupistrae chinensis. A proper amount of humulus lupulus, chionanthus retusus leaves and rhizoma tupistrae chinensis are matched and used as functional components, and the humulus lupulus, the chionanthus retusus leaves and the rhizoma tupistrae Meanwhile, by combining a gradient decompression reflux extraction mode, effective components are efficiently extracted and fully reserved, so that the improvement effect of the obtained traditional Chinese medicine composition on the skin itch symptom of the jaundice patient is remarkably improved, the treatment effect is superior to that of an existing conventional medicine, a new means is provided for treating the skin itch disease of the jaundice patient, and the application prospect is wide.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a topical preparation for treating skin itching in patients with jaundice and its preparation method. Background Technology

[0002] Jaundice, a common clinical symptom, can be caused by various factors, such as liver diseases (e.g., hepatitis, cirrhosis), biliary obstruction, and hemolytic diseases. In the development of jaundice, in addition to typical manifestations like yellowing of the skin and sclera, itchy skin is a common and distressing symptom. This itching is often severe, can be systemic or localized, significantly impacting the patient's quality of life, leading to sleep disturbances, irritability, and even complications such as skin damage and infection due to repeated scratching, further aggravating the condition.

[0003] Currently, treatment options for skin itching in patients with jaundice are relatively limited. In clinical practice, commonly used methods mainly include treatment of the underlying disease and symptomatic treatment. Treatment of the underlying disease, such as treating liver disease or relieving biliary obstruction, can improve jaundice at its root, but relieving skin itching often takes time, and the itching may persist even during the treatment of the underlying disease, causing significant suffering for patients.

[0004] In terms of symptomatic treatment, Western medicine often uses antihistamines and bile acid conjugating resins. While antihistamines can relieve itching symptoms to some extent, they can cause side effects such as drowsiness and dry mouth, affecting patients' daily lives and work. Bile acid conjugating resins may cause gastrointestinal discomfort such as constipation and bloating, and some patients have poor tolerance to them. Moreover, long-term use of these drugs may lead to drug resistance, causing the efficacy to gradually decrease, requiring increasingly higher doses to maintain the therapeutic effect, thus increasing the risk of adverse reactions.

[0005] In addition, some topical medications, such as ointments containing corticosteroids, can quickly relieve skin itching and inflammation, but long-term use can easily lead to serious adverse reactions such as skin atrophy, telangiectasia, and steroid-dependent dermatitis. They are especially unsuitable for jaundice patients who need long-term control of itching symptoms.

[0006] Traditional Chinese medicine (TCM) has a long history and unique advantages in treating skin diseases. The multi-component and multi-target nature of TCM allows it to regulate bodily functions at multiple levels, achieving both symptomatic and root-cause treatment, with relatively few adverse reactions. However, currently, there are relatively few TCM topical preparations on the market specifically targeting itchy skin in patients with jaundice, and their therapeutic effects are often unsatisfactory, failing to meet clinical needs. Summary of the Invention

[0007] To address the above problems, this invention provides a topical preparation for treating skin itching in patients with jaundice and its preparation method.

[0008] In a first aspect, the present invention provides a topical preparation for treating skin itching in patients with jaundice, comprising extracts of traditional Chinese medicine; The herbal extract comprises the following raw materials in parts by weight: 25-35 parts hops, 10-20 parts fringe leaves, and 10-20 parts bamboo root.

[0009] Furthermore, the weight ratio of the hops, the tamarind leaves, and the bamboo root is 2:1:1.

[0010] Furthermore, by weight, the herbal extract comprises the following raw materials: 30 parts hops, 15 parts fringe leaves, and 15 parts bamboo root.

[0011] Furthermore, the preparation method of the traditional Chinese medicine extract includes the following steps: Hops, tamarind leaves and bamboo root are mixed and crushed to obtain a mixture; The mixture is added to water for a first vacuum distillation extraction. When the volume of the distillate is half the initial volume of the water added, the first vacuum distillation extraction is stopped, and a first distillate and a residual liquid containing the residue are obtained. Add water of the same volume as the first distillate to the remaining liquid containing the dregs, and then perform a second vacuum distillation extraction. When the volume of the distillate is half the initial volume of water added, stop the second vacuum distillation extraction to obtain the second distillate. The first distillate and the second distillate were combined, concentrated, and dried to obtain the traditional Chinese medicine extract; The working conditions for the first vacuum distillation extraction include: a temperature of 30-48°C and a pressure of 3-9 kPa; the working conditions for the second vacuum distillation extraction include: a temperature of 78-85°C and a pressure of 35-42 kPa; and the weight ratio of the mixture to the water is 1:(8-15).

[0012] Furthermore, the characteristic of the first vacuum distillation extraction is that the working conditions parameters include: a temperature of 37°C and a pressure of 5 kPa.

[0013] Furthermore, the operating conditions for the second vacuum distillation extraction include: a temperature of 80°C and a pressure of 38 kPa.

[0014] Furthermore, the dosage form of the topical preparation for treating skin itching in patients with jaundice includes at least one of liquid lotion, ointment, and gel.

[0015] Furthermore, by weight percentage, the topical preparation for treating pruritus in patients with jaundice comprises the following components: The herbal extracts contained 4% to 9%; Carbomer 940: 0.2%~0.5%; EDTA-2Na: 0.02%~0.05%; Methylparaben: 0.05%~0.15%; Glycerin: 3%~5%; Ethanol: 2%~4%; pH adjuster: Appropriate amount, used to adjust the pH of the system to 5.8~6.5; The remainder is water.

[0016] Furthermore, the pH adjuster includes a citrate-phosphate buffer.

[0017] In a second aspect, the present invention provides a method for preparing the topical preparation for treating skin itching in patients with jaundice as described in the first aspect, comprising the following steps: Obtain Chinese herbal extracts; The herbal extract and the remaining components are stirred and mixed to obtain the topical preparation for treating skin itching in patients with jaundice.

[0018] The technical solutions provided in the embodiments of the present invention have at least the following advantages compared with the prior art: This invention provides a topical preparation for treating pruritus in patients with jaundice and its preparation method. The invention uses appropriate amounts of hops, fringe leaves, and bamboo root as active ingredients, which synergistically enhance the efficacy. Simultaneously, a gradient vacuum reflux extraction method is used to efficiently extract and fully retain the active ingredients, thereby significantly improving the effect of the resulting traditional Chinese medicine composition on improving pruritus symptoms in patients with jaundice. The therapeutic effect is superior to existing conventional drugs, providing a new approach for treating pruritus in patients with jaundice, with broad application prospects. Specifically, the pharmacological effects of the main traditional Chinese medicine raw materials involved in this invention are as follows: Hops: The immature flowering spikes of the hop plant (Humulus lupulus L.) belonging to the Cannabisaceae family. They have a bitter taste, are slightly cool in nature, and enter the liver and stomach meridians. They are rich in isopentenyl flavonoids such as humulone, lupus syringone, α-acid, β-acid, and fulvicol, as well as active ingredients such as astragaloside and rutin.

[0019] Fringe tree leaves: The buds and leaves of the fringe tree (Chionanthus retusus Lindl. et Paxt.), a plant in the Oleaceae family. They are bitter, neutral in nature, and enter the Heart Meridian. They are rich in flavonoids, glycosides, terpenes, lignans, coumarins, polysaccharides, and other beneficial components.

[0020] Disporopsis fuscularta Hance: The rhizome of the plant Disporopsis fuscularta Hance (family Liliaceae). It has a sweet and slightly pungent taste, is neutral in nature, and enters the lung and liver meridians. It is rich in polysaccharides, saponins, and other active ingredients.

[0021] Based on this, the present invention uses appropriate amounts of hops, tamarind leaves and bamboo root as active ingredients. The three ingredients work synergistically to enhance the efficacy and significantly improve the effect of the obtained traditional Chinese medicine composition on improving the skin itching symptoms of jaundice patients. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] It should be noted that, unless otherwise specified or indicated, the raw materials involved in the topical preparation for treating skin itching in patients with jaundice provided by this invention can be self-made according to the preparation process disclosed in the prior art or directly use commercially available products; at the same time, unless otherwise specified or indicated, the preparation process operation steps and parameters involved can be carried out according to the preparation process disclosed in the prior art or using existing equipment, and this invention document will not elaborate further.

[0024] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed according to national standards. If no corresponding national standard exists, then generally accepted international standards, conventional conditions, or conditions recommended by the manufacturer are followed. Example 1

[0025] This example provides a topical preparation for treating pruritus in patients with jaundice, comprising the following components by weight percentage: Traditional Chinese medicine extracts: 6.8%; Carbomer 940: 0.3%; EDTA-2Na 0.05%; Methylparaben: 0.1%; Glycerin: 4%; Ethanol: 3.2%; pH adjuster: Appropriate amount, used to adjust the pH of the system to 6.2; The remainder is water; The herbal extract, by weight, includes the following ingredients: 30 parts hops, 15 parts fringe leaves, and 15 parts bamboo root. The preparation method of the traditional Chinese medicine extract includes the following steps: Hops, fringe leaves, and bamboo root are mixed and pulverized to obtain a mixture; the mixture is added to water at a weight of 10 times for a first vacuum distillation extraction, the operating conditions of which are: temperature 37℃, pressure 5kPa; when the volume of the distillate is half the initial volume of water added, the first vacuum distillation extraction is stopped, resulting in a first distillate and a residual liquid containing medicinal residue; water of the same volume as the first distillate is added to the residual liquid containing medicinal residue, followed by a second vacuum distillation extraction, the operating conditions of which are: temperature 80℃, pressure 38kPa; when the volume of the distillate is half the initial volume of water added, the second vacuum distillation extraction is stopped, resulting in a second distillate; the first and second distillates are combined, concentrated, and dried to obtain the traditional Chinese medicine extract.

[0026] The preparation method of the above-mentioned topical preparation for treating skin itching in patients with jaundice includes the following steps: Obtain Chinese herbal extracts; The herbal extract and the remaining components are stirred and mixed to obtain the topical preparation for treating skin itching in patients with jaundice. Example 2

[0027] This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) By weight, the herbal extract includes the following raw materials: 25 parts of hops, 10 parts of fringe leaf and 10 parts of bamboo root; (2) The working conditions parameters for the first vacuum distillation extraction include: temperature of 48℃ and pressure of 9kPa; (3) The working conditions parameters for the second vacuum distillation extraction include: temperature of 85℃ and pressure of 42kPa. Example 3

[0028] This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 2 only in that: (1) By weight, the Chinese herbal extract includes the following raw materials: 25 parts of hops, 12.5 parts of fringe leaf and 12.5 parts of bamboo root. Example 4

[0029] This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) By weight, the herbal extract includes the following raw materials: 35 parts of hops, 17.5 parts of fringe leaf and 17.5 parts of bamboo root; (2) The working conditions parameters for the first vacuum distillation extraction include: temperature of 30℃ and pressure of 3kPa; (3) The working conditions parameters for the second vacuum distillation extraction include: temperature of 78℃ and pressure of 35kPa.

[0030] Comparative Example 1 This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) Adjust the hops to 0 (i.e., no hops were added).

[0031] Comparative Example 2 This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) Adjust the amount of tassel leaves to 0 (i.e., no tassel leaves were added).

[0032] Comparative Example 3 This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) Adjust the amount of bamboo root to 0 (i.e., only bamboo root is not added).

[0033] Comparative Example 4 This example provides a topical preparation for treating skin itching in patients with jaundice and its preparation method, which differs from Example 1 only in that: (1) The working conditions for the first vacuum distillation extraction are adjusted to: temperature 80℃ and pressure 38kPa (i.e., extraction is performed using only the working conditions for the second vacuum distillation extraction).

[0034] Test case The purpose of this test case is to examine the therapeutic effect of the topical formulations provided in the examples and comparative examples on pruritus in patients with jaundice, with hydrocortisone butyrate cream as a comparison.

[0035] 1. Patient Basic Information Inclusion criteria: Age 30-61, gender not limited; The type of jaundice is clear (primary biliary cirrhosis, hepatitis B cirrhosis, etc.), and the skin itching belongs to the blood stasis and blood heat type; VAS score ≥4 (see subsequent scoring criteria), and symptoms lasting ≥2 weeks.

[0036] Exclusion criteria: Pregnant / lactating women, patients with hepatic encephalopathy; Coexisting with other skin conditions (such as eczema, psoriasis); Recent use of antihistamines, glucocorticoids, or immunosuppressants; Severe hepatic and renal insufficiency (Child-Pugh Class C); Those with allergies, such as a history of drug or food allergies, or allergies to the test drug or its components or excipients; Those currently participating in other clinical trials; Other factors that may affect the results of this trial, or individuals deemed unsuitable for the trial by the researchers.

[0037] 2. Scoring Criteria The following scores were assessed before and after treatment using the Visual Analogue Scale (VAS): Mild: Itching occurs occasionally, or only at night or in a quiet environment, and is relatively localized and mild, not affecting work and sleep, with a VAS score of 1-5.

[0038] Moderate: Frequent itching, which may occur in several places at the same time, is quite severe and may even affect work and sleep. VAS score is 6-8.

[0039] Severe: Persistent, generalized itching that is severe and affects work and sleep. It may be accompanied by skin scratches, scabs, pigmentation, eczema, lichenification, etc. VAS score of 8-10.

[0040] 3. Treatment plan: The topical preparations provided in the examples and comparative examples were applied once daily, with 20 cases in each group, for 2 weeks.

[0041] Hydrocortisone butyrate cream, once daily, 20 cases, treatment for 2 weeks.

[0042] The treatment effect was statistically analyzed based on the VAS scores before and after treatment. Significant effect: the skin itching symptoms basically disappeared or significantly decreased, and the VAS score reduction value before and after treatment was >4 and the VAS score value after treatment was <2; Effective: the skin itching symptoms were reduced and relieved to varying degrees, and the VAS score reduction value before and after treatment remained between 1 and 4; Ineffective: the skin itching symptoms were basically not relieved, and the VAS score reduction value before and after treatment was <1.

[0043] The test results are shown in Table 1.

[0044] Table 1 Group Number of people showing significant effects (individuals) Number of valid participants (individuals) Invalid number of individuals Example 1 Group 11 8 1 Example 2 group 5 13 2 Example 3 Group 7 12 1 Example 4 group 9 10 1 Comparative Example 1 2 10 8 Comparative Example 2 3 12 5 Comparative Example 3 Groups 2 11 7 Comparative Example 4 Groups 4 12 4 Existing drug group 6 13 1 The test results above show that, compared with comparative examples 1 to 4, the topical preparations provided in the embodiments of the present invention have a better therapeutic effect on skin itching in patients with jaundice, and the number of patients with significant efficacy of the topical preparations provided in Example 1 group is significantly better than that of existing conventional treatment drugs.

[0045] In summary, this invention provides a topical preparation for treating pruritus in patients with jaundice and its preparation method. The invention uses appropriate amounts of hops, fringe leaves, and bamboo root as active ingredients, which synergistically enhance the efficacy. Simultaneously, a gradient vacuum reflux extraction method is used to efficiently extract and fully retain the active ingredients, thereby significantly improving the effect of the obtained traditional Chinese medicine composition on improving pruritus symptoms in patients with jaundice. The therapeutic effect is superior to existing conventional drugs, providing a new approach for treating pruritus in patients with jaundice, with broad application prospects.

[0046] Various embodiments of the present invention may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of the invention; therefore, it should be considered that the range description has specifically disclosed all possible subranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the range referred to.

[0047] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A topical preparation for treating pruritus in patients with jaundice, characterized in that, Including extracts of traditional Chinese medicine; The herbal extract comprises the following raw materials in parts by weight: 25-35 parts hops, 10-20 parts fringe leaves, and 10-20 parts bamboo root.

2. The topical preparation for treating pruritus in patients with jaundice according to claim 1, characterized in that, The weight ratio of the hops, the tamarind leaves, and the bamboo root is 2:1:

1.

3. The topical preparation for treating pruritus in patients with jaundice according to claim 1, characterized in that, The herbal extract comprises the following raw materials in parts by weight: 30 parts hops, 15 parts fringe leaves, and 15 parts bamboo root.

4. The topical preparation for treating pruritus in patients with jaundice according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine extract includes the following steps: Hops, tamarind leaves and bamboo root are mixed and crushed to obtain a mixture; The mixture is added to water for a first vacuum distillation extraction. When the volume of the distillate is half the initial volume of the water added, the first vacuum distillation extraction is stopped, and a first distillate and a residual liquid containing the residue are obtained. Add water of the same volume as the first distillate to the remaining liquid containing the dregs, and then perform a second vacuum distillation extraction. When the volume of the distillate is half the initial volume of water added, stop the second vacuum distillation extraction to obtain the second distillate. The first distillate and the second distillate were combined, concentrated, and dried to obtain the traditional Chinese medicine extract; The working conditions for the first vacuum distillation extraction include: a temperature of 30-48°C and a pressure of 3-9 kPa; the working conditions for the second vacuum distillation extraction include: a temperature of 78-85°C and a pressure of 35-42 kPa; and the weight ratio of the mixture to the water is 1:(8-15).

5. The topical preparation for treating pruritus in patients with jaundice according to claim 4, characterized in that, The feature is that the working conditions for the first vacuum distillation extraction include: a temperature of 37°C and a pressure of 5 kPa.

6. The topical preparation for treating pruritus in patients with jaundice according to claim 4, characterized in that, The working conditions for the second vacuum distillation extraction include: a temperature of 80°C and a pressure of 38 kPa.

7. The topical preparation for treating pruritus in patients with jaundice according to any one of claims 1 to 6, characterized in that, The dosage form of the topical preparation for treating skin itching in patients with jaundice includes at least one of liquid lotion, ointment, and gel.

8. The topical preparation for treating pruritus in patients with jaundice according to any one of claims 1 to 6, characterized in that, The topical preparation for treating pruritus in patients with jaundice comprises the following components by weight percentage: The herbal extracts contained 4% to 9%; Carbomer 940: 0.2%~0.5%; EDTA-2Na: 0.02%~0.05%; Methylparaben: 0.05%~0.15%; Glycerin: 3%~5%; Ethanol: 2%~4%; pH adjuster: Appropriate amount, used to adjust the pH of the system to 5.8~6.5; The remainder is water.

9. The topical preparation for treating pruritus in patients with jaundice according to claim 8, characterized in that, The pH adjuster includes citrate-phosphate buffer.

10. A method for preparing a topical preparation for treating pruritus in patients with jaundice, as described in any one of claims 1 to 9, characterized in that, Includes the following steps: Obtain Chinese herbal extracts; The herbal extract and the remaining components are stirred and mixed to obtain the topical preparation for treating skin itching in patients with jaundice.