Traditional Chinese medicine compound composition for treating sweating syndrome as well as preparation method and application of traditional Chinese medicine compound composition

Abstract

The invention discloses a traditional Chinese medicine compound composition for treating sweating syndrome as well as a preparation method and application thereof. The traditional Chinese medicine compound composition is prepared from 60-360 parts of gypsum, 15-90 parts of coptis chinensis, 9-54 parts of scutellaria baicalensis, 10-60 parts of golden cypress, 10-60 parts of rhizoma anemarrhenae, 18-108 parts of talc, 18-108 parts of oriental wormwood, 18-108 parts of fried coix seeds, 12-72 parts of dried ginger and 6-36 parts of honey-fried licorice roots. A compound is screened through syndrome differentiation and treatment and clinical tests, and the whole formula has the effects of clearing heat and drying dampness and clearing and purging yangming, so that the effects of clearing heat and dampness and eliminating sweating and eliminating symptoms are achieved. Clinical tests prove that the traditional Chinese medicine compound composition is effective in 12 cases, effective in 10 cases and clinically cured in 17 cases in sweat syndrome patients, and the total effective rate is 84.78%; 13 cases in a control group are effective, 5 cases are effective, 8 cases are cured clinically, and the total effective rate is 56.52%. The traditional Chinese medicine compound composition provided by the invention has an exact curative effect on the sweating syndrome and is good in safety.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine compound, and in particular to a traditional Chinese medicine compound composition for treating sweating disorders, its preparation method and applications. Background Art

[0002] Sweating disorders are called "hyperhidrosis" in Western medicine and are common and frequently-occurring diseases in clinical practice. Although hyperhidrosis does not endanger life, it often has a negative impact on the quality of life of patients. Excessive sweating not only causes obvious physical discomfort and social barriers to patients, increases the risk of skin infections, but also affects the mental health of patients, increasing the prevalence of depression, anxiety and attention deficit disorder.

[0003] The clinical symptoms of sweating disorders are mainly manifested as: sweating during the day when moving, sweating at night during sleep, stopping gradually after waking up, sweating profusely like pouring rain, the sweat being sticky or staining clothes yellow, bitter taste in the mouth, usually being averse to heat, having a plump build, or being irritable, having yellowish urine, loose or dry stools; the pulse is slippery, large and rapid or soft, large and rapid, the tongue is red, and the tongue coating is yellow and greasy.

[0004] At present, Western medicine has limited means, drugs and efficacy in the treatment of sweating disorders. Traditional Chinese medicine has unique curative effects in the treatment of sweating disorders. Therefore, it is very necessary to research and develop a traditional Chinese medicine compound with good therapeutic effects on sweating disorders and low adverse reactions on the basis of the existing technology. Summary of the Invention

[0005] Object of the Invention: The object of the present invention is to solve the deficiencies of the existing technology and provide a traditional Chinese medicine compound composition with a scientific and reasonable ratio, having good effects of purging fire and promoting fluid production, clearing heat and drying dampness, and having good therapeutic effects on sweating disorders. Another object of the present invention is to provide a preparation method and applications of the traditional Chinese medicine compound composition.

[0006] Technical Solution: To achieve the above objects, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine compound composition for treating sweating disorders, characterized in that it comprises the following raw materials in parts by weight: gypsum (decocted first) 60 - 360 parts, coptis 15 - 90 parts, scutellaria baicalensis 9 - 54 parts, phellodendron amurense 10 - 60 parts, anemarrhena asphodeloides 10 - 60 parts, talc (decocted first) 18 - 108 parts, artemisia capillaris 18 - 108 parts, stir-fried coix seed 18 - 108 parts, dried ginger 12 - 72 parts, and honey-fried licorice 6 - 36 parts.

[0008] As a preferred embodiment, the above-mentioned traditional Chinese medicine compound composition for treating sweating disorders comprises the following raw materials in parts by weight: gypsum (decocted first) 60 - 180 parts, coptis 15 - 45 parts, scutellaria baicalensis 9 - 27 parts, phellodendron amurense 10 - 30 parts, anemarrhena asphodeloides 10 - 30 parts, talc (decocted first) 18 - 54 parts, artemisia capillaris 18 - 54 parts, stir-fried coix seed 18 - 54 parts, dried ginger 12 - 36 parts, and honey-fried licorice 6 - 18 parts.

[0009] As a preferred embodiment, the traditional Chinese medicine compound composition for treating sweating syndromes is made from the following raw materials by weight: gypsum (decocted first) 60 parts, coptis 15 parts, scutellaria baicalensis 9 parts, phellodendron amurense 10 parts, anemarrhena asphodeloides 10 parts, talc (decocted first) 18 parts, artemisia capillaris 18 parts, stir-fried coix seed 18 parts, dried ginger 12 parts, and roasted licorice root 6 parts.

[0010] A drug for treating sweating syndromes, which is a drug prepared from an extract of the traditional Chinese medicine compound composition of the present invention and a pharmaceutically acceptable carrier into an oral liquid, granule, capsule, tablet, pill, powder, extract, mixture or injection dosage form.

[0011] A preparation method of a drug for treating sweating syndromes, which comprises the following steps:

[0012] By weight, take gypsum and talc, add water and decoct for extraction for a period of time, then add coptis, scutellaria baicalensis, phellodendron amurense, anemarrhena asphodeloides, artemisia capillaris, stir-fried coix seed, dried ginger and roasted licorice root, add water for extraction, filter, combine the filtrates, concentrate to a thick paste, and then prepare the thick paste with a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.

[0013] As a preferred embodiment, the preparation method of the drug for treating sweating syndromes described above comprises the following steps:

[0014] By weight, first take gypsum and talc, add 6 - 12 times the amount of water and decoct for extraction for 10 - 30 minutes, then add coptis, scutellaria baicalensis, phellodendron amurense, anemarrhena asphodeloides, artemisia capillaris, stir-fried coix seed, dried ginger and roasted licorice root, add 6 - 12 times the amount of water of the above medicinal materials and decoct for extraction for 0.5 - 2 hours, repeat the extraction 1 - 3 times, filter, combine the filtrates, concentrate to a thick paste, and then prepare the thick paste with a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.

[0015] Beneficial effects: The traditional Chinese medicine compound composition for treating sweating syndromes provided by the present invention has the following advantages compared with the prior art:

[0016] The formula interpretation rule of the traditional Chinese medicine compound composition screened by the present invention is as follows: In the formula, raw gypsum is pungent, sweet and extremely cold, and belongs to the lung and stomach meridians, clearing qi and purging fire, relieving restlessness and quenching thirst; coptis is bitter and cold, and belongs to the heart, spleen, stomach, gallbladder and large intestine meridians, clearing and drying the damp-heat of the triple energizer, mainly focusing on the upper and middle energizers. The two are used as the monarch drugs together.

[0017] The present invention selects anemarrhena asphodeloides, which is bitter and cold, and belongs to the lung, stomach and kidney meridians, clearing heat and purging fire, nourishing yin and moistening dryness; scutellaria baicalensis is bitter and cold, clearing and drying the damp-heat of the upper energizer, and phellodendron amurense is bitter and cold, clearing and drying the damp-heat of the lower energizer; the three are used as the ministerial drugs together.

[0018] For this invention, talc is selected. Talc is sweet, bland and cold in nature, and acts on the bladder, lung and stomach meridians, clearing heat and promoting diuresis to eliminate dampness; stir-fried coix seed is sweet, bland and cool in nature, promoting diuresis to percolate dampness and strengthening the spleen to stop diarrhea; dried ginger is pungent and hot in nature, acting on the spleen and stomach meridians, warming the middle-jiao to dispel cold and preventing the spleen and stomach from being damaged by cold and bitter herbs. The three together serve as assistant herbs.

[0019] For this invention, licorice is selected. Licorice is sweet and neutral in nature, and acts on the heart, lung, spleen and stomach meridians, strengthening the spleen and regulating the stomach, and harmonizing all the herbs, serving as the guiding herb.

[0020] The whole formula functions to clear heat and remove dampness, and purge the Yangming meridian, achieving the effects of clearing heat, purging fire, removing dampness and eliminating sweating and symptoms.

[0021] The traditional Chinese medicine compound composition of this invention is verified through clinical trials. Among 46 patients with sweating syndrome, 12 cases are effective, 10 cases are markedly effective, 17 cases are clinically cured, and 7 cases are ineffective, with a total effective rate of 83.33%. In the control group, 8 cases are effective, 5 cases are markedly effective, 13 cases are clinically cured, and 20 cases are ineffective, with a total effective rate of 56.52%. It shows that the traditional Chinese medicine compound composition provided by this invention has definite curative effect in treating sweating syndrome and is superior to the control group.

[0022] The traditional Chinese medicine compound composition provided by this invention can be conveniently prepared into various dosage forms, is convenient for clinical administration, and has low side reactions. Detailed implementation mode

[0023] The above content of this invention will be further described in detail below in the form of examples. However, it should not be understood that the scope of the above theme of this invention is limited to the following examples. All technologies implemented based on the above content of this invention belong to the scope of this invention.

[0024] Example 1

[0025] 1. A traditional Chinese medicine compound composition for treating sweating syndrome, which is made from the following raw materials by weight: gypsum (decocted first) 60g, coptis 15g, scutellaria baicalensis 9g, phellodendron amurense 10g, anemarrhena asphodeloides 10g, talc (decocted first) 18g, artemisia capillaris 18g, stir-fried coix seed 18g, dried ginger 12g, and roasted licorice 6g.

[0026] 2. A preparation method of a drug for treating sweating syndrome, which includes the following steps:

[0027] Weigh 60g of gypsum and 18g of talc by weight, add 8 times the amount of water and decoct for extraction for 30 minutes first, then add 15g of coptis, 9g of scutellaria baicalensis, 10g of phellodendron amurense, 10g of anemarrhena asphodeloides, 18g of artemisia capillaris, 18g of stir-fried coix seed, 12g of dried ginger, and 6g of roasted licorice, add 12 times the amount of water based on the weight of the herbs and decoct for extraction for 1 hour, then filter; add 10 times the amount of water based on the weight of the herbs to the medicinal residues and decoct for extraction for 1 hour, filter, and then add 8 times the amount of water based on the weight of the herbs to the medicinal residues and decoct for extraction for 0.5 hour. Combine the filtrates obtained from the three decoctions and extractions, place them in a heat-sealed bag, sterilize at 105°C, and package to obtain the product.

[0028] Example 2

[0029] 1. A traditional Chinese medicine compound composition for treating sweating syndrome, which is made from the following raw materials by weight: Gypsum Fibrosum (decocted first) 180 g, Coptidis Rhizoma 45 g, Scutellariae Radix 27 g, Phellodendri Chinensis Cortex 30 g, Anemarrhenae Rhizoma 30 g, Talcum (decocted first) 54 g, Artemisiae Scopariae Herba 54 g, Coicis Semen Praeparatum 54 g, Zingiberis Rhizoma Recens 36 g, Glycyrrhizae Radix Praeparata cum Melle 18 g.

[0030] 2. A preparation method of a drug for treating sweating syndrome, which comprises the following steps:

[0031] Weigh 180 g of Gypsum Fibrosum and 54 g of Talcum by weight, add 10 times the amount of water and decoct for extraction for 30 minutes first, then add 45 g of Coptidis Rhizoma, 27 g of Scutellariae Radix, 30 g of Phellodendri Chinensis Cortex, 30 g of Anemarrhenae Rhizoma, 54 g of Artemisiae Scopariae Herba, 54 g of Coicis Semen Praeparatum, 36 g of Zingiberis Rhizoma Recens, 18 g of Glycyrrhizae Radix Praeparata cum Melle, add 10 times the amount of water based on the weight of the medicinal materials and decoct for extraction for 1 hour, then filter. Add 8 times the amount of water based on the weight of the medicinal materials to the medicinal residues and decoct for extraction for 1 hour, filter. Then add 8 times the amount of water based on the weight of the medicinal materials to the medicinal residues again and decoct for extraction for 0.5 hour. Combine the filtrates extracted three times, concentrate the filtrate, add the carrier lactose, add the lubricant magnesium stearate, mix evenly, and then press into tablets to make tablets.

[0032] Example 3

[0033] A traditional Chinese medicine compound composition for treating sweating syndrome, which is made from the following raw materials by weight: Gypsum Fibrosum (decocted first) 360 g, Coptidis Rhizoma 90 g, Scutellariae Radix 54 g, Phellodendri Chinensis Cortex 60 g, Anemarrhenae Rhizoma 60 g, Talcum (decocted first) 108 g, Artemisiae Scopariae Herba 108 g, Coicis Semen Praeparatum 108 g, Zingiberis Rhizoma Recens 72 g, Glycyrrhizae Radix Praeparata cum Melle 36 g.

[0034] 2. A preparation method of a drug for treating sweating syndrome, which comprises the following steps:

[0035] Weigh 360 g of Gypsum Fibrosum and 108 g of Talcum by weight, add 12 times the amount of water and decoct for extraction for 20 minutes first, then add 90 g of Coptidis Rhizoma, 54 g of Scutellariae Radix, 60 g of Phellodendri Chinensis Cortex, 60 g of Anemarrhenae Rhizoma, 108 g of Artemisiae Scopariae Herba, 108 g of Coicis Semen Praeparatum, 72 g of Zingiberis Rhizoma Recens, 36 g of Glycyrrhizae Radix Praeparata cum Melle, add 12 times the amount of water based on the weight of the medicinal materials and decoct for extraction for 1 hour, then filter. Add 10 times the amount of water based on the weight of the medicinal materials to the medicinal residues and decoct for extraction for 1 hour, filter. Add 8 times the amount of water based on the weight of the medicinal materials to the medicinal residues again and decoct for extraction for 0.5 hour. Combine the filtrates extracted three times, concentrate under reduced pressure, add corn starch to the concentrate and mix evenly, granulate, and then fill into capsules to make capsules.

[0036] Example 4

[0037] A traditional Chinese medicine compound composition for treating sweating syndrome, which is made from the following raw materials by weight: gypsum (decocted first) 60g, coptis 15g, scutellaria baicalensis 9g, phellodendron amurense 10g, anemarrhena asphodeloides 10g, talc (decocted first) 18g, artemisia capillaris 18g, stir-fried coix seed 18g, dried ginger 12g, and roasted licorice root 6g.

[0038] 2. A preparation method of a drug for treating sweating syndrome, which comprises the following steps:

[0039] Weigh 60g of gypsum and 18g of talc by weight, add 10 times the amount of water and decoct for extraction for 20 minutes first, then add 15g of coptis, 9g of scutellaria baicalensis, 10g of phellodendron amurense, 10g of anemarrhena asphodeloides, 18g of artemisia capillaris, 18g of stir-fried coix seed, 12g of dried ginger, and 6g of roasted licorice root, and then add 10 times the amount of water based on the weight of the medicinal materials and decoct for extraction for 1 hour. Then filter, add 8 times the amount of water based on the weight of the medicinal materials to the medicinal residues and decoct for extraction for 1 hour, filter, and add 8 times the amount of water based on the weight of the medicinal materials to the medicinal residues and decoct for extraction for 1 hour. Combine the filtrates extracted three times, concentrate under reduced pressure, mix the concentrate evenly with diluent lactose, granulate, dry, and make into granules.

[0040] Example 5 Clinical Efficacy Study

[0041] 1. Clinical Data

[0042] Patients with sweating syndrome who visited the outpatient clinic of Professor Li Qiyi at the First Affiliated Hospital of Nanjing University of Chinese Medicine from January 1, 2018 to December 30, 2023.

[0043] 2. Research Methods

[0044] 2.1 Case Collection and Sorting

[0045] Let the patients with sweating syndrome who come for the first visit fill in the "Sweating Syndrome Condition Assessment Form", record the main condition of the patients and the Hyperhidrosis Disease Severity Scale (HDSS), and score.

[0046] 2.1.1 Diagnostic, Inclusion and Exclusion Criteria

[0047] Diagnostic criteria: The Hyperhidrosis Disease Severity Scale (HDSS) is a widely accepted scale used to evaluate the impact of hyperhidrosis on patients' lives. Specifically, it includes: 1 point: sweating is never obvious and never interferes with daily life; 2 points: sweating is still tolerable, but sometimes it interferes with daily life; 3 points: sweating is almost intolerable and often interferes with daily life; 4 points: sweating is unbearable and always interferes with daily activities. Among them, 3 points and 4 points indicate severity, 2 points indicate moderate HH, and 1 point indicates the absence of HH.

[0048] Inclusion criteria: Patients with sweating syndrome who visited the outpatient clinic of Professor Li Qiyi from January 1, 2018 to December 30, 2023; the score of the Hyperhidrosis Disease Severity Scale is 2 points and above.

[0049] Exclusion criteria: Normal sweating caused by objective factors such as environment and activities; accompanied by sweating, but not mainly complaining of hyperhidrosis; having received treatment from other medical institutions or other methods before visiting; stopping taking medicine on one's own due to personal reasons, and the treatment time is less than one course of treatment; the corresponding electronic medical record of the patient is missing; those with mental disorders.

[0050] 2.1.2 Efficacy evaluation criteria

[0051] Compare the HDSS scores of patients with sweating syndromes before and after treatment, and conduct statistics with reference to the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medical Syndromes" of the State Administration of Traditional Chinese Medicine: Recovery: The symptoms disappear or basically disappear after treatment; 2. Marked effect: The symptoms are significantly improved after treatment compared with before treatment; 3. Effective: The symptoms are improved after treatment compared with before treatment; 4. Ineffective: The symptoms are not improved after treatment compared with before treatment.

[0052] 2.1.3 HDSS score

[0053] Record the HDSS scores before and after treatment.

[0054] 2.2 Treatment methods

[0055] 92 included cases were divided into the Shihuang Quhan Decoction group and the Yupingfeng Oral Liquid control group, with an open label. The Shihuang Quhan Decoction group took the extract of the traditional Chinese medicine compound composition prepared in Example 1 of the present invention, 200 ml each in the morning and evening, and was treated for 4 weeks. The Yupingfeng group took Yupingfeng Oral Liquid according to the drug instruction manual and was treated for 4 weeks.

[0056] 2.3 Record data

[0057] Use Excel to count the gender, age, HDSS scores before and after treatment of patients with sweating syndromes; the occurrence site of hyperhidrosis, the duration of hyperhidrosis, aggravating factors, the frequency of hyperhidrosis occurrence, the area of hyperhidrosis, the degree of sweating volume, etc.; efficacy and adverse reactions.

[0058] 2.4 Statistical methods

[0059] Use the statistical software SPSS 26.0 software package for statistical analysis. Count data are expressed in absolute values, rates, and constituent ratios. For categorical variables in count data, χ 2 test or Fisher's exact probability method is used; for ordinal variables in count data, nonparametric tests or rank sum tests are used. When P is less than 0.05, the difference can be considered statistically significant.

[0060] 3. Clinical treatment results

[0061] 3.1 Comparison of efficacy of patients with sweating syndromes before and after treatment

[0062] Table 1: Efficacy of Shihuang Quhan Decoction on patients with sweating disorders

[0063] Group Cured Markedly effective Effective Ineffective Effective rate (%) Shihuang Quhan Recipe group 17 10 12 7 84.78 Jade Screen Control group 8 5 13 20 56.52

[0064] The effective rate of the Shihuang Quhan prescription group was 84.78%, and the effective rate of the Yupingfeng prescription group was 56.52%. There was a significant difference between the two groups (P = 0.0029).

[0065] 3.2 Comparison of HDSS scores before and after treatment in the two groups

[0066] Table 2: HDSS scores of the two groups

[0067]

[0068] Further analysis showed that the HDSS scores of patients with sweating syndromes before and after treatment were non-normally distributed. After the rank sum test for paired data, the results showed that Z = -2.614, P == 0.009. There was a significant difference between the Shihuang Quhan prescription group and the control group, indicating that the traditional Chinese medicine compound composition provided by the present invention has a definite curative effect on treating sweating syndromes.

Claims

1. A Chinese medicinal compound composition for treating sweating, characterized in that: The invention comprises the following raw materials in parts by weight: 60-360 parts of gypsum, 15-90 parts of coptis root, 9-54 parts of scutellaria root, 10-60 parts of phellodendron, 10-60 parts of rhizoma anemarrhenae, 18-108 parts of talc, 18-108 parts of capillaris, 18-108 parts of stir-fried coix seeds, 12-72 parts of dried ginger and 6-36 parts of roasted liquorice root.

2. The Chinese medicinal compound composition for treating sweating according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 60-180 parts of gypsum, 15-45 parts of coptis root, 9-27 parts of scutellaria root, 10-30 parts of phellodendron, 10-30 parts of rhizoma anemarrhenae, 18-54 parts of talc, 18-54 parts of capillaris, 18-54 parts of stir-fried coix seeds, 12-36 parts of dried ginger and 6-18 parts of roasted liquorice root.

3. The Chinese medicinal compound composition for treating sweating according to claim 2, characterized in that: The medicine is prepared from the following raw materials in parts by weight: 60 parts of gypsum, 15 parts of coptis root, 9 parts of scutellaria root, 10 parts of phellodendron amurense, 10 parts of rhizoma anemarrhenae, 18 parts of talc, 18 parts of capillaris, 18 parts of fried coix seeds, 12 parts of dried ginger and 6 parts of roasted liquorice root.

4. A medicine for treating sweating, characterized in that: The extract of the Chinese medicine compound composition according to any one of claims 1 to 3 and a pharmaceutically acceptable carrier are prepared into a drug in the form of oral liquid, granules, capsules, tablets, pills, powders, decoctions, mixtures or injections.

5. The method for preparing the medicine for treating sweating according to claim 4, characterized in that: The following steps are involved: According to the weight proportions described in any one of claims 1 to 3, gypsum and talc are added with water and boiled for a period of time, and then coptis root, scutellaria baicalensis, phellodendron chinense, anemarrhena asphodeloides, capillaris, fried coix seeds, dried ginger and roasted liquorice are added, water is added for extraction, filtered, the filtrate is combined, concentrated to a thick paste, and then the thick paste is prepared into a traditional Chinese medicine preparation with a pharmaceutically acceptable carrier.

6. The method for preparing a medicine for treating sweating according to claim 5, wherein: The following steps are involved: According to the weight proportions described in any one of claims 1 to 3, first take gypsum and talc, add 6 to 12 times the amount of water, boil or reflux for 10 to 30 minutes, then add coptis root, scutellaria baicalensis, phellodendron, anemarrhena, capillaris, stir-fried coix seeds, dried ginger and roasted liquorice, then add 6 to 12 times the amount of water, boil and extract for 0.5 to 2 hours, repeat the extraction 1 to 3 times, filter, combine the filtrate, concentrate to a thick paste, and then prepare the thick paste and a pharmaceutically acceptable carrier into a traditional Chinese medicine preparation.

7. Use of the Chinese medicine compound composition according to any one of claims 1 to 3 in the preparation of a medicine for treating sweating.

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