A traditional Chinese medicine composition, extract and application thereof

Abstract

The application provides a traditional Chinese medicine composition, an extract and application thereof. Specifically, the application provides a traditional Chinese medicine composition for treating asthenospermia of kidney deficiency and dampness obstruction, which is composed of cassia twig, atractylodes, dried tangerine or orange peel, pinellia, white peony root, dried ginger, white cardamom, radix morindae officinalis, semen cuscutae and licorice. The application has the advantages of simple prescription and definite clinical curative effect. Clinical research verifies that the traditional Chinese medicine composition of the application can improve sperm activity and sperm quality, has high cure rate and total efficiency, and has a good effect on treating or improving asthenospermia of kidney deficiency and dampness obstruction.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine treatment, and specifically relates to a traditional Chinese medicine composition, extract and its application. Background Technology

[0002] Modern life is fast-paced, and living environments have changed. Long-term consumption of raw and cold foods, insufficient warmth in winter, and prolonged use of air conditioning in summer have led to a growing prevalence of "cold and dampness" constitutions among clinical patients, resulting in asthenospermia. The classic Chinese medicine text, *Huangdi Neijing*, points out that kidney function is significantly related to the occurrence and development of male infertility.

[0003] Currently, the TCM approach to treating asthenospermia in clinical practice mainly focuses on warming and nourishing kidney yang and replenishing kidney essence. The formulation principles of common commercially available TCM preparations such as Wuzi Yanzong Wan, Qilin Wan, Shengjing Pian, Yougui Capsules, and Fufang Xuanju Capsules are all based on this approach. However, there is very little attention paid to asthenospermia caused by kidney deficiency and dampness.

[0004] Therefore, there is an urgent need in this field to develop a treatment method for asthenospermia caused by kidney deficiency and dampness obstruction. Summary of the Invention

[0005] The purpose of this invention is to provide a treatment method for asthenospermia of the kidney deficiency and dampness obstruction type, specifically involving a traditional Chinese medicine composition, extract and its application.

[0006] In a first aspect of the present invention, a traditional Chinese medicine composition is provided, said traditional Chinese medicine composition being composed of the following raw materials or extracts thereof:

[0007] 7-23 parts by weight of cinnamon twigs;

[0008] Atractylodes lancea 7-23 parts by weight;

[0009] 7-23 parts by weight of dried tangerine peel;

[0010] Pinellia ternata 10-30 parts by weight;

[0011] 7-23 parts by weight of Poria cocos;

[0012] 7-23 parts by weight of dried ginger;

[0013] 7-23 parts by weight of white cardamom;

[0014] Morinda officinalis 20-40 parts by weight;

[0015] Cuscuta chinensis 20-40 parts by weight;

[0016] Prepared licorice root, 2-8 parts by weight.

[0017] In another preferred embodiment, the raw medicinal materials include fresh medicinal materials, partially dried medicinal materials, dried medicinal materials, or a combination thereof.

[0018] In another preferred embodiment, when the composition contains raw medicinal materials, the weight parts are calculated based on the dry weight of the corresponding raw medicinal materials.

[0019] In another preferred embodiment, when the composition comprises an extract of a raw material, the compatibility of the extract is calculated based on the dry weight of the corresponding raw material.

[0020] In another preferred embodiment, the extract includes: an aqueous extract, an alcoholic extract, an aqueous solvent extract, a supercritical carbon dioxide extract, or an active ingredient, or a combination thereof, preferably an aqueous extract or an alcoholic extract.

[0021] In another preferred embodiment, the active ingredient includes a single ingredient or a mixture of ingredients.

[0022] In another preferred embodiment, the traditional Chinese medicine composition comprises the following raw medicinal materials or their extracts:

[0023] 10-20 parts by weight of cinnamon twigs, preferably 15 parts by weight;

[0024] Atractylodes lancea 10-20 parts by weight, preferably 15 parts by weight;

[0025] 10-20 parts by weight of dried tangerine peel, preferably 15 parts by weight;

[0026] Pinellia ternata 15-25 parts by weight, preferably 20 parts by weight;

[0027] 10-20 parts by weight of Poria cocos, preferably 15 parts by weight;

[0028] 10-20 parts by weight of dried ginger, preferably 15 parts by weight;

[0029] 10-20 parts by weight of white cardamom, preferably 15 parts by weight;

[0030] Morinda officinalis 25-35 parts by weight, preferably 30 parts by weight

[0031] Cuscuta seeds 25-35 parts by weight, preferably 30 parts by weight

[0032] Prepared licorice root, 3-7 parts by weight, preferably 5 parts by weight.

[0033] In another preferred embodiment, the weight ratio of cinnamon twig, atractylodes rhizome, tangerine peel, pinellia rhizome, white poria cocos, dried ginger, white cardamom, morinda root, dodder seed, and prepared licorice root in the traditional Chinese medicine composition is (0.7-1.2):(0.7-1.2):(0.7-1.2):(1-1.5):(0.7-1.2):(0.7-1.2):(0.7-1.2):(1.4-2.4):(1.4-2.4):(0.1-0.5), preferably 1:1:1:(1-1.4):1:1:1:(1.8-2.2):(1.8-2.2):(0.2-0.4).

[0034] In another preferred embodiment, the traditional Chinese medicine composition consists of 15g of cinnamon twig, 15g of atractylodes rhizome, 15g of dried tangerine peel, 20g of pinellia tuber, 15g of white poria cocos, 15g of dried ginger, 15g of white cardamom, 30g of morinda root, 30g of dodder seed, and 5g of prepared licorice root.

[0035] In a second aspect of the invention, a traditional Chinese medicine composition extractant is provided, the extractant being prepared by extraction using the traditional Chinese medicine composition as described in the first aspect, wherein the extraction solvent of the extractant is an aqueous solvent.

[0036] In another preferred embodiment, the extraction solvent is water or alcohol.

[0037] In another preferred embodiment, the extractant includes an extractant with an unadjusted (or unchanged) concentration, a concentrated extractant, or a diluted extractant.

[0038] In another preferred embodiment, the extractant is a decoction or extract of the traditional Chinese medicine composition.

[0039] In another preferred embodiment, the extractant is a concentrated decoction or extract.

[0040] In a third aspect of the present invention, a method for preparing an extract of a traditional Chinese medicine composition as described in the second aspect is provided, comprising the steps of: extracting the components of the traditional Chinese medicine composition as described in the first aspect with hot water to obtain the extract of the traditional Chinese medicine composition as described in the second aspect.

[0041] In a fourth aspect of the invention, a pharmaceutical preparation is provided, the preparation comprising:

[0042] i) The traditional Chinese medicine composition as described in the first aspect or the extract of the traditional Chinese medicine composition as described in the second aspect;

[0043] ii) Other pharmaceutically acceptable excipients, carriers or excipients.

[0044] In another preferred embodiment, the pharmaceutical preparation is a traditional Chinese medicine preparation.

[0045] In another preferred embodiment, the formulation is an oral formulation or a non-oral formulation.

[0046] In another preferred embodiment, the formulation includes a liquid formulation, a semi-solid formulation, or a solid formulation.

[0047] In another preferred embodiment, the preparation includes: powder, granules, capsules, mixture, powder, injection, tincture, oral liquid, tablets, lozenges, or drops.

[0048] In a fifth aspect of the invention, there is provided the use of a traditional Chinese medicine composition as described in the first aspect, an extract of a traditional Chinese medicine composition as described in the second aspect, or a pharmaceutical preparation as described in the fourth aspect, for preparing a pharmaceutical composition for the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness obstruction.

[0049] In another preferred embodiment, the kidney deficiency and dampness-retention type asthenospermia has characteristics selected from the group below:

[0050] (1) Long-term infertility and thin, watery semen; and

[0051] (2) Symptoms including soreness and weakness of the waist and knees, fatigue, heaviness of the head and body, dampness of the scrotum, sticky stools, white and greasy tongue coating, and slow and slippery pulse.

[0052] In another preferred embodiment, the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness means that the patient's scores for one or more symptoms improve before and after treatment.

[0053] In another preferred embodiment, the degree of improvement is expressed by a syllabus scoring method based on the symptom scores of the relevant features, wherein the syllabus is selected from the following groups: severe (3 points), moderate (2 points), mild (1 point), and asymptomatic (0 points).

[0054] In another preferred embodiment, the relevant features are selected from the group consisting of: ① soreness and weakness in the lower back and knees, ② fatigue and weakness, ③ heaviness in the head and body, ④ dampness in the scrotum, ⑤ sticky stools, ⑥ white and greasy tongue coating, and slow and slippery pulse.

[0055] In another preferred embodiment, the relevant features are recorded and assessed with reference to the "Guidelines for the Diagnosis and Treatment of Male Infertility Using Integrated Traditional Chinese and Western Medicine" (2023 edition).

[0056] In another preferred embodiment, the overall efficacy of the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness is represented by characteristics selected from the group consisting of:

[0057] (a) Recovery: The spouse conceives or all indicators of the routine semen analysis are normal;

[0058] (b) Significant effect: Sperm motility and total sperm motility (PR+NP) ≥ 40%;

[0059] (c) Effective: Total sperm motility (PR+NP) ≤40%, but percentage increase ≥30%;

[0060] (d) Ineffective: No significant improvement in sperm motility after treatment, or an increase in sperm motility percentage of <30%.

[0061] In another preferred embodiment, the overall efficacy of the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness is: (number of cured cases + number of cases with significant effect + number of cases with effect) / total number of cases * 100%.

[0062] In a sixth aspect of the invention, a method for treating asthenospermia of the kidney deficiency and dampness obstruction type is provided, comprising the steps of: administering to a subject in need a medically effective amount of a traditional Chinese medicine composition as described in the first aspect, an extract of a traditional Chinese medicine composition as described in the second aspect, or a pharmaceutical preparation as described in the fourth aspect.

[0063] In another preferred embodiment, the subject is a patient with asthenospermia due to kidney deficiency and dampness obstruction.

[0064] It should be understood that, within the scope of this invention, the above-described technical features of this invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be described in detail here. Detailed Implementation

[0065] Through extensive and in-depth research, the inventors have unexpectedly developed a traditional Chinese medicine composition for the first time targeting asthenospermia caused by kidney deficiency and dampness obstruction. The composition uses cinnamon twig as the principal ingredient to enhance sperm motility; Atractylodes lancea, Pinellia ternata, and Poria cocos to strengthen the spleen; Amomum villosum and Citrus reticulata peel to regulate qi and strengthen the spleen; dried ginger combined with Er Chen (Citrus reticulata peel and Pinellia ternata) to further invigorate the spleen; and Euphorbia pekinensis and Cuscuta chinensis to tonify the kidneys and replenish essence. This traditional Chinese medicine composition is concise and has definite clinical efficacy. Clinical studies have verified that this composition can improve sperm motility and quality, with high cure rate and overall efficiency, demonstrating good therapeutic or improvement effects on asthenospermia caused by kidney deficiency and dampness obstruction. This invention was completed based on these findings.

[0066] the term

[0067] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0068] As used herein, the terms “comprising,” “including,” and “containing” are used interchangeably and include not only closed definitions but also semi-closed and open definitions. In other words, the terms include “consisting of” and “substantially consisting of”.

[0069] As used herein, the term “pharmaceuticalally acceptable excipient, carrier or excipient” refers to a substance that is suitable for use in humans and / or animals without excessive adverse side effects (such as toxicity, irritation and allergic reactions), i.e., a substance with a reasonable benefit / risk ratio.

[0070] As used herein, the term "effective amount" refers to an amount that is functional or active in humans and / or animals and is acceptable to humans and / or animals. Those skilled in the art will understand that the "effective amount" can vary depending on the form of the pharmaceutical composition, the severity of the disease, and whether it is used in combination with other drugs.

[0071] The "prevention," "treatment," or "improvement" described in this invention includes delaying and halting the progression of the disease, or eliminating the disease, and does not require 100% inhibition, eradication, or reversal. In some embodiments, compared to levels observed in the absence of the herbal compositions or pharmaceutical preparations of this invention, the herbal compositions or pharmaceutical preparations of this invention are able to prevent the occurrence of asthenospermia due to kidney deficiency and dampness obstruction, or reduce, inhibit, and / or reverse existing asthenospermia due to kidney deficiency and dampness obstruction or its symptoms by, for example, at least about 10%, at least about 30%, at least about 50%, or at least about 80%.

[0072] As used herein, the terms "parts by weight" and "number of parts by weight" are used interchangeably. A part by weight can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1 mg, 1 g, 2 g, or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (number of parts by weight of that component / sum of the number of parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0073] As used herein, the term "raw material" refers to a traditional Chinese medicinal material that serves as an active ingredient in the compositions of the present invention. The raw material may include various forms, such as (but not limited to) dried, fresh, raw, processed, or combined raw materials. Furthermore, when the compositions of the present invention contain an extract of a certain raw material, the term also includes the raw material corresponding to the extract or the corresponding raw material used to prepare the extract.

[0074] The traditional Chinese medicine composition of the present invention

[0075] This invention provides a traditional Chinese medicine composition that can be used to prevent, treat and / or improve asthenospermia of the kidney deficiency and dampness obstruction type.

[0076] Theoretical support for this research: In this invention, cinnamon twig is used as the principal ingredient, which is pungent and sweet in taste and can enhance sperm motility.

[0077] This formula also emphasizes protecting the spleen. The spleen in the middle jiao prefers dryness and dislikes dampness, so Atractylodes lancea, Pinellia ternata, and Poria cocos are used as assistant herbs, while dried ginger, white cardamom, and tangerine peel are used as adjuvant herbs. Cardamom and tangerine peel promote qi circulation and strengthen the spleen, while dried ginger is stabilizing and warms the spleen in the middle jiao.

[0078] When dried ginger and prepared licorice are used together, on the one hand, they can clear away the evil influences of Yin in the middle Jiao, allowing the kidney-tonifying and essence-replenishing herbs such as Morinda officinalis and Cuscuta chinensis to reach the kidneys directly, while the prepared licorice has the strongest earth element, which can achieve the effect of strengthening the earth and suppressing fire.

[0079] The extractant and its preparation method of the present invention

[0080] This invention provides an extractant for a traditional Chinese medicine composition, wherein the extractant is prepared by extracting from the traditional Chinese medicine composition of this invention.

[0081] As used herein, "extractant of the present invention" refers to an extract obtained by solvent extraction and filtration of the traditional Chinese medicine composition of the present invention, which exists in the form of decoction or extract.

[0082] The active ingredients of the traditional Chinese medicine composition of the present invention are purified by solvent extraction and filtration. The extraction method used can be selected based on the physicochemical properties of the active ingredients in the drug, choosing appropriate extraction solvents and conditions. Preferably, the extractant of the present invention is prepared by the following method:

[0083] The components of the traditional Chinese medicine composition of the present invention are decocted in hot water, the decoction is filtered, and the filtrate is collected to obtain the extract of the traditional Chinese medicine composition.

[0084] Preparation and administration

[0085] This invention provides a formulation containing one or more of the following medicinal materials or extracts: cinnamon twig, atractylodes lancea, tangerine peel, pinellia ternata, poria cocos, dried ginger, white cardamom, morinda officinalis, cuscuta chinensis, and prepared licorice root. In the formulation, the content of the raw medicinal materials or their extracts can be 0.1-99.9 wt%, based on the weight of the formulation. The composition may also contain a pharmaceutically or health-product-acceptable carrier.

[0086] In this invention, it should be understood that the extract includes not only concentrated solutions (such as extracts) or active ingredients (such as powders) obtained by extracting a mixture of raw medicinal materials, but also mixtures of concentrated solutions (such as extracts) or active ingredients obtained from extracting individual raw medicinal materials (including mixtures between concentrated solutions, between active ingredients, or between concentrated solutions and active ingredients). The active ingredients of the raw medicinal materials include single components or mixed components.

[0087] There are no particular limitations on the dosage form of the formulations described in this invention; any dosage form suitable for mammals can be used. Preferably, the dosage form may include tablets, capsules, granules, pills, mixtures, powders, oral liquids, lozenges, or aerosols. From the standpoint of ease of preparation, administration, or consumption, the preferred composition is a solid dosage form. Oral administration is preferred.

[0088] The formulations of this invention can incorporate various conventional carriers and / or excipients required for preparing different dosage forms. The excipients described in this invention are pharmaceutical grade excipients, including dextrin, lactose, sodium bicarbonate, citric acid, sodium hydroxymethyl starch, micronized silica gel, starch, soluble starch, polyethylene glycol, or magnesium stearate. They can be prepared into any commonly used dosage form, such as tablets, capsules, granules, pills, or powders, using conventional methods for preparing traditional Chinese medicine formulations.

[0089] Examples of pharmaceutically acceptable excipients include cellulose and its derivatives (such as methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, etc.), gelatin, talc, solid lubricants (such as stearic acid, magnesium stearate), calcium sulfate, vegetable oils (such as soybean oil, sesame oil, peanut oil, olive oil, etc.), polyols (such as propylene glycol, glycerin, mannitol, sorbitol, etc.), emulsifiers (such as Tween), wetting agents (such as sodium lauryl sulfate), buffers, chelating agents, thickeners, pH adjusters, transdermal penetration enhancers, colorants, flavoring agents, stabilizers, antioxidants, preservatives, antibacterial agents, pyrogen-free water, etc.

[0090] The formulations of this invention can avoid the need for traditional Chinese medicine decoctions to be prepared on the spot before administration, which can easily lead to mold and spoilage and cause many inconveniences to patients if left for a long time. Based on the characteristics of clinical medication, the physicochemical properties of the main medicinal ingredients in the prescription are preserved. Combined with modern pharmaceutical technology, solid dosage forms such as granules, tablets, capsules, and powders are made to conveniently and effectively meet the needs of patients.

[0091] The formulations of the present invention can be directly prepared as drugs for the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness obstruction. The formulations of the present invention may also contain other optional medicinal materials or extracts thereof, or other drugs effective in treating and / or preventing asthenospermia due to kidney deficiency and dampness obstruction. Preferably, the formulations of the present invention can alleviate the symptoms caused by asthenospermia due to kidney deficiency and dampness obstruction.

[0092] Typically, the formulations of this invention are administered daily at a dose of 0.001-20 g / kg of animal body weight, preferably in 1-4 divided doses daily, or in a sustained-release form. For most mammals, the total daily dose is 0.05-600 g. Of course, the specific dosage will vary depending on the mode of administration, dosage form, and severity of the disease being treated, all within the skill of a skilled physician. Administration can be carried out via conventional routes, including (but not limited to): oral, intramuscular, transdermal, or topical administration. Oral administration is preferred.

[0093] This invention also provides a method for preventing and / or treating asthenospermia of the kidney deficiency and dampness obstruction type, the method comprising the step of administering the composition or preparation of this invention to a desired subject. The subject is a human being.

[0094] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0095] 1) The traditional Chinese medicine composition of the present invention has definite curative effect and high safety, with a total effective rate of up to 90%;

[0096] 2) The preparation method of the traditional Chinese medicine composition of the present invention is simple, low in cost, and the raw materials are readily available;

[0097] 3) The traditional Chinese medicine composition of the present invention can improve sperm motility, improve sperm quality, and improve asthenospermia of the kidney deficiency and dampness obstruction type, with high cure rate and overall efficiency.

[0098] 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 under conventional conditions or as recommended by the manufacturer. Percentages and parts are by weight unless otherwise stated.

[0099] The following clinical trials were conducted to observe and evaluate the clinical efficacy and safety of the traditional Chinese medicine composition of the present invention in treating male asthenospermia.

[0100] Example 1 Clinical Study

[0101] 1. Study population

[0102] 1.1 General Information

[0103] Among patients who visited the Department of Andrology at Shanghai Seventh People's Hospital, 106 patients with asthenospermia due to kidney deficiency and dampness were selected using a randomized controlled study method and randomly divided into a control group and an experimental group at a ratio of 1:1, with 53 patients in each group.

[0104] 1.2 Western Medicine Diagnostic Criteria

[0105] According to the World Health Organization's "Standardized Examination and Treatment Manual for Male Infertility," asthenospermia is defined as follows: In cases where sexual and ejaculatory functions are normal, the patient has normal sperm density, but the percentage of progressively motile sperm is lower than the laboratory reference value and does not meet other diagnostic criteria.

[0106] Sperm parameter levels: Within 60 minutes after ejaculation, at room temperature, total motility (PR+NP) < 40%, or progressively motile sperm (PR) < 32%. (Refer to the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition): Progressive motility (PR): Sperm actively move in a straight line or along a large circle, regardless of their speed; Non-progressive motility (NP): All other forms of non-progressive motility, such as swimming in small circles, where tail movement barely drives head movement, or only tail wagging is observed.)

[0107] 1.3 Traditional Chinese Medicine Syndrome Differentiation Standards

[0108] Based on the "Guidelines for the Diagnosis and Treatment of Male Infertility Using Integrated Traditional Chinese and Western Medicine" (2023 Edition) and the "Guidelines for the Diagnosis and Treatment of Male Infertility" (2022 Edition), and considering the patient's clinical manifestations, the primary symptom of asthenospermia due to kidney deficiency and dampness obstruction is defined as: prolonged infertility and clear, cold semen. Secondary symptoms include: ① lower back and knee pain, ② fatigue and weakness, ③ heaviness in the head and body, ④ scrotal dampness, ⑤ sticky stools, ⑥ white and greasy tongue coating, and a slow and slippery pulse. The patient must meet at least two of the above primary and secondary symptoms.

[0109] 1.4 Inclusion Criteria

[0110] ① Male aged 22-50; ② Married and cohabiting for more than one year without using any contraception, with the female partner being infertile due to male factors; ③ Meets the diagnostic criteria for asthenospermia; meets the TCM syndrome differentiation criteria for "kidney deficiency and dampness obstruction"; ④ Has normal sexual function and no other organic lesions of the reproductive system; ⑤ The patient has signed an informed consent form and participates voluntarily.

[0111] 1.5 Exclusion Criteria

[0112] ① Diagnosed with azoospermia or oligospermia; ② Congenital malformations, vas deferens obstruction, or grade II or higher varicocele; ③ Mental illness or other similar diseases; ④ Any serious psychological abnormality that is not well controlled; ⑤ History of reproductive system surgery, trauma, or uncontrolled organic lesions; ⑥ The spouse has a serious gynecological disease that cannot rule out the impact on fertility or even a confirmed diagnosis of infertility; ⑦ Regular, unprotected sexual intercourse less than once every 2 months or erectile dysfunction or ejaculation abnormalities; ⑧ Taking anti-epileptic drugs, anti-tumor drugs, or other medications that impair spermatogenesis and sperm motility; ⑨ Comorbid serious primary diseases of the cardiovascular, liver, kidney, and hematopoietic systems; ⑩ Using medications for asthenospermia within the past 3 months.

[0113] 2. Treatment methods

[0114] Patients diagnosed with asthenospermia due to kidney deficiency and dampness were randomly divided into a control group and an experimental group. The experimental group was given the traditional Chinese medicine formula described in this invention, while the control group was given a commercially available formula.

[0115] The traditional Chinese medicine formula of this invention is as follows: 15g of cinnamon twig, 15g of atractylodes rhizome, 15g of dried tangerine peel, 20g of pinellia tuber, 15g of white poria cocos, 15g of dried ginger, 15g of white cardamom, 30g of morinda root, 30g of dodder seed, and 5g of prepared licorice root.

[0116] Experimental group: The formula of this invention is decocted in water, taken twice a day, 150ml each time, half an hour after meals, for a treatment period of 3 months.

[0117] Control group: Wuzi Yanzong Wan (concentrated pill, composed of Schisandra chinensis, Rubus idaeus, Lycium barbarum, Cuscuta chinensis, and Plantago asiatica. Beijing Tongrentang Pharmaceutical Co., Ltd., National Medicine Approval Number Z11020188) 100g / bottle, 6g twice daily, swallowed with warm water after meals, for a treatment period of 3 months.

[0118] 3. Observation Indicators

[0119] 3.1 Sperm motility analysis

[0120] Semen motility was observed and recorded for all observed cases within 3 months before and after treatment.

[0121] 3.2 Traditional Chinese Medicine Syndrome Scoring

[0122] Referring to the "Guidelines for the Diagnosis and Treatment of Male Infertility Using Integrated Traditional Chinese and Western Medicine" (2023 Edition), the changes in the main symptoms of patients with asthenospermia of the kidney deficiency and dampness obstruction type before and after treatment were observed and recorded. Symptoms were recorded using a rating scale: severe (3 points), moderate (2 points), mild (1 point), and asymptomatic (0 points). The following symptoms were scored before and after treatment: ① lower back and knee pain, ② fatigue, ③ heaviness in the head and body, ④ scrotal dampness, ⑤ sticky stools, ⑥ white and greasy tongue coating, and slow and slippery pulse. The sum of all the above symptoms was the symptom score.

[0123] 3.3 Overall Efficacy

[0124] Recovery: The spouse conceives or all indicators in a routine semen analysis are normal;

[0125] Effective: Sperm motility (PR+NP) ≥ 40%;

[0126] Effective: Total sperm motility (PR+NP) ≤40%, but percentage increase ≥30%;

[0127] Ineffective: No significant improvement in sperm motility after treatment, or an increase in sperm motility percentage of <30%.

[0128] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases * 100%.

[0129] 3.4 Safety Indicators

[0130] ①Routine blood, urine, liver function, and kidney function tests;

[0131] ② Types, severity, and incidence of adverse events.

[0132] 4. Statistical methods

[0133] Data analysis was performed using SPSS 25.0 statistical software. Quantitative data conforming to a normal distribution were analyzed. For statistical analysis, independent samples t-tests were used for comparisons between groups, and paired t-tests were used for comparisons within groups. For continuous data that did not conform to a normal distribution, the M(P25, P75) method was used, with the Mann-Whitney U test used for comparisons between groups and the Wilcoxon signed-rank test used for comparisons within groups. Categorical data were described using frequencies (or proportions), and the χ² test was used for comparisons between groups. Ordinal data were analyzed using radit or rank-sum tests. All statistical tests were two-tailed, and P < 0.05 was considered statistically significant.

[0134] 5. Treatment Results

[0135] 5.1 General Information

[0136] During the study, 3 patients in the treatment group and 2 patients in the control group were excluded due to incomplete clinical data, resulting in a total of 101 patients (50 in the treatment group and 51 in the control group) included in the final statistical analysis. The mean age of the treatment group was (30.12±2.27) years, and the mean duration of infertility was (29.33±13.15) months. The mean age of the control group was (31.26±2.33) years, and the mean duration of infertility was (28.52±14.29) months. The baseline general characteristics (age and duration of infertility) of the two groups were similar (P>0.05), making them comparable.

[0137] 5.2 Comparison of sperm motility between the two groups of patients

[0138] Before treatment, there was no significant difference in the percentage of total sperm motility between the two groups (P>0.05), making them comparable. After treatment, the percentage of total sperm motility in the treatment group improved compared to before treatment (P<0.05), and the treatment group was superior to the control group (P<0.05). See Table 1 for details.

[0139] Table 1: Comparison of sperm motility between the two groups of patients ( %)

[0140]

[0141]

[0142] Note: *P<0.05 compared with pre-treatment levels; △P<0.05 compared with the control group.

[0143] 5.3 Comparison of TCM syndrome scale scores between the two groups of patients

[0144] Before treatment, there was no significant difference in the total scores of the TCM syndrome scale between the two groups (P>0.05), indicating comparability. After treatment, both groups showed a decrease, but the score in the treatment group was lower than that in the control group (P<0.05). See Table 2 for details.

[0145] Table 2: Comparison of TCM syndrome scale scores between the two groups of patients ( point)

[0146]

[0147] Note: *P<0.05 compared with pre-treatment levels; △P<0.05 compared with the control group.

[0148] 5.4 Comparison of clinical efficacy between the two groups of patients

[0149] After treatment, 8 cases in the treatment group recovered, including 4 cases of pregnancy, with a total effective rate of 90%. In contrast, only 2 cases in the control group recovered, with a total effective rate of 68.63%. The recovery rate in the treatment group was 4 times that of the control group, and the total effective rate was more than 1.3 times that of the control group. The difference between the two groups was statistically significant (P<0.05). See Table 3 for details.

[0150] Table 3: Comparison of clinical efficacy between the two groups of patients

[0151]

[0152] Note: Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%; compared with the control group, *P<0.05.

[0153] 5.5 Security Assessment

[0154] During the medication treatment, tests on patients' blood routine, urine routine, liver function, kidney function and other safety indicators before and after treatment showed that no patients experienced liver or kidney damage or abnormalities in blood and urine routine tests.

[0155] 6. Conclusion

[0156] The above clinical research results indicate that the traditional Chinese medicine combination of the present invention can significantly improve sperm quality and clinical symptoms in patients with asthenospermia due to kidney deficiency and dampness obstruction.

[0157] Current TCM approaches to treating asthenospermia primarily focus on warming and nourishing kidney yang and replenishing kidney essence, neglecting the specific causes of asthenospermia due to kidney deficiency and dampness obstruction. This invention, based on the Six Channels theory, addresses the issue from the perspective of the Taiyang and Shaoyin channels, employing a formula that tonifies the kidneys, replenishes essence, warms yang, and eliminates dampness, thus aligning with the fundamental pathogenesis of asthenospermia due to kidney deficiency and dampness obstruction. Furthermore, in controlled trials, the key combinations of this invention demonstrated significant advantages in cure rate and overall efficacy, showcasing both innovative invention and clinical practical value.

[0158] All documents mentioned in this invention are incorporated herein by reference as if each document were individually incorporated by reference. Furthermore, it should be understood that after reading the foregoing teachings of this invention, those skilled in the art can make various alterations or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating asthenospermia of the kidney deficiency and dampness obstruction type, characterized in that, The traditional Chinese medicine composition is made from the following raw materials or their extracts: 7-23 parts by weight of cinnamon twigs; Atractylodes lancea 7-23 parts by weight; 7-23 parts by weight of dried tangerine peel; Pinellia ternata 10-30 parts by weight; 7-23 parts by weight of Poria cocos; 7-23 parts by weight of dried ginger; 7-23 parts by weight of white cardamom; Morinda officinalis 20-40 parts by weight; Cuscuta chinensis 20-40 parts by weight; Prepared licorice root, 2-8 parts by weight.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The raw materials include fresh medicinal materials, partially dried medicinal materials, dried medicinal materials, or combinations thereof.

3. A traditional Chinese medicine composition extract for treating asthenospermia of the kidney deficiency and dampness obstruction type, wherein the extract is prepared by extraction using the traditional Chinese medicine composition as described in claim 1, and wherein the extraction solvent of the extract is an aqueous solvent.

4. A method for preparing the extractant of the traditional Chinese medicine composition as described in claim 3, comprising the steps of: extracting the components of the traditional Chinese medicine composition as described in claim 1 with hot water to obtain the extractant of the traditional Chinese medicine composition as described in claim 3.

5. A pharmaceutical preparation for treating asthenospermia of the kidney deficiency and dampness obstruction type, the preparation comprising: i) The traditional Chinese medicine composition as described in claim 1 or the extract of the traditional Chinese medicine composition as described in claim 3; ii) Other pharmaceutically acceptable excipients, carriers or excipients.

6. The use of the traditional Chinese medicine composition as described in claim 1, the extract of the traditional Chinese medicine composition as described in claim 3, or the pharmaceutical preparation as described in claim 5 in the preparation of a pharmaceutical composition for the prevention and / or treatment of asthenospermia due to kidney deficiency and dampness obstruction.

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