A traditional Chinese medicine composition, a preparation method therefor and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition, a preparation method and application thereof. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: cassia twig 10-20 parts, fennel 20-30 parts, bupleurum 15-30 parts, angelica 8-15 parts, evodia 2-5 parts, white peony root 4-10 parts, licorice 5-10 parts, cassia 16-26 parts, and tuckahoe 9-17 parts. The preparation method comprises the following steps: preparing fennel extract, tuckahoe extract, cassia twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cassia extract, mixing the above extracts to obtain a mixed extract, and soaking evodia in the mixed extract to obtain the traditional Chinese medicine composition by reflux extraction. In the present application, the main drug can warm the meridians and dispel cold, the auxiliary drug can invigorate blood and warm channels, and can also nourish the liver and yin, so that the main drug can achieve better effect. The main drug, the auxiliary drug and the auxiliary auxiliary drug can achieve synergistic effect, and are indispensable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Varicocele is usually asymptomatic and is often discovered during routine physical examinations, or by finding a painless, worm-like mass in the scrotum during self-examination, or when seeking medical attention for infertility. Some patients may experience symptoms such as a feeling of heaviness, dull pain, or discomfort, which worsen after prolonged standing or walking and are relieved or disappear when lying down. It may be accompanied by other conditions such as varicose veins in the lower extremities and hemorrhoids. Western medicine currently lacks specific medications for varicocele, and treatment often involves surgery, which can be invasive and has limited effectiveness. Traditional Chinese medicine often addresses the underlying pathogenesis of varicocele, achieving better results with minimal harm to the body.

[0003] Existing technology discloses a traditional Chinese medicine composition, its preparation, and its application for treating varicocele and fallopian tube obstruction. Referring to Chinese Patent CN 105434515 B, it consists of the following raw materials in parts by weight: 200-400 parts of *Patrinia scabiosaefolia*, 30-80 parts of *Tetrapanax papyriferus*, 200-400 parts of *Vaccaria segetalis*, 100-200 parts of *Liquidambar formosana*, 200-400 parts of *Spatholobus suberectus*, 150-250 parts of *Luffa cylindrica*, and 50-150 parts of *Manis pentadactyla*. This patent primarily focuses on clearing heat and detoxifying, and promoting blood circulation and removing blood stasis. However, the pathogenesis of varicocele may also involve liver cold. If clearing heat and detoxifying, and promoting blood circulation and removing blood stasis are the main treatments, they will be ineffective for varicocele caused by liver cold and may even worsen the condition. Therefore, there is an urgent need to develop a traditional Chinese medicine composition for preparing a drug to treat varicocele caused by liver cold. Summary of the Invention

[0004] This invention provides a traditional Chinese medicine composition, its preparation method, and its application, solving the problem that existing technologies lack drugs specifically targeting varicocele caused by liver cold when preparing traditional Chinese medicine compositions for treating varicocele.

[0005] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 10-20 parts of cinnamon twig, 20-30 parts of fennel, 15-30 parts of bupleurum, 8-15 parts of angelica, 2-5 parts of evodia, 4-10 parts of white peony root, 5-10 parts of licorice root, 16-26 parts of cinnamon bark, and 9-17 parts of poria cocos.

[0006] Preferably, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 14-16 parts of cinnamon twig, 23-27 parts of fennel, 20-25 parts of bupleurum, 10-13 parts of angelica, 3-4 parts of evodia, 6-8 parts of white peony root, 6-8 parts of licorice root, 20-22 parts of cinnamon bark, and 12-14 parts of poria cocos.

[0007] Preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts cinnamon twig, 25 parts fennel, 23 parts bupleurum, 12 parts angelica, 3 parts evodia, 7 parts white peony root, 7 parts licorice, 21 parts cinnamon bark, and 13 parts poria cocos.

[0008] The second objective of this invention is to protect a method for preparing the aforementioned traditional Chinese medicine composition, specifically comprising the following steps:

[0009] Preparation of fennel extract: Crush fennel seeds, put them in a bag, add water and boil for 30-45 minutes, then filter to obtain fennel extract;

[0010] Preparation of Poria cocos extract: Slice Poria cocos, reflux with ethanol for 1-2 hours, and filter to obtain Poria cocos extract;

[0011] The methods for preparing cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice root extract, and cinnamon bark extract are the same as those for preparing poria extract.

[0012] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0013] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1-1.5 hours, refluxed for 45-60 minutes, filtered, and the solvent was removed to obtain the traditional Chinese medicine composition.

[0014] Preferably, when preparing fennel extract, the fennel is pulverized to 100-200 mesh.

[0015] Preferably, when preparing fennel extract, the mass ratio of fennel to water is 1:6 to 8.

[0016] Preferably, when preparing the Poria cocos extract, the Poria cocos slices are cut to 1-2 mm.

[0017] Preferably, when preparing the Poria cocos extract, the mass ratio of Poria cocos to ethanol is 1:10-12.

[0018] A third objective of this invention is to protect the use of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating varicocele.

[0019] Preferably, the varicocele is caused by liver cold.

[0020] Pharmacological effects of each raw material in the traditional Chinese medicine composition:

[0021] Cinnamon twig: Its properties are pungent, sweet, and warm. It enters the heart, lung, and bladder meridians. Cinnamon twig is pungent and warming, sweet and warm, assisting yang. It warms and unblocks, assisting the yang qi of the whole body and unblocking the blood vessels. Entering the lung and bladder meridians, it is good at dispelling wind-cold and relieving wind-cold or wind evil on the surface. Entering the heart meridian and blood aspect, it is good at warming and unblocking, assisting yang, dispelling cold evil, unblocking blood vessels, promoting chest yang, warming and transforming dampness, and relieving pain. It is not as good as ephedra in inducing sweating, but it is better at assisting yang and unblocking blood vessels. It acts on both the exterior and interior, and is suitable for all wind-cold exterior syndromes, whether deficient or excessive, and for all cold syndromes, whether deficient or excessive, whether external cold directly invades or yang deficiency generates internally. It enters both the qi and blood aspects, and is suitable for blood stasis with cold and yang deficiency with water retention.

[0022] Fennel: It has the effects of strengthening the stomach and regulating qi, sterilizing and preventing infection, and dispelling cold and relieving pain. Strengthening the stomach and regulating qi: The fennel oil contained in fennel can stimulate the nerves and blood vessels of the gastrointestinal tract, expelling gas accumulated in the stomach and intestines, thus playing a role in strengthening the stomach and regulating qi. In addition, fennel contains anethole, which can effectively reduce inflammation, irritation, and colic caused by nausea. Dispelling cold and relieving pain: Fennel has the effect of dispelling cold and relieving pain, and can treat abdominal pain caused by cold hernia, lower abdominal cold pain, and joint and muscle pain, numbness, and difficulty in flexion and extension caused by wind and cold.

[0023] Bupleurum: Its medicinal properties are pungent, bitter, and slightly cold. It enters the liver, gallbladder, and lung meridians. Bupleurum is bitter and pungent, aromatic and ascending, and slightly cold, clearing heat. It enters the liver and gallbladder meridians. It disperses pathogenic factors in the gallbladder meridian to harmonize and reduce fever, disperses stagnant Qi in the liver and gallbladder meridians to soothe the liver and relieve depression, and also raises the clear Yang Qi of the liver and gallbladder to lift sunken Qi. It is a principal herb for the liver and gallbladder meridians. When used raw, it both disperses and clears; when processed with vinegar, its dispersing and clearing effects decrease, but its liver-soothing effect increases.

[0024] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. Its sweetness nourishes and moistens, while its pungent and warm properties promote circulation. It primarily enters the liver and heart meridians, and secondarily the spleen meridian. It excels at nourishing and invigorating blood, regulating menstruation and relieving pain, moistening the intestines and promoting bowel movements, and dispelling cold. It is suitable for all conditions of blood deficiency, blood stasis with cold, and is especially beneficial for those with constipation due to intestinal dryness. It is an essential medicine for regulating menstruation in gynecology, a superior blood tonic in internal medicine, and commonly used in surgery and traumatology for reducing swelling and treating injuries.

[0025] Evodia rutaecarpa: pungent, bitter, and hot. It enters the liver, spleen, and stomach meridians. Evodia rutaecarpa is pungent, hot, fragrant, and dispersing; bitter and drying; with a relatively strong effect. It primarily enters the liver meridian, and also the spleen and stomach meridians. It is effective in soothing the liver, descending the rebellious cold qi of the Jueyin meridian, warming the liver and dispelling cold, warming yang and drying dampness, harmonizing the liver and stomach to neutralize acidity, relieving pain, stopping hiccups, and also killing parasites. Externally, it dries dampness, kills parasites, and relieves itching, while also drawing fire and blood downwards to lower blood pressure. It is effective in treating liver cold with qi stagnation (dampness) and various symptoms of yang deficiency. It has strong medicinal power and is suitable for both internal and external use.

[0026] White peony root: Slightly cold in nature, bitter and sour in taste, it enters the liver and spleen meridians. It has the effects of dispersing blood stasis and unblocking collaterals, soothing the liver and relieving pain, and beautifying the skin. White peony root enters the liver and spleen meridians, and has the function of harmonizing the liver and spleen, soothing the liver and relieving pain. It is suitable for pain in the hypochondriac region due to liver stagnation and blood deficiency, abdominal cramps and pain due to liver and spleen disharmony, and cramps and pain in the limbs due to liver blood deficiency and malnourishment of tendons and vessels. It can play a role in soothing the liver and relieving pain.

[0027] Licorice: Its medicinal properties are sweet and neutral, and it enters the heart, lung, spleen, and stomach meridians. Licorice is sweet, nourishing, and moistening, with a slightly cooling effect when raw and a slightly warming effect when neutral. It primarily enters the spleen and lung meridians, and also the stomach and heart meridians. It not only tonifies qi and strengthens the middle jiao, but also relieves spasms and pain, moderates the properties of other herbs, and also eliminates phlegm, stops coughs, and detoxifies. Roasted licorice has a stronger tonifying and relieving effect; raw licorice can clear heat and detoxify.

[0028] Cinnamon: Its medicinal properties are pungent, sweet, and very hot. It enters the kidney, spleen, heart, and liver meridians. Cinnamon is pungent, sweet, and hot, warming and tonifying, dispersing and invigorating, with a thick and pure yang nature. Entering the kidney meridian, it gently tonifies kidney yang, supplementing fire and assisting yang, or guiding fire back to its source. Entering the liver, heart, and spleen meridians, it dispels deep-seated cold and stagnation, disperses cold and relieves pain, warms and unblocks the meridians, and invigorates blood and dissipates blood stasis. It is less effective at assisting yang than aconite, and is generally not used for restoring yang or rescuing from collapse. It excels at benefiting yang and eliminating yin, gently tonifying kidney yang, and guiding fire back to its source, making it an essential medicine for tonifying fire and assisting yang; it also enters the blood level, effectively warming and unblocking the meridians, improving microcirculation, and is suitable for those with blood stasis and cold.

[0029] Poria cocos: Its medicinal properties are sweet, bland, and neutral. It enters the heart, lung, spleen, and kidney meridians. Poria cocos is sweet and bland, promoting diuresis and tonifying simultaneously. Its nature is neutral and unbiased. Entering the spleen and kidney meridians, it effectively drains dampness and eliminates water retention, strengthening the spleen and promoting the transformation and transportation of fluids. It also enters the heart meridian, effectively calming the mind and soothing the spirit, making it suitable for treating those with water retention affecting the heart. It is suitable for all cases of water retention and fluid retention, regardless of whether they are due to cold or heat, or whether spleen deficiency is present. It is especially beneficial for those with spleen deficiency edema or excessive dampness.

[0030] Compared with the prior art, the beneficial effects of the present invention are:

[0031] Traditional Chinese medicine believes that one of the pathogenic mechanisms of varicocele is liver cold, because the entire male reproductive system belongs to the liver meridian. Varicocele is caused by cold in the liver meridian, which congeals the meridians and impairs blood circulation. This invention uses cinnamon twig, fennel, and cassia bark as the principal herbs: cinnamon twig warms and invigorates yang, dispels cold, unblocks blood vessels, and relieves exterior cold; fennel enters the liver meridian and is used to dispel liver cold, its medicinal properties are mobile and not stagnant, it can both dispel cold and promote qi circulation; cassia bark warms and tonifies kidney yang, guides fire back to its source, directs the patient's own yang qi to the lower jiao to act on the affected area, and can also prevent the patient from experiencing upper heat and lower cold. Bupleurum, angelica, and white peony root are used as assistant herbs: Bupleurum is used to soothe the liver and relieve depression, regulate liver qi stagnation, because liver qi stagnation can lead to qi stagnation, which in turn can lead to blood stasis, aggravating the condition. Adding bupleurum helps to regulate qi and prevent blood stasis; angelica nourishes liver blood and moistens the liver, replenishing blood and promoting blood circulation; white peony root softens the liver and nourishes yin, and can also astringe liver fire. Evodia rutaecarpa, Poria cocos, and Glycyrrhiza uralensis are used as adjuvant and guiding herbs: Evodia rutaecarpa is good at dispelling cold from the liver meridian, but its medicinal properties are relatively strong, so only a small amount is used to prevent excessive cold stagnation; Poria cocos removes dampness to prevent cold and dampness from accumulating in the patient's body; Glycyrrhiza uralensis harmonizes the effects of the other herbs. In this invention, the principal herb warms the meridians and dispels cold, the assistant herb invigorates blood and warms the body while also nourishing the liver and yin, and the adjuvant and guiding herbs assist the principal herb to achieve better results; the principal, assistant, and guiding herbs work synergistically and are all indispensable. Detailed Implementation

[0032] The technical solutions of this invention will be clearly and completely described below with reference to specific embodiments. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0033] Unless otherwise specified, the methods described in the various embodiments of this invention are conventional methods. Unless otherwise specified, the materials and reagents used are commercially available.

[0034] Example 1

[0035] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 10 parts cinnamon twig, 20 parts fennel, 15 parts bupleurum, 8 parts angelica, 2 parts evodia, 4 parts white peony root, 5 parts licorice root, 16 parts cinnamon bark, and 9 parts poria cocos.

[0036] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0037] Preparation of fennel extract: Fennel seeds were crushed to 100 mesh, placed in a gauze bag, and boiled in water at 95°C for 30 minutes. The extract was then filtered through 200 mesh gauze. The mass ratio of fennel seeds to water was 1:6.

[0038] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:10.

[0039] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:10.

[0040] Preparation of Bupleurum extract: Cut Bupleurum into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol is 1:10.

[0041] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:10.

[0042] Preparation of white peony extract: Cut white peony into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:10.

[0043] Preparation of licorice extract: Cut licorice into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:10.

[0044] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:10.

[0045] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0046] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1 hour, refluxed for 45 minutes, filtered through 100-mesh gauze to remove the solvent and obtain the traditional Chinese medicine composition.

[0047] Example 2

[0048] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 14 parts cinnamon twig, 23 parts fennel, 20 parts bupleurum, 10 parts angelica, 3 parts evodia, 6 parts white peony root, 6 parts licorice root, 20 parts cinnamon bark, and 12 parts poria cocos.

[0049] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0050] Preparation of fennel extract: Fennel seeds were crushed to 100 mesh, placed in a gauze bag, and boiled in water at 96℃ for 35 minutes. The extract was then filtered through 200 mesh gauze. The mass ratio of fennel seeds to water was 1:6.

[0051] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:10.

[0052] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:10.

[0053] Preparation of Bupleurum extract: Cut Bupleurum into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol is 1:10.

[0054] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:10.

[0055] Preparation of white peony extract: Cut white peony into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:10.

[0056] Preparation of licorice extract: Cut licorice into slices with a thickness of 1 mm, add 95% ethanol and reflux at 73°C for 1 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:10.

[0057] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 1 mm, refluxed with 95% ethanol at 73°C for 1 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:10.

[0058] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0059] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1 hour, refluxed for 50 minutes, filtered through 100-mesh gauze to remove the solvent and obtain the traditional Chinese medicine composition.

[0060] Example 3

[0061] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 15 parts cinnamon twig, 25 parts fennel, 23 parts bupleurum, 12 parts angelica, 3 parts evodia, 7 parts white peony root, 7 parts licorice root, 21 parts cinnamon bark, and 13 parts poria cocos.

[0062] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0063] Preparation of fennel extract: Fennel seeds were pulverized to 200 mesh, placed in a gauze bag, and boiled in water at 97°C for 40 minutes. The extract was then filtered through 200-mesh gauze. The mass ratio of fennel seeds to water was 1:7.

[0064] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:11.

[0065] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:11.

[0066] Preparation of Bupleurum extract: Bupleurum was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol was 1:11.

[0067] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:11.

[0068] Preparation of white peony extract: Cut white peony into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74℃ for 1.5 h, filter with 100 mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:11.

[0069] Preparation of licorice extract: Cut licorice into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74°C for 1.5 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:11.

[0070] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:11.

[0071] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0072] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1 hour, refluxed for 55 minutes, filtered through 100-mesh gauze to remove the solvent and obtain the traditional Chinese medicine composition.

[0073] Example 4

[0074] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 16 parts cinnamon twig, 27 parts fennel, 25 parts bupleurum, 13 parts angelica, 4 parts evodia, 8 parts white peony root, 8 parts licorice root, 22 parts cinnamon bark, and 14 parts poria cocos.

[0075] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0076] Preparation of fennel extract: Fennel seeds were pulverized to 200 mesh, placed in a gauze bag, and boiled in water at 98°C for 45 minutes. The extract was then filtered through 200-mesh gauze. The mass ratio of fennel seeds to water was 1:8.

[0077] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:12.

[0078] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:12.

[0079] Preparation of Bupleurum extract: Cut Bupleurum into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol is 1:12.

[0080] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:12.

[0081] Preparation of white peony extract: Cut white peony into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:12.

[0082] Preparation of licorice extract: Cut licorice into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:12.

[0083] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:12.

[0084] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0085] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1.5 hours, refluxed for 60 minutes, filtered through 100-mesh gauze to remove the solvent, and the traditional Chinese medicine composition was obtained.

[0086] Example 5

[0087] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 20 parts cinnamon twig, 30 parts fennel, 30 parts bupleurum, 15 parts angelica, 5 parts evodia, 10 parts white peony root, 10 parts licorice root, 26 parts cinnamon bark, and 17 parts poria cocos.

[0088] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0089] Preparation of fennel extract: Fennel seeds were pulverized to 200 mesh, placed in a gauze bag, and boiled in water at 100℃ for 45 minutes. The fennel extract was then filtered through 200 mesh gauze. The mass ratio of fennel seeds to water was 1:8.

[0090] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:12.

[0091] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:12.

[0092] Preparation of Bupleurum extract: Cut Bupleurum into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol is 1:12.

[0093] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:12.

[0094] Preparation of white peony extract: Cut white peony into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:12.

[0095] Preparation of licorice extract: Cut licorice into slices with a thickness of 2 mm, add 95% ethanol and reflux at 75°C for 2 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:12.

[0096] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 75°C for 2 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:12.

[0097] The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0098] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1.5 hours, refluxed for 60 minutes, filtered through 100-mesh gauze to remove the solvent, and the traditional Chinese medicine composition was obtained.

[0099] Comparative Example 1 (without principal drug)

[0100] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: Bupleurum chinense 23 parts, Angelica sinensis 12 parts, Evodia rutaecarpa 3 parts, Paeonia lactiflora 7 parts, Glycyrrhiza uralensis 7 parts, and Poria cocos 13 parts.

[0101] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0102] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:11.

[0103] Preparation of Bupleurum extract: Bupleurum was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol was 1:11.

[0104] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:11.

[0105] Preparation of white peony extract: Cut white peony into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74℃ for 1.5 h, filter with 100 mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:11.

[0106] Preparation of licorice extract: Cut licorice into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74°C for 1.5 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:11.

[0107] The obtained Poria cocos extract, Bupleurum chinense extract, Angelica sinensis extract, Paeonia lactiflora extract, and Glycyrrhiza uralensis extract are mixed to obtain a mixed extract.

[0108] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1 hour, refluxed for 55 minutes, filtered through 100-mesh gauze to remove the solvent and obtain the traditional Chinese medicine composition.

[0109] Comparative Example 2 (without medication)

[0110] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 15 parts cinnamon twig, 25 parts fennel, 3 parts evodia fruit, 7 parts licorice root, 21 parts cinnamon bark, and 13 parts poria cocos.

[0111] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0112] Preparation of fennel extract: Fennel seeds were pulverized to 200 mesh, placed in a gauze bag, and boiled in water at 97°C for 40 minutes. The extract was then filtered through 200-mesh gauze. The mass ratio of fennel seeds to water was 1:7.

[0113] Preparation of Poria cocos extract: Poria cocos was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain the Poria cocos extract; the mass ratio of Poria cocos to 95% ethanol was 1:11.

[0114] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:11.

[0115] Preparation of licorice extract: Cut licorice into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74°C for 1.5 h, and filter with 100-mesh gauze to obtain licorice extract; the mass ratio of licorice to 95% ethanol is 1:11.

[0116] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:11.

[0117] The obtained fennel extract, poria extract, cinnamon twig extract, tetrapanax papyrifer extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract;

[0118] Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1 hour, refluxed for 55 minutes, filtered through 100-mesh gauze to remove the solvent and obtain the traditional Chinese medicine composition.

[0119] Comparative Example 3 (without adjuvant drugs)

[0120] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 15 parts cinnamon twig, 25 parts fennel, 23 parts bupleurum, 12 parts angelica, 7 parts white peony root, and 21 parts cinnamon bark.

[0121] A method for preparing a traditional Chinese medicine composition specifically includes the following steps:

[0122] Preparation of fennel extract: Fennel seeds were pulverized to 200 mesh, placed in a gauze bag, and boiled in water at 97°C for 40 minutes. The extract was then filtered through 200-mesh gauze. The mass ratio of fennel seeds to water was 1:7.

[0123] Preparation of cinnamon twig extract: Cinnamon twigs were cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon twig extract; the mass ratio of cinnamon twigs to 95% ethanol was 1:11.

[0124] Preparation of Bupleurum extract: Bupleurum was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Bupleurum extract; the mass ratio of Bupleurum to 95% ethanol was 1:11.

[0125] Preparation of Angelica sinensis extract: Angelica sinensis was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74℃ for 1.5 h, and filtered through 100-mesh gauze to obtain Angelica sinensis extract; the mass ratio of Angelica sinensis to 95% ethanol was 1:11.

[0126] Preparation of white peony extract: Cut white peony into slices with a thickness of 2 mm, add 95% ethanol and reflux at 74℃ for 1.5 h, filter with 100 mesh gauze to obtain white peony extract; the mass ratio of white peony to 95% ethanol is 1:11.

[0127] Preparation of cinnamon extract: Cinnamon was cut into slices with a thickness of 2 mm, refluxed with 95% ethanol at 74°C for 1.5 h, and filtered through 100-mesh gauze to obtain cinnamon extract; the mass ratio of cinnamon to 95% ethanol was 1:11.

[0128] The prepared fennel extract, poria cocos extract, cinnamon twig extract, bupleurum extract, angelica extract, tetrapanax papyrifer extract, white peony root extract, licorice root extract, and cinnamon bark extract are mixed, and the solvent is removed to obtain the traditional Chinese medicine composition.

[0129] 1. Diagnostic criteria

[0130] Grade III: When the patient is standing, dilated veins can be seen protruding on the scrotal skin, like a cluster of earthworms, and are easy to feel;

[0131] Grade II: Dilated veins are easily palpable during outpatient visits, but cannot be seen.

[0132] Grade I: Not obvious on palpation, but may be present on Valsalva test;

[0133] Grade 0: Not obvious on palpation, not present during Valsalva test.

[0134] Based on the above diagnostic criteria, 480 patients diagnosed with varicocele were randomly divided into 8 groups, with 60 patients in each group. Patients in different groups took the traditional Chinese medicine compositions prepared in Examples 1-5 and Comparative Examples 1-3 of this invention, respectively, twice daily (morning and evening), diluted with warm water to 300 mL each time. Each course of treatment lasted 7 days, and two courses were administered to observe the effects.

[0135] 2. Criteria for judging therapeutic efficacy

[0136] Cured: The varicose veins in the scrotum disappeared, and the symptoms disappeared.

[0137] Effective: Varicose veins in the scrotum are reduced, and symptoms improve.

[0138] Ineffective: If the varicose veins in the scrotum do not change or worsen after two courses of treatment, and the symptoms do not improve, it is considered ineffective.

[0139] The efficacy of different groups is shown in Table 1.

[0140] Table 1. Statistical analysis of treatment results in different groups

[0141]

[0142]

[0143] Note: Overall effective rate = cure rate + effective rate.

[0144] As shown in Table 1, compared with Examples 1-5, the traditional Chinese medicine composition of Comparative Example 1 did not contain the principal herb. The cure rate, effective rate, and total effective rate of Comparative Example 1 were significantly lower than those of Examples 1-5, indicating that the principal herb plays a crucial role in the traditional Chinese medicine composition of this invention. Compared with Examples 1-5, the traditional Chinese medicine composition of Comparative Example 2 did not contain the assistant herb. The cure rate, effective rate, and total effective rate of Comparative Example 2 were slightly higher than those of Comparative Example 1, but still significantly lower than those of Examples 1-5, indicating that the assistant herb is indispensable in the traditional Chinese medicine composition of this invention. Compared with Examples 1-5, the traditional Chinese medicine composition of Comparative Example 3 did not contain the adjuvant herb. The cure rate, effective rate, and total effective rate of Comparative Example 3 were also lower than those of Examples 1-5, indicating that the adjuvant herb can synergistically enhance the effects of the principal and assistant herbs in the traditional Chinese medicine composition of this invention. Therefore, the traditional Chinese medicine composition prepared by this invention relies on the synergistic effects of the principal, assistant, adjuvant, and guide herbs, and none of them can be omitted.

[0145] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including both the preferred embodiments and all changes and modifications falling within the scope of the invention.

[0146] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating varicocele caused by liver cold, characterized in that, The Chinese herbal composition contains the following raw materials by weight: 10-20 parts of cinnamon twig, 20-30 parts of fennel, 15-30 parts of bupleurum, 8-15 parts of angelica, 2-5 parts of evodia, 4-10 parts of white peony root, 5-10 parts of licorice root, 16-26 parts of cinnamon bark, and 9-17 parts of poria cocos.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The Chinese herbal composition contains the following raw materials by weight: 14-16 parts of cinnamon twig, 23-27 parts of fennel, 20-25 parts of bupleurum, 10-13 parts of angelica, 3-4 parts of evodia, 6-8 parts of white peony root, 6-8 parts of licorice root, 20-22 parts of cinnamon bark, and 12-14 parts of poria cocos.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials by weight: 15 parts cinnamon twig, 25 parts fennel, 23 parts bupleurum, 12 parts angelica, 3 parts evodia, 7 parts white peony root, 7 parts licorice root, 21 parts cinnamon bark, and 13 parts poria cocos.

4. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Specifically, the following steps are included: Preparation of fennel extract: Crush fennel seeds, put them in a bag, add water and boil for 30-45 minutes, then filter to obtain fennel extract; Preparation of Poria cocos extract: Slice Poria cocos, reflux with ethanol for 1-2 h, and filter to obtain Poria cocos extract; The methods for preparing cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are the same as those for preparing poria extract. The obtained fennel extract, poria extract, cinnamon twig extract, bupleurum extract, angelica extract, white peony root extract, licorice extract, and cinnamon bark extract are mixed to obtain a mixed extract; Preparation of the traditional Chinese medicine composition: Evodia rutaecarpa was soaked in a mixed extract for 1-1.5 h, refluxed for 45-60 min, filtered, and the solvent was removed to obtain the traditional Chinese medicine composition.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, When preparing fennel extract, fennel seeds should be pulverized to 100-200 mesh.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, When preparing fennel extract, the mass ratio of fennel to water is 1:6~8.

7. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, When preparing Poria cocos extract, slice the Poria cocos to a thickness of 1-2 mm.

8. The method for preparing the traditional Chinese medicine composition according to claim 7, characterized in that, When preparing Poria cocos extract, the mass ratio of Poria cocos to ethanol is 1:10~12.

9. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a drug for treating varicocele.

10. The application according to claim 9, characterized in that, The varicocele mentioned is caused by liver cold.

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