A Chinese medicine composition for treating fallopian tube obstruction infertility and its preparation method and application

Abstract

The invention provides a traditional Chinese medicine composition for treating infertility caused by fallopian tube obstruction, and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-15 parts of cassia twig, 10-15 parts of red peony root, 15-20 parts of angelica, 10-15 parts of chuanxiong, 15-30 parts of tuckahoe, 3-6 parts of leech, 10-15 parts of sapodilla thorn, 10-30 parts of liquidambar formosana, 10-15 parts of fenugreek, 15-20 parts of dandelion, 10-15 parts of plantain, 15-20 parts of forsythia, 10-15 parts of antler frost, 10-15 parts of safflower fruit, 15-30 parts of magnolia bark and 3-9 parts of notoginseng. The Chinese medicine composition provided in this application has been proven through clinical trials to be able to promote the recovery of fallopian tube function, improve fallopian tube adhesions and hydrops, and treat fallopian tube obstructive infertility, with good results and clinical application value. At the same time, it can regulate the patient's physical condition and achieve the effects of relieving dysmenorrhea and improving menstrual conditions.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating fallopian tube obstruction infertility and a preparation method and application thereof. Background Art

[0002] The main factors causing fallopian tube obstruction include pelvic inflammatory disease, endometriosis, mycoplasma infection, history of pelvic and abdominal surgery, and congenital anatomical abnormalities. These factors lead to adhesion, hydrops, and obstruction of the fallopian tubes to varying degrees, affecting its functions of egg collection, fertilization, and transport of fertilized eggs, leading to infertility. Western medicine mainly treats fallopian tube obstruction infertility through laparoscopic surgery, interventional surgery, physical therapy, and other methods. Such therapies can improve the patency of the fallopian tubes and improve adhesion, but they do not fundamentally solve the problem of impaired contraction function and ciliary movement function of the fallopian tubes. It is easy to relapse. In addition, surgical treatment is easy to damage the body. Some anti-inflammatory drugs are easy to develop drug resistance and affect egg development. Therefore, the long-term efficacy is poor and the pregnancy rate is low. Summary of the invention

[0003] In view of this, the purpose of the present invention is to provide a Chinese medicine composition for treating fallopian tube obstruction infertility and its preparation method and application, so as to solve the above problems.

[0004] The technical solution of the present invention is achieved in this way:

[0005] On the one hand, the present application provides a traditional Chinese medicine composition for treating infertility caused by fallopian tube obstruction, comprising the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-15 parts of cinnamon twig, 10-15 parts of red peony root, 15-20 parts of angelica, 10-15 parts of chuanxiong, 15-30 parts of tuckahoe, 3-6 parts of leech, 10-15 parts of sapodilla thorn, 10-30 parts of rhizoma liquidambar formosana, 10-15 parts of fenugreek, 15-20 parts of dandelion, 10-15 parts of plantain, 15-20 parts of forsythia, 10-15 parts of antler cream, 10-15 parts of safflower fruit, 15-30 parts of magnolia bark and 3-9 parts of panax notoginseng.

[0006] Preferably, it is made from the following raw materials in parts by weight: 12 parts of peach kernel, 15 parts of cinnamon twig, 15 parts of red peony root, 20 parts of angelica, 15 parts of chuanxiong, 30 parts of tuckahoe, 3 parts of leech, 15 parts of sapodilla thorn, 30 parts of rhizoma liquidambar formosana, 15 parts of fenugreek, 20 parts of dandelion, 15 parts of plantain, 20 parts of forsythia, 10 parts of antler frost, 15 parts of safflower fruit, 30 parts of magnolia bark and 9 parts of panax notoginseng.

[0007] Preferably, the following raw materials are also included in parts by weight: 15 to 30 parts of Leonurus japonicus and 10 to 20 parts of Astragalus membranaceus.

[0008] More preferably, it is made from the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-12 parts of cinnamon twig, 10-12 parts of red peony root, 15-17 parts of angelica, 10-12 parts of chuanxiong, 15-17 parts of poria, 3-4 parts of leech, 13-15 parts of sapodilla spines, 10-12 parts of rhizoma liquidambar formosana, 10-12 parts of fenugreek, 10-12 parts of dandelion, 13-15 parts of plantain, 15-17 parts of forsythia, 10-12 parts of antler powder, 10-12 parts of red safflower fruit, 15-17 parts of magnolia bark, 3-4 parts of panax notoginseng, 15-17 parts of motherwort and 13-15 parts of astragalus.

[0009] Preferably, the following raw materials are also included in parts by weight: 10 to 15 parts of Atractylodes lancea.

[0010] More preferably, it is made from the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-12 parts of cinnamon twig, 10-12 parts of red peony root, 15-17 parts of angelica, 10-12 parts of chuanxiong, 15-17 parts of poria, 5-6 parts of leech, 10-12 parts of gleditsia thorn, 10-12 parts of rhizoma liquidambar formosana, 10-12 parts of fenugreek, 10-12 parts of dandelion, 13-15 parts of plantain, 15-17 parts of forsythia, 10-12 parts of antler powder, 10-12 parts of safflower fruit, 15-17 parts of magnolia bark, 5-7 parts of panax notoginseng and 10-12 parts of atractylodes.

[0011] On the other hand, the present application provides a Chinese medicine honey pill for treating fallopian tube obstruction infertility, which is prepared from the above-mentioned Chinese medicine composition.

[0012] Preferably, a method for preparing a Chinese medicine honey pill for treating fallopian tube obstruction infertility comprises the following steps:

[0013] S1 Weighing and powdering: Weigh the raw materials of medicinal materials by weight according to the formula, mix and grind them, pass through a 90-110 mesh sieve, and obtain mixed powder for standby use; during the grinding process, control the powder temperature not to exceed 60°C;

[0014] S2 Honey refining: First boil the honey with high heat, then simmer with low heat until the honey turns yellow and has evenly distributed mung bean-sized bubbles. It is sticky but not stringy when touched, which means the honey is refined.

[0015] S3 seasoning and mixing: mixing the powder obtained in step S1 and the honey refined in step S2 at a weight ratio of 1:1 to 1.2;

[0016] S4 finished product pilling: the mixed material combined in step S3 is pilled to obtain the Chinese medicine honey pills.

[0017] In the embodiments of the present application, the drug is an oral preparation.

[0018] According to the embodiment of the present application, the drug is in the form of an oral preparation, thereby being easy to use.

[0019] In the embodiment of the present application, the Chinese medicine decoction-free granules are prepared from the Chinese medicine composition as raw materials. The preparation method of the Chinese medicine decoction-free granules includes the following steps:

[0020] The Chinese herbal medicine slices that meet the processing specifications are used as raw materials, the Chinese herbal medicine composition is weighed, the effective ingredients of the Chinese herbal medicine are fully extracted and concentrated by using standard decoction technology to obtain an extract, the extract is spray-dried by using a high-speed centrifugal spray drying device, excipient ingredients are added, and dry granulation is performed to form Chinese herbal medicine decoction-free granules.

[0021] In the embodiments of the present application, the Chinese medicine composition may or may not include pharmaceutically acceptable excipients.

[0022] According to the embodiments of the present application, the Chinese medicine composition may or may not include pharmaceutically acceptable excipients, thereby forming different dosage forms for easy use.

[0023] The excipient ingredients include: dextrin.

[0024] According to the embodiments of the present application, the decoction-free granules of traditional Chinese medicine are prepared from the traditional Chinese medicine composition as raw materials, so that it is convenient for patients to take.

[0025] In the embodiments of the present application, the Chinese medicine honey pills are prepared using the Chinese medicine composition as raw materials.

[0026] According to the embodiments of the present application, the Chinese medicine water-honeyed pills are prepared from the Chinese medicine composition as raw materials, thereby making it convenient for patients to take the pills.

[0027] Finally, the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating fallopian tube obstruction infertility.

[0028] This application aims at the main pathogenesis of patients with tubal obstructive infertility, and adopts the treatment method of "activating blood circulation and eliminating symptoms, removing blood stasis and promoting diuresis, unblocking meridians and relieving pain". In the Chinese medicine composition provided by this application, peach kernel is bitter, sweet and flat in nature; it enters the heart, liver and large intestine meridians; it has the effects of activating blood circulation and removing blood stasis, moistening the intestines and relieving constipation, relieving cough and relieving asthma, and is used for amenorrhea, dysmenorrhea, lumps and masses, lung abscesses and intestinal abscesses, injuries from falls, dry intestines and constipation, cough and asthma and other diseases. Studies have shown that peach kernel can significantly prolong thrombin time, inhibit platelet aggregation, and reduce vascular endothelial cell damage. Cinnamon twig is pungent and sweet in taste, warm in nature, enters the lung, heart and bladder meridians, and has the effects of sweating and relieving muscles, balancing and descending adverse, warming meridians and unblocking meridians, and assisting yang and transforming qi. It is used for colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid retention, edema, palpitations, and running pigs. Pharmacological studies have shown that cinnamon twigs have analgesic, antibacterial, anti-inflammatory, and vasodilation-promoting pharmacological effects. Red peony root is bitter, slightly cold, and enters the liver meridian. It has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain. It is mainly used to treat stasis and amenorrhea, hernia accumulation, abdominal pain and hypochondria, epistaxis and bloody dysentery, intestinal wind and blood, and red eyes and carbuncle. It has multiple pharmacological effects such as anti-inflammatory, anti-thrombotic, antioxidant, and anti-endotoxin. Poria cocos is sweet and light, has a flat nature, enters the heart, kidney, lung, and spleen meridians, can promote diuresis and reduce swelling, strengthen the spleen and calm the mind. It is mainly used to treat edema, phlegm and fluid retention, palpitations, etc. Modern pharmacological studies have found that Poria cocos has anti-inflammatory, diuretic, sedative, and immunomodulatory effects. The four medicines are components of the classic prescription Guizhi Fuling Pill, which work together to promote blood circulation and eliminate symptoms, and remove blood stasis and promote diuresis.

[0029] Further, in the Chinese medicine composition provided by the present application, Angelica sinensis is sweet, warm and pungent in nature and flavor, and belongs to the heart, spleen and liver meridians. It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. It is mainly used for blood deficiency and sallowness, irregular menstruation, amenorrhea and dysmenorrhea, dizziness and palpitations, injuries from falls and injuries, dry intestines and constipation, stroke and cramps, cough and reverse breathing, warm malaria and cold and heat, and various pains. Pharmacological studies have shown that Angelica sinensis has the effect of inhibiting platelet aggregation. Anti-inflammatory, analgesic, antioxidant, and anti-aging effects. Chuanxiong is warm in nature and pungent in taste, and belongs to the liver meridian, gallbladder meridian, and pericardium meridian. It has the effects of activating blood circulation and qi, dispelling wind and relieving pain. Chuanxiong is pungent, warm, fragrant and dry, and it moves but does not stay. It can disperse and reach the top of the head; it also enters the blood and reaches the sea of ​​blood. It has a wide range of blood circulation and blood stasis removal effects, and is suitable for various diseases of blood stasis; it dispels wind and relieves pain, and has a very good effect, and can treat headaches, rheumatic arthralgia and other symptoms. The main effects are analgesia, anti-inflammatory, antioxidant, anti-coagulation, anti-atherosclerosis, and cell protection. Gleditsia thorns are warm in nature, pungent in taste, and enter the liver, lung, and stomach meridians. They have the effects of disinfection, pus removal, wind removal, and insecticide. They are mostly used in the treatment of carbuncle, arthritis, etc. Modern medical research has found that it has antibacterial, antiviral, anti-coagulation, antioxidant, and immunomodulatory effects. The three medicines are taken from the ingredients of the famous surgical prescription Tounongsan to promote blood circulation, remove toxins, and discharge pus.

[0030] Further, in the Chinese medicine composition provided by the present application, leeches are salty and bitter, flat in nature, and belong to the liver meridian. They have the effects of breaking blood and promoting menstruation, removing blood stasis and eliminating symptoms, and are mainly used to treat blood stasis amenorrhea, lumps and masses, and hemiplegia caused by stroke. It has significant pharmacological effects such as anticoagulation, antithrombosis, and anti-tumor. Rhizoma Lulutong is bitter and flat in nature and belongs to the liver and kidney meridians. It can dispel wind and dampness, soothe the liver and activate the collaterals, promote diuresis and promote menstruation, and has anti-inflammatory, analgesic, swelling, inhibition of pathogenic microorganisms, and antioxidant effects. Vaccaria segetalis is flat in nature; it enters the liver and stomach meridians, has the effects of promoting blood circulation and promoting menstruation, reducing swelling, and promoting diuresis and relieving stranguria. It is mainly used for women's dysmenorrhea, amenorrhea, milk retention, mastitis, swelling and pain, stranguria and other diseases, and has antibacterial and anti-inflammatory, antioxidant, anti-tumor, and pharmacological effects such as promoting milk secretion. The three medicines can be used together to break blood, promote menstruation and activate collaterals, and dredge the fallopian tubes.

[0031] Further, in the composition provided by the present application, dandelion tastes bitter and sweet, is cold in nature, has the effects of clearing away heat and detoxifying, reducing swelling and dispersing stagnation, and promoting diuresis and relieving stranguria, and is used for furuncle swelling and poison, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, and hot stranguria. Modern pharmacology has the effects of anti-inflammatory, antibacterial, and enhancing immunity. Plantain is cold in nature, sweet in taste, has the effects of clearing heat and promoting diuresis, removing phlegm, cooling blood, and detoxifying, and is used for edema, oliguria, summer-damp diarrhea, phlegm-heat cough, carbuncle swelling and poison. It has the effects of antibacterial, anti-inflammatory, regulating immunity, and repairing damaged cells. Forsythia suspensa is bitter and slightly cold in nature. It enters the lung, heart and small intestine meridians. It has the effects of clearing away heat and detoxifying, reducing swelling and dispersing stagnation, and evacuating wind-heat. It is often used to treat wind-heat colds, early stage of febrile diseases, warm and hot entering the camp, high fever and thirst, hot stranguria and urinary retention, carbuncle, scrofula, breast carbuncle, erysipelas and swelling. It has anti-inflammatory, antibacterial, antiviral, antioxidant, and immunomodulatory activities. The three medicines can clear away heat and detoxify, reduce swelling and promote diuresis, and enhance immunity.

[0032] Further, in the Chinese medicine composition provided by the present application, the antler frost tastes salty and astringent, and is warm in nature; it enters the liver and kidney meridians. It can warm the kidney and assist yang, and astringe and stop bleeding. It is suitable for excessive leucorrhea, enuresis and frequent urination, metrorrhagia and bleeding, and sores that do not astringe. The seeds of safflower are cold in nature, salty in taste, enter the liver, stomach, and spleen meridians, and have the functions of dispersing blood and eliminating lameness, eliminating accumulation and relieving pain, and promoting diuresis and reducing swelling. It is used for lumps, goiters, indigestion, stomach pain, edema and ascites, and has pharmacological effects such as immunosuppression, anti-oxidation, and eliminating accumulation and relieving pain. Magnolia officinalis is pungent, bitter, and warm in nature and flavor, and enters the spleen, stomach, lung, and large intestine meridians, and has the effects of drying dampness and eliminating phlegm, and removing fullness from the lower qi. Clinically, it is mainly used to treat dampness stagnation and injury to the middle, vomiting and diarrhea due to abdominal distension, stagnation of qi due to food accumulation, abdominal distension and constipation, phlegm and cough, etc. It has anti-inflammatory, bactericidal, and anti-oxidant effects. Panax notoginseng is sweet, slightly bitter and warm in nature. It enters the liver, stomach, heart, lung and large intestine meridians. It has the functions of removing blood stasis and stopping bleeding, promoting blood circulation and relieving pain. It is mainly used to treat vomiting blood, coughing up blood, and bleeding caused by trauma. It has anti-inflammatory, analgesic and anti-platelet aggregation effects. The four medicines nourish the kidney and promote blood circulation, resolve phlegm and eliminate symptoms. The whole prescription is used together to promote blood circulation and eliminate symptoms, remove blood stasis and promote diuresis, and dredge the meridians and relieve pain.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] (1) The granules and honey pills prepared from the Chinese medicine composition provided in the present application are easy to take, have a rapid therapeutic effect, few side effects, and a low recurrence rate. Clinical trials have shown that the Chinese medicine composition of the present application can promote the recovery of fallopian tube function, improve fallopian tube adhesions and hydrops, and treat fallopian tube obstructive infertility, with good results and clinical application value.

[0035] (2) The Chinese medicine composition of the present application has a rigorous compatibility and has a high efficacy in treating tubal obstructive infertility. At the same time, it regulates the patient's physical condition to achieve the effects of relieving dysmenorrhea and improving menstrual conditions. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This application is a scoring table for patients with fallopian tube obstruction and infertility before and after treatment. DETAILED DESCRIPTION

[0037] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0038] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0039] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0040] Example 1

[0041] Preparation of Chinese medicine composition, 1 weight part = 1 gram

[0042] 10 parts of peach kernel, 10 parts of cinnamon twig, 10 parts of red peony root, 15 parts of angelica, 10 parts of chuanxiong, 15 parts of tuckahoe, 6 parts of leeches, 10 parts of gleditsia spinosa, 10 parts of liquidambar formosana, 10 parts of fenugreek, 15 parts of dandelion, 10 parts of plantain, 15 parts of forsythia, 15 parts of antler powder, 10 parts of safflower seeds, 15 parts of magnolia bark and 6 parts of notoginseng.

[0043] Example 2

[0044] Preparation of Chinese medicine composition, 1 weight part = 1 gram

[0045] 12 parts of peach kernel, 15 parts of cassia twig, 15 parts of red peony root, 20 parts of angelica, 15 parts of chuanxiong, 30 parts of tuckahoe, 3 parts of leech, 15 parts of gleditsia spinosa, 30 parts of liquidambar formosana, 15 parts of fenugreek, 20 parts of dandelion, 15 parts of plantain, 20 parts of forsythia, 10 parts of antler powder, 15 parts of safflower seeds, 30 parts of magnolia bark and 9 parts of notoginseng.

[0046] Example 3

[0047] Preparation of Chinese herbal medicine granules without decoction

[0048] Weigh each raw material medicine in Example 1 or Example 2, use dynamic reflux high-efficiency extraction equipment to fully extract and concentrate all effective components of traditional Chinese medicine to obtain an extract; spray dry the extract with a high-speed centrifugal spray drying device; add excipient ingredients; and dry granulate to form a prescription traditional Chinese medicine decoction-free granule. The instruments and methods involved in this embodiment are commonly used in the field of traditional Chinese medicine preparations.

[0049] According to the embodiment of the present application, a preparation method of a decoction-free Chinese medicine granule for treating fallopian tube obstruction infertility is adopted, Chinese herbal medicine slices that meet the processing specifications are used as raw materials, a Chinese medicine composition is weighed, and the effective ingredients of the Chinese medicine are fully extracted and concentrated to obtain an extract using standard decoction technology, the extract is spray-dried using a high-speed centrifugal spray drying device, excipient ingredients are added, and dry granulation is performed to form a decoction-free Chinese medicine granule, thereby preparing a decoction-free Chinese medicine granule for treating fallopian tube obstruction infertility, which is convenient for patients to take.

[0050] According to the embodiment of the present application, the excipient ingredients include dextrin, thereby facilitating the molding of the decoction-free granules of traditional Chinese medicine.

[0051] Example 4 - Preparation of Chinese medicine honey pills

[0052] Weigh the raw materials in Example 1; mix and crush, pass through a 100-mesh sieve to obtain a mixed powder for standby use; control the powder temperature not to exceed 60° C. during the crushing process; boil the honey over high heat, and then simmer over low heat until the honey turns yellow and foams evenly and form mung bean-sized honey bubbles, which are sticky but not stringy when touched, thus achieving the effect of refining honey; uniformly clumping the powder and the refined honey at a weight ratio of 1:1 to 1.2; adding the clumped mixture to a pill-rolling machine for pill-rolling; packaging the obtained finished pills with edible medicine paper, sealing the honey pill shell, and storing them in a cool place or in a refrigerator. The instruments and methods involved in this embodiment are commonly used equipment and methods in the field of traditional Chinese medicine preparations.

[0053] According to the embodiment of the present application, the preparation method of the Chinese medicine water honey pill for treating fallopian tube obstruction infertility is as follows: weigh each raw material according to weight; mix and crush, pass through a 100-mesh sieve to obtain a mixed powder for standby use; control the powder temperature not to exceed 60°C during the crushing process; boil the honey with high heat, and then simmer with low heat until the honey turns yellow and foams and reaches uniform mung bean-sized honey bubbles, which are sticky but not stringy when touched, that is, the effect of refining honey is achieved; the powder and the refined honey are evenly mixed in a weight ratio of 1:1 to 1.2; the mixed material is added to the inside of a pill rolling machine for pill rolling; the finished pills are packaged with edible medicine paper, the honey pill shell is sealed, and placed in a cool place or in a refrigerator for storage, thereby preparing Chinese medicine honey pills for treating fallopian tube obstruction infertility, which are convenient for patients to take.

[0054] The beneficial effects of the present invention are described below through test examples.

[0055] Test Example 1 - Treatment of ovulatory infertility with the pharmaceutical composition of the present invention

[0056] 1 Materials and methods

[0057] 1.1 General Information

[0058] A total of 71 patients diagnosed with fallopian tube obstruction infertility in the Traditional Chinese Medicine Clinic in Nanhai, Hainan from January 1, 2022 to January 31, 2023 were collected. Their ages ranged from 22 to 36 years old, with an average age of (29.0±3.6) years old. The course of disease ranged from 12 to 42 months, with an average course of disease of (20.9±6.5) months.

[0059] 1.2 Drugs and preparation

[0060] Experimental drugs: 10g of peach kernel, 10g of cinnamon twig, 10g of red peony root, 15g of angelica, 10g of Chuanxiong, 15g of Poria, 6g of Leech, 10g of Gleditsia thorn, 10g of Rhizoma Smilacis Glabrae, 10g of Fructus Vaccariae, 10g of Taraxaci, 15g of Herba Plantaginis, 10g of Fructus Forsythiae, 15g of Prunus Antlers, 10g of Fructus Polygoni Orientalis, 15g of Magnolia officinalis and 6g of Panax Notoginseng, were made into Chinese medicine granules that do not require decoction.

[0061] 1.3 Diagnostic criteria

[0062] 1.3.1 Western medicine diagnostic criteria

[0063] (1) Couples with normal sexual life who have not used contraception for more than one year and still have not been able to get pregnant; (2) Patients whose results of routine hysterosalpingography (HSG) or pelvic ultrasound angiography show that the fallopian tubes are obstructed on one or both sides or blocked (with or without hydrosalpinx, atresia or adhesion); (3) Patients whose fallopian tubes are obstructed or blocked after laparoscopic tubal insufflation; (4) Of the above three items, (1) is required, and the diagnosis can be made if either (2) or (3) is met.

[0064] 1.3.2 TCM diagnostic criteria

[0065] Main symptoms: Failure to conceive after long marriage without taking any contraceptive measures, frequent lower abdominal pain during normal times or during menstruation, and pain extending to the lumbar region.

[0066] Secondary symptoms: normal or prolonged menstruation, more or less menstrual flow, dark color, blood clots (+), blood clots, dark purple tongue, petechiae or ecchymosis on the edges, thin white fur, stringy or fine pulse. If the patient has the main symptoms and tongue and pulse, and any one of the other secondary symptoms, the patient can be diagnosed as having blood stasis.

[0067] The diagnosis can be made if the patient has the main symptoms, tongue and pulse, and any one of the other secondary symptoms.

[0068] 1.4 Case inclusion criteria

[0069] (1) Meet the above-mentioned Western medicine and traditional Chinese medicine diagnostic criteria; (2) The male has normal reproductive function; (3) The patient is of childbearing age and wishes to have children; (4) The patient voluntarily participates and gives informed consent.

[0070] 1.5 Treatment

[0071] For treatment with granules, the above 1.2 is the dosage for one dose. According to Example 3, prepare the Chinese medicine decoction-free granules. The patient takes one dose per day, brewed with boiled water, and taken twice a day after meals in the morning and evening. 21 days is one course of treatment. After three menstrual cycles of continuous treatment, pregnancy testing can be started.

[0072] 1.6 Efficacy observation indicators

[0073] According to the clinical symptoms, signs, imaging examinations and other characteristics of tubal obstructive infertility, a score sheet for patients with tubal obstructive infertility before and after treatment was developed, involving multiple aspects such as lower abdominal pain, menstrual conditions, and tubal patency. If the difference between the scores before and after treatment is less than 20, it is considered ineffective.

[0074] 1.7 Evaluation of efficacy

[0075] Refer to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes";

[0076] Cured: normal pregnancy within six months, complete disappearance of clinical signs, or HSG showing complete patency of the fallopian tubes; Effective: no pregnancy within six months, improvement of the patient's clinical signs, or HSG showing improvement in the patency of the fallopian tubes; Ineffective: no pregnancy, no improvement or worsening of the patient's clinical signs, or HSG showing no changes in the fallopian tubes.

[0077] 2 Results

[0078] Table 1 Scores of patients with tubal infertility before and after treatment

[0079]

[0080] After SW test, the scale scores and differences before and after treatment were in line with normal distribution, so paired t-test was used. The mean score before treatment was 58.58±8.33, and the mean score after treatment was 23.18±10.09. There was a statistically significant difference between the scores before and after treatment (t=28.083, P≈0.000<0.001).

[0081] Table 2 Clinical efficacy results of the drug combination

[0082]

[0083] The test results show that the cure rate of the test group is 29.58%, the effective rate is 61.97%, and the total effective rate is 91.55%, indicating that the pharmaceutical composition of the present invention can effectively treat infertility caused by fallopian tube obstruction.

[0084] Test Example 2-Typical Case

[0085] In the application examples, the Chinese medicine composition is used to treat a typical case of fallopian tube obstruction infertility:

[0086] Case 1: Lu, female, 25 years old, infertile for 4 years after marriage, salpingography showed bilateral hydrosalpinx and obstruction, normal menstrual cycle, heavy menstruation, dark color, blood clots, dysmenorrhea, the method of Example 1 and Example 3 was used to prepare Chinese medicine decoction-free granules, which were taken twice a day, with warm water after meals in the morning and evening, 21 days as one course of treatment, and 3 courses of treatment were taken continuously. During the medication period, brown secretions were discharged from the vagina, dysmenorrhea was cured, and pregnancy occurred that month.

[0087] Case 2: Wu, female, 30 years old, salpingography showed: obstruction of the interstitial part of the fallopian tubes on both sides, normal menstrual cycle, 4-5 days, small amount, black color, blood clots, lower abdominal pain, the method of Example 1 and Example 3 was used to prepare the Chinese medicine decoction-free granules, which were taken twice a day, with warm water after meals in the morning and evening, 21 days as one course of treatment, and the medicine was taken continuously for 3 courses of treatment. Hysterosalpingography was performed again, which showed: the left fallopian tube was unobstructed, and the interstitial part of the right fallopian tube was blocked.

[0088] Case 3: Lu, female, 28 years old, had an ectopic pregnancy with left fallopian tube removal, but the right fallopian tube was obstructed, with a menstrual cycle of 21 days, scanty menstruation, dark color, blood clots, low back pain, and leucorrhea resembling tofu dregs. The method of Example 1 and Example 3 was used to prepare Chinese medicine decoction-free granules, which were taken twice a day, washed down with warm water after meals in the morning and evening. 21 days was one course of treatment, and the medicine was taken continuously for 3 courses of treatment. The fallopian tube was unobstructed during angiography examination, and the menstrual quantity, color and quality were basically normal. The patient became pregnant 2 months after stopping the medication.

[0089] Example 5

[0090] Case 4: Fan, female, 24 years old, did not get pregnant after minimally invasive surgery for ectopic pregnancy on the left fallopian tube in 2018. In November 2022, ultrasound imaging of the fallopian tube showed: right fallopian tube obstruction, left fallopian tube obstruction, normal menstrual cycle, heavy menstruation, blood clots, low back pain. Prescription composition and dosage per dose: peach kernel 10g, cinnamon twig 10g, red peony root 10g, angelica 15g, chuanxiong 10g, tuckahoe 15g, leech 3g, sapodilla thorn 15g, tonglutong 10g, astragalus 15g, fennel 10g, dandelion 15g, plantain 15g, forsythia suspensa 15g, antler frost 10g, motherwort 15g, safflower seed 10g, magnolia bark 15g and panax notoginseng 3g. The method of Example 3 was adopted to prepare the Chinese medicine decoction-free granules, 1 dose per day, taken twice a day after meals, morning and evening, 21 days as a course of treatment, 2 courses of treatment were taken continuously, and the pregnancy was announced half a month after stopping the medication. A daughter was born in September 2023.

[0091] Example 6

[0092] Case 5: Sun, female, 31 years old, October 2022 fallopian tube imaging showed: inflammatory changes in the distal end of the bilateral fallopian tubes, obstruction of the distal end of the right fallopian tube, and lack of patency of the distal end of the left fallopian tube. The menstrual cycle is 21 days, with small amount, black color, blood clots, dysmenorrhea, and yellow leucorrhea with odor. Prescription composition and dosage of each dose: peach kernel 10g, cinnamon twig 10g, red peony root 10g, angelica 15g, Chuanxiong 10g, Poria 15g, leech 6g, Gleditsia sinensis 10g, Scutellaria baicalensis 10g, Vaccaria segetalis 10g, dandelion 15g, plantain 15g, forsythia suspensa 15g, antler frost 10g, water safflower fruit 10g, Atractylodes lancea 10g, Magnolia officinalis 15g and Panax notoginseng 6g. The method of Example 4 was adopted to prepare Chinese medicine honey pills, one dose per day, taken twice a day after meals, 21 days as one course of treatment, and three courses of treatment were taken continuously. The menstrual quantity, color and quality were basically normal, and pregnancy occurred 2 months after stopping the medication.

[0093] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating infertility caused by fallopian tube obstruction, characterized in that: The invention comprises the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-15 parts of cassia twig, 10-15 parts of red peony root, 15-20 parts of angelica sinensis, 10-15 parts of chuanxiong, 15-30 parts of tuckahoe, 3-6 parts of leech, 10-15 parts of sapodilla thorn, 10-30 parts of rhizoma smilacis Glabrae, 10-15 parts of fenugreek, 15-20 parts of dandelion, 10-15 parts of plantain, 15-20 parts of forsythia, 10-15 parts of antler frost, 10-15 parts of safflower fruit, 15-30 parts of magnolia bark and 3-9 parts of notoginseng.

2. A Chinese medicinal composition for treating infertility due to fallopian tube obstruction according to claim 1, characterized in that: The invention is prepared from the following raw materials in parts by weight: 12 parts of peach kernel, 15 parts of cinnamon twig, 15 parts of red peony root, 20 parts of angelica, 15 parts of chuanxiong, 30 parts of tuckahoe, 3 parts of leech, 15 parts of sapodilla thorn, 30 parts of liquidambar formosana, 15 parts of fenugreek, 20 parts of dandelion, 15 parts of plantain, 20 parts of forsythia, 10 parts of antler frost, 15 parts of safflower fruit, 30 parts of magnolia bark and 9 parts of notoginseng.

3. A Chinese medicinal composition for treating infertility due to fallopian tube obstruction according to claim 1, characterized in that: The invention also comprises the following raw materials in parts by weight: 15 to 30 parts of Leonurus japonicus and 10 to 20 parts of Astragalus membranaceus.

4. A Chinese medicinal composition for treating infertility due to fallopian tube obstruction according to claim 3, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-12 parts of cassia twig, 10-12 parts of red peony root, 15-17 parts of angelica, 10-12 parts of chuanxiong, 15-17 parts of tuckahoe, 3-4 parts of leech, 13-15 parts of sapodilla thorn, 10-12 parts of rhizoma liquidambar formosana, 10-12 parts of fenugreek, 15-17 parts of dandelion, 13-15 parts of plantain, 15-17 parts of forsythia, 10-12 parts of antler frost, 10-12 parts of safflower fruit, 15-17 parts of magnolia bark, 3-4 parts of panax notoginseng, 15-17 parts of motherwort and 13-15 parts of astragalus.

5. A Chinese medicinal composition for treating infertility due to fallopian tube obstruction according to claim 1, characterized in that: It also includes the following raw materials in parts by weight: 10 to 15 parts of Atractylodes lancea.

6. A Chinese medicinal composition for treating infertility due to fallopian tube obstruction according to claim 5, characterized in that: The invention is prepared from the following raw materials in parts by weight: 10-12 parts of peach kernel, 10-12 parts of cassia twig, 10-12 parts of red peony root, 15-17 parts of angelica, 10-12 parts of chuanxiong, 15-17 parts of tuckahoe, 5-6 parts of leech, 10-12 parts of sapodilla thorn, 10-12 parts of rhizoma liquidambar formosana, 10-12 parts of fenugreek, 15-17 parts of dandelion, 13-15 parts of plantain, 15-17 parts of forsythia, 10-12 parts of antler frost, 10-12 parts of safflower fruit, 15-17 parts of magnolia bark, 5-7 parts of panax notoginseng and 10-12 parts of atractylodes.

7. A Chinese medicine honey pill for treating infertility caused by fallopian tube obstruction, characterized in that: Prepared from the Chinese medicine composition according to any one of claims 1 to 6.

8. The method for preparing the Chinese medicine honey pill for treating infertility due to fallopian tube obstruction according to claim 7, characterized in that: The steps include: S1 Weighing and powdering: Weigh the raw materials of medicinal materials by weight according to the formula, mix and grind them, pass through a 90-110 mesh sieve, and obtain mixed powder for standby use; during the grinding process, control the powder temperature not to exceed 60°C; S2 Honey refining: First boil the honey with high heat, then simmer with low heat until the honey turns yellow and has evenly distributed mung bean-sized bubbles. It is sticky but not stringy when touched, which means the honey is refined. S3 seasoning and mixing: mixing the powder obtained in step S1 and the honey refined in step S2 at a weight ratio of 1:1 to 1.2; S4 finished product pilling: the mixed material combined in step S3 is pilled to obtain the Chinese medicine honey pills.

9. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating infertility due to fallopian tube obstruction.

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