A traditional Chinese medicine composition for treating moist heat and blood stasis type pelvic inflammation

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for damp-heat and blood stasis type pelvic inflammation, which comprises oral medicine, enema liquid and external application bag, and the oral medicine is made of the following raw materials according to weight fractions: 8-12 parts of bupleurum, 13-17 parts of angelica, 13-17 parts of red peony root, 13-17 parts of red vine, 13-17 parts of soapberry thorn, 10-14 parts of immature bitter orange fruit, 10-14 parts of cyperus, 8-12 parts of magnolia bark, 13-17 parts of orpiment, 13-17 parts of litchi kernel, 13-17 parts of parnassia, 13-17 parts of gold dragon vine, and 8-12 parts of chuanxiong rhizome; the traditional Chinese medicine composition for damp-heat and blood stasis type pelvic inflammation has the effects of warming meridians, promoting blood circulation, regulating qi and relieving pain, and is used for treating damp-heat and blood stasis type pelvic inflammation; the whole composition has the effects of clearing heat, removing blood stasis, promoting blood circulation and relieving pain; the filtrate has strong efficacy; and the application combines the Chinese medicine proprietary therapy of oral administration, external application and enema, promotes blood circulation and relieves pain.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type. Background Technology

[0002] Pelvic inflammatory disease (PID) is a common condition among women, often presenting with symptoms such as lower abdominal pain, back pain, and vaginal discomfort, and is also prone to negative emotions. PID includes endometritis, salpingitis, tubo-ovarian abscess, and pelvic peritonitis. Traditional Chinese medicine theory considers PID to be primarily caused by damp-heat invasion and heat-toxin infection.

[0003] In Traditional Chinese Medicine (TCM) theory, damp-heat with blood stasis refers to a condition where prolonged emotional distress or stagnation leads to liver qi stagnation, affecting the body's normal functioning. The liver governs the free flow of qi; if liver qi stagnates, it impairs the liver's normal function of regulating qi, thus triggering pelvic inflammatory disease. The main cause of pelvic pain is insufficient vital energy and emptiness of the uterine vessels, allowing damp-heat toxins to invade, resulting in lower abdominal pain.

[0004] Currently, Western medicine primarily uses antibiotics, such as levofloxacin. However, these can easily cause stomach pain and nausea. Single-drug therapy is often ineffective, and long-term use can lead to drug resistance, dysbiosis, and a high relapse rate. Meanwhile, Traditional Chinese Medicine (TCM) mainly relies on oral herbal remedies, which often have a slow onset of action. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for damp-heat and blood stasis type pelvic inflammatory disease. This composition has the effects of clearing heat and dampness, regulating qi and relieving pain, and is used to treat this type of pelvic inflammatory disease. The entire formula works synergistically to clear heat and dampness, resolve blood stasis and harmonize the meridians. The filtrate of this invention has strong medicinal efficacy. This invention combines the unique TCM therapy of "internal administration + external application + enema" to promote blood circulation and relieve pain.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type, the composition comprising an oral medication, an enema solution, and an external application pack, wherein the oral medication is made from the following raw materials in parts by weight:

[0008] Bupleurum chinense 8-12 parts, Angelica sinensis 13-17 parts, Paeonia lactiflora 13-17 parts, Sargentodoxa cuneata 13-17 parts, Gleditsia sinensis 13-17 parts, Citrus aurantium 10-14 parts, Cyperus rotundus 10-14 parts, Lindera strychnifolia 8-12 parts, Liquidambar formosana 13-17 parts, Litchi chinensis 13-17 parts, Patrinia scabiosaefolia 13-17 parts, Smilax china 13-17 parts, Ligusticum chuanxiong 8-12 parts;

[0009] The enema solution is made from the following raw materials in parts by weight:

[0010] Red vine 28-32 parts, Patrinia scabiosaefolia 28-32 parts, Taraxacum mongolicum 28-32 parts, Polygonum cuspidatum 28-32 parts, Paeonia lactiflora 13-17 parts, Prunus persica 13-17 parts, Salvia miltiorrhiza 28-32 parts, Lepidium apetalum 13-17 parts, Sparganium stoloniferum 10-14 parts, Curcuma zedoaria 10-14 parts, Curcuma longa 10-14 parts, Corydalis yanhusuo 10-14 parts, Artemisia argyi 8-12 parts, Coix lacryma-jobi 13-17 parts;

[0011] The external dressing is made from the following raw materials in parts by weight:

[0012] 18-22 parts of *Homalomena occulta*, 18-22 parts of Sichuan pepper, 18-22 parts of *Eupatorium fortunei*, 18-22 parts of *Angelica pubescens*, 18-22 parts of *Notopterygium incisum*, 8-12 parts of *Dracaena cochinchinensis*, 18-22 parts of *Acanthopanax senticosus*, 18-22 parts of *Aconitum carmichaelii* (processed), 18-22 parts of *Aconitum kusnezoffii* (processed), 18-22 parts of *Smilax china*, 38-42 parts of *Artemisia argyi*, 8-12 parts of *Asarum heterotropoides*, 18-22 parts of *Epimedium brevicornu*, and 18-22 parts of *Gleditsia sinensis* thorns.

[0013] Preferably, the oral medication is made from the following raw materials in parts by weight:

[0014] Bupleurum 10 parts, Angelica sinensis 15 parts, Paeonia lactiflora 15 parts, Sargentodoxa cuneata 15 parts, Gleditsia sinensis 15 parts, Citrus aurantium 12 parts, Cyperus rotundus 12 parts, Lindera strychnifolia 10 parts, Liquidambar formosana 15 parts, Litchi chinensis seed 15 parts, Patrinia scabiosaefolia 15 parts, Smilax china 15 parts, Ligusticum chuanxiong 10 parts.

[0015] Preferably, the enema solution is made from the following raw materials in parts by weight:

[0016] 30 parts of red vine, 30 parts of patrinia, 30 parts of dandelion, 30 parts of Japanese knotweed, 15 parts of red peony root, 15 parts of peach kernel, 30 parts of salvia miltiorrhiza, 15 parts of lepidium seed, 12 parts of sparganium rhizome, 12 parts of turmeric, 12 parts of corydalis rhizome, 10 parts of mugwort leaf, and 15 parts of coix seed.

[0017] Preferably, the external dressing is made from the following raw materials in parts by weight:

[0018] 20 parts of *Hypericum perforatum*, 20 parts of Sichuan pepper, 20 parts of *Cyperus rotundus*, 20 parts of *Angelica pubescens*, 20 parts of *Notopterygium incisum*, 10 parts of *Dracaena cochinchinensis*, 20 parts of *Acanthopanax senticosus*, 20 parts of processed *Aconitum carmichaelii*, 20 parts of processed *Aconitum kusnezoffii*, 20 parts of *Smilax china*, 40 parts of *Artemisia argyi*, 10 parts of *Asarum heterotropoides*, 20 parts of *Epimedium brevicornu*, and 20 parts of *Gleditsia sinensis* thorns.

[0019] Preferably, the method for preparing the oral medication includes the following steps:

[0020] Step 1: Weigh out the following ingredients according to the proportions: Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Linderae, and Rhizoma Scutellariae, add 6 to 8 times the amount of water and decoct for 1 to 2 hours at a temperature of 80 to 100°C. Filter after decoction.

[0021] Step 2: Weigh out Bupleurum, Liquidambar formosana, and Ligusticum chuanxiong according to the proportions, add them to the dregs filtered in Step 1, add 6 to 8 times the amount of water, and decoct for 1 to 2 hours at a temperature of 70 to 80°C. Filter after decoction.

[0022] Step 3: Weigh out the red peony root, red vine, soapberry thorn, and litchi seed according to the proportion, grind them into powder and mix them evenly. Add them together with the angelica and patrinia in the above proportion to the dregs filtered in Step 2, add 6 to 8 times the amount of water and decoct for 2 to 3 hours at a temperature of 70 to 80°C. Filter after decoction.

[0023] Step 4: Mix the filtrates obtained in Steps 2 and 3 evenly, and then fill them into containers.

[0024] Preferably, the preparation method of the enema solution includes the following steps: weigh each Chinese herbal medicine according to the proportion, mix and crush them, soak them in water for half an hour, then boil them twice, each time for 1 to 1.5 hours, combine the decoctions and put them into a vacuum concentrator to concentrate to a relative density of 1.06 to 1.08 (60°C), let it stand for 24 hours, take the supernatant and filter it, and fill the filtrate to obtain the product.

[0025] Preferably, the preparation method of the external application pack includes the following steps: weighing each Chinese herbal medicine in proportion and grinding it into powder, mixing the powder evenly and packing it into a non-woven bag to make an external application pack.

[0026] Preferably, the method of using the oral medication, enema solution, and external dressing is to first take the oral medication orally, then lie on one's side, administer the enema solution through an enema operation, and after the enema, lie flat and place the heated external dressing on the lower abdomen.

[0027] More preferably, the enema steps are as follows: 1. Close the flow regulating valve of the enema bag; 2. Preheat the enema bag containing the enema solution to 35-38°C in warm water, and then pour the enema solution into the enema bag; 3. Lie on your side, apply lubricant to the outlet tube of the enema bag, slowly insert it into the anus, and open the flow regulating valve to allow the enema solution to flow into the body; 4. Lie still for 30-60 minutes.

[0028] More preferably, the external application pack is steamed in hot water for 5 to 10 minutes and then laid flat on the lower abdomen.

[0029] The pathogenesis of damp-heat with blood stasis type pelvic inflammatory disease is as follows:

[0030] In Traditional Chinese Medicine (TCM) theory, this disease is caused by improper procedures during menstruation, intrauterine surgery, or inadequate care during abortion or postpartum, allowing pathogenic factors to enter the uterus and affect the flow of Qi and blood in the Chong, Ren, Du, and Dai meridians. Due to insufficient Qi during menstruation or postpartum, external dampness and heat pathogens can easily invade, or blood stasis can obstruct the flow, accumulating in the uterus and its vessels. The invasion of damp-heat toxins directly affects the uterus, leading to a struggle between pathogenic factors and the body's resistance. Symptoms include lower abdominal pain, distending pain, or stabbing pain, sometimes accompanied by soreness and discomfort in the lumbosacral region. The struggle between pathogenic factors and the body's resistance can cause the disease to progress or regress, with possible fever or fluctuating low-grade fever. Damp-heat in the lower Jiao (lower burner) results in excessive vaginal discharge, which is yellow or white, thin, sticky, and foul-smelling. Internal damage from damp-heat stagnation causes fatigue, chest tightness, and poor appetite. A reddish tongue with a yellow, greasy coating and a thready, wiry, and rapid pulse are also signs of damp-heat stagnation.

[0031] Bupleurum, in its medicinal properties, is 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 qi in the gallbladder meridian to harmonize and reduce fever, disperses stagnant qi in the liver and gallbladder meridians to soothe the liver and relieve stagnation, and also raises the clear yang qi of the liver and gallbladder to lift sunken qi. It is a principal medicine for the liver and gallbladder meridians. When used raw, it both ascends and disperses, while when processed with vinegar, its ascending and dispersing power decreases, but its liver-soothing power increases. The *Compendium of Materia Medica*, Volume 13, states: "There are five types of overwork, affecting the five internal organs. If the overwork affects the liver, gallbladder, heart, and pericardium with heat, or if there is cold or heat in the Shaoyang meridian, then Bupleurum is an essential medicine for the Jueyin and Shaoyang meridians of the hands and feet; if the overwork affects the spleen and stomach with heat, or if the yang qi sinks, then Bupleurum is an essential medicine for guiding clear qi and reducing fever; only in cases of overwork affecting the lungs and kidneys should it be avoided. However, Li Dongyuan said that it should be added for those with heat, but not for those without heat."

[0032] Angelica sinensis, sweet and pungent in taste, warm in nature, enters the liver, heart, and spleen meridians. Its sweetness nourishes and moistens, while its pungent and warm properties disperse and 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 and blood stasis with cold, especially those with dry intestines and constipation. 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. The Compendium of Materia Medica states: "It treats headaches, various pains in the heart and abdomen, moistens the intestines and stomach, muscles, bones, and skin, treats carbuncles, drains pus and relieves pain, and harmonizes and nourishes blood."

[0033] Red peony root (Chi Shao) is bitter and slightly cold in nature. It enters the liver meridian. Its bitterness disperses stagnation, and its slight coldness clears heat. Specifically targeting the liver meridian, it clears heat and disperses blood stasis. It clears liver fire and cools the blood, while also promoting blood circulation and removing blood stasis. Combining the functions of cooling blood heat, clearing liver fire, and dispersing blood stasis, it can be used for all types of blood heat, blood stasis, and liver fire, whether occurring singly or concurrently, especially suitable for those with pain due to blood heat with stasis, blood stasis with heat, or liver fire accompanied by stasis. The *Diannan Materia Medica* states: "It drains spleen fire, lowers qi, promotes blood circulation, breaks up blood stasis, disperses blood clots, stops abdominal pain, reduces blood heat, attacks carbuncles and sores, and treats scabies."

[0034] Red vine (Sargentodoxa cuneata) is the stem of the climbing shrub *Sargentodoxa cuneata*, belonging to the Lardizabalaceae family. It is bitter and neutral in nature. It enters the stomach and large intestine meridians. Its functions include clearing heat and detoxifying, reducing swelling, promoting blood circulation and unblocking meridians to relieve pain.

[0035] Gleditsia spine has a pungent and warm property. It belongs to the Liver and Stomach Meridians. According to "Sichuan Traditional Chinese Medicine", "It can treat scrofula and wind heat sores, and can also promote lactation." It is used for the initial stage of carbuncles or abscesses that do not rupture when ripe; externally, it is used to treat scabies, tinea manus, and leprosy.

[0036] Immature Bitter Orange has a bitter, pungent, sour, and slightly cold property. It belongs to the Spleen and Stomach Meridians. Immature Bitter Orange is bitter and can descend, pungent and can disperse, slightly cold and not warm, with a relatively strong medicinal power. It enters the Spleen, Stomach, and Large Intestine Meridians. It is good at breaking qi and reducing accumulation to relieve distension, and is also good at promoting qi and eliminating phlegm to relieve stuffiness and obstruction. Therefore, it is an important herb for treating gastrointestinal stagnation and phlegm stagnation in chest impediment. In addition, it can also treat organ prolapse. According to "Shennong Ben Cao Jing", "It is mainly used to treat wind in the skin like sesame seeds and beans, with itching, bitterness, and coldness, relieve dysentery, promote muscle growth, benefit the five zang-organs, and strengthen qi and lighten the body."

[0037] Cyperus rotundus has a pungent, slightly bitter, slightly sweet, and flat property. It belongs to the Liver, Spleen, and Sanjiao Meridians. Cyperus rotundus is pungent and fragrant, can disperse, slightly bitter and can descend slightly, slightly sweet and can harmonize, and is flat without bias. Entering the Liver and Sanjiao Meridians, it is good at soothing the liver and regulating qi to relieve pain, and is an excellent herb for soothing the liver and regulating qi. Li Shizhen praised it as "the general controller of qi diseases and the main herb for women's diseases." When the liver qi is smooth and the qi and blood are harmonious, menstruation will be self-regulated and pain can be relieved. Therefore, it is also an important herb for regulating menstruation and relieving pain. According to "Tangye Bencao", "Cyperus rotundus is a qi-tonifying herb in blood. When used in prescriptions to treat metrorrhagia and metrostaxis, it is to tonify qi and stop bleeding. It can also dissolve coagulated blood, which is to promote the removal of the old."

[0038] Lindera aggregata is a traditional Chinese medicine with a pungent and warm property. It belongs to the Lung, Spleen, Kidney, and Bladder Meridians. Lindera aggregata is pungent, warm, fragrant, and dispersing. It enters the Lung Meridian above, the Spleen Meridian in the middle, and reaches the Kidney Meridian and Bladder Meridian below. It is good at promoting qi, dispersing cold, and relieving pain, and is used to treat various pains caused by cold coagulation and qi stagnation in the triple burner. It is an excellent herb for regulating qi, dispersing cold, and relieving pain. It can also warm the kidney and disperse cold qi in the bladder, and is used to treat enuresis and frequent urination due to yang deficiency. According to "Bencao Shiyi", "It is mainly used to treat sudden syncope, abdominal pain, indigestion of retained food, epidemic diseases, cold qi attacking the back and spine between the bladder and kidney, qi and blood disorders in women, and various intestinal worms in children."

[0039] Liquidambar formosana has a bitter and flat property. It belongs to the Liver and Kidney Meridians. Liquidambar formosana is pungent and can disperse, bitter and can drain, and is flat with little bias. It enters the Liver, Stomach, and Bladder Meridians, and enters both the blood aspect and the qi aspect. It is good at expelling wind, dredging the meridians, promoting diuresis, and relieving arthralgia, itching, swelling, and promoting lactation. It is suitable for treating arthralgia syndrome regardless of cold or heat, especially for those with tendon and vessel contracture; for treating insufficient lactation or rubella itching, it is suitable regardless of cold or heat or with or without blood stasis.

[0040] Semen Litchi has the effects of promoting qi circulation to disperse stagnation and dispersing cold to relieve pain. It is used to treat hernia pain. It mainly enters the Liver Meridian. It is pungent and can promote qi circulation, bitter and can drain. It has the effect of dispelling cold with pungency and warmth. Therefore, it has the effects of soothing the liver and regulating qi, promoting qi circulation to disperse stagnation, and dispersing cold to relieve pain.

[0041] Patrinia scabiosaefolia, medicinally pungent, bitter, and slightly cold; enters the stomach, large intestine, and liver meridians. Its pungent and bitter properties clear heat and purge, and its slightly cold nature allows it to clear stagnation. It enters the stomach, large intestine, and liver meridians. It moves through the qi and blood, clearing heat and detoxifying, draining pus and eliminating carbuncles, as well as removing blood stasis and relieving pain. It is suitable for cases of heat toxins and blood stasis, or heat toxins combined with blood stasis. It treats both internal and external carbuncles, but is particularly effective for internal carbuncles. It is primarily used to treat intestinal carbuncles and abdominal pain, and also treats liver carbuncles, lung carbuncles, and chest and abdominal pain due to blood stasis. The *Mingyi Bielu* states: "It removes carbuncles, edema, heat accumulation, wind-dampness deficiency, and postpartum abdominal pain." The *Bencao Congxin* states: "It detoxifies and drains pus, treats carbuncles, breaks up blood stasis, and treats various postpartum ailments."

[0042] Smilax glabra, warm in nature and slightly pungent in taste. It dispels wind, invigorates blood, and detoxifies. It treats rheumatic pain in the lower back and legs, injuries from falls and blows, and scrofula. It is the rhizome of Smilax glabra, a plant in the Liliaceae family. It enters the Liver and Kidney meridians. *The Essential Compendium of Materia Medica* states: it disperses swelling and toxins. *Compendium of Materia Medica* states: it treats diabetes, metrorrhagia, and diarrhea.

[0043] Chuanxiong (Ligusticum striatum) is pungent and warm in nature. It enters the liver, gallbladder, and pericardium meridians. Chuanxiong is pungent, aromatic, dispersing, and warming, entering these meridians. It ascends to the head and descends to the blood sea, internally circulating blood and qi, and externally dispersing wind and cold. It has a strong blood-activating effect, treating various pains caused by blood stasis and qi stagnation, especially those accompanied by cold. It was praised by the ancients as "the qi-regulating herb in the blood." It treats various headaches, best for those caused by wind-cold and blood stasis; it can also be used for those caused by wind-heat, wind-dampness, and blood deficiency. Hence the saying, "For headaches, one should not do without Chuanxiong." The Compendium of Materia Medica, Volume 14, states: "It is a qi-regulating herb in the blood. The liver suffers from stagnation, so it is supplemented with pungent herbs, therefore it is suitable for those with blood deficiency; pungent herbs disperse qi, therefore it is suitable for those with qi stagnation."

[0044] The mechanism of action of enema solution is that, through enema injection and rectal administration, the effective concentration in the pelvic cavity is quickly achieved. By retaining the solution for a long time, the pharmacological effects are fully exerted. The drug improves pelvic blood circulation by directly reaching the lesion, avoiding the first-pass effect, so that the lesion can be improved rapidly, thereby enhancing the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain.

[0045] Dandelion, in medicinal properties, is bitter, sweet, and cold, and enters the liver and stomach meridians. Dandelion clears heat and detoxifies, reduces swelling and dissipates nodules, promotes urination and relieves strangury. It is used for boils, carbuncles, mastitis, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful urination due to heat. The *Ben Cao Jing Shu* states: "Dandelion is sweet and neutral in taste, and non-toxic. It enters the liver and stomach meridians, and is an essential medicine for clearing heat and cooling the blood. Mastitis belongs to the liver meridian, and after menstruation, the liver meridian is dominant; therefore, it is effective for mastitis and breast abscesses in women, and is also beneficial for warming the body."

[0046] Polygonum cuspidatum, slightly bitter and slightly cold in nature; enters the liver, gallbladder, and lung meridians. It promotes diuresis and relieves jaundice, clears heat and detoxifies, disperses blood stasis and relieves pain, and stops cough and resolves phlegm. It contains free asarone and asarone glycosides, stilbene glycosides, polysaccharides, amino acids, etc., and has the functions of promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and stopping cough and resolving phlegm. The *Mingyi Bielu* states: "It mainly promotes menstruation and breaks up blood stasis."

[0047] Peach kernels have a slight fragrance and a slightly bitter taste. They enter the heart, liver, and large intestine meridians. They promote blood circulation to remove blood stasis, moisten the intestines to relieve constipation, and relieve cough and asthma. They are used for amenorrhea and dysmenorrhea, lung abscess and intestinal abscess, traumatic injury, intestinal dryness and constipation, cough and asthma.

[0048] Salvia miltiorrhiza has a bitter and slightly cold nature and enters the heart and liver meridians. Bitter in taste, it can disperse and purge; slightly cold in nature, it can clear heat. Entering the heart and liver meridians, it not only promotes blood circulation to remove blood stasis and dredges the meridian to relieve pain, but also clears heat and cools the blood to relieve restlessness and eliminate carbuncles. It mainly treats various syndromes of blood stasis, blood heat, and heat disturbing the mind, and also treats swelling and pain of poisonous carbuncles. It is said in ancient times that "a single herb of Salvia miltiorrhiza has the same efficacy as the Four Substances Decoction", and it is actually a herb for cooling blood and promoting blood circulation, removing blood stasis and generating new blood.

[0049] Semen Lepidii has a pungent, bitter, and extremely cold taste and enters the lung and bladder meridians. Bitter in taste, it can purge; pungent in taste, it can disperse; extremely cold in nature, it can clear and descend. Entering the lung and bladder meridians, its medicinal power is quite strong. It can purge the congestion of the lung qi, regulate the water passages, and eliminate phlegm retention. It has the effects of purging the lung to relieve asthma and promoting diuresis to reduce swelling, and is good at treating asthma due to phlegm congestion in the lung and edema with less urine.

[0050] Rhizoma Sparganii has a pungent, bitter, and neutral nature and enters the liver and spleen meridians. It enters both blood and qi aspects, with relatively strong medicinal power and belongs to the type of herbs that can move and purge. It is good at breaking blood and promoting qi to eliminate masses and relieve pain, and can promote qi and eliminate accumulation to relieve distension and pain. It can be used for severe cases of blood stasis, qi stagnation, and food accumulation.

[0051] Rhizoma Curcumae has a pungent, bitter, and warm nature and enters the liver and spleen meridians. It enters the blood aspect and moves in the qi aspect, with relatively strong medicinal power and belongs to the type of herbs that can break blood and break qi. It not only breaks blood and promotes qi to relieve pain and eliminate masses, but also promotes qi and eliminates accumulation to relieve distension and pain, and mainly treats severe cases of blood stasis, qi stagnation, and food accumulation.

[0052] Rhizoma Curcumae Longae is pungent, bitter, and warm. It enters the spleen and liver meridians. It promotes qi and blood circulation within the body to dredge the meridian and relieve pain, and dispels wind-cold-dampness externally to treat arthralgia and relieve pain, and also spreads horizontally to the extremities and arms. It treats various pains due to blood stasis and qi stagnation, especially those with cold syndrome; for treating pain in the shoulder and arm due to wind-dampness, it is most effective for those with cold coagulation blocking the meridians. "Newly Revised Materia Medica": "It is mainly used for treating abdominal masses, pestilent qi, promoting qi downward, breaking blood, removing wind-heat, and eliminating carbuncle swelling."

[0053] Rhizoma Corydalis has a pungent, bitter, and warm nature and enters the liver and spleen meridians. It promotes blood circulation and qi movement, and has a strong pain-relieving effect. It can be used for pain caused by blood stasis and qi stagnation, and is better for those with cold syndrome.

[0054] Artemisia argyi has a pungent, bitter, and warm nature and is slightly poisonous. It enters the liver, spleen, and kidney meridians. "Materia Medica of Medicinal Properties": "It stops uterine bleeding, prevents miscarriage, and relieves abdominal pain. It stops red and white dysentery and bleeding from hemorrhoids in the five internal organs." "Taking it for a long time stops cold dysentery. Also, for evil qi in the heart and abdomen, take the juice of the leaves."

[0055] Semen Coicis has a sweet, light, and cool nature and enters the spleen, stomach, and lung meridians. Diuretic without harming healthy qi, strengthening the spleen without being greasy. Raw Semen Coicis is sweet, light, slightly cold, promoting diuresis, clearing and tonifying. It can not only clear away damp-heat, remove obstruction in the meridians, and drain pus, but also slightly strengthen the spleen. It is suitable for those with damp-heat or damp-heat combined with spleen deficiency. Stir-fried Semen Coicis has a neutral nature, sweet, light, promoting diuresis and tonifying. It strengthens the spleen and promotes diuresis to stop diarrhea. It is suitable for those with spleen deficiency and dampness accumulation without heat or with mild heat. Raw Semen Coicis is good at promoting diuresis, removing obstruction in the meridians, clearing heat, and draining pus.

[0056] The mechanism of traditional Chinese medicine external application is to apply drugs of different preparations to the skin, pores, acupoints and other parts. The external application of drugs is close to the skin, and the smell of the drugs reaches the meridians directly through the skin to regulate qi, blood, yin and yang, and strengthen the healthy qi and eliminate pathogenic factors. After local external application, the drugs directly enter the affected part to produce therapeutic effects and promote blood circulation. Through osmosis, they enter the local skin, change the local blood circulation, relieve pain and promote the absorption of inflammation.

[0057] Homalomena occulta (Lour.) Schott is bitter, pungent and warm in nature. It acts on the liver and kidney meridians. It is used for wind-cold-dampness syndrome, cold pain in the waist and knees, numbness and stiffness, and flaccidity of muscles and bones.

[0058] Piper wallichii (Miq.) Hand.-Mazz. acts on the spleen meridian. It can relax muscles and tendons, activate collaterals, dispel wind and promote blood circulation.

[0059] Angelica pubescens Maxim. f. biserrata Shan & Yuan is pungent, bitter and slightly warm in nature. It acts on the kidney and bladder meridians. Its action is more focused on the interior and lower part. It mainly disperses wind pathogen lurking in the interior and dampness pathogen, dredges the joints and relieves pain. It is especially good at treating headache due to wind pathogen lurking in the Shaoyin meridian and wind-cold-dampness arthralgia of the lower body.

[0060] Notopterygium incisum Ting ex Hsiao & K. C. Hsia is pungent, bitter and warm in nature. It acts on the bladder and kidney meridians. It is pungent and dispersing, bitter and drying, warm and dredging, ascending and dispersing, with a strong and fierce nature.

[0061] Dracaena cochinchinensis (Lour.) S. C. Chen is sweet, salty and flat in nature. It acts on the heart and liver meridians. It can activate blood circulation, disperse stasis and relieve pain, treating various blood stasis syndromes; it can also remove stasis and astringe to stop bleeding, treating traumatic bleeding; and it can promote granulation, reduce swelling and astringe ulcers, treating non-healing ulcers.

[0062] Acanthopanax gracilistylus W. W. Smith is pungent, bitter and warm in nature as a traditional Chinese medicine. It acts on the liver and kidney meridians. "Shennong Ben Cao Jing" records that it "mainly treats abdominal hernia, abdominal pain, supplements qi and treats carbuncles, and helps children who cannot walk, and treats carbuncle ulcers and yin erosion."

[0063] Radix Aconiti Kusnezoffii Praeparata and Radix Aconiti Carmichaeli Praeparata are pungent, bitter and hot in nature; they act on the heart, liver, kidney and spleen meridians. They have the effects of dispelling wind and dampness, warming the channels and stopping pain. They are used for wind-cold-dampness arthralgia, joint pain, cold pain in the heart and abdomen, pain due to cold-induced hernia and pain relief during anesthesia.

[0064] Asarum sieboldii Miq. is pungent and warm in nature. It acts on the heart, lung and kidney meridians. "Ben Cao Zheng Yi" records that it "is good at relieving qi stagnation, purging stasis and stagnation, and can reach the top of the head, dredging the ears and eyes."

[0065] Epimedium brevicornu Maxim. is pungent, sweet and warm in nature. It acts on the liver and kidney meridians. It can tonify the kidney yang, strengthen muscles and bones, dispel wind and dampness, and relieve arthralgia.

[0066] Compared with the prior art, the present invention has the following beneficial effects:

[0067] (1) The traditional Chinese medicine composition prescription for treating pelvic inflammatory disease of dampness-heat and blood stasis type in the present invention has the effects of warming the channels and promoting blood circulation, regulating qi and relieving pain. It is used to treat pelvic inflammatory disease of dampness-heat and blood stasis type, and can treat sequelae of pelvic inflammatory disease, repeated implantation failure, intrauterine adhesions, thin endometrium, adenomyosis, secondary dysmenorrhea, infertility, ovarian cysts, promoting ovulation and preventing pelvic adhesions after gynecological surgery, etc., and achieves good results.

[0068] (2) In this invention, Bupleurum soothes the liver and relieves depression, and is slightly cold and can clear heat and stagnation; Angelica sinensis is good at nourishing blood, promoting blood circulation, regulating menstruation and relieving pain; Paeonia lactiflora clears heat and disperses blood stasis, and promotes blood circulation and removes blood stasis; Red vine clears heat and detoxifies, and promotes blood circulation and unblocks collaterals; Gleditsia sinensis thorns treat wind-heat sores and rashes; Citrus aurantium breaks up qi and eliminates accumulation, and removes cold and heat accumulation; Cyperus rotundus soothes the liver and regulates qi, and benefits qi and stops bleeding; Lindera strychnifolia regulates qi and disperses cold, relieves pain and promotes qi circulation; Liquidambar formosana promotes urination and relieves numbness, and dispels wind and unblocks collaterals; Litchi chinensis kernel promotes qi circulation and disperses accumulation, and disperses cold and relieves pain; Patrinia scabiosaefolia clears heat and detoxifies, drains pus and eliminates carbuncles, and removes blood stasis and relieves pain; Smilax china promotes blood circulation and detoxifies, and relieves diarrhea and dispels wind; Ligusticum chuanxiong has strong blood-activating power and treats blood stasis and qi stagnation. The whole formula works together to clear heat and disperse blood stasis, promote blood circulation and relieve pain.

[0069] (3) In this invention, the ingredients of Citrus aurantium, Cyperus rotundus, Lindera strychnifolia, and Smilax china are first boiled at high temperature to soften their texture and facilitate the release of medicinal effects. Then, Bupleurum chinense, Liquidambar formosana, and Ligusticum chuanxiong are boiled together with the softened Citrus aurantium, Cyperus rotundus, Lindera strychnifolia, and Smilax china at medium to high temperature to make the medicinal effects more effective. At the same time, the decoction time of Bupleurum chinense, Liquidambar formosana, and Ligusticum chuanxiong is not too long. The medicinal properties are effectively brought into play by controlling the heat. Finally, Paeonia lactiflora, Smilax china, Gleditsia sinensis, and Litchi chinensis are ground into powder and boiled together with Angelica sinensis and Patrinia scabiosifolia. The powdering makes it easier to exert the medicinal effects of Paeonia lactiflora, Smilax china, Gleditsia sinensis, and Litchi chinensis. At the same time, the decoction time is not too long to prevent the medicinal properties from being lost. In addition, the mixing of Angelica sinensis and Patrinia scabiosifolia makes the powder and dregs of the medicine clump together during decoction, which reduces the loss of medicinal components and makes it less likely to gelatinize during decoction, which would lead to the destruction of medicinal properties. Finally, the extracted filtrate has strong medicinal effects.

[0070] (4) This invention combines the proprietary Chinese medicine therapy of "oral administration + external application + enema". The method of this invention prepares a Chinese medicine composition for pelvic inflammatory disease of damp-heat and blood stasis type. The oral administration has a strong effect and can regulate the system. After oral administration, the enema solution prepared by this invention is used to avoid the first-pass effect of the liver and kidneys. The enema solution can directly reach the lesion of pelvic inflammatory disease. The combination is more conducive to drug absorption, promotes blood circulation, and enhances the drug concentration at the lesion. At the same time, the external application pack acts on the lower abdomen, allowing the drug to penetrate the skin of the lower abdomen through the aroma and enter the internal organs to regulate qi and blood, promote blood circulation and relieve pain. Through the multi-dimensional synergistic effect of oral administration, external application and enema on the lesion, it has a good analgesic effect and fast effect in the treatment of pelvic inflammatory disease of damp-heat and blood stasis type. Detailed Implementation

[0071] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. Of course, the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0072] Although the steps in this invention are arranged by reference numerals, this is not intended to limit the order of the steps. Unless the order of the steps is explicitly stated or the execution of a step requires other steps as a basis, the relative order of the steps can be adjusted. It is understood that the term "and / or" as used herein refers to and covers any and all possible combinations of one or more of the associated listed items.

[0073] Unless otherwise specified, all chemical reagents and materials in this invention are purchased from the market or synthesized from raw materials purchased from the market.

[0074] Example 1

[0075] A traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type, the composition comprising an oral medication, an enema solution, and an external application pack, wherein the oral medication is made from the following raw materials in parts by weight: Bupleurum chinense 10 parts, Angelica sinensis 15 parts, Paeonia lactiflora 15 parts, Sargentodoxa cuneata 15 parts, Gleditsia sinensis thorns 15 parts, Citrus aurantium 12 parts, Cyperus rotundus 12 parts, Lindera strychnifolia 10 parts, Liquidambar formosana 15 parts, Litchi chinensis seed 15 parts, Patrinia scabiosaefolia 15 parts, Smilax china 15 parts, and Ligusticum chuanxiong 10 parts.

[0076] The enema solution is made from the following ingredients by weight: 30 parts of red vine, 30 parts of patrinia, 30 parts of dandelion, 30 parts of polygonum cuspidatum, 15 parts of red peony root, 15 parts of peach kernel, 30 parts of salvia miltiorrhiza, 15 parts of lepidium seed, 12 parts of sparganium rhizome, 12 parts of turmeric, 12 parts of corydalis rhizome, 10 parts of mugwort leaf, and 15 parts of coix seed.

[0077] The external application pack is made from the following raw materials in parts by weight: 20 parts of *Hypericum perforatum*, 20 parts of Sichuan pepper, 20 parts of *Eupatorium fortunei*, 20 parts of *Angelica pubescens*, 20 parts of *Notopterygium incisum*, 10 parts of *Dracaena cochinchinensis*, 20 parts of *Acanthopanax senticosus*, 20 parts of processed *Aconitum carmichaelii*, 20 parts of processed *Aconitum kusnezoffii*, 20 parts of *Smilax china*, 40 parts of *Artemisia argyi*, 10 parts of *Asarum heterotropoides*, 20 parts of *Epimedium brevicornu*, and 20 parts of *Gleditsia sinensis* thorns.

[0078] The method for preparing the oral medication includes the following steps:

[0079] Step 1: Weigh out the following ingredients according to the proportions: Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Linderae, and Rhizoma Scutellariae. Add 7 times the amount of water and decoct for 1.5 hours at a temperature of 90°C. Filter after decoction.

[0080] Step 2: Weigh out Bupleurum, Liquidambar formosana, and Ligusticum chuanxiong according to the proportions, add them to the dregs filtered in Step 1, add 7 times the amount of water and decoct for 1.5 hours at a temperature of 75℃. Filter after decoction.

[0081] Step 3: Weigh out the red peony root, red vine, soapberry thorn, and lychee seed according to the proportion, grind them into powder and mix them evenly. Add them together with the angelica and patrinia in the above proportion to the dregs filtered in Step 2, add 7 times the amount of water and decoct for 2.5 hours at a decoction temperature of 75℃. Filter after decoction.

[0082] Step 4: Mix the filtrates obtained in Steps 2 and 3 evenly, and then fill them into containers.

[0083] The preparation method of the enema solution includes the following steps: weigh each Chinese herbal medicine according to the proportion, mix and crush them, soak them in water for half an hour, then boil them twice, 1 hour each time, combine the decoctions and put them into a vacuum concentrator to concentrate to a relative density of 1.07 (60℃), let them stand for 24 hours, take the supernatant and filter it, and fill the filtrate to obtain the solution.

[0084] The preparation method of the external application pack includes the following steps: weigh each Chinese herbal medicine according to the proportion and grind them into powder, mix the powder evenly and put it into a non-woven bag to make an external application pack.

[0085] The method of using the oral medication, enema solution, and external dressing is as follows: first, take the oral medication orally, then lie on your side and administer the enema solution through an enema procedure. After the enema, lie flat and place the heated external dressing on your lower abdomen.

[0086] Example 2

[0087] A traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type, the composition comprising an oral medication, an enema solution, and an external application pack, wherein the oral medication is made from the following raw materials in parts by weight: Bupleurum chinense 8 parts, Angelica sinensis 13 parts, Paeonia lactiflora 13 parts, Sargentodoxa cuneata 13 parts, Gleditsia sinensis 13 parts, Citrus aurantium 10 parts, Cyperus rotundus 10 parts, Lindera strychnifolia 8 parts, Liquidambar formosana 13 parts, Litchi chinensis 13 parts, Patrinia scabiosaefolia 13 parts, Smilax china 13 parts, and Ligusticum chuanxiong 8 parts.

[0088] The enema solution is made from the following ingredients by weight: 28 parts of red vine, 28 parts of patrinia, 28 parts of dandelion, 28 parts of polygonum cuspidatum, 13 parts of red peony root, 13 parts of peach kernel, 28 parts of salvia miltiorrhiza, 13 parts of lepidium seed, 10 parts of sparganium rhizome, 10 parts of turmeric, 10 parts of corydalis rhizome, 8 parts of mugwort leaf, and 13 parts of coix seed.

[0089] The external application pack is made from the following raw materials in parts by weight: 18 parts of *Hypericum perforatum*, 18 parts of Sichuan pepper, 18 parts of *Euphorbia pekinensis*, 18 parts of *Angelica pubescens*, 18 parts of *Notopterygium incisum*, 8 parts of *Dracaena cochinchinensis*, 18 parts of *Acanthopanax senticosus*, 18 parts of *Aconitum carmichaelii*, 18 parts of *Aconitum kusnezoffii*, 18 parts of *Smilax china*, 38 parts of *Artemisia argyi*, 8 parts of *Asarum heterotropoides*, 18 parts of *Epimedium brevicornu*, and 18 parts of *Gleditsia sinensis* thorns.

[0090] The method for preparing the oral medication includes the following steps:

[0091] Step 1: Weigh out the following ingredients according to the proportions: Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Linderae, and Rhizoma Scutellariae, add 6 times the amount of water and decoct for 1 hour at a temperature of 80°C. Filter after decoction.

[0092] Step 2: Weigh out Bupleurum, Liquidambar formosana, and Ligusticum chuanxiong according to the proportions, add them to the dregs filtered in Step 1, add 6 times the amount of water and decoct for 1 hour at a temperature of 70℃. Filter after decoction.

[0093] Step 3: Weigh out the red peony root, red vine, soapberry thorn, and lychee seed according to the proportion, grind them into powder and mix them evenly. Add them together with the angelica and patrinia in the above proportion to the dregs filtered in Step 2, add 6 times the amount of water and decoct for 2 hours at a temperature of 70℃. Filter after decoction.

[0094] Step 4: Mix the filtrates obtained in Steps 2 and 3 evenly, and then fill them into containers.

[0095] The preparation method of the enema solution includes the following steps: weigh each Chinese herbal medicine according to the proportion, mix and crush them, soak them in water for half an hour, then boil them twice, 1 hour each time, combine the decoctions and put them into a vacuum concentrator to concentrate to a relative density of 1.06 (60℃), let them stand for 24 hours, take the supernatant and filter it, and fill the filtrate to obtain the solution.

[0096] The preparation method of the external application pack includes the following steps: weigh each Chinese herbal medicine according to the proportion and grind them into powder, mix the powder evenly and put it into a non-woven bag to make an external application pack.

[0097] The method of using the oral medication, enema solution, and external dressing is as follows: first, take the oral medication orally, then lie on your side and administer the enema solution through an enema procedure. After the enema, lie flat and place the heated external dressing on your lower abdomen.

[0098] Example 3

[0099] A traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type, the composition comprising an oral medication, an enema solution, and an external application pack, wherein the oral medication is made from the following raw materials in parts by weight: Bupleurum chinense 12 parts, Angelica sinensis 17 parts, Paeonia lactiflora 17 parts, Sargentodoxa cuneata 17 parts, Gleditsia sinensis 17 parts, Citrus aurantium 14 parts, Cyperus rotundus 14 parts, Lindera strychnifolia 12 parts, Liquidambar formosana 17 parts, Litchi chinensis seed 17 parts, Patrinia scabiosaefolia 17 parts, Smilax china 17 parts, and Ligusticum chuanxiong 12 parts.

[0100] The enema solution is made from the following ingredients by weight: 32 parts of red vine, 32 parts of patrinia, 32 parts of dandelion, 32 parts of polygonum cuspidatum, 17 parts of red peony root, 17 parts of peach kernel, 32 parts of salvia miltiorrhiza, 17 parts of lepidium seed, 14 parts of sparganium rhizome, 14 parts of turmeric, 14 parts of corydalis rhizome, 12 parts of mugwort leaf, and 17 parts of coix seed.

[0101] The external application pack is made from the following raw materials in parts by weight: 22 parts of *Hypericum perforatum*, 22 parts of Sichuan pepper, 22 parts of *Eupatorium fortunei*, 22 parts of *Angelica pubescens*, 22 parts of *Notopterygium incisum*, 12 parts of *Dracaena cochinchinensis*, 22 parts of *Acanthopanax senticosus*, 22 parts of processed *Aconitum carmichaelii*, 22 parts of processed *Aconitum kusnezoffii*, 22 parts of *Smilax china*, 42 parts of *Artemisia argyi*, 12 parts of *Asarum heterotropoides*, 22 parts of *Epimedium brevicornu*, and 22 parts of *Gleditsia sinensis* thorns.

[0102] The method for preparing the oral medication includes the following steps:

[0103] Step 1: Weigh out the following ingredients according to the proportions: Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Linderae, and Rhizoma Scutellariae, add 6 times the amount of water and decoct for 2 hours at 100℃. Filter after decoction.

[0104] Step 2: Weigh out Bupleurum, Liquidambar formosana, and Ligusticum chuanxiong according to the proportions, add them to the dregs filtered in Step 1, add 8 times the amount of water and decoct for 2 hours at a temperature of 80℃. Filter after decoction.

[0105] Step 3: Weigh out the red peony root, red vine, soapberry thorn, and lychee seed according to the proportion, grind them into powder and mix them evenly. Add them together with the angelica and patrinia in the above proportion to the dregs filtered in Step 2, add 8 times the amount of water and decoct for 3 hours at a temperature of 80℃. Filter after decoction.

[0106] Step 4: Mix the filtrates obtained in Steps 2 and 3 evenly, and then fill them into containers.

[0107] The preparation method of the enema solution includes the following steps: weigh each Chinese herbal medicine according to the proportion, mix and crush them, soak them in water for half an hour, then boil them twice, 1.5 hours each time, combine the decoctions and put them into a vacuum concentrator to concentrate to a relative density of 1.08 (60℃), let them stand for 24 hours, take the supernatant and filter it, and fill the filtrate to obtain the solution.

[0108] The preparation method of the external application pack includes the following steps: weigh each Chinese herbal medicine according to the proportion and grind them into powder, mix the powder evenly and put it into a non-woven bag to make an external application pack.

[0109] The method of using the oral medication, enema solution, and external dressing is as follows: first, take the oral medication orally, then lie on your side and administer the enema solution through an enema procedure. After the enema, lie flat and place the heated external dressing on your lower abdomen.

[0110] Experimental Results Section:

[0111] Basic information: This study included 240 patients aged 18-45 years who met the diagnostic criteria for pelvic inflammatory disease and were treated at the Department of Traditional Chinese Medicine, Hubei Provincial Maternal and Child Health Hospital from January 1, 2020 to January 1, 2023.

[0112] Diagnostic criteria:

[0113] (1) Western Medicine Diagnostic Criteria: Meets the diagnostic criteria for chronic pelvic inflammatory disease in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" and "Obstetrics and Gynecology": Lower abdominal distending pain or lumbosacral soreness and pain, which often worsens with fatigue, sexual intercourse, emotional fluctuations, or before and after menstruation. Symptoms are often not obvious, sometimes only low-grade fever, easy fatigue, weakness in the lower limbs, and some patients with long-term disease may develop neurasthenia symptoms, such as lethargy, general malaise, irritability, or insomnia. Increased vaginal discharge, which is yellow, light yellow, or yellowish-white, and viscous, thin, or watery. Menstrual irregularities, with heavy menstrual flow or prolonged menstrual period being more common. Fallopian tube obstruction infertility. The uterus is often retroverted, with limited mobility or adhesions and fixed, accompanied by tenderness. Cord-like thickening or sheet-like thickening or cystic masses can be palpated in the adnexal region, accompanied by tenderness, and the uterine ligaments are often thickened, accompanied by tenderness. Ultrasound examination: May detect fluid accumulation in the rectouterine pouch, inflammatory masses or swelling in the pelvic cavity, enlarged fallopian tubes, or slightly enlarged ovaries. Complete blood count: White blood cell count or neutrophil count is normal or slightly elevated. Vaginal or cervical secretion smear or culture: May show abnormalities or detect pathogens.

[0114] (2) Traditional Chinese Medicine Diagnostic Criteria: The diagnosis must meet the criteria outlined in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" and the "Obstetrics and Gynecology" diagnostic criteria for chronic pelvic inflammatory disease. Primary symptoms: 1. Lower abdominal pain and distension; 2. Lumbosacral distending pain; 3. Excessive vaginal discharge, white or yellow in color, thin in consistency and with an odor. Secondary symptoms: 1. Anal distension; 2. Fluctuating low-grade fever; 3. Chest, rib, and breast distending pain; 4. Fatigue and weakness; 5. Irritability and depression; 6. Insomnia; 7. Dizziness; 8. Early or late menstruation, or prolonged menstrual period, dark red, light red, or bright red in color, with blood clots or a sticky consistency, accompanied by menstrual bleeding; 9. Frequent urination, urgency, or nocturia; 10. Loose stools or constipation. Tongue and pulse: Pale red or dark red tongue; thin yellow coating; deep and wiry pulse, or thin and wiry pulse. At least two primary symptoms and three secondary symptoms must be present for a diagnosis.

[0115] Inclusion criteria: 1. Meeting the above diagnostic criteria; 2. Tolerating enema and topical treatment; 3. Cooperating with relevant investigations and treatment.

[0116] Exclusion criteria: 1. Not meeting the above diagnostic criteria; 2. Pregnant women or women planning to become pregnant in the near future, or breastfeeding women; 3. Patients with other pelvic diseases such as uterine fibroids, ovarian tumors, endometriosis, or vaginitis.

[0117] Treatment efficacy assessment and evaluation indicators:

[0118] Cure: Symptoms such as lower abdominal pain and lumbosacral soreness and pain disappeared after treatment;

[0119] Significant effect: After treatment, symptoms such as lower abdominal pain and lumbosacral soreness and pain disappeared or were significantly reduced, and gynecological examination and physical and chemical examination showed significant improvement;

[0120] Effective: After treatment, symptoms such as lower abdominal pain and lumbosacral soreness and pain were relieved, and gynecological examination and physical and chemical examination showed improvement;

[0121] Ineffective: The symptoms of lower abdominal pain and lumbar soreness and pain did not lessen or even worsened after treatment, and gynecological examination and physical and chemical examination showed no improvement or even worsened compared with before treatment.

[0122] Case selection: From January 1, 2020 to January 1, 2023, 240 patients who met the diagnostic criteria for pelvic inflammatory disease were clinically observed in the Department of Traditional Chinese Medicine of Hubei Provincial Maternal and Child Health Hospital. They were divided into four groups: Group A, Group B, Group C, and Group D. After a 14-day course of treatment, no obvious abnormal reactions or side effects were observed in the patients during the treatment period.

[0123] Dosage regimen:

[0124] Group A served as control group 1, and was given levofloxacin 0.4g and metronidazole 0.4g intravenously once a day for 14 consecutive days as one course of treatment.

[0125] Group B served as control group 2, and was administered the herbal composition from Example 1 of this invention, either orally or topically, once daily. One course of treatment consisted of 14 consecutive days of topical application.

[0126] Group C served as the control group (3), and received the herbal composition from Example 1 of this invention, either orally or via enema, once daily. One course of treatment consisted of 14 consecutive days of external application.

[0127] Group D was the observation group, receiving the herbal composition of Example 1 of this invention, taken orally and applied externally, plus as an enema, once daily. One course of treatment consisted of 14 consecutive days of external application.

[0128] Contraindications and Precautions: Do not use during menstruation or pregnancy. Contraindicated in patients with serious internal medical conditions, mental illnesses, or those who cannot tolerate topical medications. Use with caution in patients with known allergies to the medication. Pay attention to temperature to avoid burns.

[0129] Treatment efficacy: The number of patients who responded to treatment and the effective rate are shown in Tables 1 and 2.

[0130] Table 1. Statistical Table of Clinical Cases

[0131] Group Number of cured Effective number Significant numbers Invalid numbers Control group 1 25 14 12 9 Control group 2 26 23 7 4 Control group 3 28 20 7 5 Observation group 39 10 8 3

[0132] Table 2. Efficiency Statistics

[0133]

[0134]

[0135] The clinical observation and efficacy evaluation results of the patients showed that the total effective rate of group D in this invention was 95%, the cure rate was 65%, and no obvious adverse reactions were observed. The traditional Chinese medicine composition of this invention for damp-heat and blood stasis type pelvic inflammatory disease clears heat and disperses blood stasis, promotes blood circulation and relieves pain, with rapid effect, promoting blood circulation and relieving pain. It can be used to improve clinical symptoms in the treatment of damp-heat and blood stasis type pelvic inflammatory disease. The total effective rates of groups B and C were 93% and 92% respectively, which were significantly better than those of group A (control group 1), but the cure rates were 43% and 47% respectively, which were much lower than those of group D in this invention. Group D of this invention has a rapid onset of action.

[0136] Specific case introduction:

[0137] Case 1: Patient: Ms. Ye, female, age: 35 years old, symptoms: lower abdominal distension and pain for one week, easy fatigue, weakness in the lower limbs, normal menstruation, dizziness, color Doppler ultrasound showed adenomyosis, pale red tongue with thin yellow coating; yellowish vaginal discharge, mild cervicitis. She came to our hospital for treatment on May 19, 2020.

[0138] Diagnosis: Pelvic inflammatory disease with damp-heat and blood stasis.

[0139] Treatment method: A combination of oral administration, enema, and external application of traditional Chinese medicine for damp-heat and blood stasis type pelvic inflammatory disease.

[0140] Therapeutic effect: After one course of treatment, the lower abdominal distension and pain disappeared, the patient's mental state was good, and the color Doppler ultrasound did not indicate adenomyosis.

[0141] Case 2. Patient: Ms. Qin, female, age 40. Symptoms: lower abdominal distension and pain for one year, taking levofloxacin hydrochloride tablets, with recurrent dull pain in the lower abdomen, accompanied by lumbosacral soreness and pain. She had a hysterosalpingography, which showed that the left fallopian tube was patent but not obstructed. She also had excessive vaginal discharge, which was yellow, thin, and had a foul odor. Her tongue was pale and dark red with a thin yellow coating, and her pulse was deep and wiry. She also had insomnia. Vaginal examination revealed no abnormalities. She came to our hospital for treatment on September 23, 2020.

[0142] Diagnosis: Chronic damp-heat with blood stasis type pelvic inflammatory disease.

[0143] Treatment method: A combination of oral administration, enema, and external application of traditional Chinese medicine for damp-heat and blood stasis type pelvic inflammatory disease.

[0144] Efficacy: After one course of treatment, the lower abdominal distension and pain disappeared, the lumbosacral soreness and pain disappeared, the amount of vaginal discharge returned to normal, and no recurrence was observed after a one-month follow-up.

[0145] Case 3. Patient: Ms. Zhang, female, age: 30. Symptoms: The patient experienced lower abdominal distension and pain, fatigue, frequent urination at night, accompanied by lumbosacral distension and pain after intercourse. The patient had a history of pelvic inflammatory disease. Ultrasound examination revealed an inflammatory mass in the pelvic cavity. She also had poor sleep, lethargy, and a pale red tongue. She came to our hospital for treatment on April 12, 2021.

[0146] Diagnosis: Acute damp-heat with blood stasis type pelvic inflammatory disease.

[0147] Treatment method: A combination of oral administration, enema, and external application of traditional Chinese medicine for damp-heat and blood stasis type pelvic inflammatory disease.

[0148] Efficacy: After one course of treatment, the abdominal pain and lumbosacral soreness completely disappeared, and a follow-up ultrasound examination showed no mass. No recurrence was observed after one month of follow-up.

[0149] Case 4. Patient: Ms. Li, female, age 32. Symptoms: lower abdominal pain and distension, excessive vaginal discharge, white in color, thin in consistency and with an odor, chest and rib pain, breast distension and pain, fatigue, loose stools or constipation, pale red tongue, slippery and weak pulse, poor sleep, weakness in the lower limbs, regular menstruation, and fair appetite. She came to our hospital for treatment on July 26, 2022.

[0150] Diagnosis: Pelvic inflammatory disease with damp-heat and blood stasis.

[0151] Treatment method: A combination of oral administration, enema, and external application of traditional Chinese medicine for damp-heat and blood stasis type pelvic inflammatory disease.

[0152] Therapeutic effect: After one course of treatment, the lower abdominal pain and distension completely disappeared, the amount of vaginal discharge returned to normal, and the patient's mental state was good.

[0153] This invention relates to a traditional Chinese medicine composition for damp-heat and blood stasis type pelvic inflammatory disease. The composition has the effects of warming the meridians, promoting blood circulation, regulating qi, and relieving pain. It is used to treat sequelae of pelvic inflammatory disease, recurrent embryo transfer failure, intrauterine adhesions, thin endometrium, adenomyosis, secondary dysmenorrhea, infertility, ovarian cysts, ovulation induction, and prevention of post-gynecological pelvic adhesions, achieving good results. This invention combines the proprietary TCM therapy of "oral administration + external application + enema." The method of this invention prepares a traditional Chinese medicine composition for damp-heat and blood stasis type pelvic inflammatory disease. The oral administration is highly effective. After oral administration, an enema is performed using the solution prepared in this invention, avoiding the first-pass effect of the liver and kidneys. The enema solution can directly reach the lesion of pelvic inflammatory disease, further facilitating drug absorption, promoting blood circulation, and increasing the drug concentration at the lesion. The external application is then applied to the lower abdomen, allowing the medicine to penetrate the skin through its aroma, reaching the internal organs to regulate qi and blood, promote blood circulation, and relieve pain.

[0154] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and modifications without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type, characterized in that, The traditional Chinese medicine composition comprises an oral medication, an enema solution, and an external application pack. The oral medication is made from the following raw materials in parts by weight: Bupleurum chinense 8-12 parts, Angelica sinensis 13-17 parts, Paeonia lactiflora 13-17 parts, Sargentodoxa cuneata 13-17 parts, Gleditsia sinensis 13-17 parts, Citrus aurantium 10-14 parts, Cyperus rotundus 10-14 parts, Lindera strychnifolia 8-12 parts, Liquidambar formosana 13-17 parts, Litchi chinensis 13-17 parts, Patrinia scabiosaefolia 13-17 parts, Smilax china 13-17 parts, Ligusticum chuanxiong 8-12 parts; The enema solution is made from the following raw materials in parts by weight: Red vine 28-32 parts, Patrinia scabiosaefolia 28-32 parts, Dandelion 28-32 parts, Polygonum cuspidatum 28-32 parts, Paeonia lactiflora 13-17 parts, Prunus persica 13-17 parts, Salvia miltiorrhiza 28-32 parts, Lepidium apetalum 13-17 parts, Sparganium stoloniferum 10-14 parts, Curcuma zedoaria 10-14 parts, Curcuma longa 10-14 parts, Corydalis yanhusuo 10-14 parts, Artemisia argyi 8-12 parts, Coix lacryma-jobi 13-17 parts; The external application pack is made from the following active pharmaceutical ingredients in parts by weight: 18-22 parts of *Hypericum perforatum*, 18-22 parts of Sichuan pepper, 18-22 parts of *Eupatorium fortunei*, 18-22 parts of *Angelica pubescens*, 18-22 parts of *Notopterygium incisum*, 8-12 parts of *Dracaena cochinchinensis*, 18-22 parts of *Acanthopanax senticosus*, 18-22 parts of *Aconitum carmichaelii* (processed), 18-22 parts of *Aconitum kusnezoffii* (processed), 18-22 parts of *Smilax china*, 38-42 parts of *Artemisia argyi*, 8-12 parts of *Asarum heterotropoides*, 18-22 parts of *Epimedium brevicornu*, and 18-22 parts of *Gleditsia sinensis* thorns.

2. The traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type according to claim 1, characterized in that, The oral medication is made from the following raw materials in parts by weight: Bupleurum 10 parts, Angelica sinensis 15 parts, Paeonia lactiflora 15 parts, Sargentodoxa cuneata 15 parts, Gleditsia sinensis 15 parts, Citrus aurantium 12 parts, Cyperus rotundus 12 parts, Lindera strychnifolia 10 parts, Liquidambar formosana 15 parts, Litchi chinensis seed 15 parts, Patrinia scabiosaefolia 15 parts, Smilax china 15 parts, Ligusticum chuanxiong 10 parts.

3. The traditional Chinese medicine composition for pelvic inflammatory disease of damp-heat and blood stasis type according to claim 1, characterized in that, The enema solution is made from the following raw materials in parts by weight: 30 parts of red vine, 30 parts of patrinia, 30 parts of dandelion, 30 parts of Japanese knotweed, 15 parts of red peony root, 15 parts of peach kernel, 30 parts of salvia miltiorrhiza, 15 parts of lepidium seed, 12 parts of sparganium rhizome, 12 parts of turmeric, 12 parts of corydalis rhizome, 10 parts of mugwort leaf, and 15 parts of coix seed.

4. The traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type according to claim 1, characterized in that, The external application pack is made from the following active pharmaceutical ingredients in parts by weight: 20 parts of *Hypericum perforatum*, 20 parts of Sichuan pepper, 20 parts of *Cyperus rotundus*, 20 parts of *Angelica pubescens*, 20 parts of *Notopterygium incisum*, 10 parts of *Dracaena cochinchinensis*, 20 parts of *Acanthopanax senticosus*, 20 parts of processed *Aconitum carmichaelii*, 20 parts of processed *Aconitum kusnezoffii*, 20 parts of *Smilax china*, 40 parts of *Artemisia argyi*, 10 parts of *Asarum heterotropoides*, 20 parts of *Epimedium brevicornu*, and 20 parts of *Gleditsia sinensis* thorns.

5. The traditional Chinese medicine composition for pelvic inflammatory disease of damp-heat and blood stasis type according to claim 1, characterized in that, The method for preparing the oral medication includes the following steps: Step 1: Weigh out the following ingredients according to the specified proportions: Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Linderae, and Rhizoma Scutellariae. Add 6-8 times the amount of water and decoct for 1-2 hours at a temperature of 80-100℃. Filter after decoction. Step 2: Weigh out Bupleurum, Liquidambar formosana, and Ligusticum chuanxiong according to the proportions, add them to the dregs filtered in Step 1, add 6-8 times the amount of water and decoct for 1-2 hours at a temperature of 70-80℃, then filter after decoction. Step 3: Weigh out the red peony root, red vine, soapberry thorn, and lychee seed according to the proportion, grind them into powder and mix them evenly. Add them together with the angelica and patrinia in the above proportion to the dregs filtered in Step 2. Add 6 to 8 times the amount of water and decoct for 2 to 3 hours at a temperature of 70 to 80°C. Filter after decoction. Step 4: Mix the filtrates obtained in Steps 2 and 3 evenly, and then fill them into containers.

6. The traditional Chinese medicine composition for pelvic inflammatory disease of damp-heat and blood stasis type according to claim 1, characterized in that, The preparation method of the enema solution includes the following steps: weigh each Chinese herbal medicine according to the proportion, mix and crush them, soak them in water for half an hour, then boil them twice, each time for 1 to 1.5 hours, combine the decoctions and put them into a vacuum concentrator to concentrate them at 60°C to a relative density of 1.06 to 1.08, let them stand for 24 hours, take the supernatant and filter it, and fill the filtrate to obtain the solution.

7. The traditional Chinese medicine composition for pelvic inflammatory disease of the damp-heat and blood stasis type according to claim 1, characterized in that, The preparation method of the external application pack includes the following steps: weigh each Chinese herbal medicine according to the proportion and grind them into powder, mix the powder evenly and put it into a non-woven bag to make an external application pack.

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