A traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy and a preparation method thereof

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The traditional Chinese medicine composition includes an oral medicine and an external patch. The external patch is prepared by grinding the following raw materials and mixing them with vinegar: Eucommia ulmoides, Boehmeria nivea root, Psoralea corylifolia, Artemisia argyi charcoal, Cassia obtusifolia, Rheum palmatum, Areca catechu, Foeniculum vulgare, Akebia quinata, Zanthoxylum bungeanum, Eugenia caryophyllata, Cinnamomum cassia, stir-fried Atractylodes macrocephala. The oral medicine is prepared by grinding the following raw materials: Cuscuta chinensis, Taxillus chinensis, Dipsacus asperoides, Colla Corii Asini, Anemarrhena asphodeloides, Phellodendron amurense, Dioscorea opposita, Paeonia lactiflora, Boehmeria nivea root, Eucommia ulmoides, Saposhnikovia divaricata, Cornus officinalis, Angelica sinensis, Rubia cordifolia, Agrimonia pilosa. The traditional Chinese medicine composition of the present invention includes an oral medicine and an external patch. The compatibility of the medicines is scientific and reasonable. The internal administration combined with external application has a significant therapeutic effect on the formation of hematoma caused by the downward aggregation of yin and blood to nourish the fetus after pregnancy, the more exuberant blood heat due to yin blood deficiency, the heat lurking in Chong and Ren meridians, the exuberant yang and blood heat, the overflow of blood due to heat, and the forced abnormal bleeding. It has the functions of stopping bleeding and preventing miscarriage.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early pregnancy and a preparation method thereof. Background Art

[0002] Subchorionic hematoma (SCH) refers to the separation and bleeding between the chorion and the decidua of the uterus, resulting in the accumulation of blood between the chorion and the decidua to form a hematoma. It is mainly detected by ultrasound, and the incidence rate is 0.46% - 48%. Research shows that SCH can increase the risks of preeclampsia, small for gestational age infants, miscarriage, placental abruption, and premature rupture of membranes. Currently, there are relatively few studies on the pathogenesis of SCH, and its potential mechanism remains unclear. It may be related to abnormal placental formation and implantation, abnormal autoimmune function, and coagulation disorders, etc. Some scholars believe that during the invasion of the outer chorion of the fetal membrane into the decidua in the early pregnancy, due to the imbalance of maternal immunity, the expression of protective cytokines is inhibited, while the expression of damaging cytokines is overexpressed, leading to abnormal coagulation function of the decidua blood vessels; at the same time, a large amount of proteolytic enzymes are released by the syncytiotrophoblasts on the outer layer of the chorion, causing the rupture of the decidua blood vessels, resulting in bleeding between the decidua and the chorion, and finally forming blood accumulation and fetal membrane detachment. Subchorionic hematoma is a common complication of early threatened abortion. On ultrasound, a crescent, triangular, or irregular high-gray area, hypoechoic or anechoic area can be seen between the gestational sac and the uterine wall. Subchorionic hematoma can occur at all stages of pregnancy. If this disease is intervened earlier, the prognosis is generally good.

[0003] Currently, the main treatments of Western medicine for this disease are to supplement progesterone for luteal support and hemostatic drugs, etc. For those with lower abdominal pain, drugs to inhibit uterine contractions (such as phloroglucinol) are added. For those with subchorionic hematoma that does not disappear for a long time, antibiotics are added for anti-infection and anti-inflammatory treatment. When treating pregnancy complicated with subchorionic hematoma, Chinese medicine doctor He Shaoshan often adds a small amount of traditional Chinese medicine for promoting blood circulation and removing blood stasis, and good clinical effects are achieved. Professor Luo Songping believes that the main pathogenesis of subchorionic hematoma during pregnancy is kidney deficiency and blood stasis. Therefore, when treating this disease, the basic treatment principles are to tonify the kidney and prevent miscarriage, promote blood circulation to remove blood stasis and stop bleeding, and promoting blood circulation to remove blood stasis and preventing miscarriage are carried out simultaneously, and the effect is obvious. Professor Chu Yuxia believes that the main pathogenesis of subchorionic hematoma during pregnancy is spleen-kidney deficiency, yin deficiency and blood heat, and concurrent blood stasis. Clinically, the main treatment principles are to invigorate the spleen and tonify the kidney, cool the blood and promote blood circulation to remove blood stasis. The commonly used modified Chu's anti-abortion formula (Cuscuta chinensis, Dipsacus asperoides, Atractylodes macrocephala, Dioscorea opposita, Sanguisorba officinalis, Eclipta prostrata, Colla Corii Asini, Perilla stem, Amomum villosum, Salvia miltiorrhiza, Scutellaria baicalensis, roasted licorice) is used. Feng Lina et al. treated 30 cases of pregnancy with subchorionic hematoma by the method of tonifying the kidney and preventing miscarriage, promoting blood circulation to remove blood stasis and stop bleeding, and the effective rate was 93.3%. Shao Rong et al. used dydrogesterone tablets, intramuscular injection of HCG injection, and orally administered traditional Chinese medicine Yigu Baotai Decoction for pregnant women with intrauterine fluid accumulation after IVF-ET, and the success rate of preventing miscarriage was 77.78%.

[0004] However, the above-mentioned treatment methods mostly adopt traditional Chinese medicine oral prescriptions, and there are few studies on the treatment of early pregnancy subchorionic hematoma by combining oral administration and external application of traditional Chinese medicine. Summary of the Invention

[0005] The object of the present invention is to provide a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The traditional Chinese medicine composition of the present invention includes oral medicine and external patches. The compatibility of the medicine is scientific and reasonable. The oral administration is combined with external application, which has a significant therapeutic effect on the formation of hematoma caused by the downward aggregation of yin blood to nourish the fetus after pregnancy, the more prosperous blood heat due to yin blood deficiency, the heat lurking in Chong and Ren meridians, the excessive yang and blood heat, the overflow of blood due to heat, and the forced and erratic flow of blood. It has the functions of stopping bleeding and preventing miscarriage. Moreover, the external traditional Chinese medicine patch and the oral medicine have remarkable curative effects, are safe and convenient, and are widely used.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy, the traditional Chinese medicine composition includes oral medicine and external patches, and the external patches are made by grinding the following raw materials and mixing them with vinegar: Eucommia ulmoides, Boehmeria nivea root, Psoralea corylifolia, Artemisia argyi carbon, Cassia obtusifolia, Rheum officinale, Areca catechu, Foeniculum vulgare, Akebia quinata, Zanthoxylum bungeanum, Eugenia caryophyllata, Cinnamomum cassia, stir-fried Atractylodes macrocephala.

[0008] The oral medicine is made by grinding the following raw materials: Cuscuta chinensis, Taxillus chinensis, Dipsacus asperoides, Colla Corii Asini, Anemarrhena asphodeloides, Phellodendron amurense, Dioscorea opposita, Paeonia lactiflora, Boehmeria nivea root, Eucommia ulmoides, Saposhnikovia divaricata, Cornus officinalis, Angelica sinensis, Rubia cordifolia, Agrimonia pilosa.

[0009] Preferably, for the external patch, by mass ratio, Eucommia ulmoides: Boehmeria nivea root: Psoralea corylifolia: Artemisia argyi carbon: Cassia obtusifolia: Rheum officinale: Areca catechu: Foeniculum vulgare: Akebia quinata: Zanthoxylum bungeanum: Eugenia caryophyllata: Cinnamomum cassia: stir-fried Atractylodes macrocephala is 30-60: 20-40: 20-40: 10-20: 15-30: 30-60: 15-30: 20-40: 10-20: 10-20: 10-20: 10-20: 15-30.

[0010] Preferably, for the external patch, by mass ratio, Eucommia ulmoides: Boehmeria nivea root: Psoralea corylifolia: Artemisia argyi carbon: Cassia obtusifolia: Rheum officinale: Areca catechu: Foeniculum vulgare: Akebia quinata: Zanthoxylum bungeanum: Eugenia caryophyllata: Cinnamomum cassia: stir-fried Atractylodes macrocephala is 3: 2: 2: 1: 1.5: 3: 1.5: 2: 1: 1: 1: 1: 1.5.

[0011] Preferably, for the oral medicine, by mass ratio, Cuscuta chinensis: Taxillus chinensis: Dipsacus asperoides: Colla Corii Asini: Anemarrhena asphodeloides: Phellodendron amurense: Dioscorea opposita: Paeonia lactiflora: Boehmeria nivea root: Eucommia ulmoides: Saposhnikovia divaricata: Cornus officinalis: Angelica sinensis: Rubia cordifolia: Agrimonia pilosa is 20-40: 20-40: 20-40: 10-20: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 20-40: 30-60.

[0012] The present invention also claims the preparation method of the external patch for promoting the absorption of subchorionic hematoma in the early pregnancy. Weigh each traditional Chinese medicine and grind them into powder, then add vinegar to reconcile into a paste, and then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another layer of gauze patch to obtain the product.

[0013] The present invention also claims the preparation method of the oral medicine for promoting the absorption of subchorionic hematoma in the early pregnancy. Weigh each drug raw material according to the proportion, wash and grind them respectively, add water with a volume 6 times that of all the ground drugs and decoct twice, 2 hours for the first time and 1 hour for the second time, combine the decoction liquids, and filter the decoction liquids to obtain the oral medicine.

[0014] Preferably, the thickness of the coated paste-like traditional Chinese medicine composition is about 5 mm.

[0015] The present invention also protects the external patch for promoting the absorption of subchorionic hematoma in the early pregnancy prepared by the above-mentioned production method and the using method of the external patch.

[0016] Preferably, the using method is to remove the upper gauze patch of the external patch and apply it on the abdomen in the range from Shenque acupoint above to Guanyuan acupoint below and 3 cun beside the umbilical midline.

[0017] In the present invention, the properties and functions of the traditional Chinese medicines used are as follows:

[0018] Eucommia ulmoides Oliv.: Sweet and warm in nature, entering the liver and kidney meridians, can tonify the liver and kidney, strengthen tendons and bones, and prevent miscarriage, being an excellent product for treating threatened abortion or fetal movement. It has functions such as sedation, immune regulation, antioxidant, anti-fatigue, antiviral, antibacterial, and neuroprotection, and has antibacterial effects on Staphylococcus aureus, Escherichia coli, and Salmonella to varying degrees.

[0019] Fructus Foeniculi: Pungent and warm in nature and flavor, belonging to the liver, kidney, spleen, and stomach meridians. It has the effects of dispelling cold and relieving pain, regulating qi and harmonizing the stomach. Hot compress can relieve constipation and abdominal distension, reduce abdominal pain, and stop bleeding. It has certain effects on the human internal organ system, central nervous system, cardiovascular system, endocrine system, immune system, and chemotherapy, including functions such as regulating gastrointestinal function, analgesia, anti-inflammatory, anti-hepatorenal toxicity, reducing blood lipid, reducing blood sugar, antioxidant, antibacterial, antiviral, anti-tumor, and regulating estrogen level.

[0020] Zanthoxylum bungeanum Maxim.: Pungent, dispersing, warm, and dry in nature, entering the spleen and stomach, can warm the middle-jiao to relieve pain and relieve itching, and has pharmacological effects such as analgesia, anti-inflammatory, promoting skin absorption, local anesthesia, antibacterial, antioxidant, and dispelling wind and dampness.

[0021] Flos Caryophylli: Pungent and warm in nature, having the effects of warming the middle-jiao to reduce adverse qi and tonifying the kidney to assist yang, and has various functions such as antibacterial and anti-inflammatory, antipyretic and analgesic, antioxidant, anti-ulcer, anesthesia, promoting transdermal absorption, and neuroprotection.

[0022] Cinnamon: Pungent, sweet and warm in nature, it belongs to the kidney and spleen meridians, can direct the floating fire back to its origin, dispel cold and relieve pain, reinforce fire and boost yang, and has various pharmacological effects such as antibacterial, anti-inflammatory, antioxidant, neuroprotective, hypoglycemic, lipid-lowering, and uric acid-lowering effects. It also has functions such as freshness preservation, deodorization, and good fragrance retention.

[0023] Psoralea corylifolia: Bitter, pungent and warm in nature, it can warm the spleen and kidney and astringe essence. Pharmacological research has proved that it has good anti-tumor, antioxidant, antibacterial, anti-inflammatory, antidepressant, estrogen level-regulating, bone growth-promoting, liver protection, vascular protection, and neuroprotective effects.

[0024] Carbonized Folium Artemisiae Argyi: Warm in nature, it can warm the meridians and warm the uterus, stop bleeding and prevent miscarriage, and has various pharmacological activities such as hemostasis, antifungal, antiviral, anti-tumor, and antioxidant. It has good curative effects on treating threatened abortion with symptoms of lower abdominal pain and vaginal bleeding.

[0025] Akebia quinata: Bitter in taste and cold in nature, it belongs to the heart, small intestine, and bladder meridians, can clear the heart and remove vexation, and promote diuresis. It has the effects of anti-inflammatory, bacteriostatic, and diuretic.

[0026] Ramie Root: Sweet and cold in nature, it can cool the blood, stop bleeding and prevent miscarriage. Ramie root can treat miscarriage through immune regulation, blood coagulation, apoptosis, and nervous system regulation, with good effects, and is widely used in fetal protection.

[0027] Areca nut: Bitter, pungent and warm in nature, it can promote qi circulation, relieve food stagnation and promote diuresis. Its pharmacological effects mainly include promoting gastrointestinal motility, anti-inflammatory and analgesic, antibacterial and bacteriostatic, anti-fatigue, antidepressant, anti-aging, antioxidant, hypoglycemic, and lipid-regulating.

[0028] Cassia Seed: Sweet, bitter and salty in taste, it belongs to the liver and large intestine meridians, can clear heat and moisten the intestine to relieve constipation, contains various chemical components and shows various pharmacological activities, such as regulating gastrointestinal function, antibacterial, protecting the liver and improving eyesight, bacteriostatic, antioxidant, antihypertensive, and lipid-regulating.

[0029] Rhubarb: Bitter and cold in nature, it belongs to the spleen, stomach, and large intestine meridians, can clear heat and purge fire, cool the blood and stop bleeding, remove blood stasis and dredge the meridians. It can be used for those with swelling pain or bleeding due to blood stasis and heat, especially those with constipation or unsmooth defecation.

[0030] Cuscuta chinensis: Sweet and warm in nature, it belongs to the kidney, liver, and spleen meridians, and has the effects of tonifying the liver and kidney, astringing essence and reducing urination, preventing miscarriage, improving eyesight, and stopping diarrhea. It can tonify both yang and yin, with the characteristics of being warm but not dry and tonifying without stagnation.

[0031] Taxillus chinensis: Bitter and sweet in taste, neutral in nature; it belongs to the liver and kidney meridians, and has the effects of dispelling wind-dampness, tonifying the liver and kidney, strengthening the bones and muscles, and preventing miscarriage.

[0032] Dipsacus asper: Tonify the liver and kidney, continue the bones and muscles, and regulate the blood vessels. It is used to treat low back and back pain, weakness of the feet and knees, fetal leakage, metrorrhagia and metrostaxis, leukorrhea, spermatorrhea, traumatic injury, metal wound, hemorrhoids and fistulas, carbuncles and sores.

[0033] Donkey-hide gelatin: Sweet in taste, neutral in nature. It acts on the lung, liver, and kidney meridians. It enriches blood, nourishes yin, moistens dryness, and stops bleeding. It is used for sallow complexion due to blood deficiency, dizziness and palpitations, muscle flaccidity and weakness, restlessness and insomnia, stirring up of endogenous wind, dry cough due to lung dryness, consumptive cough with hemoptysis, hematemesis, hematuria, bloody stool, metrorrhagia and metrostaxis, and fetal leakage during pregnancy.

[0034] Anemarrhena rhizome: Bitter and sweet in taste, cold in nature. It acts on the lung, stomach, and kidney meridians. It clears heat and purges fire, promotes the production of body fluid and moistens dryness. It is used for exogenous febrile diseases, high fever with restlessness and thirst, dry cough due to lung heat, hectic fever due to yin deficiency, internal heat with polydipsia, and constipation due to intestinal dryness.

[0035] Phellodendron bark: Bitter in taste, cold in nature; it acts on the kidney, bladder, and large intestine meridians. It clears and dries dampness-heat, purges fire and detoxifies, and clears away asthenic fever. It is used for damp-heat diarrhea and dysentery, jaundice, leukorrhea, stranguria with heat, beriberi, flaccidity syndrome, hectic fever due to yin deficiency, night sweating, spermatorrhea, sores and ulcers, and eczema with itching.

[0036] Chinese yam: Sweet in taste, neutral in nature; it acts on the spleen, lung, and kidney meridians. It benefits qi and nourishes yin, strengthens the spleen, lung, and kidney, and astringes essence and stops leukorrhea.

[0037] Red peony root: Bitter in taste, slightly cold in nature; it acts on the liver meridian. It clears heat and cools blood, promotes blood circulation and removes stasis.

[0038] Ledebouriella root: Pungent and sweet in taste, slightly warm in nature. It has the effects of expelling wind and relieving exterior syndrome, eliminating dampness and relieving pain, and stopping convulsions.

[0039] Asiatic cornelian cherry fruit: Sour and astringent in taste, slightly warm in nature; it acts on the liver and kidney meridians. It tonifies the liver and kidney, and astringes and consolidates.

[0040] Angelica sinensis: Warm in nature, sweet and pungent in taste. It acts on the liver, heart, and spleen meridians. It enriches blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes defecation. It is used for sallow complexion due to blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency-cold, constipation due to intestinal dryness, rheumatic arthralgia, traumatic injury, and sores and ulcers.

[0041] Indian madder root: Bitter in taste, cold in nature; it acts on the liver meridian. It cools blood and dispels stasis, stops bleeding and dredges meridians.

[0042] Hairyvein agrimony herb: Bitter and astringent in taste, neutral in nature; it acts on the heart and liver meridians. It arrests bleeding, stops dysentery, treats malaria, and tonifies deficiency.

[0043] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0044] (1) The external patch of the present invention takes a large amount of ramie root and takes advantage of the cold nature of Akebia, which enters the Shaoyin Heart Channel, reduces heart fire, clears away heat, stops bleeding and stabilizes pregnancy; at the same time, Eucommia ulmoides, Psoralea corylifolia and Artemisia argyi charcoal enter the Shaoyin Kidney Channel, nourish the liver and kidney, warm the kidney and assist yang, increase the circulation of qi, blood and body fluids in the body, improve metabolism, and promote hematoma absorption while stopping bleeding; the above drugs are used together to achieve the balance of water and fire, stabilize pregnancy and stop bleeding; fennel, prickly ash, clove and cinnamon can increase the effect of warming the kidney, and can also promote transdermal absorption and increase the utilization rate of drugs; betel nut, cassia seed and rhubarb can promote qi and laxative, promote gastrointestinal peristalsis, improve digestive tract function, reduce constipation, make bowel movements smooth, and prevent the increase of abdominal pressure caused by constipation, thereby compressing the uterus and causing further bleeding; the above Chinese medicine combination plays the role of stopping bleeding and stabilizing pregnancy.

[0045] (2) The oral medicine of the present invention uses donkey-hide gelatin, Chinese angelica, and red peony root to nourish yin and blood, while madder and agrimony cool blood, stop bleeding and stabilize pregnancy; Cuscuta, Viscum album, and Dipsacus asper have the functions of tonifying liver and kidney, strengthening tendons and bones, strengthening waist and knees, consolidating Chong and Ren meridians, and stabilizing pregnancy. Their combined use is more effective; Anemarrhena asphodeloides and Phellodendron chinense have the effects of clearing away heat and dampness, nourishing yin and reducing fire; Chinese yam and Saposhnikovia divaricata can nourish the spleen and stomach, promote the production of body fluid and benefit the lungs, and enhance immunity; Cornus officinalis can nourish the liver and kidney, astringe and stop bleeding; the above Chinese medicine combination can harmonize Chong and Ren meridians, stop bleeding and stabilize pregnancy.

[0046] (3) The present invention has a significant therapeutic effect on hematoma formed by the accumulation of Yin blood to nourish the fetus after pregnancy, Yin blood deficiency and more severe blood heat, heat hidden in Chong and Ren meridians, Yang excess and blood heat, blood overflowing due to heat, and forced blood to flow indiscriminately, which is not inferior to the therapeutic effect of Western medicine.

[0047] (4) The Chinese medicine composition of the present invention comprises an oral medicine and an external patch, and the drug compatibility is scientific and reasonable. The internal and external applications have a significant therapeutic effect on the accumulation of yin blood to nourish the fetus after pregnancy, yin blood deficiency and more blood heat, heat hidden in Chong and Ren meridians, yang excess and blood heat, blood overflowing due to heat, and forced blood to flow indiscriminately, thus forming hematomas. It has the function of stopping bleeding and stabilizing the fetus. In addition, the external Chinese medicine patch and the oral medicine have significant therapeutic effects, are safe and convenient, and are widely used. DETAILED DESCRIPTION

[0048] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0049] It should be noted that the terms "first", "second", etc. in the description and claims of the present invention are used to distinguish similar objects and do not necessarily describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of the present invention described herein can be implemented in an order other than those described herein. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units need not be limited to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0050] Example 1

[0051] A method for preparing a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The preparation method of the external patch is as follows: Weigh 30 parts of Eucommia ulmoides, 20 parts of Boehmeria nivea root, 20 parts of Psoralea corylifolia, 10 parts of carbonized Artemisia argyi, 15 parts of Cassia obtusifolia, 30 parts of Rheum palmatum, 15 parts of Areca catechu, 20 parts of Foeniculum vulgare, 10 parts of Akebia quinata, 10 parts of Zanthoxylum bungeanum, 10 parts of Eugenia caryophyllata, 10 parts of Cinnamomum cassia, and 15 parts of stir-fried Atractylodes macrocephala, grind them into powder, then add vinegar to make a paste, then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another layer of gauze patch to obtain it.

[0052] The preparation method of the oral medicine is as follows: Weigh 20 parts of Cuscuta chinensis, 20 parts of Taxillus chinensis, 20 parts of Dipsacus asperoides, 10 parts of Colla Corii Asini, 20 parts of Anemarrhena asphodeloides, 20 parts of Phellodendron amurense, 20 parts of Dioscorea opposita, 20 parts of Paeonia lactiflora, 20 parts of Boehmeria nivea root, 20 parts of Eucommia ulmoides, 20 parts of Saposhnikovia divaricata, 20 parts of Cornus officinalis, 20 parts of Angelica sinensis, 20 parts of Rubia cordifolia, and 30 parts of Agrimonia pilosa. Wash and grind them respectively, add water with a volume 6 times that of all the ground drugs and decoct twice. The first time is for 2 hours, and the second time is for 1 hour. Combine the decoction liquid and filter the decoction liquid to obtain the oral medicine.

[0053] Example 2

[0054] A method for preparing a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The preparation method of the external patch is as follows: Weigh 40 parts of Eucommia ulmoides, 30 parts of Boehmeria nivea root, 30 parts of Psoralea corylifolia, 15 parts of carbonized Artemisia argyi, 20 parts of Cassia obtusifolia, 45 parts of Rheum palmatum, 20 parts of Areca catechu, 30 parts of Foeniculum vulgare, 15 parts of Akebia quinata, 15 parts of Zanthoxylum bungeanum, 15 parts of Eugenia caryophyllata, 15 parts of Cinnamomum cassia, and 20 parts of stir-fried Atractylodes macrocephala, grind them into powder, then add vinegar to make a paste, then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another layer of gauze patch to obtain it.

[0055] The preparation method of the oral medicine is as follows: Weigh 30 parts of Cuscuta chinensis, 30 parts of Taxillus chinensis, 30 parts of Dipsacus asperoides, 15 parts of donkey-hide gelatin, 30 parts of Anemarrhena asphodeloides, 30 parts of Phellodendron amurense, 30 parts of Dioscorea opposita, 30 parts of Paeonia lactiflora, 30 parts of Boehmeria nivea root, 30 parts of Eucommia ulmoides, 30 parts of Saposhnikovia divaricata, 30 parts of Cornus officinalis, 30 parts of Angelica sinensis, 30 parts of Rubia cordifolia, and 45 parts of Agrimonia pilosa. Wash and grind them separately. Add water with a volume 6 times that of all the ground medicines and decoct twice. The first time is for 2 hours and the second time is for 1 hour. Combine the decoctions and filter the decoction liquid to obtain the oral medicine.

[0056] Example 3

[0057] A preparation method of a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The preparation method of the external patch is as follows: Weigh 50 parts of Eucommia ulmoides, 35 parts of Boehmeria nivea root, 35 parts of Psoralea corylifolia, 15 parts of carbonized Artemisia argyi, 25 parts of Cassia obtusifolia, 50 parts of Rheum officinale, 25 parts of Areca catechu, 35 parts of Foeniculum vulgare, 15 parts of Akebia quinata, 15 parts of Zanthoxylum bungeanum, 15 parts of Eugenia caryophyllata, 15 parts of Cinnamomum cassia, and 25 parts of stir-fried Atractylodes macrocephala. Grind the traditional Chinese medicines into powder, then add vinegar to make a paste, and then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another gauze patch to obtain the product.

[0058] The preparation method of the oral medicine is as follows: Weigh 35 parts of Cuscuta chinensis, 35 parts of Taxillus chinensis, 35 parts of Dipsacus asperoides, 15 parts of donkey-hide gelatin, 35 parts of Anemarrhena asphodeloides, 35 parts of Phellodendron amurense, 35 parts of Dioscorea opposita, 35 parts of Paeonia lactiflora, 35 parts of Boehmeria nivea root, 35 parts of Eucommia ulmoides, 35 parts of Saposhnikovia divaricata, 35 parts of Cornus officinalis, 35 parts of Angelica sinensis, 35 parts of Rubia cordifolia, and 50 parts of Agrimonia pilosa. Wash and grind them separately. Add water with a volume 6 times that of all the ground medicines and decoct twice. The first time is for 2 hours and the second time is for 1 hour. Combine the decoctions and filter the decoction liquid to obtain the oral medicine.

[0059] Example 4

[0060] A preparation method of a traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy. The preparation method of the external patch is as follows: Weigh 60 parts of Eucommia ulmoides, 60 parts of Boehmeria nivea root, 60 parts of Psoralea corylifolia, 20 parts of carbonized Artemisia argyi, 30 parts of Cassia obtusifolia, 60 parts of Rheum officinale, 30 parts of Areca catechu, 40 parts of Foeniculum vulgare, 40 parts of Akebia quinata, 40 parts of Zanthoxylum bungeanum, 40 parts of Eugenia caryophyllata, 40 parts of Cinnamomum cassia, and 30 parts of stir-fried Atractylodes macrocephala. Grind the traditional Chinese medicines into powder, then add vinegar to make a paste, and then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another gauze patch to obtain the product.

[0061] The preparation method of the oral medicine is as follows: Weigh 40 parts of Cuscuta chinensis, 40 parts of Taxillus chinensis, 40 parts of Dipsacus asperoides, 20 parts of donkey-hide gelatin, 40 parts of Anemarrhena asphodeloides, 40 parts of Phellodendron amurense, 40 parts of Dioscorea opposita, 40 parts of Paeonia lactiflora, 40 parts of Boehmeria nivea root, 40 parts of Eucommia ulmoides, 40 parts of Saposhnikovia divaricata, 40 parts of Cornus officinalis, 40 parts of Angelica sinensis, 40 parts of Rubia cordifolia, and 60 parts of Agrimonia pilosa. Wash and grind them separately. Add water with a volume 6 times that of all the ground medicines and decoct twice. The first decoction is for 2 hours, and the second is for 1 hour. Combine the decoction liquids and filter them to obtain the oral medicine.

[0062] Application example

[0063] 1. Case selection: Select patients who received fetal protection treatment in the Department of Traditional Chinese Medicine of Hubei Maternal and Child Health Hospital from May 2021 to November 2022. Observe 180 patients with threatened abortion in early pregnancy complicated with subchorionic hematoma, and divide them into three groups: Group A, Group B, and Group C, with 60 patients in each group. The general data of the three groups of patients in terms of age, average number of abortions, average abortion and current gestational weeks were analyzed statistically, and there were no statistically significant differences (all P>0.05), and the groups were comparable. See Table 1 for details.

[0064] Table 1 Comparison of the average age, average number of abortions, average abortion and current gestational weeks of pregnant patients

[0065]

[0066] The comparison between the three groups showed P>0.05, with no obvious differences and no statistical significance. It indicates that the three groups are comparable.

[0067] 2. Diagnostic criteria: (1) Diagnostic criteria for threatened abortion in early pregnancy: Refer to "Obstetrics and Gynecology" and "Clinical Guidelines for New Chinese Medicines (Trial)": ① There is a small amount of vaginal bleeding before 12 weeks of pregnancy, no pregnancy products are discharged, and lower abdominal pain or low back pain appears successively; ② Gynecological examination shows that the cervical os is not open, and the size of the uterus is consistent with the number of weeks of menopause; ③ B-ultrasound examination shows that the size of the uterus, the gestational sac, embryo or fetus is consistent with the gestational week. (2) Diagnostic criteria for subchorionic hematoma: Refer to "Atlas of Obstetric and Gynecological Ultrasound". The B-ultrasound image shows an anechoic area between the uterine wall and the gestational sac in the uterine cavity, and the shape is mostly crescent, triangular or polygonal.

[0068] (1) Inclusion criteria: ① Meet the diagnostic criteria for threatened abortion in early pregnancy; ② B-ultrasound examination shows subchorionic hematoma; ③ Aged 20-40 years old; ④ Voluntarily accept the treatment of this trial, without major diseases of the heart, liver, kidney and other organs, and the spouse is in good health (especially no organic lesions in the reproductive system); ⑤ Sign the informed consent form.

[0069] (2) Exclusion criteria: ① Those with ≥ 3 consecutive spontaneous abortions; ② Those infected with rubella, cytomegalovirus, toxoplasma, or herpes simplex virus; ③ Those with severe anemia, heart failure, chronic nephritis, hypertension, diabetes, or systemic infections such as high fever; ④ Those with uterine malformations, uterine fibroids, or adenomyosis; ⑤ Those with untreated intrauterine adhesions, intrauterine effusion, endometrial polyps, or endometrial hyperplasia lesions; ⑥ Those with mental disorders; ⑦ Those unable to adhere to the treatment course.

[0070] 3. Treatment methods:

[0071] Group A: Start miscarriage prevention treatment from the time of diagnosis. Use traditional miscarriage prevention treatment with progesterone injection (National Medicine Approval No. H33020828, Zhejiang Xianju Pharmaceutical Co., Ltd., 20 mg / ampoule, adjusted to 20 - 60 mg according to the condition, once a day) + dydrogesterone tablets (Registration Certificate No. H20170221, Abbott Healthcare Products B.V., Netherlands, 10 mg / tablet, adjusted according to the condition, orally 1 tablet each time, 3 times a day) until the subchorionic hematoma disappears.

[0072] Group B: The patient takes a supine or sitting position. Remove the upper gauze patch of the external patch prepared in Example 1 and apply it to the abdomen, covering the area from the Shenque acupoint above to the Guanyuan acupoint below, and within three inches beside the midline of the umbilicus. Apply it twice a day, with 5 days as a treatment course, and treat for 5 treatment courses.

[0073] Group C: Use the combination of the external patch in Example 1 and oral medications. The patient takes a supine or sitting position. Remove the upper gauze patch of the external patch and apply it to the abdomen, covering the area from the Shenque acupoint above to the Guanyuan acupoint below, and within three inches beside the midline of the umbilicus. Apply it twice a day, with 5 days as a treatment course, and treat for 5 treatment courses; at the same time, take the oral medications, 1 dose per day, taken twice in the morning and evening, with 5 days as a treatment course, and treat for 5 treatment courses.

[0074] 4. Efficacy evaluation: (1) Color ultrasound examination: Use a GE Voluson 730 type three-dimensional color Doppler ultrasound instrument. The abdominal probe frequency is 3.5 MHz. A specialized doctor operates to measure the bilateral uterine arteries, subchorionic hematoma area, and gestational sac area of the patient by transvaginal color Doppler ultrasound before treatment, 10 days after treatment, 18 days after treatment, and 25 days after treatment. (2) Use SPSS 22.0 statistical software for data analysis. First, perform normality and homogeneity of variance tests. Measurement data that conform to a normal distribution are expressed as the mean ± standard deviation (x-±s). The t-test for two independent samples is used for comparison among the three groups, and the paired sample t-test is used for comparison before and after treatment within the group. Non-parametric rank sum tests are used for non-normal distributions; the rank sum test for rank data is used for comparison of clinical efficacy, and the X test is used for comparison of count data. A P < 0.05 is considered statistically significant.

[0075] 5. Treatment results:

[0076] Table 2 Comparison of the areas of subchorionic hematomas in 3 groups of patients before treatment and 10 days, 18 days, and 25 days after treatment

[0077]

[0078] Table 3 Comparison of pregnancy outcomes in 3 groups of patients

[0079] Group n Abortion Premature birth Full-term birth Gestational age of abortion Gestational age of delivery Group A 60 11 10 39 9.7±2.3 37.3±1.1 Group B 60 8 3 49 10.2±2.1 38.3±1.7 Group C 60 6 2 52 10.6±2.0 38.7±1.3

[0080] It can be seen from the above evaluation results that the traditional Chinese medicine composition prepared by the present invention for promoting the absorption of subchorionic hematomas in the early stage of pregnancy has better effects than western medicine treatment, with significant curative effects. Moreover, when the external traditional Chinese medicine patch is used together with the oral medicine, it is safer and more convenient, and has greater comprehensive significance for the treatment of fetal protection.

[0081] As mentioned above, the above are only the preferred specific embodiments of the present invention, and the protection scope of the present invention is not limited thereto. Any simple changes or equivalent replacements of the technical solutions that can be obviously obtained by those skilled in the art within the technical scope disclosed by the present invention all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for promoting the absorption of subchorionic hematoma in the early stage of pregnancy, characterized in that, The traditional Chinese medicine composition is made up of an oral medicine and an external patch. The external patch is made by grinding the following raw materials and then mixing them with vinegar: Eucommia ulmoides, Boehmeria nivea root, Psoralea corylifolia, Artemisia argyi carbonized, Cassia obtusifolia, Rheum palmatum, Areca catechu, Foeniculum vulgare, Akebia quinata, Zanthoxylum bungeanum, Eugenia caryophyllata, Cinnamomum cassia, stir-fried Atractylodes macrocephala. The oral medicine is made from the following raw materials: Cuscuta chinensis, Taxillus chinensis, Dipsacus asperoides, Colla Corii Asini, Anemarrhena asphodeloides, Phellodendron amurense, Dioscorea opposita, Paeonia lactiflora, Boehmeria nivea root, Eucommia ulmoides, Saposhnikovia divaricata, Cornus officinalis, Angelica sinensis, Rubia cordifolia, Agrimonia pilosa. For the external patch, by mass ratio, Eucommia ulmoides: Boehmeria nivea root: Psoralea corylifolia: Artemisia argyi carbonized: Cassia obtusifolia: Rheum palmatum: Areca catechu: Foeniculum vulgare: Akebia quinata: Zanthoxylum bungeanum: Eugenia caryophyllata: Cinnamomum cassia: stir-fried Atractylodes macrocephala is 30 - 60: 20 - 40: 20 - 40: 10 - 20: 15 - 30: 30 - 60: 15 - 30: 20 - 40: 10 - 20: 10 - 20: 10 - 20: 10 - 20: 15 - 30. For the oral medicine, by mass ratio, Cuscuta chinensis: Taxillus chinensis: Dipsacus asperoides: Colla Corii Asini: Anemarrhena asphodeloides: Phellodendron amurense: Dioscorea opposita: Paeonia lactiflora: Boehmeria nivea root: Eucommia ulmoides: Saposhnikovia divaricata: Cornus officinalis: Angelica sinensis: Rubia cordifolia: Agrimonia pilosa is 20 - 40: 20 - 40: 20 - 40: 10 - 20: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 20 - 40: 30 - 60.

2. The traditional Chinese medicine composition according to claim 1, wherein, The preparation method of the external patch: Weigh each traditional Chinese medicine, grind them into powder, then add vinegar and mix into a paste. Then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch, and then cover it with another gauze patch to obtain the external patch.

3. The Chinese medicinal composition according to claim 1, wherein, The preparation method of the oral medicine: Weigh each drug raw material according to the proportion, wash and grind them respectively. Add water with a volume 6 times that of all the ground drugs and decoct twice. The first time is for 2 hours, and the second time is for 1 hour. Combine the decoction liquid and filter it to obtain the oral medicine.

4. The traditional Chinese medicine composition according to claim 2, wherein The thickness of the coated paste-like traditional Chinese medicine composition is about 5 mm.

5. The traditional Chinese medicine composition according to claim 2, wherein The using method of the external patch is to remove the upper gauze patch of the external patch and apply it to the abdomen, covering the area from the Shenque acupoint to the Guanyuan acupoint and three inches lateral to the midline of the umbilicus.

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