A traditional Chinese medicine composition for nourishing yin, promoting blood circulation and preventing miscarriage

Abstract

The present invention discloses a traditional Chinese medicine composition for nourishing yin, activating blood circulation and preventing miscarriage, including an external plaster and an oral medicine. Among them, the external plaster is made from Taxillus chinensis, Dipsacus asper, Cuscuta chinensis, Codonopsis pilosula, Atractylodes macrocephala, stir-fried Dolichos lablab, Dioscorea opposita, Amomum villosum, Pueraria lobata, Dendrobium officinale, Angelica sinensis, Salvia miltiorrhiza, Paeonia suffruticosa, Ligusticum wallichii, Astragalus membranaceus, Olibanum, Myrrha, Angelica dahurica, Mentha haplocalyx, Glycyrrhiza uralensis, Zanthoxylum bungeanum in specific proportions. The oral medicine is made from Taxillus chinensis, Dipsacus asper, Cuscuta chinensis, Codonopsis pilosula, Atractylodes macrocephala, stir-fried Dolichos lablab, Dioscorea opposita, Amomum villosum, Pueraria lobata, Dendrobium officinale, Angelica sinensis, Salvia miltiorrhiza, Paeonia suffruticosa, Ligusticum wallichii in specific proportions. The present invention treats both the principal and secondary aspects of the disease by oral administration and external application on Yongquan acupoint, Xuehai acupoint and Zusanli acupoint, and has the effects of supplementing qi and nourishing blood, nourishing yin and promoting fluid production, activating blood circulation and removing stasis, and improving uterine blood supply during pregnancy. It is used for symptoms such as vaginal bleeding during pregnancy, five centers fever, dry mouth and throat, slow embryo development, red tongue or dark tongue with petechiae and ecchymoses, scanty tongue coating, thready, slippery and rapid pulse caused by deficiency of both qi and blood, deficiency of kidney yin, and qi stagnation and blood stasis.

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 nourishing yin, promoting blood circulation and preventing miscarriage. Background Art

[0002] In recent years, spontaneous abortion has become a common and frequently-occurring disease in obstetrics and gynecology. Its total incidence rate among women of childbearing age is approximately 15%. Therefore, early miscarriage prevention and fetal protection are particularly important. "Ye's Treatise on Women's Diseases" states: "During pregnancy, a woman entirely depends on blood for nourishment and qi for protection", indicating that once pregnancy occurs, it relies on the accumulation of qi and blood in the mother's body for nourishment. If the mother has qi deficiency, qi stagnation, blood deficiency or blood stasis, etc., it can all affect the growth and development of the fetus. Wang Qingren in the Qing Dynasty stated in "Corrections to Medical Writings, Volume II": "There are often cases of consecutive miscarriages... They don't know that there is already blood stasis in the uterus occupying its space. When the fetus grows to three months, there is no room for it to grow inside. The fetus gets sick due to crowding... Therefore, bleeding occurs first; since the blood doesn't enter the fetal sac, the fetus has no blood for nourishment, so miscarriage occurs", proposing that blood stasis can cause miscarriage. Blood stasis can be formed due to external pathogenic factors, internal injuries from the seven emotions, falls and injuries, etc. Blood stasis is both a pathogenic factor and a pathological product. After pregnancy, in order to supply the fetus, the body is often in a state of excessive qi and insufficient blood. When yin blood is insufficient, yin deficiency generates internal heat. The heat burns and injures yin fluid, and over time, blood stasis is formed. Blood stasis blocks the uterine cavity, making the fetal element unstable, resulting in local blood stasis and obstruction in the uterine cavity, poor blood circulation in the uterine collaterals, blood stasis remaining in the uterine cavity, and the fetus losing its nourishment. Eventually, it can lead to unstable fetal element or fetal atrophy and growth retardation, resulting in miscarriage. Therefore, the method of nourishing yin, promoting blood circulation and removing blood stasis is needed to prevent miscarriage.

[0003] Clinically, pregnant women with yin deficiency and blood stasis type may present with vaginal bleeding during pregnancy, either with or without bleeding, the color of the blood is bright red, accompanied by feverish sensation over the five centers (palms, soles and chest), dry mouth and throat, red tongue with petechiae or ecchymoses, scanty tongue coating, and thready, slippery and rapid pulse. The blood of pregnant women of this type often tends to be in an abnormally hypercoagulable state, which is highly consistent with the modern medical understanding of the prethrombotic state. The prethrombotic state refers to the deposition of fibrin in the local tissues of the placenta and uterus due to increased coagulation function and decreased fibrinolytic function, which changes the blood flow state of the placenta, forms microthrombi in the local tissues, affects the maternal-fetal material exchange, reduces the placental blood perfusion volume, decreases the placental blood supply capacity, and the fetus is in a state of hypoxia and ischemia, leading to miscarriage due to poor fetal development. Patients are prone to thrombosis, and it is also related to various adverse pregnancy outcomes such as recurrent miscarriage, hypertensive disorders in pregnancy, gestational diabetes mellitus, placental abruption, preterm birth, fetal growth restriction, stillbirth, etc. The causes of the prethrombotic state are divided into hereditary and acquired. The former is caused by genetic mutations related to coagulation and deficiency of related proteins, and the latter is mainly related to diseases that cause hypercoagulable states such as antiphospholipid syndrome, acquired hyperhomocysteinemia, and acquired activated protein C resistance. The auxiliary examinations carried out clinically for the prethrombotic state include: relevant gene examinations, D-dimer, anti-β2 glycoprotein antibody, platelet aggregation rate, lupus anticoagulant, antiphospholipid antibody, transvaginal B-ultrasound examination of uterine artery blood flow, etc. In early pregnancy, the blood supply of the uterine artery is crucial for the development of the embryo. The higher the pulsatility index (PI) and resistance index (RI) of the hemodynamic indexes of the uterine spiral artery blood flow, the higher the probability of inevitable miscarriage. Both blood stasis syndrome in traditional Chinese medicine and the prethrombotic state in modern medicine can cause hypercoagulable state of the blood. Whether the blood supply in the uterus is sufficient or not is closely related to the development of the embryo. The method of nourishing yin and activating blood circulation can improve the hypercoagulable state of the blood of pregnant women, reduce blood viscosity, reduce the resistance of the uterine artery, regulate the qi and blood circulation of the whole body, make the uterine blood supply sufficient, fully nourish the fetus, and improve the success rate of fetal protection. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for nourishing yin, activating blood circulation and preventing miscarriage. The present invention treats both the symptoms and root causes by oral administration and external application at Yongquan, Xuehai and Zusanli acupoints, and has the effects of supplementing qi and nourishing blood, nourishing yin and promoting fluid production, promoting blood circulation to remove blood stasis, and improving the uterine blood supply during pregnancy. It is used for symptoms such as vaginal bleeding during pregnancy, feverish sensation over the five centers, dry mouth and throat, slow embryo development, red or dark tongue with petechiae or ecchymoses, scanty tongue coating, and thready, slippery and rapid pulse caused by deficiency of both qi and blood, deficiency of kidney yin, and qi stagnation and blood stasis.

[0005] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0006] A traditional Chinese medicine composition for nourishing yin, activating blood circulation and preventing miscarriage, wherein the traditional Chinese medicine composition includes an external plaster traditional Chinese medicine composition and an oral traditional Chinese medicine composition;

[0007] Among them, the traditional Chinese medicine composition for external plaster is made of the following components in parts by weight: Taxillus sutchuenensis 15 - 30 parts, Dipsacus asperoides 15 - 30 parts, Cuscuta chinensis 15 - 30 parts, Codonopsis pilosula 15 - 30 parts, Atractylodes macrocephala 15 - 30 parts, stir-fried Dolichos lablab 15 - 30 parts, Dioscorea opposita 15 - 30 parts, Amomum villosum 6 - 12 parts, Pueraria lobata 15 - 30 parts, Dendrobium officinale 15 - 30 parts, Angelica sinensis 10 - 20 parts, Salvia miltiorrhiza 15 - 30 parts, Cortex Moutan 10 - 20 parts, Ligusticum wallichii 6 - 12 parts, Astragalus membranaceus 15 - 30 parts, Olibanum 15 - 30 parts, Myrrha 15 - 30 parts, Angelica dahurica 10 - 20 parts, Mentha haplocalyx 10 - 20 parts, Glycyrrhiza uralensis 6 - 12 parts, Zanthoxylum bungeanum 5 - 10 parts;

[0008] The oral traditional Chinese medicine composition is composed of the following components in parts by weight: Taxillus sutchuenensis 15 - 30 parts, Dipsacus asperoides 15 - 30 parts, Cuscuta chinensis 15 - 30 parts, Codonopsis pilosula 15 - 30 parts, Atractylodes macrocephala 15 - 30 parts, stir-fried Dolichos lablab 15 - 30 parts, Dioscorea opposita 15 - 30 parts, Amomum villosum 6 - 12 parts, Pueraria lobata 15 - 30 parts, Dendrobium officinale 15 - 30 parts, Angelica sinensis 10 - 20 parts, Salvia miltiorrhiza 15 - 30 parts, Cortex Moutan 10 - 20 parts, Ligusticum wallichii 6 - 12 parts.

[0009] Preferably, the external plaster is made of the following components in parts by weight: Taxillus sutchuenensis 20 parts, Dipsacus asperoides 20 parts, Cuscuta chinensis 20 parts, Codonopsis pilosula 20 parts, Atractylodes macrocephala 20 parts, stir-fried Dolichos lablab 20 parts, Dioscorea opposita 20 parts, Amomum villosum 8 parts, Pueraria lobata 20 parts, Dendrobium officinale 20 parts, Angelica sinensis 15 parts, Salvia miltiorrhiza 20 parts, Cortex Moutan 15 parts, Ligusticum wallichii 8 parts, Astragalus membranaceus 20 parts, Olibanum 20 parts, Myrrha 20 parts, Angelica dahurica 15 parts, Mentha haplocalyx 15 parts, Glycyrrhiza uralensis 8 parts, Zanthoxylum bungeanum 7 parts.

[0010] Preferably, the oral medicine is composed of the following components in parts by weight: Taxillus sutchuenensis 20 parts, Dipsacus asperoides 20 parts, Cuscuta chinensis 20 parts, Codonopsis pilosula 20 parts, Atractylodes macrocephala 20 parts, stir-fried Dolichos lablab 20 parts, Dioscorea opposita 20 parts, Amomum villosum 8 parts, Pueraria lobata 20 parts, Dendrobium officinale 20 parts, Angelica sinensis 15 parts, Salvia miltiorrhiza 20 parts, Cortex Moutan 15 parts, Ligusticum wallichii 8 parts.

[0011] Preferably, the production steps of the external plaster are as follows:

[0012] Weigh the Chinese medicinal materials according to the above components. After mixing the Chinese medicinal materials evenly, then crush them, and then pass through a 100 - 150 - mesh sieve to make fine powder. Add at least one of a small amount of honey, petrolatum, and acetic acid to the above fine powder, and stir well to mix into a paste to obtain the external plaster.

[0013] Preferably, the preparation steps of the oral medicine are as follows: Weigh each drug raw material according to the proportion, wash and grind them separately, then put all the ground drugs into a porcelain pot and mix them. Add 4 - 8 times the weight of water to soak the drugs, then heat and decoct for 30 - 60 minutes, and then filter to remove the residue to obtain the first decoction. Continue to put the filtered drug residue into the porcelain pot, add distilled water 4 - 8 times the total weight of the drugs to cover the drugs, bring the decoction to a boil over high heat, then simmer for 30 - 60 minutes, filter and pour out the second decoction. Mix the first obtained decoction with the second decoction to obtain the oral medicine.

[0014] The present invention also provides a method for using the external plaster in the pharmaceutical composition prepared by the above method. The method is: Apply acupoint application therapy, and stick the external plaster on the bilateral Yongquan, Xuehai, and Zusanli acupoints.

[0015] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for nourishing yin, promoting blood circulation and preventing miscarriage.

[0016] In the present invention, the properties and functions of the traditional Chinese medicines used are as follows:

[0017] Taxillus chinensis: It is the leafy stem branch of the small shrub Taxillus chinensis in the family Loranthaceae. It is sweet, pungent, bitter, and neutral in nature. It belongs to the liver and kidney meridians. It dispels wind-dampness, dredges meridians, supplements the liver and kidney, strengthens the tendons and bones, and prevents miscarriage.

[0018] Dipsacus asperoides: It is a perennial herb in the family Dipsacaceae. It supplements the liver, strengthens the tendons and bones, regulates the meridians, stops pain, prevents miscarriage, treats leucorrhea in women, generates fresh blood, breaks stasis, stops cough and hemoptysis, and treats red and white turbid urine.

[0019] Cuscuta chinensis: It is the mature seed of the annual parasitic twining herb Cuscuta chinensis in the family Convolvulaceae. It is sweet, astringent, and warm in nature. It belongs to the kidney, liver, and spleen meridians. It tonifies kidney yang, benefits kidney essence, improves eyesight, arrests seminal emission, reduces urination, stops leukorrhea, stops diarrhea, and prevents miscarriage.

[0020] Codonopsis pilosula: It is the root of the perennial herb Codonopsis pilosula in the family Campanulaceae. It is sweet and neutral in nature. It belongs to the spleen and lung meridians. It supplements the spleen and lung qi, promotes fluid production, and nourishes blood.

[0021] Atractylodes macrocephala: It is the rhizome of the perennial herb Atractylodes macrocephala in the family Asteraceae. It is sweet, bitter, and warm in nature. It belongs to the spleen and stomach meridians. It supplements spleen qi, dries dampness, promotes diuresis, stops sweating on the body surface, and prevents miscarriage.

[0022] Fried Dolichos lablab: Dolichos lablab is sweet in taste and belongs to the spleen and stomach meridians. It supplements the spleen without being greasy and eliminates dampness without being too drastic. It is used for general weakness and loose stools caused by dampness in the spleen deficiency, and can strengthen the function of strengthening the spleen and eliminating dampness.

[0023] Dioscorea opposita: It is the rhizome of the perennial trailing herb Dioscorea opposita in the family Dioscoreaceae. It is sweet and neutral in nature. It belongs to the spleen, lung, and kidney meridians. It supplements the qi of the spleen, lung, and kidney, and benefits the yin of the spleen, lung, and kidney.

[0024] Amomum villosum: The dried ripe fruit of the herbaceous plant Amomum villosum Lour. or Amomum longiligulare T. L. Wu of the Zingiberaceae family. Pungent in flavor and warm in nature. It acts on the spleen and stomach meridians. It can promote digestion, regulate qi flow, warm the middle-jiao, and stop vomiting.

[0025] Pueraria lobata: The dried root of the leguminous plant Pueraria lobata (Willd.) Ohwi. It is dry. Sweet, pungent, and cool in nature. It has the functions of relieving muscle fever, promoting eruption, promoting fluid production to quench thirst, ascending yang to stop diarrhea, dredging channels and collaterals, and detoxifying alcohol.

[0026] Dendrobium officinale: It acts on the stomach and kidney meridians, sweet in flavor and slightly cold in nature. It can clear the stomach and promote fluid production, nourish yin and clear heat. Modern pharmacology shows that it has pharmacological effects such as anti-tumor, anti-inflammatory, antioxidant, and hypoglycemic effects.

[0027] Angelica sinensis: A perennial herbaceous plant of the genus Angelica in the Apiaceae family. It acts on the liver, heart, and spleen meridians, sweet and pungent in flavor and warm in nature. It has the effects of tonifying blood, promoting blood circulation, moistening the intestines and facilitating defecation.

[0028] Salvia miltiorrhiza: Bitter in flavor and slightly cold in nature. It has the functions of promoting blood circulation to remove blood stasis and calming the mind. Modern pharmacology shows that it has the effects of improving myocardial ischemia, improving microcirculation, antiplatelet aggregation, reducing blood lipid, enhancing myocardial contractility, and scavenging free radicals in the ischemic area.

[0029] Moutan cortex: The root bark of the peony plant Paeonia suffruticosa Andr. of the Paeoniaceae family. Pungent and bitter in flavor and cool in nature. It has the functions of clearing heat, cooling blood, harmonizing blood, and removing stasis. It is used to treat heat invading the blood system, hematemesis, and traumatic injuries.

[0030] Ligusticum chuanxiong: The rhizome of the perennial herbaceous plant Ligusticum chuanxiong Hort. of the Apiaceae family. Pungent in flavor and warm in nature. It acts on the heart and liver meridians. It has the effects of promoting blood circulation and qi movement, dispelling wind and relieving pain.

[0031] Astragalus membranaceus: Sweet in flavor and slightly warm in nature. It has the effects of tonifying qi and consolidating the exterior, promoting diuresis, strengthening the heart, reducing blood pressure, antibacterial, expelling toxins, discharging pus, promoting granulation, tonifying qi and ascending yang, consolidating the exterior to stop sweating, promoting diuresis and relieving edema, promoting fluid production and nourishing blood, promoting qi movement and dredging collaterals, expelling toxins and discharging pus, and astringing sores and promoting granulation.

[0032] Olibanum: Pungent, bitter, and warm in nature. It acts on the heart, liver, and spleen meridians. It can promote blood circulation, regulate qi flow to relieve pain, reduce swelling and promote granulation, and stretch tendons.

[0033] Myrrh: Bitter, pungent, and neutral in flavor. It enters the liver, spleen, heart, and kidney meridians. It has the effects of promoting blood circulation to relieve pain, reducing swelling and promoting granulation.

[0034] Angelica dahurica: Warm in nature and pungent in flavor. It acts on the stomach, large intestine, and lung meridians. It can relieve exterior cold, dispel wind and relieve pain, dredge nasal orifices, dry dampness and arrest leukorrhea, reduce swelling and discharge pus. Modern pharmacology shows that it has anti-inflammatory, antioxidant, antispasmodic, and shortening coagulation time effects.

[0035] Mentha haplocalyx Briq.: Pungent in flavor and cool in nature. It enters the lung and liver meridians. It can disperse wind-heat, clear the head and eyes, soothe the throat, promote eruption, and soothe the liver and regulate qi. Modern pharmacology shows that it can be used as a transdermal enhancer.

[0036] Glycyrrhiza uralensis Fisch.: Sweet in flavor and neutral in nature. It enters the twelve meridians. It has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, moistening the lungs and relieving cough.

[0037] Zanthoxylum bungeanum: pungent in taste and warm in nature. It acts on the spleen, stomach and kidney meridians. It can warm the middle-jiao to stop pain, kill parasites and relieve itching, and can increase transdermal absorption when used externally.

[0038] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0039] (1) In the present invention, Taxillus chinensis (DC.) Danser, Dipsacus asperoides C. Y. Cheng et T. M. Ai, and Cuscuta chinensis Lam. are used to tonify the liver and kidney to prevent miscarriage and nourish the prenatal endowment; Codonopsis pilosula (Franch.) Nannf., Atractylodes macrocephala Koidz., Dolichos lablab L. var. semen, Dioscorea opposita Thunb., and Amomum villosum Lour. are used to invigorate the spleen and replenish qi to cultivate the postnatal endowment and promote the absorption of drugs and foods in the gastrointestinal tract; the prenatal and postnatal endowments complement each other; Adenophora stricta Miq., Ophiopogon japonicus (Thunb.) Ker-Gawl., Pueraria lobata (Willd.) Ohwi, and Dendrobium nobile Lindl. are used to nourish yin and promote the production of body fluid; Angelica sinensis (Oliv.) Diels, Salvia miltiorrhiza Bunge, Paeonia suffruticosa Andr., and Ligusticum wallichii Franch. are used to promote blood circulation to remove blood stasis and improve the blood supply of uterine arteries; Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav., Mentha haplocalyx Briq., and Zanthoxylum bungeanum are used for their aromatic properties to promote transdermal absorption.

[0040] (2) The traditional Chinese medicine composition of the present invention includes two parts: an external plaster and an internal traditional Chinese medicine. Its drug compatibility is scientific and reasonable. The external medicine is applied to the Yongquan, Xuehai, and Zusanli acupoints, which can nourish yin and activate blood circulation and promote blood circulation; the internal medicine can tonify the kidney and strengthen the spleen, nourish yin and activate blood circulation. The method of nourishing yin and activating blood circulation can significantly improve the hypercoagulable state of the blood of pregnant women with yin deficiency and blood stasis, reduce blood viscosity, reduce the resistance of uterine arteries, and thus reduce the probability of miscarriage. At the same time, by improving the regulation of the overall qi and blood circulation of pregnant women, the blood flow supply in the uterus is abundant, the fetus is fully nourished, and the success rate of fetal protection is improved.

[0041] (3) The traditional Chinese medicine composition of the present invention has the effects of replenishing qi and nourishing blood, nourishing yin and promoting the production of body fluid, promoting blood circulation to remove blood stasis, and improving the blood supply of the uterus during pregnancy. It is used for symptoms such as vaginal bleeding during pregnancy, restlessness of the five centers, dry mouth and throat, slow embryo development, red tongue or dark tongue with petechiae and ecchymoses, less tongue coating, and thready, slippery and rapid pulse caused by deficiency of both qi and blood, deficiency of kidney yin, and qi stagnation and blood stasis. Detailed implementation mode

[0042] In order to enable those skilled in the art of the present technology to better understand the technical solution of the present invention, the technical solution in the embodiment of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0043] 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 illustrated or 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 does not necessarily have to 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.

[0044] Example 1

[0045] A traditional Chinese medicine composition for nourishing yin, activating blood circulation and preventing miscarriage, comprising an external plaster and an oral medicine.

[0046] The external plaster is made of the following components by weight: 15 parts of Taxillus chinensis, 15 parts of Dipsacus asperoides, 15 parts of Cuscuta chinensis, 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 15 parts of stir-fried Dolichos lablab, 15 parts of Dioscorea opposita, 6 parts of Amomum villosum, 15 parts of Pueraria lobata, 15 parts of Dendrobium officinale, 10 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 10 parts of Paeonia suffruticosa, 6 parts of Ligusticum chuanxiong, 15 parts of Astragalus membranaceus, 15 parts of Olibanum, 15 parts of Myrrha, 10 parts of Angelica dahurica, 10 parts of Mentha haplocalyx, 6 parts of Glycyrrhiza uralensis, 5 parts of Zanthoxylum bungeanum.

[0047] The oral medicine is composed of the following components by weight: 15 parts of Taxillus chinensis, 15 parts of Dipsacus asperoides, 15 parts of Cuscuta chinensis, 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 15 parts of stir-fried Dolichos lablab, 15 parts of Dioscorea opposita, 6 parts of Amomum villosum, 15 parts of Pueraria lobata, 15 parts of Dendrobium officinale, 10 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 10 parts of Paeonia suffruticosa, 6 parts of Ligusticum chuanxiong.

[0048] The preparation method of the above external plaster is as follows: Weigh the Chinese medicinal materials according to the above components. After mixing the Chinese medicinal materials evenly, crush them, and then pass through a 100-mesh sieve to make fine powder. Add a small amount of honey to the above fine powder, stir well to mix into a paste, and then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch to obtain the external plaster.

[0049] The preparation method of the above oral medicine is as follows: Weigh each drug raw material according to the ratio, wash and grind them respectively, and then put all the ground drugs into a porcelain jar and mix them. Add 6 times the weight of water to soak the drugs and cover them. Then heat and decoct for 45 minutes, and then filter to remove the residue to obtain the first decoction. Continue to put the filtered drug residues into the porcelain jar, add distilled water 4 times the total weight of the drugs to cover the drugs, bring the decoction to a boil over high heat, and then decoct over low heat for 30 minutes. Filter and pour out the second decoction. Mix the first obtained decoction with the second decoction to obtain the oral medicine.

[0050] Example 2

[0051] A traditional Chinese medicine composition for nourishing yin, promoting blood circulation and preventing miscarriage, comprising an external plaster and an oral medicine.

[0052] The external plaster is composed of the following components in parts by weight: 30 parts of Taxillus sutchuenensis, 30 parts of Dipsacus asperoides, 30 parts of Cuscuta chinensis, 30 parts of Codonopsis pilosula, 30 parts of Atractylodes macrocephala, 30 parts of stir-fried Dolichos lablab, 30 parts of Dioscorea opposita, 12 parts of Amomum villosum, 30 parts of Pueraria lobata, 30 parts of Dendrobium officinale, 20 parts of Angelica sinensis, 30 parts of Salvia miltiorrhiza, 20 parts of Paeonia suffruticosa, 12 parts of Ligusticum chuanxiong, 30 parts of Astragalus membranaceus, 30 parts of Olibanum, 30 parts of Myrrha, 20 parts of Angelica dahurica, 20 parts of Mentha haplocalyx, 12 parts of Glycyrrhiza uralensis, 10 parts of Zanthoxylum bungeanum.

[0053] The oral medicine is composed of the following components in parts by weight: 30 parts of Taxillus sutchuenensis, 30 parts of Dipsacus asperoides, 30 parts of Cuscuta chinensis, 30 parts of Codonopsis pilosula, 30 parts of Atractylodes macrocephala, 30 parts of stir-fried Dolichos lablab, 30 parts of Dioscorea opposita, 12 parts of Amomum villosum, 30 parts of Pueraria lobata, 30 parts of Dendrobium officinale, 20 parts of Angelica sinensis, 30 parts of Salvia miltiorrhiza, 20 parts of Paeonia suffruticosa, 12 parts of Ligusticum chuanxiong.

[0054] The preparation method of the above external plaster is as follows: Weigh the Chinese medicinal materials according to the above components, stir the Chinese medicinal materials evenly, then crush them, and then pass through a 150-mesh sieve to make fine powder. Add a small amount of petrolatum to the above fine powder, stir well and mix evenly into a paste, and then evenly coat the paste-like traditional Chinese medicine composition on a gauze patch to obtain the external plaster.

[0055] The preparation method of the above oral medicine is as follows: Weigh each drug raw material according to the ratio, wash and grind and crush them respectively, then put all the ground and crushed drugs into a porcelain pot and mix them. Add 5 times the weight of water of the drugs to soak and cover the drugs, then heat and decoct for 60 minutes, and then filter to remove the residue to obtain the first medicinal liquid; continue to put the filtered drug residue into the porcelain pot, add distilled water 4 times the total weight of the drugs to cover the drugs, bring the medicinal liquid to a boil over high heat, then decoct over low heat for 40 minutes, filter and pour out the second medicinal liquid, and mix the first obtained medicinal liquid with the second medicinal liquid to obtain the oral medicine.

[0056] Example 3

[0057] A traditional Chinese medicine composition for nourishing yin, promoting blood circulation and preventing miscarriage, comprising an external plaster and an oral medicine.

[0058] The external plaster is composed of the following components in parts by weight: 22 parts of Taxillus sutchuenensis, 22 parts of Dipsacus asperoides, 22 parts of Cuscuta chinensis, 22 parts of Codonopsis pilosula, 22 parts of Atractylodes macrocephala, 22 parts of stir-fried Dolichos lablab, 22 parts of Dioscorea opposita, 9 parts of Amomum villosum, 22 parts of Pueraria lobata, 22 parts of Dendrobium officinale, 15 parts of Angelica sinensis, 22 parts of Salvia miltiorrhiza, 15 parts of Paeonia suffruticosa, 9 parts of Ligusticum chuanxiong, 22 parts of Astragalus membranaceus, 22 parts of Olibanum, 22 parts of Myrrha, 15 parts of Angelica dahurica, 15 parts of Mentha haplocalyx, 9 parts of Glycyrrhiza uralensis, 7 parts of Zanthoxylum bungeanum.

[0059] The oral medicine described above is composed of the following components by weight: 22 parts of Taxillus sutchuenensis, 22 parts of Dipsacus asperoides, 22 parts of Cuscuta chinensis, 22 parts of Codonopsis pilosula, 22 parts of Atractylodes macrocephala, 22 parts of stir-fried Dolichos lablab, 22 parts of Dioscorea opposita, 9 parts of Amomum villosum, 22 parts of Pueraria lobata, 22 parts of Dendrobium officinale, 15 parts of Angelica sinensis, 22 parts of Salvia miltiorrhiza, 15 parts of Paeonia suffruticosa, and 9 parts of Ligusticum chuanxiong.

[0060] The preparation method of the above-mentioned external plaster is as follows: Weigh the Chinese medicinal materials according to the above components. After stirring the Chinese medicinal materials evenly, crush them, and then pass through a 125-mesh sieve to make fine powder. Add a small amount of acetic acid to the above fine powder, stir well and mix evenly to form a paste. Then evenly coat the paste-like traditional Chinese medicine composition on the gauze patch to obtain the external plaster.

[0061] The preparation method of the above-mentioned oral medicine is as follows: Weigh each drug raw material according to the proportion, wash and grind them separately, and then put all the ground and broken drugs into a porcelain jar for mixing. Add 6 times the weight of water to soak the drugs and cover them. Then heat and decoct for 60 minutes, and then filter to remove the residue to obtain the first medicinal liquid; continue to put the filtered drug residues into the porcelain jar, add distilled water 5 times the total weight of the drugs to cover the drugs, bring the medicinal liquid to a boil over high heat, and then decoct over low heat for 45 minutes. Filter and pour out the second medicinal liquid. Mix the first obtained medicinal liquid with the second medicinal liquid to obtain the oral medicine.

[0062] Clinical trials

[0063] Case selection: Select patients who received nourishing yin and activating blood circulation for fetal protection treatment in Hubei Maternal and Child Health Hospital from October 2020 to October 2022. Observe 90 patients undergoing treatment, with 30 patients in each group, divided into groups A, B, and C.

[0064] For the general data of the three groups of patients in terms of age, average number of miscarriages, average miscarriage and current gestational weeks, after statistical analysis, the differences were not statistically significant (all P>0.05), and the groups were comparable. See Table 1 for details.

[0065]

[0066] The comparison between the three groups showed P>0.05, with no significant differences and no statistical significance. It indicates that the two 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 opened and the size of the uterus is consistent with the number of weeks of amenorrhea; ③ B-ultrasound examination shows that the size of the uterus, the gestational sac, embryo or fetus is consistent with the gestational week.

[0068] (1) Inclusion criteria: ① Meet the diagnostic criteria for threatened abortion in early pregnancy; ② Subchorionic hematoma on B-ultrasound examination; ③ Age 20–40 years old; ④ Voluntary to accept the treatment in this trial, no major diseases of the heart, liver, kidney or 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, toxoplasmosis, or herpes simplex virus; ③ Those with severe anemia, heart failure, chronic nephritis, hypertension, diabetes, or systemic infection such as high fever; ④ Those with uterine malformation, uterine fibroids, or adenomyosis; ⑤ Those with untreated intrauterine adhesions, intrauterine effusions, endometrial polyps, or endometrial hyperplasia; ⑥ Those with mental illness; ⑦ Those who cannot adhere to the course of treatment.

[0070] 3. Treatment methods:

[0071] Group A: Treatment started from the time of consultation, using the oral medication described in the example, taken with water, 1 dose 1 day, taken twice, and the patients were advised to pay attention to rest and adjust their mood. One month of continuous use was a course of treatment.

[0072] Group B: The patients were in supine or sitting position, and the external plaster prepared in Example 1 was applied to the acupoints of Yongquan, Xuehai and Zusanli. One month of continuous use was regarded as one course of treatment.

[0073] Group C: Treatment started from the time of consultation, with a combination of oral medication and external plaster in Example 1. Oral medication was taken orally, 1 dose 1 day, taken twice, and acupoint application therapy was applied, with external plaster applied to Yongquan, Xuehai, and Zusanli acupoints, and one month of continuous use was a course of treatment.

[0074] 4. Efficacy evaluation: (1) Color ultrasound examination: The ultrasound instrument used was a GE Voluson 730 three-dimensional color Doppler ultrasound instrument with an abdominal probe frequency of 3.5MHz. A specialist doctor performed transvaginal color Doppler ultrasound to measure the bilateral uterine arteries of the patients before treatment, 10 days after treatment, 15 days after treatment, and 20 days after treatment. (2) SPSS 22.0 statistical software was used for data analysis. Normality and variance homogeneity tests were first performed. Normally distributed quantitative data were expressed as mean ± standard deviation (x-±s). The comparison between the two groups was performed using the t-test of two independent samples. The comparison before and after treatment within the group was performed using the paired sample t-test. The non-parametric rank sum test was used for non-normal distribution. The rank sum test was used for clinical efficacy comparison, and the X-test was used for enumeration data comparison. P < 0.05 was considered statistically significant.

[0075] 5. Treatment results:

[0076] (1) Comparison of the uterine artery blood flow resistance index (RI) on the left and right sides of 3 groups of patients in groups A, B, and C before treatment, 10 days, 15 days, and 20 days after treatment.

[0077]

[0078] As shown in the above table, the combined application of the oral medicine and external plaster of the present invention has significant curative effects, and the treatment effect is better than that of using only oral medicine or only external plaster alone.

[0079] (2) The clinical efficacy evaluation criteria refer to the following guiding principles

[0080] Cured: Vaginal bleeding stops after 5 days of treatment, lower abdominal pain disappears, and gynecological color Doppler ultrasound examination shows that the size of the uterus and the embryonic development are consistent with the gestational week, and the fetal development is normal;

[0081] Markedly effective: Vaginal bleeding stops after 7 days of treatment, lower abdominal pain is significantly reduced, and gynecological color Doppler ultrasound examination shows that the size of the uterus and the embryonic development are consistent with the gestational week, and the fetal development is normal;

[0082] Effective: Vaginal bleeding stops after 10 days of treatment, lower abdominal pain is somewhat reduced, and gynecological color Doppler ultrasound examination shows that the size of the uterus and the embryonic development are basically consistent with the gestational week;

[0083] Ineffective: Vaginal bleeding does not stop after 10 days of treatment, lower abdominal pain during menstruation has no obvious improvement, and gynecological color Doppler ultrasound examination shows that the size of the uterus and the embryonic development are basically consistent with the gestational week or smaller than the gestational week, and the embryonic development is poor or has stopped developing.

[0084] Table 3 shows the comparison results of the curative effects of the above three groups A, B, and C

[0085]

[0086] (3) Comparison of the pregnancy outcomes of 3 groups of patients, see Table 3 below

[0087] Table 3 Comparison of the pregnancy outcomes of 3 groups of patients

[0088] Group n Abortion Premature birth Full-term delivery Gestational age of abortion Gestational age of delivery Group A 30 3 2 25 10.7±1.5 38.0±1.2 Group B 30 5 4 21 10.3±2.0 38.6±1.5 Group C 30 1 1 28 11.2±1.5 38.9±1.2

[0089] From the above results, it can be seen that the combined application of the oral medicine and external plaster prepared by the present invention has significant curative effects, has the effects of nourishing yin and promoting fluid production, promoting blood circulation and removing blood stasis, and is of great significance for the treatment of threatened abortion.

[0090] The above is only a preferred specific embodiment 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 nourishing yin, promoting blood circulation and preventing miscarriage, characterized in that, The described traditional Chinese medicine composition is composed of an external plaster traditional Chinese medicine composition and an internal administration traditional Chinese medicine composition; Among them, the external plaster traditional Chinese medicine composition is made of the following components in parts by weight: 15-30 parts of Taxillus sutchuenensis, 15-30 parts of Dipsacus asperoides, 15-30 parts of Cuscuta chinensis, 15-30 parts of Codonopsis pilosula, 15-30 parts of Atractylodes macrocephala, 15-30 parts of stir-fried Dolichos lablab, 15-30 parts of Dioscorea opposita, 6-12 parts of Amomum villosum, 15-30 parts of Pueraria lobata, 15-30 parts of Dendrobium officinale, 10-20 parts of Angelica sinensis, 15-30 parts of Salvia miltiorrhiza, 10-20 parts of Paeonia suffruticosa, 6-12 parts of Ligusticum chuanxiong, 15-30 parts of Astragalus membranaceus, 15-30 parts of Olibanum, 15-30 parts of Myrrh, 10-20 parts of Angelica dahurica, 10-20 parts of Mentha haplocalyx, 6-12 parts of Glycyrrhiza uralensis, 5-10 parts of Zanthoxylum bungeanum; The internal administration traditional Chinese medicine composition is made of the following components in parts by weight: 15-30 parts of Taxillus sutchuenensis, 15-30 parts of Dipsacus asperoides, 15-30 parts of Cuscuta chinensis, 15-30 parts of Codonopsis pilosula, 15-30 parts of Atractylodes macrocephala, 15-30 parts of stir-fried Dolichos lablab, 15-30 parts of Dioscorea opposita, 6-12 parts of Amomum villosum, 15-30 parts of Pueraria lobata, 15-30 parts of Dendrobium officinale, 10-20 parts of Angelica sinensis, 15-30 parts of Salvia miltiorrhiza, 10-20 parts of Paeonia suffruticosa, 6-12 parts of Ligusticum chuanxiong.

2. The traditional Chinese medicine composition according to claim 1, wherein, The described external plaster is made of the following components in parts by weight: 20 parts of Taxillus sutchuenensis, 20 parts of Dipsacus asperoides, 20 parts of Cuscuta chinensis, 20 parts of Codonopsis pilosula, 20 parts of Atractylodes macrocephala, 20 parts of stir-fried Dolichos lablab, 20 parts of Dioscorea opposita, 8 parts of Amomum villosum, 20 parts of Pueraria lobata, 20 parts of Dendrobium officinale, 15 parts of Angelica sinensis, 20 parts of Salvia miltiorrhiza, 15 parts of Paeonia suffruticosa, 8 parts of Ligusticum chuanxiong, 20 parts of Astragalus membranaceus, 20 parts of Olibanum, 20 parts of Myrrh, 15 parts of Angelica dahurica, 15 parts of Mentha haplocalyx, 8 parts of Glycyrrhiza uralensis, 7 parts of Zanthoxylum bungeanum.

3. The traditional Chinese medicine composition according to claim 1, wherein The internal administration traditional Chinese medicine composition is made of the following components in parts by weight: 20 parts of Taxillus sutchuenensis, 20 parts of Dipsacus asperoides, 20 parts of Cuscuta chinensis, 20 parts of Codonopsis pilosula, 20 parts of Atractylodes macrocephala, 20 parts of stir-fried Dolichos lablab, 20 parts of Dioscorea opposita, 8 parts of Amomum villosum, 20 parts of Pueraria lobata, 20 parts of Dendrobium officinale, 15 parts of Angelica sinensis, 20 parts of Salvia miltiorrhiza, 15 parts of Paeonia suffruticosa, 8 parts of Ligusticum chuanxiong.

4. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The manufacturing steps of the external plaster traditional Chinese medicine composition are as follows: Weigh the Chinese medicinal materials according to the above components, mix the Chinese medicinal materials evenly and then crush them, and then pass through a 100-150 mesh sieve to make fine powder. After that, add at least one of a small amount of honey, vaseline, and acetic acid to the above fine powder, stir well and mix evenly into a paste, and then evenly coat the paste-like traditional Chinese medicine composition on the gauze patch to obtain the external plaster.

5. The traditional Chinese medicine composition according to claim 1 or 3, characterized in that The preparation steps of the internal administration traditional Chinese medicine composition are as follows: Weigh each drug raw material according to the ratio, wash and grind and crush them respectively, and then put all the ground and crushed drugs into a porcelain jar and mix them. Add 4-8 times the weight of water to soak the drugs and cover them, then heat and decoct for 30-60 minutes, and then filter to remove the residue to obtain the first decoction; continue to put the filtered drug residue into the porcelain jar, add distilled water according to 4-8 times the total weight of the drugs to cover the drugs, bring the decoction to a boil over high heat, and then decoct over low heat for 30-60 minutes, filter and pour out the second decoction, and mix the first obtained decoction with the second decoction to obtain the internal administration traditional Chinese medicine composition.

6. The traditional Chinese medicine composition according to claim 4, wherein The usage method of the external plaster is as follows: Apply acupoint application therapy, and apply the external plaster at the bilateral Yongquan, Xuehai, and Zusanli acupoints.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a drug for nourishing yin, promoting blood circulation and preventing miscarriage.

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