A traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus

Abstract

The application discloses a traditional Chinese medicine composition for tonifying kidney, promoting blood circulation and nourishing fetus, which comprises an external ointment and an internal medicine, wherein the external ointment is prepared from specific proportion of taxilli herba, rhizoma discontinu, semen euryales, radix codonopsis, rhizoma atractylodis, fried lentil, rhizoma dioscoreae, amomum villosum, radix puerariae, dendrobium, angelica sinensis, salvia miltiorrhiza, cortex moutan, chuanxiong rhizome, radix astragali, frankincense, myrrh, radix angelicae, and zanthoxylum bungeanum; and the internal medicine is prepared from specific proportion of semen euryales, cornus officinalis, ligustrum lucidum, eucommia ulmoides, taxilli herba, fried radix atractylodis, rhizoma discontinu, amomum villosum, radix codonopsis, rhizoma cimicifugae, herba agastache, radix puerariae, dendrobium, angelica sinensis, salvia miltiorrhiza, cortex moutan, radix notoginseng and radix ophiopogonis. The application can treat the root and branch by oral administration and external application on blood sea, yinlingquan and san yin jiao, has the effects of benefiting qi and blood, nourishing yin and promoting blood circulation, and can improve the blood supply of uterus during pregnancy, and is used for treating the symptoms of vaginal bleeding during pregnancy, slow embryo development, less moss and fine and smooth pulse caused by deficiency of qi and blood, deficiency of kidney yin and stagnation of qi and blood.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus. BACKGROUND

[0002] In recent years, spontaneous abortion has become a common and frequently-occurring disease in obstetrics, and its total incidence in women of gestational age is about 15%, so early fetus nourishment and abortion prevention are particularly important. It is stated in Yeshi Gynecological Disease and Treatment that “women have pregnancy, and rely on blood to nourish and qi to protect”, which points out that the fetus relies on the accumulation of qi and blood in the mother to be nourished, and if the mother has qi deficiency, qi stagnation or blood deficiency and blood stasis, etc., the fetus growth and development can be affected. In the Medical Linian Gaizuo (Volume 2), Wang Qingren stated that “there are often several fetuses injured, …… do not know that there is blood stasis in the uterus, and the fetus is crowded out of the place when it grows to three months, and the fetus is sick and crowded out…… so see blood first; blood does not enter the fetus, and the fetus is not nourished, so there is abortion”, which proposes that blood stasis can cause abortion. Blood stasis can be caused by exogenous pathogenic factors, internal injury of seven emotions, and injury from falling and bumping, etc., and blood stasis is both a pathogenic factor and a pathological product. At the same time, the main causes of fetal leakage and fetal movement instability are kidney deficiency, qi deficiency and blood deficiency, which make the chong and ren not firm, the fetus lose the connection, the fetus lose the load, and the fetus lose the nourishment, among which kidney deficiency is the most common cause. Female pregnancy, kidney and chong and ren two pulses are the key, the root of chong and ren is in the kidney, and if the kidney essence is insufficient, the chong and ren will not be firm. Blood stasis in the uterus can cause the fetus to be not firm, resulting in local blood stasis and obstruction in the uterus, poor blood circulation in the uterus, blood stasis in the uterus, and the fetus losing the nourishment, which can eventually cause the fetus to be not firm or the fetus to be not long and abortion, so the method of tonifying kidney, activating blood and removing blood stasis is needed to nourish the fetus.

[0003] The pregnant women of kidney deficiency and blood stasis type can clinically show that there is or is not vaginal bleeding during pregnancy, the color is bright red, the waist is sour, the waist is painful, the mouth is dry and the throat is dry, the tongue is red with blood spots or blood blots, the tongue is less and the pulse is thin and smooth, etc. The blood of this type of pregnant women is often in an abnormal high coagulation state, which is highly consistent with the cognition of pre-thrombotic state in modern medicine. The pre-thrombotic state refers to that due to abnormal increase of coagulation function and decrease of fibrinolysis function, fibrin is deposited in the placenta and local tissues of the uterus, the blood flow state of the placenta is changed, microthrombosis is formed in the local tissues, the exchange of maternal and fetal materials is affected, the placental blood perfusion volume is reduced, the placental blood supply capacity is reduced, the fetus is in a state of hypoxia and ischemia, leading to miscarriage due to poor development of the fetus. Patients are prone to thrombosis, and are also related to many adverse pregnancy outcomes such as recurrent miscarriage, gestational hypertension disease, gestational diabetes, placental abruption, premature delivery, fetal growth restriction, stillbirth and the like. The causes of pre-thrombotic state are hereditary and acquired. The former is caused by mutation of coagulation related genes and deficiency of related proteins, and the latter is mainly related to diseases that cause high coagulation state such as anti-cardiolipin syndrome, acquired hyperhomocysteinemia, acquired active protein C resistance and the like. The auxiliary examinations carried out clinically for the pre-thrombotic state include: related gene examination, D-dimer, anti-beta 2 protein antibody, platelet aggregation rate, lupus anticoagulant, anti-cardiolipin antibody, vaginal B-ultrasound examination of uterine artery blood flow and the like. In early pregnancy, the blood supply of uterine artery is crucial to the development of embryo, the higher the pulsatility index (PI) and resistance index (RI) of uterine spiral artery hemodynamics index, the higher the probability of inevitable abortion. Blood stasis syndrome and pre-thrombotic state in modern medicine can both cause high blood coagulation state, and whether the blood flow supply in the uterus is sufficient is closely related to the development of embryo. The method of tonifying kidney and activating blood can improve the high blood coagulation state of pregnant women, reduce the blood viscosity, reduce the resistance of uterine artery, regulate the running of qi and blood in the whole body, make the blood supply of uterus sufficient, fully nourish the fetus, and improve the success rate of tocolysis. SUMMARY

[0004] The purpose of the present application is to provide a traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus. The present application treats the symptoms and the root cause by oral administration and external application of Xuehai, Yinlingquan and Sanyinjiao, has the effects of benefiting qi and blood, nourishing yin and generating fluid, activating blood and removing blood stasis, and is used for treating pregnancy vaginal bleeding, five heart heat, dry mouth and throat, slow embryo development, tongue red or tongue dark with blood spots and blood blots, less tongue and thin and smooth pulse caused by deficiency of both qi and blood, deficiency of kidney yin and stagnation of qi and blood.

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

[0006] A traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus, which is composed of an external ointment and an oral medicine.

[0007] The external ointment patch is made of the following components by weight: Morinda 15-30 parts, Dipsacus 15-30 parts, Semen Nelumbinis 15-30 parts, Codonopsis 15-30 parts, Fried Mung Beans 15-30 parts, Yam 15-30 parts, Amomum 6-12 parts, Pueraria 15-30 parts, Dendrobium 15-30 parts, Angelica 10-20 parts, Salvia 15-30 parts, Danpi 10-20 parts, Chuanxiong 6-12 parts, Astragalus 15-30 parts, Olibanum 15-30 parts, Baizhi 10-20 parts, Mint 10-20 parts, Licorice 6-12 parts, Zanthoxylum 5-10 parts;

[0008] The internal medicine is composed of the following components by weight: Semen Nelumbinis 15-30 parts, Cornus 15-30 parts, Ligustri 15-30 parts, Eucommia 15-30 parts, Morinda 15-30 parts, Fried Mung Beans 15-30 parts, Dipsacus 15-30 parts, Amomum 15-30 parts, Codonopsis 15-30 parts, Cimicifuga 10-20 parts, Agrimonia 20-40 parts, Pueraria 15-30 parts, Dendrobium 15-30 parts, Angelica 10-20 parts, Salvia 15-30 parts, Danpi 10-20 parts, South Adenosma 15-30 parts, Ophiopogon 15-30 parts.

[0009] The external ointment patch is made of the following components by weight: Morinda 15 parts, Dipsacus 15 parts, Semen Nelumbinis 15 parts, Codonopsis 15 parts, Fried Mung Beans 15 parts, Yam 15 parts, Amomum 6 parts, Pueraria 15 parts, Dendrobium 15 parts, Angelica 10 parts, Salvia 15 parts, Danpi 10 parts, Chuanxiong 6 parts, Astragalus 15 parts, Olibanum 15 parts, Baizhi 10 parts, Mint 10 parts, Licorice 6 parts, Zanthoxylum 5 parts.

[0010] The internal medicine is composed of the following components by weight: Semen Nelumbinis 15 parts, Cornus 15 parts, Ligustri 15 parts, Eucommia 15 parts, Morinda 15 parts, Fried Mung Beans 15 parts, Dipsacus 15 parts, Amomum 15 parts, Codonopsis 15 parts, Cimicifuga 10 parts, Agrimonia 20 parts, Pueraria 15 parts, Dendrobium 15 parts, Angelica 10 parts, Salvia 15 parts, Danpi 10 parts, South Adenosma 15 parts, Ophiopogon 15 parts.

[0011] The preparation steps of the external ointment patch are as follows:

[0012] The traditional Chinese medicinal materials are weighed according to the above components, mixed uniformly, crushed, and then sieved through a 100-180 mesh screen to form fine powder. Then, at least one of honey, vaseline, and acetic acid is added to the fine powder, and the mixture is stirred and mixed uniformly to form an ointment. The ointment is then uniformly coated on gauze to obtain the external ointment patch.

[0013] The preparation steps of the oral medicine are as follows: proportionally weighing each medicinal material raw material, washing and grinding respectively, then putting all the ground medicinal materials into a multifunctional extraction tank to decoct twice with water, adding 5-8 times of water of the total medicinal materials to soak for 30-60 minutes in the first time, decocting for 1-2 hours, taking the decoction, and filtering; adding 4-6 times of water of the total amount in the second time, decocting for 1-1.5 hours, taking the two times of decoction, mixing, and filtering; putting the filtered filtrate into a double-effect vacuum concentrator to concentrate into a concentrated liquid, putting the concentrated liquid into low-temperature refrigeration at 0-5 DEG C for 24 hours; adding filter aid diatomite to the concentrated liquid after refrigeration, filtering, putting the filtrate into a double-effect vacuum concentrator to concentrate to 1g of medicinal material per 1ml, drying into powder, and then blending with honey or dextrin to prepare granules, so that the oral medicine is obtained.

[0014] The use method of the external ointment is as follows: applying acupoint application therapy, and sticking the external ointment on the acupoints of Xuehai, Yinlingquan and Sanyinjiao.

[0015] The dosage form of the oral medicine is sugar-coated tablet, film-coated tablet, granule, pill, and powder.

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

[0017] Sangjisheng: leafy stem and branch of Ruscus aculeatus L. of Ruscus family, sweet, bitter and acrid in nature, and neutral in property, and belongs to liver and kidney channels, and can dispel wind and dampness, dredge meridians, tonify liver and kidney, strengthen bones and muscles, and prevent miscarriage.

[0018] Xuduan: perennial herb of Dipsacaceae, can tonify liver, strengthen bones and muscles, regulate meridians, stop acid pain, prevent miscarriage, treat leukorrhea of women, produce new blood, break blood stasis, stop cough and hemoptysis, and treat red and white turbid stool.

[0019] Tuisizi: mature seeds of Cuscuta chinensis Lam. of Cuscutaceae, sweet and astringent in nature, and warm in property, and belongs to kidney, liver and spleen channels, and can tonify kidney yang, benefit kidney essence, improve eyesight, astringe essence, reduce urine, stop leukorrhea, stop diarrhea, and prevent miscarriage.

[0020] Dangshen: root of Codonopsis pilosula Nannf. of Siphonostephaniaceae, sweet and neutral in nature, and belongs to spleen and lung channels, and can tonify spleen and lung qi, produce body fluid, and tonify blood.

[0021] Baizhu: rhizome of Atractylodes macrocephala Koidz. of Compositae, sweet and bitter in nature, and warm in property, and belongs to spleen and stomach channels, and can tonify spleen qi, dry dampness, benefit urination, consolidate exterior to stop sweating, and prevent miscarriage.

[0022] Fried Huangan-Doa: Dolichos lablab L. is sweet in flavor, and enters the spleen and stomach channels, and can tonify the spleen without causing greasiness, and dry dampness without causing dryness, and is used for body fatigue and lack of strength, food less and loose stool caused by spleen deficiency and dampness, and can strengthen the ability of tonifying the spleen and resolving dampness.

[0023] Shanyao: rhizome of Dioscorea opposita Thunb. of Dioscoreaceae, sweet and neutral in nature, and belongs to spleen, lung and kidney channels, and can tonify spleen, lung and kidney qi, and benefit spleen, lung and kidney yin.

[0024] Amomum villosum: The dried mature fruit of Amomum villosum or Amomum hainanense. It is pungent in taste and warm in nature. It is associated with the spleen and stomach meridians. It can eliminate dampness, regulate qi, warm the middle, and stop vomiting.

[0025] Radix Puerariae: The dried root of Pueraria lobata. It is sweet and pungent in taste and cool in nature. It can clear heat, remove rashes, produce saliva, and relieve thirst, diarrhea, and alcohol toxicity.

[0026] Dendrobium: It is associated with the stomach and kidney meridians, and has a sweet taste and a slightly cold nature. It can clear the stomach, produce saliva, nourish yin, and clear heat. Modern pharmacology shows that it has anti-tumor, anti-inflammatory, antioxidant, and hypoglycemic effects.

[0027] Angelica sinensis: It is a perennial herb of the genus Angelica in the Apiaceae family. It is associated with the liver, heart, and spleen meridians, and has a sweet and pungent taste and a warm nature. It can tonify blood, activate blood, moisten dryness, and move the bowels.

[0028] Salvia miltiorrhiza: It has a bitter taste and a slightly cold nature. It can activate blood and resolve stasis, calm the mind, and soothe the heart. Modern pharmacology shows that it can improve myocardial ischemia, improve microcirculation, prevent platelet aggregation, lower blood lipids, enhance myocardial contractility, and eliminate free radicals in ischemic areas.

[0029] Radix Paeoniae Alba: It is the root bark of Paeonia suffruticosa. It is pungent and bitter in taste and cool in nature. It can clear heat, cool blood, and resolve stasis. It is used to treat heat entering the blood, hemoptysis, and traumatic injury.

[0030] Rhizoma Chuanxiong: It is the rhizome of the perennial herbaceous plant Chuanxiong. It is pungent and warm in nature, and is associated with the heart and liver meridians. It can activate blood and regulate qi, dispel wind and relieve pain.

[0031] Radix Astragali: It is sweet in taste and slightly warm in nature. It can tonify qi, astringe the exterior, promote diuresis, strengthen the heart, lower blood pressure, resist bacteria, promote pus discharge, promote blood circulation, and relieve pain.

[0032] Olibanum: It is pungent and bitter in taste and neutral in nature. It is associated with the heart, liver, spleen, and kidney meridians. It can activate blood, relieve pain, and promote pus discharge.

[0033] Myrrh: It is bitter and pungent in taste and neutral in nature. It is associated with the liver, spleen, heart, and kidney meridians. It can activate blood, relieve pain, and promote pus discharge.

[0034] Radix Angelicae Dahuricae: It is warm in nature and pungent in taste. It is associated with the stomach, large intestine, and lung meridians. It can dispel wind and relieve pain, and is used to treat nasal congestion, diarrhea, and other conditions.

[0035] Mentha haplocalyx: It is pungent in taste and cool in nature. It is associated with the lung and liver meridians. It can dispel wind and heat, clear the eyes, and relieve throat irritation. Modern pharmacology shows that it can be used as a transdermal enhancer.

[0036] Gancao: sweet, nature, into twelve, with spleen and kidney, heat detoxification, lung and cough.

[0037] Zanthoxylum: bitter, warm. Spleen, stomach, kidney. Warm middle and stop pain, kill insects and stop itching, external use can increase transdermal absorption.

[0038] Cornus: bitter, astringent, slightly warm; liver, kidney, spleen, liver, kidney, astringent.

[0039] Herba Agrimoniae: bitter, astringent, nature; heart, liver, astringent, dysentery, malaria, deficiency.

[0040] Eucommia: sweet, warm, liver and kidney, can liver and kidney, strong bones, an embryo, for the treatment of fetal leakage or fetal movement of the good product. Has a calming, immune regulation, antioxidant, anti-fatigue, antiviral, antibacterial, neuroprotective effects, staphylococcus aureus, escherichia coli and salmonella have varying degrees of antibacterial effect.

[0041] Ligustrum lucidum: Qi, sweet, bitter and astringent, nourishing yin, yin fire, hot and dry, stop virtual sweat, diabetes, and turbidity, abortion, blood, blood, yin sores, hemorrhoids pain. Also clear liver fire, can stop tears. Nourishing yin and kidney, gas liver.

[0042] Fried atractylodes: dry wet water, stop sweating, an embryo. For spleen deficiency, abdominal distension, diarrhea, dizziness, edema, sweating, fetal movement of the unstable.

[0043] Chuan: bitter, pungent, slightly warm; liver, kidney; liver and kidney, strong bones, continue to break, stop abortion; for liver and kidney deficiency, soreness of the waist and knees, rheumatism, injury, fracture, abortion, fetal leakage, injury, etc. Symptoms.

[0044] Cimicifuga: bitter, sweet, slightly cold. Lung, spleen, large intestine, stomach. Release rash, heat detoxification, Yang.

[0045] South Adenophora: sweet, slightly cold. Lung, stomach. Nourishing yin and lung, stomach, phlegm, gas. For dry cough, yin deficiency, dry cough, phlegm, stomach, food, vomiting, gas, hot and dry.

[0046] Ophiopogon: sweet, bitter, slightly cold. Moisturizing lung and heart, heat, phlegm, stop vomiting, cure cough.

[0047] Compared with the prior art, the beneficial effects of the present application are as follows:

[0048] (1) The external use patch of the present application takes Taxillus, Dipsacus, Semen Euryale, to nourish liver and kidney and prevent miscarriage, to nourish the congenital; takes Radix Codonopsis, Poria, fried mung bean, Chinese yam, and Amomum villosum, to invigorate the spleen and replenish qi, to promote the absorption of drugs and food in the gastrointestinal tract; takes Pueraria and Dendrobium, to nourish yin and produce fluid; the congenital and acquired are mutually complementary; takes Angelica, Radix Paeoniae Alba, Salvia miltiorrhiza, and Radix Angelica sinensis, to activate blood and resolve stasis, to improve the blood supply of uterine artery; takes Radix Angelicae Pubescentis, Herba Menthae, and Zanthoxylum bungeanum, to promote transdermal absorption.

[0049] (2) The internal use traditional Chinese medicine of the present application takes Semen Euryale, Cornus, Ligusticum, Euonymus, Taxillus, and Dipsacus, to nourish kidney and essence, to consolidate the Chong and Ren channels, to make the kidney strong and thus to protect the fetus, as the monarch drug; takes Pueraria, Dendrobium, Radix Angelica sinensis, Salvia miltiorrhiza, and Radix Angelica sinensis, to activate blood and resolve stasis, to nourish yin and blood, to make the Chong and Ren channels strong, as the minister drug; takes fried Poria, Amomum villosum, Radix Codonopsis, and Rhizoma Cimicifugae, to invigorate the spleen, to supplement the middle and replenish qi, to raise yang and lift depression, as the assistant drug; takes Herba Lysimachiae, to nourish deficiency and stop bleeding, as the minister drug.

[0050] (3) The traditional Chinese medicine composition of the present application includes two parts of external use ointment and internal use traditional Chinese medicine, the drug compatibility is scientific and reasonable, the external use medicine patch is applied to the acupoints of blood sea, Yinlingquan, and Sanyinjiao, to nourish yin and activate blood, to promote blood circulation; the internal use medicine can nourish kidney and invigorate the spleen, to activate blood and resolve stasis, to dredge channels and collaterals, internal use and external application, to promote the good development of embryo, to balance the immune state of the mother, to reduce the blood viscosity, to improve the level of pregnancy hormone, to reduce the resistance of uterine artery, thus to reduce the probability of miscarriage. It has the effect of invigorating the spleen and replenishing qi to prevent miscarriage, effectively alleviating the symptoms of pregnancy.

[0051] (4) The traditional Chinese medicine composition of the present application has the effects of replenishing qi and nourishing blood, nourishing yin and producing fluid, and activating blood and resolving stasis, and is used for the symptoms of vaginal bleeding, lumbago, dry mouth, and slow embryo development caused by deficiency of both qi and blood, deficiency of kidney yin, and stagnation of qi and blood during pregnancy. It can promote the balance of qi and blood, improve the immunity of the body, significantly improve the cure rate, reduce the pain of patients, and reduce the recurrence after cure. DETAILED DESCRIPTION

[0052] In order for those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application are described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should belong to the scope of protection of the present application.

[0053] It is to be understood that the terms "first", "second", and the like in the description and in the claims of this application are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the use of data between steps in the description is for the purpose of illustration and explanation only and does not limit the scope of the embodiments of the application described herein. Furthermore, the use of the terms "comprise", "comprises", "comprising", "containing", "includes", "including" and "contain" are not intended to exclude other additives, components, steps, or elements not expressly stated. The use of the terms "a" and "an" and "the" and "said" are intended to include both singular and plural, unless the context clearly indicates otherwise.

[0054] Embodiment 1

[0055] A traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus, and a preparation method of an external use ointment patch is provided. The traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of Taxillus delavayi, 15 parts of Euonymus alatus, 15 parts of Semen Euryale, 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala Koidz, 15 parts of Cicer arietinum L., 15 parts of Dioscorea opposita, 6 parts of Amomum villosum, 15 parts of Pueraria lobata, 15 parts of Dendrobium nobile, 10 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 10 parts of Paeonia suffruticosa, 6 parts of Chuanxiong Rhizome, 15 parts of Astragalus membranaceus, 15 parts of Boswellia sacra, 15 parts of Commiphora myrrha, 10 parts of Angelica dahurica, 10 parts of Mentha haplocalyx, 6 parts of Glycyrrhiza uralensis, and 5 parts of Zanthoxylum bungeanum. The above components are mixed, ground, and sieved to obtain a fine powder. Then, a small amount of honey is added to the fine powder, and the mixture is stirred to obtain an ointment. The ointment is coated on a gauze patch to obtain the external use ointment patch.

[0056] The preparation steps of the internal medicine are as follows: 15 parts of Semen Euryale, 15 parts of Cornus officinalis, 15 parts of Ligustrum lucidum, 15 parts of Eucommia ulmoides, 15 parts of Taxillus delavayi, 15 parts of Atractylodes macrocephala Koidz, 15 parts of Euonymus alatus, 15 parts of Amomum villosum, 15 parts of Codonopsis pilosula, 10 parts of Cimicifuga foetida, 20 parts of Agrimonia pilosa, 15 parts of Pueraria lobata, 15 parts of Dendrobium nobile, 10 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 10 parts of Paeonia suffruticosa, 15 parts of Adenophora stricta, and 15 parts of Ophiopogon japonicus are weighed. Then, the above components are washed and ground. The ground components are added into a multifunctional extraction tank, and water is added for twice decoction. For the first time, 6 times the amount of water is added to soak the components for 60 minutes, and the components are decocted for 1.5 hours. The decoction is obtained and filtered. For the second time, 6 times the amount of water is added, and the components are decocted for 1 hour. The decoctions obtained in the two times are mixed and filtered. The filtered filtrate is placed into a double-effect vacuum concentrator, and concentrated into a concentrated solution. The concentrated solution is placed in a low-temperature refrigerator at 0℃ for 24 hours. The concentrated solution after the cold storage is added with filter aid diatomite, and filtered. The filtrate is placed into a double-effect vacuum concentrator, and concentrated to 1g of medicinal material per 1ml. The concentrated solution is dried into a powder, and mixed with honey to obtain granules. The internal medicine is obtained.

[0057] Embodiment 2

[0058] A traditional Chinese medicine composition for tonifying the kidneys, promoting blood circulation, and nourishing the fetus is prepared as follows: Weigh out 30 parts of *Taxillus chinensis*, 30 parts of *Dipsacus asper*, 30 parts of *Cuscuta chinensis*, 30 parts of *Codonopsis pilosula*, 30 parts of *Atractylodes macrocephala*, 30 parts of stir-fried *Hymenopus hyacinthus*, 30 parts of *Dioscorea opposita*, 12 parts of *Amomum villosum*, 30 parts of *Pueraria lobata*, 30 parts of *Dendrobium nobile*, 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 *Boswellia carterii*, 30 parts of *Commiphora myrrha*, 20 parts of *Angelica dahurica*, 20 parts of *Mentha haplocalyx*, 12 parts of *Glycyrrhiza uralensis*, and 10 parts of *Zanthoxylum bungeanum*. Mix the weighed medicinal materials evenly, pulverize them, and then pass them through a 160-mesh sieve to obtain a fine powder. Add a small amount of acetic acid to the fine powder and stir thoroughly to form a paste. Then, evenly coat the paste-like traditional Chinese medicine composition onto gauze to obtain the external plaster.

[0059] The preparation steps for the oral medication are as follows: Weigh out 30 parts of Cuscuta chinensis, 30 parts of Cornus officinalis, 30 parts of Ligustrum lucidum, 30 parts of Eucommia ulmoides, 30 parts of Taxillus chinensis, 30 parts of stir-fried Atractylodes macrocephala, 30 parts of Dipsacus asper, 30 parts of Amomum villosum, 30 parts of Codonopsis pilosula, 20 parts of Cimicifuga foetida, 40 parts of Agrimonia pilosa, 30 parts of Pueraria lobata, 30 parts of Dendrobium nobile, 20 parts of Angelica sinensis, 30 parts of Salvia miltiorrhiza, 20 parts of Paeonia suffruticosa, 30 parts of Adenophora stricta, and 30 parts of Ophiopogon japonicus. The herbs were then washed, ground, and crushed. All the crushed herbs were then placed in a multi-functional extraction tank and decocted twice. For the first decoction, 8 times the total amount of water was added, and the herbs were soaked for 60 minutes and decocted for 2 hours. The decoction was collected and filtered. For the second decoction, 6 times the total amount of water was added, and the herbs were decocted for 1.5 hours. The two decoctions were combined and filtered. The filtered liquid was placed in a double-effect vacuum concentrator and concentrated into a concentrate. The concentrate was then refrigerated at 0°C for 24 hours. Diatomaceous earth was added to the refrigerated concentrate, and the mixture was filtered again. The concentrate was then placed in a double-effect vacuum concentrator and concentrated until each ml contained 1g of raw herb. After drying into powder, the powder was mixed with dextrin to form granules, thus obtaining the oral medication.

[0060] Example 3

[0061] A traditional Chinese medicine composition for tonifying the kidneys, promoting blood circulation, and nourishing the fetus, prepared as an external plaster, is as follows: Weigh out 20 parts of *Taxillus chinensis*, 20 parts of *Dipsacus asper*, 20 parts of *Cuscuta chinensis*, 20 parts of *Codonopsis pilosula*, 20 parts of *Atractylodes macrocephala*, 20 parts of stir-fried *Hymenopus hyacinthus*, 20 parts of *Dioscorea opposita*, 9 parts of *Amomum villosum*, 20 parts of *Pueraria lobata*, 20 parts of *Dendrobium nobile*, 15 parts of *Angelica sinensis*, 20 parts of *Salvia miltiorrhiza*, 15 parts of *Paeonia suffruticosa*, 9 parts of *Ligusticum chuanxiong*, 20 parts of *Astragalus membranaceus*, 20 parts of *Boswellia carterii*, 20 parts of *Commiphora myrrha*, 15 parts of *Angelica dahurica*, 15 parts of *Mentha haplocalyx*, 9 parts of *Glycyrrhiza uralensis*, and 7 parts of *Zanthoxylum bungeanum*. Mix the weighed medicinal materials evenly, pulverize them, and then pass them through an 180-mesh sieve to obtain a fine powder. Add a small amount of petroleum jelly to the fine powder and mix thoroughly to form a paste. Then, evenly coat this paste-like traditional Chinese medicine composition onto gauze to obtain the external plaster.

[0062] The preparation steps for the oral medication are as follows: Weigh out 20 parts of Cuscuta chinensis, 20 parts of Cornus officinalis, 20 parts of Ligustrum lucidum, 20 parts of Eucommia ulmoides, 20 parts of Taxillus chinensis, 20 parts of stir-fried Atractylodes macrocephala, 20 parts of Dipsacus asper, 20 parts of Amomum villosum, 20 parts of Codonopsis pilosula, 15 parts of Cimicifuga foetida, 30 parts of Agrimonia pilosa, 20 parts of Pueraria lobata, 20 parts of Dendrobium nobile, 15 parts of Angelica sinensis, 20 parts of Salvia miltiorrhiza, 15 parts of Paeonia suffruticosa, 20 parts of Adenophora stricta, and 20 parts of Ophiopogon japonicus. The herbs were then washed, ground, and crushed. All the crushed herbs were then placed in a multi-functional extraction tank and decocted twice. For the first decoction, 6 times the total amount of water was added, and the herbs were soaked for 45 minutes and decocted for 1.5 hours. The decoction was collected and filtered. For the second decoction, 4 times the total amount of water was added, and the herbs were decocted for 1 hour. The two decoctions were combined and filtered. The filtered liquid was placed in a double-effect vacuum concentrator and concentrated into a concentrate. The concentrate was then refrigerated at 5°C for 24 hours. Diatomaceous earth was added to the refrigerated concentrate, and the mixture was filtered again. The concentrate was then placed in a double-effect vacuum concentrator and concentrated until each ml contained 1g of raw herbs. After drying into powder, the powder was mixed with honey to form granules, thus obtaining the oral medication.

[0063] Clinical trials

[0064] Case selection: Patients who received kidney-tonifying, blood-activating, and pregnancy-nourishing treatment at Hubei Provincial Maternal and Child Health Hospital from June 2022 to June 2023 were selected. A total of 120 patients were observed, with 40 patients in each group, divided into three groups: A, B, and C.

[0065] There were no statistically significant differences among the three groups of patients in terms of age, average number of miscarriages, average number of miscarriages, and current gestational age (all P>0.05), indicating comparability between the groups. See Table 1 for details.

[0066]

[0067] The comparison among the three groups showed no significant difference (P>0.05), indicating that the three groups were comparable.

[0068] 2. Diagnostic criteria: (1) Diagnostic criteria for threatened miscarriage in early pregnancy: Refer to "Obstetrics and Gynecology" and "Guiding Principles for Clinical Practice of New Traditional Chinese Medicine (Trial)": ① A small amount of vaginal bleeding occurs before the end of the 12th week of pregnancy, without the expulsion of pregnancy products, followed by lower abdominal pain or back pain; ② Gynecological examination shows that the cervix is ​​not dilated and the size of the uterus is consistent with the number of weeks of amenorrhea; ③ Ultrasound examination shows that the size of the uterus, gestational sac, embryo or fetus is consistent with the gestational age; ④ History of amenorrhea; ⑤ Positive urine pregnancy test.

[0069] (1) Inclusion criteria: ① Meets the diagnostic criteria for early pregnancy threatened abortion; ② Ultrasound examination shows subchorionic hematoma; ③ Age 20-40 years; ④ Voluntarily accept this trial treatment, have no major diseases of the heart, liver, kidneys or other organs, and the spouse is in good health (especially no organic lesions of the reproductive system); ⑤ Sign informed consent form.

[0070] (2) Exclusion criteria ① Patients with ≥3 consecutive spontaneous abortions; ② Patients with rubella, cytomegalovirus, toxoplasma, and herpes simplex virus infections; ③ Patients with severe anemia, heart failure, chronic nephritis, hypertension, diabetes, and systemic infection such as high fever; ④ Patients with uterine malformation, uterine fibroids, and adenomyosis; ⑤ Patients with untreated intrauterine adhesions, hydrosalpinx, endometrial polyps, and endometrial hyperplasia; ⑥ Patients with mental illness; and ⑦ Patients who cannot adhere to the treatment regimen.

[0071] 3. Treatment method:

[0072] Group A: Treatment was initiated at the first visit, and the oral medicine of Example 1 was administered, which was taken orally, one dose per day, and taken in the morning and evening, and the patient was advised to rest and adjust their mood, and one month of continuous use was regarded as one course of treatment.

[0073] Group B: The patient was placed in a supine or sitting position, and the external ointment paste prepared in Example 1 was applied to acupoint application therapy, and the external ointment paste was applied to the blood sea, Yinlingquan, and Sanyinjiao, and one month of continuous use was regarded as one course of treatment.

[0074] Group C: Treatment was initiated at the first visit, and the oral medicine of Example 1 was administered in combination with the external ointment paste. The oral medicine was taken orally, one dose per day, and taken in the morning and evening, and the external ointment paste was applied to acupoint application therapy, and the external ointment paste was applied to the blood sea, Yinlingquan, and Sanyinjiao, and one month of continuous use was regarded as one course of treatment.

[0075] 4. Efficacy evaluation: (1) Color ultrasound examination: A GE Voluson 730 three-dimensional color Doppler ultrasound instrument was used, the abdominal probe frequency was 3.5 MHz, and a specialized doctor operated the instrument to measure the bilateral uterine arteries of the patient before treatment, 5 days after treatment, 10 days after treatment, and 14 days after treatment by transvaginal color Doppler ultrasound. (2) Data analysis was performed using SPSS 22.0 statistical software. First, normality and variance homogeneity were tested. Measurement data that met the normal distribution were expressed as mean ± standard deviation (x ± s). Three independent sample t tests were used for comparison among the three groups. Paired sample t tests were used for comparison before and after treatment within the group. Non-parametric rank sum tests were used for non-normal distribution. Rank sum tests were used for comparison of clinical efficacy. X tests were used for comparison of count data. P<0.05 was considered statistically significant.

[0076] (1) Table 1 Clinical efficacy evaluation criteria refer to the following guidelines

[0077]

[0078] The statistical analysis software SPSS 26.0 is applied to process the data, and the measurement data is described, if the measurement data meets the normal distribution and the variance homogeneity, the t test is adopted, if the measurement data does not meet the normal distribution, the nonparametric test is adopted, the rank sum test is adopted for the grade data, and the chi-square test is adopted for the count data. When P<0.05, it is considered that there is a statistical difference.

[0079] 5, treatment results:

[0080] (2) Table 2 A, B, C 3 group of patients before treatment, treatment 5 days, 10 days, 14 days after the left and right uterine artery blood flow resistance index RI comparison.

[0081]

[0082] The combination of the oral medicine and the external ointment paste of the application has a significant effect, and the treatment effect is better than that of only using the oral medicine or only using the external ointment paste.

[0083] (3) Table 3 is the comparison result of the above-mentioned A, B, C three groups

[0084]

[0085] (4) Comparison of pregnancy outcomes of 3 groups of patients, see Table 4 below

[0086] Table 4 Comparison of pregnancy outcomes of 3 groups of patients

[0087]

[0088] From the above results, it can be seen that the traditional Chinese medicine composition prepared by the application has the effects of benefiting qi and nourishing blood, nourishing yin and generating fluid, and promoting blood circulation to remove blood stasis, and is used for treating pregnancy vaginal bleeding, lumbago, dry mouth and throat, slow embryonic development, red tongue or dark tongue with blood spots, and other symptoms caused by qi and blood deficiency, kidney yin deficiency, and blood stasis. Reach the purpose of promoting qi and blood and regulating, improving the body's immunity, at the same time, it can also significantly improve the cure rate, reduce the pain of patients, reduce the recurrence after cure, and has great significance for the treatment of miscarriage.

[0089] The above is only a preferred embodiment of the application, the protection scope of the application is not limited thereto, any person skilled in the art can obtain simple changes or equivalent replacements of the technical solutions within the technical range disclosed by the application, which falls within the protection scope of the application.

Claims

1. A traditional Chinese medicine composition for tonifying kidney, activating blood and nourishing fetus, characterized in that, The traditional Chinese medicine composition is composed of an external ointment and an internal medicine; The external ointment is prepared from the following components in parts by weight: 15-30 parts of Radix Morindae Officinalis, 15-30 parts of Radix Dipsaci, 15-30 parts of Semen Euryale Fructus, 15-30 parts of Radix Codonopsis, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 6-12 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 6-12 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 6-12 parts of Radix Puerariae, 5-10 parts of Radix Puerariae. The internal medicine is composed of the following components in parts by weight: 15-30 parts of Semen Euryale Fructus, 15-30 parts of Fructus Corni, 15-30 parts of Ligustrum Lucidum, 15-30 parts of Eucommia Ulmoides, 15-30 parts of Radix Morindae Officinalis, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 20-40 parts of Herba Agrimoniae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae. The preparation steps of the external ointment are as follows: The traditional Chinese medicine materials are weighed according to the above components, mixed uniformly, crushed, and then sieved through a 100-180 mesh screen to form a fine powder. Then, at least one of honey, vaseline, and acetic acid is added to the fine powder, and the mixture is stirred and mixed uniformly to form an ointment. The ointment is then evenly coated on gauze to obtain the external ointment. The preparation steps of the internal medicine are as follows: The raw materials are weighed according to the proportions, washed, and ground. Then, all the ground materials are put into a multifunctional extraction tank and boiled twice with water. For the first boiling, the total amount of water is 5-8 times the amount of the materials, and the boiling time is 30-60 minutes and 1-2 hours, respectively. The filtrate is obtained by filtering. For the second boiling, the total amount of water is 4-6 times the amount of the materials, and the boiling time is 1-1.5 hours. The filtrate obtained from the two boilings is mixed and filtered. The filtered filtrate is placed in a double-effect vacuum concentrator and concentrated into a concentrated liquid. The concentrated liquid is placed in a low-temperature refrigerator at 0-5℃ for 24 hours. The concentrated liquid after refrigeration is filtered with filter aid diatomite, and the filtrate is placed in a double-effect vacuum concentrator and concentrated to 1g of raw medicinal material per 1ml. The dry powder is mixed with honey or dextrin to form granules, and the internal medicine is obtained.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The external ointment is prepared from the following components in parts by weight: 15-30 parts of Radix Morindae Officinalis, 15-30 parts of Radix Dipsaci, 15-30 parts of Semen Euryale Fructus, 15-30 parts of Radix Codonopsis, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 6-12 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 15-30 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 10-20 parts of Radix Puerariae, 6-12 parts of Radix Puerariae, 5-10 parts of Radix Puerariae.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The oral medicine is composed of the following components in parts by weight: Semen cuscutae 15 parts, Fructus corni 15 parts, Ligustrum lucidum Ait 15 parts, Eucommia ulmoides Oliv 15 parts, Taxillus sutchuenensis 15 parts, Fried Atractylodes 15 parts, Szechwan Lovage Rhizome 15 parts, Fructus Amomi Rotundus 15 parts, Codonopsis pilosula 15 parts, Rhizoma Cimicifugae 10 parts, Herba Impatientis 20 parts, Radix Puerariae 15 parts, Dendrobium 15 parts, Angelica sinensis 10 parts, Salvia miltiorrhiza 15 parts, Radix Paeoniae Alba 10 parts, Radix Adenophorae 15 parts, Radix Ophiopogonis 15 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The use method of the external ointment patch is: applying acupoint application therapy, and sticking the external ointment patch at the acupoint positions of Xuehai, Yinlingquan and Sanyinjiao.

5. The traditional Chinese medicine composition of any one of claims 1 or 3, characterized in that, The dosage form of the oral medicine is sugar-coated tablet, film-coated tablet, pill or powder.

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