CN117752735A - Traditional Chinese medicine composition for promoting absorption of subcapillary hematoma in early pregnancy and preparation method thereof - Google Patents

Traditional Chinese medicine composition for promoting absorption of subcapillary hematoma in early pregnancy and preparation method thereof Download PDF

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CN117752735A
CN117752735A CN202311808704.7A CN202311808704A CN117752735A CN 117752735 A CN117752735 A CN 117752735A CN 202311808704 A CN202311808704 A CN 202311808704A CN 117752735 A CN117752735 A CN 117752735A
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韩红伟
张晓燕
刘敏
张迎春
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Hubei Maternal And Child Care Service Center (hubei Women And Children Hospital)
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for promoting absorption of subchorionic hematoma in early pregnancy, which comprises an oral medicine and an external patch, wherein the external patch is prepared by crushing the following raw materials and blending with vinegar: eucommia ulmoides, ramie root, fructus psoraleae, charred folium artemisiae argyi, semen cassiae, rheum officinale, betel nuts, fennel, akebia stem, pepper, clove, cinnamon and stir-fried bighead atractylodes rhizome; the oral medicine is prepared by crushing the following raw materials: semen Cuscutae, herba Taxilli, radix Dipsaci, colla Corii Asini, rhizoma anemarrhenae, cortex Phellodendri, rhizoma Dioscoreae, radix Paeoniae Rubra, radix Boehmeriae, eucommiae cortex, radix Saposhnikoviae, corni fructus, radix Angelicae sinensis, radix Rubiae and herba et Gemma Agrimoniae. The traditional Chinese medicine composition comprises an oral medicine and an external patch, has scientific and reasonable medicine compatibility, is combined with external application for oral administration, has obvious treatment effect on treating hematoma, and has the effects of stopping bleeding and preventing miscarriage, and has the effects of nourishing yin and blood heat, heat Fu Chong, yang and blood heat, and blood heat and bleeding.

Description

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物及其制备 方法A traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy and its preparation method

技术领域Technical field

本发明属于中医药技术领域,具体涉及一种促进妊娠早期绒毛膜下血肿吸收的中药组合物及其制备方法。The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy and a preparation method thereof.

背景技术Background technique

绒毛膜下血肿(Subchorionic hematoma,SCH)是指绒毛膜与子宫蜕膜分离出血,使血液积聚在绒毛膜与子宫蜕膜之间形成血肿。主要通过超声发现,发病率为0.46%~48%。研究显示,SCH可增加子痫前期、小于胎龄儿、流产、胎盘早剥和胎膜早破的风险。目前,SCH发病机制相关研究较少,其潜在机制仍不清楚,其可能与异常胎盘形成和植入、自身免疫功能异常和凝血功能障碍等相关。有学者认为妊娠早期胎膜外层绒毛膜向蜕膜侵入过程中,由于母体免疫失衡,保护性细胞因子表达受抑制,损伤性细胞因子过度表达,导致蜕膜血管凝血功能异常;同时绒毛外层的合体滋养细胞释放大量蛋白水解酶,引起蜕膜血管破裂,导致蜕膜和绒毛膜之间出血,最终形成积血、胎膜剥离。绒毛膜下血肿是早期先兆流产的常见并发症,超声可见孕囊和子宫壁之间存在新月形、三角形或不规则的高灰度区,低回声或无回声区。绒毛膜下血肿可发生在妊娠的各个时期,若本病干预较早,预后一般较好。Subchorionic hematoma (SCH) refers to the separation and bleeding of the chorion and uterine decidua, causing blood to accumulate between the chorion and uterine decidua to form a hematoma. Mainly discovered through ultrasound, the incidence rate is 0.46% to 48%. Studies have shown that SCH can increase the risk of preeclampsia, small for gestational age, miscarriage, placental abruption and premature rupture of membranes. At present, there are few studies on the pathogenesis of SCH, and its underlying mechanism is still unclear. It may be related to abnormal placenta formation and implantation, abnormal autoimmune function, and coagulation dysfunction. Some scholars believe that during the invasion of the outer layer of fetal membranes into the decidua by the chorionic membrane in early pregnancy, due to maternal immune imbalance, the expression of protective cytokines is inhibited and damaging cytokines are overexpressed, resulting in abnormal coagulation function of the decidual blood vessels; at the same time, the outer layer of the villous membranes The syncytiotrophoblasts release a large amount of proteolytic enzymes, causing the decidua blood vessels to rupture, leading to bleeding between the decidua and the chorion, and eventually hemorrhage and fetal membrane peeling. Subchorionic hematoma is a common complication of early threatened abortion. Ultrasound shows the existence of crescent-shaped, triangular or irregular high-gray-scale, hypoechoic or anechoic areas between the gestational sac and the uterine wall. Subchorionic hematoma can occur at any stage of pregnancy. If the disease is intervened early, the prognosis is generally better.

目前西药在治疗本病主要是补充孕激素黄体支持、以及止血药等,合并下腹疼痛者加用抑制宫缩药物(如间苯三酚),对于绒毛膜下血肿久久不消则加用抗生素抗感染炎治疗。中医何少山在治疗妊娠合并绒毛膜下血肿时常加入少量活血化瘀中药,收到良好的临床效果。罗颂平教授认为妊娠期绒毛膜下血肿的主要病机为肾虚血瘀,故在治疗本病时,拟固肾安胎、化瘀止血为基本治则,化瘀与安胎并举,效果明显。褚玉霞教授认为妊娠期绒毛膜下血肿的主要病机是脾肾两虚、阴虚血热、兼有血瘀,临证以健脾补肾、凉血化瘀为主要治则,常用褚氏安胎方加减(菟丝子、续断、白术、山药、地榆、旱莲草、阿胶、苏梗、砂仁、丹参、黄芩、炙甘草)。凤丽娜等用固肾安胎化瘀止血法治疗妊娠绒毛膜下血肿30例,有效率93.3%。邵蓉等对IVF-ET术后妊娠合并宫腔积液患者用地屈孕酮片、HCG针肌注、中药拟固肾保胎汤内服,保胎成功率77.78%。At present, Western medicine mainly treats this disease by supplementing progesterone, luteal support, and hemostatic drugs. For patients with lower abdominal pain, tocolytic drugs (such as phloroglucinol) are added. For subchorionic hematoma that persists for a long time, antibiotics are added to fight infection. inflammation treatment. Traditional Chinese medicine doctor He Shaoshan often adds a small amount of traditional Chinese medicine to promote blood circulation and remove blood stasis in the treatment of pregnancy complicated by subchorionic hematoma, and has achieved good clinical results. Professor Luo Songping believes that the main pathogenesis of subchorionic hematoma during pregnancy is kidney deficiency and blood stasis. Therefore, when treating this disease, the basic treatment principles are to strengthen the kidneys, stabilize the fetus, remove blood stasis and stop bleeding, and to eliminate blood stasis and prevent fetus simultaneously, the effect is obvious. Professor Chu Yuxia believes that the main pathogenesis of subchorionic hematoma during pregnancy is spleen and kidney deficiency, yin deficiency, blood heat, and blood stasis. The main clinical treatment principles are to strengthen the spleen and kidneys, cool the blood and remove blood stasis, and Chu's An is commonly used. Add or subtract fetal prescriptions (Cuscutae, Dipsacus, Atractylodes, Chinese yam, Sanguisorba, Eclipta, donkey-hide gelatin, Scutellaria baicalensis, Amomum villosum, Salvia miltiorrhiza, Scutellaria baicalensis, Zhigancao). Feng Lina et al. treated 30 cases of subchorionic hematoma in pregnancy with the method of strengthening the kidney, relieving fetus, removing blood stasis and stopping bleeding, with an effective rate of 93.3%. Shao Rong et al. used dydrogesterone tablets, intramuscular injection of HCG needle, and oral administration of the Chinese medicine Xiangshen Baotai Decoction for pregnant women with uterine effusion after IVF-ET. The success rate of fetal preservation was 77.78%.

但是,上述治疗方法多采用中药口服药方,中医药内服联合外敷治法治疗早起妊娠期绒毛膜下血肿的研究尚少。However, the above-mentioned treatment methods mostly use oral Chinese medicine prescriptions, and there are still few studies on the treatment of subchorionic hematoma in early pregnancy using oral Chinese medicine combined with external application.

发明内容Contents of the invention

本发明的目的在于提供一种促进妊娠早期绒毛膜下血肿吸收的中药组合物,本发明的中药组合物包括内服药物与外用贴片,其药物配伍科学合理,内服联合外敷,对孕后阴血下聚养胎,阴血虚而血热更盛,热伏冲任,阳盛血热,血得热则溢,迫血妄行,形成血肿治疗效果显著,具有止血安胎之功,并且外用中药贴片与内服药物疗效显著,安全方便,应用广泛。The purpose of the present invention is to provide a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The traditional Chinese medicine composition of the present invention includes oral medicine and an external patch. The medicine compatibility is scientific and reasonable, and the combination of oral administration and external application can effectively treat yin blood after pregnancy. Lower gathering to nourish the fetus, Yin and blood are deficient and blood heat is more abundant, heat is suppressed and the blood is hot, and Yang is excessive and blood heat, the blood will overflow when the blood is heated, forcing the blood to flow indiscriminately, forming hematoma, the therapeutic effect is remarkable, it has the effect of stopping bleeding and anti-fetal, and can be used externally Traditional Chinese medicine patches and oral medicines are highly effective, safe, convenient and widely used.

为实现上述目的,本发明所采取的技术方案为:In order to achieve the above objects, the technical solutions adopted by the present invention are:

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物,所述中药组合物包括内服药物与外用贴片,所述外用贴片由如下原料粉碎后用醋调和制成:杜仲、苎麻根、补骨脂、艾叶炭、决明子、大黄、槟榔、小茴香、木通、花椒、丁香、肉桂、炒白术;A traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The traditional Chinese medicine composition includes oral medicine and an external patch. The external patch is made by crushing the following raw materials and blending them with vinegar: Eucommia ulmoides, ramie root, and tonic. Bone fat, moxa leaf charcoal, cassia seeds, rhubarb, betel nut, cumin, akebia, peppercorns, cloves, cinnamon, fried atractylodes;

所述内服药物由如下原料粉碎后制成:菟丝子、桑寄生、续断、阿胶、知母、黄柏、山药、赤芍、苎麻根、杜仲、防风、山茱萸、当归、茜草、仙鹤草。The oral medicine is made from the following raw materials after being crushed: Cuscuta semen, locust, Dipsacus bark, donkey-hide gelatin, Anemarrhena, Phellodendron, yam, red peony root, ramie root, Eucommia ulmoides, saposhnikovia, dogwood, angelica, madder, and agrimony.

优选的,所述外用贴片,以质量比计,杜仲:苎麻根:补骨脂:艾叶炭:决明子:大黄:槟榔:小茴香:木通:花椒:丁香:肉桂:炒白术为30-60:20-40:20-40:10-20:15-30:30-60:15-30:20-40:10-20:10-20:10-20:10-20:15-30。Preferably, the external patch, in terms of mass ratio, Eucommia ulmoides: Ramie root: Psoralen: Mugwort charcoal: Cassia seed: Rhubarb: Areca nut: Cumin: Akebia: Zanthoxylum bungeanum: Clove: Cinnamon: Fried Atractylodes rhubarb is 30-60 :20-40:20-40:10-20:15-30:30-60:15-30:20-40:10-20:10-20:10-20:10-20:15-30.

优选的,所述外用贴片,以质量比计,杜仲:苎麻根:补骨脂:艾叶炭:决明子:大黄:槟榔:小茴香:木通:花椒:丁香:肉桂:炒白术为3:2:2:1:1.5:3:1.5:2:1:1:1:1:1.5。Preferably, the external patch has a mass ratio of Eucommia ulmoides: Ramie root: Psoralen: mugwort charcoal: Cassia seed: Rhubarb: Areca nut: Cumin: Akebia: Zanthoxylum bungeanum: Clove: Cinnamon: Stir-fried Atractylodes macrocephala is 3:2. :2:1:1.5:3:1.5:2:1:1:1:1:1.5.

优选的,所述内服药物,以质量比计,菟丝子:桑寄生:续断:阿胶:知母:黄柏:山药:赤芍:苎麻根:杜仲:防风:山茱萸:当归:茜草:仙鹤草为20-40:20-40:20-40:10-20:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:30-60。Preferably, the internal medicine, in terms of mass ratio, Cuscuta: Loranth: Dipsacus: Donkey-hide gelatin: Anemarrhena: Phellodendron: Chinese yam: Red peony: Ramie root: Eucommia: Windbreak: Dogwood: Angelica: Rubia: Agrimony is 20 -40:20-40:20-40:10-20:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40 :20-40:30-60.

本发明还要求保护所述促进妊娠早期绒毛膜下血肿吸收的外用贴片的制备方法,称取各味中药打成粉末,然后加入醋调和成膏状,然后将该膏状中药组合物均匀涂覆于纱布贴上,之后再盖上一层纱布贴即得。The present invention also claims a method for preparing the external patch for promoting the absorption of subchorionic hematoma in early pregnancy. Weigh various traditional Chinese medicines and beat them into powder, then add vinegar to mix them into a paste, and then apply the paste-like traditional Chinese medicine composition evenly. Cover it with gauze and then cover it with a layer of gauze.

本发明还要求保护所述促进妊娠早期绒毛膜下血肿吸收的内服药物的制备方法,按比例称量各药物原料,分别洗净并研磨破碎,将研磨破碎后的所有药物中加入6倍体积的水煎煮两次,第一次2小时,第二次1小时,合并煎液,将煎液滤过,即得所述内服药物。The present invention also claims a method for preparing the oral medicine that promotes the absorption of subchorionic hematoma in early pregnancy. Each pharmaceutical raw material is weighed in proportion, washed, ground and crushed respectively, and 6 times the volume of all the ground and crushed medicines is added. Decoct in water twice, the first time for 2 hours and the second time for 1 hour. Combine the decoctions and filter the decoctions to obtain the oral medicine.

优选的,所述膏状中药组合物涂覆的厚度约为5mm。Preferably, the thickness of the paste-like traditional Chinese medicine composition is about 5 mm.

本发明还保护所述制作方法制作得到的用于促进妊娠早期绒毛膜下血肿吸收的外用贴片以及所述外用贴片的使用方法。The present invention also protects the external patch produced by the production method for promoting the absorption of subchorionic hematoma in early pregnancy and the use method of the external patch.

优选的,所述使用方法是将所述外用贴片的上层纱布贴取下,贴敷于腹部上至神阙穴,下至关元穴,脐中线旁开三寸的范围。Preferably, the method of use is to remove the upper layer of gauze from the external patch, and apply it on the abdomen from the upper part of the abdomen to the Shenque point, the lower part to the Guanyuan point, and a range of three inches from the midline of the umbilicus.

在本发明中,所使用的中药的性能和作用如下:In the present invention, the properties and functions of the traditional Chinese medicine used are as follows:

杜仲:性甘温,入肝肾经,可补肝肾、强筋骨、安胎,为治疗胎漏或胎动不安之佳品。具有镇静、免疫调节、抗氧化、抗疲劳、抗病毒、抗菌、神经保护等作用,对金黄色葡萄球菌、大肠杆菌和沙门氏菌有不同程度的抑菌作用。Eucommia ulmoides: sweet and warm in nature, enters the liver and kidney meridian, can nourish the liver and kidneys, strengthen muscles and bones, and prevent miscarriage. It is a good product for treating fetal leakage or fetal movements. It has sedative, immunomodulatory, antioxidant, anti-fatigue, antiviral, antibacterial, neuroprotective and other effects, and has varying degrees of antibacterial effects on Staphylococcus aureus, Escherichia coli and Salmonella.

小茴香:性味辛温,归肝、肾、脾、胃经。具有散寒止痛、理气和胃的功效,热敷可以缓解便秘和腹胀,减轻腹痛,止血。对人体内脏系统、中枢神经系统、心血管系统、内分泌系统、免疫系统及化学治疗方面均具有一定作用,包括调节胃肠功能、镇痛、抗炎、抗肝肾毒性、降血脂、降血糖、抗氧化、抗菌、抗病毒、抗肿瘤、调节雌激素水平等功能活性。Cumin: pungent and warm in nature and flavor, and returns to the liver, kidney, spleen and stomach meridians. It has the effects of dispelling cold, relieving pain, regulating qi and regulating the stomach. Hot compress can relieve constipation and bloating, relieve abdominal pain and stop bleeding. It has certain effects on the human visceral system, central nervous system, cardiovascular system, endocrine system, immune system and chemical therapy, including regulating gastrointestinal function, analgesia, anti-inflammation, anti-hepatorenal toxicity, lowering blood lipids, lowering blood sugar, Antioxidant, antibacterial, antiviral, antitumor, regulating estrogen levels and other functional activities.

花椒:性辛散温燥,入脾胃,可温中止痛,止痒,具有镇痛、抗炎、促进皮肤吸收、局部麻醉、抗菌、抗氧化、祛风湿等药理作用。Zanthoxylum bungeanum: pungent in nature, warm and dry in nature, enters the spleen and stomach, can warm the body, relieve pain, and relieve itching. It has pharmacological effects such as analgesia, anti-inflammatory, skin absorption promotion, local anesthesia, antibacterial, antioxidant, and rheumatism dispelling.

丁香:性辛温,有温中降逆,补肾助阳的功效,具有抗菌消炎、解热镇痛、抗氧化、抗溃疡、麻醉、促透皮吸收、神经保护等多种作用。Clove: pungent and warm in nature, has the effects of warming and reducing adverse effects, tonifying the kidneys and supporting yang, and has many functions such as antibacterial and anti-inflammatory, antipyretic and analgesic, antioxidant, anti-ulcer, anesthesia, promotion of transdermal absorption, and neuroprotection.

肉桂:性辛甘,归肾脾经,可以引火归元、散寒止痛、补火助阳,具有抗菌作用、抗炎、抗氧化、神经保护、降糖、降脂、降尿酸等多种药理作用,还具有保鲜、除臭等功能以及良好的持香作用。Cinnamon: Pungent and sweet in nature, it returns to the kidney and spleen meridian. It can induce fire, dissipate cold and relieve pain, replenish fire and help yang. It has antibacterial effects, anti-inflammatory, antioxidant, neuroprotective, hypoglycemic, lipid-lowering, uric acid-lowering and other pharmacological effects. It also has the functions of freshness preservation, deodorization and good fragrance retention.

补骨脂:性苦辛温,可温脾肾,固精。药理研究方面证明其具有良好的抗肿瘤、抗氧化、抗菌、抗炎、抗抑郁、调节雌激素水平、促进骨生长、肝保护及血管保护、神经保护等作用。Psoralen: bitter, pungent and warm in nature, it can warm the spleen and kidneys and solidify essence. Pharmacological research has proven that it has good anti-tumor, antioxidant, antibacterial, anti-inflammatory, anti-depressant, regulating estrogen levels, promoting bone growth, liver protection, vascular protection, neuroprotection and other effects.

艾叶炭:性温,可温经暖宫,止血安胎,有止血、抗真菌、抗病毒、抗肿瘤、抗氧化等多种药理活性,对治疗先兆流产有小腹痛和阴道流血的症状有很好的疗效。Mugwort charcoal: warm in nature, can warm the menstruation and warm the uterus, stop bleeding and prevent pregnancy, has various pharmacological activities such as hemostasis, antifungal, antiviral, antitumor, antioxidant, etc. It is very useful in treating symptoms of threatened abortion, lower abdominal pain and vaginal bleeding. Good curative effect.

木通:味苦,性寒,归心、小肠、膀胱经,能清心除烦,利水。具有抗炎、抑菌、利水的作用。Akebia: bitter in taste, cold in nature, and directed to the heart, small intestine, and bladder meridians. It can clear away the heart, eliminate troubles, and diuretic. It has anti-inflammatory, antibacterial and diuretic effects.

苎麻根:性甘寒,凉血止血安胎,苎麻根可以通过免疫、凝血、凋亡,神经系统调控治疗流产,效果佳,在保胎中应用广泛。Ramie root: sweet and cold in nature, cooling blood, stopping bleeding, and promoting miscarriage. Ramie root can treat miscarriage through immunity, coagulation, apoptosis, and nervous system regulation. It has good effects and is widely used in miscarriage.

槟榔:性苦辛温,行气消积利水,药理作用主要有促胃肠运动、消炎镇痛、抗菌抑菌、抗疲劳、抗抑郁、抗衰老、抗氧化、降血糖、调节血脂等。Betel nut: Bitter and pungent in nature, it promotes qi, eliminates accumulation of water and promotes diuresis. Its main pharmacological effects include promoting gastrointestinal motility, anti-inflammatory and analgesic, antibacterial and bacteriostatic, anti-fatigue, anti-depressant, anti-aging, antioxidant, lowering blood sugar, regulating blood lipids, etc.

决明子:味甘苦咸,归肝、大肠经,可清热润肠通便,含有多种化学成分并表现出多种药理活性,如调节胃肠道功能、抗菌、保肝明目、抑菌、抗氧化、降压、调脂等。Cassia seed: sweet, bitter and salty, returns to the liver and large intestine meridian, can clear away heat, moisturize the intestines and relieve constipation. It contains a variety of chemical components and exhibits a variety of pharmacological activities, such as regulating gastrointestinal function, antibacterial, protecting the liver and improving eyesight, antibacterial, and antibacterial. Oxidation, blood pressure reduction, lipid regulation, etc.

大黄:性苦寒,归脾、胃、大肠经,可清热泻火,凉血止血,逐瘀通经,凡血瘀有热之肿痛或出血者可投,兼有便秘或排便不爽者尤佳。Rhubarb: Bitter and cold in nature, it returns to the spleen, stomach and large intestine meridians. It can clear away heat and purge fire, cool blood and stop bleeding, remove blood stasis and stimulate menstruation. It can be used for those with blood stasis, heat, swelling, pain or bleeding, especially those with constipation or uncomfortable defecation. .

菟丝子:甘、温,归肾、肝、脾经,具有滋补肝肾、固精缩尿、安胎、明目、止泻之功效,既可补阳,又可益阴,具有温而不燥,补而不滞的特点。Cuscuta: sweet and warm, returns to the kidney, liver and spleen meridians. It has the effects of nourishing the liver and kidneys, fixing sperm and reducing urine, anti-fetal, improving eyesight and stopping diarrhea. It can nourish yang and yin, and is warm but not dry. , the characteristics of supplementing without stagnating.

桑寄生:味苦、甘,性平;归肝、肾经,具有祛风湿,补肝肾,强筋骨,安胎的功效。Mistletoe: bitter and sweet in taste, neutral in nature; enters the liver and kidney meridians, has the effects of eliminating rheumatism, nourishing the liver and kidneys, strengthening the bones and muscles, and calming the fetus.

续断:补肝肾,续筋骨,调血脉。治腰背酸痛,足膝无力,胎漏,崩漏,带下,遗精,跌打损伤,金疮,痔漏,痈疽疮肿。Dipsacus Dipsacus: nourishes the liver and kidneys, regenerates muscles and bones, and regulates blood vessels. It can be used to treat pain in the lower back, weakness in the feet and knees, fetal bleeding, metrorrhagia, vaginal discharge, spermatorrhea, bruises, sores, hemorrhoids, and carbuncles.

阿胶:味甘,性平。归肺、肝、肾经。补血滋阴,润燥,止血。用于血虚萎黄,眩晕心悸,肌痿无力,心烦不眠,虚风内动,肺燥咳嗽,劳嗽咯血,吐血尿血,便血崩漏,妊娠胎漏。Donkey-hide gelatin: sweet in taste and neutral in nature. Returns to the lung, liver and kidney meridians. Nourishes blood, nourishes yin, moistens dryness, and stops bleeding. It is used for blood deficiency and chlorosis, dizziness and palpitations, muscle weakness, restlessness and insomnia, internal movement of wind due to deficiency, cough caused by dryness of the lungs, hemoptysis due to fatigue, hemoptysis, hematuria, hematochezia, and fetal leakage during pregnancy.

知母:味苦、甘,性寒。归肺、胃、肾经。清热泻火,生津润燥。用于外感热病,高热烦渴,肺热燥咳,骨蒸潮热,内热消渴,肠燥便秘。Anemarrhena: bitter, sweet, cold in nature. Returns to the lung, stomach and kidney meridians. Clear away heat, purge fire, promote body fluid and moisturize dryness. It is used for exogenous fever, high fever and polydipsia, lung-heat dryness and cough, bone-steaming hot flashes, internal heat to quench thirst, intestinal dryness and constipation.

黄柏:味苦,性寒;归肾、膀胱、大肠经,清热燥湿,泻火解毒,除骨蒸清虚热。用于湿热泻痢,黄疸,带下,热淋,脚气,痿辟,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒。Cortex Phellodendri: bitter in taste, cold in nature; returns to the kidney, bladder, and large intestine meridians, clears away heat and dampness, purges fire and detoxifies, removes bones and steams to clear away heat. Used for damp-heat diarrhea, jaundice, leucorrhea, hot stranguria, athlete's foot, impotence, bone steaming and labor fever, night sweats, spermatorrhea, sores, swollen poison, eczema and itching.

山药:味甘,性平;归脾、肺、肾经,益气养阴,补脾肺肾,固精止带。Yam: sweet in taste and neutral in nature; returns to the spleen, lung, and kidney meridians, replenishes qi and nourishes yin, nourishes the spleen, lungs and kidneys, consolidates essence and stops vaginal discharge.

赤芍:味苦,性微寒;归肝经,清热凉血,活血祛瘀。Red peony root: bitter in taste, slightly cold in nature; returns to liver meridian, clears away heat and cools blood, activates blood circulation and removes blood stasis.

防风:味辛、甘,性微温,具有祛风解表、胜湿止痛、止痉等功效。Fangfeng: pungent, sweet, slightly warm in nature, has the effects of dispelling wind and relieving superficial inflammation, relieving dampness and relieving pain, and relieving spasm.

山茱萸:味酸、涩,性微温;归肝、肾经,补益肝肾,收敛固涩。Cornus officinalis: sour, astringent, slightly warm in nature; returns to the liver and kidney meridians, replenishes the liver and kidneys, astringes and solidifies astringency.

当归:性温,昧甘、辛。归肝、心、脾经,补血活血,调经止痛,润肠通便。用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。Angelica sinensis: warm in nature, sweet and pungent. Returns to the liver, heart and spleen meridians, nourishes and activates blood circulation, regulates menstruation and relieves pain, moistens the intestines and relieves constipation. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, intestinal dryness and constipation, rheumatic arthralgia, injuries from falls, and carbuncle sores.

茜草:味苦,性寒;归肝经,凉血化瘀,止血通经。Madder: bitter in taste, cold in nature; returns to liver meridian, cools blood and removes blood stasis, stops bleeding and stimulates menstruation.

仙鹤草:味苦、涩,性平;归心、肝经,收敛止血,止痢,截疟,补虚。Agrimony: bitter, astringent, neutral in nature; returns to the heart and liver meridian, astringes and stops bleeding, stops dysentery, cuts malaria, and replenishes deficiency.

与现有技术相比,本发明的有益效果如下:Compared with the prior art, the beneficial effects of the present invention are as follows:

(1)本发明外用贴片取大量苎麻根,取木通寒凉之性,入少阴心经,降心火,清热止血安胎;同时配伍杜仲、补骨脂、艾叶炭入少阴肾经,补肝肾,温肾助阳,增加体内的气血津液运行,提高代谢,在止血的同时促进血肿吸收;以上药物寒热并用,如此可得水火既济,安胎止血,小茴香、花椒、丁香、桂皮即可增加温肾的效果,也可促进透皮吸收,增加药物的利用率;槟榔、决明子、大黄行气通便,促进胃肠道蠕动,改善消化道功能,减少便秘,使大便通畅,可防止便秘而引起的腹压增加,从而压迫子宫出现进一步出血的情况;以上中药组合共奏止血安胎之功。(1) The external patch of the present invention takes a large amount of ramie root, takes the cold and cool properties of Akebia, and enters the Shaoyin heart meridian to reduce heart fire, clear away heat, stop bleeding, and prevent miscarriage; at the same time, it is combined with Eucommia ulmoides, psoralen, and moxa leaf charcoal to enter the Shaoyin kidney meridian. , nourish the liver and kidneys, warm the kidneys and help yang, increase the circulation of qi, blood and body fluids in the body, improve metabolism, and promote the absorption of hematomas while stopping bleeding; the above drugs are used together with cold and heat, so that both water and fire can be combined, to prevent miscarriage and stop bleeding, fennel, pepper, Cloves and cinnamon can increase the effect of warming the kidneys, and can also promote transdermal absorption and increase the utilization rate of drugs; betel nut, cassia seed, and rhubarb can promote qi and laxatives, promote gastrointestinal peristalsis, improve digestive tract function, reduce constipation, and make stool easier. Unobstructed, it can prevent the increase in abdominal pressure caused by constipation, thereby compressing the uterus and causing further bleeding; the combination of the above traditional Chinese medicines can stop bleeding and prevent miscarriage.

(2)本发明内服药物取阿胶、当归、赤芍滋阴养血,茜草、仙鹤草凉血止血安胎;菟丝子、桑寄生、续断具有补肝肾、强筋骨、壮腰膝、固冲任、安胎之功,其参合使用,其力益彰;知母、黄柏具有清热燥湿、滋阴降火的功效;山药、防风、补脾养胃,生津益肺,增强免疫力;山茱萸补益肝肾,收敛固涩止血;以上中药组合可调和冲任,止血安胎。(2) The oral medicines of the present invention include donkey-hide gelatin, angelica root, and red peony root to nourish yin and nourish blood; madder and agrimony cool blood, stop bleeding, and prevent miscarriage; Cuscuta, mulberry, and Dipsacus have the functions of nourishing the liver and kidneys, strengthening the muscles and bones, strengthening the waist and knees, and strengthening the lungs. Ren, the effect of anti-abortion, their combined use will bring out the best effects; Anemarrhena and Phellodendron have the effect of clearing away heat and drying dampness, nourishing yin and reducing fire; Yam, Fangfeng, nourishing the spleen and stomach, promoting the production of body fluid and benefiting the lungs, and enhancing immunity; Dogwood It can nourish the liver and kidneys, astringe and stop bleeding; the above combination of traditional Chinese medicine can harmonize Chong and Ren, stop bleeding and relieve miscarriage.

(3)本发明对孕后阴血下聚养胎,阴血虚而血热更盛,热伏冲任,阳盛血热,血得热则溢,迫血妄行,而形成的血肿治疗效果显著,不逊于西药治疗疗效。(3) The present invention can treat hematomas caused by the accumulation of yin blood in the fetus after pregnancy, when the yin blood is deficient and the blood heat is more abundant, the heat is suppressed and the blood is hot, and when the yang is excessive and the blood is hot, the blood will overflow when the blood is hot, and the blood will be forced to move indiscriminately, resulting in hematoma. The effect is significant and not inferior to that of Western medicine.

(4)本发明的中药组合物包括内服药物与外用贴片,其药物配伍科学合理,内用外敷,对孕后阴血下聚养胎,阴血虚而血热更盛,热伏冲任,阳盛血热,血得热则溢,迫血妄行,而形成血肿治疗效果显著,具有止血安胎之功,并且外用中药贴片与内服药物疗效显著,安全方便,应用广泛。(4) The traditional Chinese medicine composition of the present invention includes oral drugs and external patches. The drug compatibility is scientific and reasonable. It can be used internally and externally. It can nourish the fetus under the yin blood after pregnancy. When yin blood is deficient and blood heat is more abundant, the heat will rush away. , when Yang is excessive and the blood is hot, the blood will overflow when the blood is hot, forcing the blood to flow freely, resulting in the formation of hematoma. The treatment effect is remarkable, and it has the effect of stopping bleeding and relieving fetus, and the external Chinese medicine patch and oral medicine have significant curative effect, are safe and convenient, and are widely used.

具体实施方式Detailed ways

为了使本技术领域的人员更好地理解本发明方案,下面对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分的实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都应当属于本发明保护的范围。In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention are clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts should fall within the scope of protection of the present invention.

需要说明的是,本发明的说明书和权利要求书中的术语“第一”、“第二”等是用于区别类似的对象,而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换,以便这里描述的本发明的实施例能够以除了在这里描述的那些以外的顺序实施。此外,术语“包括”和“具有”以及他们的任何变形,意图在于覆盖不排他的包含,例如,包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元,而是可包括没有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。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 are not necessarily used to describe a specific order or sequence. It is to be understood that the data so used are interchangeable under appropriate circumstances so that the embodiments of the invention described herein are capable of being practiced in sequences other than those described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, e.g., a process, method, system, product, or apparatus that encompasses a series of steps or units and need not be limited to those explicitly listed. Those steps or elements may instead include other steps or elements not expressly listed or inherent to the process, method, product or apparatus.

实施例1Example 1

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物的制作方法,所述外用贴片的制备方法为:称取杜仲30份、苎麻根20份:补骨脂20份:艾叶炭10份:决明子15份:大黄30份:槟榔15份:小茴香20份:木通10份:花椒10份:丁香10份:肉桂10份:炒白术15份中药打成粉末,然后加入醋调和成膏状,然后将该膏状中药组合物均匀涂覆于纱布贴上,之后再盖上一层纱布贴即得。A preparation method of a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The preparation method of the external patch is: weigh 30 parts of Eucommia ulmoides, 20 parts of ramie root: 20 parts of psoralen: 10 parts of moxa leaf charcoal: 15 parts of cassia seeds: 30 parts of rhubarb: 15 parts of betel nut: 20 parts of cumin: 10 parts of Akebia: 10 parts of Sichuan peppercorns: 10 parts of cloves: 10 parts of cinnamon: 15 parts of stir-fried Atractylodes. Beat Chinese medicine into powder, then add vinegar to make a paste. , then apply the paste-like traditional Chinese medicine composition evenly on the gauze patch, and then cover it with a layer of gauze patch.

所述内服药物的制备方法为:称取菟丝子20份、桑寄生20份、续断20份、阿胶10份、知母20份、黄柏20份、山药20份、赤芍20份、苎麻根20份、杜仲20份、防风20份、山茱萸20份、当归20份、茜草20份、仙鹤草30份,分别洗净并研磨破碎,将研磨破碎后的所有药物中加入6倍体积的水煎煮两次,第一次2小时,第二次1小时,合并煎液,将煎液滤过,即得所述内服药物。The preparation method of the medicine for oral administration is as follows: weigh 20 parts of dodder, 20 parts of locust, 20 parts of Dipsacus, 10 parts of donkey-hide gelatin, 20 parts of Anemarrhena, 20 parts of Cortex Phellodendron, 20 parts of Chinese yam, 20 parts of red peony root, and 20 parts of ramie root. 20 parts of Eucommia ulmoides, 20 parts of Fructus Fructus, 20 parts of Dogwood, 20 parts of Chinese Angelica, 20 parts of Rubia, and 30 parts of Agrimony. Wash, grind and crush them respectively. Add 6 times the volume of water to decoct all the grinded and crushed medicines. Two times, the first time is 2 hours, the second time is 1 hour, the decoctions are combined, and the decoctions are filtered to obtain the oral medicine.

实施例2Example 2

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物的制作方法,所述外用贴片的制备方法为:称取杜仲40份、苎麻根30份:补骨脂30份:艾叶炭15份:决明子20份:大黄45份:槟榔20份:小茴香30份:木通15份:花椒15份:丁香15份:肉桂15份:炒白术20份中药打成粉末,然后加入醋调和成膏状,然后将该膏状中药组合物均匀涂覆于纱布贴上,之后再盖上一层纱布贴即得。A preparation method of a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The preparation method of the external patch is as follows: weigh 40 parts of Eucommia ulmoides, 30 parts of ramie root: 30 parts of psoralen: 15 parts of moxa leaf charcoal: 20 parts of cassia seeds: 45 parts of rhubarb: 20 parts of betel nut: 30 parts of fennel: 15 parts of Akebia: 15 parts of Sichuan peppercorns: 15 parts of cloves: 15 parts of cinnamon: 20 parts of fried Atractylodes. Beat Chinese medicine into powder, then add vinegar to make a paste. , then apply the paste-like traditional Chinese medicine composition evenly on the gauze patch, and then cover it with a layer of gauze patch.

所述内服药物的制备方法为:称取菟丝子30份、桑寄生30份、续断30份、阿胶15份、知母30份、黄柏30份、山药30份、赤芍30份、苎麻根30份、杜仲30份、防风30份、山茱萸30份、当归30份、茜草30份、仙鹤草45份,分别洗净并研磨破碎,将研磨破碎后的所有药物中加入6倍体积的水煎煮两次,第一次2小时,第二次1小时,合并煎液,将煎液滤过,即得所述内服药物。The preparation method of the oral medicine is as follows: weigh 30 parts of dodder, 30 parts of locust, 30 parts of Dipsacus, 15 parts of donkey-hide gelatin, 30 parts of Anemarrhena, 30 parts of Cortex Phellodendron, 30 parts of Chinese yam, 30 parts of red peony root, and 30 parts of ramie root. 30 parts of Eucommia ulmoides, 30 parts of Fructus Fructus, 30 parts of Dogwood, 30 parts of Chinese Angelica, 30 parts of Rubia, and 45 parts of Agrimony. Wash, grind and crush them respectively. Add 6 times the volume of water to decoct all the grinded and crushed medicines. Two times, the first time is 2 hours, the second time is 1 hour, the decoctions are combined, and the decoctions are filtered to obtain the oral medicine.

实施例3Example 3

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物的制作方法,所述外用贴片的制备方法为:称取杜仲50份、苎麻根35份:补骨脂35份:艾叶炭15份:决明子25份:大黄50份:槟榔25份:小茴香35份:木通15份:花椒15份:丁香15份:肉桂15份:炒白术25份中药打成粉末,然后加入醋调和成膏状,然后将该膏状中药组合物均匀涂覆于纱布贴上,之后再盖上一层纱布贴即得。A preparation method of a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The preparation method of the external patch is as follows: weigh 50 parts of Eucommia ulmoides, 35 parts of ramie root: 35 parts of psoralen: 15 parts of moxa leaf charcoal: 25 parts of cassia seeds: 50 parts of rhubarb: 25 parts of betel nut: 35 parts of cumin: 15 parts of Akebia: 15 parts of Sichuan peppercorns: 15 parts of cloves: 15 parts of cinnamon: 25 parts of fried Atractylodes. Beat Chinese medicine into powder, then add vinegar to make a paste. , then apply the paste-like traditional Chinese medicine composition evenly on the gauze patch, and then cover it with a layer of gauze patch.

所述内服药物的制备方法为:称取菟丝子35份、桑寄生35份、续断35份、阿胶15份、知母35份、黄柏35份、山药35份、赤芍35份、苎麻根35份、杜仲35份、防风35份、山茱萸35份、当归35份、茜草35份、仙鹤草50份,分别洗净并研磨破碎,将研磨破碎后的所有药物中加入6倍体积的水煎煮两次,第一次2小时,第二次1小时,合并煎液,将煎液滤过,即得所述内服药物。The preparation method of the medicine for oral administration is as follows: weigh 35 parts of dodder, 35 parts of locust, 35 parts of Dipsacus, 15 parts of donkey-hide gelatin, 35 parts of Anemarrhena, 35 parts of Cortex Phellodendron, 35 parts of Chinese yam, 35 parts of red peony root and 35 parts of ramie root. 35 parts of Eucommia ulmoides, 35 parts of Fructus Fructus, 35 parts of Dogwood, 35 parts of Chinese Angelica, 35 parts of Rubia, and 50 parts of Agrimony. Wash, grind and crush them respectively. Add 6 times the volume of water to all the grinded and crushed medicines and boil them. Two times, the first time is 2 hours, the second time is 1 hour, the decoctions are combined, and the decoctions are filtered to obtain the oral medicine.

实施例4Example 4

一种促进妊娠早期绒毛膜下血肿吸收的中药组合物的制作方法,所述外用贴片的制备方法为:称取杜仲60份、苎麻根60份:补骨脂60份:艾叶炭20份:决明子30份:大黄60份:槟榔30份:小茴香40份:木通40份:花椒40份:丁香40份:肉桂40份:炒白术30份中药打成粉末,然后加入醋调和成膏状,然后将该膏状中药组合物均匀涂覆于纱布贴上,之后再盖上一层纱布贴即得。A preparation method of a traditional Chinese medicine composition that promotes the absorption of subchorionic hematoma in early pregnancy. The preparation method of the external patch is: weigh 60 parts of Eucommia ulmoides, 60 parts of ramie root: 60 parts of psoralen: 20 parts of moxa leaf charcoal: 30 parts of cassia seeds: 60 parts of rhubarb: 30 parts of betel nut: 40 parts of cumin: 40 parts of Akebia: 40 parts of Sichuan peppercorns: 40 parts of cloves: 40 parts of cinnamon: 30 parts of fried Atractylodes. Beat Chinese medicine into powder, then add vinegar to mix into a paste. , then apply the paste-like traditional Chinese medicine composition evenly on the gauze patch, and then cover it with a layer of gauze patch.

所述内服药物的制备方法为:称取菟丝子40份、桑寄生40份、续断40份、阿胶20份、知母40份、黄柏40份、山药40份、赤芍40份、苎麻根40份、杜仲40份、防风40份、山茱萸40份、当归40份、茜草40份、仙鹤草60份,分别洗净并研磨破碎,将研磨破碎后的所有药物中加入6倍体积的水煎煮两次,第一次2小时,第二次1小时,合并煎液,将煎液滤过,即得所述内服药物。The preparation method of the medicine for oral administration is as follows: weigh 40 parts of Cuscuta semen, 40 parts of Locust root, 40 parts of Dipsacus bark, 20 parts of donkey-hide gelatin, 40 parts of Anemarrhenae, 40 parts of Cortex Phellodendron, 40 parts of Chinese yam, 40 parts of red peony root, and 40 parts of ramie root. 40 parts of Eucommia ulmoides, 40 parts of Fructus Fructus, 40 parts of Dogwood, 40 parts of Chinese Angelica, 40 parts of Rubia, and 60 parts of Agrimony. Wash, grind and crush them respectively. Add 6 times the volume of water to all the grinded and crushed medicines and boil them. Two times, the first time is 2 hours, the second time is 1 hour, the decoctions are combined, and the decoctions are filtered to obtain the oral medicine.

应用例Application examples

1、病例选择:选择2021年5-2022年11月在湖北省妇幼保健院中医科进行保胎治疗的患者,观察早期妊娠先兆流产合并绒毛膜下血肿的患者180例,分三组,分别为A组、B组、C组各60例。三组患者在年龄、平均流产次数、平均流产及现孕周数情况一般资料,经统计学分析,差异均无统计学意义(均P>0.05),组间具有可比性,详见表11. Case selection: Select patients who received miscarriage treatment in the Department of Traditional Chinese Medicine of Hubei Maternal and Child Health Hospital from May 2021 to November 2022, and observe 180 patients with early pregnancy threatened abortion combined with subchorionic hematoma, divided into three groups, respectively: There were 60 cases in each group A, B, and C. After statistical analysis, the general information of the three groups of patients in terms of age, average number of miscarriages, average number of miscarriages, and current gestational age was not statistically significant (all P>0.05), and the groups were comparable. See Table 1 for details.

表1妊娠患者平均年龄、平均流产次数、平均流产及现孕周数比较Table 1 Comparison of the average age, average number of abortions, average abortions and current gestational weeks of pregnant patients

三组之间比较P>0.05,均无明显差异,无统计学意义。提示三组间具有可比性。Comparison between the three groups P>0.05, there was no significant difference and no statistical significance. It indicates that the three groups are comparable.

2、诊断标准:(1)早期妊娠先兆流产诊断标准:参照《妇产科学》和《中药新药临床指导原则(试行)》:①妊娠12周末以前出现少量阴道出血,无妊娠物排出,相继出现下腹痛或腰背痛;②妇科检查宫颈日未开,子宫大小与停经周数相符;③B超检查子宫大小,孕囊、胚胎或胎儿与孕周相符。(2)绒毛膜下血肿诊断标准:参照《妇产科超声图谱》,B超声像图表现为宫腔内宫壁与妊娠囊之间的无回声区,形态多为新月形、三角形或多边形。2. Diagnostic criteria: (1) Diagnostic criteria for threatened abortion in early pregnancy: refer to "Obstetrics and Gynecology" and "Clinical Guidelines for New Traditional Chinese Medicines (Trial)": ① A small amount of vaginal bleeding occurs before the 12th week of pregnancy, without discharge of pregnancy products, and occurs one after another Lower abdominal pain or low back pain; ② Gynecological examination, the cervix is not dilated, and the size of the uterus is consistent with the number of weeks of menopause; ③ B-ultrasound examination, the size of the uterus, the gestational sac, embryo or fetus are consistent with the gestational age. (2) Diagnostic criteria for subchorionic hematoma: Refer to the "Ultrasound Atlas of Obstetrics and Gynecology". The B-ultrasound image shows an echoless area between the uterine wall and the gestational sac in the uterine cavity. The shape is mostly crescent, triangle or polygon. .

(1)纳入标准:①符合早期妊娠先兆流产诊断标准;②B超检查有绒毛膜下血肿;③年龄20~40岁;④自愿接受本试验治疗,无心、肝、肾等脏器重大疾病,配偶身体健康(尤其生殖系统无器质性病变);⑤签署知情同意书。(1) Inclusion criteria: ① Meet the diagnostic criteria for threatened abortion in early pregnancy; ② Subchorionic hematoma on B-ultrasound examination; ③ Aged 20 to 40 years old; ④ Voluntarily accept the treatment of this trial, no major diseases of heart, liver, kidney and other organs, spouse Good health (especially no organic disease in the reproductive system); ⑤ Sign the informed consent form.

(2)排除标准①连续自然流产≥3次者;②风疹、巨细胞病毒、弓形虫、单纯疤疹病毒感染者;③有严重贫血、心力衰竭、慢性肾炎、高血压、糖尿病、全身性感染如高热者;④子宫畸形、子宫肌瘤、子宫腺肌症者;⑤宫腔粘连、宫腔积液、子宫内膜息肉、内膜增生病变等未治疗者;⑥有精神疾患者;⑦不能坚持按疗程进行治疗者。(2) Exclusion criteria ① Those with ≥ 3 consecutive spontaneous abortions; ② Those infected with rubella, cytomegalovirus, Toxoplasma gondii, and herpes simplex virus; ③ Those with severe anemia, heart failure, chronic nephritis, hypertension, diabetes, and systemic infection Such as those with high fever; ④ those with uterine malformation, uterine fibroids, adenomyosis; 5) those with untreated uterine adhesions, uterine effusion, endometrial polyps, endometrial hyperplasia, etc.; 6) those with mental illness; 7 unable to Those who insist on following the course of treatment.

3、治疗方法:3. Treatment methods:

A组:于就诊起开始保胎治疗,传统安胎治疗,采用黄体酮注射液(国药准字H33020828,浙江仙琚制药股份有限公司,20mg/支,按照病情调整20~60mg,每日1次)+地屈孕酮片(注册证号H20170221,荷兰Abbott Healthcare Products B.V,10mg/片,按照病情调整,口服每次1片,每日3次)至绒毛膜下血肿消失。Group A: Tocolytic treatment was started from the time of diagnosis, traditional tocolytic treatment, using progesterone injection (National Drug Approval No. H33020828, Zhejiang Xianju Pharmaceutical Co., Ltd., 20 mg/tube, adjusted according to the condition 20 to 60 mg, once a day )+dydrogesterone tablets (registration number H20170221, Abbott Healthcare Products B.V, Netherlands, 10 mg/tablet, adjusted according to the condition, 1 tablet orally each time, 3 times a day) until the subchorionic hematoma disappears.

B组:患者取仰卧位或者坐位,将实施例1制作的外用贴片的上层纱布贴取下,贴敷于腹部上至神阙穴,下至关元穴,脐中线旁开三寸的范围,每日两次,5天为一个疗程,治疗5个疗程。Group B: The patient takes a supine or sitting position, removes the upper gauze patch of the external patch produced in Example 1, and applies it on the abdomen from the Shenque point to the Guanyuan point, and three inches from the midline of the umbilicus. , twice a day, 5 days as a course of treatment, 5 courses of treatment.

C组:采用实施例1中的外用贴片与内服药物组合使用,患者取仰卧位或者坐位,将外用贴片的上层纱布贴取下,贴敷于腹部上至神阙穴,下至关元穴,脐中线旁开三寸的范围,每日两次,5天为一个疗程,治疗5个疗程;同时,口服内服药物,1剂1d,分早晚两次服用,5天为一个疗程,治疗5个疗程。Group C: The external patch in Example 1 is used in combination with oral drugs. The patient takes a supine or sitting position, removes the upper gauze patch of the external patch, and applies it on the abdomen to Shenque point and down to Guanyuan acupoint, within three inches of the midline of the umbilicus, twice a day, 5 days as a course of treatment, and 5 courses of treatment; at the same time, oral medicine, 1 dose 1 day, taken twice a day in the morning and evening, 5 days as a course of treatment, 5 courses of treatment.

4、疗效评价:(1)彩色超声检查:使用超声仪器为GE Voluson 730型三维彩色多普勒超声仪,腹部探头频率3.5MHz,由专门医生操作分别于治疗前、治疗10d、治疗18d、治疗25d经阴道彩色多普勒超声测定患者双侧子宫动脉、绒毛膜下血肿面积及孕囊面积。(2)采用SPSS22.0统计软件进行数据分析先进行正态性、方差齐性检验,符合正态分布的计量资料用均数士标准差(x-±s)表示,三组间比较采用两个独立样本的t检验,组内治疗前后比较采用配对样本t检验,非正态分布用非参数秩和检验;临床疗效比较采用等级资料秩和检验,计数资料比较采用X检验以P<0.05为差异有统计学意义。4. Efficacy evaluation: (1) Color ultrasound examination: The ultrasound instrument used is GE Voluson 730 three-dimensional color Doppler ultrasound instrument with an abdominal probe frequency of 3.5MHz. It is operated by a specialized doctor before treatment, 10 days after treatment, 18 days after treatment, and Transvaginal color Doppler ultrasound was used to measure the patient's bilateral uterine arteries, subchorionic hematoma area and gestational sac area on the 25th day. (2) Use SPSS22.0 statistical software for data analysis. First, test for normality and homogeneity of variances. Measurement data that conform to normal distribution are expressed as mean ± standard deviation (x-±s). Comparisons between three groups are done using two-dimensional tests. t-test for independent samples, paired-sample t-test for comparison before and after treatment within the group, and non-parametric rank-sum test for non-normal distribution; rank-sum test for clinical efficacy was used for comparison of clinical efficacy, and X-test was used for comparison of count data, with P<0.05 considered The difference was statistically significant.

5、治疗结果:5. Treatment results:

表2 3组患者治疗前、治疗10天、18天、25天后绒毛膜下血肿面积比较Table 2 Comparison of subchorionic hematoma area in three groups of patients before treatment and after 10, 18 and 25 days of treatment

表3 3组患者妊娠结局比较Table 3 Comparison of pregnancy outcomes among 3 groups of patients

组别Group nn 流产abortion 早产premature birth 足月产term birth 流产孕周Abortion gestational age 分娩孕周gestational age A组Group A 6060 1111 1010 3939 9.7±2.39.7±2.3 37.3±1.137.3±1.1 B组Group B 6060 88 33 4949 10.2±2.110.2±2.1 38.3±1.738.3±1.7 C组Group C 6060 66 22 5252 10.6±2.010.6±2.0 38.7±1.338.7±1.3

从上述评价结果可以看出,本发明所制备的促进妊娠早期绒毛膜下血肿吸收的中药组合物相对于西药治疗取得的效果更好,疗效显著,且外用中药贴片与内服药物一起使用时更加安全方便,对保胎治疗综合意义更大。It can be seen from the above evaluation results that the Chinese medicine composition prepared by the present invention for promoting the absorption of subchorionic hematoma in early pregnancy has better effects than Western medicine treatment, and the curative effect is significant, and the external Chinese medicine patch is more effective when used together with oral medicine. It is safe and convenient and has greater comprehensive significance for miscarriage treatment.

以上所述,仅为本发明较佳的具体实施例,本发明的保护范围不限于此,任何熟悉本技术领域的技术人员在本发明披露的技术范围内,可显而易见地得到的技术方案的简单变化或等效替换均落入本发明的保护范围内。The above are only preferred specific embodiments of the present invention, and the protection scope of the present invention is not limited thereto. Any person familiar with the technical field can obviously obtain the simple technical solutions within the technical scope disclosed in the present invention. Changes or equivalent substitutions fall within the protection scope of the present invention.

Claims (7)

1. The traditional Chinese medicine composition for promoting the absorption of the subcapillary hematoma of early pregnancy is characterized by comprising an oral medicine and an external patch, wherein the external patch is prepared by crushing the following raw materials and blending with vinegar: eucommia ulmoides, ramie root, fructus psoraleae, charred folium artemisiae argyi, semen cassiae, rheum officinale, betel nuts, fennel, akebia stem, pepper, clove, cinnamon and stir-fried bighead atractylodes rhizome;
the oral medicine is prepared by crushing the following raw materials: semen Cuscutae, herba Taxilli, radix Dipsaci, colla Corii Asini, rhizoma anemarrhenae, cortex Phellodendri, rhizoma Dioscoreae, radix Paeoniae Rubra, radix Boehmeriae, eucommiae cortex, radix Saposhnikoviae, corni fructus, radix Angelicae sinensis, radix Rubiae and herba et Gemma Agrimoniae.
2. The traditional Chinese medicine composition according to claim 1, wherein the patch for external use comprises eucommia ulmoides in terms of mass ratio: radix Boehmeriae: fructus psoraleae: mugwort leaf charcoal: semen cassiae: rhubarb: betel nut: fennel: akebia stem: pricklyash peel: clove: cinnamon: the fried bighead atractylodes rhizome is 30-60:20-40:20-40:10-20:15-30:30-60:15-30:20-40:10-20:10-20:10-20:10-20:15-30.
3. The traditional Chinese medicine composition according to claim 1, wherein the oral medicine comprises, by mass, semen cuscutae: loranthus mulberry mistletoe: teasel root: donkey-hide gelatin: rhizoma anemarrhenae: cortex Phellodendri: chinese yam: radix paeoniae rubra: radix Boehmeriae: eucommia ulmoides: wind prevention: fructus Corni: chinese angelica root: radix Rubiae: 20-40% of hairyvein agrimony: 20-40:20-40:10-20:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:20-40:30-60.
4. The method for preparing the patch according to claim 1, wherein the preparation method comprises weighing each Chinese medicinal material, pulverizing into powder, adding vinegar, concocting into paste, uniformly coating the paste on gauze patch, and covering with a layer of gauze patch.
5. The Chinese medicinal composition according to claim 1, wherein the preparation method of the oral medicament is characterized in that raw materials of the oral medicament are weighed according to a proportion, respectively washed, ground and crushed, all the ground and crushed medicaments are added with water with a volume of 6 times for decoction twice, the first time is 2 hours, the second time is 1 hour, the decoctions are combined, and the decoction is filtered, so that the oral medicament is obtained.
6. The composition of claim 4, wherein the paste of the composition is applied to a thickness of about 5mm.
7. The composition of claim 4, wherein the patch is applied by removing the upper gauze layer of the patch and applying it to the abdomen to the Shenque acupoint, down to the Guanyuan acupoint, and three inches laterally to the umbilicus midline.
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