Traditional Chinese medicine composition for preventing miscarriage and stopping bleeding

Abstract

The traditional Chinese medicine composition is prepared from the following medicines in parts by weight: 6-13 parts of radix rehmanniae recen, 6-13 parts of prepared rehmannia root, 6-13 parts of Chinese yam, 6-13 parts of Chinese herbaceous peony, 6-13 parts of scutellaria baicalensis, 6-13 parts of golden cypress, 6-13 parts of teasel root, 3-9 parts of liquorice, 9-18 parts of ramie root, 6-15 parts of colla corii asini, 9-18 parts of eclipta alba and 9-18 parts of hairyvein agrimony. The traditional Chinese medicine has the effects of tonifying yin and blood, tonifying qi and blood, regulating yin and yang and improving physical conditions; the compatibility of the medicines has the exact effects of tonifying kidney qi, regulating thoroughfare and conception vessels, strengthening qi and blood, strengthening blood and preventing miscarriage, and the medicines are mixed according to a reasonable proportion, so that the medicinal effects of the medicines are improved, and the traditional Chinese medicine has good miscarriage prevention and hemostasis effects.

Description

Technical Field

[0001] The invention relates to the technical field of medical drugs, and in particular to a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding. Background Art

[0002] Although people's living standards are constantly improving, the miscarriage rate among pregnant women has not decreased significantly, especially for women who have aborted their first child and then become pregnant again. At the same time, habitual miscarriage is not uncommon among women of childbearing age. The causes of miscarriage are extremely complex. The physical fitness, psychological effects, and external environment of pregnant women may affect them and lead to miscarriage.

[0003] At present, Western medicine mainly treats threatened abortion by targeting luteal insufficiency or hypothyroidism. The drugs are nothing more than progesterone and vitamin E, etc. However, the effect of Western medicine alone is often poor and has certain side effects. Among them, the main ingredient of many Western medicines for tocolysis is progesterone. Under normal circumstances, the amount of progesterone in pregnant women during pregnancy is sufficient. If an inappropriate amount of tocolysis is taken, the pregnant woman will have too much progesterone, which will cause miscarriage and delay pregnancy, resulting in overdue pregnancy. Overdue pregnancy not only causes birth injury and pain to the mother, but more importantly, it causes the aging of the placenta, insufficient oxygen and nutrients for the fetus, and the fetus is prone to hypoxia and suffocation, which will increase the neonatal mortality rate. In particular, some Western medicines are more likely to cause adverse effects such as embryonic malformation due to their pharmacological effects.

[0004] According to traditional Chinese medicine, the etiology and pathogenesis of fetal movement disorder (threatened abortion) are mainly kidney deficiency, qi deficiency, and blood deficiency. Therefore, clinical application has found that traditional Chinese medicine has a definite effect on the treatment of this disease, has no obvious side effects, has no effect on the fetus, and is easily accepted by patients.

[0005] According to traditional Chinese medicine, kidneys govern reproduction, and the uterine vessels are connected to the kidneys. The mother's kidney qi is the driving force for fetal development, and the growth of the fetus depends on the nourishment of qi and blood. Qi and blood are generated by the spleen and stomach. Therefore, insufficient kidney qi and weak spleen and stomach are the main pathogenesis of habitual miscarriage. Insufficient kidney qi includes two aspects. One is the essence of the parents. If it is insufficient, although yin and yang can be combined to form, the fetus is not solid, or there are deformities, which eventually lead to miscarriage or even frequent miscarriage; the other is maternal weakness and insufficient kidney qi. At the same time, weak spleen and stomach mainly lead to insufficient qi and blood. Qi deficiency cannot carry the fetus, and blood deficiency cannot nourish the fetus, so miscarriage occurs.

[0006] Therefore, a Chinese medicine composition for stabilizing pregnancy and stopping bleeding is proposed to solve the current shortcomings. Summary of the invention

[0007] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned technology and provide a Chinese medicine composition for stabilizing pregnancy and stopping bleeding.

[0008] To solve the above technical problems, the technical solution provided by the present invention is a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, which is prepared from the following medicines in weight ratio: 6-13 parts of raw rehmannia root, 6-13 parts of cooked rehmannia root, 6-13 parts of yam, 6-13 parts of peony root, 6-13 parts of scutellaria baicalensis, 6-13 parts of phellodendron chinense, 6-13 parts of dipsaci, 3-9 parts of liquorice, 9-18 parts of ramie root, 6-15 parts of donkey-hide gelatin, 9-18 parts of eclipta herb, and 9-18 parts of agrimony.

[0009] As an improvement, it also includes 16 to 24 parts of microcrystalline cellulose, 16 to 24 parts of lactose, 3 to 6 parts of cross-linked sodium carboxymethyl cellulose, 2 to 3 parts of hydroxypropyl methylcellulose, 1 to 2 parts of polyvinyl pyrrolidone, 0.1 to 0.5 parts of silicon dioxide, and 2 to 3 parts of talc.

[0010] As an improvement, it is made of the following drugs in weight ratio: 9 parts of raw rehmannia, 9 parts of cooked rehmannia, 9 parts of yam, 9 parts of peony, 9 parts of scutellaria, 9 parts of phellodendron, 9 parts of dipsacus, 6 parts of licorice, 15 parts of ramie root, 10 parts of donkey-hide gelatin, 15 parts of eclipta herb, and 15 parts of agrimony.

[0011] As an improvement, it also includes 20 parts of microcrystalline cellulose, 20 parts of lactose, 5 parts of cross-linked carboxymethyl cellulose sodium, 2.5 parts of hydroxypropyl methylcellulose, 1.5 parts of polyvinyl pyrrolidone, 0.3 parts of silicon dioxide, and 2.5 parts of talc.

[0012] A method for preparing a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding comprises the following steps:

[0013] S1. Drug screening and cleaning: select the corresponding drugs (except donkey-hide gelatin) according to the above weight proportions, remove impurities, clean, dry and set aside;

[0014] S2, slicing: cutting the dried medicine into thin slices for subsequent decoction and extraction;

[0015] S3, decoction: put the sliced ​​drugs into an extraction tank, and then add the drugs and clean water into the extraction tank at a ratio of 1:6 for decoction;

[0016] S4, filtration and separation: after the decoction is completed, the liquid and the residue are separated by a filter or centrifuge, and the extract is retained;

[0017] S5, concentration: using an evaporator to heat and concentrate the extract to obtain a thick extract, then grinding donkey-hide gelatin into powder and adding it to the extract and stirring evenly;

[0018] S6. Adding auxiliary materials: adding fillers such as microcrystalline cellulose, lactose and cross-linked sodium carboxymethyl cellulose into the extract and stirring evenly;

[0019] S7, granulation: continue to add hydroxypropyl methylcellulose, polyvinyl pyrrolidone, silicon dioxide and talc in sequence, mix and dry, and then press and crush into granules;

[0020] S8, granulation and screening: To ensure the uniformity of the granules, use a granulator to granulate the dried granules, remove oversized or undersized granules, ensure the consistency of the granules, and obtain finished granules;

[0021] S9. Inspection: The finished granules must undergo multiple quality inspections such as microbial limit inspection, heavy metal content determination, pesticide residue testing, etc. to ensure compliance with pharmacopoeia standards;

[0022] S10. Packaging: Granules that meet the standards shall be measured according to the specifications and packaged in aluminum foil bags or plastic bottles, with batch number, expiration date and other information indicated;

[0023] S11. Storage and transportation: Finished granules should be stored in a cool and dry place, away from direct sunlight and humid environment to ensure long-term effectiveness and safety.

[0024] As an improvement, the relative density of the concentrated solution obtained in S5 measured at 60°C is 1.1-1.30 kg / m3.

[0025] The present invention also provides a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, which comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0026] As an improvement, the Chinese medicine composition is in the form of tablets, oral liquid, soft capsules, hard capsules, granules, pills or pastes.

[0027] As an improvement, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine capable of stabilizing pregnancy and stopping bleeding.

[0028] The pharmacological properties of the Chinese medicinal materials used are as follows:

[0029] Shengdihuang: sweet and bitter in taste, cold in nature; enters the heart, liver and kidney meridians; has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid; used for heat entering the blood, fever caused by warm toxins, vomiting blood and epistaxis, yin damage caused by febrile diseases, red tongue and thirst, constipation caused by body fluid damage, fever caused by yin deficiency, steaming bones and fatigue, and thirst caused by internal heat; "Ben Cao Hui Yan" records that "Shengdi is an important kidney-tonifying medicine and a top-grade yin-tonifying medicine, so it has the effect of cooling blood and nourishing blood... It can also treat fatigue and injury during pregnancy and childbirth, all of which are caused by blood. If the blood is nourished, the pregnancy and childbirth will be safe."

[0030] Rehmannia root: sweet in taste, slightly warm in nature; enters the liver and kidney meridians; has the effects of nourishing yin and blood; treats yin deficiency and blood deficiency, weakness of waist and knees, fatigue cough and bone steaming, spermatorrhea, metrorrhagia, irregular menstruation, thirst, frequent urination, deafness, blurred vision;

[0031] Chinese Yam: sweet in taste, neutral in nature; enters the lung, spleen, and kidney meridians; has the effects of strengthening the spleen, nourishing the lungs, consolidating the kidneys, and benefiting the essence; treats spleen deficiency diarrhea, chronic dysentery, consumptive cough, thirst, spermatorrhea, leucorrhea, and frequent urination; nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, and nourishes the kidneys and astringes the essence;

[0032] Peony: bitter, slightly cold; enters the liver and spleen meridians; has the effects of nourishing blood and softening the liver, relieving pain, and restraining yin and sweating; treats chest, abdomen, flank pain, diarrhea, abdominal pain, spontaneous sweating, night sweats, yin deficiency fever, irregular menstruation, metrorrhagia, and leucorrhea;

[0033] Scutellaria baicalensis: bitter in taste, cold in nature; enters the lung, gallbladder, spleen, large intestine, and small intestine meridians; has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus; used for damp-heat, summer-heat, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, blood-heat vomiting and bleeding, carbuncle, sore, and fetal movement disorder;

[0034] Huangbai: bitter, cold in nature; enters the kidney and bladder meridians; has the effects of clearing away heat and dampness, purging fire and removing steam, detoxifying and curing sores; used for damp-heat diarrhea, jaundice, red urine, leucorrhea, itching of the genitals, painful stranguria due to heat, beriberi, bone steaming, fatigue and fever, night sweats, spermatorrhea, sores, swelling and poison, eczema and wet sores;

[0035] Dipsacus root: bitter, pungent, slightly warm; enters the liver and kidney meridians; has the effects of nourishing the liver and kidney, strengthening tendons and bones, regulating blood vessels, healing fractures, and stopping metrorrhagia; treats back pain, weakness of feet and knees, miscarriage, metrorrhagia, leukorrhea, spermatorrhea, traumatic injuries, wounds, hemorrhoidal fistula, carbuncle, sores and swellings;

[0036] Licorice: sweet in taste, neutral in nature; enters the heart, lung, spleen, and stomach meridians; has the effects of replenishing qi and tonifying the middle, removing phlegm and relieving cough, purging fire and detoxifying, relieving urgency and relieving pain, and alleviating the properties of drugs; as the main drug, it can replenish qi and tonify the middle, relieve urgency and relieving pain, moisten the lungs and relieve cough, and purge fire and detoxify; as a blending agent, it can blend various drugs, alleviate the intensity and toxicity of other medicinal materials, and reduce the bitterness and spiciness of the medicine;

[0037] Ramie root: sweet in taste, cold in nature; has the effects of cooling blood and stopping bleeding, calming the fetus, clearing away heat and detoxifying. Used for colds and fever, measles and high fever, urinary tract infection, nephritis and edema, abdominal pain in pregnant women, restless fetuses, and threatened abortion;

[0038] Donkey-hide gelatin: sweet in taste, neutral in nature; enters the lung, liver, and kidney meridians; has the effects of nourishing blood, stopping bleeding, nourishing yin and moistening dryness; used for blood deficiency and sallow complexion, dizziness and palpitations, muscle weakness, restlessness and insomnia, internal wind movement, dry cough, hemoptysis due to fatigue, hematemesis and hematuria, bloody stool and metrorrhagia, and fetal bleeding during pregnancy;

[0039] Eclipta prostrata: sweet, sour, cool in nature; enters the liver and kidney meridians; has the effects of nourishing the liver and kidney, cooling blood and stopping bleeding; used for liver and kidney deficiency, dizziness, premature graying of hair, hematemesis, hemoptysis, epistaxis, bloody stool, bloody dysentery, metrorrhagia, fistula, and bleeding from trauma;

[0040] Herba Agrimoniae: bitter, astringent, neutral in nature; enters the heart and liver meridians; has the effects of astringing and stopping bleeding, stopping malaria, stopping dysentery, detoxifying, and tonifying deficiency; used for hemoptysis, hematemesis, metrorrhagia, malaria, bloody dysentery, carbuncles, sores, vaginal itching, leucorrhea, exhaustion and strain.

[0041] The advantages of the present invention compared with the prior art are:

[0042] The invention has the effects of nourishing yin and blood, can nourish both qi and blood, regulate yin and yang, and improve physical condition; the combination of various medicines has the definite effects of nourishing kidney qi, regulating Chong and Ren meridians, consolidating qi and blood, and consolidating blood to stabilize the fetus, and the mixing of various medicines in a reasonable ratio also improves the efficacy of each medicinal material, and has a good effect of stabilizing the fetus and stopping bleeding. DETAILED DESCRIPTION

[0043] The content of the present invention can be more easily understood by selecting the following detailed description of the preferred implementation method of the present invention and the embodiments included. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs. When there is a conflict, the definition in this specification shall prevail.

[0044] As used herein, the term "prepared from" is synonymous with "comprising." As used herein, the terms "comprising," "including," "having," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises the listed elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0045] The conjunction "consisting of excludes any unspecified element, step, or component. If used in a claim, this phrase renders the claim closed-ended so that it does not include materials other than those described, except for conventional impurities associated therewith. When the phrase "consisting of" appears in a clause of the body of a claim rather than immediately following the subject matter, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0046] When amount, concentration or other value or parameter is expressed as range, preferred range or a series of upper preferred value and lower preferred value limit range, this should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value and any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when disclosing range "1 to 5", described range should be interpreted as including range "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5" etc. When numerical range is described in this article, unless otherwise stated, the range is intended to include its end value and all integers and fractions within the range.

[0047] Singular forms include plural references unless the context clearly indicates otherwise. "Optional" or "either" means that the subsequently described event or incident may or may not occur, and that the description includes instances where the event occurs and instances where it does not.

[0048] Approximate terms in the specification and claims are used to modify quantities, indicating that the present invention is not limited to the specific quantity, but also includes acceptable and modified parts close to the quantity without causing changes in the relevant basic functions. Accordingly, the use of "about", "approximately", etc. to modify a numerical value means that the present invention is not limited to the exact numerical value. In some examples, the approximate terms may correspond to the accuracy of the instrument for measuring the numerical value. In the specification and claims of this application, range limitations can be combined and / or interchanged, and if not otherwise stated, these ranges include all subranges contained therein.

[0049] In addition, the indefinite articles "a" and "an" before the elements or components of the present invention have no restrictions on the quantity requirements (i.e. the number of occurrences) of the elements or components. Therefore, "a" or "an" should be interpreted as including one or at least one, and the elements or components in the singular form also include the plural form, unless the number is obviously intended to be in the singular form.

[0050] "Polymer" means a polymeric compound prepared by polymerizing monomers of the same or different types. The general term "polymer" includes the terms "homopolymer", "copolymer", "terpolymer" and "interpolymer". "Interpolymer" means a polymer prepared by polymerizing at least two different monomers. The general term "interpolymer" includes the term "copolymer" (which is generally used to refer to a polymer prepared from two different monomers) and the term "terpolymer" (which is generally used to refer to a polymer prepared from three different monomers). It also includes polymers made by polymerizing more monomers. "Blend" means a polymer formed by mixing two or more polymers together by physical or chemical methods.

[0051] In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only and cannot limit the content of this application.

[0052] The experimental methods in the following examples are conventional methods unless otherwise specified; the experimental materials and test strains used in the following examples are purchased from commercial channels unless otherwise specified.

[0053] Embodiment 1

[0054] A traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding is prepared from the following medicines in weight proportion: 6 parts of raw rehmannia root, 6-13 parts of cooked rehmannia root, 6 parts of yam, 6 parts of peony root, 6 parts of scutellaria root, 6 parts of phellodendron amurense, 6 parts of dipsaci, 3 parts of liquorice, 9 parts of ramie root, 6 parts of donkey-hide gelatin, 9 parts of eclipta herb and 9 parts of agrimony.

[0055] It also includes 16 parts of microcrystalline cellulose, 16-24 parts of lactose, 3 parts of cross-linked carboxymethyl cellulose sodium, 2 parts of hydroxypropyl methylcellulose, 1 part of polyvinyl pyrrolidone, 0.1 part of silicon dioxide and 2 parts of talc.

[0056] The present invention also provides a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, which comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0057] Furthermore, the Chinese medicine composition is in the form of tablets, oral liquid, soft capsules, hard capsules, granules, pills or pastes.

[0058] Furthermore, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine capable of stabilizing pregnancy and stopping bleeding.

[0059] A method for preparing a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding comprises the following steps:

[0060] S1. Drug screening and cleaning: select the corresponding drugs (except donkey-hide gelatin) according to the above weight proportions, remove impurities, clean, dry and set aside;

[0061] S2, slicing: cutting the dried medicine into thin slices for subsequent decoction and extraction;

[0062] S3, decoction: put the sliced ​​drugs into an extraction tank, and then add the drugs and clean water into the extraction tank at a ratio of 1:6 for decoction;

[0063] S4, filtration and separation: after the decoction is completed, the liquid and the residue are separated by a filter or centrifuge, and the extract is retained;

[0064] S5, concentration: using an evaporator to heat and concentrate the extract to obtain a thick extract, then grinding donkey-hide gelatin into powder and adding it to the extract and stirring evenly;

[0065] Furthermore, the relative density of the concentrated solution obtained at 60° C. is 1.1 to 1.30 kg / m 3 .

[0066] S6. Adding auxiliary materials: adding fillers such as microcrystalline cellulose, lactose and cross-linked sodium carboxymethyl cellulose into the extract and stirring evenly;

[0067] S7, granulation: continue to add hydroxypropyl methylcellulose, polyvinyl pyrrolidone, silicon dioxide and talc in sequence, mix and dry, and then press and crush into granules;

[0068] S8, granulation and screening: To ensure the uniformity of the granules, use a granulator to granulate the dried granules, remove oversized or undersized granules, ensure the consistency of the granules, and obtain finished granules;

[0069] S9. Inspection: The finished granules must undergo multiple quality inspections such as microbial limit inspection, heavy metal content determination, pesticide residue testing, etc. to ensure compliance with pharmacopoeia standards;

[0070] S10. Packaging: Granules that meet the standards shall be measured according to the specifications and packaged in aluminum foil bags or plastic bottles, with batch number, expiration date and other information indicated;

[0071] S11. Storage and transportation: Finished granules should be stored in a cool and dry place, away from direct sunlight and humid environment to ensure long-term effectiveness and safety.

[0072] Embodiment 2

[0073] A traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding is prepared from the following medicines in weight proportion: 9 parts of raw rehmannia root, 9 parts of cooked rehmannia root, 9 parts of yam, 9 parts of peony root, 9 parts of scutellaria root, 9 parts of phellodendron amurense, 9 parts of dipsacus root, 6 parts of liquorice, 15 parts of ramie root, 10 parts of donkey-hide gelatin, 15 parts of eclipta herb and 15 parts of agrimony.

[0074] It also includes 20 parts of microcrystalline cellulose, 20 parts of lactose, 5 parts of cross-linked carboxymethyl cellulose sodium, 2.5 parts of hydroxypropyl methylcellulose, 1.5 parts of polyvinyl pyrrolidone, 0.3 parts of silicon dioxide, and 2.5 parts of talc.

[0075] The present invention also provides a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, which comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0076] Furthermore, the Chinese medicine composition is in the form of tablets, oral liquid, soft capsules, hard capsules, granules, pills or pastes.

[0077] Furthermore, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine capable of stabilizing pregnancy and stopping bleeding.

[0078] A method for preparing a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding comprises the following steps:

[0079] S1. Drug screening and cleaning: select the corresponding drugs (except donkey-hide gelatin) according to the above weight proportions, remove impurities, clean, dry and set aside;

[0080] S2, slicing: cutting the dried medicine into thin slices for subsequent decoction and extraction;

[0081] S3, decoction: put the sliced ​​drugs into an extraction tank, and then add the drugs and clean water into the extraction tank at a ratio of 1:6 for decoction;

[0082] S4, filtration and separation: after the decoction is completed, the liquid and the residue are separated by a filter or centrifuge, and the extract is retained;

[0083] S5, concentration: using an evaporator to heat and concentrate the extract to obtain a thick extract, then grinding donkey-hide gelatin into powder and adding it to the extract and stirring evenly;

[0084] Furthermore, the relative density of the concentrated solution obtained at 60° C. is 1.1 to 1.30 kg / m 3 .

[0085] S6. Adding auxiliary materials: adding fillers such as microcrystalline cellulose, lactose and cross-linked sodium carboxymethyl cellulose into the extract and stirring evenly;

[0086] S7, granulation: continue to add hydroxypropyl methylcellulose, polyvinyl pyrrolidone, silicon dioxide and talc in sequence, mix and dry, and then press and crush into granules;

[0087] S8, granulation and screening: To ensure the uniformity of the granules, use a granulator to granulate the dried granules, remove oversized or undersized granules, ensure the consistency of the granules, and obtain finished granules;

[0088] S9. Inspection: The finished granules must undergo multiple quality inspections such as microbial limit inspection, heavy metal content determination, pesticide residue testing, etc. to ensure compliance with pharmacopoeia standards;

[0089] S10. Packaging: Granules that meet the standards shall be measured according to the specifications and packaged in aluminum foil bags or plastic bottles, with batch number, expiration date and other information indicated;

[0090] S11. Storage and transportation: Finished granules should be stored in a cool and dry place, away from direct sunlight and humid environment to ensure long-term effectiveness and safety.

[0091] Embodiment 3

[0092] A traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding is prepared from the following medicines in weight proportion: 13 parts of raw rehmannia root, 13 parts of cooked rehmannia root, 13 parts of yam, 13 parts of peony root, 13 parts of scutellaria root, 13 parts of phellodendron amurense, 13 parts of dipsaci, 9 parts of liquorice, 18 parts of ramie root, 15 parts of donkey-hide gelatin, 18 parts of eclipta herb and 18 parts of agrimony.

[0093] It also includes 24 parts of microcrystalline cellulose, 24 parts of lactose, 6 parts of cross-linked carboxymethyl cellulose sodium, 3 parts of hydroxypropyl methylcellulose, 2 parts of polyvinyl pyrrolidone, 0.5 parts of silicon dioxide, and 3 parts of talc.

[0094] The present invention also provides a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, which comprises the above-mentioned traditional Chinese medicine composition or other pharmaceutically acceptable physical forms.

[0095] Furthermore, the Chinese medicine composition is in the form of tablets, oral liquid, soft capsules, hard capsules, granules, pills or pastes.

[0096] Furthermore, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine capable of stabilizing pregnancy and stopping bleeding.

[0097] A method for preparing a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding comprises the following steps:

[0098] S1. Drug screening and cleaning: select the corresponding drugs (except donkey-hide gelatin) according to the above weight proportions, remove impurities, clean, dry and set aside;

[0099] S2, slicing: cutting the dried medicine into thin slices for subsequent decoction and extraction;

[0100] S3, decoction: put the sliced ​​drugs into an extraction tank, and then add the drugs and clean water into the extraction tank at a ratio of 1:6 for decoction;

[0101] S4, filtration and separation: after the decoction is completed, the liquid and the residue are separated by a filter or centrifuge, and the extract is retained;

[0102] S5, concentration: using an evaporator to heat and concentrate the extract to obtain a thick extract, then grinding donkey-hide gelatin into powder and adding it to the extract and stirring evenly;

[0103] Furthermore, the relative density of the concentrated solution obtained at 60° C. is 1.1 to 1.30 kg / m 3 .

[0104] S6. Adding auxiliary materials: adding fillers such as microcrystalline cellulose, lactose and cross-linked sodium carboxymethyl cellulose into the extract and stirring evenly;

[0105] S7, granulation: continue to add hydroxypropyl methylcellulose, polyvinyl pyrrolidone, silicon dioxide and talc in sequence, mix and dry, and then press and crush into granules;

[0106] S8, granulation and screening: To ensure the uniformity of the granules, use a granulator to granulate the dried granules, remove oversized or undersized granules, ensure the consistency of the granules, and obtain finished granules;

[0107] S9. Inspection: The finished granules must undergo multiple quality inspections such as microbial limit inspection, heavy metal content determination, pesticide residue testing, etc. to ensure compliance with pharmacopoeia standards;

[0108] S10. Packaging: Granules that meet the standards shall be measured according to the specifications and packaged in aluminum foil bags or plastic bottles, with batch number, expiration date and other information indicated;

[0109] S11. Storage and transportation: Finished granules should be stored in a cool and dry place, away from direct sunlight and humid environment to ensure long-term effectiveness and safety.

[0110] In order to better illustrate the technical effect of the present invention, the following experiment was conducted.

[0111] 1. Experimental Materials

[0112] (1) Test sample: the Chinese medicine composition prepared in Examples 1 to 3.

[0113] (2) Research subjects: 160 patients aged 22 to 38 years old with symptoms of early threatened abortion were selected and randomly divided into 4 groups, 40 in each group, namely Example 1, Example 2, Example 3 and a control group. There was no significant difference between the two groups in terms of age, onset time, condition, etc., and the two groups were comparable.

[0114] Description: The symptoms of the research subjects are a small amount of vaginal bleeding, mostly dark red or bloody leucorrhea; paroxysmal pain in the lower abdomen or waist and back, a falling lower abdomen, and sore knees; secondary symptoms are dizziness, tinnitus, and frequent urination at night.

[0115] (3) Treatment method: During the treatment, the patients were required to rest in bed and sexual intercourse was prohibited. The patients in the Example group took the granules prepared from the Chinese medicine composition obtained in Examples 1 to 3 for corresponding treatment, three times a day in the morning, noon and evening, 5 g each time, for a course of treatment of 2 weeks. The patients in the control group were orally administered progesterone, 100 mg each in the morning and evening, for a course of treatment of 2 weeks.

[0116] (4) Testing standards:

[0117] 1) B-ultrasound: routine examination to monitor the size of the gestational sac, embryo and the presence of fetal heartbeat.

[0118] 2) Whether the subjective symptoms are alleviated, improved or disappeared.

[0119] (5) Efficacy assessment:

[0120] A) Cure: After medication, bleeding stops and the fetus is safe, vaginal bleeding stops, accompanying symptoms disappear, all examination indicators confirm normal pregnancy, and B-ultrasound examination shows fetal heart beats.

[0121] B) Improvement: Vaginal bleeding stops, accompanied by symptoms that improve or almost disappear, and B-ultrasound examination shows fetal heart beats.

[0122] C) Ineffective: Vaginal bleeding does not improve or does not stop, accompanying symptoms do not improve or worsen, and ultrasound examination shows that the embryo is poorly developed or has stopped developing.

[0123] (6) Efficacy results

[0124] Table 1: Efficacy results

[0125]

[0126] Through the above experiments, it can be found that the therapeutic effect of the embodiment group is significantly better than that of the control group, and the total effective rate of the embodiment group can reach more than 97.5%. At the same time, the hemostatic and fetal stabilizing Chinese medicine composition of the present invention can effectively improve or eliminate the main symptoms of threatened abortion such as vaginal bleeding, lower abdominal or waist and back pain. At the same time, B-ultrasound detection shows that it can effectively promote the normal development of the embryo, so that the patient's pregnancy can continue. The drug efficacy is definite, which proves that the Chinese medicine composition of the present invention has the effects of tonifying kidney qi, regulating Chong and Ren meridians, consolidating qi and blood, consolidating blood and stabilizing fetus, and improving physical condition.

[0127] The present invention and its implementation methods are described above, but such description is not restrictive, and what is shown is only one of the implementation methods of the present invention, and the actual structure is not limited thereto. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design a structure and embodiment similar to the technical solution without creativity, which should belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition for stabilizing pregnancy and stopping bleeding, characterized in that: The medicine is prepared from the following medicines in weight proportion: 6-13 parts of raw rehmannia root, 6-13 parts of cooked rehmannia root, 6-13 parts of yam, 6-13 parts of peony root, 6-13 parts of scutellaria root, 6-13 parts of phellodendron amurense, 6-13 parts of dipsaci, 3-9 parts of liquorice, 9-18 parts of ramie root, 6-15 parts of donkey-hide gelatin, 9-18 parts of eclipta herb and 9-18 parts of agrimony.

2. A Chinese medicine composition for stabilizing pregnancy and stopping bleeding according to claim 1, characterized in that: It also includes 16-24 parts of microcrystalline cellulose, 16-24 parts of lactose, 3-6 parts of cross-linked carboxymethyl cellulose sodium, 2-3 parts of hydroxypropyl methylcellulose, 1-2 parts of polyvinyl pyrrolidone, 0.1-0.5 parts of silicon dioxide, and 2-3 parts of talc.

3. A Chinese medicine composition for stabilizing pregnancy and stopping bleeding according to claim 1, characterized in that: The medicine is prepared from the following medicines in weight proportion: 9 parts of raw rehmannia root, 9 parts of cooked rehmannia root, 9 parts of yam, 9 parts of peony root, 9 parts of scutellaria root, 9 parts of phellodendron amurense, 9 parts of dipsacus root, 6 parts of liquorice root, 15 parts of ramie root, 10 parts of donkey-hide gelatin, 15 parts of eclipta herb and 15 parts of agrimony.

4. A Chinese medicine composition for stabilizing pregnancy and stopping bleeding according to claim 2, characterized in that: It also includes 20 parts of microcrystalline cellulose, 20 parts of lactose, 5 parts of cross-linked carboxymethyl cellulose sodium, 2.5 parts of hydroxypropyl methylcellulose, 1.5 parts of polyvinyl pyrrolidone, 0.3 parts of silicon dioxide, and 2.5 parts of talc.

5. A method for preparing a Chinese medicine composition for stabilizing pregnancy and stopping bleeding, characterized in that: The following steps are involved: S1. Drug screening and cleaning: select the corresponding drugs (except donkey-hide gelatin) according to the above weight proportions, remove impurities, clean, dry and set aside; S2, slicing: cutting the dried medicine into thin slices for subsequent decoction and extraction; S3, decoction: put the sliced ​​drugs into an extraction tank, and then add the drugs and clean water into the extraction tank at a ratio of 1:6 for decoction; S4, filtration and separation: after the decoction is completed, the liquid and the residue are separated by a filter or centrifuge, and the extract is retained; S5, concentration: using an evaporator to heat and concentrate the extract to obtain a thick extract, then grinding donkey-hide gelatin into powder and adding it to the extract and stirring evenly; S6. Adding auxiliary materials: adding fillers such as microcrystalline cellulose, lactose and cross-linked sodium carboxymethyl cellulose into the extract and stirring evenly; S7, granulation: continue to add hydroxypropyl methylcellulose, polyvinyl pyrrolidone, silicon dioxide and talc in sequence, mix and dry, and then press and crush into granules; S8, granulation and screening: To ensure the uniformity of the granules, use a granulator to granulate the dried granules, remove oversized or undersized granules, ensure the consistency of the granules, and obtain finished granules; S9. Inspection: The finished granules must undergo multiple quality inspections such as microbial limit inspection, heavy metal content determination, pesticide residue testing, etc. to ensure compliance with pharmacopoeia standards; S10. Packaging: Granules that meet the standards shall be measured according to the specifications and packaged in aluminum foil bags or plastic bottles, with batch number, expiration date and other information indicated; S11. Storage and transportation; Finished granules should be stored in a cool and dry place, away from direct sunlight and humid environment to ensure long-term effectiveness and safety.

6. The method for preparing a traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding according to claim 5, characterized in that: The relative density of the concentrated solution obtained in S5 measured at 60°C is 1.1-1.30 kg / m3.

7. A traditional Chinese medicine composition for stabilizing pregnancy and stopping bleeding, the traditional Chinese medicine composition comprising the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition obtained by the preparation method according to claims 5-6 or other pharmaceutically acceptable physical forms.

8. A Chinese medicinal composition for stabilizing pregnancy and stopping bleeding according to claim 7, characterized in that: The Chinese medicine composition is in the form of tablets, oral liquid, soft capsules, hard capsules, granules, pills or pastes.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine composition obtained by the preparation method according to claims 5 to 6 in the preparation of a drug capable of stabilizing pregnancy and stopping bleeding.

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