CN112656867A

CN112656867A - Traditional Chinese medicine composition for treating abnormal uterine bleeding and preparation method thereof

Info

Publication number: CN112656867A
Application number: CN202110128478.2A
Authority: CN
Inventors: 吴维海; 牛景月; 田野; 王贵金; 李金凤; 李建勇; 王�琦; 纪玉哲
Original assignee: Shijiazhuang Ping An Hospital Co ltd
Current assignee: Shijiazhuang Ping An Hospital Co ltd
Priority date: 2021-01-29
Filing date: 2021-01-29
Publication date: 2021-04-16
Anticipated expiration: 2041-01-29
Also published as: CN112656867B

Abstract

The invention discloses a traditional Chinese medicine composition for treating abnormal uterine bleeding and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 100-500 parts of ginseng, 100-500 parts of astragalus membranaceus, 100-400 parts of prepared rehmannia root, 100-400 parts of angelica sinensis, 100-400 parts of white peony root, 100-500 parts of folium artemisiae argyi charcoal, 100-500 parts of hairyvein agrimonia herb and bud and 100-400 parts of motherwort. The invention utilizes the efficacy of each medicine to generate synergistic effect, and has the effects of supplementing qi and controlling blood, fixing thoroughfare and arresting metrorrhagia, arresting bleeding and removing blood stasis, thereby effectively treating abnormal uterine bleeding.

Description

Traditional Chinese medicine composition for treating abnormal uterine bleeding and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating abnormal uterine bleeding and a preparation method thereof.

Background

Abnormal Uterine Bleeding (AUB) is a symptom and sign common to gynecology, and as a general term, refers to abnormal bleeding from the uterine cavity that does not coincide with any 1 item of normal menstrual cycle frequency, regularity, menstrual length, and menstrual bleeding volume. The international obstetrical and gynecological union menstrual group in 2011 limits abnormal uterine bleeding to abnormal uterine bleeding of non-pregnant women in the reproductive age, and classifies the etiology of the abnormal uterine bleeding into PALM-COEIN nine types.

The treatment principle of abnormal uterine bleeding is to reduce bleeding, correct body anemia symptoms, adjust menstrual cycle and improve life quality, and the treatment scheme mainly comprises uterus resection, ovarian castration, curettage, drug treatment and the like. The treatment regimens vary according to the etiology. C in etiology indicates that the body has bleeding-stopping related diseases and is in a bleeding-prone state. The rule and self-limitation of uterine bleeding are closely related to a hormone secretion system and a blood coagulation fibrinolysis system in a body, abnormal uterine bleeding is easier to occur and heavier for patients with diseases related to hemostasis, and the existence of abnormal uterine bleeding only aggravates the severity of primary diseases, reduces the blood coagulation capacity of the body again and causes vicious circle.

Currently, for clinical treatment, the treatment of primary diseases of abnormal uterine bleeding caused by bleeding-stopping related diseases is key, but the types of primary diseases of bleeding-stopping related diseases are many, clinical detection indexes are various, accurate diagnosis is difficult, and the period required for treating the primary diseases is long. The treatment cycle is long for blood system diseases such as thrombocytopenia, aplastic anemia, myelodysplastic syndrome and the like, and is very unfavorable for hemostasis and recovery of abnormal uterine bleeding of patients.

The application of hormones causes psychological disorders and is also prone to induce various diseases and hormonal disorders. The traditional Chinese medicine has advantages and potentials for treating dysfunctional uterine bleeding. The anovulation type functional uterine bleeding in the traditional Chinese medicine belongs to the category of metrorrhagia and metrostaxis. Profound insights into metrorrhagia and metrostaxis are proposed by physicians of all ages in the following (Danxi Xin Fa Yuan): it is indicated for bleeding at the beginning to stop bleeding, and for clearing heat and cooling blood to clarify the source, and for tonifying blood to restore the original. The method is called three methods of 'plug flow', 'clarification' and 'rejuvenation'. { Jingyue quan shu, fu ren yin } is more comprehensive and exquisitely directed at the discussion of metrorrhagia and metrostaxis. It is clearly indicated that even though metrorrhagia and metrostaxis occur in disorder, it is suggested that the spleen and stomach, inferior and thoroughfare and conception vessels, and the kidney are impaired first. The onset of uterine bleeding is a severe disorder of the kidney-semiaquilegia-chong-ren-uterus axis. The main pathogenesis of the uterine bleeding is thoroughfare and conception vessel injury, and the menstrual blood cannot be restricted, so that the uterine bleeding is abnormal, and the common causes and pathogenesis of the uterine bleeding are spleen deficiency, kidney deficiency, blood heat and blood stasis. The method comprises the following steps: deficiency, heat, stasis.

Metrorrhagia and metrostaxis is a disease, which is summarized as the mechanism of deficiency, heat and stasis, like the blood syndrome. However, the zang-fu organs are mutually restricted, so the zang-fu organs, qi and blood, and meridians are closely related, the disease is mainly in the kidney, the location of the disease is in the thoroughfare and conception vessels and the uterus, and the change is in qi and blood, manifesting as metrorrhagia and metrostaxis. The accumulation and diarrhea can be classified as serious disorder of the kidney-Tian Dec-Chong and ren-uterus axis. Metrorrhagia and metrostaxis refers to the condition of spleen and kidney deficiency, which causes qi deficiency, blood heat and blood stasis, resulting in irregular flow of menstrual blood from the uterus. Spleen deficiency or kidney deficiency damages the thoroughfare and conception vessels, which fail to control blood due to qi deficiency, causing the menstrual fluid to be discharged occasionally. The root cause of the disease is qi deficiency, which can cause blood loss and blood loss, leading to more qi consumption and more deficiency of Chong and ren meridians. Qi invigorating is the root of treating dysfunctional uterine bleeding, and hemostasis is the key point of treatment. The kidney deficiency is the main pathogenesis of functional blood, but the spleen is the source of the generation and transformation of qi and blood, mainly governing blood, and is the acquired root, blood is also the root of women, qi can control blood, spleen deficiency cannot control blood, and qi deficiency cannot control blood is the root cause of functional blood. The spleen is closely related to the female reproductive system.

Disclosure of Invention

The invention aims to solve the technical problems that the traditional Chinese medicine composition for treating abnormal uterine bleeding and the preparation method thereof are provided, aiming at the defects of the existing medicines for fundamentally treating abnormal uterine bleeding, such as the western medicine treatment mainly adopts chemical medicine treatment, the side effects are large, the symptoms are not treated, the root causes are not treated, the pain of patients cannot be fundamentally solved, and the abundant clinical experience is accumulated in the traditional Chinese medicine for hundreds of years; deficiency of spleen qi can lead to palpitation, shortness of breath, lassitude, asthenia, lassitude, pale mouth, poor appetite, and distending pain after eating; the spleen blood deficiency causes sallow complexion, and the spleen yang deficiency causes loose stool which is closely related to the dysfunction of organs such as heart, liver, kidney, spleen and the like, and the malnutrition or uneasiness of heart and mind. The invention discloses a traditional Chinese medicine composition for treating abnormal uterine bleeding and a preparation method thereof, and the traditional Chinese medicine composition is used for fundamentally treating metrorrhagia and metrostaxis by adopting a method of tonifying qi, controlling blood, nourishing blood and stopping bleeding.

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition for treating abnormal uterine bleeding, which comprises the following components in parts by weight: 100-500 parts of ginseng, 100-500 parts of astragalus membranaceus, 100-400 parts of prepared rehmannia root, 100-400 parts of angelica sinensis, 100-400 parts of white peony root, 100-500 parts of folium artemisiae argyi charcoal, 100-500 parts of hairyvein agrimonia herb and bud and 100-500 parts of motherwort.

The traditional Chinese medicine composition for treating abnormal uterine bleeding preferably comprises the following components in parts by weight: 100-300 parts of ginseng, 100-300 parts of astragalus membranaceus, 100-200 parts of prepared rehmannia root, 100-200 parts of angelica sinensis, 100-300 parts of white peony root, 100-300 parts of folium artemisiae argyi charcoal, 100-300 parts of hairyvein agrimonia herb and bud and 100-300 parts of motherwort.

The traditional Chinese medicine composition for treating abnormal uterine bleeding is prepared from the following components in parts by weight: 200-500 parts of ginseng, 200-500 parts of astragalus membranaceus, 200-400 parts of prepared rehmannia root, 200-400 parts of angelica sinensis, 200-400 parts of white peony root, 200-500 parts of folium artemisiae argyi charcoal, 200-500 parts of hairyvein agrimonia herb and bud and 200-500 parts of motherwort.

The traditional Chinese medicine composition for treating abnormal uterine bleeding is prepared from the following components in parts by weight: 250-350 parts of ginseng, 250-350 parts of astragalus membranaceus, 100-200 parts of prepared rehmannia root, 100-200 parts of angelica sinensis, 100-200 parts of white peony root, 250-350 parts of folium artemisiae argyi charcoal, 250-350 parts of hairyvein agrimonia herb and bud and 250-350 parts of motherwort.

The traditional Chinese medicine composition for treating abnormal uterine bleeding can be prepared into any one of common preparations.

The traditional Chinese medicine composition for treating abnormal uterine bleeding can be prepared into preparations including tablets, capsules, granules, pills, mixtures, syrups, soft extracts, powders, suppositories, gels, sprays or injections.

The traditional Chinese medicine can be replaced by traditional Chinese medicines with the same or similar efficacies, and the medicinal materials can be processed according to national traditional Chinese medicine processing standards or traditional Chinese medicine dictionary, for example, prepared rehmannia root can be replaced by radix rehmanniae recen, folium artemisiae argyi charcoal can be replaced by folium artemisiae argyi, and radix astragali can be replaced by radix astragali preparata, and the replaced efficacy is better than that of the original medicine, but the invention belongs to the content of the traditional Chinese medicine.

In order to solve the technical problems, the invention provides a preparation method of a traditional Chinese medicine composition for treating abnormal uterine bleeding, which comprises the following steps:

weighing 100-500 parts of ginseng, 100-500 parts of astragalus, 100-400 parts of prepared rehmannia root, 100-400 parts of angelica, 100-400 parts of white paeony root, 100-500 parts of folium artemisiae argyi charcoal, 100-500 parts of hairyvein agrimony and 100-500 parts of motherwort according to the proportion. Standby;

heating and refluxing ginseng, astragalus membranaceus, prepared rehmannia root, angelica sinensis, radix paeoniae alba, folium artemisiae argyi charcoal, hairyvein agrimony and motherwort with water in an amount which is 6-14 times that of crude drugs for 0.5-5 hours, heating and refluxing for 1-3 times, filtering, combining extracting solutions, and concentrating the extracting solutions at 40-90 ℃ under reduced pressure until the density is 1.01-1.20 for later use;

thirdly, drying the concentrated solution obtained in the second step at 50-90 ℃, crushing the dry paste, adding auxiliary materials, and preparing the preparation.

In order to solve the above technical problems, the present invention further provides a preparation method of a traditional Chinese medicine composition for treating abnormal uterine bleeding, the preparation method comprising the following steps:

secondly, adding 50-90% ethanol which is 6-14 times of the crude drug into the ginseng, the astragalus and the folium artemisiae argyi charcoal, heating, refluxing and extracting for 0.5-5 hours, heating, refluxing and extracting for 1-3 times, filtering, combining extracting solutions, and concentrating under reduced pressure at 40-90 ℃ until the density is 1.01-1.20 for later use;

thirdly, taking prepared rehmannia root, Chinese angelica, white paeony root, hairyvein agrimony and motherwort herb, adding water with the crude drug amount of 6-14 times, carrying out reflux extraction for 0.5-5 hours, filtering, keeping the filtrate for later use, adding water with the crude drug amount of 6-14 times into the dregs of a decoction, carrying out reflux extraction for 0.5-5 hours by heating, carrying out reflux extraction for 1-3 times by heating, filtering, combining the extracting solutions, carrying out reduced pressure concentration at 40-90 ℃ until the density is 1.01-1.20, combining the concentrated solutions obtained in the second step, and continuously concentrating until the density is 1.05-1.15 for later use;

fourthly, drying the concentrated solution obtained in the third step at 50-90 ℃, crushing the dry paste, adding auxiliary materials, and preparing the preparation.

In order to solve the technical problems, the invention also provides a preparation method of the traditional Chinese medicine composition for treating abnormal uterine bleeding, which comprises the following steps:

secondly, taking ginseng, astragalus membranaceus, prepared rehmannia root, Chinese angelica, white paeony root, folium artemisiae argyi charcoal, hairyvein agrimony and motherwort, adding 50-90% of ethanol which is 6-12 times of the crude drug amount, heating and refluxing for 1-3 hours, heating and refluxing for 1-3 times, filtering, combining extracting solutions, and concentrating the extracting solutions at 50-80 ℃ under reduced pressure until the density is 1.05-1.20 for later use;

weighing 100-500 parts of ginseng, 100-500 parts of astragalus, 100-400 parts of prepared rehmannia root, 100-400 parts of angelica, 100-400 parts of white paeony root, 100-500 parts of folium artemisiae argyi charcoal, 100-500 parts of hairyvein agrimony and 100-500 parts of motherwort for later use;

② crushing angelica and sieving to obtain middle powder for standby;

thirdly, adding 6-14 times of crude drug amount of water into ginseng, astragalus membranaceus, prepared rehmannia root, white paeony root, folium artemisiae argyi charcoal, hairyvein agrimony and motherwort, soaking for 0.5-1 hour, heating and refluxing for extraction for 1-3 hours, heating and refluxing for extraction for 1-3 times, filtering, combining extracting solutions, concentrating at 50-90 ℃ under reduced pressure until the density is 1.05-1.20, adding the powder obtained in the last step, and stirring for later use;

fourthly, drying the thick paste obtained in the third step at 50-90 ℃, crushing the dry paste, adding auxiliary materials, and preparing the preparation.

pulverizing Ginseng radix, radix astragali, radix rehmanniae Preparata, radix Angelicae sinensis, radix Paeoniae alba, folium Artemisiae Argyi preparata, herba et Gemma Agrimoniae, and herba Leonuri into powder, and sieving;

and thirdly, adding auxiliary materials into the powder obtained in the step II, and preparing a preparation.

In order to solve the technical problems, the invention provides an application of a traditional Chinese medicine composition for treating abnormal uterine bleeding in treating abnormal uterine bleeding.

Drawings

FIG. 1 is a graph showing the trend of the change in body weight of animals between groups of female rats after 12 weeks of administration.

Detailed Description

The following examples are intended to illustrate the preparation of the medicaments according to the invention, but they are not intended to limit the scope of the invention in any way.

Example 1

A traditional Chinese medicine composition for treating abnormal uterine bleeding comprises, by weight, 300 parts of ginseng, 300 parts of astragalus membranaceus, 200 parts of prepared rehmannia root, 400 parts of angelica sinensis, 300 parts of radix paeoniae alba, 300 parts of folium artemisiae argyi charcoal, 300 parts of hairyvein agrimony and 300 parts of motherwort.

The preparation method comprises the following specific steps:

adding 80% ethanol 12 times of crude drug into ginseng, astragalus and folium artemisiae argyi charcoal, performing reflux extraction for 2 hours, filtering, reserving filtrate, adding 80% ethanol 12 times of crude drug into dregs of a decoction, performing reflux extraction for 2 hours, filtering, combining 2 times of extracting solutions, and performing reduced pressure concentration at 60 ℃ until the density is 1.08 for later use;

secondly, adding 12 times of crude drug amount of water into prepared rehmannia root, Chinese angelica, white paeony root, hairyvein agrimony and motherwort, carrying out reflux extraction for 2 hours, filtering, reserving filtrate for later use, adding 12 times of crude drug amount of water into dregs of a decoction, carrying out reflux extraction for 2 hours, filtering, merging 2 times of extracting solutions, carrying out reduced pressure concentration at the temperature of 60 ℃ until the density is 1.08, merging the concentrated solutions obtained in the first step, and continuing to concentrate until the density is 1.10 for later use;

③ drying the concentrated solution obtained in the step (②) at 70 ℃, crushing the dry paste, adding auxiliary materials and preparing into capsules.

Example 2

The preparation method comprises the following specific steps:

③ drying the concentrated solution obtained in the step (②) at 70 ℃, crushing the dry paste, adding auxiliary materials and preparing into granules.

Example 3

A traditional Chinese medicine composition for treating abnormal uterine bleeding comprises, by weight, 400 parts of ginseng, 400 parts of astragalus membranaceus, 200 parts of prepared rehmannia root, 200 parts of angelica sinensis, 300 parts of radix paeoniae alba, 300 parts of folium artemisiae argyi charcoal, 300 parts of hairyvein agrimony and 300 parts of motherwort herb.

The preparation method comprises the following specific steps:

adding water with the crude drug amount being 12 times that of ginseng, astragalus membranaceus, prepared rehmannia root, Chinese angelica, white paeony root, charred folium artemisiae argyi, hairyvein agrimony and motherwort into water, performing reflux extraction for 2 hours, filtering, keeping filtrate for later use, adding water with the crude drug amount being 12 times that of decoction dregs, performing reflux extraction for 2 hours, filtering, combining 2 times of extracting solutions, and performing reduced pressure concentration at the temperature of 60 ℃ until the density is 1.08 for later use;

② drying the concentrated solution at 60 ℃, adding auxiliary materials after crushing the dry paste, and preparing into capsules.

Example 4

The preparation method comprises the following specific steps:

② drying the concentrated solution at 60 ℃, adding auxiliary materials after crushing the dry paste, and preparing into granules.

Example 5

A traditional Chinese medicine composition for treating abnormal uterine bleeding comprises, by weight, 300 parts of ginseng, 300 parts of astragalus membranaceus, 100 parts of prepared rehmannia root, 100 parts of angelica sinensis, 200 parts of radix paeoniae alba, 200 parts of folium artemisiae argyi charcoal, 200 parts of hairyvein agrimony and 200 parts of motherwort.

The preparation method comprises the following specific steps:

pulverizing angelica sinensis, and sieving to obtain medium powder for later use;

adding water with the crude drug amount being 10 times that of ginseng, astragalus membranaceus, prepared rehmannia root, white paeony root, charred folium artemisiae argyi, hairyvein agrimony and motherwort into the ginseng, performing reflux extraction for 1.5 hours, filtering, keeping the filtrate for later use, adding water with the crude drug amount being 10 times that of the dregs of a decoction, performing reflux extraction for 1.5 hours, filtering, combining 2 times of extracting solutions, performing reduced pressure concentration at 70 ℃ until the density is 1.06, adding the powder obtained in the step I, and uniformly stirring for later use;

③ drying the thick paste obtained in the step (②) at 60 ℃, crushing the dry paste, adding auxiliary materials and preparing into capsules.

Example 6

The preparation method comprises the following specific steps:

③ drying the thick paste obtained in the step (②) at 60 ℃, crushing the dry paste, adding auxiliary materials, and preparing into granules.

Example 7

A traditional Chinese medicine composition for treating abnormal uterine bleeding comprises, by weight, 200 parts of ginseng, 200 parts of astragalus membranaceus, 100 parts of prepared rehmannia root, 100 parts of angelica sinensis, 100 parts of radix paeoniae alba, 100 parts of folium artemisiae argyi charcoal, 100 parts of hairyvein agrimony and 100 parts of motherwort.

The preparation method comprises the following specific steps:

pulverizing ginseng, astragalus, prepared rehmannia root, angelica, white paeony root, folium artemisiae argyi charcoal, hairyvein agrimony and motherwort into powder and sieving for later use;

② adding auxiliary materials into the powder obtained in the step I, and preparing the capsule.

Example 8

The preparation method comprises the following specific steps:

② adding auxiliary materials into the powder of the first step, and preparing into granules.

Example 9

A traditional Chinese medicine composition for treating abnormal uterine bleeding comprises, by weight, 400 parts of ginseng, 400 parts of astragalus membranaceus, 300 parts of prepared rehmannia root, 300 parts of angelica sinensis, 400 parts of radix paeoniae alba, 400 parts of folium artemisiae argyi charcoal, 400 parts of hairyvein agrimony and 400 parts of motherwort herb.

The preparation method comprises the following specific steps:

adding 80% ethanol of 10 times of crude drug amount into ginseng, astragalus membranaceus, prepared rehmannia root, Chinese angelica, white paeony root, charred folium artemisiae argyi, hairyvein agrimonia herb and motherwort, performing reflux extraction for 1.5 hours, filtering, reserving filtrate, adding 80% ethanol of 10 times of crude drug amount into dregs of a decoction, performing reflux extraction for 1.5 hours, filtering, combining 2 times of extracting solutions, and performing reduced pressure concentration at 60 ℃ until the density is 1.10 for later use;

② drying the concentrated solution of the first step at 60 ℃, adding auxiliary materials after crushing the dry paste, and preparing into capsules.

Example 10

The preparation method comprises the following specific steps:

② drying the concentrated solution of the first step at 60 ℃, adding auxiliary materials after crushing the dry paste, and preparing into granules.

Example 11

The preparation method comprises the following specific steps:

pulverizing ginseng, astragalus, prepared rehmannia root, angelica, white paeony root, folium artemisiae argyi charcoal, hairyvein agrimony and motherwort into fine powder for later use;

② preparing the fine powder of the step I into powder to obtain the medicine.

The pharmacodynamics study of the traditional Chinese medicine composition of the invention is as follows:

the Chinese medicinal composition of the invention has the advantages of anti-hemorrhage and hemostasis test:

the purpose is as follows: by measuring the bleeding time and the blood coagulation time of the KM mice, the anti-bleeding and hemostatic effects of the test sample (the traditional Chinese medicine composition disclosed by the invention) given by gastric lavage are observed.

The method comprises the following steps: 50 KM mice with qualified quarantine are taken, female is not pregnant, 18-22 g, are adaptively raised for 5 days before test, and are randomly divided into 5 groups according to the body weight, a solvent control group and a positive control group (uterus preserving hemostasis granules), wherein the test article (the traditional Chinese medicine composition provided by the invention) comprises 10 groups of low, medium and high dose groups. The method comprises the steps of respectively administering 1.25g/kg, 2.5g/kg and 5.0g/kg of test article suspension to a low-dose component, a medium-dose component and a high-dose component of a test article (the traditional Chinese medicine composition disclosed by the invention), administering 3.9g/kg of uterine bleeding stopping particle suspension to a positive control group, administering 0.5% sodium carboxymethylcellulose suspension to a solvent control group, performing intragastric administration to each group, administering the injections with the administration volume of 0.2mL/10g, administering the injections 1 time per day for 7 days continuously, administering the injections 30min after the last administration, fixing the mice, measuring and marking the rat tail length by a millimeter ruler, cutting the rat tail end 3mm by tissue scissors respectively, starting timing when blood overflows automatically, slightly sucking blood drops 1 time by using filter paper every 30s until the blood stops naturally (no blood exists when the filter paper sucks), and obtaining the bleeding time. After the bleeding time is measured, the inner canthus blood sampling is carried out on the mouse by using a broken capillary tube (about 1.5cm long), after the 1 st drop of blood is removed, 1 drop of blood is dropped on a glass slide, a stopwatch is used for timing immediately, a pin is used for gently picking from the edge of the blood drop to the middle 1 time every 20s, the timing is stopped when the blood silk is picked up, the time is recorded, and the bleeding and blood coagulation time of each group is compared.

As a result: bleeding time: compared with a solvent control group, the test article (the traditional Chinese medicine composition of the invention) is continuously administrated for 7 days, the bleeding time of mice in a low-dose group and a high-dose group is obviously shortened (P is less than 0.05), the bleeding time of mice in a positive control group is also obviously shortened (P is less than 0.05), and the result shows that the bleeding time of the test article (the traditional Chinese medicine composition of the invention) can be obviously shortened; blood coagulation time: compared with a solvent control group, the test article (the traditional Chinese medicine composition of the invention) is continuously administrated for 7 days, the coagulation time of a medium-dose group mouse is obviously shortened (P is less than 0.05), the coagulation time of a positive control group mouse is also obviously shortened (P is less than 0.05), and the result shows that the test article (the traditional Chinese medicine composition of the invention) can obviously shorten the coagulation time. The results are shown in Table 1.

Table 1 effect of the Chinese medicinal composition on bleeding and clotting time in mice (n 10, Mean ± SD)

P < 0.05 compared to vehicle control.

And (4) conclusion: the traditional Chinese medicine composition is continuously infused into the stomach for 7 days at the concentration of 1.25g/kg, 2.5g/kg and 5.0g/kg, and the bleeding and blood coagulation time of the mouse can be obviously shortened.

The traditional Chinese medicine composition has the following effects on a rat model with spleen failing to control blood:

the purpose is as follows: SD rats are adopted to prepare a rat model with spleen qi deficiency by a method of fatigue (swimming) and purgation (senna leaves), and then bleeding factors (leech powder) are added to cause the rat model with spleen failing to control blood, so that the influence of a test product (the traditional Chinese medicine composition in the invention) on the aspects of ovarian estrogen, blood coagulation, blood convention, uterine weight and the like of the rat model with the spleen failing to control blood is researched, and the functional indications of the test product are evaluated.

The method comprises the following steps: 60 quarantine qualified SD rats with female infertility and weight of 180-220g are taken, and are randomly divided into 6 groups according to the weight during the test, a normal control group, a spleen failure governing blood syndrome model group, a positive control group (ginseng spleen-invigorating pill), low, medium and high dose groups of the test article (the traditional Chinese medicine composition in the invention), and 10 groups. The rat is adapted to the environment for 6 days, then the model is made, except for a normal control group, the other 5 groups swim for 15min every day, the water temperature is 21-22 ℃, the stomach is filled with the senna leaf leech powder solution, the administration volume is 3 mL/mouse/day, and the model making period is 15 days. The drug administration starts on the 6 th day after the model building, about 4 hours after the model building every day, 0.5% carboxymethyl cellulose sodium suspension is given to a normal control group and a spleen failing to control blood, 0.8g/kg, 1.6g/kg and 3.2g/kg of suspension of a test article (the traditional Chinese medicine composition in the invention) is given to a low, medium and high dose groups of a test article group respectively, 1.08g/kg of suspension of a ginseng-spleen pill is given to a positive control group, the drug administration is performed by gastric perfusion in each group, the drug administration volume is 1mL/100g, the drug administration is performed 1 time every day, and the drug administration is performed continuously for 10 days. 0.5h after the last administration, 3% sodium pentobarbital is injected into the abdominal cavity for anesthesia, the abdominal aorta is used for blood sampling, the E2 (estradiol) and P (progesterone) levels in the serum are measured by an enzyme-linked immunosorbent assay, a full-automatic animal blood analyzer is used for measuring the blood routine, a Prothrombin Time (PT) is measured by a hemagglutination instrument, rats are killed, the uterus and the ovary are removed, the weight of the uterus and the ovary is weighed, and the organ indexes of the uterus and the ovary are calculated.

As a result: general conditions: during the molding period, the fur of each group of animals is not glossy, the ingestion and drinking water are reduced, and on the 6 th day of molding, the animals of each group begin to diarrhea, most animals are not shaped and thin but have mucus, and few animals have water-like feces. The continuous administration treatment is carried out for 10 days, the stool dilution rate of the model control group is 100 percent, the stool dilution rate of the low, medium and high dose groups of the test sample group is 90 percent, 100 percent and 80 percent, and the stool dilution rate of the positive control group is 50 percent. The result shows that the ginseng test sample has no obvious influence on the stool dilution rate of the rats with spleen failing to control blood; weight: the weight of the model control group animal is obviously reduced (P is less than 0.05 or 0.01) after 6-15 days of molding, the continuous administration treatment is carried out for 10 days, and compared with the model control group, the weight average of each dose group of the test sample and the positive control group is in an improvement trend, but no statistical difference is seen; the hematology index is as follows: after the model is made, the number of red blood cells of the model control group is increased, the hemoglobin content (HGB) is obviously increased (P is less than 0.05), the treatment is continuously carried out for 10 days, and compared with the model control group, the hematology indexes of each dose group and the positive control group of the test sample are not obviously different. The result shows that the test article (the traditional Chinese medicine composition of the invention) has no obvious influence on the hematology indexes of the rats with spleen failing to control blood; estrogen: after modeling, the estradiol (E2) of the model control group is obviously increased (P is less than 0.05), and the estradiol of each dosage group of the test sample is in a descending trend compared with the estradiol of the model control group after continuous administration for 10 days, wherein the estradiol of the high dosage group of the test sample is obviously reduced (P is less than 0.05). After modeling, the progesterone (Pg) of the model control group is obviously reduced, (P is less than 0.05), the progesterone of each dosage group of the test article is increased compared with the progesterone of the model control group after continuous administration for 10 days. The result shows that the test article (the traditional Chinese medicine composition of the invention) can improve the level of the estrogen of the rat with the spleen failing to control the blood; uterus and ovarian organ index: after modeling, the uterus index of the model control group is obviously increased (P is less than 0.05), and the uterus index of each dosage group of the test article is in a decreasing trend compared with the uterus index of the model control group after continuous administration for 10 days, wherein the uterus index of the high dosage group of the test article is obviously decreased (P is less than 0.05). After modeling, the ovarian index of the model control group is in a decreasing trend, the ovarian index of each dose group of the test sample is in an increasing trend compared with the ovarian index of the model control group after continuous administration for 10 days, wherein the ovarian index of the low dose group of the test sample is obviously increased (P is less than 0.05). The result shows that the test article (the traditional Chinese medicine composition of the invention) can improve the abnormal index of the uterus and the ovary viscera of the rat with the spleen failing to control blood. The results are shown in tables 2, 3, 4, 5 and 6.

TABLE 2 influence of Chinese medicinal composition on the stool dilution rate of rats with spleen failing to control blood

TABLE 3 influence of the Chinese medicinal composition on the body weight of rats with spleen failing to control blood (g, n 10, Mean + -SD)

Comparing with normal control group^*p<0.05，^**p<0.01

TABLE 4 influence of the Chinese medicinal composition on the hematological index of rats with spleen failing to control blood (Mean + -SD)

P < 0.05 compared to normal control group

TABLE 5 influence of the Chinese medicinal composition on the Pg and E2 indexes of rats with spleen failing to control blood (Mean + -SD)

P < 0.05 compared to normal control; compared with the model control group,^#P＜0.05

TABLE 6 influence of the Chinese medicinal composition on index of uterus and ovary of rat with spleen failing to control blood (n 10, Mean + -SD)

and (4) conclusion: the traditional Chinese medicine composition is continuously infused into the stomach for 10 days at the ratio of 0.8g/kg, 1.6g/kg and 3.2g/kg, so that the abnormal levels of estrogen and the abnormal indexes of uterus and ovary viscera of rats with spleen failing to control blood can be improved; the weight loss of rats with spleen failing to control blood is also improved, but the loose stool rate and hematology indexes of rats with spleen failing to control blood are not obviously affected.

Acute toxicity test:

the purpose is as follows: the animals were observed for acute toxicity after oral administration of the Chinese medicinal composition.

The method comprises the following steps: 20 female SD rats with the weight of 199.6-232.4 g (the weight of the scheme is estimated to be 180-220g) are taken, and after the female SD rats are adaptively fed for 4 days before the test, the female SD rats are randomly divided into 2 groups according to the weight, namely a solvent control group and a test object group, and each group comprises 10 female SD rats. All animals were fasted for about 16 hours before the test and had free access to water. The animals in the vehicle control group are administered with 0.5 percent of sodium carboxymethylcellulose, the animals in the test group are administered with test substance (the traditional Chinese medicine composition of the invention) suspension, the administration concentration is 0.5g/mL (according to the maximum preparation concentration), the injection is performed 3 times by intragastric administration within one day, the administration interval is about 2 hours, the administration volume is 20 mL/kg/time, namely the administration amount is 30g/kg, the injection amount is 18.5 times of the clinical daily dose according to the conversion of the body surface area, the general state, the toxicity performance and the dead animal number of the animals are observed and recorded within the period from the moment to 0.5h after each administration and 2h and 4h after the last administration. The animals were examined once daily for 14 days from day 2, and the body weights were measured 7 and 14 days after administration, and after the examination, gross anatomy examination was conducted on all animals, histopathology examination was conducted if abnormality occurred, and gross anatomy examination was conducted on dead animals at any time during the test, and histopathology examination was conducted if abnormality occurred.

As a result: no animal death is observed 14 days after the test sample (the traditional Chinese medicine composition of the invention) is administered with the maximum dosage of 30g/kg, and the body weight of the test sample is not obviously different from that of a vehicle control group. Gross anatomical examination showed no significant toxic pathological changes to the major animal organs. The results are shown in tables 7 and 8.

TABLE 7 acute toxicity test results for Chinese medicinal composition

TABLE 8 results of weight change (g, Mean + -SD) in acute toxicity test of Chinese medicinal composition

And (4) conclusion: the traditional Chinese medicine composition is basically nontoxic through oral acute toxicity.

Long-term toxicity test:

the purpose is as follows: observing the toxic reaction and the severity thereof of the body generated by the traditional Chinese medicine composition continuously administrated by gastric lavage to SD rats for 12 weeks, providing the reversibility of target organs of the toxic reaction and the damage thereof, determining the dose of the non-toxic reaction, and providing animal experiment data for clinical research and application.

The method comprises the following steps: 84 female SD rats (including 4 sentinel animals) which are qualified for quarantine are 6-7 weeks old, the weight is 165.8-190.5 g (the weight is estimated to be 160-180 g according to a scheme) after the quarantine is finished, the female SD rats are adaptively raised for 6 days before the test, the female SD rats are randomly divided into 4 groups according to the weight during the test, and the female SD rats are 20 animals in each group, namely a solvent control group, a low-subject group, a medium-subject group and a high-subject group. The low, medium and high dose components of the test substance are respectively administered with 2.5, 5.0 and 10.0g/kg of the suspension of the traditional Chinese medicine composition of the invention, the solvent control group is administered with 0.5 percent sodium carboxymethyl cellulose suspension, and the test substance is administered by intragastric administration, the administration volume is 2mL/100g of body weight, the administration is carried out for 1 time every day, the administration is carried out for 6 days every week, the rest is carried out for 1 day, and the administration is carried out for 12 weeks continuously. During dosing animals were observed daily for signs of appearance, behavioral activity, and weekly body weights and food intake were measured. After continuous administration for 12 weeks, sorting according to animal numbers, selecting 12 animals with small animal numbers in each group, after fasting for about 16 hours, performing intraperitoneal injection anesthesia by using 1.5mL/kg of 3% sodium pentobarbital, performing abdominal aorta blood collection to observe changes of animal hematology indexes and blood biochemical indexes, then performing general dissection, weighing heart, liver, spleen, kidney, adrenal gland, thymus, uterus, ovary and brain, and calculating organ coefficients; histopathological examination was performed on the following organs: brain (brain, cerebellum, brainstem), spinal cord (neck, chest, lumbar), pituitary, thymus, thyroid, esophagus, stomach, large and small intestine, liver, kidney, adrenal gland, spleen, pancreas, trachea, lung, heart, aorta, ovary, uterus, vagina, breast, sciatic nerve (with skeletal muscle), bladder, femur (with bone marrow), mesenteric lymph nodes, salivary glands, and other abnormal tissues found at the autopsy of the system. And (4) observing the rest animals for 4 weeks, and after the observation period is finished, killing the rest animals and detecting the indexes. The sentinel animals are also completely killed after the test is finished, and the corresponding data of the sentinel animals are only used as the background data of the center and are irrelevant to the test result of the special subject.

As a result: general condition and death: continuously administering for 12 weeks and stopping and recovering for 4 weeks, wherein animals in the high-dose group resist struggle when being administered due to the long-term administration of viscous liquid medicine, wherein 3 animals are slightly choked due to stomach filling misoperation, and further have symptoms such as periodic respiratory abnormality, emaciation, inactivity or increased aggressiveness, and the appearance and physical signs of other groups of animals are not obviously abnormal, and all groups of animals do not die; food intake: compared with a solvent control group, during the continuous administration period of the test article, the food intake of the medium-dose group at the 9 th week is obviously increased, the food intake of the high-dose group at the 7 th week is obviously reduced, the change is transient, and dose and time correlation is not seen, so that the food intake of each group is considered to be independent of the toxicity of the test article, and the food intake of each group is not obviously abnormal in the recovery period after the drug is stopped; weight: compared with the vehicle control group, the animal body weight is obviously increased in the test article at 2 and 9 weeks of the administration of the high dose group and at 2 weeks of the administration of the test article, the change is transient, and dose and time correlation is not seen, so the test article is considered to be unrelated to the toxicity of the test article; and (3) hematology examination: the test sample is continuously administrated for 12 weeks, and no obvious abnormality is found in hematological indexes of each dosage group; after stopping the drug and recovering for 4 weeks, the mononuclear cell ratio (MO%) of the low-dose group is obviously increased, the red/white blood cell ratio (R: W) of the high-dose group is obviously increased, the changes occur in the recovery period of the drug stopping, and do not exceed the reference range of the background data of normal animals in the center, and no clear dose correlation is seen, so the changes are considered to have statistical significance but have no toxicological significance, and other hematological indexes are not obviously abnormal; blood biochemical examination: the Creatinine (CRE) of the high-dose group is obviously reduced after the test sample is continuously administered for 12 weeks, the change does not exceed the range of the historical control value of the center, and no clear dose correlation is seen, so that the test sample is considered to have statistical significance but no toxicological significance, the drug withdrawal is recovered for 4 weeks, and no obvious abnormality is seen in blood biochemical indexes of each dose group; organ weight and organ coefficient: the test sample is continuously administrated for 12 weeks, and the body ratio coefficient of the liver and the kidney of the high-dose group animal is obviously increased; the change has statistical significance, but no clear dose correlation is seen, and no related toxic pathological change is seen in histopathological examination, so that the change is considered to have no toxic pathological significance, the drug withdrawal is recovered for 4 weeks, and the weight of the viscera and the viscera volume ratio coefficient of each dose group of animals have no obvious abnormality. And (3) pathological examination: the test article is clinically used for female metrorrhagia and metrostaxis, vaginal blood stranguria and metrorrhagia and functional uterine bleeding; the test samples 2.5, 5.0 and 10.0g/kg are continuously administered to female rats by intragastric administration for 12 weeks and the drug withdrawal is recovered for 4 weeks, and no abnormal pathological changes are found in the female reproductive system. During the continuous administration and withdrawal recovery period, the vehicle control group and each administration group can have multiple tracheitis and lung inflammation, and compared with the vehicle control group, the incidence rate of each administration group is similar, so the background lesion is considered. Therefore, it is considered that the samples 2.5, 5.0 and 10.0g/kg are continuously administered to female rats by gavage for 12 weeks and the withdrawal is recovered for 4 weeks, and no pathological changes related to drug toxicity are found. The data results are shown in FIG. 1; table 9, table 10 and table 11.

TABLE 9 Effect of the Chinese medicinal composition on SD rat body weight (g, Mean + -SD) for 12 weeks with drug administration and 4 weeks without drug administration

TABLE 10 influence of the composition on food intake in SD rats (g/mouse, Mean + -SD) for 12 weeks with drug and 4 weeks without drug

P < 0.05 compared to vehicle control; p < 0.01.

TABLE 11 histopathological examination results summary Table (number of incidences/number of animals)

And (4) conclusion: the traditional Chinese medicine composition is basically safe to use under the experimental condition, and is safe and reliable to use under the specified dosage.

The clinical test of the traditional Chinese medicine composition provided by the invention comprises the following steps:

the clinical application of the traditional Chinese medicine composition of the invention is typically as follows:

case 1: zhao, woman, age 32, patient self-declares discontinuous bleeding spots on skin, ecchymosis for 10 years, dripping menstruation for more than 1 month, diagnosis: pale complexion, lassitude, shortness of breath, no desire to speak, poor appetite, pale lips and nails, dizziness, lassitude, dripping menstruation, pale and thin tongue with white and thin coating, slow pulse, metrorrhagia and metrostaxis-qi failing to control blood. After the traditional Chinese medicine composition of the embodiment 1 of the invention is taken for 10 days, the menstruation is clean, the bleeding is not caused, the subjective physical strength is improved, the taking is continued for 7 days, and the blood routine is rechecked to be normal. The menstruation of the patients is normal after continuous follow-up for 3 months, and the hemoglobin rises to be normal.

Case 2: lu Yi, female, 45 years old, patients with menorrhagia, face-whitening, debilitation 4 years, aggravation 3 days, diagnosis: pale complexion, palpitation, shortness of breath, empty abdomen, profuse menstruation, pale red, clear and thin quality, pale tongue with white coating, thready and weak pulse, manifested as menorrhagia-qi failing to control blood. After the traditional Chinese medicine composition 2 of the embodiment 2 of the invention is taken, the menstrual bleeding is obviously reduced compared with the previous one, the menstruation is finished after 4 days, the examination is carried out again after one week, the hypodynamia is continuously improved compared with the previous one, the administration is continued, the menstruation is performed after 4 weeks, the menstrual blood is adequate, the discomfort such as blood clots and dysmenorrhea is avoided, the hemoglobin is recovered to be normal by the conventional blood examination, the continuous return visit is carried out for 3 months, the menstrual blood volume and the menstrual cycle are normal, the spirit and the diet are good, and the normal work and life can be realized.

Case 3: wangzhi, female, age 33, patient self-declares that the discontinuous menstrual cycle advances 8 days with face whitening and fatigue for 2 months, diagnosis: pale complexion, shortness of breath, no desire to speak, occasional dizziness, poor appetite, loose stool, advanced menstruation, profuse menstruation volume, pale red tongue with white coating, and weak and slow pulse. Syndrome of advanced menstruation, qi failing to control blood. After taking the traditional Chinese medicine composition of the embodiment 3 of the invention for 1 week, the vagina is rechecked to avoid bleeding again, and the sense and the strength are improved. The patient complains of poor appetite with diarrhea, after 2 weeks, the fatigue is continuously improved than before, no other discomfort is complained, and the menstrual flow is induced after the patient continues to take the medicine for 1 month, the menstrual flow is moderate, and the discomfort such as blood clots, dysmenorrheal and the like does not exist. Taking the medicine for half a month, and examining blood again to show that hemoglobin is normal. After the patient is followed for 3 months, the menstruation of the patient is not advanced any more, and the menstrual cycle returns to normal.

Case 4: li Shi, female, age 48, patient self-reported 10 days of intermittent menstruation, accompanied with facial whiteness, debilitation for more than 1 month, diagnosis: pale complexion, palpitation, shortness of breath, marked asthenia with dizziness, scanty menstruation, pale tongue with white coating, deep, thready and weak pulse, advanced menstruation disease-qi failing to control blood. After the traditional Chinese medicine composition of the embodiment 4 of the invention is taken for 2 days, the vaginal bleeding is obviously reduced before the administration, the vagina does not bleed again after the administration for 4 days, the conscious spirit is improved, the routine normality of the blood is rechecked after the continuous administration for 2 weeks, the complaint is obviously improved before the debilitation, the menstruation does not come again, the follow-up diagnosis is carried out after the continuous administration for 2 months, the menstrual cycle of a patient is recovered to be normal, and the bleeding is not irregular any more.

Case 5: liu Yi, female, age 44, with the patient dripping with menstruation with white complexion and hypodynamia for 20 days, and diagnosis: edema of face and limbs, shortness of breath, no desire to speak, cold limbs, palpitation, shortness of breath, continuous menstruation, pale and thin tongue with thin and white coating, slow pulse, metrorrhagia and metrostaxis. After the traditional Chinese medicine composition of the embodiment 5 of the invention is taken for 2 days, the vaginal bleeding is obviously reduced compared with the previous vaginal bleeding. After 4 days, the patient has better self-complaint and fatigue without vaginal bleeding, and after taking the medicine for 10 days, the blood checking routine returns to normal, the menstrual cycle returns to normal, and the bleeding is not irregular. After 3 months of continuous follow-up, the menstrual flow and menstrual cycle of the patient are both normal and can work normally.

Case 6: and (3) diagnosing that the female is 32 years old, the patient is self-reported to have a white face and hypodynamia with the menostaxis for 1 year: pale complexion, pale lips and nails, palpitation, short breath, lassitude, prolonged menstrual period, incomplete expiration, large dose, pale red, thin, pale tongue with white coating, slow and weak pulse, prolonged menstrual period-qi failing to control blood. After taking the traditional Chinese medicine composition of the embodiment 6 of the invention, the menstrual cycle is normal and has a tidal bore after half a month, the hypodynamia is better than before, the traditional Chinese medicine composition is continuously taken, and after 6 days, the menstruation time of a patient is over. After 2 weeks, the normal blood routine is checked again, the medicine is continuously taken, and after 1 month, the menstruation, the blood routine and the ferritin are recovered to be normal without the condition of prolonging the menstruation time. The continuous follow-up visit is 3 months, and the menstrual cycle and menstrual period are normal.

Case 7: for a certain period of time, women, age 34, patients self-reported a white complexion, weakness with menorrhagia for 10 months, and diagnosis: pale complexion, lassitude, fatigue, shortness of breath, no desire to speak, empty belly, profuse menstruation, pale tongue with thin coating, thready and weak pulse, menorrhagia-qi failing to control blood. After the traditional Chinese medicine composition disclosed by the embodiment 7 of the invention is taken for 2 days, the menstrual flow is reduced compared with that before, after 5 days, the menstruation is finished, after 1 week, the fatigue is better than that before, the traditional Chinese medicine composition is continuously taken, and after 14 days, the blood is checked again to be normal. Continuously taking for 2 months, continuously visiting for normal menstruation, wherein menstruation time is 5-7 days, and period is about 28 days, and blood routine and ferritin are checked to recover to normal without increasing menstruation.

Case 8: senior, female, age 28, patient with menorrhagia with pale complexion and asthenia for 1 year, diagnosis: pale complexion, lassitude, fatigue, shortness of breath, no desire to speak, empty belly, profuse menstruation, pale tongue with thin coating, thready and weak pulse, menorrhagia-qi failing to control blood. After the traditional Chinese medicine composition of the embodiment 8 of the invention is taken for 5 days, the menstruation is finished, after 3 weeks, the fatigue is better and better, the stool of a patient is dry, the traditional Chinese medicine composition is continuously taken, after 1 month, the blood routine is recovered to be normal, the menstruation volume is reduced compared with the previous one, and the period is normal. The menstrual flow is normal after continuous follow-up for 2 months, the menstruation time is about 6 days, the period is about 28 days, the blood routine and the ferritin are checked to be recovered to be normal, and the condition of menstrual flow increase is not generated.

Case 9: bear a certain amount, female, age 44, patient self-declares discontinuous skin bleeding point, ecchymosis 12 years, menstrual flow increase 3 days, diagnosis: moderate body, normal complexion, clear and powerful voice, unhealthy smell, cough and asthma and other abnormal odor, old purpura in skin, excessive menstruation, pale tongue, thin and white coating, thready and weak pulse, excessive menstruation-qi failing to control blood. When the traditional Chinese medicine composition of the embodiment 9 of the invention is taken on the 1 st day, the menstrual flow is reduced compared with the previous day, the patient complaints about the menstrual flow on the 3 rd day is obviously reduced compared with the previous day, the menstruation is clean on the 4 th day, the blood is checked to be normal, the traditional Chinese medicine composition is taken continuously, and the condition of menstrual flow increase does not occur any more. The follow-up visit is 2 months, and the menstrual cycle and the menstrual volume are recovered to be normal.

Case 10: yuan Zhi, female, age 48, patient self-reported 4 and half years of intermittent skin bleeding spots, ecchymosis with increased menstrual flow, diagnosed: the traditional Chinese medicine composition of the embodiment 10 of the invention is obviously reduced in menstrual volume after 1 day compared with the previous one after the administration of the composition for 1 day, normal in blood reexamination after 4 days, better and better in spirit, and tolerable to hypodynamia, and patients complain of diarrhea, and the patients complain of hemoglobin rising to normal after continuing to take the composition for 1 month, the menstrual volume of the menstrual cycle is reduced than the previous one, the cycle is normal, and the situation that the menstrual cycle lasts for 10 days is not stopped is not caused. The subsequent visit is continued for 3 months, the menstrual volume is not increased, the menstrual cycle is normal, and the mental state is good.

Claims

1. A traditional Chinese medicine composition for treating abnormal uterine bleeding is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 100-500 parts of ginseng, 100-500 parts of astragalus membranaceus, 100-400 parts of prepared rehmannia root, 100-400 parts of angelica sinensis, 100-400 parts of white peony root, 100-500 parts of folium artemisiae argyi charcoal, 100-500 parts of hairyvein agrimonia herb and bud and 100-500 parts of motherwort.

2. The traditional Chinese medicine composition for treating abnormal uterine bleeding according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 100-300 parts of ginseng, 100-300 parts of astragalus membranaceus, 100-200 parts of prepared rehmannia root, 100-200 parts of angelica sinensis, 100-300 parts of white peony root, 100-300 parts of folium artemisiae argyi charcoal, 100-300 parts of hairyvein agrimonia herb and bud and 100-300 parts of motherwort.

3. The traditional Chinese medicine composition for treating abnormal uterine bleeding according to claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 200-500 parts of ginseng, 200-500 parts of astragalus membranaceus, 200-400 parts of prepared rehmannia root, 200-400 parts of angelica sinensis, 200-400 parts of white peony root, 200-500 parts of folium artemisiae argyi charcoal, 200-500 parts of hairyvein agrimonia herb and bud and 200-500 parts of motherwort.

4. The traditional Chinese medicine composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising 250-350 parts of ginseng, 250-350 parts of astragalus membranaceus, 100-200 parts of prepared rehmannia root, 100-200 parts of angelica sinensis, 100-200 parts of radix paeoniae alba, 250-350 parts of folium artemisiae argyi charcoal, 250-350 parts of hairyvein agrimony and 250-350 parts of motherwort herb.

5. The traditional Chinese medicine composition for treating abnormal uterine bleeding according to any one of claims 1 to 4, wherein the traditional Chinese medicine composition is prepared into any one of common preparations, including tablets, capsules, granules, pills, mixtures, syrups, soft extracts, powders, suppositories, gels, sprays, or injections.

6. The method for preparing a Chinese medicinal composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising the steps of:

7. The method for preparing a Chinese medicinal composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising the steps of:

8. The method for preparing a Chinese medicinal composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising the steps of:

9. The method for preparing a Chinese medicinal composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising the steps of:

② crushing angelica and sieving to obtain middle powder for standby;

10. The method for preparing a Chinese medicinal composition for treating abnormal uterine bleeding according to claim 1, which is characterized by comprising the steps of: