Traditional Chinese medicine composition for treating early recurrent abortion caused by unknown reasons

Abstract

The invention relates to a traditional Chinese medicine for treating early recurrent abortion caused by unknown reasons, which can effectively solve the medication problem of the early recurrent abortion caused by unknown reasons. The traditional Chinese medicine composition is composed of a formula A and a formula B, wherein the formula A is composed of semen cuscutae, herba taxilli, radix dipsaci, radix angelicae sinensis, radix salviae miltiorrhizae, radix scutellariae, radix codonopsis, rhizoma atractylodis macrocephalae, semen ziziphi spinosae and radix glycyrrhizae preparata; the components of the formula B and the formula A are the same, but the dosages of the angelica sinensis and the salvia miltiorrhiza are different, the dosages of the angelica sinensis and the salvia miltiorrhiza in the formula A are respectively 15g, and the dosages of the angelica sinensis and the salvia miltiorrhiza in the formula B are respectively 10g. The traditional Chinese medicine composition is matched and mutually supported according to the primary and secondary relation of monarch, minister, assistant and guide, the prescription A has the effects of tonifying kidney, promoting blood circulation, clearing heat and preventing injury before pregnancy, the prescription B has the effects of continuously clearing heat, reinforcing kidney and preventing miscarriage after pregnancy, and the traditional Chinese medicine composition can be effectively used for treating early-stage unexplained recurrent spontaneous abortion, is convenient to take and good in effect, is a new breakthrough in medicine for treating early-stage unexplained recurrent spontaneous abortion and has a wide application prospect. The economic and social benefits are huge.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating early unexplained recurrent spontaneous abortion. Background Art

[0002] Abortion refers to the termination of pregnancy before 28 weeks and the fetal weight below 1000 grams. Recurrent spontaneous abortion (RSA) is defined as two or more consecutive spontaneous abortions. Among them, more than 50% of RSA cases have unknown causes, which is called unexplained recurrent spontaneous abortion (URSA). Most URSA cases occur before 12 weeks of pregnancy, which is called early URSA. The pathogenesis of URSA is unknown. Studies have shown that its occurrence may be related to the imbalance of maternal-fetal immune tolerance, abnormal placental blood supply, polymorphisms of folate metabolism-related genes, etc. Therefore, modern medicine often treats URSA by regulating immunity, anticoagulation, nutritional supplementation, etc. For example, progesterone is supplemented, anticoagulants such as aspirin, heparin or low molecular weight heparin are used, and immunosuppressants such as prednisone, hydroxychloroquine, and cyclosporine are used. However, there are still great controversies in the efficacy and safety. At present, there is no mature treatment plan to effectively improve the live birth rate of URSA patients; repeated pregnancy loss will bring heavy mental pressure to women. Moreover, due to the unknown cause of URSA and the lack of effective treatment drugs, patients are even more anxious and depressed. Psychological stress can become a new pathogenic factor of RSA, which further increases the difficulty of treatment. Therefore, finding safe and effective treatment drugs for URSA and promoting the reproductive health of patients has become a hot and difficult technical problem to be solved at home and abroad. URSA belongs to the categories of "several abortions", "habitual abortion", "repeated pregnancy loss" in traditional Chinese medicine. Traditional Chinese medicine has a civilization history of thousands of years. Due to the complex components of Chinese herbal medicines, their multi-target and multi-pathway mechanism of action makes them play a unique advantage in preventing miscarriage. Whether it is possible to develop a traditional Chinese medicine composition for treating early unexplained recurrent spontaneous abortion by utilizing the unique advantages of traditional Chinese medicine is a technical problem that needs to be seriously solved, but there has been no public report so far. Summary of the Invention

[0003] In view of the above situation, in order to overcome the deficiencies of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating early unexplained recurrent spontaneous abortion, which can effectively solve the medication problem of early unexplained recurrent spontaneous abortion.

[0004] The technical solution adopted by the present invention is a traditional Chinese medicine composition for treating early unexplained recurrent miscarriage. Based on the complex components, multi-target and multi-pathway mechanism of traditional Chinese herbs, and in combination with the actual situation of early unexplained recurrent miscarriage, after repeated research, traditional Chinese medicine therapy of tonifying the kidney, promoting blood circulation and clearing heat is used to dialectically treat early URSA. Party A is given for intervention three months before pregnancy, and Party B with appropriately reduced dosage of medicinal herbs is used to protect the fetus after pregnancy, achieving a new breakthrough in the continuous pregnancy rate and live birth rate. Accordingly, a traditional Chinese medicine composition for treating early unexplained recurrent miscarriage of the present invention is composed of Party A and Party B. Party A is composed of dodder seed, taxillus sutchuenensis, dipsacus asperoides, angelica sinensis, salvia miltiorrhiza, scutellaria baicalensis, codonopsis pilosula, atractylodes macrocephala, wild jujube seed and roasted licorice root; Party B has the same components as Party A, but the dosages of angelica sinensis and salvia miltiorrhiza are different. The dosages of angelica sinensis and salvia miltiorrhiza in Party A are 15g respectively, while the dosages of angelica sinensis and salvia miltiorrhiza in Party B are 10g respectively (per dose).

[0005] The traditional Chinese medicine composition of the present invention is combined according to the primary and secondary relationships of monarch, minister, assistant and envoy, supporting each other. Party A before pregnancy tonifies the kidney, promotes blood circulation and clears heat to pre-treat the damage, and Party B after pregnancy continues to clear heat, strengthen the kidney and prevent miscarriage, which can be effectively used to treat early unexplained recurrent miscarriage. It is convenient to use and has good effects, which is a new breakthrough in the drugs for treating early unexplained recurrent miscarriage, and has good economic and social benefits. Detailed implementation mode

[0006] The following combines examples and specific situations to elaborate in detail on the specific implementation mode of the present invention.

[0007] The specific implementation of the present invention is given by the following examples:

[0008] A traditional Chinese medicine composition for treating early unexplained recurrent miscarriage of the present invention is composed of Party A and Party B. Party A is composed of, by weight: 30g of dodder seed, 15g of taxillus sutchuenensis, 15g of dipsacus asperoides, 15g of angelica sinensis, 15g of salvia miltiorrhiza, 15g of scutellaria baicalensis, 15g of codonopsis pilosula, 15g of atractylodes macrocephala, 10g of wild jujube seed and 6g of roasted licorice root; Party B is composed of, by weight: 30g of dodder seed, 15g of taxillus sutchuenensis, 15g of dipsacus asperoides, 10g of angelica sinensis, 10g of salvia miltiorrhiza, 15g of scutellaria baicalensis, 15g of codonopsis pilosula, 15g of atractylodes macrocephala, 10g of wild jujube seed and 6g of roasted licorice root. The preparation methods of Party A and Party B are the same. The method is: mix each component together, soak it in water at room temperature for 30 - 40 min, bring to a boil over high heat, then simmer for 40 - 60 min, filter to obtain the first filtrate. Add water to submerge the medicinal residues again, bring to a boil over high heat, then simmer for 30 - 40 min, filter to obtain the second filtrate. Combine the two filtrates to form a decoction, one dose per day, taken twice, once in the morning and once in the evening.

[0009] For the composition given in the above embodiments, any amount of traditional Chinese medicine can be prepared as needed. The given embodiments are only used to illustrate the specific implementation manners of the present invention, rather than to limit the protection scope of the present invention. The core technology protected by the present invention is the traditional Chinese medicine composition, and this traditional Chinese medicine composition can also be made into any amount or any dosage form according to actual needs.

[0010] Among the above components, where:

[0011] Cuscuta chinensis: It is of mild nature, pungent and sweet in taste; it belongs to the liver meridian, kidney meridian, and spleen meridian; it tonifies the kidney and benefits essence, nourishes the liver and improves eyesight.

[0012] Taxillus chinensis: It is bitter, sweet, and of mild nature; it belongs to the liver meridian and kidney meridian; it tonifies the liver and kidney, strengthens the tendons and bones, dispels wind-dampness, and prevents miscarriage.

[0013] Dipsacus asperoides: It is of slightly warm nature, bitter and pungent in taste; it belongs to the liver meridian and kidney meridian; it tonifies the liver and kidney, strengthens the tendons and bones, continues fractured injuries, and stops metrorrhagia and metrostaxis.

[0014] Angelica sinensis: It is of warm nature, sweet and pungent in taste; it belongs to the liver meridian, heart meridian, and spleen meridian; it enriches blood and promotes blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes defecation.

[0015] Scutellaria baicalensis: It is of cold nature, bitter in taste; it belongs to the lung meridian, gallbladder meridian, spleen meridian, large intestine meridian, and small intestine meridian; it clears heat and dries dampness, purges fire and detoxifies, stops bleeding, and prevents miscarriage.

[0016] Codonopsis pilosula: It is of mild nature, sweet in taste; it belongs to the spleen meridian and lung meridian; it replenishes the middle-jiao and benefits qi, strengthens the spleen and nourishes the lung.

[0017] Atractylodes macrocephala: It is of warm nature, sweet and bitter in taste; it belongs to the spleen meridian and stomach meridian; it strengthens the spleen, benefits qi, dries dampness and promotes diuresis, stops sweating, and prevents miscarriage.

[0018] Ziziphus jujuba var. spinosa: It is of mild nature, sweet and sour in taste; it belongs to the liver meridian, gallbladder meridian, and heart meridian; it nourishes the liver, calms the heart, arrests sweating, and promotes the production of body fluid.

[0019] Honey-fried Licorice Root: It is of mild nature, sweet in taste; it belongs to the heart meridian, stomach meridian, spleen meridian, and lung meridian; it invigorates the spleen and replenishes qi, relieves cough and reduces phlegm, alleviates spasm and pain, and harmonizes the properties of medicines.

[0020] Salvia miltiorrhiza: It is of slightly cold nature, bitter in taste; it belongs to the heart meridian and liver meridian; it dispels stasis and relieves pain, promotes blood circulation and regulates menstruation, clears the heart and removes vexation.

[0021] It should be noted that Salvia miltiorrhiza is a traditional Chinese medicine, commonly used for promoting blood circulation and removing blood stasis. However, due to its blood-activating function, it may have an adverse impact on pregnancy, especially in the early pregnancy (the first three months) and near delivery. At this time, the female body is relatively sensitive, and blood-activating drugs may cause miscarriage or premature birth. This is also the reason for cautious use in anti-abortion drugs (Note: After the applicant's search, no use of Salvia miltiorrhiza has been found in the related patents that have been applied for or authorized). However, the research experiments of this application found that a small dose of Salvia miltiorrhiza can promote blood circulation and remove blood stasis and has the effect of preventing miscarriage, while a large dose may have the risk of causing abortion. The key lies in the dosage. Therefore, 15g of Salvia miltiorrhiza is used in Formula A, and 10g of Salvia miltiorrhiza is used in Formula B, which exactly reflects the dual effects of "Salvia miltiorrhiza can both promote blood circulation and remove blood stasis and has the effect of preventing miscarriage".

[0022] Currently, most medical experts believe that "blood stasis" is an important pathogenesis of habitual abortion. Therefore, for more than thirty years, the inventor has preferred to use Salvia miltiorrhiza with added flavors to promote blood circulation and remove blood stasis and nourish the blood for preventing miscarriage, and achieved good curative effects. Therefore, Salvia miltiorrhiza is still used in Formula B and the dosage is appropriately reduced, which is effectively used for treating early unexplained recurrent miscarriage. However, it can be used more before pregnancy and less after pregnancy. This is a major breakthrough of the applicant in anti-abortion drugs.

[0023] According to the principles of traditional Chinese medicine, the above components are related to each other in function according to the primary, secondary, monarch, minister, assistant, and guide, and interact and cooperate with each other. In the formula, Cuscuta chinensis, Taxillus chinensis, and Dipsacus asperoides strengthen the kidney and consolidate the root, and are the monarch drugs; Codonopsis pilosula, Atractylodes macrocephala, and roasted Glycyrrhiza glabra invigorate the spleen and replenish qi, nourish the acquired to nourish the congenital, and jointly cultivate the root deficiency, and are the minister drugs; Angelica sinensis and Salvia miltiorrhiza nourish the blood, promote blood circulation, generate new blood, and prevent miscarriage, and Scutellaria baicalensis clears heat and prevents miscarriage, and are the assistant drugs; Ziziphus jujuba var. spinosa nourishes the heart and soothes the mind and is the guiding drug. The whole formula jointly exerts the effects of tonifying the kidney and promoting blood circulation, removing blood stasis and clearing heat, combining attack and supplementation, pre-cultivating the damage, removing blood stasis without harming the healthy qi, promoting the stability of the fetal element, and is effectively used for treating early unexplained recurrent miscarriage, with good curative effects, high efficiency, and no toxic and side effects, and has achieved very good beneficial technical effects through clinical observation. The relevant research materials are as follows:

[0024] I. Objects for Selecting Cases

[0025] Abortion refers to the termination of pregnancy before 28 weeks and the fetal weight is less than 1000 grams. Recurrent spontaneous abortion (RSA) refers to two or more consecutive spontaneous abortions. Among them, more than 50% of the causes of RSA are unknown, which is called unexplained recurrent spontaneous abortion (URSA). Most URSA occur before 12 weeks of pregnancy, and the recurrence risk of abortion can reach more than 40%, that is, the live birth rate < 60% (Magnus MC, Wilcox AJ, Morken NH, et al. Role of maternal age and pregnancy history in risk of miscarriage: prospective register based study[J]. BMJ, 2019, 364:l869.). Those with the above symptoms are selected as case subjects.

[0026] II. Case Selection

[0027] URSA patients diagnosed from September 2, 2019 to October 30, 2024 are selected as case subjects and take the drugs of the present invention.

[0028] III. Treatment Plan

[0029] URSA patients are treated with the present invention's plan. Start taking Formula A orally three months before pregnancy, one dose per day, taken in the morning and evening. Start taking it after menstruation stops, take it orally for three weeks per menstrual cycle, and stop taking it during menstruation; after pregnancy, take Formula B orally, one dose per day, taken in the morning and evening, and continue to take it for fetal protection until 12 weeks of pregnancy (or stop taking the medicine if pregnancy loss or ectopic pregnancy occurs within 12 weeks of pregnancy).

[0030] IV. Efficacy Evaluation Criteria

[0031] The efficacy evaluation criteria are aimed at preventing early unexplained recurrent spontaneous abortion. That is to say, it is evaluated based on the number of people who have spontaneous abortion within 12 weeks after pregnancy. The definition criteria are as follows:

[0032] Cured: Pregnancy and live birth (that is, giving birth to a healthy baby normally);

[0033] Effective: Continuing pregnancy ≥ 12 weeks, but not having a live birth or being pregnant due to other reasons;

[0034] Invalid: Losing the pregnancy within 12 weeks;

[0035] Effective rate: Number of effective people / Number of pregnant people × 100%;

[0036] Cure rate: Number of cured people / Number of pregnant people × 100%.

[0037] V. Statistical Analysis

[0038] According to the above technical solution, a total of 66 patients with URSA took the traditional Chinese medicine composition of the present invention. Among them, 33 patients became pregnant, and the pregnancy duration exceeded 12 weeks for all of them. 25 live births occurred, and no obvious adverse reactions were observed. This drug has greatly improved the pregnancy continuation rate and live birth rate at 12 weeks of pregnancy in URSA patients, providing a feasible therapeutic drug for the treatment of URSA across the country and even the world.

[0039] Number of pregnant women Number of cured patients Number of effective patients Number of ineffective patients Total effective rate 33 25(75.76％) 8(24.24％) 0(0％) 100％

[0040] VI. Typical Cases

[0041] Patient Liu, 29 years old, visited the outpatient department of obstetrics and gynecology on December 28, 2020, with the main complaint of "more than 1 month after uterine curettage due to fetal arrest". After the operation, she took Femoston orally, and had withdrawal bleeding on January 29, 2021. The patient usually had regular menstruation, with a cycle of 6 / 30 - 32 days, G2SA2, and both pregnancies ended in uterine curettage due to fetal arrest at more than 40 days of gestation. There was no special past medical history, no allergy history was found, and family genetic history was denied. No obvious abnormalities were found in the gynecological examination. On the same day, B-ultrasound showed: endometrium 2.7 mm, uneven echo, and no other obvious abnormalities. No obvious abnormalities were found after systematic screening for the causes of RSA. In the subsequent treatment, the patient was advised to avoid pregnancy for half a year. During this period, she took Prescription A orally to nourish her body, 1 dose per day, decocted in water to make 200 ml, taken twice a day, half an hour after meals and warmed before taking. It was taken for 3 weeks after menstruation stopped and stopped during menstruation. After 4 months of conditioning, the patient became pregnant smoothly. After pregnancy, she took Prescription B orally and continued to protect the fetus until 12 weeks of pregnancy and then stopped taking the medicine. The patient had a smooth pregnancy and terminated the pregnancy by cesarean section at 39 weeks of pregnancy due to cephalopelvic disproportion, and a healthy female live infant was delivered smoothly.

[0042] VII. Conclusion

[0043] Traditional Chinese medicine has accumulated rich clinical experience in understanding the etiology, pathogenesis, syndrome differentiation and treatment of URSA. It is believed that the kidney is the foundation of congenital constitution, storing essence and governing reproduction. Kidney essence can not only promote the development and maturity of the maternal reproductive system, but also is the basic substance for embryo formation and development. As stated in "Fu Qingzhu's Gynecology": "Regarding the fetus... in fact, it is all nourished by kidney water. Therefore, when kidney water is sufficient, the fetus is stable; when kidney water is deficient, fetal movement occurs." In patients with URSA, due to insufficient congenital kidney qi of the mother, multiple previous pregnancies and childbirths, or over the age of 35, the depletion of kidney yuan can all lead to deficiency of kidney essence and qi. When the fetus loses nourishment, it is weakly endowed and fails to grow properly, resulting in adverse pregnancy outcomes such as fetal restlessness, fetal leakage, abortion, or even repeated miscarriages. Therefore, the root cause of URSA is kidney deficiency. In addition, multiple miscarriages in URSA patients are likely to damage the thoroughfare and conception vessels and the uterine collaterals, causing stasis of blood to stagnate in the uterus. Or long-term failure to achieve a satisfactory pregnancy outcome leads to qi stagnation and blood stasis. Over time, heat is generated from blood stasis, and the stasis heat disturbs the fetal element. Just as Zhu Danxi stated in "On the Theory of Spontaneous Abortion in Gezhi Yulun": "Spontaneous abortion or emotional distress due to fatigue and anger can also cause internal fire to move and lead to abortion. Tracing back to the root cause, it is all due to heat." The traditional Chinese medicine of the present invention is formulated according to the primary and secondary compatibility relationship of monarch, minister, assistant, and envoy herbs. The compatibility is scientific and reasonable, and they are functionally interrelated and work together through mutual compatibility. The whole formula plays a role in tonifying the kidney, promoting blood circulation, removing stasis and clearing heat, treating both excess and deficiency simultaneously, preventing damage in advance, removing stasis without harming healthy qi, promoting the stability of the fetal element, and effectively treating early unexplained recurrent miscarriage. It has good curative effect, high efficiency, no toxic and side effects, with a total effective rate of 100% and a cure rate of over 75%. New breakthroughs have been achieved in the continuous pregnancy rate and live birth rate. It is a major innovation in the treatment of URSA drugs, with good social and economic benefits.

Claims

1. A Chinese medicine for treating early unexplained recurrent spontaneous abortion, characterized in that: The Chinese medicine composition is composed of A and B, wherein A is composed of, by weight: 30g of Cuscuta, 15g of Loranthus parasiticus, 15g of Dipsacus, 15g of Angelica sinensis, 15g of Salvia miltiorrhiza, 15g of Scutellaria baicalensis, 15g of Codonopsis pilosula, 15g of Atractylodes macrocephala, 10g of Ziziphus jujuba seeds and 6g of Radix Glycyrrhizae; and B is composed of, by weight: 30g of Cuscuta, 15g of Loranthus parasiticus, 15g of Dipsacus, 10g of Angelica sinensis, 10g of Salvia miltiorrhiza, 15g of Scutellaria baicalensis, 15g of Codonopsis pilosula, 15g of Atractylodes macrocephala, 10g of Ziziphus jujuba seeds and 6g of Radix Glycyrrhizae. The preparation method of recipe A and recipe B is the same, which is: mix the components together, add water to immerse them at room temperature for 30-40 minutes, boil over high heat, simmer over low heat for 40-60 minutes, filter to obtain the first filtrate, add water to immerse the residue again, boil over high heat, simmer over low heat for 30-40 minutes, filter to obtain the second filtrate, combine the two filtrates, make a decoction, take one dose per day, divided into two doses, once in the morning and once in the evening.