A Traditional Chinese Medicine Composition for Preventing and Treating Premature Ovarian Failure and Its Application

By using a combination of traditional Chinese medicines such as Euryale ferox to regulate ovarian function, this treatment addresses the reproductive dysfunction and abnormal follicle development associated with premature ovarian failure, achieving a safe and effective treatment for premature ovarian failure. It is applicable to various pathogenesis issues in modern women and improves their reproductive health.

CN120437251BActive Publication Date: 2025-10-28HUNAN ACAD OF CHINESE MEDICINE
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Patent Information

Application Number
CN202510830066.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-06-20
Publication Date
2025-10-28
Estimated Expiration
2045-06-20

AI Technical Summary

Technical Problem

In existing technologies, treatments for premature ovarian failure have safety risks and cannot effectively improve reproductive dysfunction and abnormal follicle development. Traditional Chinese medicine combinations have limited efficacy in the context of complex pathogenesis in modern women.

Method used

This product uses a combination of traditional Chinese medicines, including Euryale ferox, Aquilaria sinensis, Sandalwood, processed Pinellia ternata, Rheum palmatum, Amomum villosum, Amomum cardamomum, processed Arisaema heterophyllum, processed Aconitum carmichaelii, Asarum sieboldii, Citrus aurantium, and Piper longum, to synergistically regulate ovarian function by regulating endocrine function, improving the uterine environment, enhancing immunity, and providing antioxidant effects.

Benefits of technology

It significantly increases estrogen levels, promotes follicle development, improves polycystic ovary syndrome and pelvic adhesions, reduces side effects, is suitable for various pathogenesis in modern women, improves conception rate and reduces the risk of long-term medication.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention discloses a Chinese medicine composition for preventing and treating premature ovarian failure and its application. It belongs to the technical field of traditional Chinese medicine. The Chinese medicine composition of the present invention comprises Euryale ferox, Aquilaria sinensis, Santalum album, processed Pinellia ternata, Rhubarb, White cardamom, Alpinia officinalis, processed Arisaema consanguineum, processed Chuanwu, Asarum sieboldii, Citrus aurantium and Piper longum. The prescription of the present invention follows the principle of "monarch, minister, assistant and envoy" compatibility in traditional Chinese medicine and belongs to a compound Chinese medicine preparation, which needs to regulate reproductive endocrine function through the synergistic effect of multiple medicinal materials. It focuses on infertility and premature ovarian failure caused by phlegm-dampness and blood stasis combined with kidney yang deficiency. The existing technology mostly focuses on simple kidney tonification (such as Rehmannia glutinosa and Cornus officinalis) or blood circulation (such as peach kernel and safflower), while the prescription of the present invention integrates multiple functions such as removing dampness, warming and promoting circulation, purging blood stasis and promoting qi, and is more targeted.
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Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically to a traditional Chinese medicine composition for preventing and treating premature ovarian failure and its application. Background Technology

[0002] Ovarian dysfunction can lead to reproductive disorders and abnormal follicle development. In the body, ovarian dysfunction is a slow and gradual process. Decreased ovarian reserve (DOR) is an early symptom of ovarian dysfunction. This process is usually accompanied by a decrease in the number and activity of follicles. This phenomenon directly affects a woman's fertility and reproductive health, requiring close attention. In recent years, people's material lives have greatly improved. However, in this process, the incidence of DOR has surged due to a combination of factors, including food safety issues, increased work and study pressure, unhealthy lifestyle habits, and environmental factors. More concerning is the obvious trend of this disease affecting younger women, necessitating serious attention and effective measures for control and prevention. Without effective treatment or intervention in early-stage patients, DOR can quickly develop into premature ovarian insufficiency (POI) or premature ovarian failure (POF). Hormonal imbalances in women are a key cause of premature ovarian failure (POF), primarily characterized by the cessation of menstruation, decreased estrogen levels, and increased gonadotropin levels. Before a diagnosis of POF, most patients experience irregular menstrual cycles and infertility. Statistics show that the prevalence of POF in the female population is approximately 0.5%. Currently, hormone therapy using progesterone, natural estrogen, or progestin is a common approach. However, hormone replacement therapy may increase the risk of breast cancer, stroke, and gallbladder disease. Traditional Chinese medicine, especially those classified as food and medicine homology, generally has a higher safety profile, making it a potential source for developing safer and more effective products to protect the ovaries.

[0003] In summary, how to provide a traditional Chinese medicine composition for the prevention and treatment of premature ovarian failure is a problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0004] In view of this, the present invention provides a traditional Chinese medicine composition for preventing and treating premature ovarian failure and its application.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] A traditional Chinese medicine composition for preventing and treating premature ovarian failure comprises the following components in parts by weight: 25-30 parts of Euryale ferox, 3-6 parts of Aquilaria sinensis, 1-3 parts of Santalum album, 8-10 parts of processed Pinellia ternata, 8-10 parts of Rheum palmatum, 6-8 parts of Amomum villosum, 6-8 parts of Amomum cardamomum, 6-8 parts of processed Arisaema heterophyllum, 1-3 parts of processed Aconitum carmichaelii, 1-3 parts of Asarum heterotropoides, 8-10 parts of Citrus aurantium, and 6-8 parts of Piper longum.

[0007] Furthermore, a traditional Chinese medicine composition for preventing and treating premature ovarian failure includes the following components in parts by weight: 25 parts of Euryale ferox, 5 parts of Aquilaria sinensis, 2 parts of Santalum album, 8 parts of processed Pinellia ternata, 8 parts of Rheum palmatum, 6 parts of Amomum villosum, 8 parts of Amomum cardamomum, 6 parts of processed Arisaema heterophyllum, 2 parts of processed Aconitum carmichaelii, 2 parts of Asarum heterotropoides, 8 parts of Citrus aurantium, and 8 parts of Piper longum.

[0008] The above-mentioned traditional Chinese medicine composition is prepared by the following method:

[0009] Weigh all the Chinese herbs according to the proportions and place them in a decoction pot. Add water at a ratio of 1:9g / mL and extract twice. Combine the two extracts and then concentrate and freeze-dry them sequentially.

[0010] The above-mentioned traditional Chinese medicine composition is used in the preparation of drugs for the prevention and treatment of premature ovarian failure.

[0011] The above-mentioned traditional Chinese medicine composition is used in the preparation of drugs for preventing and treating ovarian damage and follicular development disorders.

[0012] Furthermore, it is used to delay ovarian aging, promote growth and development, and regulate serum sex hormones.

[0013] Furthermore, the serum sex hormones are follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and testosterone (T).

[0014] The compatibility mechanism between the components of the traditional Chinese medicine composition of this invention is as follows:

[0015] (1) Regulate endocrine and reproductive functions

[0016] Tonifying the kidneys and spleen: Euryale ferox, processed Aconitum carmichaelii, and Asarum heterotropoides regulate the hypothalamus-pituitary-ovarian axis, improving estrogen levels and promoting follicle development and corpus luteum function. Resolving phlegm and dampness: Processed Pinellia ternata and processed Arisaema heterophyllum can reduce insulin resistance and improve metabolic disorders in patients with polycystic ovary syndrome.

[0017] (2) Improve the uterine and fallopian tube environment

[0018] Warming the meridians and dispelling cold: Prepared aconite and asarum dilate blood vessels, increase uterine blood flow, and alleviate embryo implantation problems caused by uterine cold. Promoting blood circulation and removing blood stasis: Rhubarb and sandalwood reduce pelvic adhesions and improve fallopian tube patency through their anti-inflammatory and anticoagulant effects.

[0019] (3) Regulating immunity and antioxidation

[0020] The polysaccharides and flavonoids in fox nuts and agarwood can enhance immunity and reduce autoimmune infertility (such as antisperm antibodies). The anthraquinone compounds in rhubarb have antioxidant properties, protecting reproductive cells from oxidative damage.

[0021] (4) Overall regulation of Qi and blood

[0022] White cardamom, black cardamom, and immature bitter orange can improve spleen and stomach function, promote nutrient absorption, and provide a material basis for egg development.

[0023] As can be seen from the above technical solution, compared with the prior art, the beneficial effects achieved by the present invention are as follows:

[0024] (I) Innovative Advantages of Formulation Design

[0025] (1) Multi-target synergistic regulation

[0026] Kidney-tonifying and spleen-strengthening + phlegm-resolving and dampness-eliminating: Euryale ferox is used as the principal herb to tonify the spleen and kidneys, eliminate dampness and stop leukorrhea, making up for the neglect of phlegm-dampness constitution in traditional kidney-tonifying formulas; Warming and dispelling cold + promoting blood circulation and removing blood stasis: Prepared Aconitum carmichaelii and Asarum warm the meridians and dispel cold, while Rheum palmatum clears heat and removes blood stasis, addressing premature ovarian failure caused by mixed cold and heat; Aromatic transformation of turbidity + qi-regulating and stagnation-relieving: Agarwood, sandalwood, and cardamom improve ovulation disorders and endocrine imbalances caused by qi stagnation and dampness obstruction.

[0027] (2) Breaking through the limitations of traditional compatibility

[0028] Enhanced efficacy and reduced toxicity of toxic medicinal materials: Although processed Pinellia ternata, processed Arisaema heterophyllum (drying dampness and resolving phlegm) and processed Aconitum carmichaelii (dispersing cold) are toxic, their side effects are reduced by rhubarb (cold nature to counteract heat toxicity) and Amomum villosum (warming the middle and harmonizing), making them safer than warming and drying formulas that use Aconitum carmichaelii and Cinnamomum cassia alone; Combination of cold and heat to adapt to complex pathogenesis: Targeting the pathogenesis of "upper heat and lower cold" in modern women (such as irritability and insomnia combined with lower abdominal cold pain), it is more comprehensive than a single warming or yin-nourishing formula.

[0029] (II) Improvement in clinical efficacy

[0030] (1) Improve reproductive function indicators

[0031] By regulating the hypothalamus-pituitary-ovarian axis with Euryale ferox and Asarum, estrogen levels are increased and follicle development is promoted; processed Pinellia ternata and processed Arisaema heterophyllum reduce insulin resistance in patients with phlegm-dampness syndrome and improve polycystic ovary syndrome-related infertility; rhubarb and Citrus aurantium enhance pelvic blood flow, reduce fallopian tube adhesions, and improve the conception rate.

[0032] (2) Comprehensive conditioning of body constitution

[0033] White cardamom and black cardamom enhance the spleen and stomach's digestive function, resolving qi and blood deficiency caused by nutrient absorption disorders; long pepper and sandalwood have anti-inflammatory and analgesic effects, relieving dysmenorrhea and chronic pelvic pain.

[0034] (III) Safety and Applicability Optimization

[0035] (1) Reduce the risks of long-term medication

[0036] Although the formula contains toxic ingredients such as processed aconite and processed pinellia, it is safer than using aconite-based formulas alone because it is combined with rhubarb (for detoxification) and long pepper (for neutralizing acid and protecting the stomach) to reduce liver and kidney damage.

[0037] (2) Expand the target audience

[0038] It is suitable for infertility caused by phlegm and blood stasis, and cold and heat (such as obesity combined with cold uterus, chronic pelvic inflammatory disease patients), while traditional kidney-tonifying formulas (such as the Rehmannia glutinosa-cinnamon combination) are ineffective or even aggravate damp-heat or phlegm-dampness syndromes. Attached Figure Description

[0039] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0040] Figure 1 Venn diagram showing the active ingredient targets and premature ovarian failure-related targets in the traditional Chinese medicine composition preparation in Example 4 of this invention;

[0041] Figure 2 This refers to the protein-protein interaction network (PPI) of "active ingredient-disease-target gene" in Example 4 of the present invention.

[0042] Figure 3 This is a PPI network diagram of the core target point in Embodiment 4 of the present invention;

[0043] Figure 4 This is a graph showing the GO function enrichment analysis in Embodiment 4 of the present invention;

[0044] Figure 5 This is a KEGG pathway enrichment analysis diagram from Example 4 of the present invention;

[0045] Figure 6 Design of the SD rat ovarian injury model experiment in Example 5 of this invention (n=12);

[0046] Figure 7 The effect of the traditional Chinese medicine composition preparation in Example 5 of the present invention on the morphology (A) and growth performance (B) of rat ovarian tissue (n=12);

[0047] Figure 8The effect of the traditional Chinese medicine composition preparation in Example 5 of the present invention on the serum levels of FSH, LH, E2 and T in rats (n=6);

[0048] Figure 9 The effect of the traditional Chinese medicine composition preparation in Example 5 of the present invention on the liver organ index (A) and liver tissue morphology (B) of rats (n=12);

[0049] Figure 10 The differential gene screening (A, red indicates significantly increased differential genes in the low-dose group compared to the model group, and blue indicates significantly decreased differential genes) and KEGG pathway enrichment analysis (B) (n=4) were performed in Example 5 of this invention. Detailed Implementation

[0050] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0051] The reagents required for this invention are conventional experimental reagents, purchased from commercially available channels; the experimental methods not mentioned are conventional experimental methods, and will not be described in detail here.

[0052] Example 1

[0053] A traditional Chinese medicine composition for preventing and treating premature ovarian failure comprises the following components in parts by weight:

[0054] 25 parts of Euryale ferox, 3 parts of Aquilaria sinensis, 1 part of Sandalwood, 8 parts of processed Pinellia ternata, 8 parts of Rheum palmatum, 6 parts of Amomum villosum, 6 parts of Amomum cardamomum, 6 parts of processed Arisaema heterophyllum, 1 part of processed Aconitum carmichaelii, 1 part of Asarum heterotropoides, 8 parts of Citrus aurantium and 6 parts of Piper longum.

[0055] The preparation method is as follows:

[0056] After weighing all the medicinal materials, place them in a decoction pot, add water at a ratio of 1:9 g / mL, bring to a boil over high heat at 100℃, then simmer over low heat at 85-90℃ for 2 hours. Filter while hot, add the same volume of water again, bring to a boil over high heat at 100℃, then simmer over low heat at 85-90℃ for 1 hour. Filter while hot, and concentrate the filtrates from both processes by rotary evaporation. Maintain a water bath temperature ≤70℃ and a vacuum of -0.08 to -0.1 MPa until a concentrated solution equivalent to 1 g / mL of medicinal material is obtained. Freeze-dry the concentrated solution, pre-freezing at -40℃ for 4-6 hours, then increasing the temperature of the separator stepwise (-20℃ to -10℃ / 24h) under a vacuum of 80 Pa. Increase the separator temperature to 25℃ (heating rate 5℃ / h), raise the vacuum to 20 Pa, and continue for 8 hours to obtain a porous freeze-dried powder with a water content ≤5%, which is the traditional Chinese medicine composition preparation.

[0057] Example 2

[0058] A traditional Chinese medicine composition for preventing and treating premature ovarian failure comprises the following components in parts by weight:

[0059] 30 parts of Euryale ferox, 6 parts of Aquilaria sinensis, 3 parts of Sandalwood, 10 parts of processed Pinellia ternata, 10 parts of Rheum palmatum, 8 parts of Amomum villosum, 8 parts of Amomum cardamomum, 8 parts of processed Arisaema heterophyllum, 3 parts of processed Aconitum carmichaelii, 3 parts of Asarum heterotropoides, 10 parts of Citrus aurantium and 8 parts of Piper longum.

[0060] The preparation method is the same as in Example 1.

[0061] Example 3

[0062] A traditional Chinese medicine composition for preventing and treating premature ovarian failure comprises the following components in parts by weight:

[0063] 25 parts of Euryale ferox, 5 parts of Aquilaria sinensis, 2 parts of Sandalwood, 8 parts of processed Pinellia ternata, 8 parts of Rheum palmatum, 6 parts of Amomum villosum, 8 parts of Amomum cardamomum, 6 parts of processed Arisaema heterophyllum, 2 parts of processed Aconitum carmichaelii, 2 parts of Asarum heterotropoides, 8 parts of Citrus aurantium and 8 parts of Piper longum.

[0064] The preparation method is the same as in Example 1.

[0065] Example 4

[0066] Network pharmacology research

[0067] Research Methods

[0068] Active ingredients and their targets were screened by searching relevant literature, TCMSP, TCMID, and BATMAN-TCM databases, based on oral bioavailability (OB) > 30% and drug-likeness (DL) ≥ 0.18. After screening, the gene names of the targets in the traditional Chinese medicine composition (Example 3) were converted and standardized. Disease (premature ovarian failure) targets were obtained by searching the GeneCards and OMIM databases, duplicate targets were removed, and disease gene targets were standardized. A Venn diagram was drawn to obtain the intersection targets.

[0069] The intersection of the active ingredient target data and the disease target dataset of traditional Chinese medicine composition preparations is obtained to obtain the common target dataset of active ingredient-disease. The dataset is then imported into the online software string to construct a protein-protein interaction (PPI) network of "active ingredient-disease-target gene". The network topology relationship of key targets is then analyzed using Cytoscape software.

[0070] Using the Metascape online website, we input common target points and performed GO functional enrichment analysis and KEGG pathway enrichment analysis on the common targets. GO functional enrichment analysis included biological processes (BP), cellular composition (CC), and molecular function (MF) to predict the functional distribution of targets. P-values ​​were set to <0.01 for all values. We sorted the targets in descending order by number of counts and selected the top ten GO annotation enrichment analyses and KEGG pathway analyses to construct a dataset of key target pathways. We then used the KEGG Mapper online tool to plot the relevant KEGG pathway maps.

[0071] Research Results

[0072] Using online tools, Venn diagrams were drawn between the active ingredient targets of traditional Chinese medicine formulations and targets related to premature ovarian failure, such as... Figure 1 As shown, the previous steps yielded 246 active ingredient targets for traditional Chinese medicine composition preparations and 2579 known disease targets. After merging and taking the intersection, 148 common drug component-disease targets were obtained.

[0073] The "active ingredient-disease-target gene" protein-protein interaction network (PPI) was constructed using the online software string. (See...) Figure 2 Further screening of key targets using Cytoscape software revealed that the top-ranked core targets included MAPK3, MAPK1, MYC, ESR1, TP53, MDM2, RELA, CCND1, CASP3, and BCL2. Figure 3 ).

[0074] The potential targets of the active ingredients in the traditional Chinese medicine (TCM) composition preparations obtained in the above steps for treating premature ovarian failure were subjected to GO annotation enrichment analysis and KEGG pathway enrichment analysis using the David database, and the top ten were selected in descending order of count. According to the GO enrichment analysis, the biological processes mainly involved in the TCM composition preparations for treating premature ovarian failure include positive regulation of transcription by RNA polymerase II, apoptotic process, positive regulation of gene expression, negative regulation of apoptotic process, positive regulation of DNA-templated transcription, response to xenobiotic stimulus, signal transduction, regulation of transcription by RNA polymerase II, positive regulation of cell population proliferation, and negative regulation of transcription by RNA polymerase II. Figure 4 KEGG pathway enrichment analysis showed that the pathways involved in the treatment of premature ovarian failure by traditional Chinese medicine compositions mainly include signal transduction, the immune system, cancer, infectious diseases, cell growth and death, and endocrine and metabolic diseases. Figure 5 ).

[0075] Example 5

[0076] Pharmacodynamic study of traditional Chinese medicine combination preparations for the treatment of premature ovarian failure

[0077] Experimental animals and grouping

[0078] Sixty SPF-grade female SD rats, weighing 180–200 g, were randomly divided into five groups of 12 rats each, with each rat constituting a replicate. These groups were: control group, model group, positive control group, low-dose traditional Chinese medicine (TCM) composition supplementation group, and high-dose TCM composition supplementation group.

[0079] Animal modeling and drug administration

[0080] Experimental design such as Figure 6 As shown, the details are as follows:

[0081] The control group received an equal volume of physiological saline intraperitoneally, while the other rats received intraperitoneal injections of cyclophosphamide for 14 days to establish an ovarian injury and follicular development disorder model (100 mg / kg on the first day, followed by 10 mg / kg). The experimental animals were housed in an SPF-grade barrier system at a temperature of 20℃–26℃ and a relative humidity of 55%–70%, with a 12-hour light / dark cycle, and free access to food and water.

[0082] Cyclophosphamide injection: Weigh the required amount of cyclophosphamide daily and mix it with the corresponding amount of physiological saline. Prepare and use immediately to ensure its activity.

[0083] Preparation of a traditional Chinese medicine composition: 62.5g of Euryale ferox seed, 12.5g of Aquilaria sinensis, 5g of Sandalwood, 20g of processed Pinellia ternata, 20g of Rheum palmatum, 15g of Amomum villosum, 20g of Amomum cardamomum, 15g of processed Arisaema heterophyllum, 5g of processed Aconitum carmichaelii, 5g of Asarum heterotropoides, 20g of Citrus aurantium, and 20g of Piper longum. After weighing all the herbs, place them in a decoction pot, add water at a ratio of 1:9g / mL, bring to a boil over high heat at 100℃, then reduce to a simmer at 85-90℃ and continue simmering for 2 hours. Filter while hot, add the same volume of water again, bring to a boil over high heat at 100℃, then reduce to a simmer at 85-90℃ and continue simmering for 1 hour. Filter while hot, and concentrate the filtrates from both processes by rotary evaporation. The water bath temperature is ≤70℃, and the vacuum degree is -0.08 to -0.1MPa, until a concentrated solution with a herb concentration of 1g / mL is obtained. The concentrate was freeze-dried at a pre-freezing temperature of -40℃ for 4 to 6 hours. Under a vacuum of 80Pa, the temperature of the partition was gradually increased (-20℃ to -10℃ / 24h), and the partition temperature was increased to 25℃ (heating rate 5℃ / h). The vacuum was increased to 20Pa and continued for 8 hours to obtain a porous freeze-dried powder with a water content of ≤5%, which is the traditional Chinese medicine composition preparation.

[0084] Rats in the low- and high-dose traditional Chinese medicine (TCM) composition supplementation groups were administered TCM composition supplements via gavage at doses of 1000 mg / kg and 2000 mg / kg, respectively, equivalent to 10g and 20g of the TCM composition supplement per day for a 70kg human. Rats in the control and model groups were administered an equal volume of physiological saline via gavage. The single gavage volume for all experimental rats was 20 mL / kg. Gavage administration began on the second day after model establishment and continued until treatment.

[0085] The positive control group rats were treated with exogenous hormone supplementation, receiving estradiol valerate solution, medroxyprogesterone acetate dispersible tablet solution, and clomiphene citrate solution by gavage. The gavage volume for each was 20 mL / kg. The gavage dose of estradiol valerate solution was 0.1 mg / kg, which, after dose conversion, is equivalent to 0.97 mg of active ingredient per person (70 kg) per day. The gavage dose of medroxyprogesterone acetate dispersible tablet solution was 0.8 mg / kg, which, after dose conversion, is equivalent to 7.78 mg of active ingredient per person (70 kg) per day. The gavage dose of clomiphene citrate solution was 10 mg / kg, which, after dose conversion, is equivalent to 97.24 mg of active ingredient per person (70 kg) per day. The positive control group rats were administered cyclically by gavage every five days. For the first three days, they were continuously administered estradiol valerate solution by gavage. On the fourth day, estradiol valerate solution was combined with medroxyprogesterone acetate dispersible tablets solution by gavage. On the fifth day, no drug treatment was administered. This cycle was repeated three times consecutively. Rats scheduled for treatment the day before were given clomiphene citrate solution by gavage. Gavage administration began on the second day after model establishment and continued until treatment.

[0086] Starting 10 days after modeling, vaginal smears were prepared daily from each group of rats to determine their estrous stage and calculate the estrous cycle. Rats that had been administered gavage for more than 14 days and were simultaneously in proestrus (determined by microscopic examination of vaginal secretions) were selected for treatment. Two hours after the last gavage, rats were anesthetized with 3% sodium pentobarbital (30 mg / kg), and blood was collected from the abdominal aorta. After clotting at room temperature for 1 hour, the blood was centrifuged at 3000 rpm for 10 minutes, and the serum was collected and stored at -20℃ for later use. One ovary was removed, fixed with 4% paraformaldehyde, and stored for later use, while the other ovary was stored in liquid nitrogen for later use.

[0087] Effects of traditional Chinese medicine compound preparations on ovarian tissue morphology and body weight in rats

[0088] The traditional Chinese medicine (TCM) composition preparation has a positive effect on alleviating ovarian damage in SD rats. Histological observation of the ovaries in each group showed that developing follicles were observed in both the low-dose TCM composition preparation group (1000 mg / kg) and the high-dose TCM composition preparation group (2000 mg / kg). Figure 7 A). Furthermore, the low-dose traditional Chinese medicine combination preparation group showed greater benefits for the growth and development of rats compared to the positive control group (estradiol valerate + megestrol acetate + clomiphene citrate). Figure 7 B).

[0089] Effects of Traditional Chinese Medicine Combinations on Serum Sex Hormones in Rats

[0090] Cyclophosphamide directly damages the ovaries, inhibiting granulosa cell function and leading to a significant decrease in estradiol (E2) secretion. Normally, E2 can negatively regulate and inhibit pituitary follicle-stimulating hormone (FSH) secretion. Therefore, when E2 levels decrease significantly, the pituitary gland will compensate by increasing FSH secretion in an attempt to promote follicle development and restore ovarian function. However, due to ovarian damage, this compensation cannot improve follicular status, resulting in a persistent increase in FSH. A low-dose traditional Chinese medicine composition effectively increased serum E2 levels in an SD rat model of ovarian injury, while simultaneously alleviating the FSH elevation caused by ovarian damage. Figure 8 ).

[0091] Effects of Traditional Chinese Medicine Compositions on Liver Organ Index and Tissue Morphology in Rats

[0092] Traditional Chinese medicine composition preparations can effectively alleviate the increase in liver organ index in rats caused by intraperitoneal injection of cyclophosphamide. Figure 9 A), and traditional Chinese medicine combination preparations are more helpful in restoring liver tissue morphology than positive drugs. Figure 9 B).

[0093] Differential gene screening and KEGG pathway enrichment analysis in rat ovarian transcriptome

[0094] Comparing the ovarian gene transcription levels of SD rats in the model group and the low-dose traditional Chinese medicine composition preparation group, 405 differentially expressed genes were identified. Figure 10 A). KEGG pathway enrichment analysis of differentially expressed genes revealed that they were mainly concentrated in extracellular matrix receptor interactions (ECM-receptor interaction), neuroactive ligand-receptor interactions, nitrogen metabolism, and renin secretion. Figure 10 B).

[0095] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0096] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for preventing and treating premature ovarian failure, characterized in that, It is made from the following components in parts by weight: 25-30 parts of Euryale ferox, 3-6 parts of Aquilaria sinensis, 1-3 parts of Sandalwood, 8-10 parts of processed Pinellia ternata, 8-10 parts of Rheum palmatum, 6-8 parts of Amomum villosum, 6-8 parts of Amomum cardamomum, 6-8 parts of processed Arisaema heterophyllum, 1-3 parts of processed Aconitum carmichaelii, 1-3 parts of Asarum heterotropoides, 8-10 parts of Citrus aurantium, and 6-8 parts of Piper longum.

2. The traditional Chinese medicine composition for preventing and treating premature ovarian failure as described in claim 1, characterized in that, It is made from the following components in parts by weight: 25 parts Euryale ferox, 5 parts Aquilaria sinensis, 2 parts Sandalwood, 8 parts Prepared Pinellia ternata, 8 parts Rheum palmatum, 6 parts Amomum villosum, 8 parts Amomum cardamomum, 6 parts Prepared Arisaema heterophyllum, 2 parts Prepared Aconitum carmichaelii, 2 parts Asarum heterotropoides, 8 parts Citrus aurantium and 8 parts Piper longum.

3. The traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that, The preparation method is as follows: Weigh all the Chinese herbs according to the proportions and place them in a decoction pot. Add water at a ratio of 1:9 g / mL and extract twice. Combine the two extracts and then concentrate and freeze-dry them sequentially.

4. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for preventing and treating premature ovarian failure.

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