Pharmaceutical composition for protecting ovarian function and resisting aging

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to an anti-aging pharmaceutical composition for protecting ovarian function, which is prepared from a pharmaceutical composition A and a pharmaceutical composition B. The pharmaceutical composition A is prepared from the following medicinal materials in parts by weight: 9-15 parts of poria cocos, 9-15 parts of peach kernel, 6-12 parts of platycladi seed, 3-12 parts of deer-horn glue, 12-30 parts of rhizoma polygonati, 9-18 parts of sea-buckthorn, 9-12 parts of armeniaca mume, 21-36 parts of fried Chinese yam, 6-12 parts of dogwood and 18-30 parts of phaseolus calcaratus; the medicine composition B is prepared from the following medicinal materials in parts by weight: 12-21 parts of prepared rehmannia root and 15-21 parts of red paeony root, or is prepared from the following medicinal materials in parts by weight: 9-18 parts of bighead atractylodes rhizome, 12-21 parts of pericarpium citri reticulatae, 9-15 parts of immature bitter orange, 9-12 parts of rhizoma pinellinae praeparata, 5-12 parts of fructus amomi, 9-18 parts of salvia miltiorrhiza, 6-12 parts of liquorice, 12-21 parts of radix rehmanniae recen, 9-15 parts of radix ophiopogonis and 6-12 parts of earthworm. The traditional Chinese medicine composition can prevent premature ovarian failure, treat ovarian reserve hypofunction and repair damaged ovarian function, and complete-cycle protection and reconstruction of the ovarian function are achieved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a pharmaceutical composition for protecting ovarian function and anti-aging. Background Technology

[0002] Decreased ovarian reserve (DOR) refers to a reduction in the number and / or quality of oocytes in the ovaries, accompanied by decreased levels of anti-müllerian hormone (AMH), decreased antral follicle counting (AFC), and increased follicle-stimulating hormone (FSH). Clinically, it can manifest as infrequent menstruation, reduced menstrual flow, and eventually amenorrhea, as well as decreased fertility or infertility, from menarche to age 40. It can further develop into premature ovarian insufficiency and premature ovarian failure. At the same time, the incidence of osteoporosis, fractures, cardiovascular disease, depression, and cognitive impairment also increases, placing enormous pressure on patients' quality of life and social medical resources.

[0003] There are several key issues with medications for treating diminished ovarian reserve: mainstream hormone replacement therapy drugs face safety controversies and insufficient individualized compatibility with long-term use; traditional Chinese medicine preparations have weak evidence-based support and unclear mechanisms of action; ovulation-inducing drugs have extremely low efficacy for patients with early-onset ovarian insufficiency and lack specific compatibility protocols; emerging preparations such as stem cell therapy are still in the experimental stage, with insufficient long-term safety and efficacy data, and all drugs share the common characteristic of "treating the symptoms but not the underlying cause," failing to fundamentally reverse ovarian function decline.

[0004] Therefore, there is an urgent need to develop a new type of drug that can prevent premature ovarian failure, treat existing ovarian reserve decline, and repair damaged ovarian function, so as to overcome the limitation of existing drugs that "treat the symptoms but not the cause" and achieve full-cycle protection and reconstruction of ovarian function. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings and deficiencies of the prior art and provide a nursing composition for treating ovarian reserve decline, aiming to break through the limitation of existing drugs that "treat the symptoms but not the cause" and achieve full-cycle protection and reconstruction of ovarian function.

[0006] This invention provides a pharmaceutical composition for protecting ovarian function and anti-aging, comprising pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is composed of the following medicinal materials in parts by weight: Poria cocos 9-15 parts, Prunus persica kernel 9-15 parts, Platycladus orientalis seed 6-12 parts, Cervi cornu colla 3-12 parts, Polygonatum sibiricum 12-30 parts, Hippophae rhamnoides 9-18 parts, Prunus mume 9-12 parts, Dioscorea opposita (fried) 21-36 parts, Cornus officinalis 6-12 parts, and Radix Rubra chinensis var. chinensis. 18-30 parts of soybeans; the drug combination B is made from the following parts by weight of medicinal materials: 12-21 parts of prepared Rehmannia glutinosa and 15-21 parts of Paeonia lactiflora, or made from the following parts of medicinal materials: 9-18 parts of Atractylodes macrocephala, 12-21 parts of Citrus reticulata peel, 9-15 parts of Citrus aurantium, 9-12 parts of prepared Pinellia ternata, 5-12 parts of Amomum villosum, 9-18 parts of Salvia miltiorrhiza, 6-12 parts of Glycyrrhiza uralensis, 12-21 parts of raw Rehmannia glutinosa, 9-15 parts of Ophiopogon japonicus, and 6-12 parts of Pheretima aspergillum.

[0007] Furthermore, the drug combination A is made from the following medicinal materials in parts by weight: 15 parts Poria cocos, 9 parts Prunus persica, 6 parts Platycladus orientalis, 3 parts Cervi cornu colla, 30 parts Polygonatum sibiricum, 12 parts Hippophae rhamnoides, 9 parts Prunus mume, 30 parts Dioscorea opposita, 9 parts Cornus officinalis, and 21 parts Phaseolus angularis; the drug combination B is made from the following medicinal materials in parts by weight: 15 parts Rehmannia glutinosa and 18 parts Paeonia lactiflora.

[0008] Furthermore, the drug combination A is made from the following medicinal materials in parts by weight: 15 parts Poria cocos, 9 parts Prunus persica, 6 parts Platycladus orientalis, 3 parts Cervi cornu colla, 30 parts Polygonatum sibiricum, 12 parts Hippophae rhamnoides, 9 parts Prunus mume, 30 parts Dioscorea opposita (fried), 9 parts Cornus officinalis, and 21 parts Phaseolus angularis; the drug combination B is made from the following medicinal materials in parts by weight: 12 parts Atractylodes macrocephala, 15 parts Citrus reticulata peel, 15 parts Citrus aurantium, 9 parts Pinellia ternata (processed), 5 parts Amomum villosum, 15 parts Salvia miltiorrhiza, 6 parts Glycyrrhiza uralensis, 15 parts Rehmannia glutinosa, 15 parts Ophiopogon japonicus, and 6 parts Pheretima aspergillum.

[0009] In a second aspect, the present invention provides a pharmaceutical preparation prepared from the pharmaceutical composition described herein.

[0010] Furthermore, the pharmaceutical formulation includes a variety of acceptable dosage forms.

[0011] Furthermore, the dosage form of the pharmaceutical preparation is any one of capsules, granules, tablets, powders, ointments, powders, pills, or liquids.

[0012] Furthermore, the pharmaceutical formulation may or may not include pharmaceutically acceptable excipients.

[0013] Furthermore, the pharmaceutical composition is used in the preparation of a medicament for preventing premature ovarian failure or treating pre-existing ovarian reserve deficiency.

[0014] Furthermore, the pharmaceutical composition is used in the preparation of a medicament for repairing damaged ovarian function.

[0015] It should be noted that the pharmacological effects of some of the medicinal materials in the formulation of this invention are as follows:

[0016] Poria cocos: The dried sclerotium of the fungus Poria cocos (Schw.) Wolf. (family Polyporaceae). Properties and Channels Entered: Sweet, bland, neutral. Enters the Heart, Lung, Spleen, and Kidney channels. Functions and Indications: Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0017] Peach kernel: The dried, mature seed of *Prunus persica* (L.) Batsch. or *Prunus davidiana* (Carr.) Franch., both belonging to the Rosaceae family. Properties and Channels Entered: Bitter, sweet, neutral. Enters the Heart, Liver, and Large Intestine channels. Functions and Indications: Promotes blood circulation and removes blood stasis, moistens the intestines and relieves constipation, stops cough and relieves asthma. Used for amenorrhea and dysmenorrhea, abdominal masses, lung abscess and intestinal abscess, traumatic injuries, constipation due to intestinal dryness, cough and asthma.

[0018] Arborvitae seed kernel: The dried, mature seed kernel of *Platycladus orientalis* (L.) Franco., a plant in the Cupressaceae family. Properties and channels: Sweet, neutral. Channels entered: Heart, Kidney, Large Intestine. Functions and indications: Nourishes the heart and calms the mind, moistens the intestines and promotes bowel movement, stops sweating. Used for yin and blood deficiency, restlessness and insomnia, palpitations, constipation due to intestinal dryness, and night sweats due to yin deficiency.

[0019] Deer antler glue: A solid glue made from deer antlers through boiling and concentration in water. Properties and Channels Entered: Sweet, salty, warm. Enters the kidney and liver channels. Functions and Indications: Warms and tonifies the liver and kidneys, nourishes essence and blood. Used for lower back and knee pain and coldness, impotence and seminal emission, general weakness and emaciation, metrorrhagia, hematochezia, hematuria, and carbuncles and boils caused by liver and kidney deficiency.

[0020] Polygonatum: The dried rhizome of *Polygonatum kingianum* Coll. et Hemsl., *Polygonatum sibiricum* Red., or *Polygonatum cyrtonema* Hua. (Liliaceae family). Properties and Channels Entered: Sweet, neutral. Enters the Spleen, Lung, and Kidney channels. Functions and Indications: Tonifies Qi and nourishes Yin, strengthens the Spleen, moistens the Lungs, and benefits the Kidneys. Used for Spleen and Stomach Qi deficiency, fatigue, Stomach Yin deficiency, dry mouth and poor appetite, Lung deficiency and dry cough, consumptive cough with hemoptysis, deficiency of essence and blood, soreness and weakness of the lower back and knees, premature graying of hair, and internal heat and thirst.

[0021] Sea buckthorn: The dried, ripe fruit of *Hippophae rhamnoides* L., a plant belonging to the Elaeagnaceae family. Properties and Channels Entered: Sour, astringent, warm. Enters the spleen, stomach, lung, and heart channels. Functions and Indications: Strengthens the spleen and promotes digestion, relieves cough and eliminates phlegm, invigorates blood and removes blood stasis. Used for spleen deficiency with poor appetite, abdominal pain due to food stagnation, cough with excessive phlegm, chest pain, amenorrhea due to blood stasis, and traumatic swelling and bruising.

[0022] Green Plum Blossom: The flowers of *Prunus mume* Sieb. et Zucc. var. *viridicalyx Makino.*, a plant in the genus *Prunus* of the Rosaceae family, are used medicinally. Properties and Channels Entered: Bitter, slightly sweet, neutral. Functions and Indications: Calms the liver and harmonizes the stomach. Used for chest and rib pain, stomachache, indigestion, and neurasthenia.

[0023] Stir-fried yam: The tuber of the yam plant (Dioscorea opposita). Properties and channels: Sweet, neutral. Functions and indications: Tonifies the spleen and stomach, promotes the production of body fluids and benefits the lungs, tonifies the kidneys and astringes essence. Used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, excessive leukorrhea, frequent urination, and thirst due to deficiency heat.

[0024] Prepared Rehmannia Root: The tuberous root of Rehmannia glutinosa, a plant in the Scrophulariaceae family, processed by steaming and drying. Properties and Channels Entered: Sweet, slightly warm. Enters the Liver and Kidney channels. Functions and Indications: Nourishes blood and Yin, replenishes essence and marrow. Used for blood deficiency and chlorosis, palpitations, irregular menstruation, metrorrhagia, liver and kidney Yin deficiency, soreness and weakness of the lower back and knees, bone steaming fever, night sweats, seminal emission, internal heat and thirst, dizziness, tinnitus, and premature graying of hair.

[0025] Cornus officinalis: The dried, ripe pulp of the plant Cornus officinalis Sieb. et Zucc. (family Cornaceae). Properties and Channels Entered: Sour, astringent, slightly warm. Enters the Liver and Kidney channels. Functions and Indications: Tonifies the Liver and Kidneys, astringes and consolidates. Used for dizziness and tinnitus, lower back and knee pain, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, and internal heat and thirst.

[0026] Red adzuki bean: The dried, mature seed of *Vigna umbellata* Ohwi et Ohashi. or *Vigna angularis* Ohwi et Ohashi., both belonging to the legume family. Properties and Channels Entered: Sweet, sour, neutral. Enters the Heart and Small Intestine channels. Functions and Indications: Promotes diuresis and reduces swelling, detoxifies and drains pus. Used for edema, beriberi, jaundice with dark urine, rheumatic fever, carbuncles and boils, and abdominal pain due to intestinal abscess.

[0027] Red peony root: The dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch, both belonging to the Ranunculaceae family. Properties and Channels Entered: Bitter, slightly cold. Enters the Liver channel. Functions and Indications: Clears heat and cools the blood, disperses blood stasis and relieves pain. Used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, red and swollen eyes, hypochondriac pain due to liver stagnation, amenorrhea, dysmenorrhea, abdominal masses, traumatic injuries, carbuncles, and sores.

[0028] Atractylodes Rhizome: The dried rhizome of Atractylodes macrocephala Koidz., a plant of the Compositae family. Properties and Channels Entered: Bitter, sweet, warm. Enter the spleen and stomach channels. Functions and Indications: Tonify the spleen and boost qi, dry dampness and promote diuresis, stop sweating, and prevent miscarriage. Used for spleen deficiency with reduced appetite, abdominal distension and diarrhea, phlegm-fluid dizziness and palpitations, edema, spontaneous sweating, and restlessness during pregnancy.

[0029] Tangerine Peel: The dried ripe pericarp of Citrus reticulata Blanco, a plant of the Rutaceae family and its cultivated varieties. Properties and Channels Entered: Bitter, pungent, warm. Enter the lung and spleen channels. Functions and Indications: Regulate qi and strengthen the spleen, dry dampness and resolve phlegm. Used for fullness and distension in the epigastrium and abdomen, reduced food intake, vomiting and diarrhea, and profuse cough with copious phlegm.

[0030] Immature Bitter Orange: The dried young fruit of Citrus aurantium L., a plant of the Rutaceae family and its cultivated varieties or Citrus sinensis Osbeck. Properties and Channels Entered: Bitter, pungent, sour, slightly cold. Enter the spleen and stomach channels. Functions and Indications: Break qi and eliminate accumulation, resolve phlegm and disperse masses. Used for internal retention of accumulation, fullness and distending pain, tenesmus after diarrhea and dysentery, constipation, phlegm stagnation obstructing qi, chest impediment, knotted chest, and visceral ptosis.

[0031] Prepared Pinellia Rhizome: The processed product of the tuber of Pinellia ternata, a plant of the Araceae family. Properties and Channels Entered: Pungent, warm. Enter the spleen, stomach, and lung channels. Functions and Indications: Dry dampness and resolve phlegm. Used for profuse phlegm with cough and asthma, phlegm-fluid dizziness and palpitations, wind-phlegm dizziness, and headache due to phlegm syncope.

[0032] Amomum Fruit: The dried ripe fruit of Amomum villosum Lour., Amomum villosum Lour. var. xanthioides T.L. Wu et Senjen, or Amomum longiligulare T.L. Wu, plants of the Zingiberaceae family. Properties and Channels Entered: Pungent, warm. Enter the spleen, stomach, and kidney channels. Functions and Indications: Transform dampness and promote appetite, warm the spleen and stop diarrhea, regulate qi and prevent miscarriage. Used for obstruction of damp-turbidity, fullness and lack of hunger in the epigastrium and abdomen, spleen-stomach yang deficiency, vomiting and diarrhea, morning sickness during pregnancy, and restlessness of the fetus.

[0033] Salvia Root: The dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. Properties and Channels Entered: Bitter, slightly cold. Enter the heart and liver channels. Functions and Indications: Promote blood circulation to remove blood stasis, dredge the channels and stop pain, clear the heart and relieve vexation, cool the blood and resolve carbuncles. Used for chest impediment with heart pain, pain in the epigastrium, abdomen, and hypochondrium, masses and accumulations, painful obstruction due to heat, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and swelling and pain of sores and ulcers.

[0034] Licorice: The dried root and rhizome of *Glycyrrhiza uralensis* Fisch., *Glycyrrhiza inflata* Bat., or *Glycyrrhiza glabra* L. (all belonging to the Fabaceae family). Properties and Channels Entered: Sweet, neutral. Enters the Heart, Lung, Spleen, and Stomach channels. Functions and Indications: Tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. Used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs.

[0035] Rehmannia glutinosa (raw): The tuberous root of Rehmannia glutinosa Libosch., a plant in the Scrophulariaceae family. Properties and Channels Entered: Sweet; bitter; slightly cold. Functions and Indications: Primarily used for feverish thirst, internal heat and thirst, steaming bone fever, febrile diseases with rashes, hematemesis, metrorrhagia, hematuria, hematochezia caused by blood heat, anemia and chlorosis, dizziness and palpitations, and amenorrhea due to blood deficiency.

[0036] Ophiopogon japonicus: The dried tuberous root of Ophiopogon japonicus, a plant in the Liliaceae family. Properties and Channels Entered: Sweet, slightly bitter, slightly cold. Enters the Heart, Lung, and Stomach channels. Functions and Indications: Nourishes Yin and generates fluids, moistens the lungs and clears the heart. Used for dry cough due to lung dryness, consumptive cough due to Yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0037] Earthworm: The dried body of *Pheretima aspergillum* (E. Perrier), *Pheretima vulgaris* Chen, *Pheretima guillelmi* (Michaelsen), or *Pheretima pectinifera* Michaelsen, all belonging to the family Pheretidae. The former is commonly known as *Guangdong earthworm*, and the latter three are commonly known as *Shanghai earthworm*. *Guangdong earthworm* is captured from spring to autumn, while *Shanghai earthworm* is captured in summer. The abdomen is promptly dissected, the internal organs and mud removed, washed, and then sun-dried or dried at low temperature. Properties and Channels: Salty, cold. Enters the Liver, Spleen, and Bladder channels. Functions and Indications: Clears heat and calms convulsions, unblocks channels, relieves asthma, and promotes diuresis. Used for high fever with delirium, convulsions, joint pain, limb numbness, hemiplegia, lung heat with cough and asthma, and edema with oliguria.

[0038] This formula draws upon Ye Tianshi's "pungent and moistening to unblock the meridians" treatment method, integrates the experience of using herbs based on the properties of "blood is the main substance" and "kidneys are dry and bitter, so pungent herbs are used to moisten them," and combines Ye's method of "timely application of herbs." It is based on profound scholarship and broad knowledge, integrates the inheritance of thousands of years of traditional Chinese medicine, extracts the insights of famous doctors, and draws on years of clinical experience. It upholds the correct principles and innovates, applying the academic thoughts of famous doctors to key problems that urgently need to be solved in clinical practice. It has unparalleled clinical significance, whether from the perspective of inheriting and passing on the classics or developing the modernization of traditional Chinese medicine.

[0039] Firstly, this combination applies the theory of "the five viscera's need for tonification and purging" proposed in the *Neijing* (Inner Canon of Medicine). The *Suwen* (Plain Questions) chapter "On the Timing of Qi in the Viscera" states, "The kidneys suffer from dryness; urgently eat pungent foods to moisten them, open the pores, promote fluid production, and facilitate the flow of qi." Later, Ye Tianshi summarized the essence of the "pungent moistening and unblocking" method: "Use pungent herbs to regulate qi without breaking it; use lubricating herbs to moisten dryness without cloying the qi mechanism; use dispersing herbs without forcing growth." This indicates that when the pathogenesis is complex, with both deficiency and excess, and for patients whose qi is weak and unable to circulate properly, and whose blood is deficient and unable to nourish, the treatment should simultaneously nourish qi and replenish blood, integrating tonification with unblocking. At this time, the prescription should not be too cold or too warm, nor should it be too sour or astringent; only pungent moistening and dispersing herbs can effectively target the condition. This is the essence of "treating the collaterals" and a wonderful method for nourishing blood. This combination incorporates peach kernel, cypress seed, deer antler glue, polygonatum, sea buckthorn, and green plum blossom into the "pungent moistening and unblocking" herbal formula to achieve the therapeutic goal of dispersing qi and blood and harmonizing the Chong and Ren meridians.

[0040] Secondly, through years of clinical experience, Ye has come to understand the academic connotation of "instability of the Chong and Ren meridians" proposed in *Study of the Eight Extraordinary Meridians*. Ye believes that "the regular meridians are for drainage, while the extraordinary meridians are for storage," therefore, the treatment of amenorrhea due to obstructed collaterals, blood deficiency, and instability of the Chong and Ren meridians must also consider the theory of the extraordinary meridians. Based on this, and with years of careful clinical experience and a thorough understanding of classical texts, Ye creatively proposed, drawing on his experience in using medicines for the extraordinary meridians, to apply deer antler glue to invigorate the extraordinary yang, calm the Chong and Ren meridians, nourish blood and flesh, and balance yin and yang, thus harmonizing the Chong and Ren meridians, achieving satisfactory clinical results.

[0041] Finally, drawing upon Ye Tianshi's therapeutic philosophy of "complementary medication in the morning and evening," medication is administered at appropriate times. In the morning, when "the weather belongs to Yang," Qi and blood flow outwards to the Yang organs, and the body's vital energy rises to resist pathogens. Furthermore, the abundance of Yang can generate and circulate blood. Therefore, in the morning, rich and heavy herbs (such as Polygonatum) are used to replenish essence and nourish blood, thus strengthening the meridians and assisting the body in resisting pathogens. In the evening, when "the weather belongs to Yin," Qi and blood return to the Yin organs, Yang diminishes and Yin flourishes, and pathogens stagnate in the meridians, obstructing the flow of menstrual blood. Therefore, at this time, pungent and moistening herbs (such as deer antler glue, peach kernel, and cypress seed) are used to invigorate blood, unblock the meridians, and harmonize the Chong and Ren meridians.

[0042] Compared with the prior art, the beneficial effects of the present invention are:

[0043] 1. Early prevention of premature ovarian failure: slowing disease progression and protecting ovarian blood supply

[0044] This drug composition offers targeted preventative value for premature ovarian failure. Early application can effectively dilate blood vessels supplying the ovaries, significantly improving ovarian blood flow and perfusion. This not only promptly improves the current blood and nutrient supply to the ovaries but also prevents further decline in ovarian function through optimized blood supply, thereby effectively alleviating or even preventing the progression of ovarian reserve decline and providing crucial support for early disease control.

[0045] 2. Facilitates the improvement of ovarian function: Alleviates ovarian reserve decline caused by estrogen imbalance.

[0046] This invention can directly regulate ovarian physiological function by improving ovarian blood flow perfusion, providing sufficient blood supply support to ovarian tissue, and thus effectively alleviating ovarian reserve decline caused by estrogen secretion disorders. Its mechanism of action focuses on both the blood supply and hormone regulation of the ovary itself, addressing the root cause of ovarian reserve decline and providing direct assistance for the maintenance and recovery of ovarian function.

[0047] 3. Improves hormone-related complications: covers multiple systemic conditions.

[0048] Given that estrogen secretion disorders can easily lead to multi-system complications, this invention, while regulating ovarian function and improving hormonal status, also has a certain therapeutic effect on a series of related symptoms caused by hormone disorders. Specifically, it can be applied to skeletal problems such as osteoporosis and fractures, circulatory problems such as cardiovascular diseases, and neurological problems such as depression and cognitive impairment, achieving synergistic improvement of multi-system symptoms related to hormone disorders. Attached Figure Description

[0049] Figure 1 A graph showing the serum E2, LH, FSH, and AMH levels in rats in the test drug group;

[0050] Figure 2 Vaginal smears of rats. Detailed Implementation

[0051] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0052] Example 1:

[0053] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 15g, peach kernel 9g, cypress seed 6g, deer antler glue 3g, Polygonatum sibiricum 30g, sea buckthorn 12g, green plum blossom 9g, stir-fried yam 30g, cornus officinalis 9g, and red adzuki bean 21g. Pharmaceutical composition B is made from the following medicinal materials by weight: Rehmannia glutinosa 15g and Paeonia lactiflora 18g.

[0054] Example 2:

[0055] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 9g, Prunus persica kernel 9g, Platycladus orientalis seed 6g, Cervi cornu colla 3g, Polygonatum sibiricum 12g, Hippophae rhamnoides 9g, Prunus mume 9g, Dioscorea opposita 21g, Cornus officinalis 6g, and Phaseolus angularis 18g. Pharmaceutical composition B is made from the following medicinal materials by weight: Rehmannia glutinosa 12g and Paeonia lactiflora 15g.

[0056] Example 3:

[0057] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 15g, Prunus persica kernel 15g, Platycladus orientalis seed 12g, Cervi cornu colla 12g, Polygonatum sibiricum 30g, Hippophae rhamnoides 18g, Prunus mume 12g, Dioscorea opposita 36g, Cornus officinalis 12g, and Phaseolus angularis 30g. Pharmaceutical composition B is made from the following medicinal materials by weight: Rehmannia glutinosa 21g and Paeonia lactiflora 21g.

[0058] Example 4:

[0059] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 12g, Prunus persica kernel 12g, Platycladus orientalis seed 9g, Cervi cornu colla 8g, Polygonatum sibiricum 21g, Hippophae rhamnoides 14g, Prunus mume 11g, Dioscorea opposita 28g, Cornus officinalis 9g, and Phaseolus angularis 18g. Pharmaceutical composition B is made from the following medicinal materials by weight: Rehmannia glutinosa 16g and Paeonia lactiflora 18g.

[0060] Example 5:

[0061] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 15g, Prunus persica kernel 9g, Platycladus orientalis seed 6g, Cervi cornu colla 3g, Polygonatum sibiricum 30g, Hippophae rhamnoides 12g, Prunus mume 9g, Dioscorea opposita (fried) 30g, Cornus officinalis 9g, and Phaseolus angularis 21g. Pharmaceutical composition B is made from the following medicinal materials by weight: Atractylodes macrocephala 12g, Citrus reticulata peel 15g, Citrus aurantium 15g, Pinellia ternata (processed) 9g, Amomum villosum 5g, Salvia miltiorrhiza 15g, Glycyrrhiza uralensis 6g, Rehmannia glutinosa 15g, Ophiopogon japonicus 15g, and Pheretima aspergillum 6g.

[0062] Example 6:

[0063] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 9g, Prunus persica kernel 9g, Platycladus orientalis seed 6g, Cervi cornu colla 3g, Polygonatum sibiricum 12g, Hippophae rhamnoides 9g, Prunus mume 9g, Dioscorea opposita (fried) 21g, Cornus officinalis 6g, and Phaseolus angularis 18g. Pharmaceutical composition B is made from the following medicinal materials by weight: Atractylodes macrocephala 9g, Citrus reticulata peel 12g, Citrus aurantium 9g, Pinellia ternata (processed) 9g, Amomum villosum 5g, Salvia miltiorrhiza 9g, Glycyrrhiza uralensis 6g, Rehmannia glutinosa 12g, Ophiopogon japonicus 9g, and Pheretima aspergillum 6g.

[0064] Example 7:

[0065] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 15g, Prunus persica kernel 15g, Platycladus orientalis seed 12g, Cervi cornu colla 12g, Polygonatum sibiricum 30g, Hippophae rhamnoides 18g, Prunus mume 12g, Dioscorea opposita (fried) 36g, Cornus officinalis 12g, and Phaseolus angularis 30g. Pharmaceutical composition B is made from the following medicinal materials by weight: Atractylodes macrocephala 18g, Citrus reticulata peel 21g, Citrus aurantium 15g, Pinellia ternata (processed) 12g, Amomum villosum 12g, Salvia miltiorrhiza 18g, Glycyrrhiza uralensis 12g, Rehmannia glutinosa 21g, Ophiopogon japonicus 15g, and Pheretima aspergillum 12g.

[0066] Example 8:

[0067] A pharmaceutical composition for protecting ovarian function and anti-aging is made from pharmaceutical composition A and pharmaceutical composition B. Pharmaceutical composition A is made from the following medicinal materials by weight: Poria cocos 12g, Prunus persica kernel 12g, Platycladus orientalis seed 9g, Cervi cornu colla 8g, Polygonatum sibiricum 21g, Hippophae rhamnoides 14g, Prunus mume 11g, Dioscorea opposita (fried) 28g, Cornus officinalis 9g, and Phaseolus angularis 18g. Pharmaceutical composition B is made from the following medicinal materials by weight: Atractylodes macrocephala 14g, Citrus reticulata peel 16g, Citrus aurantium 12g, Pinellia ternata (processed) 11g, Amomum villosum 9g, Salvia miltiorrhiza 14g, Glycyrrhiza uralensis 9g, Rehmannia glutinosa 16g, Ophiopogon japonicus 12g, and Pheretima aspergillum 9g.

[0068] Application Example 1: Animal Experiments

[0069] I. Effects of this invention on a rat model of premature ovarian failure

[0070] 1. Experimental Methods: Healthy female SD rats were selected and randomly divided into 5 groups after one week of acclimatization: blank control group, model control group, positive drug control group, and test drug intervention group, with 10 rats in each group. The test drug was drug composition A of Example 1. The intervention group was divided into three groups according to the concentration: low-dose group (1 / 2 medium-dose group), medium-dose group, and high-dose group (2 times the medium-dose group). Except for the blank control group, the rat premature ovarian failure model was established by intraperitoneal injection of cyclophosphamide (CTX, 90 mg / kg, first day injection). After modeling, the low-dose group (the dose was converted from the rat dose to the human dose by the body surface area method, specifically 3.4 g / kg), medium-dose group (6.75 g / kg), and high-dose group (13.5 g / kg) were administered by gavage. The positive drug control group was administered the positive control drug (6.75 g / kg) by gavage. The blank control group and the model control group were administered an equal volume (6.75 g / kg) of physiological saline. The intervention was carried out once a day for 21 consecutive days. During the experiment, the changes in the estrous cycle of rats were observed and recorded daily. The morphological characteristics of cells were analyzed by vaginal exfoliated cell smear staining to assess the reproductive endocrine status. After the intervention, serum was collected from the abdominal aorta, centrifuged to separate the serum, and the levels of estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and anti-Müllerian hormone (AMH) in the serum were detected.

[0071] Table 1. Serum levels of E2, LH, FSH, and AMH

[0072]

[0073]

[0074] Note: Compared with the control group, ** = P < 0.01; compared with the model group, ## =P<0.01.

[0075] 2. Experimental conclusion: This invention uses drug combination A as the core component, which can effectively improve ovarian function and regulate hormone secretion and ovarian reserve.

[0076] Table 1 shows that, compared with the control group, the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) in the model group rats were significantly increased (P<0.01). Serum estradiol (E2) and anti-Müllerian hormone (AMH) levels were significantly decreased. The model group successfully simulated the core pathological features of ovarian failure: "estrogen-related hormone imbalance and decreased ovarian reserve." Compared with the model group, the positive control group and the test drug groups containing drug combination A (low-dose, medium-dose, and high-dose groups) showed significantly decreased LH and FSH levels (P<0.01), and significantly increased E2 and AMH levels (P<0.01). Further observation revealed that as the serum concentration of drug combination A increased from half the medium-dose group to twice the medium-dose group, LH and FSH gradually decreased, while E2 and AMH gradually increased.

[0077] The above results indicate that the pharmaceutical composition with drug combination A as its core can effectively regulate the secretion of ovarian function-related hormones and improve ovarian reserve function, and exhibits a clear dose-dependent effect; that is, the higher the concentration of drug combination A, the more significant the improvement effect on estrogen disorders and decreased ovarian reserve. This confirms that the present invention can improve ovarian function and alleviate ovarian dysfunction caused by estrogen disorders.

[0078] Table 2. Estrogenic cycle disorder in rats

[0079]

[0080]

[0081] The control group rats (K1-K6) exhibited a regular estrous cycle (0% disorder rate), showing a regular 4-5 day rhythm of "proestrus-estrus-metaestrus-interestrus"; while the model group rats (1-6) had an estrous cycle disorder rate of 100%, with most rats in the interestrus or metaestrus phase, confirming that cyclophosphamide successfully constructed a model of ovarian reserve decline, simulating the core phenotype of "loss of estrous cycle rhythm".

[0082] Experimental results showed that both the test drug group containing drug combination A and the positive drug group effectively restored estrous cycle disorders in rats with diminished ovarian reserve, and the test drug exhibited a concentration-dependent effect. As shown in Table 2, as the concentration of drug combination A increased from low to high doses, the estrous cycle disorder rate decreased from 83.3% to 50.0%; the disorder rate in the high-dose group was 33.3 percentage points lower than that in the low-dose group and 16.7 percentage points lower than that in the medium-dose group. The disorder rate in the positive drug group (25-36) was as low as 16.7%.

[0083] The regularity of the estrous cycle is precisely regulated by estrogen and progesterone secreted by the ovaries, serving as a direct external phenotypic marker of ovarian function. A normal estrous cycle rhythm indicates coordination between ovarian endocrine and reproductive functions, while rhythm loss is one of the core phenotypic characteristics of diminished ovarian reserve. The test drug group containing drug combination A, by improving estrous cycle disorder and restoring the rhythmic alternation of "proestrus-estrus-metaestrus-interestrus," not only provided direct experimental phenotypic evidence for drug intervention in premature ovarian failure but also formed a dual phenotypic-biochemical validation with the biochemical indicators of drug combination A regulating the secretion of ovarian function-related hormones such as E2 (estradiol) and AMH (anti-Müllerian hormone).

[0084] The synergistic improvement effect of hormone levels and the estrous cycle further demonstrates that this invention, with drug combination A as its core component, can provide "preventive maintenance" for ovaries that have not yet experienced premature ovarian failure, maintaining hormonal balance and cyclical rhythm, and delaying the decline in ovarian reserve. It can also play a "therapeutic" and "repairing" role in ovaries that have already experienced decreased or damaged ovarian reserve, correcting hormonal imbalances and restoring cyclical rhythm. Therefore, this invention can prevent ovarian reserve decline, treat existing ovarian reserve decline, and repair damaged ovarian function, achieving full-cycle protection and reconstruction of ovarian function.

[0085] Application Example 2: Clinical Case

[0086] To demonstrate that the traditional Chinese medicine composition of this invention has positive effects in preventing ovarian dysfunction, treating existing ovarian insufficiency, and repairing damaged ovarian function, the inventors conducted extensive clinical trials on the pharmaceutical compositions of Examples 1 and 5. Some of the clinical trial reports are selected below.

[0087] Case 1: Ms. Cheng, 38 years old.

[0088] Chief complaint: Infertility for over a year.

[0089] Present illness: Infertility for ten years after marriage, irregular menstrual cycle, scanty and dark menstrual flow, melancholy and sadness; feeling tired and weak, unable to endure labor, tired and wanting to lie down, poor appetite, difficult bowel movements, dark yellow urine, pale tongue with yellow coating, dark tongue body, and thready and hesitant pulse.

[0090] Past medical history: Anti-Müllerian hormone: 0.2 ng / mL.

[0091] Western medical diagnosis: 1. Infertility; 2. Decreased ovarian reserve.

[0092] Traditional Chinese Medicine diagnosis: Infertility, blood deficiency and obstruction of collaterals, disharmony of the Chong and Ren meridians.

[0093] Drug formulation: Prepared according to the formulation in Example 1.

[0094] Usage: Prepare the decoction using conventional methods, for a total of 7 doses, one dose per day.

[0095] Second visit: May 25, 2023. The patient reported that after taking the medication, sleep gradually improved, and mood improved. However, the patient still felt lethargic, had poor appetite, abdominal distension, constipation, and scanty urination. The tongue coating was thick and greasy, the tongue body was bluish-purple and dark, and the pulse was wiry and hesitant.

[0096] Drug formulation: Prepared according to the formulation in Example 5.

[0097] Usage: Prepare the decoction using conventional methods, for a total of 14 doses, one dose per day.

[0098] Third visit: June 8, 2023, menstruation began, with increased flow compared to the previous period. Mood swings were significantly relieved, and the frequency and severity of abdominal pain improved. Bowel movements were formed once a day, and urine was clear. Tongue coating was thin and white, tongue body was pale red, and pulse was thready and weak.

[0099] Drug formulation: Prepared according to the formulation in Example 5.

[0100] Usage: Prepare the decoction using conventional methods, for a total of 14 doses, one dose per day.

[0101] Four diagnostic methods: On June 22, 2023, menstruation began, with increased menstrual flow. Sleep gradually improved, mood returned to normal, appetite improved, abdominal distension decreased, bowel movements occurred once a day, and urination was normal. The tongue coating was thin, the tongue body was pale, and the pulse was thready. Examination showed: Anti-Müllerian hormone: 0.5 ng / mL

[0102] Drug formulation: Prepared according to the formulation in Example 5.

[0103] Usage: Prepare into pills using conventional methods. Take 3-6g at a time, twice a day.

[0104] After taking the drug compositions of Examples 1 and 5, the following effects occurred: increased menstrual flow; significant reduction in fatigue and lethargy; improved sleep quality and more stable sleep patterns; slow weight gain; and a gradually more rosy complexion and improved facial radiance. Tongue examination revealed a red tongue with a yellow coating, and pulse examination revealed a thready and rapid pulse. It is also known that the patient currently has one daughter.

[0105] Case 2: Ms. Yang, 36 years old, visited the hospital on June 17, 2023.

[0106] Chief complaint: Reduced menstrual flow for one year, which has worsened recently.

[0107] Present illness: menstrual cycle is early, scanty and dark in color, mood is depressed, irritable and easily angered, insomnia and restlessness; feeling tired and weak, unable to endure labor, tired and wanting to lie down, poor appetite, fullness after eating, lower abdominal cramps, difficult defecation, dark yellow urine, pale tongue with white and yellow coating.

[0108] Western medical diagnosis: Decreased ovarian reserve.

[0109] Traditional Chinese Medicine diagnosis: Scanty menstruation, blood deficiency and obstruction of collaterals, disharmony of the Chong and Ren meridians.

[0110] Drug formulation: Prepared according to the formulation in Example 1.

[0111] Usage: Prepare the decoction using conventional methods, for a total of 7 doses, one dose per day.

[0112] Second visit: June 24, 2023. The patient reported that after taking the medication, the symptoms of fullness and cramping had eased, and the frequency and severity of abdominal pain had improved this week. Currently, the patient still experiences poor sleep, mood swings, lethargy, poor appetite, abdominal distension, constipation, and scanty urination. The tongue coating is thick and greasy, the tongue body is bluish-purple and dark, and the pulse is wiry and hesitant.

[0113] Drug formulation: Prepared according to the formulation in Example 5.

[0114] Usage: Prepare the decoction using conventional methods, for a total of 14 doses, one dose per day.

[0115] On July 7, 2023, the patient reported that after taking the medication, her menstruation resumed, with increased flow compared to the previous period. Her mood swings were significantly relieved, and the frequency and severity of her abdominal pain improved. She had one formed bowel movement per day, and her urine was clear. Her tongue coating was thin and white, her tongue body was pale red, and her pulse was thready and weak.

[0116] Drug formulation: Prepared according to the formulation in Example 5.

[0117] Usage: Prepare the decoction using conventional methods, for a total of 14 doses, one dose per day.

[0118] After taking the drug compositions of Examples 1 and 5, the following effects occurred: increased menstrual flow; significant reduction in fatigue and lethargy; gradual improvement in sleep quality and more stable sleep; slow weight gain; and a gradually rosier complexion with improved facial radiance. The tongue was red with a yellow coating, and the pulse was thready and rapid.

[0119] The pharmacological explanation is as follows: Traditional Chinese medicine theory holds that "the liver governs the free flow of qi and blood and stores blood," making it the core hub for regulating the circulation of qi and blood throughout the body. As stated in "Miscellaneous Writings of Famous Physicians," "When liver qi flows smoothly, heart qi is harmonious," revealing that the liver's function of regulating qi is fundamental to the smooth flow of qi—the liver's function of regulating qi can promote the ascending, descending, entering, and exiting of qi. Only when qi flows smoothly can qi and blood be distributed to the ovaries and other organs and tissues throughout the body. It also emphasizes that the liver's storage of blood is the material basis for blood circulation—the liver, through storing and regulating blood, provides a "blood source" guarantee for the heart to govern blood vessels and for the organs to be nourished. If liver qi is stagnant, it is easy to trigger a chain reaction of "qi stagnation → blood stasis." Therefore, it is necessary to first use the drug composition of Example 1 to soothe liver qi and relieve the "source obstacle" of qi stagnation, laying the foundation for subsequent blood nourishment and blood vessel unblocking.

[0120] From the perspective of the interdependent relationship between Qi and blood, "Qi is the commander of blood, and blood is the mother of Qi," and the smooth flow of Qi is a prerequisite for the normal distribution of blood. If the process of nourishing blood is skipped by directly nourishing the liver Qi, the stagnant Qi will act like a "blocked pipe," hindering the absorption and distribution of blood in two ways: First, stagnant liver Qi will interfere with the spleen and stomach's digestive functions, making it difficult for the body to absorb the effective components of blood-nourishing drugs; second, even if blood is replenished, the stagnant Qi cannot propel it to target organs such as the ovaries, ultimately leading to a "nourishing without reaching" dilemma. Only by first nourishing the liver Qi and restoring the smooth flow of Qi can the subsequent blood-nourishing drugs be efficiently absorbed and distributed to damaged tissues along with the Qi, truly exerting their nourishing and blood-clearing effects. Based on this, after using the liver Qi-nourishing method in Example 1, the drug composition in Example 5 should be used for blood-nourishing and blood-clearing treatment to achieve a progressive therapeutic effect of "smooth Qi flow → unobstructed blood flow → nourishment of target organs."

[0121] In summary, this invention, based on the traditional Chinese medicine theories of "the liver governs the free flow of qi and stores blood" and the interdependent relationship between qi and blood ("qi is the commander of blood, and blood is the mother of qi"), constructs a progressive treatment system of "soothing liver qi – nourishing blood and unblocking meridians," which can achieve full-cycle protection and reconstruction of ovarian function. First, the drug composition of Example 1 is used to soothe liver qi, relieving the "source obstacle" of qi stagnation and clearing the pathway for nourishing blood and unblocking meridians. Then, the drug composition of Example 5 is used to nourish blood and unblock meridians, ensuring efficient absorption of blood-nourishing components and their distribution to the ovarian target organ with qi, avoiding "supplementation without reaching the target." This system can provide "preventive maintenance" for non-declining ovaries to maintain hormonal balance and cyclical rhythm, delaying the decline process; it can also play a "therapeutic" and "repairing" role in correcting hormonal imbalances and reconstructing cyclical rhythms in ovaries with already diminished or damaged ovarian function. Furthermore, the clinical manifestations of increased menstrual flow, relief of fatigue and lethargy, improved sleep, and rosy complexion after medication also confirm its effectiveness in protecting and reconstructing ovarian function.

[0122] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within the present invention.

Claims

1. A pharmaceutical composition for protecting ovarian function and combating aging, characterized in that, The medicine is made from drug combination A and drug combination B. Drug combination A is made from the following medicinal materials in parts by weight: Poria cocos 9-15 parts, Prunus persica kernel 9-15 parts, Platycladus orientalis seed 6-12 parts, Cervi cornu colla 3-12 parts, Polygonatum sibiricum 12-30 parts, Hippophae rhamnoides 9-18 parts, Prunus mume 9-12 parts, Dioscorea opposita (fried) 21-36 parts, Cornus officinalis 6-12 parts, and Phaseolus angularis 18-30 parts. Drug combination B is made from the following medicinal materials in parts by weight: Rehmannia glutinosa (processed) 12-21 parts and Paeonia lactiflora 15-21 parts, or from the following medicinal materials in parts by weight: Atractylodes macrocephala 9-18 parts, Citrus reticulata peel 12-21 parts, Citrus aurantium 9-15 parts, Pinellia ternata (processed) 9-12 parts, Amomum villosum 5-12 parts, Salvia miltiorrhiza 9-18 parts, Glycyrrhiza uralensis 6-12 parts, Rehmannia glutinosa (raw) 12-21 parts, Ophiopogon japonicus 9-15 parts, and Pheretima aspergillum 6-12 parts.

2. The pharmaceutical composition for protecting ovarian function and anti-aging according to claim 1, characterized in that, Drug combination A is made from the following medicinal materials in parts by weight: 15 parts Poria cocos, 9 parts Prunus persica, 6 parts Platycladus orientalis, 3 parts Cervi cornu colla, 30 parts Polygonatum sibiricum, 12 parts Hippophae rhamnoides, 9 parts Prunus mume, 30 parts Dioscorea opposita, 9 parts Cornus officinalis, and 21 parts Phaseolus angularis; Drug combination B is made from the following medicinal materials in parts by weight: 15 parts Rehmannia glutinosa and 18 parts Paeonia lactiflora.

3. The pharmaceutical composition for protecting ovarian function and anti-aging according to claim 1, characterized in that, Drug combination A is made from the following medicinal materials in parts by weight: Poria cocos 15 parts, Prunus persica kernel 9 parts, Platycladus orientalis seed 6 parts, Cervi cornu colla 3 parts, Polygonatum sibiricum 30 parts, Hippophae rhamnoides 12 parts, Prunus mume 9 parts, Dioscorea opposita 30 parts, Cornus officinalis 9 parts, and Phaseolus angularis 21 parts. Drug combination B is made from the following medicinal materials in parts by weight: Atractylodes macrocephala 12 parts, Citrus reticulata peel 15 parts, Citrus aurantium 15 parts, Pinellia ternata 9 parts, Amomum villosum 5 parts, Salvia miltiorrhiza 15 parts, Glycyrrhiza uralensis 6 parts, Rehmannia glutinosa 15 parts, Ophiopogon japonicus 15 parts, and Pheretima aspergillum 6 parts.

4. A pharmaceutical preparation made from the pharmaceutical composition according to any one of claims 1 to 3.

5. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparations include a variety of acceptable dosage forms.

6. The pharmaceutical preparation according to claim 5, characterized in that, The dosage form of the pharmaceutical preparation is any one of capsules, granules, tablets, powders, ointments, powders, pills, or liquids.

7. The pharmaceutical preparation according to claim 6, characterized in that, The pharmaceutical preparation may or may not include pharmaceutically acceptable excipients.

8. The use of the pharmaceutical composition according to any one of claims 1 to 3 in the preparation of a medicament for preventing premature ovarian failure or treating ovarian reserve deficiency.

9. The use of the pharmaceutical composition according to any one of claims 1 to 3 in the preparation of a medicament for repairing damaged ovarian function.

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