CN111588798A - Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof - Google Patents

Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof Download PDF

Info

Publication number
CN111588798A
CN111588798A CN202010592787.0A CN202010592787A CN111588798A CN 111588798 A CN111588798 A CN 111588798A CN 202010592787 A CN202010592787 A CN 202010592787A CN 111588798 A CN111588798 A CN 111588798A
Authority
CN
China
Prior art keywords
preparation
ovarian
traditional chinese
chinese medicine
hypofunction
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202010592787.0A
Other languages
Chinese (zh)
Inventor
王凌
张娜
李丽莎
邱学敏
潘心瑶
陈力嘉
周璟
李楚宇
黄锃恕
梁颖婷
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Obstetrics and Gynecology Hospital of Fudan University
Original Assignee
Obstetrics and Gynecology Hospital of Fudan University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Obstetrics and Gynecology Hospital of Fudan University filed Critical Obstetrics and Gynecology Hospital of Fudan University
Publication of CN111588798A publication Critical patent/CN111588798A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964Anemarrhena
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236Ligusticum (licorice-root)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/29Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296Epimedium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725Ziziphus, e.g. jujube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/756Phellodendron, e.g. corktree
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/06Antiabortive agents; Labour repressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Diabetes (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention belongs to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a traditional Chinese medicine compound preparation for improving low ovarian function and a preparation method thereof.

Description

Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicine pharmacy, relates to a traditional Chinese medicine compound preparation for treating gynecological diseases, and particularly relates to a traditional Chinese medicine compound preparation for improving low ovarian function and a preparation method thereof.
Background
According to the literature, the ovarian reserve function refers to the number and quality of the remaining follicles in the ovary, reflecting the fertility potential of women. The ovary has weakened capability of producing ova, the quality of follicular cells is reduced, and the female fertility is reduced and the sexual hormone is deficient, which is called as the hypofunction of ovary reserve. Ovarian hypofunction is manifested by a low response of the ovary to gonadotropins released by the pituitary gland, and inability to secrete normal levels of sex hormones, resulting in disorders of follicular growth, development, and excretion. Clinical studies show that hypofunction of ovarian reserve can bring a series of harm to women, and for women with fertility demand, hypofunction of ovarian reserve can increase the incidence of infertility, recurrent abortion and preeclampsia in pregnancy, and simultaneously bring obstruction to the use of an assisted reproduction technology; for women with no fertility demand, menstrual disorder, endocrine disturbance and premature ovarian failure can be caused, so that symptoms such as hot flashes, sweating, sleep disorder, poor spirit, osteoporosis and the like can occur; the hypofunction of the ovary can be developed into ovarian failure within 1 to 6 years, so that the decline of the function of the ovary reserve can be treated in time, the fertility potential and the sex hormone level of the female can be improved, the success rate of the female infertility, especially the birth aid technology (ART), can be improved, the occurrence of Premature Ovarian Failure (POF) can be prevented, delayed and even reversed, a brand-new way can be explored, the endocrine metabolism of the female can be improved, a series of symptoms caused by endocrine disturbance can be relieved, and the life quality can be improved.
In clinical practice, hormone replacement therapy is mostly adopted for treating hypofunction of ovary, and exogenous supplementation of estrogen or progestogen can maintain sex hormone level in physiological state, thereby improving endocrine state in vivo and promoting follicular development, but long-term hormone replacement therapy has the risk of increasing incidence rate of breast cancer and cardiovascular diseases. The androgen dehydroepiandrosterone can be converted into estrogen and androgen in peripheral tissues, and is currently used for treating hypofunction of ovary in clinical practice, but the use of the dehydroepiandrosterone is often accompanied by side effects such as acne and the like. In recent years, the traditional Chinese medicine treatment gradually shows unique effects and advantages in clinical treatment, and the traditional Chinese medicine compound medicine can treat diseases and assist western medicine treatment and also has the advantage of small side effect.
Based on the current situation of the prior art, the inventor of the application intends to provide a traditional Chinese medicine compound preparation for improving ovarian hypofunction, which is used for treating and improving gynecological diseases caused by ovarian hypofunction.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine compound preparation for improving hypofunction of ovaries based on the current situation of the prior art, and the traditional Chinese medicine compound preparation is used for treating and improving gynecological diseases caused by hypofunction of ovaries.
The traditional Chinese medicine compound preparation has definite curative effect and high safety in treating the ovarian hypofunction, can slow down the adverse reaction possibly brought by western medicines, and makes up the limited action of certain traditional Chinese medicine formulas in clinic at present.
The traditional Chinese medicine compound preparation of the invention follows a comprehensive kidney tonifying and yang supporting method, a liver soothing and qi regulating method and a blood circulation promoting and blood stasis removing method, and can fundamentally improve the microenvironment of ovaries, improve the functions of the ovaries, promote ovulation and maintain normal hormone level.
Specifically, the traditional Chinese medicine compound preparation is prepared from active ingredients and pharmaceutical excipients, wherein the active ingredients comprise the following raw material medicines in parts by weight: 9-15g of rhizoma anemarrhenae, 9-12g of golden cypress, 9-20g of radix rehmanniae, 9-15g of tortoise plastron, 9-15g of medlar or 9-15g of dodder, 9-15g of glossy privet fruit, 9-15g of herba epimedii or 9-15g of fructus psoraleae, 9-15g of morinda officinalis, 9-15g of red paeony root, 9-15g of white paeony root, 10-30g of raw astragalus root, 9-15g of angelica, 9-15g of peach kernel, 9-15g of ligusticum wallichii and 9-12g of spina date seed.
The raw material medicines of the invention have the weight ratio and the main effective components as shown in the table 1,
TABLE 1
Figure BDA0002556343200000021
Figure BDA0002556343200000031
The traditional Chinese medicine compound prescription of the invention is as follows: su Wen, Shang Gu Tian Zhen Lun: seven years old in women, kidney qi is flourishing, teeth are growing more, two seven but the heaven is full of blood, ren and ren meridians are connected, Taichong meridians are flourishing, the moon is around the morning, so there are son … … seven, ren and ren meridians are deficient, Taichong meridians are weak, heaven and ren meridians are exhausted, the earth is obstructed, and there is no son or son in bad condition. "Su Wen & Yin Yang congress treaty on the general treaty: forty years, and yin qi is also half. The preponderance or decline of kidney qi is directly related to menstruation and ovarian failure. Rhizoma anemarrhenae, which is pungent, bitter, cold and smooth, clears the lung and gold to purge fire, moistens kidney dryness to nourish yin, enters qi system of two channels, cortex phellodendri, which is bitter, cold and slightly pungent, sinks yin and descends, purges bladder fire, replenishes kidney water deficiency, strengthens the kidney to moisten dryness, enters blood system of two channels, rhizoma anemarrhenae and cortex phellodendri mutually reinforce to achieve the function of purging fire, moistening dryness and tonifying kidney, radix rehmanniae purges fire into heart and kidney, tortoise plastron, which is a product with emotion in blood and meat, is sweet, salty and cold, is good at replenishing essence and nourishing marrow, nourishing yin and nourishing blood; fructus Lycii and fructus Ligustri Lucidi have effects of nourishing liver and kidney, blackening beard and improving eyesight; the dodder seed is pungent and sweet in flavor and slightly warm in nature, enters liver, kidney and spleen meridians and is the essential drug for tonifying kidney yin and kidney yang; herba epimedii is pungent, fragrant, sweet and warm, has the effect of nourishing the Mingmen, morinda officinalis is pungent, sweet and warm, has the effects of strengthening tendons and bones, tonifying kidney and strengthening yang, fructus psoraleae is pungent, bitter and warm, enters the kidney channel, heart channel, spleen, stomach and lung channel, and has the effects of tonifying kidney and yang, and the theory of 'benefiting fire to eliminate nebula' is taken together, just like Zhang Jingyue: "tonifying yang should seek yang from yin, yang will help yin and become infinite; for those who are good at tonifying yin, they must seek yin from yang, so yin will rise to yang and the source will be exhausted; radix paeoniae alba is used for nourishing liver and blood, radix paeoniae rubra is used for cooling blood and removing stasis, rhizoma ligustici wallichii is used for soothing liver and regulating qi, peach kernel is used for lubricating intestines and activating blood, and angelica is used for replenishing blood and moistening dryness and is used as a qi medicine in blood; radix astragali can tonify qi, raise yang, tonify qi, strengthen superficial resistance, induce diuresis to alleviate edema, and increase blood stasis; the spina date seed has the effects of astringing qi and soothing the nerves, and nourishing tendons and marrow. The medicines are used together to tonify the kidney and fill the marrow, soothe the liver and regulate qi, and tonify qi and activate blood circulation, so that essence and blood are full and the Chong and ren channels are harmonized.
In the invention, the preferable mixture ratio of the raw materials and the weight is as follows: 9-15g of rhizoma anemarrhenae, 9-12g of golden cypress, 9-20g of radix rehmanniae, 9-15g of medlar, 9-15g of herba epimedii, 9-15g of red paeony root, 10-30g of raw astragalus mongholicus, 9-15g of angelica sinensis, 9-15g of ligusticum wallichii and 9-12g of spina date seed
In the invention, the more preferable mixture ratio of the raw materials and the weight is as follows: 11-15g of rhizoma anemarrhenae, 10-12g of golden cypress, 12-19g of radix rehmanniae, 10-13g of tortoise plastron, 10-13g of medlar, 10-13g of herba epimedii, 9-13g of red paeony root, 20-30g of raw astragalus membranaceus, 10-13g of angelica sinensis, 10-13g of peach kernel, 10-13g of ligusticum wallichii and 9-12g of spina date seed.
In the invention, the most preferable mixture ratio of the raw materials and the weight is as follows: 13-15g of rhizoma anemarrhenae, 11-12g of golden cypress, 16-19g of radix rehmanniae, 11-13g of tortoise plastron, 11-13g of medlar, 11-13g of glossy privet fruit, 11-13g of herba epimedii, 11-12g of fructus psoraleae, 9-11g of red paeony root, 9-11g of white paeony root, 25-30g of raw astragalus, 11-13g of angelica, 11-13g of peach kernel, 11-13g of ligusticum wallichii and 9-12g of spina date seed.
The invention further aims to provide a preparation method of the compound preparation, the active ingredients of the compound preparation are purified by methods of ethanol or aqueous solvent extraction, alcohol precipitation and filtration, wherein the adopted extraction method is to select an extraction solvent and extraction conditions for alcohol precipitation and filtration according to the physicochemical properties of the active ingredients in the medicine; the adopted purification method adopts an ethanol precipitation method for purification treatment under the premise of ensuring the curative effect.
More specifically, the preparation method of the compound preparation of the invention comprises the following steps:
weighing the raw materials according to the weight ratio range, adding 10 times of water, soaking for 40min, decocting at 90 ℃ for 2 times, each time for 1h, combining water decoction, adding 65-75% ethanol to ensure that the ethanol content reaches 60%, recovering ethanol, concentrating to obtain concentrated solution with the drug content ratio of 1:1, and granulating by a dry method to prepare granules, or preparing tablets, capsules and dripping pills.
The preparation method of the compound preparation can efficiently extract the effective components in the medicinal materials, remove impurities and ensure the curative effect; the traditional Chinese medicine decoction can be prepared into various oral preparations such as granules, tablets, capsules, dripping pills or powder by adding medicinal auxiliary materials according to a conventional method, has the outstanding advantages of avoiding the problems that the traditional Chinese medicine decoction is temporarily decocted before being taken, is easy to be deteriorated by enzyme after being placed for a long time and brings much inconvenience to patients, and can conveniently and effectively meet the requirements of the patients according to the characteristics of clinical medication and the physicochemical properties of main medicinal flavors in the preparation.
Clinical tests are carried out on the compound preparation, and after patients with low ovarian function continuously take the compound preparation for 1-12 months, the compound preparation can obviously improve the level of estrogen such as estradiol (E2) secreted by ovaries and the levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and anti-mullerian hormone (AMH) reflecting the ovarian function, which are shown in that the FSH and LH levels are reduced along with the increase of the E2 level at the 2-5 th day of menstruation; in addition, the volume of endometrium and ovary can be increased to be equivalent to that of a person with normal ovary function, the number of antral follicles is increased, the blood supply of ovary and uterus can be obviously improved, and the blood flow resistance of ovary artery and uterine artery under ultrasound is reduced.
The invention provides a traditional Chinese medicine compound preparation for improving hypofunction of ovaries, which is used for treating and improving gynecological diseases caused by hypofunction of ovaries, and can fundamentally improve microenvironment of ovaries, improve functions of ovaries, promote ovulation and maintain normal hormone level. The compound preparation has definite curative effect and high safety in treating the ovarian hypofunction, can slow down the adverse reaction possibly brought by western medicines, and makes up the limited action of some traditional Chinese medicine formulas in clinic at present.
Drawings
FIG. 1 flow chart of clinical trial
FIG. 2 shows the effect of the formula of tonifying kidney, invigorating qi and promoting blood circulation on reproductive endocrine hormone; wherein the content of the first and second substances,
treatment time: the time of treatment; e + D, Bu Jia le Jia Da Fu Tong treatment group; zuogui pill: zuogui pill treatment group; BSYQHXD: a treatment group of a prescription for tonifying kidney, benefiting qi and activating blood circulation; FSH: follicle stimulating hormone; LH: luteinizing hormone; e2: estradiol; AMH: anti-mullerian hormone.
FIG. 3 shows the effect of invigorating kidney, replenishing qi and promoting blood circulation on ovarian function, wherein,
treatment time: the time of treatment; e + D, Bu Jia le Jia Da Fu Tong treatment group; zuogui pill: zuogui pill treatment group; BSYQHXD: a treatment group of a prescription for tonifying kidney, benefiting qi and activating blood circulation; endometric thickness: (ii) endometrial thickness; ovarianvolume: ovarian volume; antral follicle count: number of antral follicles; RI of ovoarian identities: ovarian arterial resistance; RI of battery characteristics: uterine artery resistance.
Detailed Description
EXAMPLE 1 preparation of the Compound Chinese medicinal preparation
The following raw material medicines are taken according to the weight part ratio: 9g of rhizoma anemarrhenae, 9g of golden cypress, 9g of radix rehmanniae, 9-15g of tortoise plastron, 9g of medlar (or 9g of semen cuscutae), 9g of glossy privet fruit, 9g of herba epimedii (or 9g of fructus psoraleae), 9g of morinda officinalis, 9g of red paeony root, 9g of white paeony root, 10g of raw astragalus root, 9g of angelica, 9g of peach kernel, 9g of ligusticum wallichii and 9g of spina date seed; adding 10 times of water, soaking for 40min, decocting at 90 ℃ for 2 times, each time for 1h, combining water decoctions, adding 65-75% ethanol to make the ethanol content reach 60%, recovering ethanol, concentrating to obtain a concentrated solution with a drug content ratio of 1:1, and granulating by dry method to obtain granules, or making into tablets, capsules and dripping pills.
Example 2 preparation of the Compound Chinese medicinal preparation
The following raw material medicines are taken according to the weight part ratio: 15g of rhizoma anemarrhenae, 12g of golden cypress, 20g of radix rehmanniae, 15g of tortoise plastron, 15g of wolfberry fruit (or semen cuscutae), 15g of glossy privet fruit, 15g of herba epimedii (or fructus psoraleae), 15g of morinda officinalis, 15g of red paeony root, 15g of white paeony root, 30g of raw astragalus mongholicus, 15g of Chinese angelica, 15g of peach kernel, 15g of ligusticum wallichii and 12g of spina date seed; adding 10 times of water, soaking for 40min, decocting at 90 ℃ for 2 times, each time for 1h, combining water decoctions, adding 65-75% ethanol to make the ethanol content reach 60%, recovering ethanol, concentrating to obtain a concentrated solution with a drug content ratio of 1:1, and granulating by dry method to obtain granules, or making into tablets, capsules and dripping pills.
Example 3 preparation of the Compound Chinese medicinal preparation
The following raw material medicines are taken according to the weight part ratio: 12g of rhizoma anemarrhenae, 10g of golden cypress, 15g of radix rehmanniae, 12g of tortoise plastron, 12g of medlar (or 12g of semen cuscutae), 12g of glossy privet fruit, 12g of herba epimedii (or 12g of fructus psoraleae), 12g of morinda officinalis, 12g of red peony root, 12g of radix paeoniae alba, 20g of raw astragalus membranaceus, 12g of angelica, 12g of peach kernel, 12g of ligusticum wallichii and 10g of spina date seed are added with 10 times of water, soaked for 40min, decocted at the high temperature of 90 ℃ for 2 times, decocted for 1h each time, water decoction is combined, 65-75% ethanol is added to ensure that the ethanol content reaches 60%, ethanol is recovered, concentrated to obtain concentrated solution with the drug content ratio of 1:1, and the concentrated solution is granulated.
EXAMPLE 4 clinical trial of treatment of ovarian dysfunction with the Compound preparation of the present invention
In the clinical contrast study (2013 to 2014), 180 patients with low ovarian function diagnosed according to clinical symptoms and reproductive endocrine hormones at the age of 18-40 years are selected and randomly divided into three groups, and respectively treated by Bujiale and Dafutong treatment (group I), ZUOGUI pill treatment (group II) and kidney tonifying, qi benefiting and blood circulation activating treatment (group III), and the compound preparation is prepared by the following steps: 15g of rhizoma anemarrhenae, 12g of golden cypress, 18g of radix rehmanniae, 12g of tortoise plastron, 12g of medlar, 12g of glossy privet fruit, 12g of herba epimedii, 12g of fructus psoraleae, 9g of red paeony root, 9g of white paeony root, 30g of raw astragalus root, 12g of angelica, 12g of peach kernel and 12g of ligusticum chuanxiong hort, wherein the treatment time is 1 treatment course for 6 months, 2 treatment courses (shown in figure 1) are continuously treated, the formula for tonifying kidney, tonifying qi and activating blood is decocted and packaged by a decoction box, 1 dose is taken every day, 200mL of liquid medicine is decocted, the liquid medicine is taken in the morning and evening;
compared with the serum hormone change of three groups of patients after 2 courses of treatment and the uterus and accessory ultrasonic indexes, the result shows that the reproductive endocrine hormone indexes including FSH, LH and E2 of the patients treated by the kidney tonifying, qi benefiting and blood activating prescription are improved, the average values of FSH of the three groups of patients are respectively 20.55IU/L, 20.38IU/L and 19.5IU/L before treatment, the average values of LH are respectively 13.94IU/L, 12.85IU/L and 12.12IU/L, the FSH and LH of the patients in the groups before treatment are not statistically and obviously different, the average values of FSH of the groups II and III are respectively reduced to 16.34IU/L and 19.12IU/L after 1 course of treatment, namely 6 months, the average value of FSH of the group I is reduced to 14.22IU/L, the average value of FSH of the group I is reduced to 9.92IU/L after 2 courses of treatment, and the average value of the IU of the group I is reduced to 9.92IU/L after 12.21IU/L and 19.92IU/L after 12 months of the A is shown); after 1 treatment course, the LH levels of the groups I, II and III are respectively 11.89IU/L, 11.99IU/L and 10.57IU/L, but after 2 treatment courses, the LH of the group I is 8.34IU/L which is obviously reduced compared with 9.53IU/L and 11.89IU/L of the groups II and III (as shown in figure 2B); FSH and LH has hypothalamic secretion and acts on ovary and stimulates the generation of E2, E2 can negatively feed back and inhibit the level of FSH and LH, so in 3-5 days of menstruation, overhigh FSH and LH can reflect low ovarian function, and after a patient uses the compound preparation of the invention to treat two courses of treatment, FSH and LH are reduced more obviously than the patient who takes other traditional Chinese medicines and western medicines, which indicates the improvement of ovarian function;
e2 is secreted by the ovary, the level of which is suggestive of ovarian function; before treatment, the average values of E2 levels of three groups of patients are respectively 49.32pg/ml, 53.45pg/ml and 50.97pg/ml, and after 1 treatment course, the E2 levels of the three groups of patients are improved, but the difference is not significant; after 2 treatment courses, the level of E2 of the patient treated by the compound preparation reaches 82.85pg/ml, and is obviously increased compared with the level of E2 of the other two groups (77.30pg/ml and 55.76pg/ml), and the result shows that the ovarian function of the patient is improved (as shown in figure 2C);
anti-mullerian hormone (AMH) is secreted hormone in the follicular development process, and the level of AMH can reflect the number of mature follicles in the ovary, so that the level of ovarian reserve function is prompted; before treatment, AMH of three groups of patients is 1.79ng/ml, 1.44ng/ml and 1.51ng/ml respectively, and after 1 course of treatment by using the traditional Chinese medicine compound disclosed by the invention, the AMH of the three groups of patients is improved, but no significant difference exists among the groups; after 2 treatment courses, the AMH average value of a patient taking the traditional Chinese medicine compound preparation is increased to 3.35ng/ml, and is obviously increased compared with the AMH average value of 1.51ng/ml of a patient treated by western medicines, which shows that the traditional Chinese medicine compound preparation can improve the ovarian reserve function (as shown in figure 2D);
ultrasound-assisted diagnosis observing functional improvement of uterus and ovary:
the mature and discharge of follicles are one of the main functions of the ovary, and the ovarian follicle number of the antrum can visually prompt the ovarian function; before treatment, the average value of the number of the antral follicles of the three groups is respectively 5.4, 5.5 and 5.9, no obvious difference exists, the number of the antral follicles of the traditional Chinese medicine compound group is increased to 7.8 after 1 treatment course, the number of the antral follicles of the other two groups is increased to 9.5 after 2 treatment courses, and the number of the antral follicles of the other two groups is not more than 7 after two stages of treatment, which is obviously lower than that of the traditional Chinese medicine compound group, so that the traditional Chinese medicine compound can promote the development and discharge of the follicles (as shown in fig. 3C);
under the action of estrogen, endometrium is thickened and ovary volume is increased, after 2 courses of treatment with different medicines, endometrium of three groups of patients is thickened, but no significant difference exists among the groups (as shown in figure 3A), but after 2 courses of treatment with the traditional Chinese medicine compound, ovary volume of the patients is increased from average value of 5.17cm3Increased to 8.13cm3Ovarian volume (6.25 cm) in the other two groups3、5.59cm3) Compared to a significant increase (as shown in fig. 3B);
the uterine artery blood flow resistance and the ovarian artery blood flow resistance prompt the blood supply of an organism to the uterus and the ovaries, the smaller the artery blood flow resistance is, the better the organ blood supply is, the more complete the function is to a certain extent, the uterine artery blood flow resistance of three groups has no significant difference before and after treatment and among the groups (as shown in figure 3D), but the ovarian artery blood flow resistance is reduced to 0.66 after 2 treatment courses of treatment by using the traditional Chinese medicine compound, and is significantly lower than the average value of the ovarian artery blood flow resistance of a western medicine treatment group (as shown in figure 3E) by 0.80;
clinical test results show that the traditional Chinese medicine compound provided by the invention can improve the responsiveness of ovaries and uteruses to endocrine hormones, increase the mature number of follicles, and increase the blood supply of organisms to the uteruses and the ovaries, thereby improving the symptoms of patients with low ovarian function.
Based on the fact that the deficiency of vital essence in kidney is the main mechanism of aging, the research of delaying aging in traditional Chinese medicine has absolute advantages of tonifying kidney. According to the traditional Chinese medicine, a patient with low ovarian function belongs to the kidney deficiency categories of irregular menstruation, blood withering, blood stasis, amenorrhea, infertility, symptoms before and after menopause and the like in the traditional Chinese medicine, after the kidney tonifying method is used for treatment, the blood E2 in the patient is increased, FSH and LH are decreased, the symptom of the kidney deficiency is improved to different degrees, and the kidney deficiency is really the basic cause of ovarian function decline, menstrual disorder, amenorrhea or menopause, infertility, perimenopausal syndrome and the like; in addition, because blood stasis is the basic cause of hypofunction of ovary, it is apt to damage yin and blood in menstruation, pregnancy, childbirth and lactation, so women have physiological characteristics of blood deficiency and excess qi. However, qi is commander in blood, qi circulation causes blood circulation, qi stagnation, and unsmooth blood circulation leads to blood vessel stasis, disharmony of thoroughfare and conception vessels, and uterus blockage, i.e., the theory of blood-separated amenorrhea. The kidney-tonifying qi-tonifying blood-activating prescription is a preparation formed from ginseng leaf saponin, salvia root, flowery knotweed root and notoginseng, and can delay senility by means of the method of tonifying kidney, tonifying qi and activating blood circulation. The research results of the invention show that: compared with FSH, LH and ovarian artery RI are obviously reduced and E2, AMH and sinus follicle digital are obviously increased before treatment when the prescription for tonifying kidney, benefiting qi and activating blood circulation is applied to treat patients with low ovarian function, and the effect is better compared with a left-homing pill control group, so that the basic pathogenesis that kidney deficiency and blood stasis are really the low ovarian function is proved.

Claims (6)

1. The traditional Chinese medicine compound preparation for improving low ovarian function is characterized by being prepared from active ingredients and pharmaceutical excipients, wherein the active ingredients comprise the following raw material medicines in parts by weight: 9-15g of rhizoma anemarrhenae, 9-12g of golden cypress, 9-20g of radix rehmanniae, 9-15g of tortoise plastron, 9-15g of medlar or 9-15g of dodder, 9-15g of glossy privet fruit, 9-15g of herba epimedii or 9-15g of fructus psoraleae, 9-15g of morinda officinalis, 9-15g of red paeony root, 9-15g of white paeony root, 10-30g of raw astragalus root, 9-15g of angelica, 9-15g of peach kernel, 9-15g of ligusticum wallichii and 9-12g of spina date seed.
2. The compound traditional Chinese medicine preparation for improving low ovarian function according to claim 1, wherein the effective components comprise the following raw material medicines in parts by weight:
11-15g of rhizoma anemarrhenae, 10-12g of golden cypress, 12-19g of radix rehmanniae, 10-13g of tortoise plastron, 10-13g of medlar, 10-13g of herba epimedii, 9-13g of red paeony root, 20-30g of raw astragalus membranaceus, 10-13g of angelica sinensis, 10-13g of peach kernel, 10-13g of ligusticum wallichii and 9-12g of spina date seed.
3. The compound traditional Chinese medicine preparation for improving low ovarian function according to claim 1, wherein the effective components comprise the following raw material medicines in parts by weight:
13-15g of rhizoma anemarrhenae, 11-12g of golden cypress, 16-19g of radix rehmanniae, 11-13g of tortoise plastron, 11-13g of medlar, 11-13g of glossy privet fruit, 11-13g of herba epimedii, 11-12g of fructus psoraleae, 9-11g of red paeony root, 9-11g of white paeony root, 25-30g of raw astragalus, 11-13g of angelica, 11-13g of peach kernel, 11-13g of ligusticum wallichii and 9-12g of spina date seed.
4. The method for preparing a compound Chinese medicinal preparation for improving ovarian hypofunction according to claim 1, which comprises: weighing the raw materials according to the weight ratio range, adding 10 times of water, soaking for 40min, decocting at 90 ℃ for 2 times, each time for 1h, combining water decoction, adding 65-75% ethanol to ensure that the ethanol content reaches 60%, recovering ethanol, concentrating to obtain concentrated solution with the drug content ratio of 1:1, and granulating by a dry method to prepare granules, or preparing tablets, capsules and dripping pills.
5. The use of the compound Chinese medicinal preparation for improving ovarian hypofunction as claimed in claim 1 in the preparation of a medicament for treating gynecological diseases caused by ovarian hypofunction.
6. The use according to claim 5, wherein the gynecological disorders resulting from ovarian hypofunction include: infertility, recurrent abortion, preeclampsia during pregnancy, menstrual disorders, endocrine disorders, premature ovarian failure, osteoporosis and ovarian failure.
CN202010592787.0A 2020-03-11 2020-06-25 Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof Pending CN111588798A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2020101645589 2020-03-11
CN202010164558 2020-03-11

Publications (1)

Publication Number Publication Date
CN111588798A true CN111588798A (en) 2020-08-28

Family

ID=72184522

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202010592787.0A Pending CN111588798A (en) 2020-03-11 2020-06-25 Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof

Country Status (1)

Country Link
CN (1) CN111588798A (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050123629A1 (en) * 2002-12-04 2005-06-09 Chan Hsiao C. Medicine for treating woman climacteric syndrome and preparation method thereof
CN104138502A (en) * 2014-07-29 2014-11-12 卞佳林 Traditional Chinese medicine compound for treating ovarian tumors and preparation method and application thereof
CN109288962A (en) * 2018-11-28 2019-02-01 贵阳中医学院 A kind of Chinese medicine composition for treating premature ovarian failure

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050123629A1 (en) * 2002-12-04 2005-06-09 Chan Hsiao C. Medicine for treating woman climacteric syndrome and preparation method thereof
CN104138502A (en) * 2014-07-29 2014-11-12 卞佳林 Traditional Chinese medicine compound for treating ovarian tumors and preparation method and application thereof
CN109288962A (en) * 2018-11-28 2019-02-01 贵阳中医学院 A kind of Chinese medicine composition for treating premature ovarian failure

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
岳小红 等: "张成秀治疗继发性闭经经验", 《甘肃中医》 *
韩柳: "中西医结合治疗卵巢早衰34例", 《中国民间疗法》 *

Similar Documents

Publication Publication Date Title
CN106075276A (en) A kind of for Chinese medicine preparation treating threatened abortion and preparation method thereof
CN1806840B (en) Chinese medicinal compound preparation and its preparing process
CN104940740A (en) Traditional Chinese medicine composition for treating polycystic ovarian syndrome and preparation method thereof
CN104922613A (en) Medicine composite for treating sterility and preparation method thereof
CN107802733B (en) Kidney-tonifying and fetus-cultivating traditional Chinese medicine composition and application thereof
CN105687927A (en) Traditional Chinese medicine composition and preparation for treating female sterility and application
CN114177256B (en) Traditional Chinese medicine composition for treating ovarian reserve hypofunction and application thereof
CN113599475B (en) Middle-warming and kidney-tonifying composition for treating polycystic ovarian syndrome and preparation method and application thereof
CN113499405B (en) Traditional Chinese medicine composition for treating secondary amenorrhea
CN111588798A (en) Traditional Chinese medicine compound preparation for improving ovarian hypofunction and preparation method thereof
CN111317777B (en) Traditional Chinese medicine decoction for treating kidney deficiency and phlegm dampness type polycystic ovarian syndrome infertility
CN110237161B (en) Medicine for treating menopausal syndrome and preparation method and application thereof
CN105944020A (en) Traditional Chinese medicine for treating ovarian function decrease
CN109200162B (en) Traditional Chinese medicine preparation for treating polycystic ovarian syndrome and preparation method thereof
CN113171402A (en) Accurate medicated diet dietary therapy product composition for preventing and treating premature ovarian failure and preparation method thereof
CN105362630A (en) Climacteric syndrome treatment pharmaceutical composition and preparation method thereof
CN112546133A (en) Fat-reducing and weight-losing traditional Chinese medicine composition, preparation method thereof and fat-reducing and weight-losing preparation
CN1994444A (en) Preparation process of postpartum rehabilitation medicament
CN104906526A (en) Chinese medicine preparation for premature ovarian failure and preparation method of Chinese medicine preparation
CN100358566C (en) Traditional Chinese medicine preparation for treating internal weakness
CN104147229B (en) A kind of compound Chinese medicinal preparation for the treatment of female climacteric syndrome kidney yin and yang deficiency type
CN104042881B (en) For regulating the compositions of ovarian function
CN102038749B (en) Traditional Chinese medicinal composite used for improving or preventing perimenopause syndrome
CN104606442B (en) A kind of Chinese medicine composition treating deficiency of kidney-essence type postmenopausal osteoporosis
CN107441313B (en) Traditional Chinese medicine composition and medicine for treating ovarian reserve function decline and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination