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CN-121971516-A - Pharmaceutical composition for treating infertility caused by luteal phase dysfunction, and preparation method and application thereof

CN121971516ACN 121971516 ACN121971516 ACN 121971516ACN-121971516-A

Abstract

The invention relates to a pharmaceutical composition for treating infertility caused by corpus luteum insufficiency, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The technical problem to be solved is to provide a pharmaceutical composition for treating infertility caused by Luteal Phase Deficiency (LPD), which has simpler formula, lower cost and better treatment effect, and the technical scheme is characterized in that the pharmaceutical composition comprises the following raw materials: radix Codonopsis, radix astragali, parched Atractylodis rhizoma, radix Angelicae sinensis, semen Cuscutae, parched Eucommiae cortex, parched radix Dipsaci, radix Glycyrrhizae Preparata, radix Aconiti lateralis Preparata and cornu Cervi Degelatinatum. The pharmaceutical composition provided by the invention can improve the ovarian injury, iron death, embryo implantation disorder, uterine artery blood flow perfusion and the like caused by the LPD, and is beneficial to various pathological problems related to the LPD.

Inventors

  • LU WENJIE
  • XU YOUZHI

Assignees

  • 安徽医科大学

Dates

Publication Date
20260505
Application Date
20260126

Claims (10)

  1. 1. A pharmaceutical composition for treating infertility caused by luteal phase deficiency is characterized by comprising the following raw materials of radix codonopsis pilosulae, radix astragali, stir-fried white atractylodes rhizome, chinese angelica, semen cuscutae, stir-fried eucommia ulmoides, stir-fried teasel root, honey-fried licorice root, prepared aconite root and cornu cervi degelatinatum.
  2. 2. A pharmaceutical composition for treating infertility caused by corpus luteum insufficiency is characterized by comprising, by weight, 15-20 parts of codonopsis pilosula, 20-30 parts of astragalus mongholicus, 20-30 parts of fried bighead atractylodes rhizome, 10 parts of Chinese angelica, 10-15 parts of semen cuscutae, 10-12 parts of fried eucommia ulmoides, 10-15 parts of fried dipsacus root, 6-8 parts of honey-fried licorice root, 3-5 parts of prepared aconite root and 10-12 parts of cornu cervi degelatinatum.
  3. 3. The pharmaceutical composition according to claim 1, which is characterized by comprising the following raw materials, by weight, 20 parts of codonopsis pilosula, 30 parts of astragalus, 30 parts of stir-fried bighead atractylodes rhizome, 10 parts of Chinese angelica, 15 parts of semen cuscutae, 12 parts of stir-fried eucommia ulmoides, 15 parts of stir-fried teasel root, 8 parts of honey-fried licorice root, 5 parts of prepared aconite root and 12 parts of cornu cervi degelatinatum.
  4. 4. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 3, characterized in that said process comprises the steps of: S1, weighing the raw materials of the pharmaceutical composition according to parts by weight for standby; S2, mixing the weighed medicinal composition raw materials, soaking in water, decocting and filtering twice, mixing the two decoctions, uniformly mixing and concentrating to obtain the medicinal composition.
  5. 5. Use of a pharmaceutical composition according to any one of claims 1-3 and/or a pharmaceutical composition prepared by the preparation method according to claim 4 for the preparation of a medicament for the treatment of infertility due to luteal phase deficiency.
  6. 6. A medicament for treating infertility caused by luteal phase deficiency, comprising a pharmaceutical composition according to any one of claims 1-3 and/or a pharmaceutical composition prepared by the preparation method according to claim 4.
  7. 7. The medicament of claim 6, wherein the dosage form of the medicament comprises a parenterally administered dosage form.
  8. 8. The medicament of claim 7, wherein the gastrointestinal administration form comprises a tablet, powder, granule, solution, capsule, emulsion, suspension or oil.
  9. 9. The pharmaceutical composition of claim 7, wherein the parenteral dosage form comprises an injectable dosage form, a respiratory dosage form, a dermal dosage form, a mucosal dosage form, or a luminal dosage form.
  10. 10. A pharmaceutical composition according to claim 6, wherein, the medicine also comprises pharmaceutically acceptable auxiliary materials.

Description

Pharmaceutical composition for treating infertility caused by luteal phase dysfunction, and preparation method and application thereof Technical Field The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for treating infertility caused by corpus luteum insufficiency, and a preparation method and application thereof. Background For understanding the technical content of the present invention: The corpus luteum is an endocrine gland formed by broken follicular walls, and the core function is to secrete progesterone (P) and a small amount of estradiol (E2), so that the proper thickness and secretion state of the endometrium are maintained, and necessary conditions are created for implantation of fertilized eggs and embryo development. Once the corpus luteum function is abnormal, the secretion amount of P and E2 is reduced, and thus fertilized ovum implantation and embryo normal development are hindered. Follicle Stimulating Hormone (FSH) is secreted by the pituitary gland and, if the ovarian function is impaired, interferes with the normal regulation process of FSH, leading to a stunted follicular development, ultimately affecting ovulation and conception. Luteal Phase Dysfunction (LPD) is an important factor in the initiation of infertility, and clinical data shows that about 3.5% -10% of infertility, 35% of early pregnancy miscarriage, and 4% of habitual miscarriage are all caused by it. Female infertility incidence rate tends to rise year by year, and is listed as one of three refractory diseases in the medical community. The medical definition of infertility is that females do not take contraceptive measures, have normal sexual life and remain ungainted 1 year with spouse. The Luteal Phase Dysfunction (LPD) is a symptom of female hypoluteal phase dysplasia after ovulation, which causes symptoms of reduced secretion of progesterone, menstrual disorder and fertility defect, and the main symptoms of the luteal phase dysfunction include cycle disorder manifestations such as shortened menstrual cycle, amenorrhea, reduced bleeding amount and the like, which not only seriously affect female conception, but also cause obvious harm to physiological and psychological health. At present, the causative factors and pathogenesis of Luteal Phase Dysfunction (LPD) are not completely defined. In the theory of traditional Chinese medicine, the LPD type infertility belongs to the categories of irregular menstruation, infertility, habitual abortion and the like, wherein the yang deficiency and cold coagulation type LPD type infertility is caused by the stagnation of internal cold evil in female reproductive cycle due to the insufficient yang qi, and the normal function of corpus luteum is affected, so that the endometrium in the corpus luteum stage cannot obtain sufficient hormone support, and the proper condition required by fertilization is difficult to be achieved, and the infertility is finally initiated. Western medicine is mainly used for supplementing progesterone, promoting ovulation and stimulating luteal function aiming at the treatment of the LPD type infertility, but the treatment mode has obvious defects of high ovulation rate, low pregnancy rate, repeated illness after stopping medicines and the like, and the treatment effect of single supplementing progesterone is limited, and the method has a certain effect on regulating menstrual cycle, maintaining endometrial environment and assisting in improving fertilized egg implantation conditions although the progesterone is used as an important hormone secreted by the corpus luteum of the ovary, so that the problem of infertility caused by the LPD is difficult to fundamentally solve. The related patent documents: The publication No. CN112891490B, publication No. 2021.06.04, discloses a medicament for treating infertility, which comprises, by weight, 10-15 parts of fried semen cuscutae, 10-12 parts of cornu Cervi Degelatinatum, 15-25 parts of roasted morinda officinalis, 10-15 parts of fried eucommia ulmoides, 10-25 parts of fried dipsacus root, 10-15 parts of fried semen euryales, 8-10 parts of medlar, 6-8 parts of fructus amomi, 15-20 parts of fried bighead atractylodes rhizome, 20-30 parts of radix codonopsis pilosulae, 10-30 parts of prepared rehmannia root, 8-10 parts of angelica sinensis, 10-15 parts of roasted astragalus mongholicus and 8-10 parts of roasted liquorice. The medicine is helpful for increasing endometrium thickness, enhancing follicular tension, recovering follicular normal development, and enhancing pregnancy. Publication No. CN1289121C, publication No. 2005.06.22, which discloses a medicine for promoting ovulation and helping pregnancy, belongs to Chinese patent medicine preparation and is mainly used for treating infertility without discharge and infertility for long wedding. The traditional Chinese medicine is prepared from the following raw materials, by weight,