Application of Dan'e Fukang combined traditional Chinese medicine in preparation of medicine for treating infertility

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to application of Dan'e Fukang combined traditional Chinese medicine to preparation of medicine for treating infertility. The invention provides application of combination of Dan'e Fukang decoction and Kangfuxin liquid or combination of Dan'e Fukang decoction and a traditional Chinese medicine composition in preparation of a medicine for treating thin endometrial infertility. Experiments prove that the combination of the Dan'e Fukang decoction and the Kangfuxin solution and the combination of the Dan'e Fukang decoction and the traditional Chinese medicine composition can effectively increase the endometrial thickness and treat thin endometrial infertility, a new choice is provided for clinical treatment of infertility, and the clinical application prospect is good.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to the use of Dan'e Fukang combined with traditional Chinese medicine in the preparation of drugs for treating infertility. Background Art

[0002] Infertility is a reproductive disorder caused by various factors. It is diagnosed when a woman fails to conceive after more than 12 months of regular, unprotected sexual intercourse, and it seriously affects her reproductive health. Epidemiological data shows that at least 15% of women in my country suffer from infertility, with thin endometrium being a major contributing factor.

[0003] Thin endometrial lining infertility refers to a condition where an ultrasound examination 6-10 days after ovulation (mid-luteal phase) shows an endometrial thickness of <8mm. The causes of this condition are complex, but clinically it is believed to be directly related to induced abortion, inflammatory responses, intrauterine infections, hormonal imbalances, and medications. The endometrium serves as the "soil" for embryo implantation and development, and its appropriate thickness is a crucial factor affecting successful implantation. Clinically, insufficient endometrial thickness and poor endometrial type, resulting in a persistently thin endometrium, significantly impact pregnancy success rates. Patients with thin endometrial lining infertility require timely treatment to increase endometrial thickness, improve sex hormone levels, and ensure successful pregnancy.

[0004] Clinically, treatment often employs Western medicine, surgery, exogenous estrogen replacement therapy, and progesterone replacement therapy to achieve therapeutic goals. While these therapies have some merit, they are still unable to effectively improve the condition of the endometrium or increase the patient's conception and pregnancy rates. Summary of the Invention

[0005] The first objective of this invention is to provide the use of Dan'e Fukang Decoction combined with Kangfuxin Liquid in the preparation of a medicament for treating infertility caused by thin endometrium.

[0006] Furthermore, the Dan'e Fuke decoction is used in combination with Kangfuxin liquid: the mass-to-volume ratio of Dan'e Fuke decoction to Kangfuxin liquid is 0.2 to 1:1 g / L.

[0007] Preferably, the mass-to-volume ratio of Dan'e Fuke decoction to Kangfuxin liquid is 0.4–0.8:1 g / L.

[0008] More preferably, the mass-to-volume ratio of Dan'e Fuke decoction to Kangfuxin liquid is 0.5:1g / L.

[0009] Furthermore, the Kangfuxin liquid and Dan'e Fukang decoction can be administered simultaneously or separately.

[0010] The second objective of this invention is to provide the use of Dan'e Fuke decoction in combination with a pharmaceutical composition in the preparation of a medicament for treating infertility caused by thin endometrium; the pharmaceutical composition is a preparation made from the following raw materials in the indicated weight ratios: 20-40 parts of American cockroach, 10-30 parts of mulberry mistletoe, 10-30 parts of cornus officinalis, 10-30 parts of raspberry, 10-30 parts of dodder seed, 10-30 parts of privet fruit, 10-30 parts of poria cocos, and 5-10 parts of licorice.

[0011] Preferably, the pharmaceutical composition is a preparation made from the following raw materials in the indicated weight ratios: 30 parts of American cockroach, 20 parts of mulberry mistletoe, 20 parts of cornus officinalis, 20 parts of raspberry, 20 parts of dodder seed, 20 parts of privet fruit, 20 parts of poria cocos, and 8 parts of licorice.

[0012] Furthermore, the preparation method of the formulation is as follows:

[0013] a. Weigh the American cockroach medicinal material, add 85% ethanol solution by volume for reflux extraction, combine the extracts, recover the ethanol, concentrate, add water to precipitate, let stand, collect the supernatant, and concentrate under reduced pressure to obtain extract 1.

[0014] b. Mix and grind the following ingredients from the prescription: mulberry mistletoe, cornus officinalis, raspberry, dodder seed, privet fruit, poria cocos, and licorice root. Add water and decoct. Combine the decoctions and filter to obtain extract 2.

[0015] c. Combine extract 1 and extract 2, concentrate under reduced pressure to obtain an extract, dry, pulverize into extract powder, add pharmaceutically acceptable excipients, and prepare an oral formulation.

[0016] Furthermore, the combined use of Dan'e Fukang Decoction and Kangfuxin Liquid can increase the thickness of the endometrium.

[0017] Furthermore, the combination of the Dan'e Fuke decoction with the pharmaceutical composition can increase the thickness of the endometrium.

[0018] Furthermore, the drug is administered orally.

[0019] The ingredients of Dan'e Fuke Decoction are: purple salvia miltiorrhiza, turmeric, bupleurum chinense, notoginseng, red peony root, angelica sinensis, sparganium rhizome, cyperus rotundus, corydalis rhizome, and licorice.

[0020] Purple Salvia is the dried root of *Salvia przewalskii* Maxim. or *Salvia przewalskii* Maxim. var. *mandarinorum* (Diels) Stib., belonging to the Lamiaceae family. It has a bitter taste and is slightly cold in nature. It enters the Heart and Liver meridians. It invigorates blood circulation, removes blood stasis, regulates menstruation, relieves pain, clears the heart, and eliminates irritability. It is used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal masses, chest and abdominal pain, painful arthralgia, insomnia, carbuncles, and boils.

[0021] Curcuma zedoaria is the dried rhizome of *Curcuma phaeocaulis* VaL, *Curcuma wangsiensis* SGLee et CFLiang, or *Curcuma wenyujin* Y.H.Chenet C.Ling (all belonging to the ginger family). It has the effects of promoting qi circulation, breaking up blood stasis, eliminating stagnation, and relieving pain. It is pungent, bitter, and warm in nature. It enters the liver and spleen meridians. It is used for abdominal masses, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0022] Yunnan Bupleurum is a processed product of the dried whole herb of *Bupleurum marginatum* Wall.ex DC, *Bupleurum microcephalum* Diels, and *Bupleurum tenue* Buch.-Ham.ex D.Don, all belonging to the Apiaceae family. It has a bitter taste and is slightly cold in nature. It enters the Liver and Gallbladder meridians. It harmonizes the exterior and interior, soothes the Liver, and raises Yang. It is used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0023] Panax notoginseng is the dried root and rhizome of Panax notoginseng (Burk.) FHChen, a plant belonging to the Araliaceae family. It has a sweet and slightly bitter taste, and is warm in nature. It enters the liver and stomach meridians. It disperses blood stasis, stops bleeding, reduces swelling, and relieves pain. It is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls.

[0024] Red peony root is the dried root of *Paeonia lactiflora* Pall or *Paeonia veitchii* Lynch, both belonging to the Ranunculaceae family. It is bitter and slightly cold in nature. It enters the liver meridian. Its functions include clearing heat and cooling the blood, dispersing blood stasis and relieving pain. It is used for heat entering the blood level, febrile diseases with rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation causing hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0025] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family. It has a sweet and pungent taste, and is warm in nature. It enters the liver, heart, and spleen meridians. It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness. Angelica sinensis brewed with wine invigorates blood and regulates menstruation. It is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, and traumatic injuries.

[0026] Sparganium stoloniferum Buch.-Ham is the dried tuber of the plant Sparganium stoloniferum Buch.-Ham, belonging to the family Sparganaceae. It has a pungent and bitter taste, and is neutral in nature. It enters the liver and spleen meridians. It breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain. It is used for abdominal masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0027] Cyperus rotundus L. is the dried rhizome of the sedge plant (Cyperus rotundus L.). [Properties and Channels Entered] Pungent, slightly bitter, slightly sweet; neutral in nature. It enters the Liver, Spleen, and Triple Energizer channels. It soothes the Liver and relieves stagnation, regulates Qi and relieves chest tightness, regulates menstruation and relieves pain. It is used for Liver Qi stagnation, chest and rib pain, hernia pain, breast pain, Spleen and stomach Qi stagnation, abdominal distension and pain, irregular menstruation, amenorrhea, and dysmenorrhea.

[0028] Corydalis yanhusuo is the dried tuber of Corydalis yanhusuo Wt. Wang, a plant in the Papaveraceae family. It has a pungent, bitter, and warm nature. It enters the liver and spleen meridians. It invigorates blood circulation, regulates qi, and relieves pain. It is used for chest and rib pain, abdominal pain, angina pectoris, amenorrhea, dysmenorrhea, postpartum blood stasis, and traumatic swelling and pain.

[0029] Licorice is the dried root and rhizome of *Glycyrrhiza uralensis* Fisch, *Glycyrrhiza inflata* Bat, or *Glycyrrhiza glabra* L., all belonging to the Fabaceae family. It has a sweet taste and neutral properties. It enters the heart, lung, spleen, and stomach meridians. Its functions include tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasms and pain, and harmonizing other herbs. It is 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 medications.

[0030] The American cockroach (Periplaneta americana) is an insect belonging to the order Blattodea, family Blattodea, and genus Periplaneta. It is used to treat hemoptysis, chills and fever, accumulations, sore throat, and infertility due to internal cold. It possesses effects such as promoting blood circulation, removing blood stasis, detoxifying, eliminating malnutrition, and reducing swelling. It contains various effective components including proteins, amino acids, peptides, sugars, and polyols. Modern research shows that American cockroach extract has significant effects in anti-tumor activity, enhancing immunity, treating cardiovascular diseases, tissue repair, antibacterial activity, and anti-inflammatory effects.

[0031] Taxillus chinensis (DC.) Danser, a plant belonging to the Loranthaceae family, is a dried stem and branch with leaves. It has a bitter and sweet taste, and is neutral in nature. It enters the liver and kidney meridians. Its functions include dispelling wind and dampness, tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is used for rheumatic pain, soreness and weakness of the lower back and knees, weakness of tendons and bones, metrorrhagia, threatened abortion, fetal restlessness, dizziness, and vertigo.

[0032] Cornus officinalis is the dried, ripe pulp of the plant Cornus officinalis Sieb. et Zucc. (family Cornaceae). It has a sour and astringent taste, and is slightly warm in nature. It enters the liver and kidney meridians. It tonifies the liver and kidneys, and has astringent and consolidating properties. It is 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.

[0033] Raspberry is the dried fruit of *Rubus chingii* Hu, a plant in the Rosaceae family. It has a sweet and sour taste, and is warm in nature. It enters the liver, kidney, and bladder meridians. It benefits the kidneys, strengthens essence, reduces urination, nourishes the liver, and improves eyesight. It is used for seminal emission, frequent urination, impotence, premature ejaculation, and blurred vision.

[0034] Cuscuta seed is the dried, mature seed of *Cuscuta australis* R.Br. or *Cuscutachinensis* Lam., both belonging to the Convolvulaceae family. It has a pungent, sweet, and neutral flavor. It enters the liver, kidney, and spleen meridians. It tonifies the liver and kidneys, strengthens essence and reduces urination, calms the fetus, improves eyesight, and stops diarrhea; externally, it dispels wind and removes blemishes. It is used for liver and kidney deficiency, lower back and knee weakness, impotence, seminal emission, enuresis, frequent urination, kidney deficiency with threatened abortion, threatened miscarriage, blurred vision and tinnitus, and spleen and kidney deficiency with diarrhea; externally, it is used to treat vitiligo.

[0035] Privet fruit is the dried, ripe fruit of *Ligustrum lucidum* Ait., a plant in the Oleaceae family. It has a sweet and bitter taste, and is cool in nature. It enters the liver and kidney meridians. It nourishes the liver and kidneys, improves eyesight, and darkens hair. It is used for liver and kidney yin deficiency, dizziness and tinnitus, soreness and weakness of the lower back and knees, premature graying of hair, blurred vision, internal heat and thirst, and steaming fever.

[0036] Poria cocos is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf, belonging to the Polyporaceae family. It has a sweet, bland, and neutral flavor. It enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is 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.

[0037] Dan'e Fuke Decoction is commonly used to treat menstrual disorders, dysmenorrhea, menstrual discomfort, abdominal masses, and pelvic endometriosis caused by blood stasis in women. However, the inventors have discovered in their research that the combined use of Dan'e Fuke Decoction and Kangfuxin Liquid can effectively increase endometrial thickness and treat infertility caused by thin endometrium. Furthermore, the combined use of Dan'e Fuke Decoction and the aforementioned composition also effectively increases endometrial thickness and treats infertility caused by thin endometrium. The overall therapeutic effect is excellent, providing a new option for the clinical treatment of infertility, and its clinical application prospects are promising. Detailed Implementation

[0038] The present invention will be further described in detail below through specific embodiments. All raw materials and reagents involved in the specific embodiments are commercially available.

[0039] Example 1

[0040] a. Weigh 30 parts by weight of American cockroach medicinal material, add 4 times the volume of 85% ethanol solution for reflux extraction, combine the extracts, recover the ethanol, concentrate, add water to precipitate, let stand, collect the supernatant, and concentrate under reduced pressure to obtain extract 1.

[0041] b. Mix and grind 20 parts by weight of mulberry mistletoe, 20 parts by weight of cornus officinalis, 20 parts by weight of raspberry, 20 parts by weight of dodder seed, 20 parts by weight of privet fruit, 20 parts by weight of poria cocos and 8 parts by weight of licorice root, add 5 times the amount of water and decoct, combine the decoctions and filter to obtain extract 2.

[0042] c. Combine extract 1 and extract 2, concentrate under reduced pressure to a paste with a relative density of 1.20 at 60℃, dry, pulverize into paste powder, add an appropriate amount of dextrin, and prepare into tablets.

[0043] Example 2

[0044] Add an appropriate amount of microcrystalline cellulose to the extract powder prepared in Example 1 to prepare capsules.

[0045] Example 3: The effect of the drug of the present invention in treating infertility

[0046] 1. Clinical Data

[0047] 1.1. Case Sources and Study Subjects

[0048] We collected data from 50 patients with scanty menstruation, thin endometrium infertility due to natural cycle, or thin endometrium with IVF-ET implantation failure who visited the gynecology outpatient clinic of Chengdu High-tech Good Doctor First Hospital between March 2020 and March 2021.

[0049] 1.2 Inclusion Criteria

[0050] (1) All patients met the diagnostic criteria in Western medicine's "Obstetrics and Gynecology"; 6 to 10 days after ovulation (mid-luteal phase, when the maximum diameter of the follicle is ≥18mm), ultrasound examination showed that the endometrial thickness was <8mm; (2) Hysterosalpingography showed that both fallopian tubes were patent, ≥3 ultrasound examinations indicated normal ovulation, normal sexual intercourse and no contraception (≥1 year) without pregnancy, and the spouse's semen analysis was normal.

[0051] (2) All patients met the diagnostic criteria in Traditional Chinese Medicine Gynecology: soreness and weakness of the waist and knees, aversion to cold, and decreased libido; secondary symptoms: prolonged menstruation, scanty menstruation or amenorrhea, dark or light red menstrual blood, thin menstrual blood, excessive vaginal discharge, frequent urination at night, pale or dark complexion, pale and swollen tongue with white coating, and weak pulse; age 22 to 42 years; duration of infertility 1 to 12 years.

[0052] (3) Patients who have not used hormone drugs, contraceptives or other medications before participating in this study; ④ Patients who have given informed consent to this study.

[0053] (4) Exclusion criteria: ① Those with malformations of the reproductive organs; ② Those with tumors of the reproductive organs; ③ Those with endometriosis or polycystic ovary syndrome, endometrial polyps, ovulation disorders, etc.; ④ Those who are also involved in other studies.

[0054] 1.3 Grouping

[0055] Patients were randomly assigned to two groups using a randomized, double-blind method: a group receiving Dan'e Fuke combined with Kangfuxin Liquid, and a group receiving Dan'e Fuke combined with another combination, with 25 patients in each group. The Dan'e Fuke combined with Kangfuxin Liquid group had an age of 24–38 years, with a mean age of (31.28±3.69) years; infertility duration of 2–10 years, with a mean duration of (6.71±3.57) years; and a menstrual cycle of 26–33 days, with a mean duration of (30.47±3.18) days. The Dan'e Fuke combined with another combination group had an age of 24–37 years, with a mean age of (30.25±3.73) years; infertility duration of 2–10 years, with a mean duration of (6.45±3.18) years; and a menstrual cycle of 26–34 days, with a mean duration of (30.51±2.67) days. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0056] 2. Research Methods

[0057] The group treated with a combination of Dan'e Fuke and Kangfuxin Liquid used Dan'e Fuke decoction (Yunnan Shengke Pharmaceutical Co., Ltd., National Drug Approval Number: Z20025253, Specification: 150g / bottle) and Kangfuxin Liquid (Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd., National Drug Approval Number Z5102183, Specification: 150mL / bottle). The medication was administered after the patients' menstruation ended. The Dan'e Fuke decoction was taken orally, 15g each time, twice a day; Kangfuxin Liquid was taken orally, 20mL each time, three times a day. Medication was discontinued during menstruation.

[0058] The group treated with the combination of Dan'e Fuke and the composition used the tablets prepared in Example 1 of this invention and Dan'e Fuke decoction (Yunnan Shengke Pharmaceutical Co., Ltd., National Drug Approval Number: Z20025253, Specification: 150g / bottle). The medication was administered after the patients' menstruation ended. The Dan'e Fuke decoction was taken orally at a dose of 15g each time, twice a day; the composition tablets were taken orally at a dose of 2 tablets three times a day. Medication was discontinued during menstruation. The clinical efficacy was evaluated after both groups of patients used the medication continuously for 3 months.

[0059] 3. Observation indicators and judgment criteria

[0060] 3.1 Efficacy assessment

[0061] 3.1.1 The efficacy evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". Cure: The patient's endometrium was significantly thickened, with a thickness ≥8mm during ovulation, and sex hormone levels returned to normal. Marked effect: Ultrasound showed ovulation, the patient's endometrium was significantly thickened, reaching a thickness of 7-8mm during ovulation, and sex hormone levels significantly improved. Effective: Ultrasound showed ovulation, the patient's endometrium was thickened, approximately 6mm thick during ovulation, and sex hormone levels showed some improvement. Ineffective: The patient's endometrial thickness and sex hormone levels showed no significant improvement compared to before treatment. Total effective rate = (Cure + Marked effect + Effective) / Total number of cases × 100%. 3.1.2 Transvaginal color Doppler ultrasound was used to detect endometrial thickness during ovulation, luteal phase, and premenstrual phase before and after treatment in both groups.

[0062] 3.1.3 Transvaginal color Doppler ultrasound was used to detect changes in intramural blood flow (PSV, RI, PI, S / D) in the luteal phase implantation region before and after treatment in both groups.

[0063] 3.1.4 Record the number and diameter of follicles at the first monitoring after treatment in both groups (days 10-12 of menstruation).

[0064] 3.1.5 Statistical analysis of clinical pregnancy rates in the two groups

[0065] A one-year follow-up was conducted for pregnancy diagnosis: If the patient had not menstruated 14 days after ovulation, and serum β-human chorionic gonadotropin (hCG) levels were >5 U / L, and ultrasound examination 45–50 days after amenorrhea showed embryonic and primitive cardiac tube pulsation, a clinical pregnancy could be confirmed. If the patient had not menstruated 14 days after ovulation, and serum hCG levels were >5 U / L, but ultrasound examination 45–50 days after amenorrhea showed no gestational sac, a biochemical pregnancy could be confirmed. If none of the above symptoms were present, a diagnosis of non-pregnancy could be made.

[0066] 3.1.6 Statistical Methods

[0067] SPSS 21.0 statistical software was used for statistical analysis. The measurement data were found to be normally distributed, and therefore expressed as mean ± standard deviation (x ± s). Independent samples t-tests were used to compare measurement data between groups, and paired samples t-tests were used to compare measurement data within groups. A p-value < 0.05 was considered statistically significant.

[0068] 4. Results

[0069] 4.1 Treatment effects of the two groups

[0070] The total effective rate of the group treated with Dan'e Fuke combined with the combination was 92.0%, which was significantly higher than the 80.0% of the group treated with Dan'e Fuke combined with Kangfuxin Liquid (see Table 1).

[0071] Table 1 Comparison of treatment effects between two groups of patients with thin uterus and infertility

[0072] Group Number of examples cure Effective efficient invalid Overall efficiency Dangofukang combined with other ingredients 25 11 10 2 2 92.0％ Dan'e Fuke and Kangfuxin Liquid combined group 25 7 8 5 5 80.0％

[0073] 4.2 Endometrial thickness during ovulation, luteal phase, and premenstrual period before and after treatment in both groups

[0074] Table 2 Comparison of endometrial thickness before and after treatment in two groups of patients with thin uterus and infertility.

[0075]

[0076] Note: *P < 0.05 according to paired t-test.

[0077] 4.3 Changes in intramural blood flow (PSV, RI, PI, S / D) during the luteal phase implantation region before and after treatment in both groups

[0078] Table 3 Comparison of uterine hemodynamic parameters before and after treatment in two groups of patients with thin uterus and infertility.

[0079]

[0080] Note: Compared with before treatment, * P < 0.05, compared with the group treated with the combination of Dan'e Fuke and Kangfuxin Liquid, # P < 0.05.

[0081] 4.4 Number and diameter of follicles at the first monitoring after treatment in both groups.

[0082] Table 4. Comparison of follicle count and follicle diameter at the first monitoring after treatment in two groups of patients with thin uterus and infertility.

[0083] Group Number of examples Number of follicles Follicle diameter (mm) Dangofukang combined with other ingredients 25 <![CDATA[1.62±0.37 * ]]> <![CDATA[19.71±1.38 * ]]> Dan'e Fuke combined with Kangfuxin Liquid 25 1.25±0.45 18.94±1.25

[0084] Note: Compared with the group using Dan'e Fuke and Kangfuxin Liquid in combination. * P < 0.05.

[0085] 4.5 Clinical pregnancy rates in the two groups

[0086] Table 5. Comparison of pregnancy rates between the two groups of patients with thin uterus and infertility [(25 cases, n(%)]]

[0087] Group Not pregnant Biochemical pregnancy Clinical pregnancy Dangofukang combined with other ingredients 5(20.0％) 6(24.0％) 14(56.0％) Dan'e Fuke combined with Kangfuxin Liquid 7(28.0％) 8(32.0％) 10(40.0％)

[0088] In summary, the combined use of Dan'e Fuke decoction and Kangfuxin liquid in this invention can increase endometrial thickness and treat infertility caused by thin endometrium. Furthermore, the combined use of Dan'e Fuke decoction with the composition can more effectively increase endometrial thickness and treat infertility caused by thin endometrium. The overall therapeutic effect is excellent, providing a new option for the clinical treatment of infertility, and its clinical application prospects are promising.

Claims

1. The use of Dan'e Fuke Decoction combined with Kangfuxin Liquid in the preparation of drugs for treating infertility caused by thin endometrium.

2. The use of Dan'e Fuke Decoction combined with a pharmaceutical composition in the preparation of a drug for treating infertility caused by thin endometrium; the pharmaceutical composition is a preparation made from the following raw materials in the indicated weight ratios: American cockroach 20-40 parts, mulberry mistletoe 10-30 parts, cornus officinalis 10-30 parts, raspberry 10-30 parts, dodder seed 10-30 parts, privet fruit 10-30 parts, poria cocos 10-30 parts, and licorice 5-10 parts.

3. The use according to claim 2, characterized in that: The pharmaceutical composition is a preparation made from the following raw materials in the indicated weight ratios: 30 parts of American cockroach, 20 parts of mulberry mistletoe, 20 parts of cornus officinalis, 20 parts of raspberry, 20 parts of dodder seed, 20 parts of privet fruit, 20 parts of poria cocos, and 8 parts of licorice.

4. The use according to claim 1, characterized in that: The combination of Dan'e Fuke decoction and Kangfuxin liquid is described: the mass-to-volume ratio of Dan'e Fuke decoction to Kangfuxin liquid is 0.2-1:1 g / L.

5. The use according to claim 4, characterized in that: The combination of Dan'e Fuke decoction and Kangfuxin liquid is described: the mass-to-volume ratio of Dan'e Fuke decoction to Kangfuxin liquid is 0.4-0.8:1g / L.

6. The use according to claim 5, characterized in that: The combination of Kangfuxin Liquid and Dan'e Fukang Decoction: the mass-to-volume ratio of Dan'e Fukang Decoction to Kangfuxin Liquid is 0.5:1 g / L.

7. The use according to claim 2, characterized in that: The preparation method of the formulation is as follows: a. Weigh the American cockroach medicinal material, add 85% ethanol solution by volume for reflux extraction, combine the extracts, recover the ethanol, concentrate, add water to precipitate, let stand, collect the supernatant, and concentrate under reduced pressure to obtain extract 1. b. Mix and grind the following ingredients from the prescription: mulberry mistletoe, cornus officinalis, raspberry, dodder seed, privet fruit, poria cocos, and licorice root. Add water and decoct. Combine the decoctions and filter to obtain extract 2. c. Combine extract 1 and extract 2, concentrate under reduced pressure to obtain an extract, dry, pulverize into extract powder, add pharmaceutically acceptable excipients, and prepare an oral formulation.

8. The use according to claim 1, characterized in that: The combined use of Dan'e Fuke Decoction and Kangfuxin Liquid can increase the thickness of the endometrium.

9. The use according to claim 2, characterized in that: The combination of the Dan'e Fuke decoction and the drug composition can increase the thickness of the endometrium.

10. The use according to claim 1 or 2, characterized in that: The drug is administered orally.

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