Application of fructus psoraleae extract and active ingredient psoralen of fructus psoraleae extract in preparation of medicine for treating polycystic ovarian syndrome

Abstract

The invention relates to the field of biomedicine, in particular to application of a fructus psoraleae extract and an active ingredient psoralen thereof in preparation of a medicine for treating polycystic ovarian syndrome. According to the invention, a letrozole-induced polycystic ovarian syndrome mouse disease model is constructed, and experiments such as estrus cycle detection, open field experiment, sex hormone ELISA detection and the like are carried out. Experimental results show that the fructus psoraleae extract and the fructus psoraleae can effectively relieve and correct a PCOS mouse estrus cycle disorder state, improve ovarian polycystic change, increase the number of corpus luteum, reduce the number of atresia follicles and cystic follicles, and recover normal ovarian functions and reproductive endocrine disorder. The invention provides a new thought for research and development of medicines for treating polycystic ovarian syndrome.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to application of a psoralea corylifolia extract and its active ingredient psoralen in preparing a medicine for treating polycystic ovary syndrome. Background Art

[0002] Polycystic ovary syndrome (PCOS) is the most common gynecological endocrine disorder in women of childbearing age, characterized by hyperandrogenism, reproductive dysfunction, endocrine abnormalities, and metabolic disorders. PCOS can affect the reproductive and endocrine systems in the early stages, with clinical manifestations primarily including menstrual irregularities, infertility, miscarriage, hirsutism, obesity, acne, and polycystic ovarian changes. Later in life, it can lead to complications such as hyperinsulinemia, endometrial cancer, diabetes, and cardiovascular and cerebrovascular diseases. Data show that as of 2024, the global incidence of PCOS among women of childbearing age is 11-13%, and is on the rise.

[0003] The pathogenesis of PCOS is currently believed to be complex, with excess androgen being a key factor contributing to the phenotypic characteristics of PCOS. Androgens are synthesized in the adrenal cortex and ovaries. Within the ovaries, under the action of gonadotropins (follicle-stimulating hormone (FSH) and luteinizing hormone (LH), androstenedione and testosterone are primarily synthesized in the ovarian theca cells. Androstenedione diffuses into granulosa cells and is converted to estrogen by aromatase (CYP19A1). Letrozole, an aromatase inhibitor, blocks the conversion of androgens to estrogen, leading to elevated androgen levels. PCOS is not mentioned in the classics of Traditional Chinese Medicine, but its symptoms are similar to those of kidney deficiency, infertility, amenorrhea, phlegm and blood stasis, and phlegm coagulation in the uterus. The kidneys are the "foundation of innate constitution." When kidney qi is strong, the celestial essence arrives, the Chong and Ren meridians flourish, the blood sea is replenished, qi and blood are balanced, menstruation occurs on time, the eggs mature, and fertility is possible. Kidney Qi deficiency, insufficient Tian Gui (Tian Gui), Chong and Ren meridians deficiency, insufficient Blood Sea (Xue Hai), decreased menstruation, and even amenorrhea. Eggs cannot mature, resulting in infertility. Despite the high prevalence of PCOS, drug intervention for this complex syndrome presents significant challenges.

[0004] Currently, the treatment options available for PCOS are limited. Due to the high heterogeneity of PCOS clinical manifestations (such as significant differences in hormone levels, metabolic status, and phenotypic distribution among different patients), its treatment has become a hot and difficult issue of common concern in the fields of gynecology and endocrinology. Summary of the Invention

[0005] In view of this, the main purpose of the present invention is to provide a new use of Psoralea corylifolia extract and its active ingredient psoralen, that is, the use of Psoralea corylifolia extract and its active ingredient psoralen in the preparation of a drug for treating polycystic ovary syndrome.

[0006] To achieve the above object, the technical solution of the present invention is as follows:

[0007] The first aspect of the present invention is to provide the use of a psoralea corylifolia extract and / or psoralen separated from the psoralea corylifolia extract in the preparation of a medicament for treating polycystic ovary syndrome.

[0008] Furthermore, the preparation method of the psoralea corylifolia extract includes: using crushed powder of dried mature fruits of psoralea corylifolia as raw material, using ethanol as solvent, sequentially performing ultrasonic extraction and solid-liquid separation to obtain a crude extract, and concentrating the crude extract under reduced pressure to remove the solvent to obtain the psoralea corylifolia extract.

[0009] Furthermore, during ultrasonic extraction, the material-liquid ratio is 1g:10-40mL, the temperature is 30-50°C, and the ultrasonic extraction time is 40-120min; during reduced pressure concentration, the temperature is 25-35°C, and the time is 2-4h.

[0010] Furthermore, the active ingredients of the psoralea corylifolia extract include neopsoralen isoflavones, psoralea corylifolia dihydroflavonone methyl ether, psoralen B, psoralen isoflavone A, psoralen A, bakuchiol, psoralen, isopsoralen, psoralen and psoralen isoflavones.

[0011] Furthermore, the polycystic ovary syndrome is polycystic ovary syndrome induced by letrozole and high-fat diet.

[0012] Furthermore, the preparation of the drug for treating polycystic ovary syndrome includes the preparation of the drug for treating estrous cycle disorders, obesity, polycystic ovarian changes, sex hormone secretion disorders, abnormal blood metabolites, and depressive-like behavior caused by polycystic ovary syndrome.

[0013] Psoralea corylifolia extract and psoralen can significantly reduce the weight of mice, improve polycystic changes in the ovaries, and also improve estrous cycle disorders to a certain extent.

[0014] Furthermore, the sex hormone secretion disorder includes secretion disorder of plasma testosterone (T), estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH).

[0015] Psoralea corylifolia extract significantly reduced elevated plasma T and LH levels, increased decreased plasma E2 levels, and showed a trend of improvement in FSH levels. Psoralea corylifolia extract significantly alleviated elevated plasma T, LH, and FSH levels, and showed a trend of improvement in E2 levels.

[0016] Furthermore, the depressive-like behavior includes a decrease in the activity and central area active time of PCOS mice in the behavioral assessment open field test (OFT), and psoralea corylifolia extract and psoralen significantly increase the activity and central area active time of PCOS mice in the open field test.

[0017] Furthermore, the dosage form of the drug includes granules, capsules, tablets, powders, oral solutions, suspensions or emulsions.

[0018] Furthermore, the psoralea corylifolia is selected from the dried mature fruits of the leguminous plant Psoralea corylifolia, the collection time is limited to summer and autumn, and the production area is one or more regions in Southwest China, Central China, South China and Gansu.

[0019] The second aspect of the present invention is to provide a drug for treating polycystic ovary syndrome, wherein the active ingredient of the drug mainly includes psoralen.

[0020] In a third aspect, the present invention provides a method for detecting active ingredients in a Psoralea corylifolia extract using ultra performance liquid chromatography-quadrupole-time of flight tandem mass spectrometry (UPLC-Q-TOF-MS / MS), comprising the following steps:

[0021] 1) taking dried mature fruits of Psoralea corylifolia, crushing them into powder with a crusher and passing them through a 50-150 mesh sieve, extracting them with an ethanol solvent having a mass concentration of 70-100% at a solid-liquid ratio of 1 g:10-40 mL, at an extraction temperature of 30-50° C., and ultrasonically extracting them for 40-120 min;

[0022] 2) After the extraction is completed according to step 1), solid-liquid separation is performed to obtain a crude product, and vacuum rotary evaporation is performed at 25-60°C for 1-6 hours to fully evaporate the ethanol solvent to obtain a brown extract or powder;

[0023] 3) dissolving an appropriate amount of the extract or powder obtained in step 2) in 80-100% methanol, filtering through a 0.45 μm filter membrane, and collecting the filtrate;

[0024] 4) Using UPLC-Q-TOF-MS / MS to identify the chemical components of the subsequent filtrate described in step 3), the active ingredients of the psoralea corylifolia extract were analyzed to be mainly a mixture of new psoralea corylifolia isoflavones (NBIF) and psoralea corylifolia methyl ether (BVC), accounting for 60-95% by mass.

[0025] Further, the powder is sieved through a 65-100 mesh sieve and extracted with 90-100% ethanol solvent at a material-liquid ratio of 1 g:30-40 mL, an extraction temperature of 30-40° C., and an ultrasonic extraction time of 40-60 min. The crude product is subjected to vacuum rotary evaporation at 25-35° C. for 2-4 h.

[0026] Furthermore, in the above-mentioned method for detecting psoralea corylifolia extract, the chromatographic column used in step 4) is: a 1.7 μm particle size C18 chromatographic column, 2.1 mm × 100 mm; the mobile phase is: by volume percentage, A: 0.1% formic acid aqueous solution, B: acetonitrile; the liquid phase conditions are: 0-4 min, 5%-15% B; 4-10 min, 15% B-25% B; 10-50 min, 25%-60% B; 50-65 min, 60%-80% B.

[0027] The beneficial effects of the present invention include at least:

[0028] The present study found that 23 consecutive days of oral administration of letrozole solution caused mice to develop PCOS symptoms such as weight gain, hyperandrogenism, elevated plasma LH / FSH ratio, estrous cycle disturbances, polycystic ovarian changes, and depressive-like behavior. Treatment with psoralea corylifolia extract and psoralen improved the weight gain and estrous cycle disturbances in PCOS mice. The polycystic ovarian changes were reversed, the number of corpora lutea increased, and the number of atretic and cystic follicles decreased, indicating that the disrupted ovarian function of the PCOS model mice was largely restored. Hyperandrogenism, increased plasma LH, FSH, and LH / FSH ratios, and decreased E2 levels were all improved. Abnormal plasma metabolites and depressive-like behavior in the mice were also improved. This study suggests that psoralea corylifolia extract and its active ingredient, psoralen, are potential drug candidates for the treatment of PCOS and have significant potential for application development. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is the total ion chromatogram of Psoralea corylifolia extract detected by UPLC-Q-TOF-MS / MS. A is the positive ion mode and B is the negative ion mode.

[0030] Figure 2 Figures 1 and 2 show changes in mouse body weight, estrous cycle, and ovarian ultrasound images after modeling. A is a line graph showing changes in mouse body weight, B is a statistical line graph showing estrous cycles of some mice, C is an ultrasound image of the mouse ovaries, and D is a bar graph showing cross-sectional area of ​​the mouse ovaries. # indicates P < 0.05 compared with the blank group, ## indicates P < 0.01 compared with the blank group, and ### indicates P < 0.001 compared with the blank group; * indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group, and *** indicates P < 0.001 compared with the model group.

[0031] Figure 3 This is a line graph showing the changes in body weight of mice after intervention with Psoralea corylifolia extract.

[0032] Figure 4Figure 1 shows the changes in the estrous cycle of mice after treatment with Psoralea corylifolia extract. A shows H&E-stained vaginal smears from each group, and B shows a statistical line graph of the estrous cycle of mice in each group. P: proestrus; E: estrus; M: metestrus; D: diestrus.

[0033] Figure 5 This is the H&E stained pathological section of the mouse ovary after intervention with Psoralea corylifolia extract.

[0034] Figure 6 Figure 2 shows the OFT results of mice after intervention with Psoralea corylifolia extract. A is a visualization of the trajectory of some mice in each group and a heat map. B is a bar graph of the activity level and central area activity time of some mice in each group. # indicates P < 0.05 compared with the blank group, ## indicates P < 0.01 compared with the blank group, and ### indicates P < 0.001 compared with the blank group; * indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group, and *** indicates P < 0.001 compared with the model group.

[0035] Figure 7 This is a bar graph showing the plasma sex hormone levels of mice after treatment with Psoralea corylifolia extract. A represents the plasma testosterone level of mice in each group, B represents the plasma estradiol level of mice in each group, C represents the plasma luteinizing hormone level of mice in each group, and D represents the plasma follicle-stimulating hormone level of mice in each group. # indicates P < 0.05 compared with the blank group, ## indicates P < 0.01 compared with the blank group, and ### indicates P < 0.001 compared with the blank group; * indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group, and *** indicates P < 0.001 compared with the model group.

[0036] Figure 8 This is a line graph showing the changes in mouse body weight after psoralen intervention.

[0037] Figure 9 The results of the changes in the estrous cycle of mice after psoralen administration intervention are shown in Figure 1, where A is a portion of H&E-stained vaginal smears from each group, and B is a statistical line graph of the estrous cycle of mice in each group.

[0038] Figure 10 This is the H&E stained pathological section of the mouse ovary after psoralen administration.

[0039] Figure 11Figure 2 shows the OFT results of mice after psoralen treatment, where A is a visualization of the trajectory of some mice in each group and a heat map, and B is a bar graph of the activity level and central area activity time of some mice in each group. # indicates P < 0.05 compared with the blank group, ## indicates P < 0.01 compared with the blank group, and ### indicates P < 0.001 compared with the blank group; * indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group, and *** indicates P < 0.001 compared with the model group.

[0040] Figure 12 This is a bar graph of plasma sex hormones in mice after psoralen treatment. A represents the plasma testosterone level in each group of mice, B represents the plasma estradiol level in each group of mice, C represents the plasma luteinizing hormone level in each group of mice, and D represents the plasma follicle-stimulating hormone level in each group of mice. # indicates P < 0.05 compared with the blank group, ## indicates P < 0.01 compared with the blank group, and ### indicates P < 0.001 compared with the blank group; * indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group, and *** indicates P < 0.001 compared with the model group. DETAILED DESCRIPTION

[0041] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0042] In addition, the technical solutions between the various embodiments of the present invention can be combined with each other, but it must be based on the fact that ordinary technicians in this field can implement it. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0043] The materials used in this example are as follows:

[0044] Psoralea corylifolia was purchased from Anhui Yixintang Health Industry Development Co., Ltd.; psoralen was purchased from Shanghai Bid Pharmaceutical Technology Co., Ltd.; the experimental animals used were 3-5 week old female C57BL / 6 mice weighing 18-22 g, purchased from Jiangsu Huachuang Xinnuo Pharmaceutical Technology Co., Ltd.; letrozole tablets were purchased from Jiangsu Hengrui Medicine Co., Ltd.; high-fat feed was purchased from Shanghai Shuyu Biotechnology (Shanghai) Co., Ltd., model SYHF60-160% fat energy supply diet; mouse testosterone, estradiol, luteinizing hormone, and follicle-stimulating hormone ELISA kits were purchased from Shanghai Jianglai Biotechnology Co., Ltd.

[0045] The solution proposed by the present invention is described in detail below through specific embodiments:

[0046] Example 1: Analysis of the main chemical components of Psoralea corylifolia extract based on UPLC-Q-TOF-MS / MS

[0047] (1) Dried mature fruits of Psoralea corylifolia were crushed into a uniform powder using a grinder and passed through a 65-mesh sieve. 50 g of Psoralea corylifolia powder was accurately weighed and extracted with anhydrous ethanol at a material-liquid ratio of 1:40 (material weight g / extraction solvent volume mL) at 40°C for 40 min. The extract after solid-liquid separation was concentrated by vacuum rotary evaporation at 45°C to produce 9.98 g of extract, obtaining a Psoralea corylifolia extract with a yield of 20.0%.

[0048] (2) Dissolve an appropriate amount of the extract obtained in the above step in methanol, filter through a 0.45 μm filter membrane, and collect the filtrate;

[0049] (3) The chemical components of the filtrate were identified using UPLC-Q-TOF-MS / MS. Chromatographic conditions: Waters C18 column (2.1 mm × 100 mm, 1.7 μm); column temperature 40°C; flow rate 0.2 mL / min; mobile phase: 15%-25% B for 4-10 min; 25%-60% B for 10-50 min; 60%-80% B for 50-65 min; injection volume 2 μL. Mass spectrometry conditions: electrospray ionization (ESI) scanning mode, positive and negative ion mode detection; nebulizer pressure: 40 psi (pounds per square inch); drying gas (N2) temperature: 200°C, drying gas flow rate: 11 L / min; fragmentor voltage: 175 V; capillary voltage: 4000 V; skimmer voltage: 65 V; mass-to-nuclear ratio acquisition range: m / z 100-1700; scan rates for both MS and MS / MS were 2.0 spectra / s; targeted MS / MS collision energy (CE) was set to 10 / 20 / 30 / 40 eV.

[0050] Based on the information on the relative molecular mass of the compounds provided by the quasi-molecular ion peaks obtained from the total ion current of UPLC-Q-TOF-MS / MS, as well as the secondary fragment ion information obtained from ion scanning, the compounds in the Psoralea corylifolia extract were identified by combining the database and consulting relevant literature. A total of 16 compounds were identified, such as Figure 1In the figure, the top 10 components ranked by response area are Neobavaisoflavone, Bavachinin A, Isobavachalcone, Corylifol A, Bavachin, (+)-Bakuchiol, Psoralen, Isopsoralene, Psoralidin and Corylin.

[0051] Table 1 Component identification of Psoralea corylifolia extract by UPLC-Q-TOF-MS / MS

[0052]

[0053]

[0054] Example 2: Comparison of the improvement effect of Psoralea corylifolia extract on the PCOS mouse model induced by letrozole plus high-fat diet

[0055] Methods: Letrozole tablets (2.5 mg / tablet) were ground into powder, dissolved in water, and ultrasonically dissolved to produce a 0.2 mg / mL suspension. Mice were randomly divided into a blank control group (n=6) and a modeling group (n=36). The blank control group received an equal amount of water and a normal diet. The modeling group received letrozole (1.5 mg / kg / d) orally by gavage and a 60% high-fat diet for 23 consecutive days. After modeling, vaginal exfoliated cells were collected from the mice at 9:00 AM daily for vaginal smears to monitor estrous cycles for 8 consecutive days. Ultrasound images of both ovaries were obtained from the abdomen of the mice, and the area of ​​the ovaries was measured at the maximum cross-section. The measurement was repeated three times to minimize error.

[0056] The successful establishment of a PCOS mouse model was determined by a 20% increase in body weight, disrupted estrous cycles, and increased ovarian volume. Successfully established mice were randomly divided into four groups (n=4): a model group, a metformin hydrochloride group (200 mg / kg / day), a low-dose psoralea corylifolia extract group (0.5 g / kg / day), and a high-dose psoralea corylifolia extract group (1.5 g / kg / day). The model group received an equal amount of water, while the drug-treated group received the corresponding drug by gavage once daily for 30 consecutive days. After the end of drug administration, vaginal exfoliated cells were collected from the mice at 9:00 AM daily for vaginal smears to observe whether the estrous cycle had recovered for 8 consecutive days.

[0057] The behavioral open field test is an experimental method used to evaluate the efficacy and pharmacological effects of drugs. PCOS patients often experience emotional and behavioral issues, such as depression, anxiety, and irritability. The behavioral open field test can be used to observe the effects of medications on these emotional and behavioral issues, such as whether medications alleviate symptoms of depression and anxiety. The activity level and central activity time of mice are indicators of their anxiety and stress responses in a novel environment.

[0058] Before the final dose, mice were placed in a square open field measuring 50 cm on a side and 40 cm high. Activity trajectories and central area exploration were recorded for 5 minutes using behavioral automated tracking software. Results were presented as activity levels and the percentage of time spent in the central area. After the final dose, blood was collected and centrifuged at 3000 rpm for 10 minutes at 4°C. Plasma sex hormone levels were measured, and ovarian sections were sectioned for pathological changes.

[0059] Results: As Figure 2 Many round or oval nucleated epithelial cells can be seen in the vaginal smears during the proestrus period; many anucleated keratinized epithelial cells can be seen in the vaginal smears during the estrus period; white blood cells, nucleated epithelial cells and anucleated keratinized epithelial cells can be seen in the vaginal smears during the metestrus period; a large number of white blood cells can be seen in the vaginal smears during the diestrus period; the estrous cycle of mice in the blank group is regular; compared with the blank group, the time interval of the estrous cycle of mice in the model group is significantly prolonged or stagnant, the estrous cycle disorder has not yet fully recovered, and most of them are in the diestrus period; the ovarian parenchyma of the blank group is plump and clearly defined, while the ovarian edge of the model group is fuzzy and the parenchyma is not plump enough; compared with the blank group, the ovarian area of ​​the model group is significantly increased.

[0060] like Figure 3 Compared with the model group, the high-dose group of Psoralea corylifolia extract could significantly improve the weight gain of mice.

[0061] like Figure 4 Compared with the model group, both the low-dose and high-dose groups of Psoralea corylifolia extract could significantly improve the estrous cycle disorder of mice.

[0062] like Figure 5 Compared with the blank group, the model group had more cystic dilated follicles and more atretic follicles in the ovaries. The number of granulosa cells did not recover significantly after the decrease, the number of granulosa cell layers decreased, the corpus luteum decreased, and the morphological structure of the ovaries was disordered. Compared with the model group, both the low-dose and high-dose groups of Psoralea corylifolia extract improved the ovarian status of mice. The number of cystic follicles and atretic follicles decreased, the number of secondary follicles increased, the number of follicles at different developmental stages increased, the number of corpora lutea increased, the number of granulosa cells increased, the granulosa cell layer thickened and tightly aggregated, and the morphological structure of the ovaries was basically restored, with obvious effects.

[0063] like Figure 6Compared with the blank group, the activity level and central area activity time of mice in the model group were significantly reduced; compared with the model group, the low-dose and high-dose groups of Psoralea corylifolia extract significantly increased the activity level and central area activity time of mice.

[0064] like Figure 7 Compared with the blank group, the plasma T, LH, and FSH levels of mice in the model group were significantly increased, and the E2 level was significantly decreased; compared with the model group, the T and LH levels of the low-dose and high-dose groups of Psoralea corylifolia extract were significantly decreased and showed a concentration-dependent pattern, the FSH level was decreased, and the E2 level was significantly increased and showed a concentration-dependent pattern.

[0065] Example 3: Comparison of the improvement effects of psoralen on the PCOS mouse model induced by letrozole plus high-fat diet

[0066] Methods: Animal modeling was performed as in Example 2. Successfully established mice were randomly divided into four groups (n=4): a model group, a metformin hydrochloride group (200 mg / kg / d), a low-dose psoralen group (30 mg / kg / d), and a high-dose psoralen group (90 mg / kg / d). The model group received an equal amount of water, while the drug-treated group received the corresponding drug by gavage once daily for 30 consecutive days. Following the completion of drug administration, vaginal exfoliated cells were collected from the mice at 9:00 AM daily for vaginal smears to observe the return of estrous cycles for 8 consecutive days.

[0067] Before the final dose, mice were placed in a 50 cm square open field (40 cm high). Activity trajectories and central area exploration were recorded for 5 minutes using behavioral automated tracking software. Results were presented as activity levels and the percentage of time spent in the central area. After the final dose, blood was collected and centrifuged at 3000 rpm for 10 minutes at 4°C. Plasma sex hormone levels were measured, and ovarian sections were sectioned for pathological changes.

[0068] Results: As Figure 8 Compared with the model group, both the low-dose and high-dose psoralen groups significantly improved the weight gain of mice.

[0069] like Figure 9 Compared with the model group, both the low-dose and high-dose psoralen groups could significantly improve the estrous cycle disorders in mice.

[0070] like Figure 10 Compared with the model group, both the low-dose and high-dose psoralen groups could improve the ovarian status of mice. The number of cystic follicles and atretic follicles decreased, the number of secondary follicles increased, the number of follicles at different developmental stages increased, the number of corpora lutea increased, the number of granulosa cells increased, the granulosa cell layer thickened and tightly aggregated, and the morphological structure of the ovary was basically restored, with obvious effects.

[0071] like Figure 11 Compared with the model group, the low-dose and high-dose psoralen groups significantly increased the activity level and central area activity time of mice in a concentration-dependent manner.

[0072] like Figure 12 Compared with the model group, the levels of T, LH, and FSH in the low-dose and high-dose psoralen groups were significantly decreased in a concentration-dependent manner, and the E2 level in the low-dose psoralen group was significantly increased.

[0073] It should be noted that, in this document, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0074] The serial numbers of the above embodiments of the present invention are for description only and do not represent the advantages or disadvantages of the embodiments.

[0075] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the purpose and scope of the technical solutions of the present invention, and all of these should be included in the scope of the claims of the present invention.

Claims

1. Use of psoralea corylifolia extract and / or psoralen in the preparation of a medicament for treating polycystic ovary syndrome.

2. The use according to claim 1, characterized in that The preparation method of the psoralea corylifolia extract comprises the following steps: using crushed powder of dried mature psoralea corylifolia fruits as raw material, using ethanol as solvent, sequentially performing ultrasonic extraction, solid-liquid separation to obtain a crude extract, and concentrating the crude extract under reduced pressure to remove the solvent, thereby obtaining the psoralea corylifolia extract.

3. The use according to claim 1, characterized in that During ultrasonic extraction, the material-liquid ratio is 1g:10-40mL, the temperature is 30-50°C, and the ultrasonic extraction time is 40-120min; during reduced pressure concentration, the temperature is 25-35°C, and the time is 2-4h.

4. The use according to claim 2 or 3, characterized in that The active ingredients of the psoralea corylifolia extract include neopsoralen isoflavone, psoralen dihydroflavone methyl ether, psoralen B, psoralen isoflavone A, psoralen A, bakuchiol, psoralen, isopsoralen, psoralen and psoralen isoflavone.

5. The use according to claim 1, characterized in that The polycystic ovary syndrome is polycystic ovary syndrome induced by letrozole and high-fat diet.

6. The use according to claim 1, characterized in that The preparation of the medicine for treating polycystic ovary syndrome includes the preparation of the medicine for treating estrous cycle disorder, obesity, polycystic ovarian changes, sex hormone secretion disorder, abnormal blood metabolites, and depressive-like behavior caused by polycystic ovary syndrome.

7. The use according to claim 6, characterized in that The sex hormone secretion disorder includes the secretion disorder of plasma testosterone, estradiol, luteinizing hormone and follicle-stimulating hormone.

8. The use according to any one of claims 1 to 7, characterized in that: The dosage forms of the drug include granules, capsules, tablets, powders, oral solutions, suspensions or emulsions.

9. A drug for treating polycystic ovary syndrome, characterized in that: The active ingredient of the drug includes psoralen.

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