阅读说明：本技术 一种治疗***的药物组合物及其用途 (Pharmaceutical composition for treating polycystic ovarian syndrome and application thereof ) 是由 朱小琳 韩亚光 韩延华 韩亚鹏 于 2020-07-08 设计创作，主要内容包括：本发明公开了固绿(Fast green FCF,FGF)在制备治疗多囊卵巢综合征(PCOS)药物中的应用。本发明还公开了一种用于治疗多囊卵巢综合征(PCOS)的药物组合物,所述药物组合物包含固绿(Fast green FCF,FGF)和药学上可接受的赋形剂。药效学实验结果显示固绿具有良好的促排卵作用,能恢复卵巢正常形态,并降低卵巢局部炎症因子水平,能够有效治疗多囊卵巢综合征。(The invention discloses application of Fast Green FCF (FGF) in preparation of a medicine for treating polycystic ovarian syndrome (PCOS). The invention also discloses a pharmaceutical composition for treating polycystic ovary syndrome (PCOS), which comprises Fast Green FCF (FGF) and pharmaceutically acceptable excipient. Pharmacodynamic experiment results show that the green fixing has good ovulation promoting effect, can restore the normal form of the ovary, reduce the level of local inflammatory factors of the ovary and can effectively treat polycystic ovary syndrome.)

1. Use of Fast Green (FGF) in preparation of medicine for treating polycystic ovarian syndrome (PCOS).

2. A pharmaceutical composition for treating polycystic ovarian syndrome, comprising: the pharmaceutical composition comprises Fast Green FCF (FGF) and a pharmaceutically acceptable excipient.

3. The pharmaceutical composition of claim 2, wherein: the pharmaceutical composition also comprises other effective components.

4. The pharmaceutical composition of claim 3, wherein: the other effective components comprise oral contraceptive, spironolactone, chlorphenamine, metformin or liraglutide.

5. The pharmaceutical composition according to any one of claims 2-4, wherein: the pharmaceutically acceptable excipient is one or more of a filler, a lubricant, a binder, a disintegrant, a stabilizer and a flavoring agent.

6. The pharmaceutical composition according to any one of claims 2-4, wherein: the pharmaceutical composition is prepared into tablets, capsules, granules, pills or dripping pills.

7. The pharmaceutical composition of claim 6, wherein: the tablet is one of common tablet, coated tablet, enteric coated tablet, effervescent tablet, dispersible tablet and buccal tablet.

Technical Field

The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating polycystic ovarian syndrome and application thereof.

Background

Cystic Ovarian Syndrome (PCOS) is a common and difficult disease in gynecological endocrine diseases, and occurs well in adolescent and child-bearing women. Clinically, no ovulation or frequent ovulation, hair growing, acne, obesity, frequent menstruation and even amenorrhea are continuously caused, and the physical and mental health and the life quality of women are seriously influenced. At present, the pathogenesis of PCOS is not completely clear, insulin resistance and hyperinsulinemia are common metabolic abnormality manifestations of patients with polycystic ovary syndrome, obvious metabolic sequelae are provided, and the risk ratio of endometrial cancer, cardiovascular diseases, dyslipidemia and type II diabetes is higher.

In the existing treatment methods for PCOS at present, different measures are generally taken according to different ages and different conditions: for the patients in the early spring, mainly regulating nerves, endocrine, metabolism or antiandrogen overhigh, but not more ovulation-promoting drug clomiphene; for patients requiring fertility, ovulation promotion and pregnancy promotion are mainly performed on the basis of adjusting body dysfunction; for the patients with existing childbearing, the functions of ovary and nerve and endocrine are mainly adjusted. Currently, the curative effects of ethinylestradiol cyproterone, spironolactone, metformin, clomiphene and the like on PCOS are widely reported. In recent years, orlistat, acarbose, liragu, and the like have also been used for treatment of PCOS.

In recent years, a great deal of literature reports that the level of inflammatory factors in PCOS patients is obviously increased, the disease has chronic and low-degree nonspecific subclinical inflammation states, and some inflammatory factors and gene changes thereof in the PCOS patients, such as the increase of leukocyte count, tumor necrosis factor alpha (TNF-alpha), C-reactive protein (CRP), Interleukins (IL), nuclear factor KB (NF-kappa B), plasma plasminogen activator inhibitor (PAI-1), monocyte chemotactic factor (MCF-1) and the like in different degrees, indicate that low-degree chronic inflammation possibly plays a role in the development of PCOS and is related to the pathogenesis of the PCOS.

Disclosure of Invention

The first aspect of the invention provides the application of Fast Green FCF (FGF) in preparing a medicine for treating polycystic ovarian syndrome (PCOS).

Fast Green FCF (FGF) is a triphenylmethane food additive approved for use by the U.S. Food and Drug Administration (FDA). It is readily soluble in water (1mg/ml) and has the following molecular structure:

fast green is widely used in food, medicine and skin care products, and also used in scientific research such as protein staining, extracellular fluid identification record and patch clamp, and has high safety (the maximum daily intake of human can reach 25 mg/kg/day). Recently, a therapeutic role of fast green in amyloid aggregation diseases has been confirmed, and fast green is reported to promote the formation of non-toxic aggregates of a β and inhibit the formation of lysozyme fibrils in vitro, indicating that fast green has a potential role in the treatment or prevention of protein aggregation diseases. In addition, studies have shown that fast green at a dose of 100mg/kg can significantly improve mouse hyperalgesia behavior and inhibit inflammatory factor levels in spinal cord and local tissues. However, the activity of fast green and PCOS related diseases is not reported in the literature.

According to the invention, an animal model similar to human PCOS is established through letrozole, and after gastric lavage is performed to fix green, the green fixation is found to have a good ovulation promoting effect, the normal form of ovaries can be recovered, the level of local inflammatory factors of the ovaries can be reduced, and polycystic ovarian syndrome can be effectively treated.

In a second aspect of the invention, there is provided a pharmaceutical composition for use in the treatment of polycystic ovarian syndrome, said pharmaceutical composition comprising Fast Green FCF (FGF) and a pharmaceutically acceptable excipient.

Further, the pharmaceutical composition also comprises other effective components.

Still further, the other active ingredients include oral contraceptives, spironolactone, chlorphenamine, metformin or liraglutide.

Preferably, the pharmaceutically acceptable excipient is one or more of a filler, a lubricant, a binder, a disintegrant, a stabilizer, a flavoring agent.

More preferably, the pharmaceutical composition is prepared into tablets, capsules, granules, pills or dripping pills.

Further preferably, the tablet is one of ordinary tablets, coated tablets, enteric-coated tablets, effervescent tablets, dispersible tablets and buccal tablets.

Preferred embodiments of the present invention and effects thereof will be described below with reference to specific examples. It should be understood, however, that the description is for illustrative purposes only and is not intended to limit the claims of the present invention in any way.

Detailed Description