CN-122005752-A - Pharmaceutical preparation for repairing endometrial damage

Abstract

The invention provides a pharmaceutical preparation for repairing endometrial damage, and belongs to the technical field of biomedicine. The pharmaceutical preparation takes modified polypeptide as an active ingredient, and the amino acid sequence of the modified polypeptide is shown as SEQ ID NO. 5. Experimental results show that the polypeptide can obviously promote proliferation and migration of human endometrial stromal cells, still keeps lower cytotoxicity at higher concentration, and shows excellent safety. Further, in a rat model of endometrial mechanical injury, the preparation can significantly increase endometrial thickness, increase Ki-67 positive cell rate, enhance proliferation activity of endometrium cells and promote repair of damaged tissues. Compared with the original polypeptide, the preparation provided by the invention has unexpected technical effects in the aspects of repair activity and safety, and has a good application prospect.

Inventors

• WANG MAOHAN
• JIANG WEIMIN

Assignees

• 超越再生医学(杭州)有限公司

Dates

Publication Date

20260512

Application Date

20260410

Claims (10)

1. 1. A pharmaceutical formulation for use in the repair of endometrial lesions, characterized in that the pharmaceutical formulation comprises an active ingredient and pharmaceutically acceptable excipients; the active ingredient is modified polypeptide, and the amino acid sequence of the modified polypeptide is shown as SEQ ID NO. 5.
2. 2. The pharmaceutical formulation of claim 1, wherein the concentration of the modified polypeptide in the pharmaceutical formulation is 10-160 μg/mL.
3. 3. The pharmaceutical formulation of claim 2, wherein the concentration of the modified polypeptide in the pharmaceutical formulation is 40 μg/mL.
4. 4. The pharmaceutical formulation of claim 1, wherein the endometrial damage repair is a repair of mechanical damage-induced thin endometrial or induced abortion or post uterine curettage endomembrane damage.
5. 5. The pharmaceutical formulation of claim 1, wherein the pharmaceutically acceptable adjuvant is normal saline, sterile water, or phosphate buffer; The dosage form of the pharmaceutical preparation is selected from one of solution, gel, injection, spray, sustained release preparation and hydrogel preparation.
6. 6. The application of the improved polypeptide in preparing a medicament for treating endometrium injury diseases is characterized in that the amino acid sequence of the improved polypeptide is shown as SEQ ID NO. 5.
7. 7. The use according to claim 6, wherein the endometrium injury disease is thin endometrium caused by mechanical injury or endometrium injury caused by artificial abortion or uterine curettage.
8. 8. The use according to claim 7, wherein the concentration of the modified polypeptide in the medicament is 10-160 μg/mL.
9. 9. The use of claim 8, wherein the use of the modified polypeptide comprises promoting proliferation and/or migration of endometrial stromal cells.
10. 10. An improved polypeptide for achieving endometrial repair, wherein the amino acid sequence of the improved polypeptide is shown in SEQ ID NO. 5.

Description

Pharmaceutical preparation for repairing endometrial damage Technical Field The invention belongs to the technical field of biomedicine, and particularly relates to a medical preparation for repairing endometrial injury. Background Endometrium is an important tissue in female reproductive system, and its integrity and functional status are of great importance for menstrual cycle maintenance, embryo implantation and pregnancy outcome. Under the influence of factors such as induced abortion, uterine curettage, hysteroscopic operation, infection, inflammation, intrauterine adhesion and the like, the endometrium can be damaged to different degrees, so that the clinical problems such as thinning of the endometrium, gland reduction, insufficient angiogenesis, aggravation of fibrosis and reduction of uterine cavity acceptance can be caused, and menstrual reduction, amenorrhea, infertility, repeated planting failure and the like can be caused when the conditions are serious. Therefore, how to effectively promote the repair of damaged endometrium and restore the normal structure and physiological function of the damaged endometrium has become a research hot spot in the fields of reproductive medicine and gynecological disease treatment. Currently, the treatment methods for endometrial lesions mainly include estrogen or progestogen supplementation therapy, hysteroscopic adhesion separation, intrauterine placement of intrauterine devices or balloons, anti-adhesion material application, stem cell therapy, platelet rich plasma therapy, local delivery of biological materials, and the like. However, there are still limitations to the existing treatments. For example, the surgical treatment is mainly applicable to organic lesions such as intrauterine adhesion, but the risk of insufficient re-adhesion and repair after operation is still encountered, and the stem cells and related regenerative medicine technology have application prospects, but the preparation is complex, the cost is high, and the safety, stability and standardization of the stem cells and the related regenerative medicine technology still need to be further verified. Therefore, the development of a pharmaceutical preparation with good repair activity and higher safety has important significance for improving the repair effect of endometrial injury. Disclosure of Invention The invention aims to provide a pharmaceutical preparation for repairing endometrial damage, thereby providing a safe and effective polypeptide preparation. In order to achieve the above purpose, the present invention provides the following technical solutions: In a first aspect, the present invention provides a pharmaceutical formulation for repair of endometrial lesions, said pharmaceutical formulation comprising an active ingredient and pharmaceutically acceptable excipients; the active ingredient is modified polypeptide, and the amino acid sequence of the modified polypeptide is shown as SEQ ID NO. 5. Preferably, the concentration of the modified polypeptide in the pharmaceutical formulation is 10-160 μg/mL. Preferably, the concentration of the modified polypeptide in the pharmaceutical formulation is 40 μg/mL. Preferably, the endometrial damage repair is a repair of thin endometrial damage caused by mechanical damage or induced abortion or post uterine curettage. Preferably, the pharmaceutically acceptable adjuvant is physiological saline, sterile water or phosphate buffer; The dosage form of the pharmaceutical preparation is selected from one of solution, gel, injection, spray, sustained release preparation and hydrogel preparation. In a second aspect, the invention provides an application of an improved polypeptide in preparing a medicament for treating endometrium injury diseases, wherein the amino acid sequence of the improved polypeptide is shown as SEQ ID NO. 5. Preferably, the endometrium injury disease is thin endometrium caused by mechanical injury or endometrium injury caused by artificial abortion or uterine curettage. Preferably, the concentration of the modified polypeptide in the drug is 10-160 μg/mL. Preferably, the use of the modified polypeptide comprises promoting proliferation and/or migration of endometrial stromal cells. In a third aspect, the present invention provides an improved polypeptide for effecting endometrial repair, said improved polypeptide having the amino acid sequence shown in SEQ ID NO. 5. The invention has the beneficial effects that: The invention provides a pharmaceutical preparation for repairing endometrial damage. Compared with the existing hormone treatment, surgical intervention, stem cell and other repair schemes, the invention takes the specific modified polypeptide as an active ingredient, and has better repair activity and safety. Experimental results show that the modified polypeptide can remarkably promote proliferation and migration of human endometrial stromal cells, wherein the polypeptide shown in SEQ ID NO.5 shows a repair promot