CN-117323361-B - Pharmaceutical composition for treating brain glioma and application thereof

Abstract

The present disclosure provides a pharmaceutical composition for treating brain glioma and application thereof, and belongs to the field of medicine. The pharmaceutical composition comprises temozolomide and radix puerariae extract, wherein the mass ratio of temozolomide to radix puerariae extract is (4:1) - (1:1), and the combination of temozolomide and radix puerariae extract has remarkable synergistic inhibition effect on glioma. The pharmaceutical composition can be applied to preparing medicines for treating brain glioma, and has wide application prospect.

Inventors

• WU WEI
• LU PING
• WANG JIE
• TANG JINGLIANG
• FU SIHAI
• Wei Kangjing

Assignees

• 长沙市第一医院

Dates

Publication Date

20260505

Application Date

20230919

Claims (8)

1. 1. The pharmaceutical composition for treating the glioma is characterized by comprising an active ingredient, wherein the active ingredient consists of temozolomide and radix puerariae extract, and the mass ratio of temozolomide to radix puerariae extract is (4:1) - (1:1).
2. 2. The pharmaceutical composition according to claim 1, wherein the mass ratio of temozolomide to kudzuvine root extract is 2:1.
3. 3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition further comprises hydroxypropyl methylcellulose.
4. 4. A pharmaceutical composition according to claim 3, wherein the hydroxypropyl methylcellulose is present in a concentration of 0.2% by mass.
5. 5. The pharmaceutical composition of claim 1, wherein, the pharmaceutical composition also comprises pharmaceutically acceptable auxiliary materials.
6. 6. The pharmaceutical composition according to any one of claims 1-5, wherein the pharmaceutical composition is in the form of an injection, a tablet, a capsule, a granule, a suspension, an emulsion, a solution, a sol, an aerosol.
7. 7. Use of a pharmaceutical composition according to any one of claims 1-5 for the preparation of a medicament for the treatment of glioma.
8. 8. The use of claim 7, wherein the brain glioma comprises a human glioma.

Description

Pharmaceutical composition for treating brain glioma and application thereof Technical Field The present disclosure relates to the field of medicine, and in particular, to a pharmaceutical composition for treating glioma and application thereof. Background Gliomas refer to tumors that originate from brain glial cells, the most common primary intracranial tumor. The annual incidence rate of the glioma in China is 5-8/10 ten thousand, and the disease death rate of 5 years is inferior to that of pancreatic cancer and lung cancer in systemic tumor. Low-grade gliomas (low-grade gliomas, LGG; WHOI, grade II) progress relatively slowly, with a good prognosis, with a median survival of 10-12.9 years, and high-grade gliomas (high-grade gliomas, HGG; WHOIII, grade IV) tend to progress rapidly, with a poor prognosis, with a median survival of only 18 months in glioblastomas (WHOIV grade). The glioma treatment mainly comprises surgical excision and can relieve clinical symptoms and prolong the survival time by combining comprehensive treatment methods such as radiotherapy, chemotherapy and the like. Although radical surgery plus chemoradiotherapy is still a basic means for treating glioma, due to the invasive growth, the surgery is difficult to completely remove the tumor due to the radioactive damage to surrounding normal brain tissues, and has the advantages of easy recurrence, high death rate and no optimistic curative effect. In 1976, the U.S. Food and Drug Administration (FDA) approved lomustine as a therapeutic drug for intracranial tumors. Only three drugs for treating brain cancer were formally approved since 40 years, carmustine wafer was approved for recurrent glioma in 1996, and is currently approved as an adjuvant therapy for new diagnosed and operated glioma patients, temozolomide (Temozolomide, TMZ) was approved for 3-stage degenerative astrocytoma patients in 1999, after which the indication was extended to new diagnosed glioma as maintenance therapy after radiotherapy, and bevacizumab was approved for accelerated after-treatment glioma patients. At present, TMZ is a gold standard for clinically treating glioma, but TMZ is a cytotoxic drug, has a great side effect of killing normal growing mucous membrane cells and fast growing cells, and is easy to resist after a period of time. The kudzu root is the dry root of the kudzu vine of the leguminous plant, is a common traditional Chinese medicine, has cool and sweet nature, and has the effects of relieving muscle and allaying fever, promoting the secretion of saliva or body fluid to quench thirst and raising yang to check diarrhea. Modern pharmacological research shows that the kudzuvine root has the functions of vasodilation, heart protection, neuroprotection, antioxidation, anti-inflammatory, anti-tumor, anti-alcohol, liver protection and insulin resistance alleviation. The kudzuvine root contains a plurality of compounds, wherein the content of puerarin is the largest. Recent researches show that puerarin has a certain therapeutic effect on colon cancer, and puerarin has a strong inhibition effect on the activity of glioma U251 cells under the induction of phorbol lipid, and can resist migration invasion of the U251 cells. The antagonism of puerarin on tumor cell migration invasion and the protection effect on normal cells can reduce the drug resistance of cytotoxic drugs and the killing of normal cells to a great extent, and puerarin can pass through the blood brain barrier, so that the puerarin has advantages in treating brain diseases, and the research of combining pueraria extract with temozolomide in treating brain glioma is not available at present. Past studies have shown that chronic inflammation is a major feature of glioblastoma biology, with the blood brain barrier being destroyed by glioblastoma, resulting in chronic neuroinflammation. Microglia are innate immune cells in the brain that can release a variety of inflammatory factors and mediators of inflammation to promote inflammatory responses. In one aspect, studies have shown that the number of selectively activated M2 microglia is positively correlated with glioma grade, directly or indirectly leading to glioma, tumor proliferation and tumor invasion. On the other hand, inhibiting activation of microglia, reducing release of inflammatory mediators can act to protect nerve cells. Disclosure of Invention The purpose of the present disclosure is to overcome the deficiencies of the prior art and provide a pharmaceutical composition for treating glioma and applications thereof. TMZ and radix Puerariae extract can inhibit activation of microglial cells, thereby reducing neuroinflammation, improving anti-tumor effect of TMZ, and reducing toxicity to normal cells. In order to achieve the aim, the technical scheme adopted by the present disclosure is that the pharmaceutical composition for treating brain glioma comprises temozolomide and radix puerariae extract, wherein the mass ratio of temozolomi