US-12622939-B2 - Ganoderma lucidum spore oil and use thereof in preparation of anti-cancer-related fatigue medicaments

Abstract

Ganoderma lucidum spore oil and use thereof in the preparation of anti-cancer-related fatigue medicaments are provided. The content of triglycerides in the Ganoderma lucidum spore oil is greater than 90%. Ganoderma lucidum triterpenoids are not detected. The Ganoderma lucidum spore oil is extracted by means of supercritical CO 2 , eluted with a silica gel column and a mixed solution of petroleum ether-ethyl acetate, concentrated under reduced pressure and vacuum-dried. The Ganoderma lucidum spore oil is highly effective in mitigating cancer-related fatigue, has good safety, and can be used in the preparation of medicaments for treating cancer-related fatigue.

Inventors

• Juyan Liu
• Guocai Wang
• Qin Zhang
• Wendong XU
• Hongfei Cai
• Jing Li
• CHENG YUAN
• Yaming Han
• Lin Cao
• Shunzhi Tang
• Yukang Mao

Assignees

• GUANGZHOU HANFANG PHARMACEUTICAL CO., LTD.

Dates

Publication Date

20260512

Application Date

20240117

Priority Date

20210722

Claims (7)

1. 1 . A method for reducing the incidence of or treating cancer-related fatigue, comprising administering to a subject in need thereof a therapeutically effective amount of Ganoderma lucidum spore oil, wherein no Ganoderma lucidum triterpenoids are detected in the Ganoderma lucidum spore oil.
2. 2 . The method according to claim 1 , wherein a content of triglyceride ingredients is greater than 90% in the Ganoderma lucidum spore oil.
3. 3 . The method according to claim 1 , wherein the Ganoderma lucidum spore oil is prepared by following steps: A. making Ganoderma lucidum spores subjected to wall-breaking, granulation, drying, and supercritical CO 2 extraction to provide a spore oil crude product; B. dissolving an appropriate amount of silica gel in a mixed solution of petroleum ether and ethyl acetate, preparing a column with the silica gel in the mixed solution to provide an elution column; and C. loading the spore oil crude product onto the elution column, eluting with the mixed solution of petroleum ether and ethyl acetate under normal pressure, collecting and combining eluents, concentrating under reduced pressure to remove solvents, and vacuum-drying, to provide the Ganoderma lucidum spore oil.
4. 4 . The method according to claim 3 , wherein a mass ratio of the spore oil crude product to the silica gel is 1:10-40.
5. 5 . The method according to claim 3 , wherein in the mixed solution of petroleum ether and ethyl acetate, a volume ratio of petroleum ether to ethyl acetate is 8.5-9.5:0.5-1.5.
6. 6 . The method according to claim 5 , wherein in the mixed solution of petroleum ether and ethyl acetate, the volume ratio of petroleum ether to ethyl acetate is 9.2:0.8.
7. 7 . The method according to claim 3 , wherein a ratio of diameter to height of the elution column is 1:10-20.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation-in-part application of international application PCT/CN2022/106599, filed on Jul. 20, 2022 and entitled “Ganoderma Lucidum Spore Oil and Use thereof in Preparation of Drug Counteracting Cancer-related Fatigue”, which claims priority to Chinese patent application No. 202110830365.7, filed on Jul. 22, 2021, the contents of which are incorporated herein by reference in their entirety. TECHNICAL FIELD The present disclosure relates to the technical field of medicine, and specifically to Ganoderma lucidum spore oil and use thereof in the preparation of anti-cancer-related fatigue medicaments. BACKGROUND ART Cancer-related fatigue (CRF) is one of the most common symptoms of patients suffering from tumors, which is also the most common side effect in tumor treatment. The National Comprehensive Cancer Network (NCCN) defines cancer-related fatigue as “a distressing, persistent, subjective sense of physical, emotional, or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning”. The International Classification of Diseases (ICD) describes the symptoms of cancer-related fatigue as non-specific acratia, weakness, general physical deterioration, lethargy and tiredness. Statistically, more than 75% of tumor patients can show the symptoms of cancer-related fatigue. However, there is neither an exact final conclusion on mechanism researches of the cancer-related fatigue, nor a therapeutic drug for the cancer-related fatigue currently. Records of diseases related to the “cancer-related fatigue” do not appear in literatures of ancient traditional Chinese medicine, which are usually described as “consumptive diseases”. It is recorded in the literature Basic Questions⋅Comprehensive Theory on Deficiency and Excess “the depletion of essence-qi may bring on deficiency syndrome”, which can be deemed as the earliest definition of consumptive disease. It is believed in the literature Synopsis of Prescriptions of the Golden Chamber⋅Consumptive Diseases that all deficiencies of internal organs and meridians, yin and yang, and qi and blood due to internal lesion caused by overexertion, with a series of symptoms of strain are consumptive diseases. With continuous development of modern traditional Chinese medicine, it is widely believed that the cancer-related fatigue is mostly caused by damage to qi and blood, and body fluid, and injury to qi in zang-fu organs due to emotional disorder, cancer invasion, improper diet and overstrain, etc., which are not recovered for a long time. Therefore, treatment of the cancer-related fatigue is mainly based on the tumor disease per se, and syndrome differentiation and treatment is carried out according to the different deficiency and excess of qi and blood, yin and yang of zang-fu organs. Reinforcing healthy qi to eliminate pathogenic factors is the main treatment principle, with primary reinforcement and supplementary elimination of pathogenic factors. In addition to eliminating causes of fatigue as much as possible, overall regulation should be emphasized. Ganoderma lucidum, as a treasure in traditional Chinese medicine of China, always has the reputation of “magical herb”. It can be used for uneasiness, insomnia and palpitation, lung deficiency and cough and asthma, consumptive disease and shortness of breath, and no appetite. Ganoderma lucidum spores are ultrafine spores projected from pileus of Ganoderma lucidum during the mature stage, as germ cells of Ganoderma lucidum, containing all genetically active materials of Ganoderma lucidum. Modern pharmacological studies show that Ganoderma lucidum spores have anti-tumor and anti-inflammation activity and efficacy of improving immune regulation, reducing blood glucose, reducing blood lipids, anti-hypoxia tolerance, scavenging free radicals, etc. Ganoderma lucidum spore oil is a fat-soluble active substance obtained by making Ganoderma lucidum spores undergo wall-breaking and supercritical carbon dioxide extraction. Modern researches show that Ganoderma lucidum spore oil has anti-tumor activity and efficacy of enhancing immunity, protecting the liver, etc. It is generally believed in current researches that main effective ingredients of Ganoderma lucidum are Ganoderma lucidum triterpenoids, and researches on various efficacies of Ganoderma lucidum are also more focused on Ganoderma lucidum triterpenoids. Accordingly, the researchers usually seek for spore oil with a higher proportion of Ganoderma lucidum triterpenoids currently, wherein a content thereof can reach 10-30%. However, there have been no relevant reports for ingredient study and efficacy analysis on other components in the spore oil, such as the most abundant triglycerides. On the other hand, existing researches on the effect of Ganoderma lucidum in alleviating fatigue are also concentrated on alleviating physi