CN119055651A - A combination drug for treating cancer - Google Patents
A combination drug for treating cancer Download PDFInfo
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- CN119055651A CN119055651A CN202310642551.7A CN202310642551A CN119055651A CN 119055651 A CN119055651 A CN 119055651A CN 202310642551 A CN202310642551 A CN 202310642551A CN 119055651 A CN119055651 A CN 119055651A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/5685—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone having an oxo group in position 17, e.g. androsterone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
本发明涉及一种治疗癌症的联合用药物，所述联合用药物包含β榄香烯，所述联合用药物为单一的复方制剂或两种单独的制剂的组合，该联用药物有效实现了药物之间的协同。The present invention relates to a combined drug for treating cancer, wherein the combined drug comprises beta-elemene and is a single compound preparation or a combination of two separate preparations, and the combined drug effectively realizes synergy between drugs.
Description
Technical Field
The invention relates to a combined medicine of beta elemene for treating cancers, and relates to the field of medicines.
Background
Cancer is the main disease threatening human health at present, about 180 ten thousand patients in China develop every year, and the incidence rate rises year by year. At present, cancer treatment mainly comprises surgery, chemotherapy and radiotherapy. However, the large number of clinical therapeutic drugs used in the present stage still have the problems of large systemic toxic and side effects, drug resistance and weak selection, and in recent years, a large number of clinical and experimental researches prove that the traditional Chinese medicine and the combined drug therapy have special effects in the aspects of tumor prevention and treatment and rehabilitation, and have become the focus of attention.
Beta elemene is the main component of zedoary turmeric oil and citronella oil, and has been widely used for treating cancer. It has been reported that elemene can be used together with antitumor drugs such as gefitinib and celecoxib to improve the effect of the substances on the growth inhibition activity of tumor cells.
In order to meet the therapeutic demands of cancer patients as soon as possible, there is a need to develop more clinically valuable combination dosage forms and modes of administration.
Disclosure of Invention
The invention provides a combined medicament for treating cancers, which comprises beta elemene and a second medicament, wherein the combined medicament is a single compound preparation or a combination of two independent preparations, and the second medicament is selected from irinotecan, everolimus and exemestane.
Further, the second drug is irinotecan, the molar ratio of irinotecan to beta elemene is less than 1:4, preferably less than 1:7, preferably 1:1000-1:4, preferably 1:1000-1:7, preferably 1:1000-1:28, preferably 1:1000-1:55, preferably 1:1000-1:111, preferably 1:1000-1:444, preferably 1:444-1:4, preferably 1:444-1:7, preferably 1:444-1:28, preferably 1:444-1:55, preferably 1:444-1:111, preferably 1:111-1:4, preferably 1:111-1:7, preferably 1:111-1:28, preferably 1:111-1:55, preferably 1:55-1:4, preferably 1:55-1:7, preferably 1:55-1:28, preferably 1:28-1:4, preferably 1:28-1:7, preferably 1:7-1:7.
Further, the molar ratio of irinotecan to beta elemene is 1:1000, 1:444, 1:111, 1:55, 1:14, 1:10, 1:7.
Further, the second drug is everolimus, the molar ratio of everolimus to beta elemene is 1:1000000-1:0.1, preferably 1:1000000-1:0.5, preferably 1:500000-1:100, preferably 1:500000-1:1000, preferably 1:500000-1:5000, preferably 1:500000-1:10000, preferably 1:500000-1:20000, preferably 1:500000-1:31250, preferably 1:500000-1:125000, preferably 1:500000-1:250000, preferably 1:250000-1:0.5, preferably 1:250000-1:100, preferably 1:250000-1:1000, preferably 1:250000-1:5000, preferably 1:250000-1:10000, preferably 1:250000-1:20000, preferably 1:000-1:31250, preferably 1:125000-1:125000, preferably 1:250000-1:100, preferably 1:125000-1:1000, preferably 1:125000-1:5000, preferably 1:125000-1:10000, preferably 1:125000-1:20000, preferably 1:125000-1:31250, preferably 1:31250-1:0.5, preferably 1:31250-1:100, preferably 1:31250-1:1000, preferably 1:31250-1:5000, preferably 1:31250-1:10000, preferably 1:31250-1:20000, preferably 1:20000-1:0.5, preferably 1:20000-1:100, preferably 1:20000-1:1000, preferably 1:20000-1:5000, preferably 1:20000-1:10000, preferably 1:10000-1:0.5, preferably 1:10000-1:100, preferably 1:10000-1:5000, preferably 1:5000-1:0.5, preferably 1:5000-1:5000, preferably 1:5000-1:1000, preferably 1:1000-1:0.5, preferably 1:1000-1:100, preferably 1:1000.0.5.
Further, the mole ratio of everolimus to beta elemene is as follows 1:0.5、1:100、1:1000、1:5000、1:10000、1:20000、1:25000、1:31000、1:31250、1:40000、1:50000、1:60000、1:125000、1:250000、1:300000、1:400000、1:500000.
Further, the second drug is exemestane, and the molar ratio of exemestane to beta elemene is 1:0.1-1:1000, preferably 1:7-1:14, preferably 1:7-1:111, preferably 1:7-1:150, preferably 1:14-1:111, preferably 1:14-1:150, preferably 1:14-1:1000, preferably 1:111-1:150, preferably 1:111-1:1000, preferably 1:150-1:1000.
Further, the mole ratio of exemestane to beta elemene is 1:10000, 1:1000, 1:150, 1:111, 1:14, 1:7, 1:1, 1:0.1.
The invention provides a pharmaceutical composition for treating cancers, wherein the active ingredient of the pharmaceutical composition comprises beta elemene and a second medicament, and the second medicament is selected from irinotecan, everolimus and exemestane.
Further, the active ingredients of the pharmaceutical composition consist of beta elemene and irinotecan.
Further, the molar ratio of irinotecan to beta elemene is less than 1:4, preferably less than 1:7, preferably 1:1000-1:4, preferably 1:1000-1:7, preferably 1:1000-1:28, preferably 1:1000-1:55, preferably 1:1000-1:111, preferably 1:1000-1:444, preferably 1:444-1:4, preferably 1:444-1:7, preferably 1:444-1:28, preferably 1:444-1:55, preferably 1:444-1:111, preferably 1:111-1:4, preferably 1:111-1:7, preferably 1:111-1:28, preferably 1:111-1:55, preferably 1:55-1:4, preferably 1:55-1:7, preferably 1:55-1:28, preferably 1:28-1:4, preferably 1:28-1:7, preferably 1:7-1:4.
Further, the molar ratio of irinotecan to beta elemene is 1:1000, 1:444, 1:111, 1:55, 1:14, 1:10, 1:7.
Further, the active ingredients of the pharmaceutical composition consist of beta elemene and everolimus.
Further, the molar ratio of everolimus to beta elemene is 1:1000000-1:0.1, preferably 1:1000000-1:0.5, preferably 1:500000-1:100, preferably 1:500000-1:1000, preferably 1:500000-1:5000, preferably 1:500000-1:10000, preferably 1:500000-1:20000, preferably 1:500000-1:31250, preferably 1:500000-1:125000, preferably 1:500000-1:250000, preferably 1:250000-1:0.5, preferably 1:250000-1:100, preferably 1:250000-1:1000, preferably 1:250000-1:5000, preferably 1:250000-1:10000, preferably 1:250000-1:20000, preferably 1:31250, preferably 1:000-1:125000, preferably 1:125000-1:250000, preferably 1:1250.5-1:100, preferably 1:125000-1:1000, preferably 1:125000-1:5000, preferably 1:125000-1:10000, preferably 1:125000-1:20000, preferably 1:125000-1:31250, preferably 1:31250-1:0.5, preferably 1:31250-1:100, preferably 1:31250-1:1000, preferably 1:31250-1:5000, preferably 1:31250-1:10000, preferably 1:31250-1:20000, preferably 1:20000-1:0.5, preferably 1:20000-1:100, preferably 1:20000-1:1000, preferably 1:20000-1:5000, preferably 1:20000-1:10000, preferably 1:10000-1:0.5, preferably 1:10000-1:100, preferably 1:10000-1:5000, preferably 1:5000-1:0.5, preferably 1:5000-1:5000, preferably 1:5000-1:1000, preferably 1:1000-1:0.5, preferably 1:1000-1:100, preferably 1:1000.0.5.
Further, the mole ratio of everolimus to beta elemene is as follows 1:0.5、1:100、1:1000、1:5000、1:10000、1:20000、1:25000、1:31000、1:31250、1:40000、1:50000、1:60000、1:125000、1:250000、1:300000、1:400000、1:500000.
Further, the active ingredients of the pharmaceutical composition consist of beta elemene and exemestane.
Further, the molar ratio of exemestane to beta elemene is 1:0.1-1:1000, preferably 1:7-1:14, preferably 1:7-1:111, preferably 1:7-1:150, preferably 1:14-1:111, preferably 1:14-1:150, preferably 1:14-1:1000, preferably 1:111-1:150, preferably 1:111-1:1000, preferably 1:150-1:1000.
Further, the mole ratio of exemestane to beta elemene is 1:10000, 1:1000, 1:150, 1:111, 1:14, 1:7, 1:1, 1:0.1.
Further, the invention provides a pharmaceutical composition for treating cancer, which comprises the combination drug, and the pharmaceutical composition comprises pharmaceutically acceptable pharmaceutical auxiliary materials, wherein the auxiliary materials comprise, but are not limited to, oil for injection, a carrier, a filling agent, a disintegrating agent, an adhesive, a lyoprotectant, a PH regulator, a preservative, an antioxidant, a wetting agent and the like. The pharmaceutical composition can be prepared into a preparation, and the preparation can be one or more of tablets, capsules, pills, mixture, gel, ointment, granules, powder, electuary, medicinal granules, pills, oral liquid, dripping pills, injection or injection, or any other dosage forms.
Further, the invention provides application of the composition or the medicine in preparing a combined medicine for treating cancers.
Further, the cancer is breast cancer, ovarian cancer, small cell lung cancer, non-small cell lung cancer (NSCLC), malignant melanoma, colorectal cancer, malignant pleural mesothelioma, pancreatic cancer, head and neck cancer, gastric cell cancer, bladder cancer, bone cancer, esophageal cancer, brain tumor, liver cancer, cervical cancer, cancerous chest, ascites, preferably the cancer is breast cancer, renal cell cancer.
Examples of the embodiments
The technical scheme of the invention is further elaborated in the following description with reference to specific examples of implementation, but the implementation of the invention is not limited to this. Equivalent substitutions, combinations, improvements or modifications of the embodiments according to the present invention will occur to those skilled in the art based on the description of the present invention.
Unless specifically stated otherwise, the reagents, methods and apparatus employed in the present invention are those conventional in the art. The reagents and materials used in the following examples are commercially available unless otherwise specified.
Examples 1-3 were performed using the following cell culture methods:
cell culture, namely inoculating the human breast cancer MCF7 into a sterile culture flask, adding a proper amount of EMEM+2mM Glu+1%NEAA+10%FBS culture medium, and culturing in an incubator with 37 ℃ and 5% CO2 and saturated humidity. The cells are grown in a single-layer adherence manner, and are passaged for 1 time every 2-3 days. And (3) during passage, digesting and culturing the cells for 2-4 min by using 0.25% trypsin plus 0.02% EDTA, sucking the culture solution by using a suction pipe, blowing the cells to prepare cell suspension, and then inoculating according to the required concentration.
Examples 1-4 used the following calculation method:
1) Judging the combined drug effect of the double drugs:
The determination was carried out by the golden average q value method (see literature: dai Tijun. Quantitative analysis of concomitant medication [ J ]. Chinese pharmacological bulletins, 1998 (5): 479-480.). q=p (A+B)/(PA+PB-PA×PB). Wherein P A、PB and P A+B are respectively the inhibition rates of the beta elemene group, the second medicament group and the two medicament combination group. q <1 indicates antagonism upon combination of the two drugs, q >1 indicates synergy upon combination of the two drugs, and q=1 indicates additive effect upon combination of the two drugs.
Example 1
Beta elemene and exemestane are divided into groups 1:2690uM beta elemene, groups 2:403.5uM beta elemene, groups 3:300uM beta elemene, groups 4:37.5uM beta elemene, groups 5:18.75uM beta elemene and groups 6:2.69uM exemestane;
Group 7:2690uM beta elemene+2.69 uM exemestane, group 8:403.5uM beta elemene+2.69 uM exemestane, group 9:300uM beta elemene+2.69 uM exemestane, group 10:37.5uM beta elemene+2.69 uM exemestane, group 11:18.75uM beta elemene+2.69 uM exemestane.
All groups described above used 0.5% dmso as vehicle.
The method comprises preparing MCF7 cells in logarithmic growth phase into single cell suspension according to passage method, counting, and regulating cell concentration to 3.34 x 10≡4/mL. The cell suspension was inoculated into 96-well cell culture plates, and 90. Mu.L of the cell suspension was added to each well. Wells without cell culture fluid were taken as blank zeroes. After the plates were placed in a 37℃and 5% CO2 incubator for 12 hours of adherent culture, groups 7-11 were each supplemented with 10. Mu.L (5. Mu.L of beta. Elemene and 5. Mu.L of exemestane at different concentrations), groups 1-5 were supplemented with 5. Mu.L of beta. Elemene+5. Mu.L of 5% DMSO medium, and group 6 was supplemented with 5. Mu.L of exemestane+5. Mu.L of 5% DMSO medium, with vehicle control being supplemented with 10. Mu.L of 5% DMSO medium. After each group was set with multiple wells and cultured for 72 hours, 50. Mu.L of CellTiter-Glo TM reagent was added to each well, and the wells were kept away from light, 300rpm/min,3min, and left to stand for 10min, and then the fluorescence signal value of each well was measured using a fully automatic microplate reader.
The results are shown in Table 1.
Example 2
The beta elemene and irinotecan are divided into:
Group 1:300uM elemene, group 2:150uM elemene, group 3:75uM elemene, group 4:18.75uM elemene, group 5:10.76uM elemene, group 6:2.69uM irinotecan
Group 7:300uM elemene+2.69 uM irinotecan, group 8:150uM elemene+2.69 uM irinotecan, group 9:75uM elemene+2.69 uM irinotecan, group 10:18.75uM+2.69uM irinotecan, group 11:10.76uM elemene+2.69 uM irinotecan
All groups described above used 0.5% dmso as vehicle.
The method comprises preparing MCF7 cells in logarithmic growth phase into single cell suspension according to passage method, counting, and regulating cell concentration to 3.34 x 10≡4/mL. The cell suspension was inoculated into 96-well cell culture plates, and 90. Mu.L of the cell suspension was added to each well. Wells without cell culture fluid were taken as blank zeroes. After the plates were placed in a 37℃incubator with 5% CO2 for 12 hours of adherent culture, groups 7-11 were each supplemented with 10. Mu.L (5. Mu.L of beta. Elemene and 5. Mu.L of irinotecan) and groups 1-5 were each supplemented with 5. Mu.L of beta. Elemene+5. Mu.L of 5% DMSO medium, and group 6 was supplemented with 5. Mu.L of irinotecan+5. Mu.L of 5% DMSO medium, with vehicle control of 10. Mu.L of 5% DMSO medium. After each group was set with multiple wells and cultured for 72 hours, 50. Mu.L of CellTiter-Glo TM reagent was added to each well, and the wells were kept away from light, 300rpm/min,3min, and left to stand for 10min, and then the fluorescence signal value of each well was measured using a fully automatic microplate reader.
The experimental results are shown in table 2:
Example 3
The beta elemene and everolimus are divided into:
group 1:500uM beta elemene, group 2:250uM beta elemene, group 3:125uM beta elemene, group 4:31.25uM beta elemene, group 5:20uM beta elemene, group 6:1nM everolimus.
Group 7:500uM beta elemene+1 nM everolimus, group 8:250uM beta elemene+1 nM everolimus, group 9:125uM beta elemene+1 nM everolimus, group 10:31.25uM beta elemene+1 nM everolimus, group 11:20uM beta elemene+1 nM everolimus.
All groups described above used 0.5% dmso as vehicle.
The method comprises preparing MCF7 cells in logarithmic growth phase into single cell suspension according to passage method, counting, and regulating cell concentration to 3.34 x 10≡4/mL. The cell suspension was inoculated into 96-well cell culture plates, and 90. Mu.L of the cell suspension was added to each well. Wells without cell culture fluid were taken as blank zeroes. After the plates were placed in a 37℃incubator with 5% CO2 for 12 hours of adherent culture, 10. Mu.L (5. Mu.L of beta. Elemene and 5. Mu.L of everolimus) was added to each of groups 7-11, 5. Mu.L of beta. Elemene+5. Mu.L of 5% DMSO medium was added to each of groups 1-5, and 5. Mu.L of everolimus+5. Mu.L of 5% DMSO medium was added to each of groups 6, with vehicle control of 10. Mu.L of 5% DMSO medium. After each group was set with multiple wells and cultured for 72 hours, 50. Mu.L of CellTiter-Glo TM reagent was added to each well, and the wells were kept away from light, 300rpm/min,3min, and left to stand for 10min, and then the fluorescence signal value of each well was measured using a fully automatic microplate reader.
The experimental results are shown in table 3:
Example 4
The beta elemene and everolimus are divided into:
Group 1:500uM beta elemene, group 2:250uM beta elemene, group 3:125uM beta elemene, group 4:31.25uM beta elemene, group 5:20uM beta elemene, group 6:10uM beta elemene, group 7:5uM beta elemene, group 8:1uM beta elemene, group 9:0.1uM beta elemene, group 10:0.0005uM beta elemene, group 11:1nM everolimus;
500uM beta elemene+1 nM everolimus, 13:250uM beta elemene+1 nM everolimus, 14:125uM beta elemene+1 nM everolimus, 15:31.25uM beta elemene+1 nM everolimus, 16:20uM beta elemene+1 nM everolimus, 17:10uM beta elemene+1 nM everolimus, 18:5uM beta elemene+1 nM everolimus, 19:1uM beta elemene+1 nM everolimus, 20:0.1uM beta elemene+1 nM everolimus, 21:0.0005uM beta elemene+1 nM everolimus.
All groups described above used 0.5% dmso as vehicle.
Cell culture method comprises inoculating human renal cell carcinoma SK-NEP-1 into a sterile culture flask, adding appropriate amount of McCoy's 5a+15% FBS culture medium, and culturing in incubator at 37deg.C, 5% CO2 and saturated humidity. The cells are grown in a single-layer adherence manner, and are passaged for 1 time every 2-3 days. And (3) during passage, digesting and culturing the cells for 2-4 min by using 0.25% trypsin plus 0.02% EDTA, sucking the culture solution by using a suction pipe, blowing the cells to prepare cell suspension, and then inoculating according to the required concentration.
The method comprises preparing SK-NEP-1 cells in logarithmic growth phase into single cell suspension according to passage method, counting, and regulating cell concentration to 5.56×10≡4. The cell suspension was inoculated into 96-well cell culture plates, and 90. Mu.L of the cell suspension was added to each well. Wells without cell culture fluid were taken as blank zeroes. After placing the plates in a 37 ℃ and 5% CO2 incubator for 12 hours of adherent culture, 10 μl (5 μl of different concentrations of beta elemene and 5 μl of everolimus) was added to each of groups 12-21, 5 μl of different concentrations of beta elemene +5 μl of 5% DMSO medium was added to each of groups 1-10, 5 μl of everolimus +5 μl of 5% DMSO medium was added to group 11, and 10 μl of 5% DMSO medium was added to each of the vehicle control groups. After each group was set with multiple wells and cultured for 72 hours, 50. Mu.L of CellTiter-Glo TM reagent was added to each well, and the wells were kept away from light, 300rpm/min,3min, and left to stand for 10min, and then the fluorescence signal value of each well was measured using a fully automatic microplate reader.
The experimental results are shown in table 4:
Claims (9)
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| WO2025149017A1 (en) * | 2024-01-11 | 2025-07-17 | 四川弘合生物科技有限公司 | Drug containing elemene and kinase inhibitor |
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