CN111632066A - Pharmaceutical composition for treating and/or preventing ovarian cancer and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating and/or preventing ovarian cancer and preparation method and application thereof Download PDFInfo
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- CN111632066A CN111632066A CN202010629114.8A CN202010629114A CN111632066A CN 111632066 A CN111632066 A CN 111632066A CN 202010629114 A CN202010629114 A CN 202010629114A CN 111632066 A CN111632066 A CN 111632066A
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/243—Platinum; Compounds thereof
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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Abstract
The invention provides a pharmaceutical composition for treating and/or preventing ovarian cancer, wherein the active ingredients of the composition comprise cisplatin and erlotinib, and the weight ratio of the cisplatin to the erlotinib is 1: 50-50: 1. the invention scientifically screens the proportion of cisplatin and the alendronic in the pharmaceutical composition, fully utilizes different anticancer principles and interaction of the two drugs, generates obvious synergistic interaction when the two drugs are used for treating ovarian cancer, greatly improves the treatment effect of the ovarian cancer, and improves the body deficiency symptom of a patient and the anticancer effect by adding icariin and reasonably screening the dosage of the icariin; secondly, the dosage of the medicine is reduced, and the medicine taking compliance of a patient is improved; thirdly, medical cost and cost burden of patients are reduced; and fourthly, the three active ingredients supplement each other internally and externally, so that the anticancer effect is comprehensively exerted, the toxic and side effects of chemotherapy are reduced, the life cycle of a patient is favorably prolonged, and the life quality of the patient is improved.
Description
Technical Field
The invention relates to the field of biological medicines, and particularly relates to a pharmaceutical composition for treating and/or preventing ovarian cancer, and a preparation method and application thereof.
Background
Ovarian cancer is one of the major malignancies of female genital 3, however, the mortality rate is the first of the gynecological malignancies. In recent years, the incidence of ovarian cancer has increased year by year. Ovarian cancer is hidden in early stage, often with abdominal metastasis before the onset of symptoms, and in the advanced stage when 60-70% of patients see the disease. The initial treatment of ovarian cancer is mainly surgery and assisted by chemotherapy, and is matched with radiotherapy, biological treatment and the like. Despite complete remission from primary surgery and chemotherapy, most advanced patients relapse in 2-3 years and eventually develop chemotherapy-resistant death.
Cisplatin is a metal platinum complex, and is one of the common chemotherapy drugs for resisting cancers at present. However, its treatment has the following limitations:
firstly, the curative effect is not ideal. The biological characteristics of tumor cells are different among different individuals, and the sensitivity of the tumor cells to chemotherapeutic drugs is different, so that the cisplatin has great uncertainty in the aspect of treatment effective rate. In order to obtain stable curative effect, the dosage of administration is usually required to be accurately controlled, which not only has high requirement on the operation level of medical personnel, but also has larger medical risk.
Secondly, the side effect is large. In the using process, cisplatin is easy to have serious adverse reactions such as nausea, vomiting, renal tubular injury, tinnitus caused by nerve damage and hearing loss, the treatment compliance of ovarian cancer patients is seriously influenced, nutrient substances are not sufficiently absorbed due to severe vomiting and poor appetite, the blood of the patients is mostly in a high-condensation state, and the risk of cancer cell far-end metastasis is increased.
Thirdly, the applicable population is limited. The toxic side effects of cisplatin make it unsuitable for patients with weakness, digestive tract malabsorption, renal insufficiency, and combination regimens with overlapping toxicities. Due to its strict limitations on the applicable population, a large number of patients lose the opportunity for cisplatin rescue.
Fourthly, the treatment cost is high, the cisplatin treatment cost is limited by economic conditions, the degree of the patient to cooperate with the treatment is poor, and partial families of the patient are difficult to bear the economic pressure and abandon the treatment.
Anaplastic Lymphoma Kinase (ALK), named for its discovery in Anaplastic Large Cell Lymphoma (ALCL), is a receptor tyrosine kinase, belonging to the insulin receptor superfamily, specifically expressed in adult brain tissue. ALK is expressed in a variety of tumors, such as diffuse large B-cell lymphoma, non-small cell lung cancer, neuroblastoma, ovarian cancer, inflammatory myofibroblastoma, etc., where gene rearrangement, point mutation and amplification occur, so the ALK gene has become a new target for anti-tumor therapy. Alletinib (alectinib) is an inhibitor of ALK (IC50 ═ 1.9 nmol. L)-1) And RET (IC50 ═ 4.8nmol · L-1) The tyrosine kinase inhibitor of (2) is found in non-clinical research, the Elletinib can inhibit the phosphorylation process of ALK and the activation of downstream signal proteins STAT3 and AKT mediated by ALK, and can reduce the survival rate of cell strains with ALK protein fusion, proliferation or mutation activation capacity, and the tyrosine kinase inhibitor of (3) is a potential drug for treating various cancers due to the ALK inhibition activity.
Icariin (ICA) is one of the main chemical components of epimedium herb, generally in light yellow color, and exists in the form of powder. Icariin has curative effects on improving cardiovascular system functions, regulating endocrine, enhancing immunity, resisting tumors and the like, wherein the anti-tumor effect is emphasized by numerous scholars at home and abroad, and the pharmacological mechanism of the icariin on the tumor resistance mainly shows the aspects of inhibiting tumor cell proliferation, promoting tumor cell apoptosis, inducing tumor cell differentiation, inhibiting tumor cell metastasis, reversing tumor cell immune escape and the like.
In conclusion, how to improve the effectiveness and safety of ovarian cancer treatment drugs and reduce the treatment cost has become a serious and urgent task for ovarian cancer prevention and treatment workers.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating and/or preventing ovarian cancer, wherein the active ingredients of the composition comprise cisplatin and alendronate, and the weight ratio of the cisplatin to the alendronate is 1: 50-50: 1.
in a preferred technical scheme of the invention, the weight ratio of the cisplatin to the alendronate is 1:10-10:1, preferably 2-6:1, and more preferably 2.8:1 or 5.6: 1.
In a preferred embodiment of the invention, the cisplatin and the alendronate are present in a fixed or free combination for simultaneous, sequential or separate administration in a medicament.
In a preferred technical scheme of the invention, the active ingredients of the composition further comprise icariin.
In a preferred technical scheme of the invention, the using amount of the icariin is 10-60% of the total weight of the active ingredients, preferably 10-30%, and more preferably 20%.
In a preferred embodiment of the present invention, the pharmaceutical composition further comprises a pharmaceutically acceptable carrier or excipient.
In a preferred embodiment of the present invention, the pharmaceutically acceptable carrier or excipient is selected from any one of excipients, diluents, fillers, binders, wetting agents, disintegrants, absorption enhancers, surfactants, preservatives, and flavoring agents, or a combination thereof.
The invention also aims to provide application of the pharmaceutical composition in preparing a medicament for preventing and/or treating ovarian cancer.
In a preferred embodiment of the present invention, the ovarian cancer is any one or a combination of ovarian epithelial cancer and ovarian tumor.
The invention also aims to provide the application of the icariin in preparing the ovarian cancer treatment synergist.
In a preferred technical scheme of the invention, the ovarian cancer treatment is combined medication of cisplatin and alendronate.
In a preferred technical scheme of the invention, the icariin synergy mode is any one or combination of the improvement of anti-ovarian cancer curative effect and the reduction of chemotherapy side effect.
In a preferred embodiment of the present invention, the chemotherapy side effect is selected from any one of digestive tract reaction, renal toxicity, bone marrow suppression, acoustic nerve damage, pancreatic injury, or a combination thereof.
It is another object of the present invention to provide a combination of pharmaceutical compositions for use in combination with other types of anti-ovarian cancer drugs.
In a preferred technical scheme of the invention, the other type of anti-ovarian cancer drug is any one or combination of carboplatin, paclitaxel, cyclophosphamide, vincristine, methotrexate, bleomycin, etoposide and doxorubicin.
In a preferred embodiment of the present invention, the composition is administered with an effective amount of the pharmaceutical composition according to the disease, severity, complications, age, sex, medical history of the patient, and the like, preferably at least once daily.
Unless otherwise indicated, when the present invention relates to percentages between liquids, said percentages are volume/volume percentages; the invention relates to the percentage between liquid and solid, said percentage being volume/weight percentage; the invention relates to the percentages between solid and liquid, said percentages being weight/volume percentages; the balance being weight/weight percent.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention scientifically screens the proportion of the cisplatin and the alendronic in the pharmaceutical composition, fully utilizes different anticancer principles and interaction of the two medicines, generates obvious synergistic interaction when the two medicines are used for treating ovarian cancer, greatly improves the treatment effect of the ovarian cancer, makes up the defect that patients with digestive tract malabsorption and renal insufficiency cannot use the cisplatin for anticancer, enriches the treatment way of the ovarian cancer, and is beneficial to improving the anticancer effectiveness and safety.
2. According to the invention, icariin is further added and the dosage of the icariin is reasonably screened, so that firstly, the body deficiency symptoms of patients are improved and the anti-cancer effect is improved by regulating the immune system; secondly, the dosage of the medicine is reduced, and the medicine taking compliance of a patient is improved; thirdly, medical cost and cost burden of patients are reduced; and fourthly, the three active ingredients supplement each other internally and externally, so that the anticancer effect is comprehensively exerted, the toxic and side effects of chemotherapy are reduced, the life cycle of a patient is favorably prolonged, and the life quality of the patient is improved.
3. The composition can be used together with other medicines, has flexible administration mode, can be used by oral administration or injection, and has wide applicable population and slight adverse reaction.
Detailed Description
The present invention will be described in detail with reference to examples, which are provided only for illustrating the technical solutions of the present invention and are not intended to limit the spirit of the present invention.
Example 1Preparation of the pharmaceutical composition of the invention
Cisplatin and alendronate were mixed in a container according to the formulation of table 1, and stirred at high speed if necessary to obtain a homogeneous and stable pharmaceutical composition 1-4.
TABLE 1 pharmaceutical compositions 1-4 formulations
| Numbering | Cis-platinum (mg) | Ailetini (mg) |
| Pharmaceutical composition 1 | 2.8 | 0.1 |
| Pharmaceutical composition 2 | 2.8 | 0.5 |
| Pharmaceutical composition 3 | 2.8 | 1 |
| Pharmaceutical composition 4 | 2.8 | 2 |
Note: cisplatin was purchased from the eastern Qilu pharmaceutical works; elotinib was purchased from roche.
Example 2Study on A2780 cell proliferation inhibitory Effect
(1) Experimental materials:
a2780 (human ovarian carcinoma cells) cell line was purchased from Shanghai Zeye Biotech Co., Ltd; example 1 pharmaceutical compositions 1-4.
(2) The experimental method comprises the following steps:
taking A2780 cells in logarithmic growth phase, centrifuging to obtain single cell suspension, and collecting the single cell suspension at a concentration of 0.5 × 10 per well5Perml was seeded in 96-well plates in 200. mu.L per well volume. After inoculation, the culture plate is put into an incubator with 37 ℃ and 5% CO2 for culture for 24h until the cells are attached to the wall completely.
Experimental groups (cis-platinum group, alendronic group, pharmaceutical composition group) and control group (DMSO) were set. DMSO as dilution solvent, cis-platinum group: the concentration of cisplatin is 280 mg/L; groups 1-4 of Alletinib: the concentration of the Aleptinib is 10mg/L, 50mg/L, 100mg/L and 200 mg/L; pharmaceutical composition group: cisplatin and alendronate were weighed according to the formulation of table 1 and dissolved in 10ml of ldmso as to be used as pharmaceutical composition groups 1 to 4.
And (3) adding 10 mu L of drug-containing solution to each experimental group to treat A2780 cells, adding the same amount of DMSO to a control group, observing the influence on the cell activity after 48 hours, measuring the absorbance value of each hole by using a microplate reader, recording the result, and calculating the cell survival rate and the drug interaction CI value of each group.
Cell survival (%) × (experimental OD value-blank OD value)/(control OD value-blank OD value) × 100%.
Evaluation of drug interaction: the method of "Jinzheng-average" is used to determine whether the two drugs have synergistic effect. Q value, drug interaction index (CI) calculated by the golden mean method: q ═ EAB/(EA+EB-EA×EB). Wherein E isA，EBEfficiency of the two drugs acting alone, EABFor combined efficiency, Q is greater than 1.05 synergistic, less than 0.95 antagonistic, and between 0.95 and 1.05 additive.
(3) The experimental results are as follows: cell viability and CI values are shown in table 2.
TABLE 2 cell viability and CI values
The results in table 2 show that the inhibition effect of cisplatin combined with erlotinib on a2780 cells is more excellent than that of single drug, which indicates that cisplatin combined with erlotinib can enhance the sensitivity of tumor cells to chemotherapy. When the two drugs are administrated simultaneously, the Q value is more than 1.05 under a certain dosage proportion, and the compound has good synergistic effect on the aspect of inhibiting A2780 cells.
Example 3Effect of ovarian tumor quality
1. Experimental materials:
the healthy Kunming mouse has 18-22g of male and female half, and is provided by the laboratory animal center of Nanjing university of traditional Chinese medicine.
A2780 (ovarian cancer cell) cell line was purchased from Shanghai ze leaf Biotech, Inc.; cisplatin was purchased from the eastern Qilu pharmaceutical works; elotinib was purchased from roche; example 1 pharmaceutical composition 2 (cisplatin + erlotinib); icariin (available from south-bound Feiyu Biotech, Inc.).
2. The experimental method comprises the following steps:
mice were randomly divided by body weight into a control group, a model group, a cis-platinum group, an aillitinib group, an icariin group, a pharmaceutical composition 2 group, a 90% pharmaceutical composition 2+ 10% icariin group (weight ratio), an 80% pharmaceutical composition 2+ 20% icariin group (weight ratio), and a 60% pharmaceutical composition 2+ 40% icariin group, each group containing 10 mice.
Culturing human ovarian cancer cell A2780, and preparing 3 x 10 with sterile physiological saline7one/mL cell suspension, 20. mu.L/mouse injected subcutaneously in ovary. Tumor size was measured daily and molding was completed when the subcutaneous tumor tissue grew to 1.2 x 1.2 cm.
Mice in each group were gavaged at 0.5 mL/time, and control groups were given an equal volume of distilled water 2 times a day for 10 consecutive days during which the mice were weighed daily. On day 11, each group of mice was sacrificed, tumors were detached, weighed, and the tumor inhibition rate and drug interaction CI value of each group were calculated.
3. Evaluation criteria:
tumor inhibition (%). 100% (1-mean tumor weight in experimental group/mean tumor weight in control group).
4. The results are shown in Table 3.
TABLE 3 Effect of the pharmaceutical compositions of the present invention on tumor weight of ovarian tumors
| Group of | The administration dose is mg/kg | Tumor inhibition rate |
| Control group | - | - |
| Model set | - | - |
| Cis platinum group | 25 | 37.92％# |
| Alletinib group | 25 | 40.56％# |
| Icariin group | 25 | 19.19％ |
| Pharmaceutical composition 2 group | 25 | 58.38％# |
| 90% pharmaceutical composition 2+ 10% icariin group | 25 | 70.48％## |
| 80% medicinal composition 2+ 20% icariin group | 25 | 79.54％## |
| 60% medicinal composition, 2+ 40% icariin group | 25 | 60.93％# |
Note: in comparison with the set of models,#P<0.05，##P<0.01。
the results in table 3 show that cisplatin and alexanib can reduce the tumor weight of mice, but the tumor weight of the mice can be obviously reduced after icariin is added, and when the icariin dosage is about 20%, the anti-tumor curative effect is maximized, so that the cisplatin and alexanib combined drug has high scientific research value and good application prospect.
The above description of the specific embodiments of the present invention is not intended to limit the present invention, and those skilled in the art may make various changes and modifications according to the present invention without departing from the spirit of the present invention, which is defined in the appended claims.
Claims (10)
1. A pharmaceutical composition for treating and/or preventing ovarian cancer, wherein the active ingredients of the composition comprise cisplatin and alendronate, and the weight ratio of the cisplatin to the alendronate is 1: 50-50: 1, preferably, the weight ratio of the cisplatin to the alendronate is 1:10-10:1, preferably 2-6:1, more preferably 2.8:1 or 5.6: 1.
2. The pharmaceutical composition according to claim 1, wherein cisplatin and erlotinib are present in fixed or free combination for simultaneous, sequential or separate administration in a medicament.
3. The pharmaceutical composition according to any one of claims 1-2, the active ingredient of the composition further comprising icariin.
4. The pharmaceutical composition according to claim 3, wherein the icariin is used in an amount of 20-50%, preferably 25-40%, more preferably 30% by weight of the total weight of the active ingredients.
5. The pharmaceutical composition of any one of claims 1-4, further comprising a pharmaceutically acceptable carrier or excipient selected from any one of excipients, diluents, fillers, binders, wetting agents, disintegrants, absorption enhancers, surfactants, preservatives, flavoring agents, or combinations thereof.
6. Use of a pharmaceutical composition according to any one of claims 1 to 5 for the preparation of a medicament for the prevention and/or treatment of ovarian cancer.
7. Application of icariin in preparation of ovarian cancer treatment synergist.
8. The use according to claim 7, wherein the ovarian cancer treatment is a combination of cisplatin and alendronate.
9. The use according to any one of claims 7-8, wherein the icariin is administered in a synergistic manner selected from any one or a combination of enhancing anti-ovarian cancer efficacy, reducing side effects of chemotherapy selected from any one or a combination of gut reaction, nephrotoxicity, bone marrow suppression, acoustic nerve damage, pancreatic injury, and ameliorating ovarian cancer symptoms.
10. A combination of a pharmaceutical composition according to any one of claims 1-6, for use in combination with another type of anti-ovarian cancer drug selected from any one of carboplatin, paclitaxel, cyclophosphamide, vincristine, methotrexate, bleomycin, etoposide, doxorubicin, or a combination thereof.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104945360A (en) * | 2015-06-25 | 2015-09-30 | 云南中烟工业有限责任公司 | Preparation method and application of phenylpropanoid compound in tobacco |
| CN108440620A (en) * | 2018-04-26 | 2018-08-24 | 赣州禾绿康健生物技术有限公司 | A kind of preparation method of high-content icariin extract |
| KR20180111077A (en) * | 2017-03-31 | 2018-10-11 | 재단법인 아산사회복지재단 | Composition for treating cancer drug resistance including the combination of aspirin and multikinase inhibitor |
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- 2020-07-03 CN CN202010629114.8A patent/CN111632066A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104945360A (en) * | 2015-06-25 | 2015-09-30 | 云南中烟工业有限责任公司 | Preparation method and application of phenylpropanoid compound in tobacco |
| KR20180111077A (en) * | 2017-03-31 | 2018-10-11 | 재단법인 아산사회복지재단 | Composition for treating cancer drug resistance including the combination of aspirin and multikinase inhibitor |
| CN108440620A (en) * | 2018-04-26 | 2018-08-24 | 赣州禾绿康健生物技术有限公司 | A kind of preparation method of high-content icariin extract |
Non-Patent Citations (1)
| Title |
|---|
| 马丁丁: "淫羊藿素联合顺铂抗非小细胞肺癌作用机制研究", 《昆明医科大学硕士学位论文》 * |
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