CN113350370A - Application of polyethylene glycol in preventing and/or treating tumor - Google Patents
Application of polyethylene glycol in preventing and/or treating tumor Download PDFInfo
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- CN113350370A CN113350370A CN202110768198.8A CN202110768198A CN113350370A CN 113350370 A CN113350370 A CN 113350370A CN 202110768198 A CN202110768198 A CN 202110768198A CN 113350370 A CN113350370 A CN 113350370A
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Abstract
The invention discloses a pharmaceutical composition capable of preventing and/or treating tumors, wherein the active ingredient of the pharmaceutical composition is polyethylene glycol or pharmaceutically acceptable salts thereof. The invention discovers that PEG can inhibit the proliferation of tumor cells in spontaneous tumor animal models through an oral administration way, and particularly PEG400 can obviously inhibit the number of spontaneous mastadenomas in SPF SD rats. This shows that PEG has the function of reducing the natural incidence of tumor, and provides a theoretical basis for the application of PEG in the aspect of treating tumor in future.
Description
Technical Field
The invention belongs to the technical field of tumor treatment, and particularly relates to application of polyethylene glycol in preventing and/or treating tumors.
Background
The tumor is a new organism formed by that certain cells of local tissues lose normal regulation and control on the growth of the local tissues at the gene level under the action of various carcinogenic factors, so that the local tissues are clonally abnormally proliferated. It is generally accepted that tumor cells are monoclonal, i.e., all tumor cells in a tumor are progeny of a mutated cell. Tumors are generally classified into two broad categories, benign and malignant. Benign tumors are commonly referred to as "tumors", malignant tumors from epithelial tissue as "carcinomas", and from mesenchymal tissue as "sarcomas". Certain such malignant tumors may also be referred to as "tumors" or "diseases," such as malignant lymphoma, seminoma, leukemia, hodgkin's disease, and the like. All malignant tumors are customarily known as cancers or carcinomas. The mechanisms of tumor development are complex and diverse, but in general, are caused by long-term accumulation of multiple factors. Currently, tumors (including benign tumors and malignant tumors) have an increasing impact on the health (including mental health) of the human body.
PEG (polyethylene glycol) is a high molecular polymer with the chemical formula of HO (CH)2CH2O)nH has the advantages of no toxicity, no immunogenicity, no antigenicity, good water solubility and the like, and is one of the most common polymer materials at present. Has wide application in the pharmaceutical, cosmetic, food processing and other industries. Among them, PEG has been used for over 20 years as an important pharmaceutical adjuvant. PEGylation modifications alter the physicochemical properties of the drug, including conformation, electrostatic binding, hydrophobicity, and the like. These physical and chemical changes increase the in vivo retention time of the drug, improve the half-life of plasma, prolong the absorption time, and also affect the binding affinity of the drug with cell receptors, improving the tumor targeting. The medicine modified by PEG can reduce the administration frequency, improve the curative effect, improve the tolerance, and reduce the severity and the incidence rate of adverse events. Meanwhile, PEG can also increase the solubility and stability of protein, and is also beneficial to the production and storage of the medicine. Therefore, PEG is often used as a drug delivery and drug modification technology, and can be directly coupled with a drug or attached to the surface of the drug and encapsulated in a nano material. The molecular weight of PEG used for drug modification ranges from 20KD to 400 KD. PEG has good safety, and the PEG400 with high oral dose can cause mild diarrhea, besides, PEG has no definite known pharmaceutical effect. At present, no research report shows that PEG has the function of reducing the natural occurrence rate of tumors.
Disclosure of Invention
The present invention has been made in an effort to provide a pharmaceutical composition for preventing and/or treating tumors, and in order to achieve the above objects, the present invention provides a pharmaceutical composition comprising polyethylene glycol or a pharmaceutically acceptable salt thereof as an active ingredient, which can reduce the incidence of spontaneous tumors.
In a first aspect, the present invention provides the use of polyethylene glycol or a pharmaceutically acceptable salt thereof in any one of:
(1) preventing and/or treating tumors;
(2) preparing a product for preventing and/or treating tumors;
(3) inhibiting tumor cell proliferation;
(4) preparing the inhibitor for tumor cell proliferation.
In certain embodiments, the tumor comprises a benign tumor and a malignant tumor. Such benign tumors include, but are not limited to, mammary fibroids, cysts, lipomas, gallbladder polyps, nodules, and the like; the malignant tumor includes but is not limited to lung cancer, breast cancer, colorectal cancer, liver cancer, brain cancer, bone cancer, esophageal cancer, thyroid cancer, pancreatic cancer, endometrial cancer, ovarian cancer and cervical cancer.
In certain embodiments, the polyethylene glycol has a molecular weight of 100-.
In certain embodiments, the polyethylene glycol is selected from one or more of PEG200, PEG400, PEG 600.
In a second aspect, the present invention provides a pharmaceutical composition, said product having any one of the following uses:
(1) preventing and/or treating tumors;
(2) preparing a product for preventing and/or treating tumors;
(3) inhibiting tumor cell proliferation;
(4) preparing an inhibitor of tumor cell proliferation;
the pharmaceutical composition comprises the following components:
(a) the active ingredient is the polyethylene glycol or the pharmaceutically acceptable salt thereof according to the first aspect of the invention; and (b) a pharmaceutically acceptable carrier.
In certain embodiments, the pharmaceutical composition further comprises other agents for preventing and/or treating tumors.
In certain embodiments, the pharmaceutical composition comprises 0.001-99 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, preferably 0.1-90 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, and preferably 1-80 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, based on the total weight of the composition.
In certain embodiments, the pharmaceutical composition is in a form selected from: tablets, capsules, granules, suspensions, pills, solutions, syrups, or injections.
In certain embodiments, the polyethylene glycol has a molecular weight of 100-.
In certain embodiments, the polyethylene glycol is selected from one or more of PEG200, PEG400, PEG 600.
In a third aspect, the present invention also provides an in vitro method for inhibiting tumor, comprising administering polyethylene glycol or a pharmaceutically acceptable salt thereof as an active ingredient for inhibiting tumor cell proliferation to a subject in need of inhibition of tumor cell proliferation.
In certain embodiments, the polyethylene glycol has a molecular weight of 100-.
In certain embodiments, the polyethylene glycol is selected from one or more of PEG200, PEG400, PEG 600.
In certain embodiments, the polyethylene glycol is administered at a dose of 0.45-1.8 g/kg.
In certain embodiments, the polyethylene glycol is administered at a concentration of 5mg/mL to 20mg/mL, preferably at a concentration of 5mg/mL, 10mg/mL, 20mg/mL, and more preferably at a concentration of 10 mg/mL.
Compared with the prior art, the polyethylene glycol or the pharmaceutically acceptable salt thereof can inhibit the proliferation of tumor cells in a spontaneous tumor animal model for the first time, and the oral administration shows that particularly PEG400 can obviously inhibit the number of spontaneous breast tumors in SPF SD rats. This shows that PEG has the function of reducing the natural incidence of tumor, and provides a theoretical basis for the application of PEG in the aspect of treating tumor in future.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments will be briefly described below.
FIG. 1 is a graph showing an example of spontaneous tumors in rats observed in this study;
FIG. 2 is a graph showing a comparison of the number of tumors in spontaneous tumor rats in two groups of rats.
Detailed Description
Hereinafter, embodiments of the present invention will be described in detail. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby. It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains.
Definition of terms
Wherein the term "pharmaceutically acceptable salt" refers to a salt of a compound of the present invention with an acid or a base, which is suitable for use as a medicament. The term "salt" as used herein refers to a salt formed from an inorganic or organic acid and a base in either an acidic or basic form. Furthermore, when a compound of the present invention contains a basic moiety, including but not limited to pyridine or imidazole, and an acidic moiety, including but not limited to carboxylic acid, zwitterions ("inner salts") that may form are included within the scope of the term "salt(s)". Pharmaceutically acceptable (i.e., non-toxic, physiologically acceptable) salts are preferred, although other salts are also useful, e.g., in isolation or purification steps during manufacture.
The term "pharmaceutical composition" means, among others, that the pharmaceutical composition of the present invention comprises a compound of the present invention or a pharmacologically acceptable salt thereof in a safe and effective amount range and a pharmacologically acceptable excipient or carrier. Wherein "safe and effective amount" means: the amount of the compound is sufficient to significantly improve the condition without causing serious side effects. Typically, the pharmaceutical composition contains 1-2000mg of a compound of the invention per dose, more preferably, 10-1000mg of a compound of the invention per dose. Preferably, said "dose" is a capsule or tablet.
Wherein the term "pharmaceutically acceptable carrier" refers to: one or more compatible solid or liquid fillers or gel substances which are suitable for human use and must be of sufficient purity and sufficiently low toxicity. By "compatible" is meant herein that the components of the composition are capable of intermixing with and with the compounds of the present invention without significantly diminishing the efficacy of the compounds. Examples of pharmaceutically acceptable carrier moieties are cellulose and its derivatives (e.g., sodium carboxymethylcellulose, sodium ethylcellulose, cellulose acetate, etc.), gelatin, talc, solid lubricants (e.g., stearic acid, magnesium stearate), calcium sulfate, vegetable oils (e.g., soybean oil, sesame oil, peanut oil, olive oil, etc.), polyols (e.g., propylene glycol, glycerin, mannitol, sorbitol, etc.), emulsifiers (e.g., sodium lauryl sulfate), colorants, flavors, stabilizers, antioxidants, preservatives, pyrogen-free water, etc.
The mode of administration of the compounds or pharmaceutical compositions of the present invention is not particularly limited, and representative modes of administration include (but are not limited to): oral, rectal, parenteral (intravenous, intramuscular, or subcutaneous), and topical administration.
Solid dosage forms for oral administration include capsules, tablets, pills, powders and granules. In these solid dosage forms, the active compound is mixed with at least one conventional inert excipient (or carrier), such as sodium citrate or dicalcium phosphate, or with the following ingredients: (a) fillers or extenders, for example, starch, lactose, sucrose, glucose, mannitol and silicic acid; (b) binders, for example, hydroxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose and acacia; (c) humectants, for example, glycerol; (d) disintegrating agents, for example, agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain complex silicates, and sodium carbonate; (e) slow solvents, such as paraffin; (f) absorption accelerators, e.g., quaternary ammonium compounds; (g) wetting agents, such as cetyl alcohol and glycerol monostearate; (h) adsorbents, for example, kaolin; and (i) lubricants, for example, talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, or mixtures thereof. In capsules, tablets and pills, the dosage forms may also comprise buffering agents.
Solid dosage forms such as tablets, dragees, capsules, pills, and granules can be prepared using coatings and shells such as enteric coatings and other materials well known in the art. They may contain opacifying agents and the release of the active compound or compounds in such compositions may be delayed in release in a certain part of the digestive tract. Examples of embedding components which can be used are polymeric substances and wax-like substances. If desired, the active compound may also be in microencapsulated form with one or more of the above-mentioned excipients.
Liquid dosage forms for oral administration include pharmaceutically acceptable emulsions, solutions, suspensions, syrups or tinctures. In addition to the active compounds, the liquid dosage forms may contain inert diluents commonly employed in the art such as, for example, water or other solvents, solubilizing agents and emulsifiers such as ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, propylene glycol, 1, 3-butylene glycol, dimethylformamide and oils, in particular, cottonseed, groundnut, corn germ, olive, castor and sesame oils or mixtures of such materials and the like.
In addition to these inert diluents, the compositions can also contain adjuvants such as wetting agents, emulsifying and suspending agents, sweetening, flavoring, and perfuming agents.
Suspensions, in addition to the active compounds, may contain suspending agents as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum methoxide and agar, or mixtures of these substances, and the like.
Compositions for parenteral injection may comprise physiologically acceptable sterile aqueous or anhydrous solutions, dispersions, suspensions or emulsions, and sterile powders for reconstitution into sterile injectable solutions or dispersions. Suitable aqueous and nonaqueous carriers, diluents, solvents or vehicles include water, ethanol, polyols and suitable mixtures thereof.
Dosage forms for topical administration of the compounds of the present invention include ointments, powders, patches, sprays, and inhalants. The active ingredient is mixed under sterile conditions with a physiologically acceptable carrier and any preservatives, buffers, or propellants which may be required if necessary.
The compounds of the present invention may be administered alone or in combination with other pharmaceutically acceptable compounds.
In using the pharmaceutical compositions, a safe and effective amount of a compound of the invention is administered to a mammal (e.g., a human) in need of treatment at a dosage that is pharmaceutically acceptable for effective administration, although the specific dosage will depend on factors such as the route of administration, the health of the patient, and the like, and is within the skill of the skilled practitioner.
Example 1
SPF grade SD rats were purchased from Shanghai Sphall-Bikay laboratory animals Co. 96 18-month-old rats were divided into two groups: PEG400 treated group 36 and control group 60. The administration route is as follows: PEG400 was diluted in animal drinking water and administered by oral route. The specific method comprises the following steps: dissolving PEG400 in rat drinking water, and regulating the concentration of PEG400 according to the daily average water intake of the rat to ensure that the daily average drug intake of the rat is about 0.15 g/mouse/day; control rats were given normal drinking water. During the experiment, the general physiological status of the rats was observed twice a week, and the drugs and water were renewed and replenished. The duration of experimental observation was 6 months.
The main observations are described below:
1) spontaneous mastadenomas in rats were frequently found in superficial subcutaneous sites and were counted by visual observation. Examples of spontaneous tumors observed in rats in this study are shown in FIG. 1. In rats with spontaneous tumors, the number of tumors per rat in the PEG 400-treated group was significantly reduced on average (see FIG. 2, note: statistical analysis using Fisher's exact test. Fisher's test: P ═ 0.0359);
2) among the spontaneously tumorous rats, the number of rats carrying 2 and more tumors in the PEG400 treated group was significantly lower than that of the control group, and the data are detailed in table 1.
TABLE 1 proportion of rats with 2 or more tumors among spontaneous tumor rats in PEG-treated group and control group
Example 2
SPF grade SD rats were purchased from Shanghai Sphall-Bikay laboratory animals Co. 104 15-month-old rats were divided into five groups: control group 24; 20 PEG600 low dose groups and 20 PEG600 high dose groups; 20 PEG400 low dose groups and 20 PEG400 high dose groups.
The administration route is as follows: PEG400 was diluted in animal drinking water and administered by oral route.
The specific method comprises the following steps: the daily average drug intake of the rats in the PEG600 low-dose group is about 0.15G/rat/day, the daily average drug intake of the rats in the PEG600 high-dose group is about 0.3G/rat/day, the daily average drug intake of the rats in the PE G400 low-dose group is about 0.15G/rat/day, and the daily average drug intake of the rats in the PEG400 high-dose group is about 0.3G/rat/day; control rats were given normal drinking water. During the experiment, the general physiological status of the rats was observed twice a week, and the drugs and water were renewed and replenished. The duration of experimental observation was 6 months.
The main observations are described below:
1) the ratio of spontaneous tumors of rats in each group is as follows: control group (4/24), PEG600 low dose group (3/20), PEG600 high dose group (5/20), PEG400 low dose group (2/20), PEG high dose group (1/20) (table 2). The results show that PEG400 has the effect of reducing the spontaneous tumor incidence, while PEG600 does not have similar effect.
TABLE 2 spontaneous tumor incidence comparison of PEG400, PEG600 and Normal Drinking group rats
To explore the maximum safe dose of PEG400, we also observed the tolerance of rats to higher doses (0.6 g/day) of PEG400, along with the experimental observations above. The observation showed that after 1 week of continuous administration, some (about 50%) of the rats exhibited more pronounced symptoms of diarrhea, in addition to which no other significant adverse effects were observed.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.
Claims (10)
1. Use of polyethylene glycol or a pharmaceutically acceptable salt thereof in any one of:
(1) preparing a medicament for preventing and/or treating tumors;
(2) preparing the inhibitor for tumor cell proliferation.
2. The use of claim 1, wherein said tumor comprises a benign tumor and a malignant tumor.
3. The use of claim 2, wherein the benign tumor includes but is not limited to mammary fibroids, cysts, lipomas, gallbladder polyps, nodules; the malignant tumor includes but is not limited to lung cancer, breast cancer, colorectal cancer, liver cancer, brain cancer, bone cancer, esophageal cancer, thyroid cancer, pancreatic cancer, endometrial cancer, ovarian cancer and cervical cancer.
4. The use as claimed in claim 1, wherein the polyethylene glycol has a molecular weight of 100-.
5. The use according to claim 4, wherein the polyethylene glycol is selected from one or more of PEG200, PEG400 and PEG 600.
6. A pharmaceutical composition, said product having any one of the following uses:
(1) preventing and/or treating tumors;
(2) preparing a product for preventing and/or treating tumors;
(3) inhibiting tumor cell proliferation;
(4) preparing an inhibitor of tumor cell proliferation;
the pharmaceutical composition is characterized by comprising the following components:
(a) the active ingredient is polyethylene glycol or pharmaceutically acceptable salt thereof;
(b) a pharmaceutically acceptable carrier;
(c) optionally, other agents for the prevention and/or treatment of tumors.
7. The pharmaceutical composition according to claim 6, wherein the molecular weight of the polyethylene glycol is 100-2000, preferably one or more of PEG200, PEG400 and PEG 600.
8. The pharmaceutical composition according to claim 6, wherein the pharmaceutical composition comprises 0.001-99 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, preferably 0.1-90 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, and preferably 1-80 wt% of polyethylene glycol or a pharmaceutically acceptable salt thereof, based on the total weight of the composition.
9. The pharmaceutical composition of claim 6, wherein the pharmaceutical composition is in a form selected from the group consisting of: tablets, capsules, granules, suspensions, pills, solutions, syrups, or injections.
10. An in vitro tumor inhibition method is characterized in that a subject needing tumor cell proliferation inhibition is administered with polyethylene glycol or pharmaceutically acceptable salt thereof as an active component for tumor cell proliferation inhibition, wherein the molecular weight of the polyethylene glycol is 100-2000, preferably one or more of PEG200, PEG400 and PEG 600.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016007856A1 (en) * | 2014-07-10 | 2016-01-14 | Academia Sinica | Multi-drug delivery system and uses thereof |
| CN105294852A (en) * | 2015-10-27 | 2016-02-03 | 岳阳新华达制药有限公司 | Conjugate of polyethylene glycol and tumor necrosis factor alpha or analogue of polyethylene glycol and tumor necrosis factor alpha and medical application of conjugate |
| CN111514309A (en) * | 2019-02-03 | 2020-08-11 | 重庆阿普格雷生物科技有限公司 | Polyethylene glycol coupled drug, preparation method and application thereof |
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- 2021-07-07 CN CN202110768198.8A patent/CN113350370A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016007856A1 (en) * | 2014-07-10 | 2016-01-14 | Academia Sinica | Multi-drug delivery system and uses thereof |
| CN105294852A (en) * | 2015-10-27 | 2016-02-03 | 岳阳新华达制药有限公司 | Conjugate of polyethylene glycol and tumor necrosis factor alpha or analogue of polyethylene glycol and tumor necrosis factor alpha and medical application of conjugate |
| CN111514309A (en) * | 2019-02-03 | 2020-08-11 | 重庆阿普格雷生物科技有限公司 | Polyethylene glycol coupled drug, preparation method and application thereof |
Non-Patent Citations (2)
| Title |
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| HEMANT K. ROY 等: "Polyethylene glycol induces apoptosis in HT-29 cells:potential mechanism for chemoprevention of colon cancer", 《FEBS LETTERS》 * |
| 陈刘: "TERT与Par-4相互作用参与2型糖尿病胰岛β细胞凋亡的机制研究", 《中国优秀博硕士学位论文全文数据库（博士） 医药卫生科技辑》 * |
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