CN112641765A - Anti-fatigue pharmaceutical application of propofol - Google Patents
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Abstract
The invention belongs to the field of medicines, and relates to an anti-fatigue pharmaceutical application of propofol. Specifically, the invention relates to the use of any one of the following items (1) to (2) in the preparation of an anti-fatigue medicament: (1) propofol, (2) a pharmaceutical composition comprising an effective amount of propofol, and one or more pharmaceutically acceptable excipients. Propofol or a pharmaceutical composition containing propofol has a good anti-fatigue effect.
Description
Technical Field
The invention belongs to the field of medicines, and relates to pharmaceutical application of propofol.
Background
Fatigue is a subjective feeling of the human body, is a protective reaction generated by the body to prevent excessive functional failure, and can be divided into physiological fatigue and pathological fatigue. Physiological fatigue is mainly represented by sports fatigue, and pathological fatigue mainly comprises chronic fatigue accompanied by diseases, chronic fatigue syndrome, postoperative fatigue syndrome and the like. The pathological fatigue seriously reduces the living ability and the working ability of people, and severe people lie in bed for the whole life, so that the patients suffer pain, and the pathological fatigue becomes a public health problem seriously harming the health of the human beings. At present, the physiological fatigue treatment mainly takes special nutrition supplement, sleep adjustment, motor therapy and the like as main components, the pathological fatigue mainly takes moderate motor and cognitive psychotherapy as main components, and the nutrition supplement and symptomatic drug treatment are assisted. Unfortunately, the anti-fatigue effect of existing interventions has not been consistently concluded, and there is no drug approved for the treatment of pathologic fatigue.
Propofol (2, 6-diisopropyl phenol) is an intravenous short-acting anesthetic, and has the characteristics of controllable anesthetic degree, quick response, short action time, quick and complete waking, less adverse reaction and the like. Since the clinical use in the eighties of the last century, it has been widely used for general anesthesia induction and maintenance, ICU sedation, and conscious sedation at the time of surgical and diagnostic procedures. The structural formula of propofol is shown in formula a below:
clinically, the dosage of the propofol used for anesthesia induction is about 1.5-2.5mg/kg, and the propofol can be continuously infused intravenously at the dosage of 4-12mg/kg/h when anesthesia is maintained. The dose of propofol administered when used for ICU patient sedation is 0.3-4mg/kg/h continuous intravenous infusion. Propofol for clinical anesthesia or sedation is typically a continuous intravenous drip.
At present, new anti-fatigue means need to be developed.
Disclosure of Invention
The inventor is subjected to intensive research and creative work, and surprisingly discovers that the non-anesthetic dose (small dose) propofol has an anti-fatigue effect in multiple models and has the potential of being applied to preparation of anti-fatigue medicines. The following invention is thus provided:
one aspect of the present invention relates to a use of any one selected from the following items (1) to (2) for the preparation of an anti-fatigue medicament:
(1) the content of the propofol is that of the propofol,
(2) a pharmaceutical composition comprising an effective amount of propofol, in combination with one or more pharmaceutically acceptable excipients.
In one or more embodiments of the invention, the use, wherein the fatigue is physiological fatigue or pathological fatigue;
preferably, the pathological fatigue is disease-associated chronic fatigue, chronic fatigue syndrome or post-operative fatigue syndrome.
In one or more embodiments of the invention, the use, wherein in item (1) or (2), the unit dose of propofol is 0.5-5mg, preferably 1-3mg, such as 1mg, 1.5mg, 2mg, 2.5mg or 3 mg.
The effective dose administered in the present invention can be converted to a dose or dose range administered in humans. In one or more embodiments of the invention, the use according to item (1) or (2), wherein the single administration dose of propofol is 0.005-0.5mg/kg, preferably 0.01-0.2mg/kg or 0.01-0.1mg/kg, more preferably 0.02-0.06mg/kg or 0.03-0.05mg/kg, such as 0.02mg/kg, 0.03mg/kg, 0.04mg/kg, 0.05mg/kg or 0.06 mg/kg;
preferably, the administration route of the propofol of item (1) or the pharmaceutical composition of item (2) is oral administration, intravenous injection or intravenous drip.
In one or more embodiments of the invention, the use, wherein, in item (2):
propofol is the only active ingredient; or
The pharmaceutical composition further comprises one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of caffeine is from 5 to 50mg, preferably from 10 to 30 mg;
preferably, the single dose of caffeine is from 0.05 to 5mg/kg, preferably from 0.1 to 2mg/kg or from 0.1 to 1 mg/kg.
In one or more embodiments of the present invention, the use, wherein, in item (2), the pharmaceutical composition is an oral preparation, such as a tablet, a capsule, a pill, a granule or an injection.
In one or more embodiments of the invention, the use wherein the propofol is administered at a dose that does not produce an anesthetic or sedative effect.
Another aspect of the present invention relates to a pharmaceutical composition comprising an effective amount of propofol, as the sole active ingredient, and a unit dose of propofol of 0.5-5mg, preferably 1-3mg, such as 1mg, 1.5mg, 2mg, 2.5mg or 3 mg;
preferably, the pharmaceutical composition is an oral formulation, such as a tablet, capsule, pill, granule or injection.
Yet another aspect of the present invention relates to a pharmaceutical composition comprising an effective amount of propofol, together with one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of propofol is from 0.5 to 5mg, preferably from 1 to 3mg, for example 1mg, 1.5mg, 2mg, 2.5mg or 3 mg;
preferably, the unit dose of caffeine is from 5 to 50mg, preferably from 10 to 30 mg;
preferably, the pharmaceutical composition is an oral formulation, such as a tablet, capsule, pill, granule or injection.
In one or more embodiments of the invention, the pharmaceutical composition of any one of the above is for use in anti-fatigue;
preferably, the fatigue is physiological fatigue or pathological fatigue;
preferably, the pathological fatigue is disease-associated chronic fatigue, chronic fatigue syndrome or post-operative fatigue syndrome.
Yet another aspect of the invention relates to a combination drug product comprising a first drug product and a second drug product packaged separately, wherein,
the first pharmaceutical product comprises propofol according to any of (1) of the present invention, or comprises a pharmaceutical composition according to any of (2) of the present invention;
the second pharmaceutical product comprises one or more anti-fatigue active ingredients other than propofol, such as caffeine, or a pharmaceutical composition containing one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of propofol in the first pharmaceutical product is 0.5-5mg, preferably 1-3mg, for example 1mg, 1.5mg, 2mg, 2.5mg or 3 mg;
preferably, the unit dose of caffeine in the second pharmaceutical product is from 5 to 50mg, preferably from 10 to 30 mg.
Yet another aspect of the present invention relates to a method for combating fatigue, comprising the step of administering to a subject in need thereof an effective amount of propofol according to any of (1) of the present invention, or a pharmaceutical composition according to any of (2) of the present invention.
In the present invention,
the term "excipient" refers herein to an excipient or vehicle used to administer the primary drug, including, but not limited to, diluents, disintegrants, precipitation inhibitors, surfactants, glidants, binders, lubricants, coating materials, and the like. Adjuvants are generally described in "Remington's Pharmaceutical Sciences" by e.w. martin. Examples of adjuvants include, but are not limited to, aluminum monostearate, aluminum stearate, carboxymethylcellulose, sodium carboxymethylcellulose, crospovidone, glyceryl isostearate, glyceryl monostearate, hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxyeicosateyl hydroxystearate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and the like.
The pharmaceutical compositions of the present invention may be administered in varying doses once or more times daily, depending on the disease to be treated and the patient and the route of administration. The dose to be administered depends on many factors, such as the severity of fatigue, sex, age, body weight and individual response of the patient, the route of administration and the number of administrations, etc. The above dosage may be administered in a single dosage form or divided into several, e.g., two, three, four dosage forms.
The actual dosage level of each principal agent in the pharmaceutical composition of the invention can be varied so as to effectively achieve the desired therapeutic response for the particular patient, composition and mode of administration. Dosage levels will be selected with regard to the route of administration, the severity of the condition being treated and the condition and prior medical history of the patient being treated. However, it is common practice in the art to start doses from a level below that required to achieve the desired therapeutic effect and to gradually increase the dose until the desired effect is achieved.
The term "effective amount" refers to a dose that achieves treatment, prevention, reduction, and/or alleviation of fatigue in a subject.
Advantageous effects of the invention
Propofol or a pharmaceutical composition containing propofol has an effective anti-fatigue effect.
Drawings
In the following drawings, if not otherwise specified:
veh represents a solvent control group;
LPS represents lipopolysaccharide;
caf means caffeine, caf3 means caffeine administered at 3 mg/kg;
pro means propofol, pro0.3 means propofol dosed at 0.3mg/kg, pro1 means propofol dosed at 1mg/kg, and pro3 means propofol dosed at 3 mg/kg.
FIG. 1: effect of propofol on distance of normal mouse running. P <0.05 compared to solvent control group (veh).
FIG. 2: effect of propofol on distance traveled by LPS fatigue model mice. P <0.01 compared to solvent control group (veh); compared to the LPS model, # p < 0.05.
Fig. 3A-3C: effects of propofol on blood glucose (FIG. 3A), lactate dehydrogenase (FIG. 3B) and lactate (FIG. 3C) in LPS fatigue model mice. P <0.05 x p <0.01 compared to solvent control group (veh); compared to the LPS model, # p <0.05# # p < 0.01.
Fig. 4A-4B: effect of propofol on liver glycogen (FIG. 4A) and muscle glycogen (FIG. 4B) in mice in LPS fatigue model. P <0.05 compared to solvent control group (veh); compared to the LPS model, # p < 0.05.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1: research on anti-fatigue effect of propofol on normal mice
Experimental animals: 40C 57BL/6J mice, male, SPF grade, 20-22g, purchased from Schbefu (Beijing) laboratory animal science, Inc.
And (3) testing a sample: coffee is self-synthesized (also commercially available) and propofol drug substance is available from MCE.
Dissolving a test sample: dissolving with distilled water as solvent for intraperitoneal injection (ip), wherein the administration volume is 0.1ml/10 g.
An experimental instrument: the mouse runs the platform.
The experimental method comprises the following steps: mice were bred adaptively for 3-5 days after purchase, and randomly divided into 8 groups of solvent control group (veh), positive drug group (caffeine, caf, 3mg/kg), and propofol (pro, 0.3mg/kg, 1mg/kg, 3mg/kg) by weight. Each group of mice was programmed for 3 runs (speed from 2m/s to 14m/s) and rejected. Each group of mice is subjected to bench running experiment after single gastric lavage and administration of solvent control, propofol and caffeine for 0.5h, and the running distance of the mice to exhaustion is recorded, wherein the exhaustion judgment standard is that the mice continuously stay at 1/4 behind a runway for more than 10 s. The increase of the running table movement distance is considered to have the anti-fatigue effect.
The results of the experiment are shown in FIG. 1.
The results show that: the single intraperitoneal administration of propofol of 0.3mg/kg can obviously increase the running distance of normal mice, and compared with a solvent control group, the statistical difference (p <0.05) shows that propofol has the anti-fatigue effect on normal animals and the effect of resisting physiological fatigue.
Example 2: research on anti-fatigue effect of propofol on Lipopolysaccharide (LPS) induced pathological fatigue model
Experimental animals: 40C 57BL/6J mice, male, SPF grade, 20-22g, purchased from Schbefu (Beijing) laboratory animal science, Inc.
Test sample and dissolution: the same as in example 1.
An experimental instrument: the mouse runs the platform.
The experimental method comprises the following steps: mice were bred adaptively for 3-5 days after purchase, and were randomly divided into 10 groups of a solvent control group (veh), an LPS fatigue model group, a positive drug group (caffeine, caf, 3mg/kg), and propofol (pro 0.3mg/kg) by weight. Each group of mice was programmed for 3 runs (speed from 2m/s to 14m/s) and rejected. Except for the solvent control group, after each group is injected with LPS (0.2mg/kg) in the abdominal cavity for 12 hours, a running bench experiment is carried out after single gastric lavage is given to the solvent control, propofol and caffeine for 0.5 hour, the running distance of the mouse to exhaustion is recorded, and the exhaustion judgment standard is that the mouse continuously stays at 1/4 behind the runway for more than 10 s. The increase of the running table movement distance is considered to have the anti-fatigue effect.
The experimental results are as follows: see fig. 2.
The results show that: compared with a solvent control group, the LPS can obviously reduce the running distance of the mouse (p is less than 0.05), and the success of the model is prompted; the single intraperitoneal administration of propofol of 0.3mg/kg can obviously increase the running distance of LPS mice, and has statistical difference (p is less than 0.05) compared with an LPS model group, which indicates that propofol has anti-fatigue effect on a pathological fatigue model, particularly an LPS-induced pathological fatigue model, and has the effect of resisting pathological fatigue.
Example 3: effect of propofol on lipopolysaccharide-induced fatigue mouse blood biochemical indexes
Experimental animals: 40C 57BL/6J mice, male, SPF grade, 20-22g, purchased from Schbefu (Beijing) laboratory animal science, Inc.
Test sample and dissolution: the same as in example 1.
An experimental instrument: a blood biochemical instrument for small animals.
The experimental method comprises the following steps: mice were bred adaptively for 3-5 days after purchase, and were randomly divided into 10 groups of a solvent control group (veh), an LPS fatigue model group, a positive drug group (caffeine, caf, 3mg/kg), and propofol (pro 0.3mg/kg) by weight. Each group of mice was programmed for 3 runs (speed from 2m/s to 14m/s) and rejected. Except the solvent control group, after each group is injected with LPS (0.2mg/kg) in the abdominal cavity for 12 hours, the patient is given the solvent control, propofol and caffeine by single gastric lavage for 0.5 hours and then is run to exhaustion, and then blood is taken out immediately by cutting off the head. After standing the whole blood at 4 ℃ for 4h, centrifuging at 3000r for 20min, taking the supernatant to obtain a serum sample, and detecting glucose (Glu), Lactate Dehydrogenase (LDH) and Lactic Acid (LAC) in a biochemical analyzer. It is considered that the increase of blood sugar and lactate dehydrogenase and the decrease of lactate have an anti-fatigue effect.
The results of the experiment are shown in FIGS. 3A-3C.
The results show that: compared with a solvent control group, the LPS can obviously reduce the blood sugar of the mouse (p <0.001) and increase the blood lactic acid (p <0.05), thereby indicating that the model is successful; a single administration of propofol at 0.3mg/kg significantly increased blood glucose (p <0.001), lactate dehydrogenase (p <0.05) and decreased blood lactate (p <0.05) in LPS model mice, suggesting that the anti-fatigue effect of propofol on LPS-induced pathological fatigue models may be exerted by regulating blood glucose and lactate.
Example 4: effect of Propofol on hepatic and muscular glycogen in lipopolysaccharide-induced fatigue mice
Experimental animals: 40C 57BL/6J mice, male, SPF grade, 20-22g, purchased from Schbefu (Beijing) laboratory animal science, Inc.
Test sample and dissolution: the same as in example 1.
An experimental instrument: a microplate reader.
The experimental method comprises the following steps: mice were bred adaptively for 3-5 days after purchase, and were randomly divided into 10 groups of a solvent control group (veh), an LPS fatigue model group, a positive drug group (caffeine, caf, 3mg/kg), and propofol (pro 0.3mg/kg) by weight. Each group of mice was programmed for 3 runs (speed from 2m/s to 14m/s) and rejected. Except for the solvent control group, after each group is injected with LPS (0.2mg/kg) in the abdominal cavity for 12 hours, the patient is subjected to table-running exercise to exhaustion after being administered with the solvent control, propofol and caffeine for 0.5 hour by single gastric lavage, and then the abdomen is opened immediately to take out liver tissues and muscle tissues. Liver and muscle tissues were examined for liver glycogen and muscle glycogen using the liver/muscle glycogen kit (Nanjing institute of bioengineering) according to the instructions. Elevated liver glycogen and muscle glycogen levels are believed to have anti-fatigue effects.
The results of the experiment are shown in FIGS. 4A-4B.
The results show that LPS can significantly reduce mouse liver glycogen (p <0.05) and muscle glycogen (p <0.001) levels compared to the solvent control group, suggesting success of the model; a single administration of propofol at 0.3mg/kg significantly increased liver glycogen (p <0.05) and muscle glycogen (p <0.05) in LPS model mice, suggesting that the anti-fatigue effect of propofol on pathological fatigue models, particularly LPS-induced pathological fatigue models, may be exerted by improving glycogen depletion.
Although specific embodiments of the invention have been described in detail, those skilled in the art will appreciate. Various modifications and substitutions of those details may be made in light of the overall teachings of the disclosure, and such changes are intended to be within the scope of the present invention. The full scope of the invention is given by the appended claims and any equivalents thereof.
Claims (10)
1. Use of any one of (1) to (2) selected from the following in the preparation of an anti-fatigue medicament:
(1) the content of the propofol is that of the propofol,
(2) a pharmaceutical composition comprising an effective amount of propofol, in combination with one or more pharmaceutically acceptable excipients.
2. The use according to claim 1, wherein the fatigue is physiological fatigue or pathological fatigue;
preferably, the pathological fatigue is disease-associated chronic fatigue, chronic fatigue syndrome or post-operative fatigue syndrome.
3. The use according to any one of claims 1 to 2, wherein in item (1) or (2), the unit dose of propofol is 0.5-5mg, preferably 1-3 mg.
4. The use according to any one of claims 1 to 3, wherein in item (1) or (2), the single administration dose of propofol is 0.005-0.5mg/kg, preferably 0.01-0.1mg/kg, more preferably 0.02-0.06 mg/kg;
preferably, the administration route of the propofol of item (1) or the pharmaceutical composition of item (2) is oral administration, intravenous injection or intravenous drip.
5. The use according to any one of claims 1 to 4, wherein in item (2):
propofol is the only active ingredient; or
The pharmaceutical composition further comprises one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of caffeine is 5-50 mg;
preferably, the single dose of caffeine is 0.05-5 mg/kg.
6. The use according to any one of claims 1 to 5, wherein, in item (2), the pharmaceutical composition is an oral formulation, such as a tablet, capsule, pill, granule or injection.
7. A pharmaceutical composition comprises an effective amount of propofol and one or more pharmaceutically acceptable excipients, wherein propofol is the only active ingredient, and the unit dose of propofol is 0.5-5mg, preferably 1-3 mg;
preferably, the pharmaceutical composition is an oral formulation, such as a tablet, capsule, pill, granule or injection.
8. A pharmaceutical composition comprising an effective amount of propofol in combination with one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of propofol is 0.5-5mg, preferably 1-3 mg;
preferably, the unit dose of caffeine is 5-50 mg;
preferably, the pharmaceutical composition is an oral formulation, such as a tablet, capsule, pill, granule or injection.
9. The pharmaceutical composition according to any one of claims 7 to 8 for use in combating fatigue;
preferably, the fatigue is physiological fatigue or pathological fatigue;
preferably, the pathological fatigue is disease-associated chronic fatigue, chronic fatigue syndrome or post-operative fatigue syndrome.
10. A combination drug product comprising a first drug product and a second drug product packaged separately, wherein,
the first pharmaceutical product comprising propofol according to claim (1) of any of claims 1 to 6, or comprising a pharmaceutical composition according to claim (2) of any of claims 1 to 6;
the second pharmaceutical product comprises one or more anti-fatigue active ingredients other than propofol, such as caffeine, or a pharmaceutical composition containing one or more anti-fatigue active ingredients other than propofol, such as caffeine;
preferably, the unit dose of propofol in the first drug product is 0.5-5mg, preferably 1-3 mg;
preferably, the unit dose of caffeine in the second pharmaceutical product is from 5 to 50 mg.
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