CN107213151B - Pharmaceutical composition for reducing salivary secretion in surgical anesthesia process and application thereof - Google Patents
Pharmaceutical composition for reducing salivary secretion in surgical anesthesia process and application thereof Download PDFInfo
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- CN107213151B CN107213151B CN201710344165.4A CN201710344165A CN107213151B CN 107213151 B CN107213151 B CN 107213151B CN 201710344165 A CN201710344165 A CN 201710344165A CN 107213151 B CN107213151 B CN 107213151B
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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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
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- A—HUMAN NECESSITIES
- 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
- A61K31/4353—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
- A61K31/4375—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 nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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Abstract
The invention relates to a pharmaceutical composition for nursing before surgical anesthesia and application thereof, wherein the pharmaceutical composition comprises imidafenacin or pharmaceutically acceptable salts thereof, tetrahydropalmatine and/or gentiana macrophylla alkali. The components of the pharmaceutical composition provided by the invention are combined to realize synergistic interaction, so that the use dosage of the single components in the composition is reduced, the pain threshold of a patient in an operation can be effectively improved, the dosage of anesthetic required by the operation can be reduced, the side effect caused by the anesthetic can be effectively reduced, the tension and anxiety mood of the patient can be relieved, the secretion of saliva and respiratory tract secretion of the patient can be reduced, and the pulmonary complications in and after the operation can be prevented, therefore, the pharmaceutical composition can be widely applied to nursing before the operation anesthesia.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for nursing before surgical anesthesia and application thereof.
Background
In the advanced medical field, surgery has become a rapid, direct and effective treatment means for many diseases, and since a doctor needs to use medical instruments to perform destructive operations such as excision and suture on a patient in the surgery, anesthesia needs to be performed on the patient before the surgery to relieve pain of the patient and ensure smooth operation of the surgery.
On one hand, the development of anesthesiology ensures the smooth operation, but the narcotic drugs have serious complications, such as acute respiratory obstruction possibly caused by vomiting and regurgitation under the anesthesia state of a patient, death of the patient caused by serious patients, gastrointestinal tract reactions such as nausea and vomiting after operation also have high incidence, and in addition, the anesthesia also has other serious adverse reactions such as cardiovascular and cerebrovascular accidents, agitation, malignant high fever and the like.
Although anesthesia can relieve pain sensation of a patient during operation, the patient often has emotions of tension, anxiety, fear and the like before anesthesia due to the risks associated with operation and anesthesia, secretion of saliva and respiratory secretions of the patient is increased, the risk of respiratory obstruction during operation is also increased, and the tension emotion of the patient is not favorable for rapidly achieving the body state required by the optimal anesthesia. Therefore, pre-operative anesthesia care is currently commonly employed to alleviate or eliminate the above problems prior to operative anesthesia. Different methods such as psychological care, drug care and the like exist for the care before surgical anesthesia, wherein the drug care before surgical anesthesia generally relieves the tension of a patient, improves the pain threshold of the patient and the like by applying a certain drug before the patient is anesthetized, the currently known drugs for the intervention before anesthesia comprise captopril, atropine, scopolamine, midazolam and the like, the application of the drugs relieves the tension of the patient to a certain extent and reduces the adverse reaction in the anesthesia process, but the drugs have adverse reactions such as excessive sedation, laryngeal spasm, cardiovascular complications and the like, and the use of the drugs is restricted to a certain extent.
In order to overcome the adverse reactions of the currently known pre-anesthesia intervention drugs, part of documents report the advantage of utilizing the low side effects of traditional Chinese medicines, and the use of the traditional Chinese medicines in the nursing before the surgical anesthesia is disclosed in patent CN 104173883, wherein the raw materials of the traditional Chinese medicines comprise alpinia japonica, parasitic safflower, cudrania root, reed stem, wild buckwheat stem and leaf, motherwort, coix seed, kudzu root, honeysuckle, murraya jasminorage, deer horn gum and fistular onion stalk, but the traditional Chinese medicines also have the defects of complex components, slow effect and the like, so the document reports the adoption of a mode of combining traditional Chinese medicines and western medicines in the nursing before the surgical anesthesia, for example, the patent CN105535489 discloses a traditional Chinese medicine containing main: short-stem celastrus orbiculatus vine fruit, sowthistle flower seed, kwan-yin bamboo, calf power, gangrene grass, Indian buead, terminalia fruit, aizoon stonecrop herb, valerian, sandalwood extract and crowndaisy chrysanthemum extract; the main components of the western medicine are: the pharmaceutical composition for nursing before surgical anesthesia contains aminomethylbenzoic acid, lysine, taurine and cefuroxime, but the used pharmaceutical ingredients are more complicated.
Imidafenacin, whose chemical name is 4- (2-methyl-1-imidazolyl) -2, 2-diphenylbutanamide, is a novel diphenylbutanamide anticholinergic drug developed by Nippon Xiaoye pharmaceutical industry Co., Ltd and apricot forest pharmacy, and can remarkably improve symptoms such as urgency of micturition, pollakisuria, urinary incontinence and the like caused by overactive bladder. CN105796554 has reported that imidafenacin can be used as a pre-anesthesia medicine and is superior to a clinical common anticholinergic drug atropine.
The invention carries out more intensive research on the effect of the imidafenacin before anesthesia on the basis of the prior art, screens active monomer components in the known traditional Chinese medicine with the effect of improving pain threshold, and tests the effect of the imidafenacin after combination of the active monomer components and the imidafenacin before anesthesia, thereby screening and obtaining the simple and effective medical composition for before anesthesia operation.
Disclosure of Invention
The invention provides a pharmaceutical composition for nursing before surgical anesthesia and application thereof.
In one aspect, the present invention provides a pharmaceutical composition for pre-surgical anesthesia care, comprising imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and/or gentiana macrophylla alkali and a pharmaceutically acceptable carrier, preferably, the pharmaceutically acceptable salt of imidafenacin is selected from: an inorganic acid salt or an organic acid salt, the inorganic acid salt selected from the group consisting of: a hydrochloride or sulfate salt, said organic acid salt being selected from: citrate, malate or tartrate.
Preferably, the weight ratio of the imidafenacin or the pharmaceutically acceptable salt thereof to the tetrahydropalmatine or the gentiana macrophylla alkali in the pharmaceutical composition is 3-5:1-3, preferably 3-4:2-3, and more preferably 3: 2;
more preferably, the pharmaceutical composition comprises imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and gentianine A, wherein the weight ratio of imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and gentianine A is 3-5:1-3:1:3, preferably 3-4:2-3:2-3, and more preferably 3:2: 2.
The daily dosage of the pharmaceutical composition is 0.02-0.05 mg/d.
The pharmaceutical composition for the pre-operative anesthesia care can be prepared into oral medicines or parenteral medicines according to the conventional method in the field, wherein the oral medicines are selected from the following medicines: a tablet, capsule or granule selected from: the medicine is a coated tablet, an orally disintegrating tablet or a sustained release tablet, and the parenteral medicine is injection or intravenous infusion.
Another object of the present invention is to provide the use of a combination of imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and/or gentianine A for the preparation of a pharmaceutical composition for pre-operative anesthesia care.
Preferably said pharmaceutically acceptable salt of imidafenacin is selected from: an inorganic acid salt or an organic acid salt, the inorganic acid salt selected from the group consisting of: a hydrochloride or sulfate salt, said organic acid salt being selected from: citrate, malate or tartrate.
The weight ratio of the imidafenacin or the pharmaceutically acceptable salt thereof to the tetrahydropalmatine or the gentiana macrophylla alkali in the pharmaceutical composition is 3-5:1-3, preferably 3-4:2-3, and more preferably 3: 2;
more preferably, the pharmaceutical composition comprises imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and gentianine A, wherein the weight ratio of imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and gentianine A is 3-5:1-3:1:3, preferably 3-4:2-3:2-3, and more preferably 3:2: 2.
Advantageous effects
The composition has a synergistic effect after combining the imidafenacin or the pharmaceutically acceptable salt thereof with the tetrahydropalmatine and/or the gentiana macrophylla alkaloid, so that the dosage of the single components in the pharmaceutical composition can be reduced, the toxic and side effects are reduced, the tension and anxiety emotions of patients can be relieved, the secretion of saliva and respiratory secretions of the patients is reduced, the pulmonary complications during and after operations are prevented, the pain threshold of the patients after the operation can be effectively improved after the composition is applied before the anesthesia, the dosage of the anesthetic required by the operation is reduced, and the side effects brought by the anesthetic can be effectively reduced, so that the composition can be widely applied to the nursing before the operation anesthesia.
Detailed Description
The present invention is described in more detail below to facilitate an understanding of the present invention.
It should be understood that the terms or words used in the specification and claims should not be construed as having meanings defined in dictionaries, but should be interpreted as having meanings that are consistent with their meanings in the context of the present invention on the basis of the following principles: the concept of terms may be defined appropriately by the inventors for the best explanation of the invention.
Example 1: effect on isolated submandibular gland secretion of rats
1.1 test drugs
Pharmaceutical composition 1: imadazine hydrochloride, tetrahydropalmatine and gentiana macrophylla alkali in a weight ratio of 3:2: 2;
pharmaceutical composition 2: imidafenacin hydrochloride and tetrahydropalmatine in a weight ratio of 3: 2;
pharmaceutical composition 3: imidafenacin hydrochloride and gentianine A in a weight ratio of 3: 2;
comparative drug 1: imidafenacin hydrochloride;
comparative drug 2: tetrahydropalmatine;
comparative drug 3: gentiana macrophylla alkali A;
comparative drug 4: atropine, tetrahydropalmatine and gentiana macrophylla alkali in a weight ratio of 3:2: 2.
1.2 Experimental methods
Adult male SD rats 70, 200-250g in weight, were randomly assigned 2 days after acclimation: model group, 1-3 groups of medicine composition and 1-3 groups of contrast medicine, 10 in each group, were anesthetized by intraperitoneal injection of phenobarbital sodium, bilateral submaxillary glands were separated, artery, vein and sublingual gland ducts were ligated and then bilateral submaxillary glands were removed. Cutting off the submaxillary gland vein, transferring to a constant temperature bath tank at 37 ℃, and inserting the main pipeline outside the submaxillary gland lobule into a hollow fluorine-containing fiber pipe for sampling; the far end of the submaxillary gland artery branch is inserted into a hollow stainless steel conduit to be connected with a perfusion device. The venous connection catheter drains saliva. Performing submaxillary gland perfusion by using a perfusion buffer solution at the speed of 2mL/min by using a peristaltic pump, adding 0.2 mu mol/L carbachol into the perfusion buffer solution after perfusion is performed until a base line is stable, then perfusing for 5min again, then respectively adding corresponding medicines into each group of perfusion buffer solution to prepare a medicine-containing perfusion buffer solution containing 2mg/mL corresponding medicines, continuously perfusing for 5min by using each group of corresponding perfusion buffer solution, wherein the model group continuously perfuses by using the perfusion buffer solution containing 0.2 mu mol/L carbachol, recording the saliva secretion of each group within 5min, and calculating the saliva secretion inhibition rate of each group, wherein the specific experimental result is shown in table 1, wherein the specific experimental result is shown in the specification, wherein
The inhibition rate (%) of salivary secretion was (model group secretion amount-experimental group secretion amount)/model group secretion amount × 100%
1.3 results of the experiment
Table 1 shows that imidafenacin hydrochloride has the effect of inhibiting saliva secretion of isolated submaxillary gland of rat with an inhibition rate of 24.72%, which is substantially inhibited from the reports of prior art that imidafenacin inhibits saliva secretion, while tetrahydropalmatine and/or fraxinine A alone do not show the effect of inhibiting saliva secretion of isolated submaxillary gland of rat, while the pharmaceutical compositions 1-3 of the present application show the significantly enhanced effect of inhibiting saliva secretion of isolated submaxillary gland of rat after imidafenacin hydrochloride is combined with tetrahydropalmatine and/or fraxinine A, wherein the pharmaceutical composition 1 comprising imidafenacin hydrochloride, tetrahydropalmatine and fraxinine A has the strongest effect of inhibiting saliva secretion of isolated submaxillary gland of rat, the inhibition rate is more than twice that of the same dosage of the individual imidafenacin hydrochloride, and the pharmaceutical compositions 2-3 of the combination of imidafenacin hydrochloride with tetrahydropalmatine or fraxinine A also show the effect of inhibiting saliva secretion of isolated submaxillary gland of rat Compared with a single imidafenacin hydrochloride group, the composition has the advantages that the effect of isolated submaxillary gland salivary secretion of rats is obviously enhanced, so that the local synergistic effect of the imidafenacin hydrochloride and the tetrahydropalmatine and/or the gentiana macrophylla alkaloid is realized after the composition has the effect of inhibiting the salivary secretion, the salivary secretion of patients in the anesthesia process can be reduced, the risk of respiratory obstruction of the patients in the anesthesia process can be reduced, and the lung complications in the operation and after the operation can be prevented.
TABLE 1 Effect on isolated submandibular gland secretion in rats
Note: comparison with model groups: p <0.05, P < 0.01.
Example 2: influence on pain threshold in mice
2.1 test drugs
1, the pharmaceutical composition comprises imidafenacin hydrochloride, tetrahydropalmatine and gentiana macrophylla alkali in a weight ratio of 3:2: 2;
pharmaceutical composition 2: imidafenacin hydrochloride and tetrahydropalmatine in a weight ratio of 3: 2;
pharmaceutical composition 3: imidafenacin hydrochloride and gentianine A in a weight ratio of 3: 2;
comparative drug 1: imidafenacin hydrochloride;
comparative drug 2: tetrahydropalmatine;
comparative drug 3: gentiana macrophylla alkali A;
comparative drug 4: atropine, tetrahydropalmatine and gentiana macrophylla alkali in a weight ratio of 3:2: 2;
the medicines are all prepared into 0.5mg/L solution or suspension by using purified water.
2.2 Experimental methods
50 mice in female Kunming are 18-22g in weight, after adaptive breeding is carried out for 2 days, the temperature of a hot plate instrument is set to 55 +/-0.2 ℃, 35 mice with foot licking reaction in 5-30S are screened by the hot plate instrument after the set temperature is reached, the selected mice are randomly divided into 7 groups, 5 mice in each group are respectively a model group and a 1-3 group of medicine composition combination contrast medicines, the normal pain threshold value of each group of mice is retested and recorded, then the corresponding medicines in each group are injected into the abdominal cavity, the dosage is 0.1ml/10g, the normal saline is injected into the abdominal cavity of the model group, the pain threshold value of the mice is respectively measured at 30 minutes and 60 minutes after administration, if the mice still have no foot licking reaction within 60 seconds in the measurement process, the mice are taken out, the pain threshold value is measured in 60 seconds, the change of the pain threshold value of each group of mice is calculated, the pain threshold value increase rate is calculated, the specific experimental results are shown in tables 2 and 3, wherein:
the pain threshold increase rate (%) (post-administration pain threshold-pre-administration pain threshold)/pre-administration pain threshold × 100%.
2.3 results of the experiment
TABLE 2 Effect on pain threshold in mice 30 min after administration
Note: comparison with model groups: p < 0.05; p < 0.001.
TABLE 3 Effect on pain threshold in mice 60 min after administration
Note: comparison with model groups: p < 0.05; p < 0.01; p < 0.001.
The mouse hot plate experiment results in tables 2 and 3 show that imidafenacin hydrochloride, tetrahydropalmatine and gentianine A all have certain effect of improving the pain threshold of mice, and after the imidafenacin tartrate is combined with tetrahydropalmatine and/or gentianine A, the effect of improving the pain threshold is obviously enhanced, wherein the effect of improving the pain threshold of the mice is most obvious when the pharmaceutical composition 1 containing the imidafenacin hydrochloride, the tetrahydropalmatine and the gentianine A is combined, the pain threshold of the mice can be improved by one time after the pharmaceutical composition is administered for 30 minutes, the pain threshold improvement rate of the mice reaches 138.96 after the administration for 60 minutes, and the pain threshold improvement rate of the pharmaceutical compositions 2-3 containing the imidafenacin hydrochloride, the tetrahydropalmatine or the gentianine A after the administration is also more than 60 percent and is obviously higher than the pain threshold improvement rate of the individual imidafenacin hydrochloride and the individual tetrahydropalmatine hydrochloride, the individual gentianine hydrochloride and the individual, Gentiana macrophylla alkali A shows the effect of improving the pain threshold of mice through synergistic interaction among the components of the pharmaceutical composition.
EXAMPLE 3 tablet preparation
Prescription:
dispersing or dissolving imidafenacin in 70% ethanol water solution, adding mixed microcrystalline cellulose and pregelatinized starch, wet granulating, drying at 40-60 deg.C, mixing the dried granules with magnesium stearate, and directly tabletting.
Claims (7)
1. A pharmaceutical composition for reducing salivary secretion in the surgical anesthesia process is characterized by comprising imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine, gentiana macrophylla alkali and a pharmaceutically acceptable carrier, wherein the weight ratio of the imidafenacin or the pharmaceutically acceptable salt thereof to the tetrahydropalmatine and the gentiana macrophylla alkali is 3:2: 2.
2. The pharmaceutical composition for reducing the amount of salivation during surgical anesthesia of claim 1, wherein said pharmaceutically acceptable salt of imidafenacin is selected from the group consisting of: inorganic acid salts or organic acid salts.
3. The pharmaceutical composition for reducing the amount of salivation associated with surgical anesthesia of claim 2, wherein said salt of an inorganic acid is selected from the group consisting of: a hydrochloride or sulfate salt, said organic acid salt being selected from: citrate, malate or tartrate.
4. The pharmaceutical composition for reducing the amount of salivation associated with surgical anesthesia of any of claims 1-3, wherein said pharmaceutical composition is an oral drug or a parenteral drug, said oral drug is selected from the group consisting of: the medicine is tablet, capsule or granule, and the medicine for parenteral is injection or intravenous infusion.
5. The pharmaceutical composition for reducing the amount of salivation associated with surgical anesthesia of claim 4, wherein said tablet is selected from the group consisting of: coated tablets, orally disintegrating tablets or sustained release tablets.
6. The pharmaceutical composition for reducing the amount of salivation during surgical anesthesia of any of claims 1-3 and 5, wherein said pharmaceutical composition is administered in a daily dose of from 0.02 to 0.05 mg/d.
7. Use of a combination of imidafenacin or a pharmaceutically acceptable salt thereof, tetrahydropalmatine and gentiana macrophylla alkali in preparing a pharmaceutical composition for reducing salivary secretion in a surgical anesthesia process, wherein the weight ratio of the imidafenacin or the pharmaceutically acceptable salt thereof to the tetrahydropalmatine and the gentiana macrophylla alkali is 3:2: 2.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105796554A (en) * | 2014-12-31 | 2016-07-27 | 张蕊 | Application of imidafenacin in preparation of drugs for pre-anesthetic medication |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105796554A (en) * | 2014-12-31 | 2016-07-27 | 张蕊 | Application of imidafenacin in preparation of drugs for pre-anesthetic medication |
Non-Patent Citations (2)
| Title |
|---|
| 不同剂量延胡索乙素在甲状腺手术中的临床探讨;杨焕杰等;《西北国防医学杂志》;20061231;第27卷(第6期);第457页左栏第1段 * |
| 秦艽化学成分及药理作用研究进展;芦启琴等;《安徽农业科学》;20071231;第35卷(第29期);第9300页左栏第2段 * |
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