CN111374982A - Pharmaceutical composition for eliminating phlegm and relieving asthma and application thereof - Google Patents
Pharmaceutical composition for eliminating phlegm and relieving asthma and application thereof Download PDFInfo
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- CN111374982A CN111374982A CN202010122463.0A CN202010122463A CN111374982A CN 111374982 A CN111374982 A CN 111374982A CN 202010122463 A CN202010122463 A CN 202010122463A CN 111374982 A CN111374982 A CN 111374982A
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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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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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
- A61K31/075—Ethers or acetals
- A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
- A61K31/09—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon having two or more such linkages
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
Abstract
The invention discloses a pharmaceutical composition for eliminating phlegm and relieving asthma, which contains theophylline, guaifenesin and auxiliary materials; the content of the theophylline is 120-200mg per unit preparation, and the content of the guaifenesin is 80-120mg per unit preparation. Correspondingly, the invention also discloses application of the phlegm-eliminating asthma-relieving pharmaceutical composition in medicines for treating the symptoms of excessive phlegm cough in respiratory diseases. The invention combines theophylline and guaifenesin, effectively improves the treatment effect of eliminating phlegm and relieving asthma, and ensures that the medicine can be used for treating asthmatic bronchitis, chronic bronchitis, bronchial asthma and other diseases.
Description
Technical Field
The invention relates to the technical field of drug spectra, in particular to a drug composition for eliminating phlegm and relieving asthma and application thereof.
Background
Respiratory diseases are counted to account for 1/4 of medical patients, and respiratory diseases are the second cause of death in the Chinese demographic. The main symptoms of respiratory diseases are cough, expectoration and asthma, and the number of clinically available drugs is gradually increased in recent years, and guaifenesin is one of the drugs.
Guaifenesin is the main expectorant, which dissolves viscous mucus and relieves dyspnea. Expectorants reduce the viscosity of bronchial secretions, thereby increasing mucus flow, which can then be removed by coughing. At the same time, expectorants also thin the mucus barrier, and as a result, cough suppressants (such as citric acid, dust, allergens, etc.) can penetrate into the lung to the maximum extent, improving the cough suppressive effect. However, the effect of a single expectorant is not ideal when treating respiratory diseases.
In order to solve the problem, patent CN201180052248.7 proposes a method for combining theobromine and guaifenesin, thereby improving the treatment effect; the patent CN201010002844.4 combines guaifenesin and chlorpheniramine, thereby improving the treatment effect. However, the two raw materials have narrow source range and high price.
On the other hand, the guaifenesin oral preparations currently used in clinical practice mainly include conventional oral preparations such as tablets and compound preparations prepared together with some antitussive drugs, such as: compound Meiyu tablet and capsule. Because of the characteristics of the preparation process technology, the tablets and capsules generally have the defects of long dissolution time, low dissolution rate, poor absorption and low bioavailability, thereby influencing the full play of the drug effect.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a pharmaceutical composition for eliminating phlegm and relieving asthma, which has good effects of eliminating phlegm and relieving asthma and can be used for treating asthmatic bronchitis, chronic bronchitis, bronchial asthma and other diseases.
The technical problem to be solved by the invention is to provide the application of the phlegm-eliminating asthma-relieving pharmaceutical composition in medicines for treating the symptoms of excessive phlegm cough in respiratory diseases.
In order to solve the technical problems, the invention provides a pharmaceutical composition for eliminating phlegm and relieving asthma, which contains theophylline, guaifenesin and auxiliary materials;
the content of the theophylline is 120-200mg per unit preparation, and the content of the guaifenesin is 80-120mg per unit preparation.
As an improvement of the technical scheme, the content of the theophylline is 150mg per unit preparation, and the content of the guaifenesin is 90mg per unit preparation.
As an improvement of the technical scheme, the pharmaceutical composition is a tablet, a granule, an emulsion, a suspension, a soft capsule or a gel preparation.
As an improvement of the technical scheme, the pharmaceutical composition is a soft capsule.
As an improvement of the technical scheme, the auxiliary materials are a suspending agent, a rubber softening agent and a rubber raw material;
the suspending agent is one or more of polyethylene glycol, vegetable oil, ethanol, propylene glycol and glycerol;
the rubber softener is selected from water, glycerol or propylene glycol.
As an improvement of the technical scheme, the suspending agent is selected from polyethylene glycol; the rubber softener is water;
wherein the weight ratio of the water to the polyethylene glycol is (1.5-7.5): 1000.
As an improvement of the technical scheme, the rubber raw materials comprise gelatin, glycerol, water, edible pigment, preservative and titanium dioxide.
As an improvement of the technical scheme, the preparation method of the soft capsule comprises the following steps:
(1) preparing a drug suspension;
(2) preparing a rubber sol;
(3) forming the medicine suspension and the rubber sol by soft capsule forming equipment to obtain pills;
(4) shaping, drying, scrubbing and drying the pills to obtain the finished soft capsule.
As an improvement of the technical scheme, the step (1) comprises the following steps:
(1.1) uniformly mixing 90-95% of the total amount of polyethylene glycol with water, heating to 30-60 ℃, adding guaifenesin, and uniformly mixing to obtain a first solution;
(1.2) adding theophylline into the first solution, and uniformly mixing;
and (1.3) adding the rest polyethylene glycol, grinding for at least three times by using a colloid mill, then degassing at least once in vacuum, and stirring for 5-10 min to obtain a medicine suspension.
Correspondingly, the invention also discloses application of the phlegm-eliminating asthma-relieving pharmaceutical composition in medicines for treating the symptoms of excessive phlegm cough in respiratory diseases.
The implementation of the invention has the following beneficial effects:
1. the invention combines theophylline and guaifenesin, effectively improves the treatment effect of eliminating phlegm and relieving asthma, and ensures that the medicine can be used for treating asthmatic bronchitis, chronic bronchitis, bronchial asthma and other diseases.
2. The preparation of the invention adopts soft capsules, and has the advantages of fast dissolution, high bioavailability, beautiful appearance, convenient carrying and taking and the like.
3. The invention adopts the compatibility of theophylline, guaifenesin, polyethylene glycol and water to form a medicament suspension formula in the soft capsule. Wherein, the guaifenesin can be dissolved in the polyethylene glycol, thereby promoting the solubility of the theophylline in water. Meanwhile, the water in the soft capsule can maintain the water balance between the drug suspension and the rubber, and prevent the polyethylene glycol from absorbing the water in the rubber so as to harden the rubber of the soft capsule. Thereby keeping the soft capsule skin and being beneficial to the disintegration of the capsule.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to specific embodiments.
The invention provides a pharmaceutical composition for eliminating phlegm and relieving asthma, which contains theophylline, guaifenesin and auxiliary materials; wherein the content of theophylline is 120-200mg per unit preparation, and the content of guaifenesin is 80-120mg per unit preparation.
The theophylline can reduce the tension of smooth muscles and expand respiratory tracts, can promote the release of endogenous adrenaline and noradrenaline and relax the smooth muscles of the airways, inhibits the release of calcium ions from endoplasmic reticulum of the smooth muscles, and reduces the concentration of the calcium ions in cells to generate the respiratory tract expansion effect, and has stronger relaxation effect on the smooth muscles but is less than β receptor agonist.
In the pharmaceutical composition, the content of theophylline is 120-200mg per unit preparation, and when the content of theophylline is more than 200mg, toxic and side effects on systems such as nerves, gastrointestinal tracts, cardiovascular systems and the like are large; when the theophylline content is less than 120mg, the half-life period of the medicine is short, the medicine supply amount needs to be increased, and the use is troublesome. Preferably, the theophylline content is 150mg per unit formulation.
Among them, guaifenesin can dissolve viscous mucus and relieve dyspnea. It reduces the viscosity of bronchial secretions, thereby increasing mucus flow, which can then be removed by coughing.
In the pharmaceutical composition, the content of the guaifenesin is 80-120mg, preferably 90mg, per unit preparation.
Specifically, the dosage form of the pharmaceutical composition of the present invention may be a tablet, a granule, an emulsion, a suspension, a soft capsule, a syrup, or a gel.
The skilled person can select corresponding common auxiliary materials according to different dosage forms. If the dosage form is syrup, adjuvants such as sucrose, distilled water, sodium benzoate, and sweetener can be selected. When the preparation is suspension, auxiliary materials such as sucrose, sorbitol, silicon dioxide, hydroxymethyl cellulose and the like can be selected.
Preferably, the dosage form of the pharmaceutical composition provided by the invention is soft capsule, and the pharmaceutical composition has the advantages of fast dissolution, high bioavailability, beautiful appearance, convenience for carrying and taking and the like.
Specifically, when the pharmaceutical composition of the present invention is in the form of a soft capsule, the pharmaceutical composition includes a pharmaceutical suspension and a gelatin skin. Wherein the medicine suspension consists of theophylline, guaifenesin and a first auxiliary material; the rubber sheet consists of a second auxiliary material.
Specifically, the first auxiliary material comprises a suspending agent, a rubber softening agent and an antioxidant. The suspending agent can be one or more selected from polyethylene glycol, vegetable oil, ethanol, propylene glycol and glycerol; the rubber softener is selected from water, glycerol or propylene glycol; the antioxidant is one or more of vitamin C, vitamin E, butyl hydroxy anisol, propyl gallate, and dibutyl hydroxy toluene.
Preferably, the suspending agent is polyethylene glycol; specifically, PEG200, PEG400, PEG600, or PEG800 may be used, but is not limited thereto. Preferably, the suspending agent is PEG400, and the suspending agent has reasonable viscosity and polarity and high solubility to the medicament.
The polyethylene glycol suspending agent has high polarity, so that water in the system is easy to absorb, and the water in the soft capsule shell is transferred to the medicine to cause hardening of the soft capsule. Therefore, the capsule softening agent is added into the medicine suspension in the invention, which can keep the water balance of the medicine suspension and the capsule, so that the capsule keeps a certain softness and is beneficial to disintegration of the capsule. Preferably, the rubber softener is water, and the weight ratio of the water to the polyethylene glycol is controlled to be (1.5-7.5): 1000.
Specifically, the second auxiliary materials for forming the rubber comprise gelatin, glycerol, water, edible pigment, preservative, disintegrant and titanium dioxide; specifically, the antiseptic can be one or more of nipagin complex ester, sodium benzoate, and potassium sorbate; the disintegrant can be fumaric acid. The second adjuvant can also comprise correctant, pH regulator, etc. The correctant can be ethyl vanillin, and the pH regulator can be phosphate.
Specifically, when the pharmaceutical composition of the present invention is in the form of a soft capsule, the preparation method thereof is as follows:
(1) preparing a drug suspension;
specifically, the method comprises the following steps:
(1.1) uniformly mixing 90-95% of the total amount of polyethylene glycol with water, heating to 30-60 ℃, adding guaifenesin, uniformly mixing, and sieving with a 40-mesh sieve to obtain a first solution;
specifically, guaifenesin is first sieved through a 40-mesh sieve and then added. The heating can accelerate the dissolution speed of the guaifenesin in the polyethylene glycol and improve the dissolution amount, and the usage amount of the guaifenesin can be reduced to a certain extent.
(1.2) adding theophylline into the first solution, and uniformly mixing;
specifically, theophylline is sieved by a 40-mesh sieve, and then added into the first solution; in the adding process, the temperature of the first solution is maintained at 30-60 ℃.
And (1.3) adding the rest polyethylene glycol, grinding for at least three times by using a colloid mill, then degassing at least once in vacuum, and stirring for 5-10 min to obtain a medicine suspension.
The preparation process of the content of the invention is simple and convenient to operate, can reduce the solid content of theophylline and guaifenesin in the medicine suspension, is beneficial to pressing into soft capsules, can improve the bioavailability of main medicines in the preparation, and ensures the curative effect.
(2) Preparing a rubber sol;
specifically, various rubber sols are mixed to obtain the rubber sol.
(3) Forming the medicine suspension and the rubber sol by soft capsule forming equipment to obtain pills;
(4) shaping, drying, scrubbing and drying the pills to obtain the finished soft capsule.
Correspondingly, the invention also discloses application of the phlegm-eliminating asthma-relieving pharmaceutical composition in medicines for treating the symptoms of excessive phlegm cough in respiratory diseases. Specifically, the respiratory system diseases are asthmatic bronchitis, chronic bronchitis and bronchial asthma.
The invention is further illustrated by the following specific examples:
example 1
The embodiment provides a pharmaceutical composition for eliminating phlegm and relieving asthma: the content of theophylline in unit preparation is 120mg, the content of guaifenesin is 100mg, and the dosage form is syrup.
The preparation method comprises the following steps: dissolving theophylline and guaifenesin in appropriate amount of water, heating to 60 deg.C, stirring for dissolving; adding 500mL of cane sugar, adding a proper amount of sodium benzoate and a corrective, uniformly stirring, and filtering to obtain the finished product.
Example 2
The present embodiment provides a pharmaceutical composition for eliminating phlegm and relieving asthma, which is in the form of a soft capsule, and comprises a pharmaceutical suspension and a gelatin skin;
wherein, the prescription of the medicine suspension is as follows:
0.09kg of guaifenesin, 0.15kg of anhydrous theophylline, 0.012kg of water and 6.38kg of PEG400;
the gum substance can be selected according to the prior art.
The preparation method comprises the following steps:
weighing about 5.75kg of polyethylene glycol 400, placing in a mixing pot, adding 0.012kg of purified water, mixing, stirring to dissolve completely, heating to 35 ℃, and keeping the temperature. Weighing 0.09kg of guaifenesin according to the prescription amount, sieving with a 40-mesh sieve, adding into the solution while stirring to fully dissolve to obtain a first solution, and continuously keeping the temperature at 35 ℃. Weighing 0.15kg of anhydrous theophylline, sieving with 40 mesh sieve, adding into the first solution under stirring, stirring thoroughly, adding 400-6.38 kg of polyethylene glycol to obtain solution B. Grinding the solution B with colloid mill for 3 times to obtain medicinal liquid. The liquid medicine is degassed for 1 time in vacuum, stirred for 10 minutes, covered and sealed for standby.
Mixing the above medicinal liquid and gelatin skin material, and making into 1000 soft capsules by soft capsule forming equipment.
Example 3
The present embodiment provides a pharmaceutical composition for eliminating phlegm and relieving asthma, which is in the form of a soft capsule, and comprises a pharmaceutical suspension and a gelatin skin;
wherein, the prescription of the medicine suspension is as follows:
0.09kg of guaifenesin, 0.15kg of anhydrous theophylline, 0.036kg of water and 6.38kg of PEG400;
the gum substance can be selected according to the prior art.
The preparation method comprises the following steps:
weighing about 6kg of polyethylene glycol, placing in a mixing pot, adding 0.036kg of purified water, mixing, stirring to dissolve completely, heating to 35 ℃, and keeping the temperature. Weighing 0.09kg of guaifenesin according to the prescription amount, sieving with a 40-mesh sieve, adding into the solution while stirring to fully dissolve to obtain a first solution, and continuously keeping the temperature at 35 ℃. Weighing 0.15kg of anhydrous theophylline, sieving with 40 mesh sieve, adding into the first solution under stirring, stirring thoroughly, adding 400-6.38 kg of polyethylene glycol to obtain solution B. Grinding the solution B with colloid mill for 3 times to obtain medicinal liquid. The liquid medicine is degassed for 1 time in vacuum, stirred for 10 minutes, covered and sealed for standby.
Mixing the above medicinal liquid and gelatin skin material, and making into 1000 soft capsules by soft capsule forming equipment.
The indexes in the preparation processes of the embodiment 2 and the embodiment 3 are monitored, and the results are shown in the following table:
| disintegration time | Difference in weight | Hardness of | |
| Example 2 | ＜30min | ＜5％ | +++ |
| Example 3 | ＜25min | ＜5％ | + |
Example 4 pharmacological experiments
Selecting 40 male guinea pigs, randomly dividing into 4 groups, and 10 male guinea pigs in each group; respectively a control group, an experimental group, a control group and a control group.
The specific test method is as follows:
the drugs were gavaged 1 hour before exposure of the guinea pigs to the citric acid aerosol. Wherein, the distilled water for intragastric administration is 2mL/kg in a control group, the phlegm-eliminating and asthma-relieving pharmaceutical composition (45mg of anhydrous theophylline/kg and 18mg/kg of guaifenesin) in the invention for intragastric administration in an experimental group, the anhydrous theophylline for intragastric administration (45mg/kg) in the control group and the guaifenesin for intragastric administration (18mg/kg) in the control group. The guinea pigs were then exposed to a 0.6mL/min aerosol of citric acid, causing a cough response. The number of coughs within 10 minutes of exposure was recorded and the experimental data was examined using the t-test. The specific results are shown in the following table:
| control group | Experimental group | Control group | Control two groups | |
| Number of coughs | 35.8±2.68 | 13.6±2.15 | 18.2±2.1 | 22.1±3.3 |
Wherein, compared with an experimental group, a control group and a control group, P is less than 0.01 through t test, and the significance is realized. Meanwhile, as can be seen from the table, the combination of theophylline and guaifenesin according to the present invention has a good effect on suppressing cough.
While the foregoing is directed to the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.
Claims (10)
1. A pharmaceutical composition for eliminating phlegm and relieving asthma is characterized in that the pharmaceutical composition contains theophylline, guaifenesin and auxiliary materials;
the content of the theophylline is 120-200mg per unit preparation, and the content of the guaifenesin is 80-120mg per unit preparation.
2. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 1, wherein the content of theophylline is 150mg per unit preparation, and the content of guaifenesin is 90mg per unit preparation.
3. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is a tablet, granule, emulsion, suspension, soft capsule or gel formulation.
4. The phlegm-eliminating asthma-relieving pharmaceutical composition according to any one of claims 1 to 3, which is a soft capsule.
5. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 1 or 4, wherein the auxiliary materials are suspending agents, rubber softeners and rubber raw materials;
the suspending agent is one or more of polyethylene glycol, vegetable oil, ethanol, propylene glycol and glycerol;
the rubber softener is selected from water, glycerol or propylene glycol.
6. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 5, wherein the suspending agent is selected from polyethylene glycol; the rubber softener is water;
wherein the weight ratio of the water to the polyethylene glycol is (1.5-7.5): 1000.
7. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 5, wherein the rubber raw material comprises gelatin, glycerin, water, food color, preservative, titanium dioxide.
8. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 4, wherein the preparation method of the soft capsule comprises the following steps:
(1) preparing a drug suspension;
(2) preparing a rubber sol;
(3) forming the medicine suspension and the rubber sol by soft capsule forming equipment to obtain pills;
(4) shaping, drying, scrubbing and drying the pills to obtain the finished soft capsule.
9. The phlegm-eliminating asthma-relieving pharmaceutical composition according to claim 8, wherein the step (1) comprises:
(1.1) uniformly mixing 90-95% of the total amount of polyethylene glycol with water, heating to 30-60 ℃, adding guaifenesin, and uniformly mixing to obtain a first solution;
(1.2) adding theophylline into the first solution, and uniformly mixing;
and (1.3) adding the rest polyethylene glycol, grinding for at least three times by using a colloid mill, then degassing at least once in vacuum, and stirring for 5-10 min to obtain a medicine suspension.
10. Use of a phlegm-eliminating asthma-relieving pharmaceutical composition according to any one of claims 1 to 9 in a medicament for treating the symptoms of excessive phlegm cough in respiratory diseases.
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