CN110856713B - Portable inhalation type medicine for treating acute heart failure attack - Google Patents
Portable inhalation type medicine for treating acute heart failure attack Download PDFInfo
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- CN110856713B CN110856713B CN201810965244.1A CN201810965244A CN110856713B CN 110856713 B CN110856713 B CN 110856713B CN 201810965244 A CN201810965244 A CN 201810965244A CN 110856713 B CN110856713 B CN 110856713B
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
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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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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Abstract
The invention relates to the field of aerosols, and particularly discloses a furosemide aerosol which can be used for rapid administration during acute heart failure attack. The furosemide aerosol comprises the following components: the furosemide, water, ethanol, propylene glycol, coenzyme Q and propellant are tetrafluoroethane and heptafluoropropane. The aerosol prepared by the invention has good spraying effect and placement stability, the content of each sprayed medicine is stable, more than 60 percent of liquid drops can reach 1-5 mu m, and the cardiopulmonary absorption effect is better. Meanwhile, the preparation method of the aerosol is simple, the amplification production difficulty is low, and the preparation method has important economic significance.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to an aerosol for acute heart failure and a preparation method thereof.
Background
Acute Heart Failure (AHF) is a clinical syndrome of acute pulmonary congestion, pulmonary edema accompanied by insufficient tissue and organ perfusion and cardiogenic shock due to pulmonary circulation congestion caused by acute cardiac output drop, increased pulmonary circulation pressure and increased peripheral circulation resistance, which are caused by myocardial contractility decrease and cardiac load aggravation caused by acute attack or aggravated left heart dysfunction, and is most common in left heart failure. Acute heart failure can be aggravated or suddenly caused based on original chronic heart failure, and most patients before onset of the disease are combined with organic cardiovascular diseases, which can be manifested as systolic heart failure or diastolic heart failure. Acute heart failure often endangers life and must be rescued urgently. In recent years, the incidence and mortality of acute heart failure have both increased. The prognosis of patients with acute heart failure is very poor, the fatality rate in hospitalization is 3%, the fatality rate in 60d is 9.6%, and the fatality rates in 3 years and 5 years are respectively as high as 30% and 60%. Therefore, the treatment of acute heart failure has brought enormous social and medical pressure. The period from the onset of the acute heart failure patient to the period of the treatment belongs to the gold period of the rescue of the patient, and if the medicine can be taken in time aiming at the period, the time can be effectively won for the subsequent treatment of the patient.
Furosemide (furosemide) is a potent diuretic with short duration in vivo, and is effective in inhibiting reabsorption of loop ascending filter sodium and chloride, dilating blood vessels in the renal cortex, and repartitioning the renal blood flow. Reasonable use of the quick urine can expand venous blood flow, relieve the pressure of pulmonary artery, relieve fore-and-after load, reduce the filling condition of the left ventricle, improve the blood output of the heart, and the quick urine has very wide application value in the treatment of heart failure. In the prior art, common formulations of furosemide are tablets and injections, and because orally taking furosemide requires a period of time for the drug to enter blood through a digestive system, intestinal wall edema of patients suffering from edema such as congestive heart failure, nephrotic syndrome and the like can also reduce the oral absorption rate of the drug, the patient often takes the drug later when the patient suffers from diseases. Although the injection directly enters blood and has fast onset speed, the injection is difficult to be taken by a patient. Therefore, it is important to provide a drug for treating acute heart failure, which can be administered by itself and has a rapid onset of action when a patient suffers from a disease.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a furosemide aerosol with good stability, which comprises a medicament, a cosolvent, a stabilizer and a propellant. The furosemide aerosol provided by the invention can be conveniently supplied for patients to self-administer medicines when the patients suffer from diseases, and the inventor finds that the formula in the invention enables the medicine to have better dispersibility and can realize the stable injection of the medicine in the research process.
The invention provides a pharmaceutical composition for acute heart failure, which comprises a medicament, water, a cosolvent and a stabilizer. Wherein the drug is furosemide, the cosolvent is one or the combination of ethanol and propylene glycol, and the stabilizer is coenzyme Q.
Coenzyme Q, because of its cardioprotective action, can exert its pharmacological effects as a protective component in a medicament for treating heart failure, and can be added to a medicament as an antioxidant component, making it safer to use. The coenzyme Q is used for the aerosol for the first time, and is found to help improve the stability of the aerosol solution and reduce the sedimentation probability of the medicine.
Preferably, in the above pharmaceutical composition, the ratio of furosemide: coenzyme Q: water: the dosage proportion of the cosolvent is (90-110) mg: (1.5-3.5) mg: (10-20) mL: (75-90) mL.
Preferably, in the pharmaceutical composition, the cosolvent is a composition of ethanol and propylene glycol, wherein the ratio of ethanol to propylene glycol is 1: 1-1.5: 1.
Further preferably, in the above pharmaceutical composition, the ratio of furosemide: coenzyme Q: water: ethanol: the proportion of propylene glycol was 103 mg: 2.9 mg: 47.6 mL: 38.8 mL: 13.6 mL.
In a second aspect of the present invention, an aerosol for acute heart failure is provided, which comprises the above pharmaceutical composition and a propellant, wherein the propellant is tetrafluoroethane, heptafluoropropane or a combination of the tetrafluoroethane and the heptafluoropropane.
Preferably, the propellant in the aerosol is a combination of tetrafluoroethane and heptafluoropropane, and the mixing ratio of tetrafluoroethane to heptafluoropropane is (6-7) to (3-4).
In a third aspect of the present invention, there is provided a method for preparing an aerosol for acute heart failure, the method comprising:
(1) measuring the prescription dose of furosemide and coenzyme Q, dissolving the furosemide and the coenzyme Q in a propylene glycol solution to obtain a medicinal organic solution, dissolving ethanol in a small amount of water, adding the medicinal organic solution into the furosemide organic solution by a method of dripping while stirring, continuously stirring, and filling the balance of aqueous solution.
(2) And (2) filtering the medicine mixed solution prepared in the step (1), filling the medicine mixed solution into an aluminum can, sealing the aluminum can, and adding a propellant to obtain the aerosol.
Preferably, in the preparation method, the usage amount of the propellant is 70% of the volume of the aluminum can, the propellant consists of tetrafluoroethane and heptafluoropropane, and the mixing ratio is (6-7) to (3-4).
Further preferably, the mixing ratio is 7: 3.
Preferably, in the above preparation method, furosemide: coenzyme Q: water: ethanol: the dosage proportion of the propylene glycol is (90-110) mg: (1.5-3.5) mg: (10-20) mL: (40-55) mL: (35-45) mL.
Further preferably, in the above preparation method, furosemide: coenzyme Q: water: ethanol: the dosage proportion of the propylene glycol is 103 mg: 2.8 mg: 13.6 mL: 47.6 mL: 38.8 mL.
The invention has the beneficial effects
1. In the prior art, most furosemide is tablets and injections, and patients with heart failure are often difficult to take in time during acute attack. The furosemide aerosol provided by the invention can be used for timely administration when a patient has an acute attack of heart failure symptoms, so that precious time is won for rescue.
2. The furosemide aerosol provided by the invention has the technical effect of stable spraying, uniform sprayed liquid drops, stable sprayed medicine amount and the like, and the particle size of most of the furosemide aerosol can reach below 5 mu m.
3. The coenzyme Q is used as the stabilizer of the aerosol for the first time, so that the coenzyme Q aerosol has good antioxidant effect and can enhance the protection effect on the heart.
Detailed Description
It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
As described in the background art, most of furosemide in the prior art is tablets and injections, and the patients are difficult to take medicine by themselves in the case of acute attack of heart failure. In order to solve the technical problems, the present application proposes a furosemide aerosol for heart failure.
In order to make the technical solutions of the present application more clearly understood by those skilled in the art, the technical solutions of the present application will be described in detail below with reference to specific examples and comparative examples. The drugs and organic solvents used in the examples are commercially available products, and can be purchased and used by those skilled in the art.
Example 1
Dissolving 103mg of furosemide and 2.8mg of coenzyme Q in 38.8mL of propylene glycol to obtain a medicinal organic solution, measuring 47.6mL of ethanol and 13.5mL of aqueous solution, adding 47.6mL of ethanol into a small amount of water to prepare an ethanol solution, placing the medicinal organic solution in a magnetic stirring device, slowly dripping the ethanol solution while stirring, then slowly dripping the rest of water into the solution in the same way, and continuously stirring for a period of time. And (2) pouring the prepared mixed solution into an aluminum can after passing through a 0.22-micron filter membrane, sealing, and adding propellants of tetrafluoroethane and heptafluoropropane, wherein the mixing ratio of the tetrafluoroethane to the heptafluoropropane is 7: 3.
example 2
Dissolving 91mg of furosemide and 1.6mg of coenzyme Q in 36mL of propylene glycol to obtain a medicinal organic solution, measuring 55mL of ethanol and 18mL of aqueous solution, adding 55mL of ethanol into a small amount of water to prepare an ethanol solution, placing the medicinal organic solution in a magnetic stirring device, slowly dripping the ethanol solution while stirring, then slowly dripping the rest amount of water into the solution in the same way, and continuously stirring for a period of time. And (2) pouring the prepared mixed solution into an aluminum can after passing through a 0.22-micron filter membrane, sealing, and adding propellants of tetrafluoroethane and heptafluoropropane, wherein the mixing ratio of the tetrafluoroethane to the heptafluoropropane is 6: 4.
example 3
Dissolving 108mg of furosemide and 3.3mg of coenzyme Q in 44mL of propylene glycol to obtain a medicinal organic solution, measuring 45mL of ethanol and 13mL of aqueous solution, adding 45mL of ethanol into a small amount of water to prepare an ethanol solution, placing the medicinal organic solution into a magnetic stirring device, slowly dripping the ethanol solution while stirring, then slowly dripping the rest amount of water into the solution in the same way, and continuously stirring for a period of time. And (2) pouring the prepared mixed solution into an aluminum can after passing through a 0.22-micron filter membrane, sealing, and adding propellants of tetrafluoroethane and heptafluoropropane, wherein the mixing ratio of the tetrafluoroethane to the heptafluoropropane is 6: 4.
example 4
Dissolving 103mg of furosemide in 38.8mL of propylene glycol to obtain a medicinal organic solution, measuring 47.6mL of ethanol and 13.5mL of aqueous solution, adding 47.6mL of ethanol into a small amount of water to prepare an ethanol solution, placing the medicinal organic solution into a magnetic stirring device, slowly dripping the ethanol solution while stirring, then slowly dripping the rest of water into the solution in the same way, and continuously stirring for a period of time. And (2) pouring the prepared mixed solution into an aluminum can after passing through a 0.22-micron filter membrane, sealing, and adding propellants of tetrafluoroethane and heptafluoropropane, wherein the mixing ratio of the tetrafluoroethane to the heptafluoropropane is 7: 3.
example 5
The three-phase aerosol specified in the Chinese pharmacopoeia 2005 edition should be subjected to particle size inspection, 400-500 is selected to be observed by a microscope, and most of the drug particles should be controlled below 10 μm and most of the drug particles should be below 5 μm according to the specification.
In the present example, an evaluation test was performed for the aerosol formulation, and the evaluation indexes were as follows:
droplet size: spraying the product in the pressure tank onto the glass slide at the same distance, placing in an incubator at 37 ℃ until the glass slide is volatilized, placing the volatilized glass slide under a microscope to observe the size of the liquid drop, and grading the size of the liquid drop and the uniformity into five grades of 100, 80, 60, 40 and 20.
Solution spraying effect: the same method is adopted to spray the product onto the glass slide, the product spraying condition is observed, and the spraying pressure and the viscosity of the liquid drops on the glass slide in the spraying state are graded into five grades of 100, 80, 60, 40 and 20.
The products of examples 1,2 and 3 were filled into pressure tanks and evaluated, the results of which are shown in the following table:
it can be seen from the data that the products of examples 1,2, and 3 all exhibited a uniform and stable state, with droplet sizes below 10 μm. In example 4, no coenzyme Q was contained, compared to example 1, and although good droplet discharging effect was achieved, the solution appeared slightly milky white. The product prepared by the method of example 1 has the best spraying effect, and more than 70% of the droplet size in the visual field can reach 1-5 μm.
Example 5
In this example, the content of each main drug spray of the product prepared by the present invention was used as an investigation object, and the uniformity of the sprayed dose and the stability of the placement were investigated. Taking 0d, 10d, 30d and 60d products respectively, spraying 10 times in advance until the pressure in the bottle is stable, taking 10 continuous spraying samples (spraying into an EP tube) respectively, and then carrying out high performance liquid chromatography for determination. Wherein, the product 60d in examples 1,2 and 3 still presents a clear and transparent state, while the product in example 4 is placed for 30d and white flocculation and sedimentation already occur.
Taking the product in example 1 as an example, the measurement result shows that the difference of the main content in each group of products is within 20%, and the product in example 1 has good standing stability.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims (4)
1. An aerosol for acute heart failure is characterized by comprising a pharmaceutical composition and a propellant, wherein the propellant is a combination of tetrafluoroethane and heptafluoropropane;
the medicine composition consists of a medicine, water, a cosolvent and a stabilizer, wherein the medicine is furosemide, the cosolvent is a combination of ethanol and propylene glycol, and the stabilizer is coenzyme Q;
the furosemide: coenzyme Q: water: the dosage proportion of the cosolvent is (90-110) mg: (1.5-3.5) mg: (10-20) mL: (75-90) mL;
in the cosolvent, the volume ratio of ethanol to propylene glycol is 1: 1-1.5: 1;
the propellant is 70% of the volume of the aluminum can and is the combination of tetrafluoroethane and heptafluoropropane, and the mixing ratio of tetrafluoroethane to heptafluoropropane is (6-7) to (3-4).
2. The aerosol for acute heart failure of claim 1, wherein the furosemide: coenzyme Q: water: ethanol: the proportion of propylene glycol was 103 mg: 2.9 mg: 47.6 mL: 38.8 mL: 13.6 mL.
3. The aerosol for acute heart failure according to claim 1, wherein the aerosol is prepared by the following process:
(1) measuring the amount of furosemide and coenzyme Q in the prescription, dissolving the furosemide and the coenzyme Q in a propylene glycol solution to obtain a medicinal organic solution, dissolving ethanol in a small amount of water, adding the ethanol into the medicinal organic solution by a method of dripping while stirring, continuously stirring, and supplementing the rest of aqueous solution;
(2) and (2) filtering the medicine mixed solution prepared in the step (1), filling the filtered medicine mixed solution into an aluminum can, sealing the aluminum can, and filling a propellant into the aluminum can to obtain the aerosol.
4. The aerosol for acute heart failure according to claim 3, wherein the mixing ratio of tetrafluoroethane and heptafluoropropane is 7: 3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810965244.1A CN110856713B (en) | 2018-08-23 | 2018-08-23 | Portable inhalation type medicine for treating acute heart failure attack |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810965244.1A CN110856713B (en) | 2018-08-23 | 2018-08-23 | Portable inhalation type medicine for treating acute heart failure attack |
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| CN110856713A CN110856713A (en) | 2020-03-03 |
| CN110856713B true CN110856713B (en) | 2021-08-24 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001035961A1 (en) * | 1999-10-29 | 2001-05-25 | Nitromed, Inc. | Methods of treating vascular diseases characterized by nitric oxide insufficiency |
| CN1878537A (en) * | 2003-11-14 | 2006-12-13 | 佳高泰克有限公司 | Dry powder formulations |
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2018
- 2018-08-23 CN CN201810965244.1A patent/CN110856713B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001035961A1 (en) * | 1999-10-29 | 2001-05-25 | Nitromed, Inc. | Methods of treating vascular diseases characterized by nitric oxide insufficiency |
| CN1878537A (en) * | 2003-11-14 | 2006-12-13 | 佳高泰克有限公司 | Dry powder formulations |
Non-Patent Citations (4)
| Title |
|---|
| "Effects of Furosemide on Ponies with Recurrent Airway Obstruction";R. V. Broadstone et al.;《Pulmonary Pharmacology》;19911231;第203-208页 * |
| "Successful management of a dog that had severe rhabdomyolysis with myocardial and respiratory failure";Raegan J. Wells et al.;《JAVMA》;20090415;第234卷(第8期);第1049-1054页 * |
| "呋塞米雾化吸入在特重度烧伤伴严重吸入性损伤患者中的应用(附20例报告)";尚小可等;《宁夏医科大学学报》;20100228;第32卷(第1期);第109-110页 * |
| "氧气驱动普鲁卡因和速尿气雾吸入治疗婴幼儿毛细支气管炎";谢树红等;《实用临床医学》;20031231;第4卷(第2期);第14页 * |
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