CN104771358A - Acebrophylline injection and preparation method thereof - Google Patents
Acebrophylline injection and preparation method thereof Download PDFInfo
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- CN104771358A CN104771358A CN201410018184.4A CN201410018184A CN104771358A CN 104771358 A CN104771358 A CN 104771358A CN 201410018184 A CN201410018184 A CN 201410018184A CN 104771358 A CN104771358 A CN 104771358A
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- injection
- acetic acid
- ambroxol
- theophylline acetic
- theophylline
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Abstract
The invention discloses a preparation method of an acebrophylline injection; dosage forms include a small-capacity injection, a large-capacity injection and a powder injection; the composition comprises an active ingredient of acebrophylline, accessories comprising one or more of mannitol, sorbitol, sodium chloride, lactose, fructose and glucose, acetic acid, citric acid and sodium bisulfate; the pH is in a range of 3.5-6.5, and a filtering system is a filter having a polyvinylidene tetrafluoroethylene membrane and having the pore size of 0.2 [mu]m. The preparation method is simple and fast in process and suitable for industrialized production, the drug administration approach has faster acting than oral administration, and the injection is more suitable for patients to take.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly, relate to injection of a kind of theophylline acetic acid ambroxol and preparation method thereof.
Background technology
Theophylline acetic acid ambroxol (acebrophylline, have another name called surfolase, ambroxolacephyllintae), CASNo.96989-76-3, a kind of double salt by waiting mole ambroxol (ambroxol) and theophylline acetic acids (acephylline) to be formed, therefore, there is ambroxol, the pharmacological action of both theophylline acetic acids and clinical efficacy, for the manufacture of antitussive and the expelling phlegm drugs with bronchiectasis and mucolysis dual function.This medicine (shows Pfizer by Pharmacia (Pharmacia) in 1992, Pfizer) in Italy with trade name surfolase Initial Public Offering, in succession go on the market in countries such as Brazil, Mexico, Korea S, clinical researches a large amount of for a long time shows that this product determined curative effect, safety are high later.
Theophylline acetic acid ambroxol, for ambroxol (Ambroxol) and the double salt of theophylline acetic acid (Acefylline), ambroxol is the active metabolite of bromhexine, almost have no side effect, make the micro-fracture of the acid mucopolysaccharide in sputum, lower the viscosity of expectorant, can promote asthma patient, the sputum particularly with the asthmatic bronchitis patient of sticky expectorant is got rid of.Bitter edible plant alkali acetic acid is phosphodiesterase inhibitor, improves a concentration life bronchial smooth muscle of intracellular loops guanyl, and can strengthen contraction of diaphragm power, also have the cilia activity strengthening bronchial mucosa columnar epithelial cell concurrently, be conducive to expectoration.Two tool synergism, strengthen greatly to the mitigation of asthma, phlegm syndrome shape.
Chronic the moon plug property Pulmonary Diseases (COPD), comprise chronic bronchitis, bronchial asthma and obstructive emphysema etc., its common feature has airway obstruction to sexually revise and obstructive ventilatory disorder, causing " expectorant, crack between the teeth, breathe heavily " three large clinical manifestations thus, is a kind of destructive pulmonary disease weakening breath function due gradually.Many patient Ke Yin expectoration is unfavorable and cause cough more than and pant and have much difficulty in healing, and patient is agonizing, and quality of life is subject to extreme influence, and cardio-pulmonary function so can be caused for a long time constantly to weaken, and finally causes death.Be in global range, cause principal disease that is dead and disease, ranked the 4th that the whole world causes dead disease.In China, chronic obstructive lung illness is the fourth-largest reason of dying of illness in city, is the first reason of dying of illness in rural area.This disease causes China about 1,000,000 people dead every year.The alternative medicine of current Linkage's treatment chronic obstructive pulmonary disease is few.
Summary of the invention
The object of the present invention is to provide a kind of theophylline acetic acid ambroxol that can be used for drug administration by injection, better fast treating obstructive pulmonary disease.
The invention provides a kind of theophylline acetic acid ambroxol injection, its prescription composition comprises: in theophylline acetic acid ambroxol, osmotic pressure regulator or excipient, pH value regulator, antioxidant and water for injection.
Detailed description of the invention
Below by embodiment, the present invention will be further described:
The preparation of theophylline acetic acid ambroxol injection
Embodiment 1 (small-volume injection)
Method for making: get a certain amount of water for injection, add glucose, sodium sulfite, be stirred to dissolve, then add theophylline acetic acid ambroxol 10g, add water for injection again to recipe quantity, with acetic acid adjust pH to 4.0, filter, fill, sealing by fusing, 121 degree of sterilizings in 15 minutes, labeling, packs and obtains theophylline acetic acid ambroxol small-volume injection.
Embodiment 2 (small-volume injection)
Method for making: get a certain amount of water for injection, add sodium chloride, sodium sulfite, be stirred to dissolve, then add theophylline acetic acid ambroxol 1g, add water for injection again to recipe quantity, with hydrochloric acid solution adjust pH to 5.0, filter, fill, sealing by fusing, 115 degree of sterilizings in 30 minutes, labeling, packs and obtains theophylline acetic acid ambroxol small-volume injection.
Embodiment 3 (small-volume injection)
Method for making: get a certain amount of water for injection, add sodium chloride, sodium pyrosulfite, be stirred to dissolve, then add theophylline acetic acid ambroxol 100g, add water for injection again to recipe quantity, with citric acid adjust pH to 6.0, filter, fill, sealing by fusing, 100 degree of 30 minutes flowing steam sterilizations, labeling, packs and obtains alkali acetic acid ambroxol small-volume injection.
Embodiment 4 (small-volume injection)
Method for making: get a certain amount of water for injection, add mannitol, sodium sulfite, be stirred to dissolve, then add theophylline acetic acid ambroxol 100g, add water for injection again to recipe quantity, with acetic acid adjust pH to 5.5, filter, fill, sealing by fusing, 121 degree of sterilizings in 15 minutes, labeling, packs and obtains alkali acetic acid ambroxol small-volume injection.
Embodiment 5 (bulk capacity injection)
Method for making: get a certain amount of water for injection, adds glucose, disodium edetate, is stirred to dissolve, add theophylline acetic acid ambroxol 50g again, then add water for injection to recipe quantity, add needle-use activated carbon 40 DEG C insulation absorption 30min, cross and filter active carbon, with citric acid adjust pH to 5.0, filter, fill, sealing, 121 degree of sterilizings in 15 minutes, labeling, packs and obtains theophylline acetic acid ambroxol bulk capacity injection.
Embodiment 6 (bulk capacity injection)
Method for making: get a certain amount of water for injection, adds sodium chloride, potassium metabisulfite, is stirred to dissolve, then adds theophylline acetic acid ambroxol 100g, add water for injection again to recipe quantity, add needle-use activated carbon 30 DEG C insulation absorption 30min, cross and filter active carbon, with hydrochloric acid adjust pH to 4.5, filter, fill, sealing, 115 degree of sterilizings in 30 minutes, labeling, packs and obtains theophylline acetic acid ambroxol bulk capacity injection.
Embodiment 7 (powder pin)
Method for making: get a certain amount of water for injection, adds mannitol, sodium sulfite, is stirred to dissolve, add theophylline acetic acid ambroxol 50g again, add water for injection to recipe quantity, add needle-use activated carbon 30 DEG C insulation absorption 30min, cross and filter active carbon, with hydrochloric acid solution adjust pH to 4.5, filter, fill, half tamponade, enter freeze drying box, outlet after drying completes, roll lid, labeling, pack and obtain theophylline acetic acid ambroxol injectable powder.
Embodiment 8 (powder pin)
Method for making: get a certain amount of water for injection, adds glucose, calcium disodium edetate, is stirred to dissolve, add theophylline acetic acid ambroxol 20g, then add water for injection to recipe quantity, add needle-use activated carbon 40 DEG C insulation absorption 30min, cross and filter active carbon, with acetic acid adjust pH to 3.5, filter, fill, half tamponade, enter freeze drying box, outlet after drying completes, roll lid, labeling, pack and obtain theophylline acetic acid ambroxol injectable powder.
According to the present invention, advantageously, described theophylline acetic acid ambroxol injection dissolubility in glucose injection and chloride injection equal solvent is good, compatibility stability is good, be applicable to intravenous drip or intravenous injection, do not need to use special solvent or cosolvent, and solution clarity meet the requirements.In addition, also there is good stability, effect duration is grown, store the advantages such as convenient transportation.
Claims (10)
1. a theophylline acetic acid ambroxol injection, is characterized in that this injection can be small-volume injection, bulk capacity injection, injectable powder.
2. theophylline acetic acid ambroxol injection according to claim 1: it is characterized in that the active component that this injection contains is theophylline acetic acid ambroxol, its small-volume injection agent concentration is 0.5 ~ 100mg/mL, greatly, volume injection agent agent concentration is 0.05 ~ 5mg/mL, and injectable powder specification is that 1 ~ 200mg/ props up.
3. theophylline acetic acid ambroxol injection according to claim 2: it is characterized in that this injection injects when being with or without one or more of adding in osmotic pressure regulator or excipient, pH value regulator, antioxidant and be converted to pharmaceutical composition with water.
4. theophylline acetic acid ambroxol injection according to claim 3: osmotic pressure regulator or excipient are one or more in mannitol, sorbitol, xylitol, sodium chloride, lactose, fructose, glucose.
5. theophylline acetic acid ambroxol injection according to claim 3: pH value regulator is one or more in hydrochloric acid, acetic acid, citric acid, succinic acid, sulphuric acid, fumaric acid, citric acid/sodium citrate buffer, acetic acid/sodium-acetate buffer.
6. theophylline acetic acid ambroxol injection according to claim 3: antioxidant be sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, potassium sulfite, Potassium acid sulfite, potassium metabisulfite, edetic acid, disodium edetate, calcium disodium edetate one or more.
7. theophylline acetic acid ambroxol injection according to claim 3: the pH value range 2.5-9.0 that it is characterized in that this injection.
8. theophylline acetic acid ambroxol injection according to claim 7: it is characterized in that the pH value of this injection is preferably 3.5-7.0.
9. theophylline acetic acid ambroxol injection according to claim 8: it is characterized in that the pH value of this injection is preferably 4.0-6.0.
10. theophylline acetic acid ambroxol injection according to claim 3, its preparation method is: get osmotic pressure regulator or excipient, antioxidant joins in a certain amount of water for injection, add theophylline acetic acid ambroxol and be stirred to solution clarification, with pH value regulator adjust pH to 4.0-6.0, add needle-use activated carbon absorption, cross and filter active carbon, fill, sterilizing or lyophilizing, pack and obtain theophylline acetic acid ambroxol injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410018184.4A CN104771358A (en) | 2014-01-14 | 2014-01-14 | Acebrophylline injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410018184.4A CN104771358A (en) | 2014-01-14 | 2014-01-14 | Acebrophylline injection and preparation method thereof |
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| CN104771358A true CN104771358A (en) | 2015-07-15 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410018184.4A Pending CN104771358A (en) | 2014-01-14 | 2014-01-14 | Acebrophylline injection and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727590A (en) * | 2016-01-04 | 2017-05-31 | 石家庄学院 | A kind of suction of stabilization theophylline acetic acid ambroxol solution |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101352419A (en) * | 2007-07-26 | 2009-01-28 | 天津药物研究院 | Acebrophylline sugar-free type granular formulation and preparation method thereof |
| CN101352415A (en) * | 2007-07-26 | 2009-01-28 | 天津药物研究院 | Dosage form and preparation method of acebrophylline oral solution |
| CN101416956A (en) * | 2007-10-22 | 2009-04-29 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride injection |
| CN102670607A (en) * | 2012-05-28 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Compound ambroxol hydrochloride composition and preparation method thereof |
| CN102716076A (en) * | 2012-07-06 | 2012-10-10 | 天津梅花医药有限公司 | Ambroxol hydrochloride medicine combination for injection |
-
2014
- 2014-01-14 CN CN201410018184.4A patent/CN104771358A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101352419A (en) * | 2007-07-26 | 2009-01-28 | 天津药物研究院 | Acebrophylline sugar-free type granular formulation and preparation method thereof |
| CN101352415A (en) * | 2007-07-26 | 2009-01-28 | 天津药物研究院 | Dosage form and preparation method of acebrophylline oral solution |
| CN101416956A (en) * | 2007-10-22 | 2009-04-29 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride injection |
| CN102670607A (en) * | 2012-05-28 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Compound ambroxol hydrochloride composition and preparation method thereof |
| CN102716076A (en) * | 2012-07-06 | 2012-10-10 | 天津梅花医药有限公司 | Ambroxol hydrochloride medicine combination for injection |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727590A (en) * | 2016-01-04 | 2017-05-31 | 石家庄学院 | A kind of suction of stabilization theophylline acetic acid ambroxol solution |
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Application publication date: 20150715 |