CN104739761A - Preparation method of ambroxol hydrochloride nanoparticles - Google Patents
Preparation method of ambroxol hydrochloride nanoparticles Download PDFInfo
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- CN104739761A CN104739761A CN201310727845.6A CN201310727845A CN104739761A CN 104739761 A CN104739761 A CN 104739761A CN 201310727845 A CN201310727845 A CN 201310727845A CN 104739761 A CN104739761 A CN 104739761A
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- ambroxol hydrochloride
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- hydrochloride nanoparticle
- nanoparticle
- ambroxol
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Abstract
The invention discloses a preparation method of ambroxol hydrochloride nanoparticles. Main components for preparing the ambroxol hydrochloride nanoparticles comprise 1-90wt% of ambroxol hydrochloride and 1-30wt% of poly(n-butylcyanoacrylate. The preparation method of the ambroxol hydrochloride nanoparticles has the advantages of simplicity and few medicinal auxiliary materials, and the above medicinal preparation has the advantages of good stability, definite therapeutic effect and high bioavailability, and is a good medicine for treating acute and chronic respiratory diseases.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of preparation method of ambroxol hydrochloride nanoparticle.
Background technology
Ambroxol hydrochloride is a kind of novel expectorant shown unique characteristics, and its phlegm-dispelling functions is stronger than bromhexine.This product has can make mucolysis, promote pulmonary surfactant synthesis and activate the effects such as mucociliary purification function to also have the adhesion strength reducing sputum and cilium, make sputum be easy to the effect of expectoration.Ambroxol hydrochloride Ambroxol HCl proves in clinical trial: the secretion of this product scalable serosity and mucus, promotes the synthesis of lung surface active material, strengthens fibre swing, increases the Scavenging activity of mucociliary transport system.These product also can increase respiratory tract liquid measure, reduce mucous secretion, can promote secretion and the bronchus ciliary movement of pulmonary surfactant, make expectorant be easy to expectoration, are applicable to accompany sputum to secrete abnormal and expectoration dysfunction acute, chronic respiratory tract disease.
At present, due to the determined curative effect of ambroxol hydrochloride, untoward reaction is few, is Clinical practice expectorant the most widely, and is applicable to old man and child.Therefore, exploitation is suitable for the novel formulation of different crowd is very necessary to meet the needs of clinical application.
Nanoparticle is a kind of novel pharmaceutical carrier, can prevent oxidation of drug, hydrolysis, improves the stability of medicine; Improve bioavailability, strengthen the transmembrane transport ability of medicine, improve curative effect, reduce toxic action etc.A kind of ambroxol hydrochloride nanoparticle of the present invention, is intended to the deficiency overcoming ambroxol hydrochloride tablet, granule clinical practice.
Summary of the invention
The present invention aims to provide a kind of pharmaceutical preparation good stability, determined curative effect, the preparation method of the ambroxol hydrochloride nanoparticle that bioavailability is high.
For achieving the above object, the preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, its specific embodiments is:
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, is characterized in that, the preparation process of this ambroxol hydrochloride nanoparticle is:
(1) PBCA is dissolved in ethanol, for subsequent use;
(2) precision measures ambroxol hydrochloride solution, adds surfactant, antioxidant, stabilizing agent, with salt acid for adjusting pH value to 1.0-3.0, for subsequent use;
(3) under 50-300r/min condition, (1) is slowly added in (2), continue to stir 1-6h, then use sodium hydroxide solution adjust ph to neutral, continue to stir 1-3h, 0.45 μm of filtering with microporous membrane, obtains the milky suspension of ambroxol hydrochloride nanoparticle.
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, is characterized in that this ambroxol hydrochloride nanoparticle take PBCA as capsule material, adopts emulsion polymerization method to prepare ambroxol hydrochloride nanoparticle.
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, it is characterized in that this ambroxol hydrochloride nanoparticle surfactant used be in pluronic gram F-68, OP emulsifying agent, polysorbas20, polysorbate40 one or more.
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, it is characterized in that this ambroxol hydrochloride nanoparticle antioxidant used be in sodium sulfite, sodium sulfite one or both.
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, it is characterized in that this ambroxol hydrochloride nanoparticle stabilizing agent used be in dextran-70, dextran-40 one or both.
The preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, is characterized in that this ambroxol hydrochloride nanoparticle main component percentage by weight is counted: ambroxol hydrochloride 1-90%, PBCA 1-30%.
Concrete, the preparation method of a kind of ambroxol hydrochloride nanoparticle of the present invention, its specific embodiments is:
(1) PBCA is dissolved in ethanol, for subsequent use.
(2) precision measures 7.5mg/ml ambroxol hydrochloride solution, adds surfactant pluronic gram F-68, dextran-70, sodium sulfite, with salt acid for adjusting pH value to 1.0-3.0, for subsequent use.
(3) under 50-300r/min condition, (1) is slowly added in (2), continue to stir 1-6h, then use sodium hydroxide solution adjust ph to neutral, continue to stir 1-3h, 0.45 μm of filtering with microporous membrane, obtains the milky suspension of ambroxol hydrochloride nanoparticle.
The present invention, compared to other dosage form ambroxol hydrochloride, has the following advantages:
1. medicine good in oxidation resistance, rapidly, stability is strong in hydrolysis;
2. the transmembrane transport ability of medicine is strong, good effect, and bioavailability is high;
3. preparation method is easy and simple to handle, and component is simple, and production cost is low.
Detailed description of the invention
Embodiment is only for further illustrating the present invention below, does not limit the present invention in any form.
Embodiment
Take PBCA as capsule material, adopt emulsion polymerization method to prepare ambroxol hydrochloride nanoparticle.
First, 10ml PBCA is used in ethanol in proper amount, for subsequent use.Then, precision measures 7.5mg/ml ambroxol hydrochloride solution 50ml, adds surfactant pluronic gram F-68 0.2-2.0g, dextran-70 0.2-2.0g, sodium sulfite 1-10g, with salt acid for adjusting pH value to 1.0-3.0, for subsequent use.Finally, under 50-300r/min condition, (1) is slowly added in (2), continues to stir 1-6h, use sodium hydroxide solution adjust ph to neutral again, continue to stir 1-3h, 0.45 μm of filtering with microporous membrane, obtains the milky suspension of ambroxol hydrochloride nanoparticle.
Claims (6)
1. a preparation method for ambroxol hydrochloride nanoparticle, is characterized in that, the preparation process of this ambroxol hydrochloride nanoparticle is:
(1) PBCA is dissolved in ethanol, for subsequent use;
(2) precision measures ambroxol hydrochloride solution, adds surfactant, antioxidant, stabilizing agent, with salt acid for adjusting pH value to 1.0-3.0, for subsequent use;
(3) under 50-300r/min condition, (1) is slowly added in (2), continue to stir 1-6h, then use sodium hydroxide solution adjust ph to neutral, continue to stir 1-3h, 0.45 μm of filtering with microporous membrane, obtains the milky suspension of ambroxol hydrochloride nanoparticle.
2. the preparation method of a kind of ambroxol hydrochloride nanoparticle according to claim 1, is characterized in that this ambroxol hydrochloride nanoparticle take PBCA as capsule material, adopts emulsion polymerization method to prepare ambroxol hydrochloride nanoparticle.
3. the preparation method of a kind of ambroxol hydrochloride nanoparticle according to claim 1, it is characterized in that this ambroxol hydrochloride nanoparticle surfactant used be in pluronic gram F-68, OP emulsifying agent, polysorbas20, polysorbate40 one or more.
4. the preparation method of a kind of ambroxol hydrochloride nanoparticle according to claim 1, it is characterized in that this ambroxol hydrochloride nanoparticle antioxidant used be in sodium sulfite, sodium sulfite one or both.
5. the preparation method of a kind of ambroxol hydrochloride nanoparticle according to claim 1, it is characterized in that this ambroxol hydrochloride nanoparticle stabilizing agent used be in dextran-70, dextran-40 one or both.
6. the preparation method of a kind of ambroxol hydrochloride nanoparticle according to claim 2, is characterized in that this ambroxol hydrochloride nanoparticle main component percentage by weight is counted: ambroxol hydrochloride 1-90%, histoacryl 1-30%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310727845.6A CN104739761A (en) | 2013-12-26 | 2013-12-26 | Preparation method of ambroxol hydrochloride nanoparticles |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310727845.6A CN104739761A (en) | 2013-12-26 | 2013-12-26 | Preparation method of ambroxol hydrochloride nanoparticles |
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| CN104739761A true CN104739761A (en) | 2015-07-01 |
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| CN201310727845.6A Pending CN104739761A (en) | 2013-12-26 | 2013-12-26 | Preparation method of ambroxol hydrochloride nanoparticles |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108057121A (en) * | 2017-12-28 | 2018-05-22 | 广东伊茗药业有限公司 | One kind makes the stability-enhanced pharmaceutical composition of ambroxol hydrochloride |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546008A (en) * | 2003-12-02 | 2004-11-17 | 沈阳药科大学 | Ambroxol hydrochloride liquid sustained release preparation and preparation method thereof |
| CN1628647A (en) * | 2004-10-11 | 2005-06-22 | 成都拜特尔药业有限公司 | Ambroxol hydrochloride granule |
| EP1820493A2 (en) * | 2006-02-10 | 2007-08-22 | PARI Pharma GmbH | Aerosols for sinunasal drug delivery |
| CN101053810A (en) * | 2007-03-01 | 2007-10-17 | 上海交通大学 | Method for preparing high molecular micro nanometer capsule |
-
2013
- 2013-12-26 CN CN201310727845.6A patent/CN104739761A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546008A (en) * | 2003-12-02 | 2004-11-17 | 沈阳药科大学 | Ambroxol hydrochloride liquid sustained release preparation and preparation method thereof |
| CN1628647A (en) * | 2004-10-11 | 2005-06-22 | 成都拜特尔药业有限公司 | Ambroxol hydrochloride granule |
| EP1820493A2 (en) * | 2006-02-10 | 2007-08-22 | PARI Pharma GmbH | Aerosols for sinunasal drug delivery |
| CN101053810A (en) * | 2007-03-01 | 2007-10-17 | 上海交通大学 | Method for preparing high molecular micro nanometer capsule |
Non-Patent Citations (3)
| Title |
|---|
| 张志荣等: "载药毫微粒制备方法及药物靶向性", 《华西药学杂志》 * |
| 盛坤贤: "制备聚氰基丙烯酸异丁酯毫微囊的新工艺", 《世界临床药物》 * |
| 高申主编: "《现代药物新剂型新技术》", 31 January 2002, 人民军医出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108057121A (en) * | 2017-12-28 | 2018-05-22 | 广东伊茗药业有限公司 | One kind makes the stability-enhanced pharmaceutical composition of ambroxol hydrochloride |
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Application publication date: 20150701 |
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