CN116077430A - Ambroxol oral solution - Google Patents
Ambroxol oral solution Download PDFInfo
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- CN116077430A CN116077430A CN202211583602.5A CN202211583602A CN116077430A CN 116077430 A CN116077430 A CN 116077430A CN 202211583602 A CN202211583602 A CN 202211583602A CN 116077430 A CN116077430 A CN 116077430A
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Abstract
The invention relates to an oral solution of ambroxol. Specifically, the invention provides an ambroxol oral solution, which comprises ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water. The ambroxol oral solution can effectively improve the bitter taste and the residual problem thereof, has excellent mouthfeel, and also has excellent illumination, high temperature and high humidity stability, thereby having excellent storage and transportation stability and ensuring quality safety.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to an ambroxol oral solution.
Background
The ambroxol oral solution contains ambroxol hydrochloride and clenbuterol hydrochloride, and is used for treating cough, viscous sputum, difficult sputum discharge, wheezing and the like caused by acute and chronic respiratory diseases (such as acute and chronic bronchitis, bronchial asthma, emphysema and the like).
The ambroxol oral solution has the advantages of convenient administration, quick effect and the like, and is widely applied clinically. However, existing oral solutions of ambroxol have the problems of bitter taste and residual thereof, which results in low oral compliance of patients, especially children, to the oral solution of ambroxol, and limits the use of the oral solution of ambroxol. In addition, the existing oral solution of ambroxol has the problems of poor light, high temperature and high humidity stability, and needs to be kept in brown bottles in a split charging mode, so that when a patient purchases or uses the oral solution of ambroxol, the characteristics of the oral solution such as clarity, whether precipitate particles exist, mildewing, foreign matters and other deterioration phenomena are difficult to be simply, quickly and effectively observed through the brown bottles, and the problem of medication safety is easy to be caused.
Therefore, there is a need in the art to develop an oral solution of ambroxol that improves the mouthfeel and stability of the oral solution of ambroxol.
Disclosure of Invention
The invention aims to provide an ambroxol oral solution with excellent taste and stability, and the application value of the ambroxol oral solution is improved.
In a first aspect of the present invention, there is provided an oral solution of ambroxol, comprising ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethylcellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water.
Preferably, the ambroxol hydrochloride is 0.05 to 0.30 weight parts, preferably 0.10 to 0.20 weight parts, more preferably 0.15 weight parts.
Preferably, the clenbuterol hydrochloride is 0.00005 to 0.0005 parts by weight, preferably 0.00005 to 0.0003 parts by weight, more preferably 0.0001 parts by weight.
Preferably, the sucralose is 0.05 to 0.3 parts by weight, preferably 0.05 to 0.15 parts by weight, more preferably 0.1 parts by weight.
Preferably, the mannitol is 1 to 4 parts by weight, preferably 1.5 to 2.5 parts by weight, more preferably 2.0 parts by weight.
Preferably, the trehalose is 2-6 parts by weight, preferably 3-5 parts by weight, more preferably 4.0 parts by weight.
Preferably, the hydroxyethyl cellulose is present in an amount of 0.5 to 1.5 parts by weight, preferably 0.7 to 0.9 parts by weight, more preferably 0.8 parts by weight.
Preferably, the citric acid is 0.05-0.5 parts by weight, preferably 0.1-0.3 parts by weight, more preferably 0.2 parts by weight.
Preferably, the sodium citrate is 0.01 to 0.1 part by weight, preferably 0.02 to 0.06 part by weight, more preferably 0.04 part by weight.
Preferably, the sodium bisulfite is in the range of 0.05 to 0.15 parts by weight, preferably 0.06 to 0.10 parts by weight, more preferably 0.08 parts by weight.
Preferably, the glycine is 0.5 to 3.0 parts by weight, preferably 1.0 to 2.0 parts by weight, more preferably 1.5 parts by weight.
Preferably, the glycerol is 2-4 parts by weight, preferably 2.5-3.5 parts by weight, more preferably 3.0 parts by weight.
Preferably, the water is 85-115 parts by weight, preferably 90-110 parts by weight, more preferably 95-105 parts by weight.
Preferably, the water is purified water.
Preferably, the oral solution of ambroxol comprises:
| component (A) | Dosage of |
| Ambroxol hydrochloride | 0.5 to 0.30 part by weight |
| Clenbuterol hydrochloride | 0.00005-0.0005 weight parts |
| Sucralose | 0.05 to 0.3 part by weight |
| Mannitol (mannitol) | 1-4 parts by weight |
| Trehalose | 2-6 parts by weight |
| Hydroxyethyl cellulose | 0.5 to 1.5 parts by weight |
| Citric acid | 0.05 to 0.5 part by weight |
| Sodium citrate | 0.01-0.1 part by weight |
| Sodium bisulfite | 0.05 to 0.15 part by weight |
| Glycine (Gly) | 0.5 to 3.0 parts by weight |
| Glycerol | 2-4 parts by weight; and |
| adding water | 95-105 parts by weight. |
Preferably, the oral solution of ambroxol comprises:
| component (A) | Dosage of |
| Ambroxol hydrochloride | 0.10 to 0.20 part by weight |
| Clenbuterol hydrochloride | 0.00005-0.0003 parts by weight |
| Sucralose | 0.05 to 0.15 part by weight |
| Mannitol (mannitol) | 1.5 to 2.5 parts by weight |
| Trehalose | 3-5 parts by weight |
| Hydroxyethyl cellulose | 0.7 to 0.9 part by weight |
| Citric acid | 0.1 to 0.3 part by weight |
| Sodium citrate | 0.02-0.06 weight portions |
| Sodium bisulfite | 0.06-0.10 part by weight |
| Glycine (Gly) | 1.0 to 2.0 parts by weight |
| Glycerol | 2.5 to 3.5 parts by weight; and |
| adding water | 95-105 parts by weight. |
Preferably, the oral solution of ambroxol comprises:
preferably, the oral solution of ambroxol comprises:
| component (A) | Dosage of |
| Ambroxol hydrochloride | 0.15g |
| Clenbuterol hydrochloride | 0.0001g |
| Sucralose | 0.1g |
| Mannitol (mannitol) | 2.0g |
| Trehalose | 4.0g |
| Hydroxyethyl cellulose | 0.8g |
| Citric acid | 0.2g |
| Sodium citrate | 0.04g |
| Sodium bisulfite | 0.08g |
| Glycine (Gly) | 1.5g |
| Glycerol | 3.0g |
| Adding water | To 100ml. |
In a second aspect of the present invention, there is provided a process for preparing an oral solution of ambroxol according to the first aspect of the present invention, said process comprising the steps of:
mixing ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water to obtain the ambroxol oral solution.
Preferably, the oral solution of ambroxol is prepared by the following method:
taking 83-87% of water with a prescription amount after boiling and cooling, adding hydroxyethyl cellulose, stirring and dissolving at 43-47 ℃, adding glycerol, citric acid and sodium citrate, stirring and dissolving at 43-47 ℃, adding ambroxol hydrochloride and clenbuterol hydrochloride, stirring and dissolving at 43-47 ℃, adding sucralose, mannitol, trehalose, sodium bisulphite and glycine, stirring and dissolving at 43-47 ℃, adding the boiled and cooled water to a fixed volume, stirring and mixing, and sequentially filtering through a microporous filter membrane of 0.45 mu m and a microporous filter membrane of 0.22 mu m to obtain an ambroxol oral solution.
In a third aspect of the invention, there is provided an ambroxol kit comprising an oral solution of ambroxol according to the first aspect of the invention and a transparent container;
the ambroxol oral solution is packaged in the transparent container.
Preferably, the transparent container comprises a transparent plastic container (such as a transparent PET bottle) or a transparent glass container.
According to a fourth aspect of the present invention, there is provided the use of an oral solution of ambroxol according to the first aspect of the present invention for the manufacture of a medicament for the treatment of cough, sticky sputum, difficult sputum ejection, wheezing caused by acute and chronic respiratory diseases.
It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions.
Detailed Description
The invention develops an ambroxol oral solution which comprises ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water. The ambroxol oral solution composed of the specific components can effectively improve the bitter taste and the residual problem thereof, has excellent mouthfeel, and also has excellent illumination, high temperature and high humidity stability, thereby having excellent storage and transportation stability and ensuring quality safety.
Terminology
As used herein, the terms "comprising," "including," and "containing" are used interchangeably, and include not only closed-form definitions, but also semi-closed-form and open-form definitions. In other words, the term includes "consisting of … …", "consisting essentially of … …".
As used herein, the term "ambroxol hydrochloride" has the structure:
ambroxol hydrochloride (CAS number: 23828-92-4)
As used herein, the term "clenbuterol hydrochloride" has the structure:
clenbuterol hydrochloride (CAS number: 21898-19-1)
As used herein, the term "impurity B" has a CAS number of 15942-08-2.
As used herein, the term "PET" refers to polyethylene terephthalate, english name Poly (ethylene Terephthalate).
As used herein, the term "parts by weight" may be any fixed weight in milligrams, grams, or kilograms (e.g., 1mg, 1g, or 1kg, etc.). For example, a composition comprising 1 part by weight of component a and 9 parts by weight of component b may be a composition comprising 1 gram of component a+9 gram of component b, or 10 grams of component a+90 gram of component b, etc. In the pharmaceutical composition, the percentage content of a certain component= (the parts by weight of the component/the sum of the parts by weight of all components) ×100%, and therefore, in the composition composed of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.
Ambroxol oral solution and preparation method thereof
The invention provides an ambroxol oral solution with excellent taste and stability, which improves the application value of the ambroxol oral solution.
The oral solution of ambroxol according to the present invention may include, but is not limited to, ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethylcellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol, and water.
In the oral solution of ambroxol, the components act together to ensure that the oral solution of ambroxol has excellent taste and stability, thereby improving the application value of the oral solution of ambroxol.
In the oral solution of ambroxol according to the present invention, the amount of ambroxol hydrochloride may be 0.05 to 0.30 parts by weight, preferably 0.10 to 0.20 parts by weight, more preferably 0.15 parts by weight.
In the oral solution of ambroxol according to the present invention, the clenbuterol hydrochloride may be used in an amount of 0.00005 to 0.0005 parts by weight, preferably 0.00005 to 0.0003 parts by weight, more preferably 0.0001 parts by weight.
In the oral solution of ambroxol according to the present invention, the sucralose may be used in an amount of 0.05 to 0.3 parts by weight, preferably 0.05 to 0.15 parts by weight, more preferably 0.1 parts by weight.
In the oral solution of ambroxol according to the present invention, mannitol may be used in an amount of 1 to 4 parts by weight, preferably 1.5 to 2.5 parts by weight, more preferably 2.0 parts by weight.
In the oral solution of ambroxol according to the present invention, the trehalose may be used in an amount of 2 to 6 parts by weight, preferably 3 to 5 parts by weight, more preferably 4.0 parts by weight.
In the oral solution of ambroxol according to the present invention, the amount of hydroxyethyl cellulose may be 0.5 to 1.5 parts by weight, preferably 0.7 to 0.9 parts by weight, more preferably 0.8 parts by weight.
In the oral solution of ambroxol according to the invention, the amount of citric acid may be 0.05-0.5 parts by weight, preferably 0.1-0.3 parts by weight, more preferably 0.2 parts by weight.
In the oral solution of ambroxol of the present invention, the amount of sodium citrate may be 0.01 to 0.1 part by weight, preferably 0.02 to 0.06 part by weight, more preferably 0.04 part by weight.
In the oral solution of ambroxol according to the present invention, the sodium bisulfite may be used in an amount of 0.05 to 0.15 parts by weight, preferably 0.06 to 0.10 parts by weight, more preferably 0.08 parts by weight.
In the oral solution of ambroxol according to the invention, glycine may be used in an amount of 0.5 to 3.0 parts by weight, preferably 1.0 to 2.0 parts by weight, more preferably 1.5 parts by weight.
In the oral solution of ambroxol according to the present invention, the glycerin may be used in an amount of 2 to 4 parts by weight, preferably 2.5 to 3.5 parts by weight, more preferably 3.0 parts by weight.
In the oral solution of ambroxol according to the invention, the water may be used in an amount of 85 to 105 parts by weight, preferably 90 to 110 parts by weight, more preferably 95 to 105 parts by weight.
Typically, the oral solution of ambroxol according to the invention comprises:
typically, the oral solution of ambroxol comprises:
| component (A) | Dosage of |
| Ambroxol hydrochloride | 0.15g |
| Clenbuterol hydrochloride | 0.0001g |
| Sucralose | 0.1g |
| Mannitol (mannitol) | 2.0g |
| Trehalose | 4.0g |
| Hydroxyethyl cellulose | 0.8g |
| Citric acid | 0.2g |
| Sodium citrate | 0.04g |
| Sodium bisulfite | 0.08g |
| Glycine (Gly) | 1.5g |
| Glycerol | 3.0g |
| Adding water | To 100ml. |
The ambroxol oral solution can be prepared by a mixing method, for example, ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water are mixed to obtain the ambroxol oral solution.
The main excellent technical effects of the invention include:
the invention develops the ambroxol oral solution, which can effectively improve the bitter taste and the residual problem, has excellent taste and strong oral compliance of patients. The ambroxol oral solution provided by the invention also has excellent illumination, high temperature and high humidity stability, so that the ambroxol oral solution has excellent storage and transportation stability, and ensures quality safety.
The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental procedure, in which specific conditions are not noted in the examples below, is generally followed by conventional conditions.
EXAMPLE 1 oral solution of ambroxol
The composition of the oral solution of ambroxol of this example 1 is shown in Table 1:
TABLE 1 prescription composition of ambroxol oral solution
| Component (A) | Dosage of |
| Ambroxol hydrochloride | 0.15g |
| Clenbuterol hydrochloride | 0.0001g |
| Sucralose | 0.1g |
| Mannitol (mannitol) | 2.0g |
| Trehalose | 4.0g |
| Hydroxyethyl cellulose | 0.8g |
| Citric acid | 0.2g |
| Sodium citrate | 0.04g |
| Sodium bisulfite | 0.08g |
| Glycine (Gly) | 1.5g |
| Glycerol | 3.0g |
| Adding purified water | To 100ml. |
Preparation method
Taking boiled and cooled purified water with a prescription amount of 85%, adding hydroxyethyl cellulose with a prescription amount of glycerin, citric acid with a prescription amount of sodium citrate after stirring and dissolving at 45 ℃, adding ambroxol hydrochloride with a prescription amount of and clenbuterol hydrochloride after stirring and dissolving at 45 ℃, adding sucralose with a prescription amount of mannitol, trehalose with a prescription amount of sodium bisulfate and glycine with a prescription amount of after stirring and dissolving at 45 ℃, adding the boiled and cooled purified water to a dosage volume after stirring and dissolving at 45 ℃, sequentially filtering through a 0.45 mu m microporous membrane and a 0.22 mu m microporous membrane after stirring and mixing to obtain an ambroxol oral solution, subpackaging in a transparent PET bottle, wherein the ambroxol hydrochloride has a specification of 1.5mg/ml and the clenbuterol hydrochloride has a specification of 1 mu g/ml.
EXAMPLE 2 oral solution of ambroxol
The formulation composition of the oral solution of ambroxol of this example 2 is shown in table 2:
table 2 prescription composition of ambroxol oral solution
Preparation method
Adding 85% of the prescription amount of purified water after boiling and cooling, adding the prescription amount of hydroxyethyl cellulose, stirring and dissolving at 45 ℃, adding the prescription amount of glycerin, the prescription amount of citric acid and the prescription amount of sodium citrate, stirring and dissolving at 45 ℃, adding the prescription amount of ambroxol hydrochloride and the prescription amount of clenbuterol hydrochloride, stirring and dissolving at 45 ℃, adding the prescription amount of sucralose, the prescription amount of mannitol, the prescription amount of trehalose and the prescription amount of sodium bisulfite, stirring and dissolving at 45 ℃, adding the boiled and cooled purified water to a dispensing volume, stirring and mixing, sequentially filtering through a microporous filter membrane of 0.45 mu m and a microporous filter membrane of 0.22 mu m to obtain an ambroxol oral solution, subpackaging in a transparent PET bottle, wherein the specification of ambroxol hydrochloride is 1.5mg/ml, and the specification of clenbuterol hydrochloride is 1 mu g/ml.
EXAMPLE 3 oral solution of ambroxol
The formulation composition of the oral solution of ambroxol of this example 3 is shown in table 3:
TABLE 3 prescription composition of ambroxol oral solution
| Component (A) | Dosage of |
| Ambroxol hydrochloride | 0.15g |
| Clenbuterol hydrochloride | 0.0001g |
| Sucralose | 0.1g |
| Mannitol (mannitol) | 4.0g |
| Trehalose | 1.0g |
| Hydroxyethyl cellulose | 0.8g |
| Citric acid | 0.2g |
| Sodium citrate | 0.04g |
| Sodium bisulfite | 0.08g |
| Glycine (Gly) | 1.5g |
| Glycerol | 3.0g |
| Adding purified water | To 100ml. |
Preparation method
Taking boiled and cooled purified water with a prescription amount of 85%, adding hydroxyethyl cellulose with a prescription amount of glycerin, citric acid with a prescription amount of sodium citrate after stirring and dissolving at 45 ℃, adding ambroxol hydrochloride with a prescription amount of and clenbuterol hydrochloride after stirring and dissolving at 45 ℃, adding sucralose with a prescription amount of mannitol, trehalose with a prescription amount of sodium bisulfate and glycine with a prescription amount of after stirring and dissolving at 45 ℃, adding the boiled and cooled purified water to a dosage volume after stirring and dissolving at 45 ℃, sequentially filtering through a 0.45 mu m microporous membrane and a 0.22 mu m microporous membrane after stirring and mixing to obtain an ambroxol oral solution, subpackaging in a transparent PET bottle, wherein the ambroxol hydrochloride has a specification of 1.5mg/ml and the clenbuterol hydrochloride has a specification of 1 mu g/ml.
EXAMPLE 4 oral solution of ambroxol
The formulation composition of the oral solution of ambroxol of this example 4 is shown in table 4:
table 4 prescription composition of ambroxol oral solution
| Component (A) | Dosage of |
| Ambroxol hydrochloride | 0.15 g |
| Clenbuterol hydrochloride | 0.0001g |
| Sucralose | 0.1 g |
| Mannitol (mannitol) | 2.0 g |
| Trehalose | 4.0 g |
| Hydroxyethyl cellulose | 1.0 g |
| Citric acid | 0.2 g |
| Sodium citrate | 0.04 g |
| Sodium bisulfite | 0.08 g |
| Glycine (Gly) | 1.5 g |
| Glycerol | 1.0 g |
| Adding purified water | To 100ml. |
Preparation method
Adding 85% of the prescription amount of purified water after boiling and cooling, adding the prescription amount of hydroxyethyl cellulose, stirring and dissolving at 45 ℃, adding the prescription amount of glycerin, the prescription amount of citric acid and the prescription amount of sodium citrate, stirring and dissolving at 45 ℃, adding the prescription amount of ambroxol hydrochloride and the prescription amount of clenbuterol hydrochloride, stirring and dissolving at 45 ℃, adding the prescription amount of sucralose, the prescription amount of mannitol, the prescription amount of trehalose, the prescription amount of sodium bisulfite and the prescription amount of glycine, stirring and dissolving at 45 ℃, adding the boiled and cooled purified water to a dosage volume, stirring and mixing, sequentially filtering through 0.45 mu m and 0.22 mu m microporous membranes to obtain an ambroxol oral solution, subpackaging in transparent PET bottles, wherein the ambroxol hydrochloride has a specification of 1.5mg/ml and the clenbuterol hydrochloride has a specification of 1 mu g/ml.
Investigation of formulations
1. Taste investigation
Oral solutions of examples 1 to 4 were orally administered to 20 subjects, and the taste of the oral solutions was evaluated as the taste bitter and bitter residual, and the evaluation criteria were as follows: 0 minutes (none, pleasant mouthfeel); score 1 (slight, no impact on mouthfeel); 2 minutes (have, influence on mouthfeel); score 3 (more severe, acceptable); score 4 (severe, unacceptable). The taste of the oral solution of ambroxol was evaluated by a single blind method, and the subject could not make a possible taste judgment in advance for the oral solution of ambroxol to be tasted, and the taste evaluation results of the oral solution of ambroxol are shown in table 5.
Table 5 taste evaluation of ambroxol oral solutions prepared in examples 1 to 4
As can be seen from table 5, the oral solution of ambroxol prepared in this example can effectively improve the bitter taste of ambroxol and the residual problem thereof, and improve the oral compliance of the oral solution of ambroxol.
2. Stability investigation
2.1 investigation of the light stability
Stability of the oral solution of ambroxol prepared in examples 1-4 and packaged in transparent PET bottle under illumination (4500 lx,25 ℃) for 0 days, 10 days and 30 days was examined according to the principle of stability test of Chinese pharmacopoeia preparations, and properties and impurity contents (%) of the oral solution of ambroxol at different examination time points were determined by high performance liquid chromatography.
The examination results of the different examination times of the ambroxol oral solutions prepared in examples 1 to 4 and packaged in transparent PET bottles under the illumination condition are shown in Table 6.
TABLE 6 stability investigation results of ambroxol oral solutions prepared in examples 1-4 under light conditions (4500 lx,25 ℃)
As can be seen from Table 6, the oral solution of ambroxol prepared in example 1 has the most excellent light stability, and can be stored in a transparent container in a split manner.
2.2 accelerated stability investigation
The stability of the oral solution of ambroxol, which is prepared in example 1 and is packaged in a transparent PET bottle, is examined according to the stability test guidelines of Chinese pharmacopoeia preparations, the stability of the oral solution of ambroxol, which is prepared in example 1, is 0 day, 1, 3 and 6 months at the temperature of 40+/-2 ℃ and the relative humidity RH of 75+/-5%, and the properties and impurity contents (%) of the oral solution of ambroxol at different examination time points are measured through high performance liquid chromatography.
The results of various examination times of the ambroxol oral solution prepared in example 1 and packaged in transparent PET bottle at a temperature of 40.+ -. 2 ℃ and a relative humidity of 75.+ -. 5% are shown in Table 7.
Table 7 results of examination of stability of oral solution of ambroxol prepared in example 1 at a temperature of 40±2 ℃ and a relative humidity of 75±5%
As can be seen from table 7, the oral solution of ambroxol prepared in example 1 has excellent high temperature and high humidity stability, can reduce storage and transportation costs, ensures stability of the oral solution of ambroxol during transportation and storage, and ensures quality safety.
While the invention has been described in terms of one embodiment, it should be noted that modifications could be made without departing from the principles of the invention, which would be apparent to those skilled in the art, would also be considered to be within the scope of the invention.
Claims (9)
1. The oral solution of ambroxol is characterized by comprising ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water.
2. An oral solution of ambroxol according to claim 1, wherein ambroxol hydrochloride is 0.05-0.30 parts by weight, preferably 0.10-0.20 parts by weight, more preferably 0.15 parts by weight;
the clenbuterol hydrochloride is 0.00005-0.0005 weight parts, preferably 0.00005-0.0003 weight parts, more preferably 0.0001 weight parts;
the sucralose is 0.05 to 0.3 weight parts, preferably 0.05 to 0.15 weight parts, more preferably 0.1 weight parts;
the mannitol is 1 to 4 parts by weight, preferably 1.5 to 2.5 parts by weight, more preferably 2.0 parts by weight;
the trehalose is 2-6 parts by weight, preferably 3-5 parts by weight, more preferably 4.0 parts by weight;
the hydroxyethyl cellulose is 0.5 to 1.5 parts by weight, preferably 0.7 to 0.9 parts by weight, more preferably 0.8 parts by weight;
the citric acid is 0.05-0.5 weight parts, preferably 0.1-0.3 weight parts, more preferably 0.2 weight parts;
the sodium citrate is 0.01-0.1 weight part, preferably 0.02-0.06 weight part, more preferably 0.04 weight part;
the sodium bisulfite is 0.05 to 0.15 part by weight, preferably 0.06 to 0.10 part by weight, more preferably 0.08 part by weight;
the glycine is 0.5 to 3.0 parts by weight, preferably 1.0 to 2.0 parts by weight, more preferably 1.5 parts by weight;
the glycerin is 2-4 parts by weight, preferably 2.5-3.5 parts by weight, more preferably 3.0 parts by weight; and
the water is 85-115 parts by weight, preferably 90-110 parts by weight, more preferably 95-105 parts by weight.
3. An oral solution of ambroxol according to claim 1, wherein said oral solution of ambroxol comprises:
4. An oral solution of ambroxol according to claim 1, wherein said oral solution of ambroxol comprises:
5. An oral solution of ambroxol according to claim 1, wherein said oral solution of ambroxol comprises:
6. An oral solution of ambroxol according to claim 1, wherein said oral solution of ambroxol comprises:
7. a method of preparing an oral solution of ambroxol according to claim 1, said method comprising the steps of:
mixing ambroxol hydrochloride, clenbuterol hydrochloride, sucralose, mannitol, trehalose, hydroxyethyl cellulose, citric acid, sodium citrate, sodium bisulphite, glycine, glycerol and water to obtain the ambroxol oral solution.
8. An ambroxol kit comprising the oral solution of ambroxol according to claim 1 and a transparent container;
the ambroxol oral solution is packaged in the transparent container.
9. Use of an oral solution of ambroxol according to claim 1 for the preparation of a medicament for the treatment of cough, sticky sputum, difficult sputum ejection, wheezing caused by acute and chronic respiratory diseases.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211583602.5A CN116077430A (en) | 2022-12-10 | 2022-12-10 | Ambroxol oral solution |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211583602.5A CN116077430A (en) | 2022-12-10 | 2022-12-10 | Ambroxol oral solution |
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