CN107550855B - A kind of ambroxol hydrochloride injection composition and preparation method thereof - Google Patents
A kind of ambroxol hydrochloride injection composition and preparation method thereof Download PDFInfo
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- CN107550855B CN107550855B CN201710948428.2A CN201710948428A CN107550855B CN 107550855 B CN107550855 B CN 107550855B CN 201710948428 A CN201710948428 A CN 201710948428A CN 107550855 B CN107550855 B CN 107550855B
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Abstract
The invention discloses a kind of ambroxol hydrochloride injection compositions, include the component of following parts by weight：15 parts of ambroxol hydrochloride, 4.5 7.5 parts of vitamin C, 35 parts of cysteine, 0.15 0.2 parts of EDTA 2Na, appropriate osmotic pressure regulator.The invention also discloses the preparation methods of the injecta composition：The ambroxol hydrochloride is added in water for injection, being heated to 40 50 DEG C makes its dissolving, then adds in EDTA 2Na, stirring and dissolving, the cysteine is added in after being cooled to 20 30 DEG C, after stirring and dissolving, by solution carbon dioxide saturation, add vitamin C, it stirs to dissolve, adds in osmotic pressure regulator, adjust pH value 5.5 6.0, embedding, sterilizing.The pH value of injecta composition of the present invention is 5.5 6.0, reduces sense of discomfort during injection, and stable quality.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of ambroxol hydrochloride injection composition and its preparation
Method.
Background technology
Ambroxol hydrochloride is a kind of respiratory mucus conditioning agent, can promote the exclusion of thick secretions in respiratory tract and subtract
The delay of few mucus, thus expectoration is remarkably promoted, improve breath state, be clinically widely used in various acute and chronic respiratory tract diseases
Thick sputum caused by disease, dys-expectoration etc..Its chemical name is trans- -4- [（2- amino -3,5- dibromo-benzyls）Ammonia
Base] cyclohexanol HCI, structural formula is：
The acute bitter fiber crops of ambroxol hydrochloride mouthfeel, bitter taste and picotement are lasting, and it cannot be by routinely adding in sweetener and rectifying
Taste agent and sheltered, and oral administration biaavailability is relatively low, work slow, be subject to many limitations in clinical practice.In order to adapt to
Parenteral solution can be made in ambroxol hydrochloride by a variety of needs clinically.
The problem of being primarily present in ambroxol hydrochloride injection preparation process is, easily free under oxidation or alkaline condition
Go out ambroxol, so as to increase the content in relation to substance during storage, influence drug effect.It is main using control note in the prior art
It penetrates the relatively low pH value of liquid and adds in stabilizer to improve its stability, but low ph value parenteral solution can be brought not in injection to human body
Suitable, patient compliance is poor.It is inevitable if can make ambroxol hydrochloride injection that can also have preferable stability under higher pH
Be conducive to its further genralrlization application.
Invention content
The purpose of the present invention is being directed to the more than state of the art, a kind of good effect and the at a high ph salt of stable quality are provided
Sour ambroxol injection composition, and preparation method is provided.
The technical solution adopted by the present invention：
A kind of ambroxol hydrochloride injection composition, it includes the components of following parts by weight：15 parts of ambroxol hydrochloride, dimension life
Plain C 4.5-7.5 parts, 3-5 parts of cysteine, 0.15-0.2 parts of EDTA-2Na, appropriate osmotic pressure regulator.
As a further improvement on the present invention, the osmotic pressure regulator is sodium chloride or glucose.
As the preferred embodiment of the present invention, the ambroxol hydrochloride injection composition includes following component：Hydrochloric acid ammonia
15 g of bromine rope, vitamin C 4.5-7.5 g, cysteine 3-5 g, EDTA-2Na 0.15-0.2 g, osmotic pressure regulator are fitted
Amount, water for injection add to 2000ml.
As a further improvement on the present invention, the preparation method of the ambroxol hydrochloride injection composition is：By described in
Ambroxol hydrochloride is added in water for injection, and being heated to 40-50 DEG C makes its dissolving, then adds in EDTA-2Na, stirring and dissolving, cooling
It adds in the cysteine after to 20-30 DEG C, after stirring and dissolving, by solution carbon dioxide saturation, adds vitamin C, stir
Mixing makes its dissolving, adds in osmotic pressure regulator, adjusts pH value 5.5-6.0, embedding, sterilizing.
The present invention also provides the preparation methods of the ambroxol hydrochloride injection composition, include the following steps：By institute
It states ambroxol hydrochloride to add in water for injection, being heated to 40-50 DEG C makes its dissolving, then adds in EDTA-2Na, and stirring and dissolving is cold
But to the cysteine is added in after 20-30 DEG C, after stirring and dissolving, by solution carbon dioxide saturation, vitamin C is added,
It stirs to dissolve, adds in osmotic pressure regulator, adjust pH value 5.5-6.0, embedding, sterilizing.
The pH value of injecta composition of the present invention is 5.5-6.0, reduces sense of discomfort during injection, reports in the prior art
Ambroxol hydrochloride injection is stablized in pH 4.3-4.8, when pH is more than 5, drug content and related content of material then change compared with
Greatly, stability is poor, and parenteral solution of the present invention is acted synergistically by vitamin C, cysteine and EDTA-2Na three, and is optimized
The addition sequence of each component in technique makes product stable quality under pH values 5.5-6.0, in high temperature, illumination, acceleration and long-term
In stability test, in relation to substance, drug content, osmotic pressure and pH value etc. significant change does not occur for the character of parenteral solution.
Carbon dioxide is passed through in preparation process can effectively buffer the variation of pH value when parenteral solution enters blood, prevent ambroxol in blood
Middle precipitation, makes efficacy stability.
It reports in the prior art, by ambroxol hydrochloride injection（Mucosolvin）Easily go out after being mixed with vitamin C injection
The situation of existing pH value apparent increase, it is not recommended that be used in mixed way ambroxol injection and vitamin C injection.The present invention is studying
It finds in the process, vitamin C is only added in ambroxol hydrochloride injection, pH value is significantly raised in storage, the Guang ammonia of vitamin C/half
PH value also has obvious raising when acid, vitamin C/EDTA are respectively combined use, so as to increase the free of ambroxol, makes to have
Closing substance increases, and drug content reduces, and influences the quality stability of parenteral solution.And three can then make the stabilization of parenteral solution after sharing
Property significantly improve, each performance parameter is without occurring apparent variation in storage process.
In addition, human body immunity when infecting breathing problem reduces, vitamin C can participate in internal a variety of metabolic processes,
Increase body resistivity, and with antioxidation, patient's body is helped to improve with ambroxol hydrochloride application
Immunocompetence is conducive to improve drug effect, makes patient's rehabilitation as early as possible.
Specific embodiment
Embodiment 1
Prescription：
Ambroxol hydrochloride 15g
Vitamin C 4.5g
Cysteine 3g
EDTA-2Na 0.2g
Appropriate sodium chloride
Water for injection adds to 2000ml
Preparation method：The ambroxol hydrochloride is added in water for injection, being heated to 40-50 DEG C makes its dissolving, Ran Houjia
Enter EDTA-2Na, stirring and dissolving adds in the cysteine after being cooled to 20-30 DEG C, after stirring and dissolving, by solution titanium dioxide
Carbon saturation, adds vitamin C, stirs to dissolve, and adds in sodium chloride and adjusts osmotic pressure, adjust pH value 5.5-6.0, embedding is gone out
Bacterium.
Embodiment 2
Prescription：
Ambroxol hydrochloride 15g
Vitamin C 7.5g
Cysteine 5g
EDTA-2Na 0.15g
Appropriate sodium chloride
Water for injection adds to 2000ml
Preparation method：The ambroxol hydrochloride is added in water for injection, being heated to 40-50 DEG C makes its dissolving, Ran Houjia
Enter EDTA-2Na, stirring and dissolving adds in the cysteine after being cooled to 20-30 DEG C, after stirring and dissolving, by solution titanium dioxide
Carbon saturation, adds vitamin C, stirs to dissolve, and adds in sodium chloride and adjusts osmotic pressure, adjust pH value 5.5-6.0, embedding is gone out
Bacterium.
Embodiment 3
Prescription：
Ambroxol hydrochloride 15g
Vitamin C 5.5g
Cysteine 4g
EDTA-2Na 0.2g
Appropriate sodium chloride
Water for injection adds to 2000ml
Preparation method：The ambroxol hydrochloride is added in water for injection, being heated to 40-50 DEG C makes its dissolving, Ran Houjia
Enter EDTA-2Na, stirring and dissolving adds in the cysteine after being cooled to 20-30 DEG C, after stirring and dissolving, by solution titanium dioxide
Carbon saturation, adds vitamin C, stirs to dissolve, and adds in glucose and adjusts osmotic pressure, adjust pH value 5.5-6.0, embedding is gone out
Bacterium.
Comparative example 1-3
The composition of comparative example 1-3 is as follows：
Preparation method is same as Example 1.
1 high temperature influence factor of experimental example is tested
The parenteral solution of embodiment 1 and comparative example 1 at 60 DEG C is stored, the results are shown in Table 1.
1 high temperature influence factor of table is tested
。
2 illumination effect Factor Experiment of experimental example
The parenteral solution of embodiment 1 and comparative example 1 under 4500LX is stored, the results are shown in Table 2.
2 illumination effect Factor Experiment of table
。
3 accelerated stability of experimental example is tested
The parenteral solution of embodiment 1 and comparative example 1 at 40 DEG C is stored, the results are shown in Table 3.
3 accelerated stability of table is tested
。
4 long-time stability of experimental example are tested
The parenteral solution of embodiment 1 and comparative example 1 at 25 DEG C is stored, the results are shown in Table 4.
4 long-time stability of table are tested
Continued 4
。
By more than experimental example as it can be seen that vitamin C, cysteine and EDTA-2Na cooperate with the work for agent of playing stably in the present invention
With making ambroxol hydrochloride injection that can keep excellent stability under the high ph-values of 5.5-6.0, character, contains related substance
Amount and pH value etc. had no significant change in 5 years.
By embodiment 1 and comparative example 1 as it can be seen that the ambroxol injection that comparative example 1 is added to vitamin C was being stored
Occurs the phenomenon that pH value is significantly raised in journey, related content of material also significantly increases, and embodiment 1 can then protect in 5 years
Hold relatively stable pH value.In addition, adding cysteine and EDTA-2Na after vitamin is added, pH value also can be compared with embodiment
1 has a degree of raising, illustrates that the preparation method of the present invention is also made that contribution to the raising of parenteral solution stability.
The quality stability and embodiment 1 of embodiment 2 and embodiment 3 are suitable, and details are not described herein.
It these are only the exhaustion of the better embodiment rather than its embodiment of the present invention, those skilled in the art exist
Any improvement for not having creativeness made under the spirit and principles in the present invention, is considered as in protection scope of the present invention
It is interior.
Claims (3)
1. a kind of ambroxol hydrochloride injection composition, it is characterised in that it includes the components of following parts by weight：Ambroxol hydrochloride
15 parts, 4.5~7.5 parts of vitamin C, 3~5 parts of cysteine, 0.15~0.2 part of EDTA-2Na, appropriate osmotic pressure regulator,
Preparation method is：The ambroxol hydrochloride is added in water for injection, being heated to 40~50 DEG C makes its dissolving, then adds in
EDTA-2Na, stirring and dissolving add in the cysteine after being cooled to 20~30 DEG C, after stirring and dissolving, by solution titanium dioxide
Carbon saturation, adds vitamin C, stirs to dissolve, and adds in osmotic pressure regulator, adjusts pH value 5.5~6.0, embedding, and sterilizing is
It can.
2. ambroxol hydrochloride injection composition according to claim 1, it is characterised in that：The osmotic pressure regulator is
Sodium chloride or glucose.
3. ambroxol hydrochloride injection composition according to claim 1, it is characterised in that it includes following components：Hydrochloric acid
Ambroxol 15g, 4.5~7.5g of vitamin C, cysteine 0.15~0.2g of 3~5g, EDTA-2Na, osmotic pressure regulator are fitted
Amount, water for injection add to 2000ml.
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