CN104887689A - Medicine composition containing ambroxol hydrochloride and fructose - Google Patents
Medicine composition containing ambroxol hydrochloride and fructose Download PDFInfo
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- CN104887689A CN104887689A CN201510237705.XA CN201510237705A CN104887689A CN 104887689 A CN104887689 A CN 104887689A CN 201510237705 A CN201510237705 A CN 201510237705A CN 104887689 A CN104887689 A CN 104887689A
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- ambroxol hydrochloride
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Abstract
The invention relates to a medicine composition containing ambroxol hydrochloride and fructose, and in particular to combination application packaging. The medicine composition comprises an ambroxol hydrochloride injection and a fructose injection. When the medicine composition is used, the ambroxol hydrochloride injection and the fructose injection are mixed for intravenous dripping, so that the sputum removing and excretion effect is achieved, and the energy and the body fluid of the human body can be further replenished.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of ambroxol-hydrochloride-containing and fructose, be specifically related to a kind of pharmaceutical composition formed primarily of ambroxol hydrochloride injection and fructose injection, belong to medical art.
Background technology
Ambroxol hydrochloride has the characteristic that mucus is got rid of facilitation and dissolved secretions.The eliminating of thick secretions in respiratory tract can be promoted and reduce the delay of mucus, because significantly promote expectoration, improving breath state.During application ambroxol hydrochloride therapy, the secretion of patient's mucus can return to normal condition.Cough and amount of expectoration significantly reduce usually, and thus the surfactant of respiratory mucosa plays its normal defencive function.Ambroxol hydrochloride is fast and remarkable to the distribution of tissue from blood, and lungs are first target organs.Plasma half-life is 7-12 hour, does not have accumulative effect.Ambroxol hydrochloride is mainly at liver metabolism, and about 90% is removed by kidney.Ambroxol hydrochloride is applicable to abnormal with sputum secretion and expectoration dysfunction acute, chronic lung disease, the treatment of eliminating the phlegm of such as chronic bronchitis acute exacerbation, asthmatic bronchitis and bronchial asthma; The prophylactic treatment of Post operation pulmonary complication; The treatment of premature infant and neonatal infant respiratory distress syndrome (IRDS).
Fructose (D-fructose) is a kind of left-handed hexose, is the isomer of glucose, energy and body fluid supplement.Fructose more easily forms glycogen than glucose, and mainly pass through fructokinase metabolism at liver, being easy to metabolism is fruit acid, is converted into energy rapidly.Pharmacokinetic data shows, Healthy People continues input fructose can reach steady plasma-drug concentration 6 ~ 8 mM/ls, in body, ATP and Phos all drop to steady-state level, hepatic clearance be 0.53 ml/g (liver is heavy)/minute, endocellular metabolism meets first order kinetics process.Fructose pharmacological action is substantially identical with glucose, has direct heat supply, supplements effect of body fluid and nutrition whole body.After fructose intravenously administrable, metabolism is but fast than glucose in vivo, is easily absorbed by body, and does not rely on insulin, little to blood sugar influence, is more suitable for diabetes, hepatopathy patients supply energy, supplements body fluid.
Fructose is mainly used in burning under the insulin-resistant states such as postoperative infection or is not suitable for need keeping the skin wet when using glucose or the body fluid supplement therapy of patient of the energy.
Existing patent application CN103393593A, which disclose the pharmaceutical composition of a kind of ambroxol hydrochloride injection and fructose injection, wherein ambroxol hydrochloride injection be add appropriate auxiliaries aseptic parenteral solution or add the sterile freeze-drying preparation that appropriate excipient makes, fructose injection is the aseptic parenteral solution adding appropriate auxiliaries.The specification of ambroxol hydrochloride injection is 2ml:15mg or 4ml:30mg or 15mg/ bottle or 30mg/ bottle; The specification of fructose injection is 250-500ml.
But finding that combination specification content of the present invention is not suitable for infant by further clinical research, dosage is excessive, ignores children aspect, there is certain defect.
But adult's medication non-reduced drug dose just can be used for children, clinical technical problem in the urgent need to address is how reduction drug dose while, also will ensure to have due drug effect.
Summary of the invention
An object of the present invention, provides and a kind ofly can be used for child and use the pharmaceutical composition comprising ambroxol hydrochloride and fructose that can be used for again being grown up and use.
An object of the present invention, provide and a kind ofly can be used for child and use the ambroxol hydrochloride injection that can be used for again being grown up and using and fructose injection to form pharmaceutical composition, wherein, ambroxol hydrochloride injection be add appropriate auxiliaries aseptic parenteral solution or add the sterile freeze-drying preparation that appropriate excipient makes, fructose injection is the aseptic parenteral solution adding appropriate auxiliaries.
Combination application packaging provided by the invention, instils ambroxol hydrochloride injection and fructose injection mixed venous during use.
The specification of drug regimen provided by the invention be ambroxol hydrochloride injection 7.5mg, 15mg, 30mg/ bottle/, fructose injection 50-1000ml.Above-mentioned content reduces drug dose, but ensure that drug effect, can also reduce the side effect of gastrointestinal side effect and anaphylaxis aspect.
As the present invention one preferred embodiment, ambroxol hydrochloride injection can be ambroxol hydrochloride injection, Ambroxol Hydrochloride Glucose Injection, ambroxol hydrochloride sodium chloride injection and Ambroxol Hydrochloride for Injection.
Ambroxol hydrochloride injection of the present invention, wherein, ambroxol hydrochloride injection is by ambroxol hydrochloride and the formulated sterile water solution of appropriate amount of auxiliary materials; Ambroxol Hydrochloride Glucose Injection is by ambroxol hydrochloride and the formulated sterile water solution of glucose; Ambroxol hydrochloride sodium chloride injection is by ambroxol hydrochloride and the formulated sterile water solution of sodium chloride; Ambroxol Hydrochloride for Injection adds by ambroxol hydrochloride the sterile freeze-drying preparation that appropriate excipient makes.
As one of specific embodiment, concrete component and consumption as follows:
As one of specific embodiment, concrete component and consumption as follows:
As one of specific embodiment, concrete component and consumption as follows:
Present invention also offers a kind of preparation method of ambroxol hydrochloride injection, concrete steps are:
(1) in Agitation Tank, the water for injection of total amount 80% is added, temperature control 50-70 DEG C;
(2) add the ambroxol hydrochloride of recipe quantity while stirring, stir and make to dissolve completely;
(3) add the adjuvant of recipe quantity again, stir and make to dissolve completely;
(4) benefit adds to the full amount of water for injection;
(5) detect medicinal liquid pH and should be 4.8-5.2, if any deviation, regulate with 0.5mol/L citric acid soln or 0.5mol/L disodium phosphate soln;
(6) joining in charcoal cabinet the injection-use activated carbon taking cumulative volume 0.03% (g/ml), the medicinal liquid of charcoal amount about 50 times is added by injection-use activated carbon moistening, for subsequent use;
(7) add the injection-use activated carbon of moistening, stir 15 minutes;
(8) solution coarse filtration takes off charcoal, filters through 0.45 μm of cartridge filter;
(9) qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, inflated with nitrogen, sealing, sterilizing, obtains ambroxol hydrochloride injection; Or qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, lyophilization, obtains Ambroxol Hydrochloride for Injection.
Fructose injection of the present invention is the formulated sterile water solution of fructose.
As one of specific embodiment, concrete component and consumption as follows:
Present invention also offers a kind of preparation method of fructose injection, concrete steps are:
(1) densely to join: the water for injection adding recipe quantity 30% in dense preparing tank, add the fructose of recipe quantity, stirring makes it to dissolve, add the moistening medicinal charcoal of recipe quantity 0.05% (g/ml), stir 15 minutes, filtering decarbonization, filters into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to recipe quantity 90%, be 3.8-4.0 by 0.1mol/L hydrochloric acid solution adjust ph, add the moistening medicinal charcoal of recipe quantity 0.05% (g/ml), stir 15 minutes, filtering decarbonization, benefit adds to the full amount of water for injection;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
Present invention also offers a kind of preparation treatment that is combined in by ambroxol hydrochloride injection and fructose injection and secrete abnormal and expectoration dysfunction acute, chronic lung disease with sputum, eliminating the phlegm of such as chronic bronchitis acute exacerbation, asthmatic bronchitis and bronchial asthma; The prevention of Post operation pulmonary complication; Application in premature infant and neonatal infant respiratory distress syndrome (IRDS) etc.Not only there is the effect of expectoration of eliminating the phlegm, and energy and the body fluid of human body can also be supplemented.
More importantly, after the compositions use of ambroxol hydrochloride of the present invention and fructose, in minimizing gastrointestinal side effect and anaphylaxis, have unexpected effect, scorching hot, dyspepsia, Nausea and vomiting phenomenon greatly reduce, and the anaphylaxiss such as erythra do not have substantially.
Detailed description of the invention
embodiment 1the preparation of ambroxol hydrochloride injection
Prescription:
Preparation process:
(1) in container, total amount 3200ml water for injection is added, temperature control 50-70 DEG C;
(2) add 30g ambroxol hydrochloride while stirring, stir and make to dissolve completely;
(3) then add 2.28g citric acid, 32g sodium chloride and 8.88g sodium hydrogen phosphate, stir and make it to dissolve completely;
(4) benefit injects water to 4000ml;
(5) detecting medicinal liquid pH is 5.0, does not regulate;
(6) joining the injection-use activated carbon taking 1.2g in charcoal cabinet, the medicinal liquid of 60ml is added by injection-use activated carbon moistening, for subsequent use;
(7) add the injection-use activated carbon of moistening, stir 15 minutes;
(8) solution coarse filtration takes off charcoal, filters through 0.45 μm of cartridge filter;
(9) qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, 1ml/ props up, and 2ml/ props up, and 4ml/ props up, inflated with nitrogen, and sealing, sterilizing, to obtain final product.
embodiment 2the preparation of Ambroxol Hydrochloride for Injection
Prescription:
Preparation process:
(1) in container, total amount 3200ml water for injection is added, temperature control 50-70 DEG C;
(2) add 30g ambroxol hydrochloride while stirring, stir and make to dissolve completely;
(3) then add 2.28g citric acid, 160g mannitol and 8.88g sodium hydrogen phosphate, stir and make it to dissolve completely;
(4) benefit injects water to 4000ml;
(5) detecting medicinal liquid pH is 5.1, does not regulate;
(6) joining the injection-use activated carbon taking 1.2g in charcoal cabinet, the medicinal liquid of 60ml is added by injection-use activated carbon moistening, for subsequent use;
(7) add the injection-use activated carbon of moistening, stir 15 minutes;
(8) solution coarse filtration takes off charcoal, filters through 0.45 μm of cartridge filter;
(9) qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, 1ml/ bottle, 2ml/ bottle, 4ml/ bottle, lyophilization, to obtain final product.
embodiment 3the preparation of Ambroxol Hydrochloride Glucose Injection
Prescription:
Preparation process:
(1) in Agitation Tank, total amount 160L water for injection is added, temperature control 50-70 DEG C;
(2) add 30g ambroxol hydrochloride while stirring, stir and make to dissolve completely;
(3) then add 10kg glucose, stir and make it to dissolve completely;
(4) benefit injects water to 200L;
(5) medicinal liquid pH is regulated to be 5.0 with 0.5mol/L citric acid soln;
(6) joining the injection-use activated carbon taking 60g in charcoal cabinet, the medicinal liquid of 3000ml is added by injection-use activated carbon moistening, for subsequent use;
(7) add the injection-use activated carbon of moistening, stir 15 minutes;
(8) solution coarse filtration takes off charcoal, filters through 0.45 μm of cartridge filter;
(9) qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, 50ml/ bag, 100ml/ bag, 200ml/ bag, inflated with nitrogen, sealing, sterilizing, to obtain final product.
embodiment 4the preparation of ambroxol hydrochloride sodium chloride injection
Prescription:
Preparation process:
(1) in Agitation Tank, total amount 160L water for injection is added, temperature control 50-70 DEG C;
(2) add 30g ambroxol hydrochloride while stirring, stir and make to dissolve completely;
(3) then add 1.8kg sodium chloride, stir and make it to dissolve completely;
(4) benefit injects water to 200L;
(5) medicinal liquid pH is regulated to be 5.1 with 0.5mol/L citric acid soln;
(6) joining the injection-use activated carbon taking 60g in charcoal cabinet, the medicinal liquid of 3000ml is added by injection-use activated carbon moistening, for subsequent use;
(7) add the injection-use activated carbon of moistening, stir 15 minutes;
(8) solution coarse filtration takes off charcoal, filters through 0.45 μm of cartridge filter;
(9) qualified to visible foreign matters with 0.22 μm of microporous filter membrane aseptic filtration, fill, 50ml/ bag, 100ml/ bag, 200ml/ bag, inflated with nitrogen, sealing, sterilizing, to obtain final product.
comparative example
pressformulation and technology in patent application CN103393593A prepares comparative example, as follows:
by prescription of the present invention andsupplementary product consumption in patent application CN103393593A prepares comparative example, as follows:
embodiment 5the preparation of fructose injection
Prescription:
Preparation process:
(1) densely to join: the water for injection adding 30L in dense preparing tank, adds 10kg fructose, stir and make it to dissolve, add the moistening medicinal charcoal of 50g, stir 15 minutes, filtering decarbonization, filter into dilute preparing tank, repeatedly rinse dense preparing tank with water for injection, and filter into dilute preparing tank;
(2) rarely to join: in dilute preparing tank, add the water for injection to 90L, be 3.9 by 0.1mol/L hydrochloric acid solution adjust ph, adds the moistening medicinal charcoal of 50g, stirs 15 minutes, filtering decarbonization, mend and inject water to 100L;
(3) with the microporous filter membrane fine straining of 0.22 μm, fill, 250ml/ bottle and 500ml/ bottle, sealing;
(4) sterilizing: 121 DEG C of pressure sterilizings 15 minutes, quick spraying cooling, offers for sale, and naturally cools to room temperature.
embodiment 6the preparation of assembly packaging medicine
Combination 1: embodiment 1 preparation and embodiment 5 fructose injection 250ml.
Combination 2: embodiment 2 preparation and embodiment 5 fructose injection 250ml.
Combination 3: embodiment 3 preparation and embodiment 5 fructose injection 250ml.
Combination 4: embodiment 4 preparation and embodiment 5 fructose injection 250ml.
Combination 5: comparative example 1a preparation and embodiment 5 fructose injection 250ml.
Combination 6: comparative example 2a preparation and embodiment 5 fructose injection 250ml.
Combination 7: comparative example 3a preparation and embodiment 5 fructose injection 250ml.
Combination 8: comparative example 4a preparation and embodiment 5 fructose injection 250ml.
Combination 9: comparative example 1b preparation and embodiment 5 fructose injection 250ml.
Combination 10: comparative example 2b preparation and embodiment 5 fructose injection 250ml.
Combination 11: comparative example 3b preparation and embodiment 5 fructose injection 250ml.
Combination 12: comparative example 4b preparation and embodiment 5 fructose injection 250ml.
Test example 1 pharmacokinetics is tested
Get 120 rats, body weight (205 ± 10) g, is divided into 12 groups at random, wherein first group to the 12 group respectively in the intravenous injection embodiment of the present invention 6 combination 1 to combination 12 medicine, after administration, 2h takes a blood sample 48 hours.
High performance liquid chromatography is adopted to detect the blood drug level of ambroxol hydrochloride.Use software 3p87 and WT1.4 to carry out data analysis, relevant pharmacokinetics parametric results is as following table.
As can be seen from the above experimental data, in 12 groups of compatible solution, bioavailability first group is better than the 5th and nine groups, second group is better than the 6th and ten groups, and the 3rd group is better than the 7th and 11 groups, and the 4th group is better than the 8th and 12 groups, absolutely prove the intravenous benefit of assembly packaging of ambroxol hydrochloride injection of the present invention and fructose injection, make injection improve bioavailability widely, add drug effect, obtain unexpected technical effect.
Test example 2 gastrointestinal side effect and anaphylactoid proof
Get the New Zealand Journal of Health Physical Education doe of 120 body weight 2.0-2.5kg, be divided into 12 groups at random, wherein first group to the 12 group respectively in the intravenous injection embodiment of the present invention 6 combination 1 to combination 12 medicine.Continuous use 7 days, observe gastrointestinal reaction and anaphylaxis situation, result is as follows:
| Scorching hot | Dyspepsia | Nausea and vomiting | Erythra | |
| First group | 0 | 1 | 1 | 0 |
| Second group | 1 | 0 | 0 | 0 |
| 3rd group | 1 | 1 | 0 | 0 |
| 4th group | 0 | 0 | 1 | 0 |
| 5th group | 2 | 2 | 1 | 1 |
| 6th group | 1 | 2 | 2 | 0 |
| 7th group | 1 | 1 | 2 | 1 |
| 8th group | 1 | 2 | 1 | 1 |
| 9th group | 0 | 2 | 1 | 1 |
| Tenth group | 1 | 0 | 2 | 2 |
| 11 group | 2 | 1 | 2 | 0 |
| 12 group | 1 | 1 | 1 | 2 |
As can be seen from the above results, gastrointestinal reaction and anaphylaxis data in 12 groups of compatible solution, first group is better than the 5th and nine groups, second group is better than the 6th and ten groups, 3rd group is better than the 7th and 11 groups, 4th group is better than the 8th and 12 groups, has absolutely proved that the assembly packaging intravenous injection of ambroxol hydrochloride injection of the present invention and fructose injection is to minimizing gastrointestinal reaction and anaphylactoid good action, obtains unexpected technical effect.
Claims (5)
1. a pharmaceutical composition for ambroxol-hydrochloride-containing and fructose, is characterized in that ambroxol hydrochloride is injection, for ambroxol hydrochloride and appropriate auxiliaries aseptic parenteral solution or add the sterile freeze-drying preparation that appropriate excipient makes; Fructose is injection, is the aseptic parenteral solution of fructose and appropriate auxiliaries.
2. pharmaceutical composition according to claim 1, it is characterized in that ambroxol hydrochloride injection specification for ambroxol hydrochloride count 7.5mg, 15mg and 30mg/ bottle/, the specification of fructose injection is 50-1000ml.
3. pharmaceutical composition according to claim 1 and 2, is characterized in that ambroxol hydrochloride injection is selected from ambroxol hydrochloride injection, Ambroxol Hydrochloride Glucose Injection, ambroxol hydrochloride sodium chloride injection and Ambroxol Hydrochloride for Injection; Described fructose injection is the formulated sterile water solution of fructose.
4. pharmaceutical composition according to claim 1 reduces the application in the irritated medicine such as scorching hot, dyspepsia, Nausea and vomiting phenomenon, erythra in preparation treatment.
5. pharmaceutical composition according to claim 1, is characterized in that this pharmaceutical composition can be packed for Combination application.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510237705.XA CN104887689A (en) | 2015-05-12 | 2015-05-12 | Medicine composition containing ambroxol hydrochloride and fructose |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510237705.XA CN104887689A (en) | 2015-05-12 | 2015-05-12 | Medicine composition containing ambroxol hydrochloride and fructose |
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| CN104887689A true CN104887689A (en) | 2015-09-09 |
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| CN201510237705.XA Pending CN104887689A (en) | 2015-05-12 | 2015-05-12 | Medicine composition containing ambroxol hydrochloride and fructose |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106074373A (en) * | 2016-08-18 | 2016-11-09 | 黑龙江中桂制药有限公司 | A kind of preparation method of Ambroxol Hydrochloride Glucose Injection |
| CN110200905A (en) * | 2019-07-01 | 2019-09-06 | 黑龙江珍宝岛药业股份有限公司 | A kind of ambroxol hydrochloride composition and its injection and application |
-
2015
- 2015-05-12 CN CN201510237705.XA patent/CN104887689A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106074373A (en) * | 2016-08-18 | 2016-11-09 | 黑龙江中桂制药有限公司 | A kind of preparation method of Ambroxol Hydrochloride Glucose Injection |
| CN110200905A (en) * | 2019-07-01 | 2019-09-06 | 黑龙江珍宝岛药业股份有限公司 | A kind of ambroxol hydrochloride composition and its injection and application |
| CN110200905B (en) * | 2019-07-01 | 2022-03-25 | 黑龙江珍宝岛药业股份有限公司 | Ambroxol hydrochloride composition, injection and application thereof |
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Application publication date: 20150909 |
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