CN107519127A - A kind of ambroxol hydrochloride injection and preparation method thereof - Google Patents
A kind of ambroxol hydrochloride injection and preparation method thereof Download PDFInfo
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- CN107519127A CN107519127A CN201710669673.XA CN201710669673A CN107519127A CN 107519127 A CN107519127 A CN 107519127A CN 201710669673 A CN201710669673 A CN 201710669673A CN 107519127 A CN107519127 A CN 107519127A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
A kind of ambroxol hydrochloride injection and preparation method thereof, belongs to technical field of medicine, and the constituent of every 2mL parenteral solution is：The 20mg of ambroxol hydrochloride 15, the 10mg of citric acid 5, the 11mg of disodium hydrogen phosphate 7, the 12mg of sodium chloride 9.Its preparation method is：Citric acid, disodium hydrogen phosphate and sodium chloride are weighed first, add proper amount of fresh water for injection, after stirring and dissolving, it is slowly added into ambroxol hydrochloride raw material, stirring is to after being completely dissolved, add to the full amount of water for injection, stir, a certain amount of medical charcoal is added at 40 DEG C~50 DEG C, stirring and adsorbing 15 minutes, carbon removal is filtered through 0.8 μm of stud filter, pH value is adjusted with citric acid soln or disodium phosphate soln if necessary, controls 4.5 5.5, filtering to visible foreign matters it is qualified after, nitrogen is filled with, embedding, is finally sterilized.
Description
Technical field
Invention belongs to technical field of medicine, and in particular to a kind of ambroxol hydrochloride injection and its preparation
Method.
Background technology
Bronchitis is the common disease in China, and cough, expectoration are its clinical cardinal symptoms.Ambroxol hydrochloride is in recent years quite
Valued novel sticky phlegm lytic agent.It is the active metabolite of bromhexine.In 1979 in German Initial Public Offering, by
It is widely used in clinic, its priority is in Italy, Switzerland, Argentina, Japan, France, Spain, Singapore, Thailand etc. 20
Individual country's listing.
Ambroxol hydrochloride can activate type Ⅱ penumonocyte, produce surface reactive material, promote alveolar surface activity thing
The synthesis and secretion of matter, alveolar surface tension is reduced, improve pulmonary ventilation and respiratory function, relax trachea and bronchus smooth muscle,
Unobstructed air flue.Ambroxol hydrochloride can alleviate respiratory tract obstruction, improve ventilation, shorten clinical disease course, subtract suitable various complication, and it is also
Antibiotic can be made to be raised in the concentration of lung tissue, strengthen sterilizing ability, shorten course for the treatment of and subtract suitable flora imbalance and the production of persister
It is raw.Because ambroxol hydrochloride is a kind of highly effective Eradicates phlegm and relieving coughs medicine, so clinic is promoted.It is domestic to be criticized in 1991
Quasi- import, it is one of Eradicates phlegm medicines the most frequently used at present.
Current authorized similar patent has the B of CN 102225049 and the B of CN 101836953, individually discloses hydrochloric acid
The preparation method of ambroxol.Contrast this two patents, although the present invention on composition with the B of patent CN 101836953 almost one
Cause, but final pH is different：The B of patent CN 101836953 are 5.5-7.0, and the present invention is 4.5-5.5.Patent CN 102225049
Although B pH are 4.5-5.5, raw material ambroxol dosage only specify that.So the present invention is by substantial amounts of prescription, technique and quality
Deng research, it is proposed that a kind of preparation method of the good ambroxol injection of preparation stability, and curative effect has obtained clinical examination
Checking is real.
The content of the invention
Present invention aims at a kind of ambroxol hydrochloride injection and preparation method thereof is provided, using concentrated compounding method system
It is standby, pass through experiment investigation, not only steady quality, and clinically have the effect of fine.
To achieve the above object, the present invention adopts the following technical scheme that：
A kind of ambroxol hydrochloride injection, every (2ml) are made up of following composition：Ambroxol hydrochloride 15-20mg, citron
Sour 5-10mg, disodium hydrogen phosphate 7-11mg, sodium chloride 9-12mg, surplus are water for injection.
The preparation method of above-mentioned ambroxol hydrochloride injection, comprises the following steps：(1) citric acid, phosphorus are weighed by recipe quantity
Sour disodium hydrogen and sodium chloride are dissolved in the fresh water for injection that temperature is 70~80 DEG C, fresh water for injection account for full dose 10~
50%, stirring and dissolving；
(2) ambroxol hydrochloride of recipe quantity is added in the solution of step (1), stirring is to being completely dissolved；
(3) remaining water for injection is added to step (2), stirred；
(4) when being cooled to about 40 DEG C~50 DEG C, medical charcoal, stirring and adsorbing 15~20 minutes are added；
(5) carbon removal is filtered through 0.8 μm of stud filter, pH is surveyed, with 5-10% (w/v) citric acid solns or 5-10% (w/
V) disodium phosphate soln regulation pH value is 4.5~5.5；
(6) filtering to visible foreign matters it is qualified after, after being filled with nitrogen, carry out embedding；
(7) sterilize.
Preferably, medical charcoal dosage accounts for the 0.03-0.06% (w/v) of parenteral solution.
Preferably, sterilizing refers to the 10~20min that sterilized at 121 DEG C.
First with total water consumption 10-50% fresh water for injection dissolving citric acid, disodium hydrogen phosphate and chlorination in step (1)
Sodium, temperature are about 70 DEG C~80 DEG C.We have found that big production is more suitable for concentrated compounding method through overtesting, first with fraction water for injection
Dissolve supplementary material, it is ensured that supplementary material dissolves fully and completely, decoction uniformity.
Medical charcoal dosage is the 0.03-0.06% (w/v) of parenteral solution in step (4), it is ensured that it is clear and bright to improve parenteral solution
Degree, and do not influence content while bacterial endotoxin is removed.
The present invention adds the remaining space that nitrogen is filled with ampoule while liquid drug, avoids note to the full extent
Penetrate liquid to be oxidized, improve the stabilization of pharmaceutical preparation.
Different sterilising conditions influence not on the character of ambroxol hydrochloride injection, content, pH value, osmotic pressure, total impurities
Greatly.In order to preferably control drug quality, we select 121 DEG C of 15min overkills, the final sterilization bar as actual production
Part.
The present invention uses concentrated compounding method, and parenteral solution is adjusted as buffer with certain density citric acid and disodium hydrogen phosphate
PH value, ensure dissolution of raw material fully and completely, decoction is homogeneous, has good stability, can farthest slow down preparation degraded.
Embodiment
Technical scheme is described in further detail below in conjunction with specific embodiment, but the protection of the present invention
Scope is not limited thereto.
Embodiment 1
A kind of ambroxol hydrochloride injection, every (2mL) composition are：Ambroxol hydrochloride 15mg, citric acid 9mg, phosphoric acid hydrogen
Disodium 8mg, sodium chloride 8.5mg, surplus are water for injection.
The preparation method of above-mentioned ambroxol hydrochloride injection, specifically comprises the following steps：
(1) citric acid, disodium hydrogen phosphate and sodium chloride are weighed by recipe quantity, 70 DEG C of addition is about the fresh of full dose 25%
Water for injection, stirring and dissolving；
(2) it is slowly added into the ambroxol hydrochloride of recipe quantity to step 1), stirring is to being completely dissolved；
(3) add to the full amount of water for injection, stir 30 minutes to step 2)；
(4) when being cooled to about 50 DEG C, 0.05% (w/v, with injection stereometer) medical charcoal is added, stirring and adsorbing 15 is divided
Clock；
(5) carbon removal is filtered through 0.8 μm of stud filter, pH is surveyed, if necessary with 10% (w/v) citric acid soln or 10%
(w/v) disodium phosphate soln regulation pH value, it is 5.0 to make final pH；
(6) filtering to visible foreign matters it is qualified after, be filled with nitrogen, carry out embedding；
(7) 121 DEG C of sterilizing 15min.
Test example 1
Ambroxol hydrochloride, citric acid, disodium hydrogen phosphate and the sodium chloride that recipe quantity is weighed by embodiment 1 are separately added into 50
DEG C, 60 DEG C, 70 DEG C, 80 DEG C of fresh water for injection, 30min is stirred, respectively at the 5th minute, 10 minutes, 20 minutes, 30 minutes
The character, content, total impurities of decoction are detected, and record the final dissolution time of medicine, result of the test is shown in Table 1.This examination
Example 1 is tested mainly to investigate：The suitable solution temperature of supplementary material and time, ensure rapidly-soluble while do not influence its stability.
The supplementary material solution temperature of table 1 and the selection result of time
As shown in Table 1, the supplementary material of ambroxol hydrochloride injection can be in 70 DEG C~80 DEG C of water for injection in 10 minutes
It is completely dissolved.Decoction character temperature, its ambroxol hydrochloride content, total impurities change less.Therefore in actual production, prepare
The water for injection temperature of decoction is 70 DEG C~80 DEG C, can be completely dissolved supplementary material faster.
Embodiment 2
A kind of ambroxol hydrochloride injection, every (2mL) are made up of following composition：Ambroxol hydrochloride 15mg, citric acid
7mg, disodium hydrogen phosphate 10.5mg, sodium chloride 9mg.
The preparation method of above-mentioned ambroxol hydrochloride injection, specifically comprises the following steps：
(1) citric acid, disodium hydrogen phosphate and sodium chloride are weighed by recipe quantity, 80 DEG C of addition is about the fresh of full dose 20%
Water for injection, stirring and dissolving；
(2) it is slowly added into the ambroxol hydrochloride of recipe quantity to step (1), stirring is to being completely dissolved；
(3) add to the full amount of water for injection, stir 30 minutes to step (2)；
(4) when being cooled to about 40 DEG C, 0.04% (w/v, with injection stereometer) medical charcoal is added, stirring and adsorbing 15 is divided
Clock；
(5) carbon removal is filtered through 0.8 μm of stud filter, pH is surveyed, if necessary with 8% (w/v) citric acid soln or 8% (w/
V) disodium phosphate soln regulation pH value, it is 4.9 to make final pH；
(6) filtering to visible foreign matters it is qualified after, be filled with nitrogen, carry out embedding；
(7) 121 DEG C of sterilizing 15min.
Test example 2
This test example 2 is mainly investigated：Influence of concentration of the citric acid in parenteral solution to liquid medicine stability.Select citric acid
Three various concentrations 0.15%, 0.35%, 0.5% (g/mL, with parenteral solution stereometer), other are configured to note with embodiment 2
Liquid is penetrated, 60 DEG C of high temperature place each project investigated for 10 days and detect parenteral solution by table 2 in the 0th day, 5 days, 10 days, result of the test
It is shown in Table 2.
The selection of the citron acid concentration of table 2
As a result show：Citric acid dosage is 0.35% (w/v) when being every (2mL) 5-10mg, and preparation degraded is most slow, the most
It is stable.
Embodiment 3
A kind of ambroxol hydrochloride injection, every (2mL) are made up of following composition：Ambroxol hydrochloride 18mg, citric acid
9.5mg, disodium hydrogen phosphate 7.5mg, sodium chloride 9.5mg.
The preparation method of above-mentioned ambroxol hydrochloride injection, specifically comprises the following steps：
(1) citric acid, disodium hydrogen phosphate and sodium chloride are weighed by recipe quantity, 70 DEG C of addition is about the fresh of full dose 30%
Water for injection, stirring and dissolving；
(2) it is slowly added into the ambroxol hydrochloride of recipe quantity to step 1), stirring is to being completely dissolved；
(3) add to the full amount of water for injection, stir 30 minutes to step 2)；
(4) when being cooled to about 45 DEG C, 0.03% (w/v, with injection stereometer) medical charcoal is added, stirring and adsorbing 15 is divided
Clock；
(5) carbon removal is filtered through 0.8 μm of stud filter, pH is surveyed, if necessary with 10% (w/v) citric acid soln or 10%
(w/v) disodium phosphate soln regulation pH value, it is 4.8 to make final pH；
(6) filtering to visible foreign matters it is qualified after, be filled with nitrogen, carry out embedding；
(7) 121 DEG C of sterilizing 15min.
Test example 3
This test example 3 is mainly investigated：By embodiment 3 prepare different pH value parenteral solution (with 10% citric acid soln or
10% disodium phosphate soln is adjusted), places under 60 DEG C of high temperature and investigate within 10 days and injected in the 0th day, 5 days, 10 days by the detection of table 3
Each project of liquid, result of the test are shown in Table 3.
Influence of the 3 different pH value of table to ambroxol hydrochloride injection
As a result show：Work as pH<When 4.5, its decoction is with the lengthening of standing time, and content substantially reduces, and total impurities has substantially
Become big trend.Work as pH>When 6.0, there is white crystals precipitation in the 10th day, decoction character changes.The medicine when pH value=5.0
Fluidity matter is the most stable.In summary, the pH value range for determining parenteral solution is 4.5~5.5.
The ambroxol hydrochloride injection of embodiment 1 to 3, Accelerated stability test investigation is carried out, condition of investigating is 40 ± 2
DEG C, relative humidity 75 ± 5%.
Result is investigated as shown in table 4 to 6.
The embodiment 1 of table 4 accelerates 6 months (result of the test)
The embodiment 2 of table 5 accelerates 6 months (result of the test)
The embodiment 3 of table 6 accelerates 6 months (result of the test)
As can be seen from the above table, accelerate to investigate experiment, hydrochloric acid ammonia bromine made from embodiment 1 to 3 by the stability of 6 months
Rope parenteral solution indices are all relatively stable, and wherein impurity B and impurity E are caused impurity during production of raw medicine,
It in formulation process and can be increased slightly in sterilization process, but not influence product quality.
Claims (4)
1. a kind of ambroxol hydrochloride injection, it is characterised in that often the constituent of 2mL parenteral solutions is：Ambroxol hydrochloride 15-
20mg, citric acid 5-10mg, disodium hydrogen phosphate 7-11mg, sodium chloride 9-12mg, surplus are water for injection.
2. the preparation method of ambroxol hydrochloride injection described in a kind of claim 1, it is characterised in that comprise the following steps：
（1）Citric acid, disodium hydrogen phosphate and sodium chloride, which are weighed, by recipe quantity is dissolved in the fresh water for injection that temperature is 70 ~ 80 DEG C
In, fresh water for injection accounts for the 10 ~ 50% of full dose, stirring and dissolving；
（2）The ambroxol hydrochloride of recipe quantity is added into step（1）Solution in, stirring is to being completely dissolved；
（3）To step（2）Remaining water for injection is added, is stirred；
（4）When being cooled to about 40 DEG C~50 DEG C, medical charcoal, stirring and adsorbing 15 ~ 20 minutes are added；
（5）Carbon removal is filtered through 0.8 μm of stud filter, pH is surveyed, uses 5-10%（w/v）Citric acid soln or 5-10%（w/v）Phosphoric acid
Disodium hydrogen solution regulation pH value is 4.5 ~ 5.5；
（6）Filtering is qualified to visible foreign matters, after being filled with nitrogen, carries out embedding；
（7）Sterilizing.
3. the preparation method of ambroxol hydrochloride injection as claimed in claim 2, it is characterised in that medical charcoal dosage accounts for parenteral solution
0.03-0.06% (w/v).
4. the preparation method of ambroxol hydrochloride injection as claimed in claim 2, it is characterised in that sterilizing refers to go out at 121 DEG C
10 ~ 20min of bacterium.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710669673.XA CN107519127A (en) | 2017-08-08 | 2017-08-08 | A kind of ambroxol hydrochloride injection and preparation method thereof |
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| CN201710669673.XA CN107519127A (en) | 2017-08-08 | 2017-08-08 | A kind of ambroxol hydrochloride injection and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110237030A (en) * | 2019-06-04 | 2019-09-17 | 华润双鹤利民药业（济南）有限公司 | A kind of production technology of ambroxol hydrochloride injection |
| CN112022840A (en) * | 2020-08-11 | 2020-12-04 | 太阳升(亳州)生物医药科技有限公司 | Method for preparing an inhaled ambroxol hydrochloride solution |
| CN112891300A (en) * | 2021-01-28 | 2021-06-04 | 朗天药业(湖北)有限公司 | Ambroxol hydrochloride injection and preparation method thereof |
| CN114053220A (en) * | 2020-12-29 | 2022-02-18 | 山东裕欣药业有限公司 | Preparation method of stable ambroxol hydrochloride sodium chloride injection |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225049A (en) * | 2011-06-17 | 2011-10-26 | 成都金典药物科技开发有限公司 | Preparation method of ambroxol hydrochloride injection with stable pH value |
| CN103126978A (en) * | 2013-02-05 | 2013-06-05 | 浙江华海药业股份有限公司 | Preparing method for ambroxol hydrochloride injection |
| CN105193712A (en) * | 2015-09-28 | 2015-12-30 | 成都天台山制药有限公司 | Ambroxol hydrochloride injection and preparation method thereof |
-
2017
- 2017-08-08 CN CN201710669673.XA patent/CN107519127A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225049A (en) * | 2011-06-17 | 2011-10-26 | 成都金典药物科技开发有限公司 | Preparation method of ambroxol hydrochloride injection with stable pH value |
| CN103126978A (en) * | 2013-02-05 | 2013-06-05 | 浙江华海药业股份有限公司 | Preparing method for ambroxol hydrochloride injection |
| CN105193712A (en) * | 2015-09-28 | 2015-12-30 | 成都天台山制药有限公司 | Ambroxol hydrochloride injection and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110237030A (en) * | 2019-06-04 | 2019-09-17 | 华润双鹤利民药业（济南）有限公司 | A kind of production technology of ambroxol hydrochloride injection |
| CN112022840A (en) * | 2020-08-11 | 2020-12-04 | 太阳升(亳州)生物医药科技有限公司 | Method for preparing an inhaled ambroxol hydrochloride solution |
| CN114053220A (en) * | 2020-12-29 | 2022-02-18 | 山东裕欣药业有限公司 | Preparation method of stable ambroxol hydrochloride sodium chloride injection |
| CN112891300A (en) * | 2021-01-28 | 2021-06-04 | 朗天药业(湖北)有限公司 | Ambroxol hydrochloride injection and preparation method thereof |
| CN112891300B (en) * | 2021-01-28 | 2022-03-15 | 朗天药业(湖北)有限公司 | Ambroxol hydrochloride injection and preparation method thereof |
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Inventor after: Li Junxia Inventor after: Wang Ruiling Inventor after: Zhou Suicheng Inventor after: Bai Yanhe Inventor after: Tian Guanglin Inventor before: Wang Ruiling Inventor before: Li Junxia Inventor before: Zhou Suicheng Inventor before: Bai Yanhe Inventor before: Tian Guanglin |
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Application publication date: 20171229 |