CN110237030A - A kind of production technology of ambroxol hydrochloride injection - Google Patents
A kind of production technology of ambroxol hydrochloride injection Download PDFInfo
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- CN110237030A CN110237030A CN201910540007.5A CN201910540007A CN110237030A CN 110237030 A CN110237030 A CN 110237030A CN 201910540007 A CN201910540007 A CN 201910540007A CN 110237030 A CN110237030 A CN 110237030A
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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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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
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Abstract
The present invention provides a kind of production technology of ambroxol hydrochloride injection, is related to chemical drug preparation technique field, a kind of production technology of ambroxol hydrochloride injection, includes the following steps: Sp1: weighing stock；Preparating liquid；It filters, is filling；Sterilizing, lamp inspection: finished product obtained by step 3 is in 121 DEG C of laggard portable lighter inspections in sterilizing 15 minutes；Packaging.Specify the committed step and technological parameter in the production process of ambroxol hydrochloride injection, the production process efficient stable for facilitating ambroxol hydrochloride injection carries out, specify that the quality standard of product should be the colourless clear liquid of content 97.0%~103.0%, pH value is between 4.7~5.3, bacterial endotoxin < 0.16EU/mg, osmotic pressure molar density is 275~325 (mosmol/Kg), the pH value of ambroxol hydrochloride injection is controlled in appropriate value, it can either guarantee the stability for guaranteeing product in the case where being added without stabilizer, production cost may make to reduce simultaneously, convenient for industrialized production.
Description
Technical field
The present invention relates to chemical drug preparation technique field, specially a kind of production technology of ambroxol hydrochloride injection.
Background technique
Respiratory disease is to endanger the common disease of the health of our people, in recent years, respiratory disease such as lung cancer, branch
The disease incidence of san bronchial asthma is all increasing, and ambroxol hydrochloride is a kind of respiratory tract eliminating the phlegm disease and mucolytic, has mucus row
Except facilitation and the characteristic of dissolution secretion, it can promote the exclusion of thick secretions in respiratory tract and reduces the stagnant of mucus
It stays, thus remarkably promotes expectoration, improve breath state.
Ambroxol hydrochloride is clinically widely used, currently, the preparation type of domestic ambroxol hydrochloride has hydrochloric acid ammonia bromine
Rope tablet and capsule, ambroxol hydrochloride oral solution agent, Sustained Release Ambroxol Hydrochloride Capsules etc., these dosage form bioavilabilities compared with
Difference works slowly, and relatively often has gastrointestinal side effect, for taking orally inconvenient patient, commonly uses ambroxol hydrochloride note
It penetrates agent aoxidizing under alkaline condition, performance is unstable, decomposites free ambroxol, will affect the quality and safety of drug
Property, the pH value of ambroxol hydrochloride injection is controlled in relatively low or addition stabilizer to improve its stabilization in the prior art
Property, but all discomfort can brought for patient to a certain degree, while also increasing production cost, it is unfavorable for industrialized production,
For this purpose, we have proposed a kind of production technologies of ambroxol hydrochloride injection.
Summary of the invention
(1) the technical issues of solving
In view of the deficiencies of the prior art, it the present invention provides a kind of production technology of ambroxol hydrochloride injection, solves
The problem of stability is poor, production cost is higher, is unfavorable for industrialized production.
(2) technical solution
In order to achieve the above object, the present invention is achieved by the following technical programs: a kind of ambroxol hydrochloride injection
Production technology includes the following steps: that the supplementary material materials are quantified according to 100,000 ml of pharmaceutical factory's production, according to reality
Border situation can carry out equal proportion reduction or optimization,
Sp1: stock is weighed；
Sp2: preparating liquid: firstly, 80.0kg water for injection is added in Agitation Tank, control water for injection temperature 60~
Between 70 DEG C, then, 763.00g sodium chloride, 368.00g disodium hydrogen phosphate, 101.00g citric acid is added, agitation cycle is many
Made to dissolve in 10 minutes, then, is added and calculates load weighted ambroxol hydrochloride (increase feed intake 1.5%), agitation cycle is no less than
Make to dissolve within 20 minutes, adjusts pH value and be added the 10g active carbon dissolved in advance with 1kg water afterwards between 4.7~5.3,60~70
DEG C stirring and adsorbing 20 minutes, 88kg (pipeline and coarse filter Chinese medicine liquid weight be 12.4kg), stirring were injected water to later
Circulation is cooled to after ten minutes between 20~30 DEG C, sample examination；
Sp3: it filters, is filling: firstly, the titanium filter stick for being 15 μm with aperture is with aperture after 20~30 DEG C of coarse filtration take off charcoal
0.45 μm of filter core refined filtration before nitrogen pipeline is connected to coarse filter, is slowly opened nitrogen valve, will be remained using nitrogen pressure
Remaining medical fluid is beaten as far as possible to receiver, after receiver weighing confirmation, after aperture is 0.22 μm of filter core refined filtration down toward
It is filling；
Sp4: sterilizing, lamp inspection: finished product obtained by step 3 is in 121 DEG C of laggard portable lighter inspections in sterilizing 15 minutes；
Sp5: packaging.
Preferably, the preparating liquid process key step and technological parameter are as follows: the drug solution preparing time is 180-240 points
Clock is prepared and completes the resting period to be filtered no more than 2 hours, is no more than 10 hours after filtering to filling preceding place, and filling
Operating time is no more than 10 hours, prepares and starts to filling end total time to be no more than 16 hours.
Preferably, the filling process process is end-filtration → fire tuning, → filling → inflation of tune loading amount → inflation → pre-
Heat → sealing → bottle outlet → is cleared out a gathering place, is cleaned.
Preferably, the filter process committed step and technological parameter are as follows: filter pressure < 0.01MPa, coarse filtration/refined filtration
Time 10-15 minute, refined filtration forward direction pressure difference < 0.01MPa are passed through the pressure < 0.2MPa of nitrogen, and the aseptic filtration time 16 hours
Within, and the medical fluid end-filtration time is within 16 hours, coarse filtration/refined filtration filtration flow-rate is 8300~10000ml/min, degerming
Filtration flow-rate is < 3800ml/min, temperature≤30 DEG C of putting in poison, positive pressure difference < 0.15MPa.
Preferably, the sterilization process process is code-disc → code vehicle → inlet → water filling → heating → sterilizing → row pressure → inspection
Leakage → primary cleaning → secondary cleaning → outlet → is cleared out a gathering place, is cleaned.
Preferably, the device model used during the preparating liquid is respectively PG-200 Agitation Tank, the filtering, filling
The device model used is respectively PG-2000 liquid storage tank during dress, QCL160 vertical ultrasonic-wave cleaning machine, and SZAX62 goes out in tunnel
Bacterium drying machine, the vertical filling and sealing machine of AGF16, the device model that the sterilizing, lamp inspection are used in the process is respectively ASM type ampoule
Water-bath sterilizer, DJ-600 lamp inspection machine.
Preferably, the filter core that the medical fluid refined filtration and when medical fluid aseptic filtration use is respectively that aperture is 0.45 μm poly-
The polyether sulfone filter core that ether sulfone filter core and aperture are 0.22 μm, the storage tank respirator filter core, compressed air filter core and nitrogen
Filter core is the polytetrafluoroethylene (PTFE) filter core that aperture is 0.22 μm.
Preferably, the intermediate products quality standard is the colourless clear liquid of content 97.0%~103.0%, and pH value is
Between 4.7~5.3, bacterial endotoxin < 0.16EU/mg, osmotic pressure molar density is 275~325 (mosmol/Kg).
(3) beneficial effect
The present invention provides a kind of production technologies of ambroxol hydrochloride injection.Have it is following the utility model has the advantages that
1, the present invention specifies committed step and technological parameter in the production process of ambroxol hydrochloride injection, so that
Ambroxol hydrochloride injection technical process can quickly get a grip on control point, facilitate the production work of ambroxol hydrochloride injection
Skill processing efficient, which is stablized, to carry out.
2, the present invention specifies that the quality standard of product should be the colourless clear liquid of content 97.0%~103.0%, pH
Value is bacterial endotoxin < 0.16EU/mg between 4.7~5.3, and osmotic pressure molar density is 275~325 (mosmol/Kg), will
The pH value of ambroxol hydrochloride injection is controlled in appropriate value, can either guarantee to guarantee product in the case where being added without stabilizer
Stability, and make product not easily cause patient using discomfort, while production cost may make to reduce, it is convenient for industrialized life
It produces.
Detailed description of the invention
Fig. 1 is flow diagram of the invention.
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete
Site preparation description, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other
Embodiment shall fall within the protection scope of the present invention.
Embodiment one:
As shown in Figure 1, the embodiment of the present invention provides a kind of production technology of ambroxol hydrochloride injection, including walk as follows
Rapid: the supplementary material materials are quantified according to 100,000 mL of pharmaceutical factory's production, according to the actual situation, the ratio such as can carry out
Example reduction or optimization,
Sp1: stock is weighed；
Sp2: firstly, 80.0kg water for injection is added in Agitation Tank, water for injection temperature preparating liquid: is controlled at 60 DEG C
Between, then, 763.00g sodium chloride, 368.00g disodium hydrogen phosphate, 101.00g citric acid is added, agitation cycle is no less than 10
Minute make to dissolve, then, is added and calculates load weighted ambroxol hydrochloride (increase feed intake 1.5%), agitation cycle is no less than 20 points
Clock makes to dissolve, and adjusts pH value and the 10g active carbon dissolved in advance with 1kg water, 60~70 DEG C of stirring and adsorbings are added afterwards between 5.3
It 20 minutes, injects water to later 88kg (pipeline and coarse filter Chinese medicine liquid weight be 12.4kg), agitation cycle 10 minutes
After be cooled between 30 DEG C, sample examination；
Sp3: it filters, is filling: firstly, the titanium filter stick for being 15 μm with aperture is 0.45 μ with aperture after 30 DEG C of coarse filtration take off charcoal
The filter core refined filtration of m before nitrogen pipeline is connected to coarse filter, slowly opens nitrogen valve, using nitrogen pressure by remaining medicine
Liquid is beaten as far as possible to receiver, after receiver weighing confirmation, down toward filling after aperture is 0.22 μm of filter core refined filtration；
Sp4: sterilizing, lamp inspection: finished product obtained by step 3 is in 121 DEG C of laggard portable lighter inspections in sterilizing 15 minutes；
Sp5: packaging.
Embodiment two:
As shown in Figure 1, the embodiment of the present invention provides a kind of production technology of ambroxol hydrochloride injection, preparating liquid process
Committed step is as follows with technological parameter: the drug solution preparing time is 180 minutes, prepares and completes the resting period to be filtered no more than 2
Hour, it is no more than 10 hours after filtering to placing before filling, and the fill operations time is no more than 10 hours, prepares and starts to filling
Terminate to be no more than 16 hours total time, filling process process is end-filtration → fire tuning, adjusts loading amount → inflation → filling → inflation
→ preheating → sealing → bottle outlet → is cleared out a gathering place, is cleaned, and filter process committed step and technological parameter are as follows: filter pressure <
0.01MPa, coarse filtration/10-15 minutes refined filtration time, refined filtration forward direction pressure difference < 0.01MPa are passed through the pressure < 0.2MPa of nitrogen,
Within 16 hours aseptic filtration time, and the medical fluid end-filtration time is within 16 hours, and coarse filtration/refined filtration filtration flow-rate is
8300ml/min, aseptic filtration flow velocity are < 3800ml/min, temperature≤30 DEG C of putting in poison, and positive pressure difference < 0.15MPa is described to go out
Bacterium process flow is code-disc → code vehicle → inlet → water filling → heating → sterilizing → row pressure → leak detection → primary cleaning → secondary clear
→ outlet → to be washed to clear out a gathering place, clean, the device model used during preparating liquid is respectively PG-200 Agitation Tank, the filtering,
The device model used in pouring process is respectively PG-2000 liquid storage tank, QCL160 vertical ultrasonic-wave cleaning machine, the tunnel SZAX62
Sterilization drier, the vertical filling and sealing machine of AGF16, the device model that the sterilizing, lamp inspection are used in the process are respectively ASM type peace
The filter core used when small jar water-bath sterilizer, DJ-600 lamp inspection machine, medical fluid refined filtration and medical fluid aseptic filtration is respectively that aperture is
The polyether sulfone filter core that 0.45 μm of polyether sulfone filter core and aperture are 0.22 μm, the storage tank respirator filter core, compressed air filter
Core and nitrogen filter core are the polytetrafluoroethylene (PTFE) filter core that aperture is 0.22 μm, and intermediate products quality standard is content 97.0%-
103% colourless clear liquid, pH value are bacterial endotoxin < 0.16EU/mg between 5.3, osmotic pressure molar density 275
(mosmol/Kg)。
Embodiment three:
As shown in Figure 1, the embodiment of the present invention provides a kind of production technology of ambroxol hydrochloride injection, the supplementary material is used
Material is quantified according to 100,000 mL of pharmaceutical factory's production, according to the actual situation, can carry out equal proportion reduction or optimization,
Sp1: stock is weighed；
Sp2: firstly, 80.0kg water for injection is added in Agitation Tank, water for injection temperature preparating liquid: is controlled at 65 DEG C
Between, then, 763.00g sodium chloride, 368.00g disodium hydrogen phosphate, 101.00g citric acid is added, agitation cycle is no less than 10
Minute make to dissolve, then, is added and calculates load weighted ambroxol hydrochloride (increase feed intake 1.5%), agitation cycle is no less than 20 points
Clock makes to dissolve, and adjusts pH value and is added the 10g active carbon dissolved in advance with 1kg water after 5,65 DEG C stirring and adsorbing 20 minutes, it
After inject water to 88kg (pipeline and coarse filter Chinese medicine liquid weight be 12.4kg), agitation cycle is cooled to 25 after ten minutes
Between DEG C, sample examination；
Sp3: it filters, is filling: firstly, the titanium filter stick for being 15 μm with aperture is 0.45 μ with aperture after 25 DEG C of coarse filtration take off charcoal
The filter core refined filtration of m before nitrogen pipeline is connected to coarse filter, slowly opens nitrogen valve, using nitrogen pressure by remaining medicine
Liquid is beaten as far as possible to receiver, after receiver weighing confirmation, down toward filling after aperture is 0.22 μm of filter core refined filtration；
Sp4: sterilizing, lamp inspection: finished product obtained by step 3 is in 121 DEG C of laggard portable lighter inspections in sterilizing 15 minutes；
Sp5: packaging.
It should be noted that, in this document, relational terms such as first and second and the like are used merely to a reality
Body or operation are distinguished with another entity or operation, are deposited without necessarily requiring or implying between these entities or operation
In any actual relationship or order or sequence.Moreover, the terms "include", "comprise" or its any other variant are intended to
Non-exclusive inclusion, so that the process, method, article or equipment including a series of elements is not only wanted including those
Element, but also including other elements that are not explicitly listed, or further include for this process, method, article or equipment
Intrinsic element.In the absence of more restrictions, the element limited by sentence " including a reference structure ", is not arranged
Except there is also other identical elements in the process, method, article or apparatus that includes the element.
It although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
A variety of variations, modification, replacement can be carried out to these embodiments without departing from the principles and spirit of the present invention by understanding
And modification, the scope of the present invention is defined by the appended.
Claims (8)
1. a kind of production technology of ambroxol hydrochloride injection, characterized by the following steps: the supplementary material materials are equal
Quantified according to 100,000 mL of pharmaceutical factory's production, according to the actual situation, equal proportion reduction or optimization can be carried out,
Sp1: stock is weighed；
Sp2: firstly, 80.0kg water for injection is added in Agitation Tank, water for injection temperature preparating liquid: is controlled at 60~70 DEG C
Between, then, 763.00g sodium chloride, 368.00g disodium hydrogen phosphate, 101.00g citric acid is added, agitation cycle is no less than 10
Minute make to dissolve, then, is added and calculates load weighted ambroxol hydrochloride (increase feed intake 1.5%), agitation cycle is no less than 20 points
Clock makes to dissolve, and adjusts pH value and the 10g active carbon dissolved in advance with 1kg water is added afterwards between 4.7~5.3,60~70 DEG C are stirred
Absorption 20 minutes is mixed, injects water to 88kg (pipeline and coarse filter Chinese medicine liquid weight be 12.4kg), agitation cycle later
It is cooled between 20~30 DEG C after ten minutes, sample examination；
Sp3: it filters, is filling: firstly, the titanium filter stick for being 15 μm with aperture is 0.45 μ with aperture after 20~30 DEG C of coarse filtration take off charcoal
The filter core refined filtration of m before nitrogen pipeline is connected to coarse filter, slowly opens nitrogen valve, using nitrogen pressure by remaining medicine
Liquid is beaten as far as possible to receiver, after receiver weighing confirmation, down toward filling after aperture is 0.22 μm of filter core refined filtration；
Sp4: sterilizing, lamp inspection: finished product obtained by step 3 is in 121 DEG C of laggard portable lighter inspections in sterilizing 15 minutes；
Sp5: packaging.
2. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: described to match pharmacy
Liquid process key step and technological parameter are as follows: the drug solution preparing time is 180-240 minutes, when storage to be filtered is completed in preparation
Between be no more than 2 hours, be no more than 10 hours after filtering to placing before filling, and the fill operations time is no more than 10 hours, prepares
Start to filling end total time to be no more than 16 hours.
3. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: the filling work
Skill process is end-filtration → fire tuning, loading amount → inflation → filling → inflation → preheating → sealing → bottle outlet → is adjusted to clear out a gathering place, clean.
4. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: described filtered
Journey committed step and technological parameter are as follows: filter pressure < 0.01MPa, coarse filtration/10-15 minutes refined filtration time, refined filtration forward direction pressure
Poor < 0.01MPa is passed through the pressure < 0.2MPa of nitrogen, within 16 hours aseptic filtration time, and the medical fluid end-filtration time
Within 16 hours, coarse filtration/refined filtration filtration flow-rate is 8300~10000ml/min, and aseptic filtration flow velocity is < 3800ml/min,
Prescribe medicine temperature≤30 DEG C, positive pressure difference < 0.15MPa.
5. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: the sterilizing work
Skill process be code-disc → code vehicle → inlet → water filling → heating → sterilizing → row pressure → leak detection → primary cleaning → secondary cleaning →
Outlet → clear out a gathering place cleans.
6. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: described to match pharmacy
The device model used during liquid is respectively PG-200 Agitation Tank, the device model point used in the filtering, pouring process
Not Wei PG-2000 liquid storage tank, QCL160 vertical ultrasonic-wave cleaning machine, SZAX62 tunnel sterilization drying machine, the vertical filling envelope of AGF16
Mouth machine, the device model that the sterilizing, lamp inspection are used in the process is respectively ASM type Water bath disinfecting apparatus for ampoules, DJ-600 lamp inspection machine.
7. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: the medical fluid essence
The filter core used when filter and medical fluid aseptic filtration is respectively the polyether sulfone filter core that aperture is 0.45 μm and aperture is 0.22 μm
Polyether sulfone filter core, the storage tank respirator filter core, compressed air filter core and nitrogen filter core are that aperture is 0.22 μm poly-
Tetrafluoroethene filter core.
8. a kind of production technology of ambroxol hydrochloride injection according to claim 1, it is characterised in that: the intermediate production
Quality standard is the colourless clear liquid of content 97.0%~103.0%, and pH value is bacterial endotoxin < between 4.7~5.3
0.16EU/mg, osmotic pressure molar density are 275~325 (mosmol/Kg).
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| CN112495201A (en) * | 2020-10-27 | 2021-03-16 | 海南卫康制药(潜山)有限公司 | Preparation process of ambroxol hydrochloride injection |
| CN115318008A (en) * | 2022-07-06 | 2022-11-11 | 神威药业集团有限公司 | Preparation method of qingkailing injection |
| CN116350581A (en) * | 2023-03-16 | 2023-06-30 | 石家庄四药有限公司 | Acetylcysteine injection and preparation method thereof |
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| CN115318008A (en) * | 2022-07-06 | 2022-11-11 | 神威药业集团有限公司 | Preparation method of qingkailing injection |
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