CN107224425A - A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride - Google Patents
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride Download PDFInfo
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- CN107224425A CN107224425A CN201610172165.6A CN201610172165A CN107224425A CN 107224425 A CN107224425 A CN 107224425A CN 201610172165 A CN201610172165 A CN 201610172165A CN 107224425 A CN107224425 A CN 107224425A
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- lavo
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- ofloxacin hydrochloride
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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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- Chemical & Material Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
The invention provides a kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride.The preparation method is using lavo-ofloxacin hydrochloride as main ingredient, gel-type vehicle, osmotic pressure regulator, pH adjusting agent, complexing of metal ion agent and bacteriostatic agent are auxiliary material, it is that 0.3%, pH scopes are the sterile gel of 6.0~7.0 lavo-ofloxacin hydrochlorides to carry out being sufficiently mixed after bacteria removing and obtaining mass percent concentration in advance respectively.The sterile gel, with good water solubility, tack is strong, dissolution rate is high, persistent, without greasy feeling and the features such as skin, mucous membrane irritation, can be not only used for bacterial conjunctivitis, ulcer of the cornea, dacryocystitis, etc. external ocular infection and the treatment of skin burn, can also cure local skin bacterial infection.Preparation method proposed by the present invention is simple and convenient, and product sterility requirements are easily achieved.
Description
Technical field
The invention belongs to technical field of medicine, more particularly, to a kind of hydrochloric acid levofloxacin
The preparation method of the sterile gel of star.
Background technology
Lavo-ofloxacin is the laevoisomer that third generation fluoroquinolones represent medicine Ofloxacin, its
Has a broad antifungal spectrum, antibacterial activity is 2~3 times of racemic modification, to aerobic gram-positive bacteria and negative bacterium
Stronger killing action is respectively provided with, so as to be used by domestic and international pharmacy corporation using different pharmaceutical dosage forms are prepared
In the various bacterial infection diseases for the treatment of.
Levofloxacin Hydrochloride Gel agent has good water solubility, and tack is strong, and dissolution rate is high, without greasy
It is the features such as sense and skin, mucous membrane irritation, persistent, sexy available for some privileged sites bacteriums
The treatment of disease is contaminated, for example：Ophthalmic infection disease, the infectious symptom of the concurrent bacterial such as skin burn,
Patient's medicining times are reduced, so that patient's treatment compliance is greatly improved.Due to《The Chinese people are total to
With state's pharmacopeia》(2015 editions) will act on the quality standard of privileged sites gel by microbial limit
It is required that being changed to sterile, therefore new requirement is had also been proposed to preparation method, to meet NF mark
Standard, better meets in clinical treatment demand.
The content of the invention
It is an object of the present invention to meet《Pharmacopoeia of People's Republic of China》Required in (2015 editions)
The quality standard for acting on privileged sites gel is changed to sterile requirement by microbial limit, is proposed
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, prepares resulting production in the method
Quality meets latest edition standards of pharmacopoeia regulation.
To achieve these goals, the invention provides following technical scheme：
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, methods described is with the left oxygen fluorine of hydrochloric acid
Sha Xing is main ingredient, gel-type vehicle, osmotic pressure regulator, pH adjusting agent, complexing of metal ion agent and
Bacteriostatic agent is auxiliary material, carries out being sufficiently mixed after bacteria removing and obtaining the described left oxygen of hydrochloric acid in advance respectively
The sterile gel of Flucloxacillin.
Bacteria removing of the present invention is moist heat sterilization.
Gel-type vehicle of the present invention is carbomer.
Preparation in accordance with the present invention obtain mass percent concentration be 0.3%, pH scopes be 6.0~
The 7.0 sterile gel of lavo-ofloxacin hydrochloride.
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, the described method comprises the following steps：
(1) the complete stirring and dissolving of the sodium chloride of recipe quantity is filtered in after appropriate water for injection through micropore
Membrane filtration is degerming, obtains filtrate；
(2) carbomer and appropriate injection of recipe quantity are added into the filtrate obtained by step (1)
Water, after homogeneous stirs, is transferred in emulsion tank after carrying out moist heat sterilization；
(3) oxybenzene formicester, natrium adetate, sodium hydroxide and the hydrochloric acid levofloxacin of recipe quantity are taken
Star, it is uniform to sequentially add in material-compound tank stirring and dissolving, through filtering with microporous membrane it is degerming after, by what is obtained
Filtrate is transferred in the emulsion tank described in step (2)；
(4) in the filtrate obtained by step (3), water for injection is added to full dose, homogeneous stirring
Intermediate products are obtained to substantially uniformity；
(5) by described in step (4) intermediate products sampling detection it is qualified after, through sterile filling and bag
Dress, obtains the described sterile gel of lavo-ofloxacin hydrochloride.
Miillpore filter of the present invention is 0.22 μm of miillpore filter.
Moist heat sterilization refers at 100-121 DEG C in step (2) of the present invention, 20-30 points of sterilizing
Clock.
Stirring in the present invention described in step (1) and (3) refers to be installed on agitating shaft in material-compound tank
The range of speeds is held for 20-100r/min.
Step (2) and the homogeneous stirring described in (4), which refer to be installed in emulsion tank, in the present invention stirs
The bearing range of speeds is 1200-2000r/min.
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, is specifically included:
(1) in 50L material-compound tanks, the sodium chloride of recipe quantity is stirred to being dissolved completely in appropriate note
Penetrate with water, it is degerming through 0.22 μm of filtering with microporous membrane, filtrate is transferred in 100L material-compound tanks；
(2) carbomer and appropriate water for injection of recipe quantity are added into the filtrate obtained by step (1),
Homogeneous stirs, after moist heat sterilization, is transferred in 200L emulsion tanks；
(3) the accurate oxybenzene formicester for weighing recipe quantity, natrium adetate, sodium hydroxide, hydrochloric acid are left
Ofloxacin, it is uniform to be added sequentially in 50L material-compound tanks stirring and dissolving, through 0.22 μm of miillpore filter
After filtration sterilization, it is transferred in 200L emulsion tanks；
(4) in 200L emulsion tanks, water for injection is added to full dose, and homogeneous is stirred to completely
It is even；
(5) after inspection by sampling is qualified, through sterile filling and packaging, that is, the described left oxygen of hydrochloric acid is obtained
The sterile gel of Flucloxacillin.
In the present invention, main ingredient is lavo-ofloxacin hydrochloride, and auxiliary material is osmotic pressure regulator sodium chloride, gold
Belong to ionic complexing agent natrium adetate, preservative oxybenzene formicester and pH adjusting agent sodium hydroxide, with
Before gel-type vehicle mixed preparing, pass through 0.22 μm of miillpore filter, filtration sterilization after complete dissolution.
Gel-type vehicle is used before hydrophilic high molecular material carbomer, mixed preparing after high-temperature heat sterilization,
Mix and be swelled with other materials, homogeneous stirs, prepare obtained Levofloxacin Hydrochloride Gel agent
Sterility requirements can be ensured.
Preparation method proposed by the present invention is simple and convenient, it is easy to accomplish, it is ensured that it is any in preparation process
The product of link reaches sterility requirements.The preparation-obtained sterile gel tool of lavo-ofloxacin hydrochloride
There is good water solubility, tack is strong, and dissolution rate is high, no greasy feeling and skin, mucous membrane irritation, effect
Persistently the features such as, administration number of times is reduced, greatly improve patient's treatment compliance.
Brief description of the drawings
Fig. 1 is the preparation method flow chart of the sterile gel of lavo-ofloxacin hydrochloride provided by the present invention
Embodiment
The present invention is further explained by detailed description below, but not as the limit of the present invention
System, protection scope of the present invention is with reference to described in claims.Prepare lavo-ofloxacin hydrochloride sterile solidifying
Main ingredient used in jelly and auxiliary material are satisfied by medicinal supplementary material requirement.
Examination criteria：
Character is provided：Faint yellow or pistac clear gel；Content is provided:90.0%~110.0%；
Microorganism provides:Aerobe, anaerobic bacteria, fungi must not detect；
HPLC is provided：Test sample main peak retention time should be consistent with reference substance main peak；
UV is provided：There is absorption maximum at 293nm；PH is provided：6.0~7.0；
Metallic foreign body is provided：It is each to examine container more than 8 persons containing metallic foreign body, it must not exceed
1, sum must not cross 50；
Embodiment 1
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, including：
(1) in 50L material-compound tanks, the sodium chloride of recipe quantity is stirred to being dissolved completely in appropriate note
Penetrate with water, wherein stirring is 100r/min to be installed on agitating shaft in material-compound tank to forward speed, through 0.22
μm filtering with microporous membrane is degerming, is transferred in 100L material-compound tanks.
(2) carbomer and appropriate water for injection of recipe quantity, homogeneous stirring are added into above-mentioned solution
Uniformly, at 121 DEG C, sterilizing carries out high-temperature heat sterilization under 20 minutes, is transferred to 200L emulsion tanks
In, it is 1200r/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(3) the accurate oxybenzene formicester for weighing recipe quantity, natrium adetate, sodium hydroxide, hydrochloric acid are left
Ofloxacin, it is uniform to be added separately in 50L material-compound tanks stirring and dissolving, through 0.22 μm of miillpore filter
After filtration sterilization, it is transferred in 200L emulsion tanks；Wherein stirring is to be installed on agitating shaft in material-compound tank
It is 50r/min to forward speed.
(4) in 200L emulsion tanks, water for injection is added to full dose, and homogeneous is stirred to completely
Even, it is 1600/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(5) by the product sampling and detecting obtained by step (4) it is qualified after, through sterile filling and bag
Dress, produces the sterile gel of lavo-ofloxacin hydrochloride.
Embodiment 2
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, including：
(1) in 50L material-compound tanks, the sodium chloride of recipe quantity is stirred to being dissolved completely in appropriate note
Penetrate with water, wherein stirring is 20r/min to be installed on agitating shaft in material-compound tank to forward speed, through 0.22
μm filtering with microporous membrane is degerming, is transferred in 100L material-compound tanks.
(2) carbomer and appropriate water for injection of recipe quantity, homogeneous stirring are added into above-mentioned solution
Uniformly, at 100 DEG C, sterilizing carries out high-temperature heat sterilization under 30 minutes, is transferred to 200L emulsion tanks
In, it is 1500r/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(3) the accurate oxybenzene formicester for weighing recipe quantity, natrium adetate, sodium hydroxide, hydrochloric acid are left
Ofloxacin, it is uniform to be added separately in 50L material-compound tanks stirring and dissolving, through 0.22 μm of miillpore filter
After filtration sterilization, it is transferred in 200L emulsion tanks；Wherein stirring is to be installed on agitating shaft in material-compound tank
It is 100r/min to forward speed.
(4) in 200L emulsion tanks, water for injection is added to full dose, and homogeneous is stirred to completely
Even, it is 2000r/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(5) by the product sampling and detecting obtained by step (4) it is qualified after, through sterile filling and bag
Dress, produces the sterile gel of lavo-ofloxacin hydrochloride.
Embodiment 3
A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, including：
(1) in 50L material-compound tanks, the sodium chloride of recipe quantity is stirred to being dissolved completely in appropriate note
Penetrate with water, wherein stirring is 50r/min to be installed on agitating shaft in material-compound tank to forward speed, through 0.22 μm
Filtering with microporous membrane is degerming, is transferred in 100L material-compound tanks.
(2) carbomer and appropriate water for injection of recipe quantity, homogeneous stirring are added into above-mentioned solution
Uniformly, at 110 DEG C, sterilizing carries out high-temperature heat sterilization under 25 minutes, is transferred to 200L emulsion tanks
In, it is 1500r/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(3) the accurate oxybenzene formicester for weighing recipe quantity, natrium adetate, sodium hydroxide, hydrochloric acid are left
Ofloxacin, it is uniform to be added separately in 50L material-compound tanks stirring and dissolving, through 0.22 μm of miillpore filter
After filtration sterilization, it is transferred in 200L emulsion tanks；Wherein stirring is to be installed on agitating shaft in material-compound tank
It is 80r/min to forward speed.
(4) in 200L emulsion tanks, water for injection is added to full dose, and homogeneous is stirred to completely
Even, it is 1800r/min that wherein homogeneous stirring, which refers to be installed on agitating shaft in emulsion tank to forward speed,.
(5) by the product sampling and detecting obtained by step (4) it is qualified after, through sterile filling and bag
Dress, produces the sterile gel of lavo-ofloxacin hydrochloride.
Respectively according to the lavo-ofloxacin hydrochloride prepared by embodiment 1, embodiment 2 and embodiment 3 without
Bacterium gel meets《Pharmacopoeia of People's Republic of China》(2015 editions) quality criteria requirements, examine knot
Fruit is specifically shown in Table 1.
The assay of the sterile gel of the lavo-ofloxacin hydrochloride of table 1
It is described above, only it is several embodiments of the application, any type of limit is not done to the application
System, although the application with preferred embodiment disclose as above, but and be not used to limit the application, it is any
Those skilled in the art, in the range of technical scheme is not departed from, are taken off using above-mentioned
The technology contents shown make a little variation or modification is equal to equivalence enforcement case, belong to technology
In aspects.
Claims (10)
1. a kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride, it is characterised in that described
Method using lavo-ofloxacin hydrochloride as main ingredient, gel-type vehicle, osmotic pressure regulator, pH adjusting agent,
Complexing of metal ion agent and bacteriostatic agent are auxiliary material, are sufficiently mixed and obtain after carrying out bacteria removing in advance respectively
To the described sterile gel of lavo-ofloxacin hydrochloride.
2. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 1
Method, it is characterised in that described bacteria removing is moist heat sterilization.
3. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 1
Method, it is characterised in that described gel-type vehicle is carbomer.
4. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 1
Method, it is characterised in that obtain mass percent concentration according to the preparation method for 0.3%, pH models
Enclose the sterile gel of lavo-ofloxacin hydrochloride for 6.0~7.0.
5. according to any described sterile gel of a kind of lavo-ofloxacin hydrochloride in Claims 1-4
The preparation method of agent, it is characterised in that the preparation method comprises the following steps：
(1) the complete stirring and dissolving of the sodium chloride of recipe quantity is filtered in after appropriate water for injection through micropore
Membrane filtration is degerming, obtains filtrate；
(2) carbomer and appropriate injection of recipe quantity are added into the filtrate obtained by step (1)
Water, after homogeneous stirs, is transferred in emulsion tank after carrying out moist heat sterilization；
(3) oxybenzene formicester, natrium adetate, sodium hydroxide and the hydrochloric acid levofloxacin of recipe quantity are taken
Star, it is uniform to sequentially add in material-compound tank stirring and dissolving, through filtering with microporous membrane it is degerming after, by what is obtained
Filtrate is transferred in the emulsion tank described in step (2)；
(4) in the filtrate obtained by step (3), water for injection is added to full dose, homogeneous stirring
Intermediate products are obtained to substantially uniformity；
(5) by described in step (4) intermediate products sampling detection it is qualified after, through sterile filling and bag
Dress, obtains the described sterile gel of lavo-ofloxacin hydrochloride.
6. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 5
Method, it is characterised in that described miillpore filter is 0.22 μm of miillpore filter.
7. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 5
Method, it is characterised in that the moist heat sterilization described in step (2) refers at 100 DEG C -121 DEG C, sterilizes
20-30 minutes.
8. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 5
Method, it is characterised in that the stirring described in step (1) and (3), which refers to be installed in material-compound tank, stirs
The bearing range of speeds is 20-100r/min.
9. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 5
Method, it is characterised in that the homogeneous stirring described in step (2) and (4) refers to be installed in emulsion tank
Agitating shaft holds the range of speeds for 1200-2000r/min.
10. a kind of preparation side of the sterile gel of lavo-ofloxacin hydrochloride according to claim 5
Method, it is characterised in that described preparation method is specifically included:
(1) in 50L material-compound tanks, the complete stirring and dissolving of sodium chloride of recipe quantity is in appropriate injection
It is degerming through 0.22 μm of filtering with microporous membrane with water, filtrate is transferred in 100L material-compound tanks；
(2) carbomer and appropriate water for injection of recipe quantity are added into the filtrate obtained by step (1),
Homogeneous stirs, after moist heat sterilization, is transferred in 200L emulsion tanks；
(3) the accurate oxybenzene formicester for weighing recipe quantity, natrium adetate, sodium hydroxide, hydrochloric acid are left
Ofloxacin, it is uniform to be added sequentially in 50L material-compound tanks stirring and dissolving, through 0.22 μm of miillpore filter
After filtration sterilization, filtrate is transferred in 200L emulsion tanks；
(4) in 200L emulsion tanks, water for injection is added to full dose, and homogeneous is stirred to completely
It is even；
(5) by the product inspection by sampling obtained by step (4) it is qualified after, through sterile filling and packaging,
Obtain the described sterile gel of lavo-ofloxacin hydrochloride.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610172165.6A CN107224425B (en) | 2016-03-24 | 2016-03-24 | Preparation method of levofloxacin hydrochloride sterile gel |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610172165.6A CN107224425B (en) | 2016-03-24 | 2016-03-24 | Preparation method of levofloxacin hydrochloride sterile gel |
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| CN107224425A true CN107224425A (en) | 2017-10-03 |
| CN107224425B CN107224425B (en) | 2021-05-25 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114504425A (en) * | 2020-11-16 | 2022-05-17 | 湖北舒邦药业有限公司 | Cold compress patch preparation method, cold compress patch and application method thereof |
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| US20150320816A1 (en) * | 2014-05-06 | 2015-11-12 | Trinity Pharma Group | Compositions for promotion of wound healing and/or scar reduction |
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| WO2002040028A1 (en) * | 2000-11-16 | 2002-05-23 | Wakamoto Pharmaceutical Co., Ltd. | Antibacterial gel eye drops |
| CN1397272A (en) * | 2002-08-19 | 2003-02-19 | 上海兴康医药研究开发有限公司 | In-vivo gel preparatino able to be dropped in eyes and its preparing process |
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