CN107224425B - Preparation method of levofloxacin hydrochloride sterile gel - Google Patents
Preparation method of levofloxacin hydrochloride sterile gel Download PDFInfo
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- CN107224425B CN107224425B CN201610172165.6A CN201610172165A CN107224425B CN 107224425 B CN107224425 B CN 107224425B CN 201610172165 A CN201610172165 A CN 201610172165A CN 107224425 B CN107224425 B CN 107224425B
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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
Abstract
The invention provides a preparation method of levofloxacin hydrochloride sterile gel. The preparation method comprises the steps of taking levofloxacin hydrochloride as a main drug, taking a gel matrix, an osmotic pressure regulator, a pH regulator, a metal ion complexing agent and a bacteriostatic agent as auxiliary materials, respectively carrying out sterilization treatment in advance, and then fully mixing to obtain the levofloxacin hydrochloride sterile gel with the mass percentage concentration of 0.3% and the pH range of 6.0-7.0. The sterile gel has the characteristics of good water solubility, strong adhesiveness, high dissolution rate, lasting effect, no greasy feeling, no irritation to skin and mucosa and the like, can be used for treating bacterial conjunctivitis, corneal ulcer, dacryocystitis, external eye infection and skin burn and scald, and can also cure local bacterial infection of the skin. The preparation method provided by the invention is simple and convenient, and the aseptic requirement of the product is easy to realize.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation method of levofloxacin hydrochloride sterile gel.
Background
The levofloxacin is a levorotatory isomer of a third-generation fluoroquinolone representative drug ofloxacin, has wide antibacterial spectrum, the antibacterial activity of 2-3 times of that of raceme, and has strong killing effect on aerobic gram-positive bacteria and aerobic gram-negative bacteria, so that the levofloxacin is utilized by pharmaceutical enterprises at home and abroad to prepare different drug formulations for treating various bacterial infection diseases.
The levofloxacin hydrochloride gel has the characteristics of good water solubility, strong adhesiveness, high dissolution rate, no greasy feeling, no irritation to skin and mucous membrane, lasting effect and the like, and can be used for treating some special parts of bacterial infection diseases, such as: the ophthalmic infection diseases, skin burns and scalds and other complicated bacterial infection symptoms reduce the administration times of patients, thereby greatly improving the treatment compliance of the patients. Because the quality standard of the gel acting on a special part is changed from the requirement of microbial limit to sterility in the pharmacopoeia of the people's republic of China (2015 edition), a new requirement is put forward on the preparation method so as to meet the standard of the national pharmacopoeia and better meet the requirement of clinical treatment.
Disclosure of Invention
The invention aims to meet the requirement that the quality standard of a gel required to act on a special part in the pharmacopoeia of the people's republic of China (2015 edition) is changed from the limit of microorganisms to be aseptic, and provides a preparation method of levofloxacin hydrochloride aseptic gel, wherein the quality of a product prepared according to the method meets the standard regulation of the latest edition of pharmacopoeia.
In order to achieve the purpose, the invention provides the following technical scheme:
the preparation method of the levofloxacin hydrochloride sterile gel comprises the steps of taking levofloxacin hydrochloride as a main drug, taking a gel matrix, an osmotic pressure regulator, a pH regulator, a metal ion complexing agent and a bacteriostatic agent as auxiliary materials, respectively carrying out sterilization treatment in advance, and then fully mixing to obtain the levofloxacin hydrochloride sterile gel.
The sterilization treatment is moist heat sterilization.
The gel matrix is carbomer.
According to the preparation method, the levofloxacin hydrochloride sterile gel with the mass percentage concentration of 0.3% and the pH range of 6.0-7.0 is obtained.
A method for preparing levofloxacin hydrochloride sterile gel, which comprises the following steps:
(1) completely stirring and dissolving the sodium chloride with the prescription amount in a proper amount of water for injection, and filtering and sterilizing through a microporous filter membrane to obtain a filtrate;
(2) adding carbomer and a proper amount of water for injection into the filtrate obtained in the step (1), homogenizing and stirring uniformly, performing moist heat sterilization, and transferring to an emulsification tank;
(3) sequentially adding the prescribed amount of methylparaben, disodium edetate, sodium hydroxide and levofloxacin hydrochloride into a proportioning tank, uniformly stirring and dissolving, filtering and sterilizing through a microporous filter membrane, and transferring the obtained filtrate into the emulsifying tank in the step (2);
(4) adding water for injection to the full amount of the filtrate obtained in the step (3), and homogenizing and stirring the mixture until the mixture is completely uniform to obtain an intermediate product;
(5) and (4) sampling and detecting the intermediate product in the step (4) to be qualified, and then carrying out aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
The microporous filter membrane is a 0.22 mu m microporous filter membrane.
The moist heat sterilization in the step (2) of the present invention means sterilization at 121 ℃ for 20-30 minutes at 100-.
The stirring in the steps (1) and (3) of the invention means that the rotating speed range of the stirring bearing arranged in the batching tank is 20-100 r/min.
The homogeneous stirring in the steps (2) and (4) in the invention means that the rotating speed range of the stirring bearing arranged in the emulsifying tank is 1200-2000 r/min.
A preparation method of levofloxacin hydrochloride sterile gel specifically comprises the following steps:
(1) stirring sodium chloride in a prescription amount in a 50L blending tank until the sodium chloride is completely dissolved in a proper amount of water for injection, filtering and sterilizing through a 0.22 mu m microporous filter membrane, and transferring the filtrate to a 100L blending tank;
(2) adding carbomer and a proper amount of water for injection into the filtrate obtained in the step (1), homogenizing and stirring uniformly, and transferring to a 200L emulsifying tank after moist heat sterilization;
(3) accurately weighing the prescribed amount of methylparaben, disodium edetate, sodium hydroxide and levofloxacin hydrochloride, sequentially adding the weighed materials into a 50L batching tank, uniformly stirring and dissolving, filtering and sterilizing by a 0.22 mu m microporous filter membrane, and transferring the mixture into a 200L emulsifying tank;
(4) adding water for injection into a 200L emulsifying tank, homogenizing, and stirring to completely uniform;
(5) sampling, inspecting, and aseptically filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
In the invention, the main drug is levofloxacin hydrochloride, the auxiliary materials are osmotic pressure regulator sodium chloride, metal ion complexing agent edetate disodium, preservative hydroxybenzene methyl ester and pH regulator sodium hydroxide, and the levofloxacin hydrochloride, the metal ion complexing agent edetate disodium, the preservative hydroxybenzene methyl ester and the pH regulator sodium hydroxide are filtered and sterilized through a 0.22 mu m microporous filter membrane before being mixed with a gel matrix for preparation.
The gel matrix adopts hydrophilic high polymer material carbomer, is subjected to high-temperature moist heat sterilization before mixing preparation, is mixed with other materials for swelling, is homogenized and stirred uniformly, and the prepared levofloxacin hydrochloride gel can meet the aseptic requirement.
The preparation method provided by the invention is simple and convenient, is easy to realize, and can ensure that products in any link in the preparation process can meet the aseptic requirement. The prepared levofloxacin hydrochloride sterile gel has the characteristics of good water solubility, strong adhesiveness, high dissolution rate, no greasy feeling, no irritation to skin and mucous membrane, lasting effect and the like, reduces the administration times, and greatly improves the treatment compliance of patients.
Drawings
FIG. 1 is a flow chart of a preparation method of levofloxacin hydrochloride sterile gel provided by the invention
Detailed Description
The present invention is further illustrated by the following detailed description, but not by way of limitation, the scope of the invention being indicated by the claims. The main medicine and the auxiliary materials used for preparing the levofloxacin hydrochloride sterile gel meet the requirements of the raw and auxiliary materials for medicine.
Detection standard:
the specification of the properties: a light yellow or yellowish green transparent gel; the content is regulated to be 90.0-110.0 percent;
regulating microorganisms that aerobes, anaerobes and fungi cannot be detected;
HPLC specification: the retention time of the main peak of the test sample is consistent with that of the main peak of the reference sample;
UV regulation: the absorption maximum at 293 nm; pH specification: 6.0 to 7.0;
the metallic foreign matter is specified: each inspection container contains more than 8 metallic foreign matters, not more than 1 metallic foreign matters and not more than 50 metallic foreign matters in total;
example 1
A preparation method of levofloxacin hydrochloride sterile gel comprises the following steps:
(1) in a 50L batching tank, the sodium chloride with the prescription amount is stirred until the sodium chloride is completely dissolved in a proper amount of water for injection, wherein the stirring is carried out by arranging the sodium chloride in the batching tank at the rotating speed of a stirring bearing of 100r/min, filtering and sterilizing the sodium chloride by a 0.22 mu m microporous membrane, and transferring the sodium chloride into a 100L batching tank.
(2) Adding carbomer and appropriate amount of water for injection into the above solution, homogenizing and stirring, sterilizing at 121 deg.C for 20 min under high temperature and humid heat, transferring to 200L emulsifying tank, wherein homogenizing and stirring means that the rotation speed of stirring bearing in the emulsifying tank is 1200 r/min.
(3) Accurately weighing the prescribed amount of methylparaben, disodium edetate, sodium hydroxide and levofloxacin hydrochloride, respectively adding the weighed materials into a 50L proportioning tank, uniformly stirring and dissolving, filtering and sterilizing by a 0.22 mu m microporous filter membrane, and transferring the mixture into a 200L emulsifying tank; wherein the stirring is that the rotating speed of a stirring bearing arranged in the batching tank is 50 r/min.
(4) Adding water for injection into 200L emulsifying tank, homogenizing and stirring to completely uniform, wherein the homogenizing and stirring means that the rotation speed of stirring bearing installed in the emulsifying tank is 1600/min.
(5) And (4) sampling the product obtained in the step (4), checking to be qualified, and performing aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
Example 2
A preparation method of levofloxacin hydrochloride sterile gel comprises the following steps:
(1) in a 50L batching tank, the sodium chloride with the prescription amount is stirred until the sodium chloride is completely dissolved in a proper amount of water for injection, wherein the stirring is carried out by arranging the sodium chloride in the batching tank at the rotating speed of 20r/min through a stirring bearing, filtering and sterilizing through a 0.22 mu m microporous membrane, and transferring the sodium chloride into a 100L batching tank.
(2) Adding carbomer and appropriate amount of water for injection into the above solution, homogenizing and stirring, sterilizing at 100 deg.C for 30 min under high temperature and humid heat, transferring to 200L emulsifying tank, wherein homogenizing and stirring means that the rotating speed of stirring bearing in the emulsifying tank is 1500 r/min.
(3) Accurately weighing the prescribed amount of methylparaben, disodium edetate, sodium hydroxide and levofloxacin hydrochloride, respectively adding the weighed materials into a 50L proportioning tank, uniformly stirring and dissolving, filtering and sterilizing by a 0.22 mu m microporous filter membrane, and transferring the mixture into a 200L emulsifying tank; wherein the stirring is that the rotating speed of a stirring bearing arranged in the batching tank is 100 r/min.
(4) Adding water for injection into a 200L emulsifying tank, and homogenizing and stirring until the water for injection is completely uniform, wherein the homogenizing and stirring means that the rotating speed of a stirring bearing arranged in the emulsifying tank is 2000 r/min.
(5) And (4) sampling the product obtained in the step (4), checking to be qualified, and performing aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
Example 3
A preparation method of levofloxacin hydrochloride sterile gel comprises the following steps:
(1) in a 50L batching tank, the sodium chloride with the prescription amount is stirred until the sodium chloride is completely dissolved in a proper amount of water for injection, wherein the stirring is carried out by arranging a stirring bearing in the batching tank at the rotating speed of 50r/min, filtering and sterilizing the mixture through a 0.22 mu m microporous membrane, and transferring the mixture into a 100L batching tank.
(2) Adding carbomer and appropriate amount of water for injection into the above solution, homogenizing and stirring, sterilizing at 110 deg.C for 25 min under high temperature and moist heat, transferring to 200L emulsifying tank, wherein homogenizing and stirring means that the rotating speed of stirring bearing in the emulsifying tank is 1500 r/min.
(3) Accurately weighing the prescribed amount of methylparaben, disodium edetate, sodium hydroxide and levofloxacin hydrochloride, respectively adding the weighed materials into a 50L proportioning tank, uniformly stirring and dissolving, filtering and sterilizing by a 0.22 mu m microporous filter membrane, and transferring the mixture into a 200L emulsifying tank; wherein the stirring is that the rotating speed of a stirring bearing arranged in the batching tank is 80 r/min.
(4) Adding water for injection into 200L emulsifying tank, homogenizing and stirring to completely uniform, wherein the homogenizing and stirring means that the rotation speed of stirring bearing installed in the emulsifying tank is 1800 r/min.
(5) And (4) sampling the product obtained in the step (4), checking to be qualified, and performing aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
The levofloxacin hydrochloride sterile gels prepared according to the example 1, the example 2 and the example 3 respectively meet the quality standard requirements of pharmacopoeia of the people's republic of China (2015 edition), and the test results are shown in table 1.
TABLE 1 examination result of levofloxacin hydrochloride aseptic gel
Although the present application has been described with reference to a few embodiments, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the application as defined by the appended claims.
Claims (6)
1. The preparation method of the levofloxacin hydrochloride sterile gel is characterized in that levofloxacin hydrochloride is used as a main drug, a gel matrix, an osmotic pressure regulator, a pH regulator, a metal ion complexing agent and a bacteriostatic agent are used as auxiliary materials, and the levofloxacin hydrochloride sterile gel is obtained by respectively carrying out sterilization treatment in advance and then fully mixing the materials;
the sterilization treatment is damp-heat sterilization;
the gel matrix is carbomer;
the osmotic pressure regulator is sodium chloride;
the pH regulator is sodium hydroxide;
the metal ion complexing agent is edetate disodium;
the bacteriostatic agent is methyl hydroxybenzoate;
obtaining the levofloxacin hydrochloride sterile gel with the mass percentage concentration of 0.3% and the pH range of 6.0-7.0 according to the preparation method;
the preparation method comprises the following steps:
(1) completely stirring and dissolving the sodium chloride with the prescription amount in a proper amount of water for injection, and filtering and sterilizing through a microporous filter membrane to obtain a filtrate;
(2) adding carbomer and a proper amount of water for injection into the filtrate obtained in the step (1), homogenizing and stirring uniformly, performing moist heat sterilization, and transferring to an emulsification tank;
(3) taking methyl hydroxybenzoate, edetate disodium, sodium hydroxide and levofloxacin hydrochloride according to the prescription amount, sequentially adding the materials into a proportioning tank, uniformly stirring and dissolving, filtering and sterilizing through a microporous filter membrane, and transferring the obtained filtrate into the emulsifying tank in the step (2);
(4) adding water for injection to the full amount of the filtrate obtained in the step (3), and homogenizing and stirring the mixture until the mixture is completely uniform to obtain an intermediate product;
(5) and (4) sampling and detecting the intermediate product in the step (4) to be qualified, and then carrying out aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
2. The method for preparing the levofloxacin hydrochloride sterile gel according to claim 1, wherein the microfiltration membrane is a 0.22 μm microfiltration membrane.
3. The process for preparing sterile levofloxacin hydrochloride gel according to claim 1, wherein the moist heat sterilization in step (2) is performed at 100-121 ℃ for 20-30 minutes.
4. The process for preparing sterile levofloxacin hydrochloride gel according to claim 1, wherein the stirring in steps (1) and (3) is carried out at a speed of 20-100r/min with a stirring bearing installed in a dosing tank.
5. The method for preparing levofloxacin hydrochloride sterile gel according to claim 1, wherein the homogeneous stirring in steps (2) and (4) is carried out at a stirring bearing rotating speed of 1200-2000r/min installed in an emulsification tank.
6. The preparation method of the levofloxacin hydrochloride sterile gel according to claim 1, which is characterized in that the preparation method specifically comprises the following steps:
(1) in a 50L batching tank, the sodium chloride with the prescription amount is completely stirred and dissolved in a proper amount of water for injection, and the mixture is filtered and sterilized by a 0.22 mu m microporous filter membrane, and the filtrate is transferred to a 100L batching tank;
(2) adding carbomer and a proper amount of water for injection into the filtrate obtained in the step (1), homogenizing and stirring uniformly, and transferring to a 200L emulsifying tank after moist heat sterilization;
(3) accurately weighing methyl hydroxybenzoate, edetate disodium, sodium hydroxide and levofloxacin hydrochloride in prescribed amount, sequentially adding into a 50L blending tank, stirring and dissolving uniformly, filtering with 0.22 μm microporous membrane for sterilization, and transferring the filtrate into a 200L emulsifying tank;
(4) adding water for injection into a 200L emulsifying tank, homogenizing, and stirring to completely uniform;
(5) sampling the product obtained in the step (4), checking to be qualified, and performing aseptic filling and packaging to obtain the levofloxacin hydrochloride aseptic gel.
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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 |
| CN1562038A (en) * | 2004-04-20 | 2005-01-12 | 沈阳药科大学 | L-ofloxacin lactate slow release gels for eye and its preparing method |
| CN102085203A (en) * | 2009-12-02 | 2011-06-08 | 沈阳兴齐制药有限公司 | Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof |
| CN102949335A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Preparation method of levofloxacin hydrochloride gel-type eye-drops |
| CN102949334A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Levofloxacin hydrochloride gel-type eye-drops |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN1562038A (en) * | 2004-04-20 | 2005-01-12 | 沈阳药科大学 | L-ofloxacin lactate slow release gels for eye and its preparing method |
| CN102085203A (en) * | 2009-12-02 | 2011-06-08 | 沈阳兴齐制药有限公司 | Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof |
| CN102949335A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Preparation method of levofloxacin hydrochloride gel-type eye-drops |
| CN102949334A (en) * | 2011-08-19 | 2013-03-06 | 苏州太湖美药业有限公司 | Levofloxacin hydrochloride gel-type eye-drops |
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