CN113842360A - Eye drops containing moxifloxacin hydrochloride and preparation method thereof - Google Patents

Eye drops containing moxifloxacin hydrochloride and preparation method thereof Download PDF

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Publication number
CN113842360A
CN113842360A CN202111318788.7A CN202111318788A CN113842360A CN 113842360 A CN113842360 A CN 113842360A CN 202111318788 A CN202111318788 A CN 202111318788A CN 113842360 A CN113842360 A CN 113842360A
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Prior art keywords
eye drops
moxifloxacin hydrochloride
feed liquid
injection
preparation
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CN202111318788.7A
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裴义海
骆后峰
吴灿灿
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Sinopharm Group Sanyi Pharmaceutical Wuhu Co Ltd
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Sinopharm Group Sanyi Pharmaceutical Wuhu Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses moxifloxacin hydrochloride eye drops and a preparation method thereof, wherein the moxifloxacin hydrochloride eye drops comprise the following raw materials in parts by weight: 0.5-0.55 part of moxifloxacin hydrochloride, 0.48-0.5 part of boric acid, 0.3-0.35 part of sodium chloride, 0.4-0.55 part of pH regulator and the balance of water for injection to 100 parts. The preparation method of the moxifloxacin hydrochloride eye drops is simple, and the prepared moxifloxacin hydrochloride eye drops have the characteristics of high efficiency, low toxicity, wide antibacterial spectrum, good stability and the like, and can effectively treat the ophthalmia; the eye drops are filled aseptically, so that the drug pollution risk is reduced, the service life of the eye drops is prolonged, the drug waste is avoided, and the components of the eye drops are simple.

Description

Eye drops containing moxifloxacin hydrochloride and preparation method thereof
Technical Field
The invention relates to the technical field of eye drops, in particular to an eye drop containing moxifloxacin hydrochloride and a preparation method thereof.
Background
Moxifloxacin is a fourth-generation fluoroquinolone antibiotic, the original manufacturer is German Bayer company, the antibiotic is wider than the former three-generation quinolone drugs and has the trade name 'bayfule', and moxifloxacin has the spectrum antibacterial activity in vitro on gram-positive bacteria, gram-negative bacteria, anaerobic bacteria, acid-fast bacteria and atypical microorganisms such as mycoplasma, chlamydia and legionella. The antibacterial mechanism is interference with II and IV topoisomerase. Topoisomerase is a key enzyme in the control of DNA topology and DNA replication, repair and transcription. Moxifloxacin has high in vivo activity.
As is well known, moxifloxacin hydrochloride eye drops are eye drops of broad-spectrum antibiotics, which are antibiotics and are mainly used for treating keratitis, conjunctivitis, blepharitis and hordeolum. However, the existing moxifloxacin hydrochloride-containing eye drops have general stability and strong irritation in the using process, and therefore, the moxifloxacin hydrochloride eye drops and the preparation method thereof are provided for solving the problems.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides moxifloxacin hydrochloride eye drops and a preparation method thereof, and aims to solve the problems in the background art.
In order to achieve the purpose, the invention provides the following technical scheme: the moxifloxacin hydrochloride eye drops comprise the following raw materials in parts by weight: 0.5-0.55 part of moxifloxacin hydrochloride, 0.48-0.5 part of boric acid, 0.3-0.35 part of sodium chloride, 0.4-0.55 part of pH regulator and the balance of water for injection to 100 parts.
The pH regulator is 1mol/L sodium hydroxide solution.
The pH value is 6.6-7.0, and the preferable pH value is 6.8.
The preparation method of the moxifloxacin hydrochloride eye drops comprises the following steps:
(1) adding 80% of water for injection into the preparation tank, and cooling the water for injection to 15-35 deg.C;
(2) adding boric acid with a formula amount, and stirring until the solution is clear, wherein the stirring speed is 1000-1200 r/min;
(3) adding moxifloxacin hydrochloride with a prescription amount, and stirring until a clear solution is observed, wherein the stirring speed is 1000-1200 r/min;
(4) and (3) pH adjustment: adjusting the pH of the mixed solution to 6.6-7 by using 1mol/L sodium hydroxide solution;
(5) adding sodium chloride according to the formula amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1000-1200 r/min;
(6) and (3) volume fixing: cooling the rest water for injection to 15-35 deg.C, adding to constant volume, stirring to uniform volume;
(7) roughly filtering the feed liquid in the preparation tank through a 0.45-micrometer PES cylinder filter element through a liquid conveying pipeline, then feeding the feed liquid into a storage tank 1, filtering the feed liquid after rough filtration through a 0.22-micrometer PES cylinder filter element, then feeding the feed liquid into a storage tank 2, and finally sterilizing and filtering the feed liquid after secondary filtration through a 0.22-micrometer PES cylinder filter element to a filling buffer tank;
(8) filling the low-density polyethylene medicinal eye drop bottle into the can under the aseptic environment, wherein the filling speed is 60-90 per minute, and the content of each bottle is 5.0-5.3 ml.
Wherein the purpose of adding sodium chloride is to adjust osmotic pressure, and the osmotic pressure is adjusted to 290-310 mOsm/L; before and after filling and sealing, the bubble point of the PES sterilizing and filtering filter element with the diameter of 0.22 mu m is required to be more than or equal to 0.32 MPa.
Compared with the prior art, the invention provides moxifloxacin hydrochloride eye drops and a preparation method thereof, and the moxifloxacin hydrochloride eye drops have the following beneficial effects:
1. the moxifloxacin hydrochloride eye drops prepared by the invention have the characteristics of high efficiency, low toxicity, wide antibacterial spectrum, good stability and the like, and can effectively treat ocular inflammation.
2. The eye drops are filled aseptically, so that the drug pollution risk is reduced, the service life of the eye drops is prolonged, the drug waste is avoided, and the components of the eye drops are simple.
Drawings
FIG. 1 is a flow chart of an eye drop containing moxifloxacin hydrochloride and a preparation method thereof.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
The moxifloxacin hydrochloride eye drops comprise the following raw materials in parts by weight: 0.52 part of moxifloxacin hydrochloride, 0.49 part of boric acid, 0.32 part of sodium chloride, 0.45 part of 1mol/L sodium hydroxide solution and the balance of water for injection to 100 parts.
The preparation method of the moxifloxacin hydrochloride eye drops comprises the following steps:
(1) adding 80% of water for injection into the preparation tank, and cooling the water for injection to 25 deg.C;
(2) adding a prescribed amount of boric acid, and stirring until the solution is observed to be clear, wherein the stirring speed is 1100 r/min;
(3) adding the moxifloxacin hydrochloride with the prescription amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1100 r/min;
(4) and (3) pH adjustment: adjusting the pH of the mixed solution to 6.7 by using 1mol/L sodium hydroxide solution;
(5) adding sodium chloride according to the prescription amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1100 r/min;
(6) and (3) volume fixing: cooling the rest water for injection to 25 deg.C, adding to constant volume, stirring to uniform volume;
(7) roughly filtering the feed liquid in the preparation tank through a 0.45-micrometer PES cylinder filter element through a liquid conveying pipeline, then feeding the feed liquid into a storage tank 1, filtering the feed liquid after rough filtration through a 0.22-micrometer PES cylinder filter element, then feeding the feed liquid into a storage tank 2, and finally sterilizing and filtering the feed liquid after secondary filtration through a 0.22-micrometer PES cylinder filter element to a filling buffer tank;
(8) and filling the low-density polyethylene medicinal eye drop bottle into the can under the aseptic environment, wherein the filling speed is 60-90 per minute, and the content of each bottle is 5.0 ml.
Wherein the sodium chloride is added for the purpose of regulating the osmotic pressure to 305 mOsm/L; before and after filling and sealing, the bubble point of the PES sterilizing and filtering filter element with the diameter of 0.22 mu m is required to be more than or equal to 0.32 MPa.
Example 2
The moxifloxacin hydrochloride eye drops comprise the following raw materials in parts by weight: 0.545 part of moxifloxacin hydrochloride, 0.5 part of boric acid, 0.34 part of sodium chloride, 0.52 part of 1mol/L sodium hydroxide solution and the balance of water for injection to 100 parts.
The preparation method of the moxifloxacin hydrochloride eye drops comprises the following steps:
(1) adding 80% of water for injection into the preparation tank, and cooling the water for injection to 28 deg.C;
(2) adding a prescribed amount of boric acid, and stirring until the solution is observed to be clear, wherein the stirring speed is 1200 revolutions per minute;
(3) adding the moxifloxacin hydrochloride with the prescription amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1200 r/min;
(4) and (3) pH adjustment: adjusting the pH of the mixed solution to 6.8 by using 1mol/L sodium hydroxide solution;
(5) adding sodium chloride according to the prescription amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1200 revolutions per minute;
(6) and (3) volume fixing: cooling the rest water for injection to 28 deg.C, adding to constant volume, stirring to uniform volume;
(7) roughly filtering the feed liquid in the preparation tank through a 0.45-micrometer PES cylinder filter element through a liquid conveying pipeline, then feeding the feed liquid into a storage tank 1, filtering the feed liquid after rough filtration through a 0.22-micrometer PES cylinder filter element, then feeding the feed liquid into a storage tank 2, and finally sterilizing and filtering the feed liquid after secondary filtration through a 0.22-micrometer PES cylinder filter element to a filling buffer tank;
(8) and filling the low-density polyethylene medicinal eye drop bottle into the can under the aseptic environment, wherein the filling speed is 60-90 per minute, and the content of each bottle is 5.0 ml.
Wherein the sodium chloride is added for the purpose of regulating the osmotic pressure to 300 mOsm/L; before and after filling and sealing, the bubble point of the PES sterilizing and filtering filter element with the diameter of 0.22 mu m is required to be more than or equal to 0.32 MPa.
The moxifloxacin hydrochloride eye drops prepared by the invention have the characteristics of high efficiency, low toxicity, wide antibacterial spectrum, good stability and the like, and can effectively treat ocular inflammation. The eye drops are filled aseptically, so that the drug pollution risk is reduced, the service life of the eye drops is prolonged, the drug waste is avoided, and the components of the eye drops are simple.
Embodiments of the present invention will be understood to those skilled in the art to which the present invention pertains that various changes, modifications, substitutions, and alterations can be made without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims (4)

1. The moxifloxacin hydrochloride eye drops are characterized by comprising the following raw materials in parts by weight: 0.5-0.55 part of moxifloxacin hydrochloride, 0.48-0.5 part of boric acid, 0.3-0.35 part of sodium chloride, 0.4-0.55 part of pH regulator and the balance of water for injection to 100 parts.
2. The moxifloxacin hydrochloride eye drops as claimed in claim 1, is characterized in that: the pH regulator is 1mol/L sodium hydroxide solution.
3. The moxifloxacin hydrochloride eye drops as claimed in claim 1, is characterized in that: the pH value is 6.6-7.0, and the preferable pH value is 6.8.
4. The method for preparing moxifloxacin hydrochloride eye drops as claimed in any one of claims 1 to 3, characterized in that the preparation process comprises:
(1) adding 80% of water for injection into the preparation tank, and cooling the water for injection to 15-35 deg.C;
(2) adding boric acid with a formula amount, and stirring until the solution is clear, wherein the stirring speed is 1000-1200 r/min;
(3) adding moxifloxacin hydrochloride with a prescription amount, and stirring until a clear solution is observed, wherein the stirring speed is 1000-1200 r/min;
(4) and (3) pH adjustment: adjusting the pH of the mixed solution to 6.6-7.0 by using 1mol/L sodium hydroxide solution;
(5) adding sodium chloride according to the formula amount, and stirring until the solution is observed to be clear, wherein the stirring speed is 1000-1200 r/min;
(6) and (3) volume fixing: cooling the rest water for injection to 15-35 deg.C, adding to constant volume, stirring to uniform volume;
(7) roughly filtering the feed liquid in the preparation tank through a 0.45-micrometer PES cylinder filter element through a liquid conveying pipeline, then feeding the feed liquid into a storage tank 1, filtering the feed liquid after rough filtration through a 0.22-micrometer PES cylinder filter element, then feeding the feed liquid into a storage tank 2, and finally sterilizing and filtering the feed liquid after secondary filtration through a 0.22-micrometer PES cylinder filter element to a filling buffer tank;
(8) filling the low-density polyethylene medicinal eye drop bottle into the can under the aseptic environment, wherein the filling speed is 60-90 per minute, and the content of each bottle is 5.0-5.3 ml.
CN202111318788.7A 2021-11-09 2021-11-09 Eye drops containing moxifloxacin hydrochloride and preparation method thereof Pending CN113842360A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116139077A (en) * 2022-12-28 2023-05-23 江苏广承药业有限公司 Moxifloxacin hydrochloride eye drops

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103181892A (en) * 2013-02-20 2013-07-03 南京恒道医药科技有限公司 Moxifloxacin hydrochloride eye drops and preparation method thereof
US20200155766A1 (en) * 2017-04-14 2020-05-21 Nal Pharmaceutical Group Limited Pre-filled syringe containing moxifloxacin
CN113288866A (en) * 2021-07-12 2021-08-24 山东诺明康药物研究院有限公司 Antibacterial eye drops and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103181892A (en) * 2013-02-20 2013-07-03 南京恒道医药科技有限公司 Moxifloxacin hydrochloride eye drops and preparation method thereof
US20200155766A1 (en) * 2017-04-14 2020-05-21 Nal Pharmaceutical Group Limited Pre-filled syringe containing moxifloxacin
CN113288866A (en) * 2021-07-12 2021-08-24 山东诺明康药物研究院有限公司 Antibacterial eye drops and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
董根山等: "盐酸莫西沙星滴眼液的制备与质量控制", 《医药导报》 *
黄依沙: "盐酸莫西沙星滴眼液的研制和质量研究", 《中国优秀硕士学位论文全文数据库工程科技Ⅰ辑》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116139077A (en) * 2022-12-28 2023-05-23 江苏广承药业有限公司 Moxifloxacin hydrochloride eye drops

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