CN107569457A - A kind of injection benzene sulphur is along atracurium composition and preparation method thereof - Google Patents

A kind of injection benzene sulphur is along atracurium composition and preparation method thereof Download PDF

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Publication number
CN107569457A
CN107569457A CN201710803166.0A CN201710803166A CN107569457A CN 107569457 A CN107569457 A CN 107569457A CN 201710803166 A CN201710803166 A CN 201710803166A CN 107569457 A CN107569457 A CN 107569457A
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CN
China
Prior art keywords
benzene sulphur
atracurium
injection
composition
along
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201710803166.0A
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Chinese (zh)
Inventor
汪晓铭
丁文明
金永红
周亚兵
顾珍珍
王小镒
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
On East (jiangsu) Pharmaceutical Co Ltd
Original Assignee
On East (jiangsu) Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by On East (jiangsu) Pharmaceutical Co Ltd filed Critical On East (jiangsu) Pharmaceutical Co Ltd
Priority to CN201710803166.0A priority Critical patent/CN107569457A/en
Priority to PCT/CN2017/101869 priority patent/WO2019047261A1/en
Publication of CN107569457A publication Critical patent/CN107569457A/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K31/472Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725Non-condensed isoquinolines, e.g. papaverine 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

It is made up of the invention discloses a kind of injection benzene sulphur along atracurium composition and preparation method thereof, described injection benzene sulphur along atracurium composition following component according to weight:Benzene sulphur is along the 19g of atracurium 14;The 35g of amino acid 31;The 9g of needle-use activated carbon 6;The 240g of polyvinylpyrrolidone 130;The 13g of sodium chloride 6;Appropriate organic acid;Water for injection adds to 2000ml.Atrophy sample ratio present invention reduces injection benzene sulphur along atracurium composition, there is provided the qualification rate of product, reduce production cost.

Description

A kind of injection benzene sulphur is along atracurium composition and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of injection benzene sulphur is along atracurium composition and its preparation Method.
Background technology
Presently used injection benzene sulphur is higher along the finished product atrophy sample ratio of atracurium composition, so as to cause to produce Cost is higher.
The content of the invention
Goal of the invention:In order to solve the deficiencies in the prior art, the invention provides a kind of benzene sulphur along atracurium composition And preparation method thereof.
Technical scheme:A kind of injection benzene sulphur is along atracurium composition, and described injection benzene sulphur is along atracurium group Compound is made up of following component according to weight:
Further, described described amino acid is 1B.
Further, described organic acid is citric acid, lactic acid, tartaric acid, malic acid.
A kind of injection benzene sulphur described in basis comprises the following steps along the preparation method of atracurium composition:
A. the aqueous solution containing amino acid, sodium chloride and polyvinylpyrrolidone recipe quantity is configured;
B. the benzene sulphur of recipe quantity is added along atracurium, and being sufficiently stirred makes its dissolving;
C. organic acid soln is added, adjusts pH to 3.0-6.0;
D. add to the full amount of water for injection, add needle-use activated carbon and stir 70~90min, with 0.35 μm of miillpore filter mistake Filter;
E. solution is sub-packed in the cillin bottle of 10ml specifications, and every bottle of sample-loading amount is 5ml;
F. temperature is risen to 17~22 DEG C by -54~-59 DEG C, lyophilization produces lyophilized finished product.
Further, in the step c, pH value 4.0.
Beneficial effect:Atrophy sample ratio present invention reduces injection benzene sulphur along atracurium composition, improves production The qualification rate of product, reduces production cost.
Embodiment
With reference to specific embodiment, the invention will be further described.
Specific embodiment 1
A kind of injection benzene sulphur is along atracurium composition, and described injection benzene sulphur is along atracurium composition by following Component forms according to weight:
Described described amino acid is 1B.
Described organic acid is citric acid, lactic acid, tartaric acid, malic acid.
A kind of injection benzene sulphur described in basis comprises the following steps along the preparation method of atracurium composition:
A. the aqueous solution containing amino acid, sodium chloride and polyvinylpyrrolidone recipe quantity is configured;
B. the benzene sulphur of recipe quantity is added along atracurium, and being sufficiently stirred makes its dissolving;
C. organic acid soln is added, adjusts pH to 3.0;
D. add to the full amount of water for injection, needle-use activated carbon stirring 70min is added, with 0.35 μm of filtering with microporous membrane;
E. solution is sub-packed in the cillin bottle of 10ml specifications, and every bottle of sample-loading amount is 5ml;
F. temperature is risen to 17 DEG C by -54 DEG C, lyophilization produces lyophilized finished product.
Specific embodiment 2
A kind of injection benzene sulphur is along atracurium composition, and described injection benzene sulphur is along atracurium composition by following Component forms according to weight:
Described described amino acid is 1B.
Described organic acid is citric acid, lactic acid, tartaric acid, malic acid.
A kind of injection benzene sulphur described in basis comprises the following steps along the preparation method of atracurium composition:
A. the aqueous solution containing amino acid, sodium chloride and polyvinylpyrrolidone recipe quantity is configured;
B. the benzene sulphur of recipe quantity is added along atracurium, and being sufficiently stirred makes its dissolving;
C. organic acid soln is added, adjusts pH to 6.0;
D. add to the full amount of water for injection, needle-use activated carbon stirring 90min is added, with 0.35 μm of filtering with microporous membrane;
E. solution is sub-packed in the cillin bottle of 10ml specifications, and every bottle of sample-loading amount is 5ml;
F. temperature is risen to 22 DEG C by -59 DEG C, lyophilization produces lyophilized finished product.
Specific embodiment 3
A kind of injection benzene sulphur is along atracurium composition, and described injection benzene sulphur is along atracurium composition by following Component forms according to weight:
Described described amino acid is 1B.
Described organic acid is citric acid, lactic acid, tartaric acid, malic acid.
A kind of injection benzene sulphur described in basis comprises the following steps along the preparation method of atracurium composition:
A. the aqueous solution containing amino acid, sodium chloride and polyvinylpyrrolidone recipe quantity is configured;
B. the benzene sulphur of recipe quantity is added along atracurium, and being sufficiently stirred makes its dissolving;
C. organic acid soln is added, adjusts pH to 4.0;
D. add to the full amount of water for injection, needle-use activated carbon stirring 80min is added, with 0.35 μm of filtering with microporous membrane;
E. solution is sub-packed in the cillin bottle of 10ml specifications, and every bottle of sample-loading amount is 5ml;
F. temperature is risen to 19 DEG C by -58 DEG C, lyophilization produces lyophilized finished product.
The present invention is not limited to above-mentioned preferred forms, and anyone can show that other are various under the enlightenment of the present invention The product of form, however, make any change in its shape or structure, it is every that there is skill identical or similar to the present application Art scheme, is within the scope of the present invention.

Claims (5)

1. a kind of injection benzene sulphur is along atracurium composition, it is characterised in that:Described injection benzene sulphur is along atracurium group Compound is made up of following component according to weight:
Water for injection adds to 2000ml.
2. injection benzene sulphur according to claim 1 is along atracurium composition, it is characterised in that:Described described ammonia Base acid is 1B.
3. injection benzene sulphur according to claim 1 is along atracurium composition, it is characterised in that:Described organic acid is Citric acid, lactic acid, tartaric acid, malic acid.
4. a kind of injection benzene sulphur according to claim 1 is along the preparation method of atracurium composition, it is characterised in that: Comprise the following steps:
A. the aqueous solution containing amino acid, sodium chloride and polyvinylpyrrolidone recipe quantity is configured;
B. the benzene sulphur of recipe quantity is added along atracurium, and being sufficiently stirred makes its dissolving;
C. organic acid soln is added, adjusts pH to 3.0-6.0;
D. add to the full amount of water for injection, add needle-use activated carbon and stir 70~90min, with 0.35 μm of filtering with microporous membrane;
E. solution is sub-packed in the cillin bottle of 10ml specifications, and every bottle of sample-loading amount is 5ml;
F. temperature is risen to 17~22 DEG C by -54~-59 DEG C, lyophilization produces lyophilized finished product.
5. injection benzene sulphur according to claim 4 is along the preparation method of atracurium composition, it is characterised in that:It is described In step c, pH value 4.0.
CN201710803166.0A 2017-09-08 2017-09-08 A kind of injection benzene sulphur is along atracurium composition and preparation method thereof Pending CN107569457A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201710803166.0A CN107569457A (en) 2017-09-08 2017-09-08 A kind of injection benzene sulphur is along atracurium composition and preparation method thereof
PCT/CN2017/101869 WO2019047261A1 (en) 2017-09-08 2017-09-15 Cisatracurium besilate composition for injection and preparation method therefor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201710803166.0A CN107569457A (en) 2017-09-08 2017-09-08 A kind of injection benzene sulphur is along atracurium composition and preparation method thereof

Publications (1)

Publication Number Publication Date
CN107569457A true CN107569457A (en) 2018-01-12

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Family Applications (1)

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WO (1) WO2019047261A1 (en)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105078909A (en) * 2015-09-18 2015-11-25 江苏盈科生物制药有限公司 Cisatracurium besilate freeze dried composition for injection and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105078909A (en) * 2015-09-18 2015-11-25 江苏盈科生物制药有限公司 Cisatracurium besilate freeze dried composition for injection and preparation method thereof

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Publication number Publication date
WO2019047261A1 (en) 2019-03-14

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Application publication date: 20180112

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