CN109431995A - Vitamin C injection and preparation method thereof - Google Patents

Vitamin C injection and preparation method thereof Download PDF

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Publication number
CN109431995A
CN109431995A CN201811579549.5A CN201811579549A CN109431995A CN 109431995 A CN109431995 A CN 109431995A CN 201811579549 A CN201811579549 A CN 201811579549A CN 109431995 A CN109431995 A CN 109431995A
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Prior art keywords
solution
vitamin
preparation
injection
added
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CN201811579549.5A
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Chinese (zh)
Inventor
邹明明
胡贤德
徐满
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Jiangxi Runze Pharmaceuticals Co Ltd
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Jiangxi Runze Pharmaceuticals Co Ltd
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Priority to CN201811579549.5A priority Critical patent/CN109431995A/en
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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
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0012—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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of vitamin C injection and preparation method thereof, the preparation method includes: that CO 1) is passed through into water for injection2To CO2Concentration be 1.2-1.449g/L, be made solvent；2) it is mixed after disodium ethylene diamine tetraacetate and vitamin C being added in solvent obtained into step 1), the first solution is made；3) sodium bicarbonate and sodium hydrogensulfite are added into the first solution, and after adjusting pH to 5.9-6.2, the second solution is made；4) decarburization after active carbon mixes is added into the second solution, third solution is made；5) vitamin C injection is made sequentially through coarse filtration and refined filtration in third solution；Wherein, the aperture of filter membrane is 0.4-0.6 μm during coarse filtration, and the aperture of filter membrane is 0.1-0.3 μm during refined filtration.The effect that the problems such as realizing the degree of oxidation that can be effectively reduced vitamin C injection, improving its quality and holding time, medical fluid is avoided to turn to be yellow occurs.

Description

Vitamin C injection and preparation method thereof
Technical field
The present invention relates to the production preparation fields of vitamin C injection, and in particular, to vitamin C injection and its system Preparation Method.
Background technique
Vitamin C also known as ascorbic acid, are a kind of water soluble vitamins, aqueous solution in acidity, in air easily by Oxidation is easily oxidized decomposition discoloration so as to cause its injection, medical fluid jaundice, unstable, the content decline of pH value etc. occurs and asks Topic, it is not easy to maintain so as to cause medical fluid, quality is uncontrollable etc..
Therefore it provides a kind of degree of oxidation that can be effectively reduced vitamin C injection, when improving its quality and saving Between, avoid the problem that the vitamin C injection and preparation method thereof that the problems such as medical fluid turns to be yellow occurs is urgent need to resolve of the present invention.
Summary of the invention
For the above-mentioned prior art, it is an object of the invention to overcome general vitamin C injection appearance in the prior art It is oxidizable, cause medical fluid to turn to be yellow the problems such as rotten, to provide a kind of oxidation journey that can be effectively reduced vitamin C injection The vitamin C injection and preparation method thereof that the problems such as spending, improving its quality and holding time, medical fluid is avoided to turn to be yellow occurs.
To achieve the goals above, the present invention provides a kind of preparation methods of vitamin C injection, wherein the system Preparation Method includes:
1) CO is passed through into water for injection2To CO2Concentration be 1.2-1.449g/L, be made solvent；
2) it is mixed after disodium ethylene diamine tetraacetate and vitamin C being added in solvent obtained into step 1), is made first Solution；
3) sodium bicarbonate and sodium hydrogensulfite are added into the first solution, and after adjusting pH to 5.9-6.2, it is molten to be made second Liquid；
4) decarburization after active carbon mixes is added into the second solution, third solution is made；
5) vitamin C injection is made sequentially through coarse filtration and refined filtration in third solution；Wherein,
The aperture of filter membrane is 0.4-0.6 μm during coarse filtration, and the aperture of filter membrane is 0.1-0.3 μm during refined filtration.
The present invention also provides a kind of vitamin C injections according to made from preparation method described above.
Through the above technical solutions, the present invention is by being passed through CO into water for injection2To reduce wherein oxygen content, one is gone forward side by side Disodium ethylene diamine tetraacetate is added on this basis for step and vitamin C is mixed, and makes it possible to further by the way that complexing is added Metal ion in the effective complex water of agent, so that ascorbic oxidation be effectively reduced.Sodium bicarbonate is further added thereto And sodium hydrogensulfite, its antioxygenic property is improved, its inoxidizability is substantially reduced, adjusts pH value on this basis to suitable model It encloses, further prevents its oxidation, substantially increase its quality, and it can be made to save the longer time, prevent its rotten jaundice etc..
Other features and advantages of the present invention will the following detailed description will be given in the detailed implementation section.
Specific embodiment
Detailed description of the preferred embodiments below.It should be understood that described herein specific Embodiment is merely to illustrate and explain the present invention, and is not intended to restrict the invention.
The endpoint of disclosed range and any value are not limited to the accurate range or value herein, these ranges or Value should be understood as comprising the value close to these ranges or value.For numberical range, between the endpoint value of each range, respectively It can be combined with each other between the endpoint value of a range and individual point value, and individually between point value and obtain one or more New numberical range, these numberical ranges should be considered as specific open herein.
The present invention provides a kind of preparation methods of vitamin C injection, wherein the preparation method includes:
1) CO is passed through into water for injection2To CO2Concentration be 1.2-1.449g/L, be made solvent；
2) it is mixed after disodium ethylene diamine tetraacetate and vitamin C being added in solvent obtained into step 1), is made first Solution；
3) sodium bicarbonate and sodium hydrogensulfite are added into the first solution, and after adjusting pH to 5.9-6.2, it is molten to be made second Liquid；
4) decarburization after active carbon mixes is added into the second solution, third solution is made；
5) vitamin C injection is made sequentially through coarse filtration and refined filtration in third solution；Wherein,
The aperture of filter membrane is 0.4-0.6 μm during coarse filtration, and the aperture of filter membrane is 0.1-0.3 μm during refined filtration.
The present invention is by being passed through CO into water for injection2To reduce wherein oxygen content, and further it is added on this basis Disodium ethylene diamine tetraacetate and vitamin C are mixed, and are made it possible to further by being added in the effective complex water of complexing agent Metal ion, so that ascorbic oxidation be effectively reduced.Sodium bicarbonate and sodium hydrogensulfite are further added thereto, mentions Its high antioxygenic property, substantially reduces its inoxidizability, adjusts pH value on this basis to suitable range, further prevents it Oxidation, substantially increases its quality, and it can be made to save the longer time, prevents its rotten jaundice etc..
The dosage of above-mentioned raw materials can select in a wide range, for example, in a kind of preferred embodiment of the invention In, relative to the water for injection of 100 parts by weight, the dosage of the disodium ethylene diamine tetraacetate is 0.03-0.08 parts by weight, The ascorbic dosage is 3-8 parts by weight, and the dosage of the sodium bicarbonate is 2-5 parts by weight, the use of the sodium hydrogensulfite Amount is 0.1-0.3 parts by weight.
Here disodium ethylene diamine tetraacetate and vitamin C can be added in solvent simultaneously to be mixed, certainly, in this hair It include first to solvent in order to further increase its antioxygenic property, in step 2) in a kind of bright more preferably embodiment After middle addition disodium ethylene diamine tetraacetate dissolution, then vitamin C mixing is added thereto, the first solution is made.
In another preferred embodiment of the invention, in step 4), mixed process is is stirred, and stirring rate For 100-300r/min, mixing time 15-20min.
Decarbonizing process can using skilled artisans appreciate that by the way of operated, for example, of the invention In a kind of preferred embodiment, in step 4), decarbonizing process is to be placed under conditions of temperature is 50-60 DEG C to be operated.
In a preferred embodiment of the invention, decarburization is to remove activity by the way of filtering in step 4) Charcoal.
In further preferred embodiment, in order to preferably improve the quality of injection obtained, also wrapped in step 5) It includes and sterilizes to the vitamin C injection after refined filtration.
Sterilization process can using skilled artisans appreciate that by the way of operated, for example, a kind of preferred In embodiment, sterilization process is to be placed in steam sterilizing 15-20min under conditions of temperature is 100-110 DEG C.
The present invention also provides a kind of vitamin C injections according to made from preparation method described above.
The present invention will be described in detail by way of examples below.
Embodiment 1
1) CO is passed through into 100 parts by weight waters for injection2To CO2Concentration be 1.2g/L, be made solvent；
2) after the dissolution of 0.03 parts by wt EDTA-disodium is added in solvent obtained into step 1), thereto It is mixed after 3 part by weight of vitamin C are added, the first solution is made；
3) 2 parts by weight sodium bicarbonates and 0.1 parts by weight sodium hydrogensulfite are added into the first solution, and after adjusting pH to 6, The second solution is made；
4) active carbon is added into the second solution in 50 DEG C, the stirring rate of 100r/min uses after being stirred 15min Third solution is made in the mode decarburization of suction filtration；
5) by third solution sequentially after 0.45 μm of aperture coarse filtration and 0.22 μm of aperture refined filtration under conditions of 100 DEG C Vitamin C injection A1 is made in steam sterilizing 20min.
Embodiment 2
1) CO is passed through into 100 parts by weight waters for injection2To CO2Concentration be 1.449g/L, be made solvent；
2) after the dissolution of 0.08 parts by wt EDTA-disodium is added in solvent obtained into step 1), thereto It is mixed after 8 part by weight of vitamin C are added, the first solution is made；
3) 5 parts by weight sodium bicarbonates and 0.3 parts by weight sodium hydrogensulfite are added into the first solution, and after adjusting pH to 6, The second solution is made；
4) active carbon is added into the second solution in 60 DEG C, the stirring rate of 300r/min uses after being stirred 20min Third solution is made in the mode decarburization of suction filtration；
5) by third solution sequentially after 0.45 μm of aperture coarse filtration and 0.22 μm of aperture refined filtration under conditions of 100 DEG C Vitamin C injection A2 is made in steam sterilizing 20min.
Embodiment 3
1) CO is passed through into 100 parts by weight waters for injection2To CO2Concentration be 1.449g/L, be made solvent；
2) after the dissolution of 0.05 parts by wt EDTA-disodium is added in solvent obtained into step 1), thereto It is mixed after 5 part by weight of vitamin C are added, the first solution is made；
3) 3 parts by weight sodium bicarbonates and 0.2 parts by weight sodium hydrogensulfite are added into the first solution, and after adjusting pH to 6, The second solution is made；
4) active carbon is added into the second solution in 55 DEG C, the stirring rate of 200r/min uses after being stirred 20min Third solution is made in the mode decarburization of suction filtration；
5) by third solution sequentially after 0.45 μm of aperture coarse filtration and 0.22 μm of aperture refined filtration under conditions of 100 DEG C Vitamin C injection A3 is made in steam sterilizing 20min.
Embodiment 4
It is prepared according to the preparation method of embodiment 1, unlike, by disodium ethylene diamine tetraacetate and dimension in step 2) Raw element C is added together to be mixed, and vitamin C injection A4 is made.
Embodiment 5
It is prepared according to the preparation method of embodiment 2, unlike, decarbonizing process is normal to be placed in temperature in step 4) It is carried out (within the scope of 20-25 DEG C) under the conditions of temperature, vitamin C injection A5 is made.
Comparative example 1
It is prepared according to the preparation method of embodiment 1, unlike, without step 1), directly use water for injection It is mixed as solvent, vitamin C injection D1 is made.
Comparative example 2
It is prepared according to the preparation method of embodiment 2, unlike, ethylenediamine tetra-acetic acid two is added without in step 2) Vitamin C injection D2 is made in sodium.
Comparative example 3
It is prepared according to the preparation method of embodiment 3, unlike, sodium hydrogensulfite is added without in step 3), and not PH is adjusted, vitamin C injection D3 is made.
Comparative example 4
It is prepared according to the preparation method of embodiment 3, unlike, without step 4), vitamin C injection is made D4。
Test case
By above-mentioned A1-A5 and D1-D4 respectively according to the note in " Chinese Pharmacopoeia " second about the measurement of Vitamin C content Load scheme detects its Vitamin C content at 0,6,12,18,24 month, obtains that the results are shown in Table 1.
The UV-vis spectroscopy that above-mentioned A1-A5 and D1-D4 are recorded according to the in " Chinese Pharmacopoeia " third portion the 0401st respectively Photometry detects its absorbance at 0,6,12,18,24 month, obtains that the results are shown in Table 2.
Table 1
Number 0 6 12 18 24
A1 101.52 101.35 100.56 100.31 99.76
A2 101.36 101.12 100.23 100.15 99.62
A3 101.55 101.23 101.12 100.56 100.13
A4 100.31 99.63 98.12 94.52 92.31
A5 99.56 98.56 97.32 97.11 95.32
D1 100.62 97.32 95.14 93.22 91.52
D2 100.55 96.75 93.12 90.11 87.51
D3 100.36 95.12 93.11 90.05 85.12
D4 100.56 99.87 99.32 98.88 95.12
Table 2
Number 0 6 12 18 24
A1 0.000 0.000 0.001 0.002 0.002
A2 0.000 0.000 0.002 0.003 0.003
A3 0.000 0.000 0.001 0.001 0.002
A4 0.000 0.001 0.002 0.003 0.005
A5 0.000 0.000 0.001 0.002 0.003
D1 0.000 0.003 0.007 0.012 0.021
D2 0.000 0.005 0.008 0.015 0.026
D3 0.000 0.006 0.010 0.016 0.031
D4 0.000 0.011 0.020 0.045 0.067
The preferred embodiment of the present invention has been described above in detail, still, during present invention is not limited to the embodiments described above Detail within the scope of the technical concept of the present invention can be with various simple variants of the technical solution of the present invention are made, this A little simple variants all belong to the scope of protection of the present invention.
It is further to note that specific technical features described in the above specific embodiments, in not lance In the case where shield, can be combined in any appropriate way, in order to avoid unnecessary repetition, the present invention to it is various can No further explanation will be given for the combination of energy.
In addition, various embodiments of the present invention can be combined randomly, as long as it is without prejudice to originally The thought of invention, it should also be regarded as the disclosure of the present invention.

Claims (9)

1. a kind of preparation method of vitamin C injection, which is characterized in that the preparation method includes:
1) CO is passed through into water for injection2To CO2Concentration be 1.2-1.449g/L, be made solvent；
2) it is mixed after disodium ethylene diamine tetraacetate and vitamin C being added in solvent obtained into step 1), the first solution is made；
3) sodium bicarbonate and sodium hydrogensulfite are added into the first solution, and after adjusting pH to 5.9-6.2, the second solution is made；
4) decarburization after active carbon mixes is added into the second solution, third solution is made；
5) vitamin C injection is made sequentially through coarse filtration and refined filtration in third solution；Wherein,
The aperture of filter membrane is 0.4-0.6 μm during coarse filtration, and the aperture of filter membrane is 0.1-0.3 μm during refined filtration.
2. preparation method according to claim 1, wherein relative to the water for injection of 100 parts by weight, the second two The dosage of amine tetraacethyl disodium is 0.03-0.08 parts by weight, and the ascorbic dosage is 3-8 parts by weight, the sodium bicarbonate Dosage be 2-5 parts by weight, the dosage of the sodium hydrogensulfite is 0.1-0.3 parts by weight.
3. preparation method according to claim 1 or 2, wherein include that ethylenediamine tetraacetic is first added into solvent in step 2) After the dissolution of acetic acid disodium, then vitamin C mixing is added thereto, the first solution is made.
4. preparation method according to claim 1 or 2, wherein in step 4), mixed process is to be stirred, and stir Rate is 100-300r/min, mixing time 15-20min.
5. preparation method according to claim 1 or 2, wherein in step 4), decarbonizing process is 50-60 to be placed in temperature It is operated under conditions of DEG C.
6. preparation method according to claim 1 or 2, wherein decarburization is to remove work by the way of filtering in step 4) Property charcoal.
7. preparation method according to claim 1 or 2, wherein further include to the vitamin C injection after refined filtration in step 5) Liquid sterilizes.
8. preparation method according to claim 7, wherein sterilization process is to be placed under conditions of temperature is 100-110 DEG C Steam sterilizing 15-20min.
9. vitamin C injection made from a kind of preparation method described in any one of -8 according to claim 1.
CN201811579549.5A 2018-12-24 2018-12-24 Vitamin C injection and preparation method thereof Pending CN109431995A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111803516A (en) * 2020-07-28 2020-10-23 河北科星药业有限公司 Vitamin C sodium chloride injection and preparation method and application thereof
CN113368040A (en) * 2021-05-21 2021-09-10 北京民康百草医药科技有限公司 Antioxidant-free vitamin C injection and preparation method thereof
CN115140361A (en) * 2022-07-21 2022-10-04 宁波依兰雅丝护肤品有限公司 Preparation method of aseptic preservative-free fresh-keeping of cigarette cartridge

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CN1830438A (en) * 2005-03-08 2006-09-13 阿尔贝拉医药控股(通化)有限公司 Preparation method of vitamin C freeze dried powder injection
CN102885771A (en) * 2012-11-07 2013-01-23 西安德天药业股份有限公司 High-concentration vitamin C injection solution and preparation method thereof

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CN102885771A (en) * 2012-11-07 2013-01-23 西安德天药业股份有限公司 High-concentration vitamin C injection solution and preparation method thereof

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111803516A (en) * 2020-07-28 2020-10-23 河北科星药业有限公司 Vitamin C sodium chloride injection and preparation method and application thereof
CN113368040A (en) * 2021-05-21 2021-09-10 北京民康百草医药科技有限公司 Antioxidant-free vitamin C injection and preparation method thereof
CN115140361A (en) * 2022-07-21 2022-10-04 宁波依兰雅丝护肤品有限公司 Preparation method of aseptic preservative-free fresh-keeping of cigarette cartridge

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