CN105726471A - Medicine composition with vitamin C and method for preparing medicine composition - Google Patents
Medicine composition with vitamin C and method for preparing medicine composition Download PDFInfo
- Publication number
- CN105726471A CN105726471A CN201610148496.6A CN201610148496A CN105726471A CN 105726471 A CN105726471 A CN 105726471A CN 201610148496 A CN201610148496 A CN 201610148496A CN 105726471 A CN105726471 A CN 105726471A
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- China
- Prior art keywords
- vitamin
- injection
- medicine composition
- water
- glutathion
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Classifications
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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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/06—Tripeptides
-
- 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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
Abstract
The invention provides a medicine composition with vitamin C and a method for preparing the medicine composition.The medicine composition comprises the vitamin C and reduced glutathione.A weight ratio of the vitamin C to the reduced glutathione is 0.1-15.0:0.05-7.0.The medicine composition and the method have the advantages that various components are reasonably prepared, the medicine composition is additionally convenient and speedy in clinical application only by the aid of a few excipients, and effects of guaranteeing the medication safety can be realized; injection with the vitamin C and the reduced glutathione is prepared by means of linkage operation and single-machine preparation jointly, and accordingly the medicine composition is good in forming and stability and high in safety.
Description
Technical field
The present invention relates to medical product technical applications, it is a kind of vitamin C pharmaceutical composition injection and preparation thereof
Method.
Background technology
Vitamin C, also known as ascorbic acid, is the vitamin with non-oxidizability, and it participates in internal hydroxylation reaction, for being formed
Between skeleton, tooth, connective tissue and non-Epithelial cell, viscous thing institute is required, can maintain the normal merit of tooth, skeleton, blood vessel
Can, increase the resistivity to disease.Glutathion (glutathioneGSH) can participate in biotransformation, thus body
Interior harmful poisonous substance is converted into harmless material, excretes external.Glutathion can also assist in keeping the most immune
Function, removing toxic substances and oxidation resistance so that glutathion has important liver protection function.According to relevant document report due to dimension
Raw element C is reversibly hydrogenated with or dehydrogenation, therefore vitamin C is the most manyRedox reactionIn play an important role.Vitamin C energy
-SH in glutathion is enough maintained to be in reducing condition and keep the activity of enzyme；Vitamin C can promote oxidized form of glutathione to change
For reduced glutathion (GSH), make the hydrogen peroxide (H that organism metabolism produces2O2) reduction.Vitamin C share gluathione Toplink
Enough improving its effect, ascorbic requirement is increased by treatment vitamin C deficiency, the treatment of chronic iron poisoning, disease, protective agents etc.
The liver function injury caused, plays liver protection function.
Summary of the invention
It is an object of the invention to provide a kind of good stability, Clinical practice and contain ascorbic drug regimen easily
Thing.
For achieving the above object, the present invention provide containing vitamin C pharmaceutical composition, it includes vitamin C, gluathione
Peptide and water for injection.The pharmaceutical composition that the present invention provides it include the component of following weight portion:
Vitamin C 0.1g-15.0g
Reduced glutathion 0.05g-7.0g
Water for injection 1ml-100ml
Reduced glutathion be a kind of containing γ-amido link andSulfydrylTripeptides, byGlutamic acid、CysteineAndGlycineGroup
Become.It is present in each cell of almost health.There is reproducibility, soluble in water.Can assist in keeping the most immune
Function, and there is antioxidation and integrationDetoxication, it is usually used in what ethanol, virus, medicine and other chemical substances caused
The auxiliary treatment of hepatic injury.In injection of the present invention, reduced glutathion has antioxidant effect, increases ascorbic stable
Property.The present inventor carries out screening in numerous stabilizers and finds, the Stabilization that glutathion plays at this is significantly better than it
His stabilizer.
The present invention also provides for a kind of method preparing aforementioned pharmaceutical compositions, and it comprises the steps: to depend on water for injection
Secondary by vitamin C, reduced glutathion stirring and dissolving, add activated carbon decolorizing, then use WK liquid medicine filtering device to filter,
Again through filtration sterilization.
The method of the most above-mentioned activated carbon decolorizing is, the method for described medical active carbon decoloring is, adds solution weight 0.1
～the activated carbon of 0.12%, 30 DEG C are stirred below 10 ~ 20 minutes, then filter carbon removal.
Above-mentioned filtration sterilization is made up of titanium rod filter and film filter (1 μm, 0.45 μm, 0.22 μm), and titanium rod filters
Device is used for decarbonization filtering, and film filter is used for impurity screening and antibacterial.Consider the pollution of liquor piping course of conveying, at bottling department
Medicine liquid outlet at require install 0.22 μm film filter additional, it is ensured that the safe and sanitary of medicinal liquid.
Pharmaceutical composition prescription of the present invention is simple, and not only stability is high, and is applicable to clinical convenient application and promotes.This
Invention preparation method avoids high temperature sterilize, uses combined operation and stand-alone configuration to share and prepare vitamin C pharmaceutical composition,
The generation of relative substance can be reduced, improve safety.
Detailed description of the invention following example are used for further illustrating the present invention, but should not be construed as the limit to the present invention
System.On the premise of without departing substantially from present invention spirit and essence, modification made for the present invention or replacement, belong to the present invention's
Category.As without particularly pointing out, the raw material used by the embodiment of the present invention is commercial.
Embodiment 1
Vitamin C pharmaceutical composition (injection)
Formula 1: vitamin C 0.1g, reduced glutathion 0.05g, water for injection 1ml
With vitamin C 1000g, glutathion 500g water for injection 10000ml as raw material, wherein vitamin C concentration is 0.1g/
Ml, glutathione concentrations is 0.05g/ml, prepares 1ml vitamin C medicine composition injection 10000 altogether.
Formula 2: vitamin C 0.25g, reduced glutathion 0.1g, water for injection 2ml
With vitamin C 1250g, glutathion 500g, water for injection 10000ml as raw material, wherein vitamin C concentration is
0.25g/ml, glutathione concentrations is 0.05g/ml, prepares 2ml vitamin C medicine composition injection 5000 altogether.
Formula 3: vitamin C 0.5g, reduced glutathion 0.25g, water for injection 5ml
With vitamin C 1000g, glutathion 500g, water for injection 10000ml as raw material, wherein vitamin C concentration is 0.1g/
Ml, glutathione concentrations is 0.05g/ml, prepares 5ml vitamin C medicine composition injection 2000 altogether.
Formula 4: vitamin C 1.0, reduced glutathion 0.5g, water for injection 10ml
With vitamin C 1000g, glutathion 500g, water for injection 10000ml as raw material, wherein vitamin C concentration is 0.1g/
Ml, glutathione concentrations is 0.05g/ml, prepares 10ml vitamin C medicine composition injection 1000 altogether.
Formula 5: vitamin C 2.5g, reduced glutathion 1.25g, water for injection 20ml
With vitamin C 1250g, glutathion 625g, water for injection 10000ml as raw material, wherein vitamin C concentration is
0.125g/ml, glutathione concentrations is 0.0625g/ml, prepares 20ml vitamin C medicine composition injection 500 altogether.
Formula 6: vitamin C 15.0g, reduced glutathion 7.0g, water for injection 100ml
With vitamin C 1500g, glutathion 700g, water for injection 10000ml as raw material, wherein vitamin C concentration is
0.15g/ml, glutathione concentrations is 0.07g/ml, prepares 100ml vitamin C medicine composition injection 100 altogether.
Preparation method is as follows:
With water for injection successively by vitamin C, reduced glutathion stirring and dissolving, add solution weight 0.1～0.12%
Activated carbon, 30 DEG C are stirred below 10 ~ 20 minutes, then use WK liquid medicine filtering device to filter, then through filtration sterilization.Filtration sterilization
Being made up of titanium rod filter and film filter (1 μm, 0.45 μm, 0.22 μm), titanium rod filter is used for decarbonization filtering, membrane filtration
Device is used for impurity screening and antibacterial.Consider the pollution of liquor piping course of conveying, require to install additional at the medicine liquid outlet of bottling department
0.22 μm film filter, sterile filling after filtration, detection.
Embodiment 2: the aqueous injection that embodiment 1-6 is prepared by safety carries out safety testing investigation, test method and result such as
Under:
Test 1, vascular stimulation test sample: experimental group 1～6 is the vitamin C injection of embodiment 1 formula 1～6 respectively configuration
Liquid pharmaceutical composition, negative control group is the sodium chloride injection of 0.9%.
Test method: Japan large ear rabbit, body weight 3.5-4.0kg, raise one week in Animal House before experiment, to adapt to ring
Border.Using rabbit 5, inject experimental group 0.5mL/kg in rabbit right ear vein, the injection of left ear vein gives identical injection volume
Negative control.With 6 number sword-shaped needles in auricular vein drug administration by injection, the direction of needle point puncture vessel is to proximal part by distal end,
Injection speed is 1-1.5mL/ minute.It is administered once a day, successive administration 7 days.And it is administered for the last time before being administered every day
Rear 48h carries out perusal to animal and injection site, 48 hours row histopathologic examinations after administration completes.
Result: 48h after being every time administered front and last administration in each group, perusal shows, experimental side (right side) is rarely seen
Blood vessel is slightly expanded, and without the most congested, congestion, lines is clear, and surrounding tissue, without edema, compares nothing with normal saline side (left side)
Difference.Histopathologic examination's result, experimental side and normal saline side respectively organize all show blood vessel without hyperemia, blood vessel endothelium completely,
Without inflammatory cell infiltration, tissues surrounding vascular is without obvious pathological changes.
Test 2 liver dysfunctions fatty liver in-patient relatively to 54 example equal extent and be randomly divided into 3 each groups, often group
Selected 18 patients.Group 1 is blank group, uses normal saline to be administered.Group 2 is experimental group, uses equivalent vitamin C medicine
Composite injection, group 3 is matched group, uses the vitamin C injection of market list marketing.Above-mentioned experiment is different except medication,
Using 5 days courses for the treatment of under remaining external condition equalization, check two groups of patient's liver functions respectively before and after use, 18 example patients put down
All check.
Result is as follows:
Table 1 liver function test result
As can be seen from the above results, using blank group to increased liver function after 15 example patient medication 5 days, prompting liver function refers to
Mark becomes big, aggravation；And use experimental group vitamin C pharmaceutical composition to every Testing index after 15 example patient medication 5 days
Being obviously reduced, the abnormal liver function causing fatty liver has good improvement result.Matched group uses the vitamin C that market is sold
Liver function index after the drug withdrawal in 5 days of 15 example patient medication be there was no significant difference by injection, and the experimental group situation at matched group is described
Under, it is possible to improve the abnormal index of liver function of patient, play the effect of hepatoprotective.
Test 3, stability test
Embodiment 1 configures the sample of 1～6 gained and the sample compareing 1 (embodiment 1 configures and is not added with preservative in 2), according to
The requirement of " Chinese Pharmacopoeia " carries out outward appearance, clarity, the detection having the index such as related substance and content and long-term stable experiment.
Take experimental example 1 and configure the sample of 1～6, in 2 DEG C of 40 DEG C of soil of temperature, place under the conditions of relative humidity 75% soil 5%
(0,6,12,24 months), are accelerated test, and measurement result is shown in Table 2.Table 2 accelerated test result
Accelerating to observe by the constant temperature of six months, embodiment 1 prepares the relevant thing of 1～6 each vitamin C medicine composition injections
Matter and content are the most qualified, and other every inspections all meet regulation.Show that vitamin C medicine composition injection of the present invention has good
Good stability.
Taking experimental example 1 and configure the sample of 1～6, be dried place's retention 12,24 months in cool place, result is as shown in table 3.
Table 3 long-time stability result
By the long-term result retaining test it can be seen that vitamin C medicine composition injection of the present invention was 12,24 months effects
Steady quality can be kept in phase.
Although having used general explanation, detailed description of the invention and experiment, the present invention is described in detail,
But on the basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.
Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to claimed model
Enclose.
Claims (5)
1. one kind comprises the injection New medicine combination thing reducing liver function injury treatment vitamin C deficiency, preventing and treating arteriosclerosis.
The most according to claim 1 containing vitamin C pharmaceutical composition, it includes the proportioning component of following weight portion:
Vitamin C 0.1g-15.0g
Reduced glutathion 0.05g-7.0g
Water for injection 1ml-100ml.
3. preparing a preparation method for pharmaceutical composition described in any one of claim 1～2, it comprises the steps: with note
Penetrate with water successively by vitamin C, reduced glutathion stirring and dissolving, add activated carbon decolorizing, then use WK medical filtration
Device filters, then through filtration sterilization.
Method the most according to claim 3, it is characterised in that the method for described medical active carbon decoloring is, adds solution
Weight 0.1～the activated carbon of 0.12%, 30 DEG C stirred below 10 ~ 20 minutes, then filters carbon removal.
Method the most according to claim 4, it is characterised in that filtration system by titanium rod filter and film filter (1 μm,
0.45 μm, 0.22 μm) composition, titanium rod filter is used for decarbonization filtering, and film filter is used for impurity screening and antibacterial.Consider medicinal liquid
The pollution of pipe conveying procedure, requires to install 0.22 μm film filter additional, it is ensured that the health of medicinal liquid at the medicine liquid outlet of bottling department
Safety.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610148496.6A CN105726471A (en) | 2016-03-16 | 2016-03-16 | Medicine composition with vitamin C and method for preparing medicine composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610148496.6A CN105726471A (en) | 2016-03-16 | 2016-03-16 | Medicine composition with vitamin C and method for preparing medicine composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105726471A true CN105726471A (en) | 2016-07-06 |
Family
ID=56251209
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610148496.6A Pending CN105726471A (en) | 2016-03-16 | 2016-03-16 | Medicine composition with vitamin C and method for preparing medicine composition |
Country Status (1)
| Country | Link |
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| CN (1) | CN105726471A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110237229A (en) * | 2019-07-31 | 2019-09-17 | 孟雨 | A kind of pharmaceutical composition of mesotherapy and preparation method thereof for reducing skin pigment and treating pain degree |
| CN113876927A (en) * | 2021-11-04 | 2022-01-04 | 常州市第四制药厂有限公司 | Liver-protecting composition and preparation thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020058628A1 (en) * | 1998-06-09 | 2002-05-16 | Noble Mark David | Antioxidants and intracellular glutathione raising agents for therapeutic treatments |
| CN102698250A (en) * | 2012-06-09 | 2012-10-03 | 东莞市照燕生物科技有限公司 | Injection for alcoholic liver and fatty liver |
| CN103656611A (en) * | 2013-12-21 | 2014-03-26 | 吴赣英 | Water-soluble vitamin combination medicament |
-
2016
- 2016-03-16 CN CN201610148496.6A patent/CN105726471A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020058628A1 (en) * | 1998-06-09 | 2002-05-16 | Noble Mark David | Antioxidants and intracellular glutathione raising agents for therapeutic treatments |
| CN102698250A (en) * | 2012-06-09 | 2012-10-03 | 东莞市照燕生物科技有限公司 | Injection for alcoholic liver and fatty liver |
| CN103656611A (en) * | 2013-12-21 | 2014-03-26 | 吴赣英 | Water-soluble vitamin combination medicament |
Non-Patent Citations (1)
| Title |
|---|
| 艾旭光，等: "《生理学与生物化学》", 28 February 2013, 郑州：河南科学技术出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110237229A (en) * | 2019-07-31 | 2019-09-17 | 孟雨 | A kind of pharmaceutical composition of mesotherapy and preparation method thereof for reducing skin pigment and treating pain degree |
| CN113876927A (en) * | 2021-11-04 | 2022-01-04 | 常州市第四制药厂有限公司 | Liver-protecting composition and preparation thereof |
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Application publication date: 20160706 |
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