CN107753571A - A kind of medicinal composition for injections of decumbent corydalis tuber - Google Patents
A kind of medicinal composition for injections of decumbent corydalis tuber Download PDFInfo
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- CN107753571A CN107753571A CN201711252539.6A CN201711252539A CN107753571A CN 107753571 A CN107753571 A CN 107753571A CN 201711252539 A CN201711252539 A CN 201711252539A CN 107753571 A CN107753571 A CN 107753571A
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- Prior art keywords
- corydalis tuber
- decumbent corydalis
- injections
- medicinal composition
- ascorbic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
- A61K9/0012—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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- 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
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Abstract
The invention discloses a kind of medicinal composition for injections of decumbent corydalis tuber, the medicinal composition for injections is mainly dissolved in water for injection by the salt of decumbent corydalis tuber, ascorbic acid and/or sodium ascorbate are added as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the dosage of the ascorbic acid and/or sodium ascorbate is 0.1mg~200.0mg/100ml.The present invention can make the parenteral solution pH value more stable, decumbent corydalis tuber degradation material substantially reduces compared with prior art, in the case where avoiding the cosolvent using other increase clinical practice risks, improve the clarity of Rhizoma corydalis decumbenti Injection, particularly solve the problems, such as that Rhizoma corydalis decumbenti Injection occurs small particles, white block, solution muddiness in the case where period of storage is longer using prior art products, it can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, be easy to clinical application and popularization.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of medicinal composition for injections of decumbent corydalis tuber.
Background technology
Decumbent corydalis tuber is used for hemiplegia, headache, injury from falling down, arthralgia pain due to rheumatism, lumbocrural pain.
Due to decumbent corydalis tuber dissolubility extreme difference, therefore be made into decumbent corydalis tuber hydrochloride or summer phosphate free in aqueous
It is water-soluble to increase it.Presently commercially available Rhizoma corydalis decumbenti Injection mainly has the phosphatic low capacity of decumbent corydalis tuber hydrochloride, decumbent corydalis tuber
Parenteral solution, and addition glucose or phenylmercuric nitrate are used as bacteriostatic agent system in decumbent corydalis tuber hydrochloride, decumbent corydalis tuber phosphate solution
Into high-capacity injection.But when preparing above-mentioned parenteral solution, it is necessary to which the pH value regulation of decoction is administered to suitable human injection
Certain limit, the pH value regulator that document report uses at present is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid molten
Liquid, but easily separated out carefully under the conditions of storage for a long time and winter low temperature using Rhizoma corydalis decumbenti Injection prepared by above-mentioned pH value regulator
The sediments such as small particles, white block, solution muddiness, cause the visible foreign matters check item of product unqualified.Now it yet there are no preferably
Solution.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of injecting drug use for improving decumbent corydalis tuber ejection preparation stability
Compositions.
The medicinal composition for injections passes through creative labor using ascorbic acid, sodium ascorbate as pH adjusting agent
It is dynamic that decoction pH value is more stablized when finding using ascorbic acid, sodium ascorbate as pH adjusting agent, decumbent corydalis tuber degradation material compared with
Prior art substantially reduces, and in the case where avoiding the cosolvent using other increase clinical practice risks, satisfactorily solves
Rhizoma corydalis decumbenti Injection of having determined easily separates out that tiny white point, white block, solution are muddy to ask under the conditions of long-term storage and winter low temperature
Topic.
Technical scheme is used by the present invention solves the above problems：One kind improves decumbent corydalis tuber drug injection preparation stability
Medicinal composition for injections, water for injection is mainly dissolved in by the salt of decumbent corydalis tuber, adds bacteriostatic agent, and add ascorbic acid and/
Or sodium ascorbate is as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the ascorbic acid and/or
The dosage of sodium ascorbate is 0.1mg~200.0mg/100ml.
The bacteriostatic agent is phenylmercuric nitrate.The dosage of bacteriostatic agent is prior art, and phenylmercuric nitrate dosage is 0.9g/100ml；
Glucose, xylitol, mannitol, fructose dosage are 5g/100ml~10g/100ml.
The salt of the decumbent corydalis tuber includes decumbent corydalis tuber hydrochloride, summer phosphate free.
The concentration of the salt of the decumbent corydalis tuber is calculated as 10mg~10g/100ml with decumbent corydalis tuber.
The decoction pH value is 3.0~6.0.
The decumbent corydalis tuber drug injection preparation formulation is parenteral solution.
The preparation method of the medicinal composition for injections of above-mentioned raising decumbent corydalis tuber drug injection preparation stability, including it is following
Step：
(1) salt of decumbent corydalis tuber is weighed with decumbent corydalis tuber amount of calculation 0.1g~100g, ascorbic acid and/or sodium ascorbate 2mg
~4.0g；
(2) ascorbic acid, sodium ascorbate are configured to 10g/100ml~20g/100ml solution respectively, standby；
(3) salt of decumbent corydalis tuber, phenylmercuric nitrate are added in 30 DEG C~40 DEG C of water for injection 500ml, and stirring is to being completely dissolved
Afterwards, the activated carbon of addition, the activated carbon dosage are 0.02g/100ml, are stirred 15 minutes, filter decarburization；
(4) ascorbic acid and/or sodium ascorbate solution regulation pH value that filtrate obtained by step (3) is configured with step (2)
For 3.0~7.0, the water for injection of less than 40 DEG C (30 DEG C~40 DEG C) is added to 1000ml；
(5) it is filling by medical filtration obtained by step (4) to clarification, sterilizing, produce.
In the step (1) ascorbic acid dosage be 1mg~2.0g, sodium ascorbate dosage be 1mg~2.0g.
Also include bacteriostatic agent 9.0g in the step (1).
The bacteriostatic agent is phenylmercuric nitrate.
In such scheme, add that ascorbic acid and/or sodium ascorbate refer to add can be ascorbic acid, Vitamin C
Any of sour sodium, or ascorbic acid, sodium ascorbate are matched with arbitrary proportion；In step (2), addition it is anti-bad
One kind in hematic acid, sodium ascorbate, then a kind of solution is made, such as includes ascorbic acid, two kinds of sodium ascorbate, then match somebody with somebody respectively
Solution for standby is made；The salt of decumbent corydalis tuber, the dosage of bacteriostatic agent can use the dosage of prior art, be adjusted according to the dosage of prior art
It is whole.
In summary, the beneficial effects of the invention are as follows：The present invention by experimental studies have found that, in decumbent corydalis tuber drug injection system
In agent, during using ascorbic acid, sodium ascorbate as pH adjusting agent, decoction pH value is more stable, decumbent corydalis tuber degradation material compared with
Prior art substantially reduces, and in the case where avoiding the cosolvent using other increase clinical practice risks, satisfactorily solves
It is muddy that Rhizoma corydalis decumbenti Injection of having determined using prior art products easily separates out tiny white point, white block, solution in storage process
Problem, it is ensured that the visible foreign matters detection for the holding parenteral solution that Rhizoma corydalis decumbenti Injection can be stablized in storage process meets medicine
The regulation of quality standard, is easy to clinical application and popularization.
The present invention is by creative work, to the original of tiny white point, white block, the solution muddiness separated out in Rhizoma corydalis decumbenti Injection
Because being analyzed and being studied, it is mainly raw material free alkali crystallization and a small amount of catabolite to determine deposit, above-mentioned reason occurs
May be relevant with sour, alkali species used in the pH value and pH adjusting agent of solution.Therefore sodium ascorbate is used to be adjusted as pH
Agent, and ascorbic acid is used as pH value counter regulation agent, in the feelings for avoiding the cosolvent using other increase clinical practice risks
Under condition, easily separate out that tiny white point, white block, solution are muddy to ask to solve this product under the conditions of long-term storage and winter low temperature
Topic.
Embodiment
With reference to embodiment, the present invention is described in further detail, but the implementation of the present invention is not limited to this.
Embodiment 1
A kind of preparation method for the medicinal composition for injections for improving decumbent corydalis tuber drug injection preparation stability, including it is following
Step：(1) bulk drug is weighed with decumbent corydalis tuber amount of calculation 0.1g~100g, phenylmercuric nitrate 9.0g, ascorbic acid 1mg~2.0g, anti-
Bad hematic acid sodium 1mg~2.0g；(2) ascorbic acid, sodium ascorbate are configured to 10%~20% solution respectively, standby.(3) add
Enter in less than 40 DEG C of water for injection 500ml, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stirring 15
Minute, filter decarburization.(4) filtrate ascorbic acid or sodium ascorbate solution regulation pH value be 3.0~7.0, add 40 DEG C with
Under water for injection to 1000ml；(5) medical filtration is extremely clarified, filling, sterilizing, is produced.
The composition and its content of the specific each component of the present embodiment are as follows：
Ascorbic acid, sodium ascorbate are configured to 10%~20% solution respectively, standby.Hydrochloric acid decumbent corydalis tuber, nitric acid benzene
Mercury is added in less than 40 DEG C of water for injection 500ml, is stirred to after being completely dissolved, is added 0.02% activated carbon (i.e. activated carbon
Dosage is 0.02g/100ml), stir 15 minutes, filter decarburization.Filtrate ascorbic acid or sodium ascorbate solution regulation pH value
For 3.8~4.2, less than 40 DEG C of water for injection is added to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, is produced.
Embodiment 2
Or the medicinal composition for injections of above-mentioned raising decumbent corydalis tuber drug injection preparation stability is made in the steps below
It is standby：
(1) bulk drug is weighed with decumbent corydalis tuber amount of calculation 0.1g~100g, ascorbic acid 1mg~2.0g, sodium ascorbate 1mg
~2.0g；(2) ascorbic acid, sodium ascorbate are configured to 10%~20% solution respectively, standby.(3) less than 40 DEG C are added
Water for injection 500ml in, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stir 15 minutes, filtering is de-
Carbon.(4) filtrate ascorbic acid or sodium ascorbate solution regulation pH value are 3.0~7.0, add less than 40 DEG C of water for injection
To 1000ml；(5) medical filtration is extremely clarified, filling, sterilizing, is produced.
The composition and its content of the specific each component of the present embodiment are as follows：
Hydrochloric acid decumbent corydalis tuber 20g
Ascorbic acid 1.0g
Sodium ascorbate 2.0g
Ascorbic acid, sodium ascorbate are configured to 10%~20% solution respectively, standby.Hydrochloric acid decumbent corydalis tuber adds 40 DEG C
In following water for injection 500ml, stir to after being completely dissolved, adding 0.02% activated carbon, (i.e. activated carbon dosage is
0.02g/100ml), stir 15 minutes, filter decarburization.Filtrate ascorbic acid or sodium ascorbate solution regulation pH value are 3.8
~4.2, less than 40 DEG C of water for injection is added to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, is produced.
Embodiment 3
Decumbent corydalis tuber phenylmercuric nitrate parenteral solution stability comparative test
Meet drug standard using the visible foreign matters detection of decumbent corydalis tuber phenylmercuric nitrate parenteral solution obtained by the present invention
Regulation, and stability of solution is fine, in the case where avoiding the cosolvent using other increase clinical practice risks, solves the summer
It easily occurs the problems such as small particles, white block, solution muddiness without phenylmercuric nitrate parenteral solution in storage process.It is made using the present invention
The decumbent corydalis tuber phenylmercuric nitrate parenteral solution obtained refers to according to the C pharmaceutical preparation stability tests of two annex of China's coastal port Ⅺ Ⅹ
The related request of principle is led, has investigated to place to place within 24 months, 40 DEG C 6 months, 60 DEG C at 25 DEG C respectively and has placed 10 days, 0~5 DEG C
Low temperature places 20 days medicine stabilities, and as a result product quality is stable at the conditions of the experiments described above, and every Testing index meets this
The regulation of quality standard.
The Pharmacological experiment result shows that：Using the decumbent corydalis tuber phenylmercuric nitrate parenteral solution of the stabilization obtained by the present invention without haemolysis
Property, without anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
1 25 DEG C of study on the stability results of table
The hydrochloric acid decumbent corydalis tuber phenylmercuric nitrate 60 DEG C of study on the stability results of parenteral solution of table 2
3 40 DEG C of study on the stability results of table
4 0~5 DEG C of low temperature visible foreign matters of table investigate result
It can be seen from the above results, decumbent corydalis tuber drug injection preparation of the invention can improve the clear and bright of Rhizoma corydalis decumbenti Injection
Degree, particularly in the case where decumbent corydalis tuber injection period of storage is longer, the visible foreign matters detection for the holding parenteral solution that can stablize
Meet the regulation of drug standard, solve decumbent corydalis tuber medicine and gone out using existing technical products in the case where period of storage is longer
The problem of existing small particles, white block, solution muddiness, it is ensured that the visible foreign matters inspection of product meets the rule of drug standard
It is fixed, it is easy to clinical application and popularization.
As described above, it can preferably realize the present invention.
Claims (6)
1. a kind of medicinal composition for injections of decumbent corydalis tuber, it is characterised in that water for injection is mainly dissolved in by the salt of decumbent corydalis tuber, added
Enter ascorbic acid and/or sodium ascorbate as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, it is described
The dosage of ascorbic acid and/or sodium ascorbate is 0.1mg~200.0mg/100ml.
2. the medicinal composition for injections of a kind of decumbent corydalis tuber according to claim 1, it is characterised in that also including antibacterial
Agent, the bacteriostatic agent are phenylmercuric nitrate.
3. the medicinal composition for injections of a kind of decumbent corydalis tuber according to claim 1, it is characterised in that the decumbent corydalis tuber
Salt includes decumbent corydalis tuber hydrochloride, summer phosphate free.
A kind of 4. medicinal composition for injections of decumbent corydalis tuber according to claim 1 or 3, it is characterised in that the summer
The concentration of the salt of nothing is calculated as 10mg~10g/100ml with decumbent corydalis tuber.
A kind of 5. medicinal composition for injections of decumbent corydalis tuber according to claim 1, it is characterised in that the decoction pH value
For 3.0~6.0.
A kind of 6. medicinal composition for injections of decumbent corydalis tuber according to claim 1, it is characterised in that the decumbent corydalis tuber medicine
Thing ejection preparation formulation is parenteral solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711252539.6A CN107753571A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of decumbent corydalis tuber |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711252539.6A CN107753571A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of decumbent corydalis tuber |
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| Publication Number | Publication Date |
|---|---|
| CN107753571A true CN107753571A (en) | 2018-03-06 |
Family
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711252539.6A Withdrawn CN107753571A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of decumbent corydalis tuber |
Country Status (1)
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008727A (en) * | 2010-12-07 | 2011-04-13 | 四川升和药业股份有限公司 | Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition |
-
2017
- 2017-12-01 CN CN201711252539.6A patent/CN107753571A/en not_active Withdrawn
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008727A (en) * | 2010-12-07 | 2011-04-13 | 四川升和药业股份有限公司 | Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition |
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| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20180306 |
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| WW01 | Invention patent application withdrawn after publication |