CN107744500A - A kind of medicinal composition for injections of Sambucus chinensis - Google Patents
A kind of medicinal composition for injections of Sambucus chinensis Download PDFInfo
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- CN107744500A CN107744500A CN201711250450.6A CN201711250450A CN107744500A CN 107744500 A CN107744500 A CN 107744500A CN 201711250450 A CN201711250450 A CN 201711250450A CN 107744500 A CN107744500 A CN 107744500A
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- sambucus chinensis
- injections
- medicinal composition
- sambucus
- chinensis
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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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- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
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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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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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Abstract
The invention discloses a kind of medicinal composition for injections of Sambucus chinensis, the medicinal composition for injections is mainly dissolved in water for injection by the salt of Sambucus chinensis, ethanedioic acid and/or sodium oxalate are added as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the dosage of the ethanedioic acid and/or sodium oxalate is 0.1mg~200.0mg/100ml.The present invention can make the parenteral solution pH value more stable, Sambucus chinensis 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 Sambucus chinensis parenteral solution, particularly solve the problems, such as that Sambucus chinensis parenteral solution 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 Sambucus chinensis.
Background technology
Sambucus chinensis has promoting blood circulation to remove blood stasis, soothing liver and strengthening spleen, dispelling, collateral-activating, sweating diuresis.For traumatic injury, for acute virus
Property hepatitis, rheumatalgia, dislocation, fracture, nephritic dropsy, tinea pedis oedema, nettle rash etc..
Due to Sambucus chinensis dissolubility extreme difference, therefore be made into Sambucus chinensis hydrochloride or Sambucus chinensis phosphate to increase in aqueous
It is water-soluble.Presently commercially available Sambucus chinensis parenteral solution mainly has the phosphatic injection with small volume of Sambucus chinensis hydrochloride, Sambucus chinensis, Yi Ji
Glucose is added in Sambucus chinensis hydrochloride, Sambucus chinensis phosphate solution or sodium acid carbonate is noted as Large Copacity made of osmotic pressure regulator
Penetrate liquid.But when preparing above-mentioned parenteral solution, it is necessary to by the pH value regulation of decoction to the certain limit for being adapted to human injection's administration, mesh
The pH value regulator that preceding document report uses is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution, but using above-mentioned
Sambucus chinensis parenteral solution prepared by pH value regulator easily separates out tiny white point, white block, molten under the conditions of long-term storage and winter low temperature
The sediments such as liquid muddiness, cause the visible foreign matters check item of product unqualified.It now yet there are no preferable solution.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of injectable drug for improving Sambucus chinensis ejection preparation stability
Composition.
The medicinal composition for injections is sent out using ethanedioic acid, sodium oxalate as pH adjusting agent, and by creative work
During now using ethanedioic acid, sodium oxalate as pH adjusting agent, decoction pH value is more stable, and Sambucus chinensis degradation material is big compared with prior art
It is big to reduce, in the case where avoiding the cosolvent using other increase clinical practice risks, Sambucus chinensis note has been satisfactorily addressed
Penetrate the problem of liquid easily separates out tiny white point, white block, solution muddiness under the conditions of long-term storage and winter low temperature.
Technical scheme is used by the present invention solves the above problems：A kind of raising Sambucus chinensis drug injection preparation stability
Medicinal composition for injections, water for injection is mainly dissolved in by the salt of Sambucus chinensis, adds osmotic pressure regulator, and add ethanedioic acid and/
Or sodium oxalate is as medicinal composition for injections, the ethanedioic acid and/or second two made of pH adjusting agent regulating liquid medicine pH value
The dosage of sour sodium is 0.1mg~200.0mg/100ml.
The osmotic pressure regulator is sodium acid carbonate.The dosage of osmotic pressure regulator is prior art, sodium acid carbonate dosage
For 0.9g/100ml；Glucose, xylitol, mannitol, fructose dosage are 5g/100ml~10g/100ml.
The salt of the Sambucus chinensis includes Sambucus chinensis hydrochloride, Sambucus chinensis phosphate.
The concentration of the salt of the Sambucus chinensis is calculated as 10mg~10g/100ml with Sambucus chinensis.
The decoction pH value is 3.0~6.0.
The Sambucus chinensis drug injection preparation formulation is parenteral solution.
The preparation method of the medicinal composition for injections of above-mentioned raising Sambucus chinensis drug injection preparation stability, including following steps
Suddenly：
(1) salt of Sambucus chinensis is weighed with Sambucus chinensis amount of calculation 0.1g~100g, ethanedioic acid and/or sodium oxalate 2mg~4.0g；
(2) ethanedioic acid, sodium oxalate are configured to 10g/100ml~20g/100ml solution respectively, standby；
(3) salt of Sambucus chinensis, sodium acid carbonate are added in 30 DEG C~40 DEG C of water for injection 500ml, are stirred to after being completely dissolved,
The activated carbon of addition, the activated carbon dosage are 0.02g/100ml, are stirred 15 minutes, filter decarburization；
(4) ethanedioic acid of filtrate step (2) configuration obtained by step (3) and/or sodium oxalate solution regulation pH value are 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) ethanedioic acid dosage be 1mg~2.0g, sodium oxalate dosage be 1mg~2.0g.
Also include osmotic pressure regulator 9.0g in the step (1).
The osmotic pressure regulator is sodium acid carbonate.
In such scheme, add that ethanedioic acid and/or sodium oxalate refer to add can be in ethanedioic acid, sodium oxalate
It is any, or ethanedioic acid, sodium oxalate match with arbitrary proportion；In step (2), ethanedioic acid, the sodium oxalate of addition
In one kind, then a kind of solution is made, such as include ethanedioic acid, two kinds of sodium oxalate, then be configured to solution for standby respectively；Sambucus chinensis
Salt, the dosage of osmotic pressure regulator can use the dosage of prior art, be adjusted according to the dosage of prior art.
In summary, the beneficial effects of the invention are as follows：The present invention by experimental studies have found that, in Sambucus chinensis drug injection preparation
In, during using ethanedioic acid, sodium oxalate as pH adjusting agent, decoction pH value is more stable, and Sambucus chinensis degradation material is compared with prior art
Substantially reduce, in the case where avoiding the cosolvent using other increase clinical practice risks, Sambucus chinensis has been satisfactorily addressed
The problem of parenteral solution easily separates out tiny white point, white block, solution muddiness using prior art products in storage process, Ke Yibao
The visible foreign matters detection for demonstrate,proving the holding parenteral solution that Sambucus chinensis parenteral solution can be stablized in storage process meets drug standard
Regulation, is easy to clinical application and popularization.
The present invention by creative work, to separated out in Sambucus chinensis parenteral solution tiny white point, white block, solution muddiness the reason for
Analyzed and studied, it is mainly raw material free alkali crystallization and a small amount of catabolite to determine deposit, and above-mentioned reason occur can
Can be relevant with sour, alkali species used in the pH value and pH adjusting agent of solution.Therefore sodium oxalate is used as pH adjusting agent, and
Using ethanedioic acid as pH value counter regulation agent, in the case where avoiding the cosolvent using other increase clinical practice risks, with
Solve the problems, such as that this product easily separates out tiny white point, white block, solution muddiness under the conditions of long-term storage and winter low temperature.
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 Sambucus chinensis drug injection preparation stability, including following steps
Suddenly：(1) bulk drug is weighed with Sambucus chinensis amount of calculation 0.1g~100g, sodium acid carbonate 9.0g, ethanedioic acid 1mg~2.0g, sodium oxalate
1mg~2.0g；(2) ethanedioic acid, sodium oxalate are configured to 10%~20% solution respectively, standby.(3) less than 40 DEG C are added
In water for injection 500ml, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stir 15 minutes, filtering is de-
Carbon.(4) filtrate ethanedioic acid or sodium oxalate solution regulation pH value are 3.0~7.0, add less than 40 DEG C of water for injection extremely
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：
Ethanedioic acid, sodium oxalate are configured to 10%~20% solution respectively, standby.Hydrochloric acid Sambucus chinensis, sodium acid carbonate add
In less than 40 DEG C of 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 ethanedioic acid or sodium oxalate solution regulation pH value be 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 Sambucus chinensis drug injection preparation stability is prepared according to the following steps：
(1) weigh bulk drug with Sambucus chinensis amount of calculation 0.1g~100g, ethanedioic acid 1mg~2.0g, sodium oxalate 1mg~
2.0g；(2) ethanedioic acid, sodium oxalate are configured to 10%~20% solution respectively, standby.(3) less than 40 DEG C of injection is added
With in water 500ml, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stir 15 minutes, filter decarburization.(4)
Filtrate ethanedioic acid or sodium oxalate 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 Sambucus chinensis 20g
Ethanedioic acid 1.0g
Sodium oxalate 2.0g
Ethanedioic acid, sodium oxalate are configured to 10%~20% solution respectively, standby.Hydrochloric acid Sambucus chinensis adds less than 40 DEG C
In 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 ethanedioic acid or sodium oxalate solution regulation pH value are 3.8~4.2, are added
Less than 40 DEG C of water for injection is to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, is produced.
Embodiment 3
Sambucus chinensis sodium bicarbonate injection stability comparative test
Meet the rule of drug standard using the visible foreign matters detection of Sambucus chinensis sodium bicarbonate injection obtained by the present invention
It is fixed, and stability of solution is fine, in the case where avoiding the cosolvent using other increase clinical practice risks, solves Sambucus chinensis
Easily there is the problems such as small particles, white block, solution muddiness in storage process in sodium bicarbonate injection.Using obtained by the present invention
Sambucus chinensis sodium bicarbonate injection is according to the C pharmaceutical preparation stability test guidelines of two annex of China's coastal port Ⅺ Ⅹ
Related request, investigated respectively placed at 25 DEG C place within 24 months, 40 DEG C place 10 days within 6 months, 60 DEG C, 0~5 DEG C of low temperature puts
20 days medicine stabilities are put, as a result product quality is stable at the conditions of the experiments described above, and every Testing index meets this quality
The regulation of standard.
The Pharmacological experiment result shows that：Using the stabilization obtained by the present invention Sambucus chinensis sodium bicarbonate injection without hemolytic,
Without anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
1 25 DEG C of study on the stability results of table
The 60 DEG C of study on the stability results of hydrochloric acid Sambucus chinensis sodium bicarbonate injection 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, Sambucus chinensis drug injection preparation of the invention can improve the clarity of Sambucus chinensis parenteral solution,
Particularly in the case where Sambucus chinensis injection period of storage is longer, the visible foreign matters detection for the holding parenteral solution that can stablize meets medicine
The regulation of quality standard, solve Sambucus chinensis medicine and little Bai occur in the case where period of storage is longer using existing technical products
The problem of point, white block, solution muddiness, it is ensured that the visible foreign matters inspection of product meets the regulation of drug standard, 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 Sambucus chinensis, it is characterised in that water for injection is mainly dissolved in by the salt of Sambucus chinensis, adds second
Diacid and/or sodium oxalate as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the ethanedioic acid and/
Or the dosage of sodium oxalate is 0.1mg~200.0mg/100ml.
2. the medicinal composition for injections of a kind of Sambucus chinensis according to claim 1, it is characterised in that also adjusted including osmotic pressure
Agent is saved, the osmotic pressure regulator is sodium acid carbonate.
A kind of 3. medicinal composition for injections of Sambucus chinensis according to claim 1, it is characterised in that the salt bag of the Sambucus chinensis
Include Sambucus chinensis hydrochloride, Sambucus chinensis phosphate.
4. the medicinal composition for injections of a kind of Sambucus chinensis according to claim 1 or 3, it is characterised in that the Sambucus chinensis
The concentration of salt is calculated as 10mg~10g/100ml with Sambucus chinensis.
5. the medicinal composition for injections of a kind of Sambucus chinensis according to claim 1, it is characterised in that the decoction pH value is
3.0~6.0.
A kind of 6. medicinal composition for injections of Sambucus chinensis according to claim 1, it is characterised in that the Sambucus chinensis medicine note
It is parenteral solution to penetrate preparation formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711250450.6A CN107744500A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of Sambucus chinensis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711250450.6A CN107744500A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of Sambucus chinensis |
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| Publication Number | Publication Date |
|---|---|
| CN107744500A true CN107744500A (en) | 2018-03-02 |
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| CN201711250450.6A Withdrawn CN107744500A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of Sambucus chinensis |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106474056A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability |
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2017
- 2017-12-01 CN CN201711250450.6A patent/CN107744500A/en not_active Withdrawn
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106474056A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability |
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Application publication date: 20180302 |
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