CN106361803A - Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation - Google Patents
Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation Download PDFInfo
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- CN106361803A CN106361803A CN201610968035.3A CN201610968035A CN106361803A CN 106361803 A CN106361803 A CN 106361803A CN 201610968035 A CN201610968035 A CN 201610968035A CN 106361803 A CN106361803 A CN 106361803A
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- radix astragali
- injection
- fruit acid
- astragalus membranaceus
- injection preparation
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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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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- 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 pharmaceutical composition for injection for improving the stability of an Astragalus membranaceus medicine injection preparation. The pharmaceutical composition for injection is prepared by dissolving Astragalus membranaceus salt in the water for injection and adding tartaric acid and/or sodium tartaric acid as a pH regulator to adjust the pH value of the liquid medicine. The use amount of the tartaric acid and/or sodium tartaric acid is 0.1 mg-200.0 mg/100 ml. The pharmaceutical composition for injection makes the pH value of the injection more stable; compared with the prior art, the Astragalus membranaceus degradation material is greatly reduced; the use of other cosolvents increasing the risks of clinical application are avoided, and the clarity of the Astragalus membranaceus medicine injection liquid is improved; the problem that Astragalus membranaceus medicine injection liquid has small white dots, white blocks and solution turbidity after a long storage time in the prior art is especially solved, the inspection of the visible foreign substances in the product conforms to the drug quality standard requirements, and the clinical use and promotion are facilitated.
Description
Technical field
A kind of the invention belongs to pharmaceutical technology field, in particular it relates to note improving Radix Astragali drug injection preparation stability
Penetrate pharmaceutical composition.
Background technology
The Radix Astragali is the alkaloid extracting from chuanxiong, and chemical constitution is tetramethylpyazine, is a kind of novel agents of calcium ion
Antagonist, has blood circulation promoting and blood stasis dispelling, anti-platelet aggregation, excited medullary respiratory center and vasomotor center, expansion of blood vessels and props up
Tracheal smooth muscle, improve multiple effect such as microcirculation, be clinically used for for obliterated cerebral vascular disease such as incomplete brain blood supply, brain blood
Bolt formation, cerebral embolism and other ischemic angiopathys such as coronary heart disease, vasculitiss etc..The injection of the Radix Astragali has been Chinese medicine
Modern hardly possible disease makes very big contribution.
Due to Radix Astragali dissolubility extreme difference in aqueous, therefore it is made into Radix Astragali hydrochlorate or Radix Astragali phosphate to increase
Its water solublity.Presently commercially available Radix Astragali injection mainly has the phosphatic injection with small volume of Radix Astragali hydrochlorate, the Radix Astragali, Yi Ji
Glucose or sodium chloride is added to inject as the Large Copacity that osmotic pressure regulator is made in Radix Astragali hydrochlorate, Radix Astragali phosphate solution
Liquid.But when preparing above-mentioned injection it is necessary to the ph value of medicinal liquid is adjusted to the certain limit of suitable human injection's administration, at present
The ph value regulator that document report uses is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution, but adopts above-mentioned ph
The Radix Astragali injection of value regulator preparation easily separates out tiny white point, white block, solution under the conditions of long-term storage and winter low temperature
The precipitate such as muddiness, cause the visible foreign matters check item of product unqualified.Prior art is to add polyoxyethylene sorbitan monoleate in the solution
As cosolvent, to solve product, the sedimentary problems such as small particles, white block, solution muddiness occur.But polyoxyethylene sorbitan monoleate due to
There is the effect of haemolysis and blood pressure lowering, and easily become sour in storage and autoclaving process, lead to the note containing polyoxyethylene sorbitan monoleate
Penetrate liquid clinical practice risk higher, make troubles to clinical application and popularization.
Content of the invention
The technical problem to be solved is to provide a kind of injectable drug improving astragalus injection preparation stability
Compositionss.
This medicinal composition for injections adopts fruit acid, fruit acid sodium as ph regulator, and finds to adopt by creative work
During with fruit acid, fruit acid sodium as ph regulator, medicinal liquid ph value is more stable, and Radix Astragali degradation material substantially reduces compared with prior art,
In the case of avoiding increasing the cosolvent of clinical practice risk using other, Radix Astragali injection is satisfactorily addressed and has grown
Tiny white point, white block, the problem of solution muddiness is easily separated out under the conditions of phase storage and winter low temperature.
The present invention solves the above problems and the technical scheme is that a kind of improves Radix Astragali drug injection preparation stability
Medicinal composition for injections, is mainly dissolved in water for injection by the salt of the Radix Astragali, adds osmotic pressure regulator, and add fruit acid and/or
The medicinal composition for injections that fruit acid sodium is made as ph regulator regulating liquid medicine ph value, the use of described fruit acid and/or fruit acid sodium
Measure as 0.1mg～200.0mg/100ml.
Described osmotic pressure regulator is glucose, sodium chloride, xylitol, Mannitol, any one or a few in Fructose.
The consumption of osmotic pressure regulator is prior art, and sodium chloride consumption is 0.9g/100ml；Glucose, xylitol, Mannitol, Fructose
Consumption is 5g/100ml～10g/100ml.
The salt of the described Radix Astragali includes Radix Astragali hydrochlorate, Radix Astragali phosphate.
The concentration of the salt of the described Radix Astragali is calculated as 10mg～10g/100ml with the Radix Astragali.
Described medicinal liquid ph value is 3.0～6.0.
Described Radix Astragali drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising Radix Astragali drug injection preparation stability, including following steps
Rapid:
(1) salt weighing the Radix Astragali is with Radix Astragali amount of calculation 0.1g～100g, fruit acid and/or fruit acid sodium 2mg～4.0g；
(2) fruit acid, fruit acid sodium are configured to the solution of 10g/100ml～20g/100ml respectively, standby；
(3) salt of the Radix Astragali, sodium chloride add in 30 DEG C～40 DEG C of water for injection 500ml, stir to after be completely dissolved, plus
The activated carbon entering, described activated carbon dosage is 0.02g/100ml, stirs 15 minutes, filters decarburization；
(4) step (3) gained filtrate step (2) configures fruit acid and/or fruit acid sodium solution adjust ph value for 3.0～
7.0, the water for injection adding less than 40 DEG C (30 DEG C～40 DEG C) is to 1000ml；
(5) by step (4) gained medical filtration to clarification, fill, sterilizing, obtain final product.
In described step (1) fruit acid consumption be 1mg～2.0g, fruit acid sodium consumption be 1mg～2.0g.
Osmotic pressure regulator 9.0g is also included in described step (1).
Described osmotic pressure regulator is sodium chloride.
In such scheme, add that fruit acid and/or fruit acid sodium refers to add can be fruit acid, any one in fruit acid sodium,
Or fruit acid, fruit acid sodium are with arbitrary proportion proportioning；In step (2), one of the fruit acid of addition, fruit acid sodium, then make
A kind of solution, such as includes fruit acid, two kinds of fruit acid sodium, is then configured to solution for standby respectively；The salt of the Radix Astragali, the use of osmotic pressure regulator
Amount can adopt the consumption of prior art, according to the consumption adjustment of prior art.
In sum, the invention has the beneficial effects as follows: the present invention pass through experimental studies have found that, in Radix Astragali drug injection preparation
In, during using fruit acid, fruit acid sodium as ph regulator, medicinal liquid ph value is more stable, and Radix Astragali degradation material is compared with prior art significantly
Reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, astragalus injection has been satisfactorily addressed
Liquid adopts prior art products easily to separate out the muddy problem of tiny white point, white block, solution in storage process it is ensured that Huang
Astragalus injection liquid can be stable in storage process the visible foreign matters detection of holding injection meet the regulation of drug standard,
It is easy to clinical application and popularization.
The present invention passes through creative work, the reason muddy to the tiny white point separating out in Radix Astragali injection, white block, solution
It is analyzed and studies, determine that deposit is mainly raw material free alkali crystallize and a small amount of catabolite, above-mentioned reason can
Can be relevant with species sour, alkali used by the ph value of solution and ph regulator.Fruit acid sodium is therefore used as ph regulator, and makes
With fruit acid as ph value counter regulation agent, in the case of avoiding increasing the cosolvent of clinical practice risk using other, to solve
This product muddy problem of the tiny white point of easy precipitation, white block, solution under the conditions of long-term storage and winter low temperature.
Specific embodiment
With reference to embodiment, the present invention is described in further detail, but embodiments of the present invention not limited to this.
Embodiment 1
A kind of preparation method of the medicinal composition for injections improving Radix Astragali drug injection preparation stability, including following steps
Rapid: (1) weigh crude drug with Radix Astragali amount of calculation 0.1g～100g, sodium chloride 9.0g, fruit acid 1mg～2.0g, fruit acid sodium 1mg～
2.0g；(2) fruit acid, fruit acid sodium are configured to 10%～20% solution respectively, standby.(3) add less than 40 DEG C of water for injection
In 500ml, stir to after be completely dissolved, add the activated carbon of 0.02% (g/ml), stir 15 minutes, filter decarburization.(4) filtrate
Adjusting ph value with fruit acid or fruit acid sodium solution is 3.0～7.0, adds less than 40 DEG C of water for injection to 1000ml；(5) medicinal liquid mistake
Filter to clarification, fill, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment:
Fruit acid, fruit acid sodium are configured to 10%～20% solution respectively, standby.The hydrochloric acid Radix Astragali, sodium chloride add 40 DEG C with
Under water for injection 500ml in, stir to after be completely dissolved, add 0.02% activated carbon (i.e. activated carbon dosage be 0.02g/
100ml), stir 15 minutes, filter decarburization.Filtrate fruit acid or fruit acid sodium solution regulation ph value are 3.8～4.2, add 40 DEG C
Following water for injection is to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 2
Or, the medicinal composition for injections of above-mentioned raising Radix Astragali drug injection preparation stability is prepared according to the following steps:
(1) weigh crude drug with Radix Astragali amount of calculation 0.1g～100g, fruit acid 1mg～2.0g, fruit acid sodium 1mg～2.0g；(2)
Fruit acid, fruit acid sodium are configured to 10%～20% solution respectively, standby.(3) add in less than 40 DEG C of water for injection 500ml,
Stir to after be completely dissolved, add the activated carbon of 0.02% (g/ml), stir 15 minutes, filter decarburization.(4) filtrate fruit acid or
It is 3.0～7.0 that fruit acid sodium solution adjusts ph value, adds less than 40 DEG C of water for injection to 1000ml；(5) medical filtration is extremely clear
Clearly, fill, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment:
Hydrochloric acid Radix Astragali 20g
Fruit acid 1.0g
Fruit acid sodium 2.0g
Fruit acid, fruit acid sodium are configured to 10%～20% solution respectively, standby.The hydrochloric acid Radix Astragali adds less than 40 DEG C of injection
With in water 500ml, stirring to after be completely dissolved, add 0.02% activated carbon (i.e. activated carbon dosage is 0.02g/100ml), stir
Mix 15 minutes, filter decarburization.Filtrate fruit acid or fruit acid sodium solution regulation ph value are 3.8～4.2, add less than 40 DEG C of injection
With water to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 3
Radix Astragali sodium chloride injection stability comparative test
Visible foreign matters detection using Radix Astragali sodium chloride injection obtained by the present invention meets the regulation of drug standard,
And stability of solution is very well, in the case of avoiding increasing the cosolvent of clinical practice risk using other, solve Radix Astragali chlorine
Change sodium injection and the problems such as small particles, white block, solution muddiness easily occurs in storage process.Using the Radix Astragali obtained by the present invention
Sodium chloride injection is according to the correlation of two annex c pharmaceutical preparation stability test guidelines of China's coastal port
Require, investigated respectively 25 DEG C place place within 24 months, 40 DEG C place within 6 months, 60 DEG C 10 days, 0～5 DEG C of low temperature places 20 days
Medicine stability, product quality is stable at the conditions of the experiments described above for result, and every Testing index all meets this product quality standard
Regulation.
The pharmacological results show: using the no hemolytic, no of the stable Radix Astragali sodium chloride injection obtained by the present invention
Anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
1 25 DEG C of study on the stability results of table
Table 2 60 DEG C of study on the stability results of hydrochloric acid Radix Astragali sodium chloride injection
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
According to the above results, the Radix Astragali drug injection preparation of the present invention can improve the clarity of Radix Astragali injection,
Particularly in the case that astragalus injection period of storage is longer, the visible foreign matters detection of holding injection that can be stable meets medicine
The regulation of quality standard, solves Radix Astragali medicine and little Bai using existing technical products in the case that period of storage is longer
The muddy problem of point, white block, solution, 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, just can preferably realize the present invention.
Claims (6)
1. a kind of medicinal composition for injections improving Radix Astragali drug injection preparation stability it is characterised in that main by the Radix Astragali
Salt be dissolved in water for injection, add the injectable drug that fruit acid and/or fruit acid sodium are made as ph regulator regulating liquid medicine ph value
Compositionss, the consumption of described fruit acid and/or fruit acid sodium is 0.1mg～200.0mg/100ml.
2. a kind of medicinal composition for injections improving Radix Astragali drug injection preparation stability according to claim 1, its
It is characterised by, also includes osmotic pressure regulator, described osmotic pressure regulator is glucose, sodium chloride, xylitol, Mannitol, really
Sugar in any one or a few.
3. a kind of medicinal composition for injections improving Radix Astragali drug injection preparation stability according to claim 1, its
It is characterised by, the salt of the described Radix Astragali includes Radix Astragali hydrochlorate, Radix Astragali phosphate.
4. the medicinal composition for injections of a kind of raising Radix Astragali drug injection preparation stability according to claim 1 or 3,
It is characterized in that, the concentration of the salt of the described Radix Astragali is calculated as 10mg～10g/100ml with the Radix Astragali.
5. a kind of medicinal composition for injections improving Radix Astragali drug injection preparation stability according to claim 1, its
It is characterised by, described medicinal liquid ph value is 3.0～6.0.
6. a kind of medicinal composition for injections improving Radix Astragali drug injection preparation stability according to claim 1, its
It is characterised by, described Radix Astragali drug injection preparation formulation is injection.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610968035.3A CN106361803A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610968035.3A CN106361803A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation |
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Citations (3)
| 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 |
| CN105106110A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
| CN105125485A (en) * | 2015-09-23 | 2015-12-09 | 成都艾比科生物科技有限公司 | Preparation method of injecting drug improving stability of puerarin drug injection preparation |
-
2016
- 2016-11-06 CN CN201610968035.3A patent/CN106361803A/en not_active Withdrawn
Patent Citations (3)
| 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 |
| CN105106110A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
| CN105125485A (en) * | 2015-09-23 | 2015-12-09 | 成都艾比科生物科技有限公司 | Preparation method of injecting drug improving stability of puerarin drug injection preparation |
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