CN106138211A - A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability - Google Patents
A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability Download PDFInfo
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- CN106138211A CN106138211A CN201610646404.7A CN201610646404A CN106138211A CN 106138211 A CN106138211 A CN 106138211A CN 201610646404 A CN201610646404 A CN 201610646404A CN 106138211 A CN106138211 A CN 106138211A
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- China
- Prior art keywords
- illicii lanceolati
- radix illicii
- injection
- medicinal composition
- injections
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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)
- A61K36/57—Magnoliaceae (Magnolia 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
-
- 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
Abstract
The invention discloses a kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability, mainly it is dissolved in water for injection by the extracting solution of Radix Illicii Lanceolati, adding the medicinal composition for injections that caffeic acid and/or sodium caffeate are made as pH adjusting agent regulation medicinal liquid pH value, the consumption of described caffeic acid and/or sodium caffeate is 1g～5g/100ml.The present invention can make this injection pH value more stable, Radix Illicii Lanceolati degradation material relatively prior art is substantially reduced, in the case of avoiding using other to increase the cosolvent of clinical practice risk, improve the clarity of Injection liquid of red fennel, particularly solving Injection liquid of red fennel uses prior art products to occur the problem that small particles, white block, solution are muddy in the case of period of storage is longer, can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, it is simple to clinical application and popularization.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of Radix Illicii Lanceolati drug injection preparation stability of improving
Medicinal composition for injections.
Background technology
Injection liquid of red fennel, subside a swelling dissipating blood stasis, promoting blood circulation and stopping pain.Grieved and the rheumatism for lumbar muscle strain, joint or muscle ligament
Pain etc..
Due to Radix Illicii Lanceolati dissolubility extreme difference in aqueous, therefore it is made into Radix Illicii Lanceolati hydrochlorate or Radix Illicii Lanceolati phosphate
To increase its water solublity.Presently commercially available Injection liquid of red fennel mainly has the phosphatic low capacity of Radix Illicii Lanceolati hydrochlorate, Radix Illicii Lanceolati
Injection, and in Radix Illicii Lanceolati hydrochlorate, Radix Illicii Lanceolati phosphate solution, add glucose or sodium chloride as osmotic pressure regulation
The high-capacity injection that agent is made.But when preparing above-mentioned injection, it is necessary to be adjusted to the pH value of medicinal liquid be suitable for human injection
The certain limit being administered, the pH value regulator that current document report uses is sodium hydroxide solution or uses hydrochloric acid solution, phosphorus
Acid solution, but the Injection liquid of red fennel using above-mentioned pH value regulator to prepare easily is analysed under the conditions of long-term storage and winter low temperature
Going out the precipitate such as tiny white point, white block, solution muddiness, the visible foreign matters check item causing product is defective.Prior art be
Solution adds polyoxyethylene sorbitan monoleate as cosolvent, occur that small particles, white block, solution are muddy etc. and sedimentary ask solving product
Topic.But polyoxyethylene sorbitan monoleate is owing to having the effect of haemolysis and blood pressure lowering, and easily become sour in storage and autoclaving process, cause
Injection clinical practice risk containing polyoxyethylene sorbitan monoleate is higher, makes troubles to clinical application and popularization.
Summary of the invention
The technical problem to be solved is to provide a kind of injection improving Radix Illicii Lanceolati drug injection preparation stability
Pharmaceutical composition.This medicinal composition for injections employing caffeic acid, sodium caffeate are as pH adjusting agent, and pass through creative labor
When dynamic discovery uses caffeic acid, sodium caffeate as pH adjusting agent, medicinal liquid pH value is more stable, and Radix Illicii Lanceolati degradation material is more existing
Technology is substantially reduced, and in the case of avoiding using other to increase the cosolvent of clinical practice risk, is satisfactorily addressed
Injection liquid of red fennel easily separates out tiny white point, white block, the problem of solution muddiness under the conditions of storage for a long time and winter low temperature.
The present invention solves the problems referred to above and be the technical scheme is that a kind of raising Radix Illicii Lanceolati drug injection preparation stability
Medicinal composition for injections, be mainly dissolved in water for injection by the extracting solution of Radix Illicii Lanceolati, add osmotic pressure regulator, and add coffee
Coffee acid and/or sodium caffeate as the pH adjusting agent regulation medicinal composition for injections made of medicinal liquid pH value, described caffeic acid and/
Or the consumption of sodium caffeate is 1g～5g/100ml.
Described osmotic pressure regulator is any one or a few in glucose, sodium chloride, xylitol, mannitol, fructose.
The consumption of osmotic pressure regulator is prior art, and sodium chloride consumption is 0.7g/100ml；Glucose, xylitol, mannitol, fructose
Consumption is 5g/100ml～10g/100ml.
The extracting solution of described Radix Illicii Lanceolati includes Radix Illicii Lanceolati hydrochlorate, Radix Illicii Lanceolati phosphate.
The concentration of the extracting solution of described Radix Illicii Lanceolati is calculated as 10mg～10g/100ml with Radix Illicii Lanceolati.
Described medicinal liquid pH value is 4.0～68.0.
Described Radix Illicii Lanceolati drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising Radix Illicii Lanceolati drug injection preparation stability, including following
Step:
(1) extracting solution 5g～100g of Radix Illicii Lanceolati, caffeic acid and/or sodium caffeate 1g～5g are weighed；
(2) caffeic acid, sodium caffeate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
(3), during the extracting solution of Radix Illicii Lanceolati adds the water for injection 500ml of 30 DEG C～40 DEG C, stir to after being completely dissolved, addition
Activated carbon, described activated carbon dosage is 0.15g/100ml, stirs 15 minutes, filters decarburization；
(4) step (3) gained filtrate step (2) configures caffeic acid and/or sodium caffeate solution regulation pH value be 4.0～
6.0, add the water for injection of 30 DEG C～40 DEG C to 1000ml；
(5) by step (4) gained medical filtration to clarification, fill, sterilizing, to obtain final product.
In described step (1) caffeic acid consumption be 1g～5g, sodium caffeate consumption be 1g～5g.
Described step also includes osmotic pressure regulator 7.0g in (1).
Described osmotic pressure regulator is sodium chloride.
In such scheme, what addition caffeic acid and/or sodium caffeate referred to addition can be in caffeic acid, sodium caffeate
Any one, or caffeic acid, sodium caffeate are with arbitrary proportion proportioning；In step (2), the caffeic acid of addition, sodium caffeate
In one, then make a kind of solution, as included caffeic acid, sodium caffeate two kinds, be configured to solution for standby the most respectively；Radix Illicii Lanceolati
Extracting solution, the consumption of osmotic pressure regulator can use the consumption of prior art, adjust according to the consumption of prior art.
In sum, the invention has the beneficial effects as follows: the present invention is by experimental studies have found that, in Radix Illicii Lanceolati drug injection system
In agent, when using caffeic acid, sodium caffeate as pH adjusting agent, medicinal liquid pH value is more stable, and Radix Illicii Lanceolati degradation material is more existing
Technology is substantially reduced, and in the case of avoiding using other to increase the cosolvent of clinical practice risk, is satisfactorily addressed
Injection liquid of red fennel uses prior art products easily to separate out tiny white point, white block, the problem of solution muddiness in storage process,
Can ensure that the visible foreign matters detection keeping injection that Injection liquid of red fennel can be stable in storage process meets medicine matter
The regulation of amount standard, it is simple to clinical application and popularization.
The present invention passes through creative work, to muddy former of the tiny white point separated out in Injection liquid of red fennel, white block, solution
Because being analyzed and studying, determine that deposit is mainly raw material free alkali crystallize and a small amount of catabolite, above-mentioned reason occurs
May be relevant with the kind of acid used by the pH value of solution and pH adjusting agent, alkali.Therefore use sodium caffeate is as pH adjusting agent,
And use caffeic acid as pH value counter regulation agent, in the case of avoiding using other to increase the cosolvent of clinical practice risks,
To solve, this product is easy under the conditions of storage for a long time and winter low temperature separates out tiny white point, white block, the problem of solution muddiness.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited to this.
Embodiment 1:
The preparation method of a kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability, including following step
Rapid: (1) weighting raw materials is with Radix Illicii Lanceolati extracting solution amount of calculation 25g, sodium chloride 7.0g, caffeic acid 2g, sodium caffeate 4mg；(2) coffee
Coffee acid, sodium caffeate are configured to the solution of 10%～20% respectively, standby；(3) add in the water for injection 500ml of less than 40 DEG C,
Stir to after being completely dissolved, add 0.02%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate caffeic acid
Or sodium caffeate solution regulation pH value is 3.0～7.0, add the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is extremely
Clarification, fill, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Radix Illicii Lanceolati extracting solution 25g
Sodium chloride 7.0g
Caffeic acid 2.0g
Sodium caffeate 4.0g
Caffeic acid, sodium caffeate are configured to the solution of 10%～20% respectively, standby.Radix Illicii Lanceolati extracting solution adds the note of less than 40 DEG C
Penetrate with in water 500ml, stir to after being completely dissolved, add the activated carbon (i.e. activated carbon dosage is 0.2g/100ml) of 0.15%, stir
Mix 15 minutes, filter decarburization.Filtrate caffeic acid or sodium caffeate solution regulation pH value are 4.0～6.0, add less than 40 DEG C
Water for injection is to 1000ml.Medical filtration, to clarification, fill, sterilizing, to obtain final product.
Embodiment 2:
The present embodiment another embodiment, as follows, the injection of above-mentioned raising Radix Illicii Lanceolati drug injection preparation stability
Pharmaceutical composition is prepared according to the following steps:
(1) weighting raw materials is with Radix Illicii Lanceolati amount of calculation 70g, caffeic acid 3g, sodium caffeate 6g；(2) caffeic acid, sodium caffeate are respectively
It is configured to the solution of 10%～20%, standby；(3) add in the water for injection 500ml of less than 40 DEG C, stirring to after being completely dissolved,
Add 0.15%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate caffeic acid or the regulation of sodium caffeate solution
PH value is 4.0～6.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clarifying, fill, sterilizing, i.e.
?.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Radix Illicii Lanceolati extracting solution 70g
Caffeic acid 3g
Sodium caffeate 5g
Caffeic acid, sodium caffeate are configured to the solution of 10%～20% respectively, standby.Hydrochloric acid Radix Illicii Lanceolati adds the injection of less than 40 DEG C
With in water 500ml, stir to after being completely dissolved, add the activated carbon (i.e. activated carbon dosage is 0.15g/100ml) of 0.15%, stir
Mix 15 minutes, filter decarburization.Filtrate caffeic acid or sodium caffeate solution regulation pH value are 4.0～6.0, add less than 40 DEG C
Water for injection is to 1000ml.Medical filtration, to clarification, fill, sterilizing, to obtain final product.
Embodiment 3:
Injection liquid of red fennel stability comparative test
The visible foreign matters detection utilizing Injection liquid of red fennel obtained by the present invention meets the regulation of drug standard, and solution is steady
Qualitative very well, in the case of avoiding using other to increase the cosolvent of clinical practice risks, solve Injection liquid of red fennel and exist
Storage process easily occurs the problems such as small particles, white block, solution are muddy.Utilize Injection liquid of red fennel obtained by the present invention according to
The related request of two annex Ⅺ Ⅹ C pharmaceutical preparation stability test guidelines of China's coastal port, investigates respectively
Place to place for 24 months, 40 DEG C at 25 DEG C and within 6 months, 60 DEG C, place 10 days, 0～5 DEG C of low temperature 20 days medicine stability of placement, result
Constant product quality at the conditions of the experiments described above, every Testing index all meets the regulation of this product quality standard.
The pharmacological results shows: utilize the stable Injection liquid of red fennel obtained by the present invention without hemolytic, without allergy
Property, nonirritant, meet the requirement of drug administration by injection.
According to the above results, the Radix Illicii Lanceolati drug injection preparation of the present invention can improve the clear and bright of Injection liquid of red fennel
Degree, particularly in the case of Radix Illicii Lanceolati injection period of storage is longer, it is possible to the stable visible foreign matters detection keeping injection
Meet the regulation of drug standard, solve Radix Illicii Lanceolati medicine and use existing technical products to go out in the case of period of storage is longer
Existing small particles, white block, the problem of solution muddiness, it is ensured that the visible foreign matters inspection of product meets the rule of drug standard
Fixed, it is simple to clinical application and popularization.
As it has been described above, just can preferably realize the present invention.
Claims (5)
1. the medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability, it is characterised in that main by red
The extracting solution of Fructus Foeniculi is dissolved in water for injection, adds caffeic acid and/or sodium caffeate and makes as pH adjusting agent regulation medicinal liquid pH value
Medicinal composition for injections, the consumption of described caffeic acid and/or sodium caffeate is 1g～5g/100ml.
A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1,
It is characterized in that, also include osmotic pressure regulator, described osmotic pressure regulator be glucose, sodium chloride, xylitol, mannitol,
Any one or a few in fructose.
A kind of injectable drug combination improving Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1 and 2
Thing, it is characterised in that the concentration of the extracting solution of described Radix Illicii Lanceolati is calculated as 0.1g～10g/100ml with Radix Illicii Lanceolati.
A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1,
It is characterized in that, described medicinal liquid pH value is 4.0～6.0.
A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1,
It is characterized in that, described Radix Illicii Lanceolati drug injection preparation formulation is injection.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610646404.7A CN106138211A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610646404.7A CN106138211A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability |
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| CN106138211A true CN106138211A (en) | 2016-11-23 |
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| CN201610646404.7A Withdrawn CN106138211A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Radix Illicii Lanceolati drug injection preparation stability |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107951919A (en) * | 2017-12-01 | 2018-04-24 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections of root of Chinese trichosanthes |
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 |
-
2016
- 2016-08-09 CN CN201610646404.7A patent/CN106138211A/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 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107951919A (en) * | 2017-12-01 | 2018-04-24 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections of root of Chinese trichosanthes |
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Application publication date: 20161123 |