CN106109404A - A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability - Google Patents
A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability Download PDFInfo
- Publication number
- CN106109404A CN106109404A CN201610646241.2A CN201610646241A CN106109404A CN 106109404 A CN106109404 A CN 106109404A CN 201610646241 A CN201610646241 A CN 201610646241A CN 106109404 A CN106109404 A CN 106109404A
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- CN
- China
- Prior art keywords
- caulis
- folium stauntoniae
- injection
- medicinal composition
- injections
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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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
- 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)
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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 discloses a kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability, mainly it is dissolved in water for injection by the extracting solution of Caulis et folium stauntoniae, adding the medicinal composition for injections that tartaric acid and/or sodium tartrate are made as pH adjusting agent regulation medicinal liquid pH value, the consumption of described tartaric acid and/or sodium tartrate is 1mg～10.0mg/100ml.The present invention can make this injection pH value more stable, Caulis et folium stauntoniae 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 stauntonvine injection, particularly solving stauntonvine injection 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 Caulis et folium stauntoniae drug injection preparation stability of improving
Medicinal composition for injections.
Background technology
Stauntonvine injection, wind-expelling pain-stopping, relaxing muscles and tendons and activating QI and blood in the collateral.Network type trigeminal neuralgia, sciatica is hindered for ailment said due to cold or exposure.
Due to Caulis et folium stauntoniae dissolubility extreme difference in aqueous, therefore it is made into Caulis et folium stauntoniae hydrochlorate or Caulis et folium stauntoniae phosphate
To increase its water solublity.Presently commercially available stauntonvine injection mainly has the phosphatic low capacity of Caulis et folium stauntoniae hydrochlorate, Caulis et folium stauntoniae
Injection, and in Caulis et folium stauntoniae hydrochlorate, Caulis et folium stauntoniae 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 stauntonvine injection 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 Caulis et folium stauntoniae drug injection preparation stability
Pharmaceutical composition.This medicinal composition for injections employing tartaric acid, sodium tartrate are as pH adjusting agent, and pass through creative labor
When dynamic discovery uses tartaric acid, sodium tartrate as pH adjusting agent, medicinal liquid pH value is more stable, and Caulis et folium stauntoniae 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
Stauntonvine injection 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 Caulis et folium stauntoniae drug injection preparation stability
Medicinal composition for injections, be mainly dissolved in water for injection by the extracting solution of Caulis et folium stauntoniae, add osmotic pressure regulator, and add wine
Stone acid and/or sodium tartrate as the pH adjusting agent regulation medicinal composition for injections made of medicinal liquid pH value, described tartaric acid and/
Or the consumption of sodium tartrate is 1mg～10.0mg/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 0.9g/100ml；Glucose, xylitol, mannitol, fructose
Consumption is 5g/100ml～10g/100ml.
The extracting solution of described Caulis et folium stauntoniae includes Caulis et folium stauntoniae hydrochlorate, Caulis et folium stauntoniae phosphate.
The concentration of the extracting solution of described Caulis et folium stauntoniae is calculated as 10mg～10g/100ml with Caulis et folium stauntoniae.
Described medicinal liquid pH value is 6.0～8.0.
Described Caulis et folium stauntoniae drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising Caulis et folium stauntoniae drug injection preparation stability, including following
Step:
(1) extracting solution 0.1g～50g of Caulis et folium stauntoniae, tartaric acid and/or sodium tartrate 1mg～10mg are weighed；
(2) tartaric acid, sodium tartrate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
(3), during the extracting solution of Caulis et folium stauntoniae 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 0.2g/100ml, stirs 15 minutes, filters decarburization；
(4) step (3) gained filtrate step (2) configures tartaric acid and/or sodium tartrate solution regulation pH value be 3.0～
7.0, add the water for injection of less than 40 DEG C (30 DEG C～40 DEG C) to 1000ml；
(5) by step (4) gained medical filtration to clarification, fill, sterilizing, to obtain final product.
Described step (1) mesotartaric acid consumption is 1mg～2.0mg, sodium tartrate consumption is 1mg～2.0mg.
Described step also includes osmotic pressure regulator 9.0g in (1).
Described osmotic pressure regulator is xylitol.
In such scheme, what addition tartaric acid and/or sodium tartrate referred to addition can be in tartaric acid, sodium tartrate
Any one, or tartaric acid, sodium tartrate are with arbitrary proportion proportioning；In step (2), the tartaric acid of addition, sodium tartrate
In one, then make a kind of solution, as included tartaric acid, sodium tartrate two kinds, be configured to solution for standby the most respectively；Caulis et folium stauntoniae
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 Caulis et folium stauntoniae drug injection system
In agent, when using tartaric acid, sodium tartrate as pH adjusting agent, medicinal liquid pH value is more stable, and Caulis et folium stauntoniae 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
Stauntonvine injection 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 stauntonvine injection 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 stauntonvine injection, 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 tartrate is as pH adjusting agent,
And use tartaric 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 Caulis et folium stauntoniae drug injection preparation stability, including following step
Rapid: (1) weighting raw materials is with Caulis et folium stauntoniae extracting solution amount of calculation 5g, xylitol 9.0g, tartaric acid 1mgmg, sodium tartrate 2.0mg；
(2) tartaric acid, sodium tartrate are configured to the solution of 10%～20% respectively, standby；(3) water for injection of less than 40 DEG C is added
In 500ml, stir to after being completely dissolved, add 0.02%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate
Regulating pH value by tartaric acid or sodium tartrate solution is 3.0～7.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medicine
Liquid is filtered until clear, fill, and sterilizing to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Caulis et folium stauntoniae extracting solution 5g
Xylitol 9.0g
Tartaric acid 1.0mg
Sodium tartrate 2.0mg
Tartaric acid, sodium tartrate are configured to the solution of 10%～20% respectively, standby.Caulis et folium stauntoniae 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 0.2%, stir
Mix 15 minutes, filter decarburization.Filtrate tartaric acid or sodium tartrate solution regulation pH value are 6.0～8.0, 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 Caulis et folium stauntoniae drug injection preparation stability
Pharmaceutical composition is prepared according to the following steps:
(1) weighting raw materials is with Caulis et folium stauntoniae amount of calculation 20g, tartaric acid 1mg～2.0g, sodium tartrate 1mg～2.0g；(2) winestone
Acid, sodium tartrate 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
Mix to after being completely dissolved, add 0.2%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate tartaric acid or wine
Stone acid sodium solution regulation pH value is 6.0～8.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clear
Clearly, fill, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Caulis et folium stauntoniae extracting solution 20g
Tartaric acid 1.0mg
Sodium tartrate 2.0mg
Tartaric acid, sodium tartrate are configured to the solution of 10%～20% respectively, standby.Hydrochloric acid Caulis et folium stauntoniae 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 0.2g/100ml) of 0.2%, stirring
15 minutes, filter decarburization.Filtrate tartaric acid or sodium tartrate solution regulation pH value are 6.0～8.0, add the note of less than 40 DEG C
Penetrate with water to 1000ml.Medical filtration, to clarification, fill, sterilizing, to obtain final product.
Embodiment 3:
Stauntonvine injection stability comparative test
The visible foreign matters detection utilizing stauntonvine injection 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 stauntonvine injection and exist
Storage process easily occurs the problems such as small particles, white block, solution are muddy.Utilize stauntonvine injection 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 stauntonvine injection 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 Caulis et folium stauntoniae drug injection preparation of the present invention can improve the clear and bright of stauntonvine injection
Degree, particularly in the case of Caulis et folium stauntoniae 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 Caulis et folium stauntoniae 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 Caulis et folium stauntoniae drug injection preparation stability, it is characterised in that main by open country
The extracting solution of Fructus Chaenomelis is dissolved in water for injection, adds tartaric acid and/or sodium tartrate and makes as pH adjusting agent regulation medicinal liquid pH value
Medicinal composition for injections, the consumption of described tartaric acid and/or sodium tartrate is 1mg～10.0mg/100ml.
A kind of medicinal composition for injections improving Caulis et folium stauntoniae 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 Caulis et folium stauntoniae 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 Caulis et folium stauntoniae is calculated as 10mg～10g/100ml with Caulis et folium stauntoniae.
A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability the most according to claim 1,
It is characterized in that, described medicinal liquid pH value is 6.0～8.0.
A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability the most according to claim 1,
It is characterized in that, described Caulis et folium stauntoniae drug injection preparation formulation is injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610646241.2A CN106109404A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610646241.2A CN106109404A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability |
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| Publication Number | Publication Date |
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| CN106109404A true CN106109404A (en) | 2016-11-16 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610646241.2A Withdrawn CN106109404A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Caulis et folium stauntoniae drug injection preparation stability |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562275A (en) * | 2004-03-22 | 2005-01-12 | 广州安健实业发展有限公司 | Stauntonvine general glycoside and injection |
| 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 CN201610646241.2A patent/CN106109404A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562275A (en) * | 2004-03-22 | 2005-01-12 | 广州安健实业发展有限公司 | Stauntonvine general glycoside and injection |
| 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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Application publication date: 20161116 |
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