CN106420918A - Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation - Google Patents
Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation Download PDFInfo
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- CN106420918A CN106420918A CN201610968020.7A CN201610968020A CN106420918A CN 106420918 A CN106420918 A CN 106420918A CN 201610968020 A CN201610968020 A CN 201610968020A CN 106420918 A CN106420918 A CN 106420918A
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- danhong
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- citric 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
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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 used for injection and enhanced in stability of a Danhong pharmaceutical injection preparation. The pharmaceutical composition is mainly prepared by dissolving an extraction solution of Danhong in water for injection and adding citric acid and/or sodium citrate serving as pH (potential of hydrogen) adjusting agents to adjust the pH value of a pharmaceutical liquid, wherein the citric acid and/or the sodium citrate are added according to the dosage of 5mg-30mg/100ml. The pharmaceutical composition has the advantages that the pH value of the pharmaceutical liquid is more stable, Danhong degradation substances are reduced as compared with that in the prior art, transparency of the Danhong injection is increased without using other cosolvent which increases clinical application risks, the problems that the Danhong injection in the prior art generates small white particles and white lumps and becomes turbid after long-time storage are solved particularly, the pharmaceutical composition meets the requirements of medicine quality standards in visible foreign matter inspection, and clinical medication and popularization are facilitated.
Description
Technical field
A kind of the invention belongs to pharmaceutical technology field, in particular it relates to note improving DANHONG drug injection preparation stability
Penetrate pharmaceutical composition.
Background technology
DANHONG ZHUSHEYE, blood circulation promoting and blood stasis dispelling, TONGMAI SHULUO.For the thoracic obstruction caused by blood stasis impatency and apoplexy, card is shown in：Chest pain,
Uncomfortable in chest, cardiopalmus, facial hemiparalysiss, sluggish speech, numb limbs and tense tendons, activity is unfavorable to wait disease；Coronary heart diseases and angina pectoris, myocardial infarction, blood stasis
Type pulmonary heart disease, ischemic encephalopathy, cerebral thrombosiss.
Due to DANHONG dissolubility extreme difference in aqueous, therefore it is made into DANHONG hydrochlorate or DANHONG phosphate to increase
Its water solublity.Presently commercially available DANHONG ZHUSHEYE mainly has the phosphatic injection with small volume of DANHONG hydrochlorate, DANHONG, Yi Ji
Glucose or sodium chloride is added to inject as the Large Copacity that osmotic pressure regulator is made in DANHONG hydrochlorate, DANHONG 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 DANHONG ZHUSHEYE 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 injection improving DANHONG drug injection preparation stability
Pharmaceutical composition.This medicinal composition for injections adopts citric acid, sodium citrate as pH adjusting agent, and passes through creative work
When finding to adopt citric acid, sodium citrate as pH adjusting agent, medicinal liquid pH value is more stable, and DANHONG degradation material is compared with prior art
Substantially reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, DANHONG has been satisfactorily addressed
Injection muddy problem of the tiny white point of easy precipitation, white block, solution under the conditions of long-term storage and winter low temperature.
The present invention solves the above problems and be employed technical scheme comprise that：A kind of raising DANHONG drug injection preparation stability
Medicinal composition for injections, is mainly dissolved in water for injection by the extracting solution of DANHONG, adds osmotic pressure regulator, and adds citric acid
And/or the medicinal composition for injections that sodium citrate is made as pH adjusting agent regulating liquid medicine pH value, described citric acid and/or Chinese holly
The consumption of rafter acid sodium is 5mg～30mg/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 extracting solution of described DANHONG includes DANHONG hydrochlorate, DANHONG phosphate.
The concentration of the extracting solution of described DANHONG is calculated as 10mg～10g/100ml with DANHONG.
Described medicinal liquid pH value is 6.0～8.0.
Described DANHONG drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising DANHONG drug injection preparation stability, including following steps
Suddenly：
（1）Weigh extracting solution 0.1g～50g, citric acid and/or the sodium citrate 5mg～30mg of DANHONG；
（2）Citric acid, sodium citrate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
（3）The extracting solution of DANHONG adds in 30 DEG C～40 DEG C of water for injection 500ml, stirs to after be completely dissolved, the work of addition
Property charcoal, described activated carbon dosage be 0.2g/100ml, stir 15 minutes, filter decarburization；
（4）Step（3）Gained filtrate step（2）Configuration citric acid and/or liquor sodii citratises adjust pH value be 3.0～
7.0, add less than 40 DEG C（30 DEG C～40 DEG C）Water for injection to 1000ml；
（5）By step（4）Gained medical filtration, to clarification, fill, sterilizing, obtains final product.
Described step（1）Middle citric acid consumption is 5mg～18mg/100ml, sodium citrate consumption is 5mg～18mg/
100ml.
Described step（1）In also include osmotic pressure regulator 9.0g.
Described osmotic pressure regulator is xylitol.
In such scheme, add that citric acid and/or sodium citrate refer to add can be citric acid, in sodium citrate
Any one, or citric acid, sodium citrate are with arbitrary proportion proportioning；In step（2）In, the citric acid of addition, sodium citrate
One of, then make a kind of solution, such as include citric acid, two kinds of sodium citrate, be then configured to solution for standby respectively；DANHONG
Extracting solution, the consumption of osmotic pressure regulator 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 DANHONG drug injection preparation
In, during using citric acid, sodium citrate as pH adjusting agent, medicinal liquid pH value is more stable, and DANHONG degradation material is compared with prior art
Substantially reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, DANHONG has been satisfactorily addressed
Injection adopts prior art products easily to separate out tiny white point, white block, the problem of solution muddiness, Ke Yibao in storage process
The visible foreign matters detection demonstrate,proving the holding injection that DANHONG ZHUSHEYE can be stable in storage process meets drug standard
Regulation, 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 DANHONG ZHUSHEYE, 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 adjusting agent.Sodium citrate is therefore used as pH adjusting agent, and
Citric acid is used as pH value counter regulation agent, in the case of avoiding increasing the cosolvent of clinical practice risk using other, with
Easily the tiny white point of precipitation, white block, solution are muddy under the conditions of long-term storage and winter low temperature to solve the problems, such as this product.
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 DANHONG drug injection preparation stability, comprises the steps：
（1）Weigh crude drug with DANHONG extracting solution amount of calculation 5g, xylitol 9.0g, citric acid 1mgmg, sodium citrate 2.0mg；（2）Chinese holly
Rafter acid, sodium citrate 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 0.02%（g/ml）Activated carbon, stir 15 minutes, filter decarburization；（4）Filtrate citric acid
Or liquor sodii citratises to adjust pH value be 3.0～7.0, add less than 40 DEG C of water for injection to 1000ml；（5）Medical filtration is extremely
Clarification, fill, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment：
DANHONG extracting solution 5g
Xylitol 9.0g
Citric acid 1.0mg
Sodium citrate 2.0mg
Citric acid, sodium citrate are configured to 10%～20% solution respectively, standby.DANHONG extracting solution adds less than 40 DEG C of injection
With in water 500ml, stirring to after be completely dissolved, add 0.2% activated carbon（I.e. activated carbon dosage is 0.2g/100ml）, stirring
15 minutes, filter decarburization.Filtrate citric acid or liquor sodii citratises adjust pH value for 6.0～8.0, add less than 40 DEG C of note
Penetrate with water to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 2：
The present embodiment another embodiment, as follows, the injecting drug use of above-mentioned raising DANHONG drug injection preparation stability
Compositions are prepared according to the following steps：
（1）Weigh crude drug with DANHONG amount of calculation 20g, citric acid 1mg～2.0g, sodium citrate 1mg～2.0g；（2）Citric acid,
Sodium citrate is configured to 10%～20% solution respectively, standby.（3）Add in less than 40 DEG C of water for injection 500ml, stir to
After being completely dissolved, add 0.2%（g/ml）Activated carbon, stir 15 minutes, filter decarburization；（4）Filtrate citric acid or citric acid
It is 6.0～8.0 that sodium solution adjusts pH value, adds less than 40 DEG C of water for injection to 1000ml；（5）Medical filtration, to clarifying, fills
Dress, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment：
DANHONG extracting solution 20g
Citric acid 1.0mg
Sodium citrate 2.0mg
Citric acid, sodium citrate are configured to 10%～20% solution respectively, standby.Hydrochloric acid DANHONG adds less than 40 DEG C of injection
In water 500ml, stir to after be completely dissolved, add 0.2% activated carbon（I.e. activated carbon dosage is 0.2g/100ml）, stir 15
Minute, filter decarburization.Filtrate citric acid or liquor sodii citratises adjust pH value for 6.0～8.0, add less than 40 DEG C of injection
With water to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 3：
DANHONG ZHUSHEYE stability comparative test
Visible foreign matters detection using DANHONG ZHUSHEYE obtained by the present invention meets the regulation of drug standard, and solution-stabilized
Property very well, in the case of avoiding increasing the cosolvent of clinical practice risks using other, solve DANHONG ZHUSHEYE in storage
During easily occur small particles, white block, solution muddy the problems such as.Using the DANHONG ZHUSHEYE obtained by the present invention according to middle traditional Chinese medicines
The related request of allusion quotation two annex of version in 2005 Ⅺ Ⅹ C pharmaceutical preparation stability test guideline, has investigated respectively at 25 DEG C
Place to place for 24 months, 40 DEG C and place within 6 months, 60 DEG C 10 days, 0～5 DEG C of low temperature 20 days medicine stability of placement, result is above-mentioned
Under experimental condition, product quality is stable, and every Testing index all meets the regulation of this product quality standard.
The pharmacological results show：Using the stable DANHONG ZHUSHEYE obtained by the present invention no hemolytic, no anaphylaxis,
Nonirritant, meets the requirement of drug administration by injection.
According to the above results, the DANHONG drug injection preparation of the present invention can improve the clarity of DANHONG ZHUSHEYE,
Particularly in the case that DANHONG 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 DANHONG 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 (5)
1. a kind of medicinal composition for injections improving DANHONG drug injection preparation stability it is characterised in that main by DANHONG
Extracting solution be dissolved in water for injection, add the note that citric acid and/or sodium citrate are made as pH adjusting agent regulating liquid medicine pH value
Penetrate pharmaceutical composition, the consumption of described citric acid and/or sodium citrate is 5mg～30mg/100ml.
2. a kind of medicinal composition for injections improving DANHONG 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 DANHONG drug injection preparation stability according to claim 1 and 2,
It is characterized in that, the concentration of the extracting solution of described DANHONG is calculated as 10mg～10g/100ml with DANHONG.
4. a kind of medicinal composition for injections improving DANHONG drug injection preparation stability according to claim 1, its
It is characterised by, described medicinal liquid pH value is 6.0～8.0.
5. a kind of medicinal composition for injections improving DANHONG drug injection preparation stability according to claim 1, its
It is characterised by, described DANHONG drug injection preparation formulation is injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610968020.7A CN106420918A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation |
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|---|---|---|---|
| CN201610968020.7A CN106420918A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation |
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| CN106420918A true CN106420918A (en) | 2017-02-22 |
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| CN201610968020.7A Withdrawn CN106420918A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation |
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Citations (2)
| 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 |
-
2016
- 2016-11-06 CN CN201610968020.7A patent/CN106420918A/en not_active Withdrawn
Patent Citations (2)
| 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 |
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Application publication date: 20170222 |