CN106361969A - Preparation method of drug composition for improving stability of Shengmai drug injection preparation - Google Patents
Preparation method of drug composition for improving stability of Shengmai drug injection preparation Download PDFInfo
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- CN106361969A CN106361969A CN201610968029.8A CN201610968029A CN106361969A CN 106361969 A CN106361969 A CN 106361969A CN 201610968029 A CN201610968029 A CN 201610968029A CN 106361969 A CN106361969 A CN 106361969A
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- rhizoma zingiberis
- zingiberis recens
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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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 preparation method of a drug composition for improving the stability of a Shengmai drug injection preparation. The drug composition for injection is mainly prepared by dissolving Shengmai salt in water for injection and adding oxalic acid and/or sodium oxalate to serve as a pH regulator for regulating a pH value of medicinal liquid. The usage amount of the oxalic acid and/or sodium oxalate is 1-100.0 mg/100ml. The pH value of the injection can be stable, substance degradability of the Shengmai is greatly reduced compared with the prior art, the clarity of the Shengmai injection is improved under the situation that other cosolvents increasing clinical application risks are not used, especially the problem that the Shengmai injection adopting a product in the prior art produces small white points, white blocks and is turbid under the condition of long storage time is solved, and it can be ensured that visible foreign matter inspection of the product meets the stipulations of the drug quality standard and the drug composition is convenient to clinically apply and popularize.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of improve Rhizoma Zingiberis Recens drug injection preparation stability medicine
The preparation method of compositionss.
Background technology
Rhizoma Zingiberis Recens are the alkaloids 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 Rhizoma Zingiberis Recens has been Chinese medicine
Modern hardly possible disease makes very big contribution.
Due to Rhizoma Zingiberis Recens dissolubility extreme difference in aqueous, therefore it is made into Rhizoma Zingiberis Recens hydrochlorate or Rhizoma Zingiberis Recens phosphate to increase
Its water solublity.Presently commercially available SHENMAI ZHUSHEYE mainly has the phosphatic injection with small volume of Rhizoma Zingiberis Recens hydrochlorate, Rhizoma Zingiberis Recens, Yi Ji
Glucose or sodium chloride is added to inject as the Large Copacity that osmotic pressure regulator is made in Rhizoma Zingiberis Recens hydrochlorate, Rhizoma Zingiberis Recens 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 SHENMAI 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 Rhizoma Zingiberis Recens drug injection preparation stability
Pharmaceutical composition.This medicinal composition for injections adopts oxalic acid, Disodium oxalate. is as ph regulator, and is found by creative work
During using oxalic acid, Disodium oxalate. as ph regulator, medicinal liquid ph value is more stable, and Rhizoma Zingiberis Recens degradation material drops significantly compared with prior art
Low, in the case of avoiding increasing the cosolvent of clinical practice risk using other, SHENMAI ZHUSHEYE is satisfactorily addressed
The 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 the technical scheme is that a kind of improves Rhizoma Zingiberis Recens drug injection preparation stabilities
Medicinal composition for injections, is mainly dissolved in water for injection by the salt of Rhizoma Zingiberis Recens, adds osmotic pressure regulator, and add oxalic acid and/or
The medicinal composition for injections that Disodium oxalate. is made as ph regulator regulating liquid medicine ph value, the use of described oxalic acid and/or Disodium oxalate.
Measure as 1mg～100.0mg/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 described Rhizoma Zingiberis Recens includes Rhizoma Zingiberis Recens hydrochlorate, Rhizoma Zingiberis Recens phosphate.
The concentration of the salt of described Rhizoma Zingiberis Recens is calculated as 0.1g～10g/100ml with Rhizoma Zingiberis Recens.
Described medicinal liquid ph value is 4.0～7.0.
Described Rhizoma Zingiberis Recens drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising Rhizoma Zingiberis Recens drug injection preparation stability, including following steps
Rapid:
(1) salt weighing Rhizoma Zingiberis Recens is with Rhizoma Zingiberis Recens amount of calculation 0.1g～100g, oxalic acid and/or Disodium oxalate. 2mg～4.0g；
(2) oxalic acid, Disodium oxalate. are configured to the solution of 10g/100ml～20g/100ml respectively, standby；
(3) salt of Rhizoma Zingiberis Recens, 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 oxalic acid and/or sodium oxalate 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.
Described step (1) mesoxalic acid consumption is 1mg～2.0g, Disodium oxalate. consumption is 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 oxalic acid and/or Disodium oxalate. refer to add can be oxalic acid, any one in Disodium oxalate.,
Or oxalic acid, Disodium oxalate. are with arbitrary proportion proportioning；In step (2), one of the oxalic acid of addition, Disodium oxalate., then make
A kind of solution, such as includes oxalic acid, two kinds of Disodium oxalate., is then configured to solution for standby respectively；The salt of Rhizoma Zingiberis Recens, 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 Rhizoma Zingiberis Recens drug injection preparation
In, during using oxalic acid, Disodium oxalate. as ph regulator, medicinal liquid ph value is more stable, and Rhizoma Zingiberis Recens degradation material is compared with prior art significantly
Reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, injection containing ginseng extract has been satisfactorily addressed
Liquid adopts prior art products easily to separate out the problem of tiny white point, white block, solution muddiness in storage process it is ensured that joining
Wheat injection 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 SHENMAI 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 regulator.Disodium oxalate. is therefore used as ph regulator, and makes
With oxalic 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 improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition, comprises the steps: that (1) claims
Take crude drug with Rhizoma Zingiberis Recens amount of calculation 0.1g～100g, sodium chloride 9.0g, oxalic acid 1mg～2.0g, Disodium oxalate. 1mg～2.0g；(2) grass
Acid, Disodium oxalate. are configured to 10%～20% solution respectively, standby.(3) add in less than 40 DEG C of water for injection 500ml, stir
Mix to after be completely dissolved, add the activated carbon of 0.02% (g/ml), stir 15 minutes, filter decarburization.(4) filtrate oxalic acid or grass
It is 3.0～7.0 that acid sodium solution adjusts ph value, adds less than 40 DEG C of water for injection to 1000ml；(5) medical filtration is extremely clarified,
Fill, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment:
Oxalic acid, Disodium oxalate. are configured to 10%～20% solution respectively, standby.Hydrochloric acid Rhizoma Zingiberis Recens, 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 oxalic acid or sodium oxalate 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 Rhizoma Zingiberis Recens drug injection preparation stability is prepared according to the following steps:
(1) weigh crude drug with Rhizoma Zingiberis Recens amount of calculation 0.1g～100g, oxalic acid 1mg～2.0g, Disodium oxalate. 1mg～2.0g；(2)
Oxalic acid, Disodium oxalate. 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 oxalic acid or
It is 3.0～7.0 that sodium oxalate 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 Rhizoma Zingiberis Recens 20g
Oxalic acid 1.0g
Disodium oxalate. 2.0g
Oxalic acid, Disodium oxalate. are configured to 10%～20% solution respectively, standby.Hydrochloric acid Rhizoma Zingiberis Recens add 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 oxalic acid or sodium oxalate 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
Rhizoma Zingiberis Recens sodium chloride injection stability comparative test
Visible foreign matters detection using Rhizoma Zingiberis Recens 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 Rhizoma Zingiberis Recens chlorine
Change sodium injection and the problems such as small particles, white block, solution muddiness easily occurs in storage process.Using the Rhizoma Zingiberis Recens 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 Rhizoma Zingiberis Recens 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 Rhizoma Zingiberis Recens 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 Rhizoma Zingiberis Recens drug injection preparation of the present invention can improve the clarity of SHENMAI ZHUSHEYE,
Particularly in the case that injection containing ginseng extract 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 Rhizoma Zingiberis Recens 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 preparation method improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition is it is characterised in that include following
Step:
(1) salt weighing Rhizoma Zingiberis Recens is with Rhizoma Zingiberis Recens amount of calculation 0.1g～100g, oxalic acid and/or Disodium oxalate. 2mg～4.0g；
(2) oxalic acid, Disodium oxalate. are configured to the solution of 10g/100ml～20g/100ml respectively, standby；
(3) salt of Rhizoma Zingiberis Recens, sodium chloride add in 30 DEG C～40 DEG C of water for injection 500ml, stir to after be completely dissolved, and add
Activated carbon, described activated carbon dosage be 0.02g/100ml, stir 15 minutes, filter decarburization；
(4) oxalic acid that step (3) gained filtrate step (2) configures and/or sodium oxalate solution regulation ph value are 3.0～7.0, plus
Enter less than 40 DEG C of water for injection to 1000ml；
(5) by step (4) gained medical filtration to clarification, fill, sterilizing, obtain final product.
2. a kind of preparation method improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition according to claim 7,
It is characterized in that, described step (1) mesoxalic acid consumption is 1mg～2.0g, Disodium oxalate. consumption is 1mg～2.0g.
3. a kind of preparation method improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition according to claim 7,
It is characterized in that, also include osmotic pressure regulator 9.0g in described step (1).
4. a kind of preparation method improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition according to claim 9,
It is characterized in that, described osmotic pressure regulator is sodium chloride.
5. a kind of preparation method improving Rhizoma Zingiberis Recens drug injection preparation stability pharmaceutical composition according to claim 1,
It is characterized in that, described Rhizoma Zingiberis Recens drug injection preparation formulation is injection.
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| CN201610968029.8A CN106361969A (en) | 2016-11-06 | 2016-11-06 | Preparation method of drug composition for improving stability of Shengmai drug injection preparation |
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| CN201610968029.8A CN106361969A (en) | 2016-11-06 | 2016-11-06 | Preparation method of drug composition for improving stability of Shengmai drug injection preparation |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107737102A (en) * | 2017-12-01 | 2018-02-27 | 成都盛世光华生物科技有限公司 | A kind of preparation method of pantocrine injection agent medicine composition |
| CN107823130A (en) * | 2017-12-01 | 2018-03-23 | 成都盛世光华生物科技有限公司 | A kind of preparation method of tetrandrine injection agent medicine composition |
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| CN101518617A (en) * | 2009-04-02 | 2009-09-02 | 四川升和制药有限公司 | Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same |
| 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 |
| CN105963247A (en) * | 2016-05-12 | 2016-09-28 | 成都易创思生物科技有限公司 | Preparation method of injection medicine for improving stability of quercetin medicine injection preparation |
-
2016
- 2016-11-06 CN CN201610968029.8A patent/CN106361969A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518617A (en) * | 2009-04-02 | 2009-09-02 | 四川升和制药有限公司 | Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same |
| 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 |
| CN105963247A (en) * | 2016-05-12 | 2016-09-28 | 成都易创思生物科技有限公司 | Preparation method of injection medicine for improving stability of quercetin medicine injection preparation |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107737102A (en) * | 2017-12-01 | 2018-02-27 | 成都盛世光华生物科技有限公司 | A kind of preparation method of pantocrine injection agent medicine composition |
| CN107823130A (en) * | 2017-12-01 | 2018-03-23 | 成都盛世光华生物科技有限公司 | A kind of preparation method of tetrandrine injection agent medicine composition |
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