CN106109405A - A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability - Google Patents
A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability Download PDFInfo
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- CN106109405A CN106109405A CN201610646397.0A CN201610646397A CN106109405A CN 106109405 A CN106109405 A CN 106109405A CN 201610646397 A CN201610646397 A CN 201610646397A CN 106109405 A CN106109405 A CN 106109405A
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- CN
- China
- Prior art keywords
- rhizoma dioscoreae
- dioscoreae nipponicae
- injection
- formic acid
- medicinal composition
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- 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
- 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)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- 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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability, mainly it is dissolved in water for injection by the extracting solution of Rhizoma Dioscoreae Nipponicae, adding the medicinal composition for injections that formic acid and/or sodium formate are made as pH adjusting agent regulation medicinal liquid pH value, the consumption of described formic acid and/or sodium formate is 1g～3g/100ml.The present invention can make this injection pH value more stable, Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae injection, particularly solving Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability of improving
Medicinal composition for injections.
Background technology
Rhizoma Dioscoreae Nipponicae, another name Dioscorea nipponica Mak. Ningpo Yam Rhizome, dioscorea japonica, Rhizoma Dioscoreae Nipponicae, ground joist, chicken bone, dragon Bi.Perennial winding herbaceous stem rattan
This, rhizome horizontal walk, cork comes off in the form of sheets, section yellow.It is its rhizome as medicine, has relaxing muscles and tendons and activating QI and blood in the collateral, effect of wind-expelling pain-stopping.
Due to Rhizoma Dioscoreae Nipponicae dissolubility extreme difference in aqueous, therefore it is made into Rhizoma Dioscoreae Nipponicae hydrochlorate or Rhizoma Dioscoreae Nipponicae phosphate
To increase its water solublity.Presently commercially available Rhizoma Dioscoreae Nipponicae injection mainly has the phosphatic low capacity of Rhizoma Dioscoreae Nipponicae hydrochlorate, Rhizoma Dioscoreae Nipponicae
Injection, and in Rhizoma Dioscoreae Nipponicae hydrochlorate, Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability
Pharmaceutical composition.This medicinal composition for injections employing formic acid, sodium formate are as pH adjusting agent, and are sent out by creative work
When now using formic acid, sodium formate as pH adjusting agent, medicinal liquid pH value is more stable, and Rhizoma Dioscoreae Nipponicae degradation material relatively prior art is significantly
Reduce, in the case of avoiding using other to increase the cosolvent of clinical practice risk, Rhizoma Dioscoreae Nipponicae note has been satisfactorily addressed
Penetrate liquid under the conditions of storage for a long time and winter low temperature, easily separate out tiny white point, white block, the problem of solution muddiness.
The present invention solves the problems referred to above and be the technical scheme is that a kind of raising Rhizoma Dioscoreae Nipponicae drug injection preparation stability
Medicinal composition for injections, be mainly dissolved in water for injection by the extracting solution of Rhizoma Dioscoreae Nipponicae, add osmotic pressure regulator, and add first
The medicinal composition for injections that acid and/or sodium formate are made as pH adjusting agent regulation medicinal liquid pH value, described formic acid and/or formic acid
The consumption of sodium is 1mg～3.0mg/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 0.5g/100ml；Glucose, xylitol, mannitol, fructose
Consumption is 0.5g/100ml～1g/100ml.
The concentration of the extracting solution of described Rhizoma Dioscoreae Nipponicae is calculated as 0.5g～5.5g/100ml with Rhizoma Dioscoreae Nipponicae.
Described medicinal liquid pH value is 5.0～7.0.
Described Rhizoma Dioscoreae Nipponicae drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising Rhizoma Dioscoreae Nipponicae drug injection preparation stability, including following
Step:
(1) extracting solution 5g～55g of Rhizoma Dioscoreae Nipponicae, formic acid and/or sodium formate 1g～3g are weighed；
(2) formic acid, sodium formate are configured to the solution of 1g/100ml～3g/100ml respectively, standby；
(3), during the extracting solution of Rhizoma Dioscoreae Nipponicae 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 0.02g/100ml, stirs 15 minutes, filters decarburization；
(4) step (3) gained filtrate step (2) configures formic acid and/or sodium formate solution regulation pH value are 5.0～7.0, add
Enter 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) formic acid consumption be 5mg～3g, sodium formate consumption be 5mg～3g.
Described step also includes osmotic pressure regulator 12.0g in (1).
Described osmotic pressure regulator is sodium chloride.
In such scheme, what addition formic acid and/or sodium formate referred to addition can be any one in formic acid, sodium formate,
Or formic acid, sodium formate are with arbitrary proportion proportioning；In step (2), the one in the formic acid of addition, sodium formate, then make
A kind of solution, as included formic acid, sodium formate two kinds, is configured to solution for standby the most respectively；The extracting solution of Rhizoma Dioscoreae Nipponicae, osmotic pressure regulate
The consumption of agent can use the consumption of prior art, adjusts 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 Rhizoma Dioscoreae Nipponicae drug injection system
In agent, when using formic acid, sodium formate as pH adjusting agent, medicinal liquid pH value is more stable, Rhizoma Dioscoreae Nipponicae degradation material relatively prior art
It is substantially reduced, in the case of avoiding using other to increase the cosolvent of clinical practice risk, has been satisfactorily addressed and has worn mountain
Dragon injection uses prior art products easily to separate out tiny white point, white block, the problem of solution muddiness in storage process, permissible
Ensure that the visible foreign matters detection keeping injection that Rhizoma Dioscoreae Nipponicae injection can be stable in storage process meets drug quality mark
Accurate regulation, 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 Rhizoma Dioscoreae Nipponicae 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 formate is as pH adjusting agent, and
Use formic acid is as pH value counter regulation agent, in the case of avoiding using other to increase the cosolvent of clinical practice risks, to solve
Certainly this product 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.
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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability, including following step
Rapid: (1) weighting raw materials is with Rhizoma Dioscoreae Nipponicae extracting solution amount of calculation 5g, sodium chloride 5.0g, formic acid 1.2g, sodium formate 2.0g；(2) first
Acid, sodium formate are configured to the solution of 10%～20% respectively, standby；(3) add in the water for injection 500ml of less than 40 DEG C, stirring
After being completely dissolved, add 0.02%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate formic acid or formic acid
Sodium solution regulation pH value is 5.0～7.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clarification, fills
Dress, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Rhizoma Dioscoreae Nipponicae extracting solution 5g
Sodium chloride 5g
Formic acid 1. 2g
Sodium formate 2. g
Formic acid, sodium formate are configured to the solution of 10%～20% respectively, standby.Rhizoma Dioscoreae Nipponicae extracting solution adds the injection of less than 40 DEG C
In water 500ml, stir to after being completely dissolved, add the activated carbon (i.e. activated carbon dosage is 0.02g/100ml) of 0.02%, stirring
15 minutes, filter decarburization.Filtrate formic acid or sodium formate solution regulation pH value are 5.0～7.0, add the injection of less than 40 DEG C
Water 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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability
Pharmaceutical composition is prepared according to the following steps:
(1) weighting raw materials is with Rhizoma Dioscoreae Nipponicae amount of calculation 55g, formic acid 3g, sodium formate 3g；(2) formic acid, sodium formate are configured to respectively
The solution of 10%～20%, standby.(3) add in the water for injection 500ml of less than 40 DEG C, stir to after being completely dissolved, addition
Activated carbon 0.2%(g/ml), stirs 15 minutes, filters decarburization；(4) filtrate formic acid or sodium formate solution regulation pH value are 5.0
～7.0, add the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clarification, fill, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Rhizoma Dioscoreae Nipponicae extracting solution 35g
Formic acid 3g
Sodium formate 3g
Formic acid, sodium formate are configured to the solution of 10%～20% respectively, standby.Hydrochloric acid Rhizoma Dioscoreae Nipponicae adds the water for injection of less than 40 DEG C
In 500ml, stir to after being completely dissolved, add the activated carbon (i.e. activated carbon dosage is 0.02g/100ml) of 0.02%, stir 15
Minute, filter decarburization.Filtrate formic acid or sodium formate solution regulation pH value are 5.0～7.0, add the water for injection of less than 40 DEG C
To 1000ml.Medical filtration, to clarification, fill, sterilizing, to obtain final product.
Embodiment 3:
Rhizoma Dioscoreae Nipponicae injection stability comparative test
The visible foreign matters detection utilizing Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae injection and exist
Storage process easily occurs the problems such as small particles, white block, solution are muddy.Utilize Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae drug injection preparation of the present invention can improve the clear and bright of Rhizoma Dioscoreae Nipponicae injection
Degree, particularly in the case of Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae drug injection preparation stability, it is characterised in that main by wearing
The extracting solution of Eumeces Chinensis is dissolved in water for injection, adds the note that formic acid and/or sodium formate are made as pH adjusting agent regulation medicinal liquid pH value
Penetrating pharmaceutical composition, the consumption of described formic acid and/or sodium formate is 1g～3g/100ml.
A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae 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 Rhizoma Dioscoreae Nipponicae is calculated as 0.5g～5.5g/100ml with Rhizoma Dioscoreae Nipponicae.
A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability the most according to claim 1,
It is characterized in that, described medicinal liquid pH value is 5.0～7.0.
A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability the most according to claim 1,
It is characterized in that, described Rhizoma Dioscoreae Nipponicae drug injection preparation formulation is injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610646397.0A CN106109405A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610646397.0A CN106109405A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability |
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| CN106109405A true CN106109405A (en) | 2016-11-16 |
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| CN201610646397.0A Withdrawn CN106109405A (en) | 2016-08-09 | 2016-08-09 | A kind of medicinal composition for injections improving Rhizoma Dioscoreae Nipponicae drug injection preparation stability |
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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 |
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2016
- 2016-08-09 CN CN201610646397.0A patent/CN106109405A/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 |
Non-Patent Citations (1)
| Title |
|---|
| 中国人民解放军六〇六二部队五七药厂: "穿山龙注射液生产工艺", 《中草药通讯》 * |
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Application publication date: 20161116 |