CN106344636A - Preparation method of Chinese thorowax root injection preparation pharmaceutical composition - Google Patents
Preparation method of Chinese thorowax root injection preparation pharmaceutical composition Download PDFInfo
- Publication number
- CN106344636A CN106344636A CN201610968030.0A CN201610968030A CN106344636A CN 106344636 A CN106344636 A CN 106344636A CN 201610968030 A CN201610968030 A CN 201610968030A CN 106344636 A CN106344636 A CN 106344636A
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- CN
- China
- Prior art keywords
- injection
- radix bupleuri
- preparation
- malic acid
- chinese thorowax
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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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
-
- 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
- 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 preparation method of a Chinese thorowax root injection preparation pharmaceutical composition. The pharmaceutical composition for injection is mainly prepared by dissolving a salt of Chinese thorowax root in injection water, and adding malic acid and/or sodium malate as a pH regulator to regulate the pH value of a medicinal solution, wherein the dosage of the malic acid and/or sodium malate is 0.1-200.0mg/100ml. The preparation method disclosed by the invention can enable the pH value of the injection to be more stable, Chinese thorowax root degradation materials are greatly reduced compared with the prior art, and under the condition that other latent solvents which can increase clinical application risks are avoided in use, the clarity of the Chinese thorowax root injection is improved, and particularly, the problem that the Chinese thorowax root injection generates small white particles, white blocks and solution turbidness under the condition that the storage time is relatively long by adopting a product of the prior art is solved, so that the inspection of visible foreign matters in the product can be ensured to meet requirements of medicine quality standards, and clinical medication and promotion are facilitated.
Description
Technical field
A kind of the invention belongs to pharmaceutical technology field, in particular it relates to preparation side of Radix Bupleuri injection agent medicine compositionss
Method.
Background technology
Radix Bupleuri is the alkaloid 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 Radix Bupleuri has been Chinese medicine
Modern hardly possible disease makes very big contribution.
Due to Radix Bupleuri dissolubility extreme difference in aqueous, therefore it is made into Radix Bupleuri hydrochlorate or Radix Bupleuri phosphate to increase
Its water solublity.Presently commercially available injection of Radix Bupleuri mainly has the phosphatic injection with small volume of Radix Bupleuri hydrochlorate, Radix Bupleuri, Yi Ji
Glucose or sodium chloride is added to inject as the Large Copacity that osmotic pressure regulator is made in Radix Bupleuri hydrochlorate, Radix Bupleuri 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 injection of Radix Bupleuri 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 preparation method of Radix Bupleuri injection agent medicine compositionss.
This medicinal composition for injections adopts malic acid, natrium malicum is as ph regulator, and is sent out by creative work
When now adopting malic acid, natrium malicum as ph regulator, medicinal liquid ph value is more stable, and Radix Bupleuri degradation material is big compared with prior art
Big reduction, in the case of avoiding increasing the cosolvent of clinical practice risks using other, has been satisfactorily addressed Radix Bupleuri note
Penetrate liquid 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 a kind of preparation of employed technical scheme comprise that Radix Bupleuri injection agent medicine compositionss
Method, comprises the steps:
(1) salt weighing Radix Bupleuri is with Radix Bupleuri amount of calculation 0.1g～100g, malic acid and/or natrium malicum 2mg～4.0g；
(2) malic acid, natrium malicum are configured to the solution of 10g/100ml～20g/100ml respectively, standby；
(3) salt of Radix Bupleuri, 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) malic acid that step (3) gained filtrate step (2) configures and/or natrium malicum solution regulation ph value are 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.
In described step (1) malic acid consumption be 1mg～2.0g, natrium malicum consumption be 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 malic acid and/or natrium malicum refer to add can be malic acid, in natrium malicum
Any one, or malic acid, natrium malicum are with arbitrary proportion proportioning；In step (2), the malic acid of addition, natrium malicum
One of, then make a kind of solution, such as include malic acid, two kinds of natrium malicum, be then configured to solution for standby respectively；Radix Bupleuri
Salt, 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 Radix Bupleuri drug injection preparation
In, during using malic acid, natrium malicum as ph regulator, medicinal liquid ph value is more stable, and Radix Bupleuri degradation material is compared with prior art
Substantially reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, Radix Bupleuri 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 injection of Radix Bupleuri 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 injection of Radix Bupleuri, 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.Natrium malicum is therefore used as ph regulator, and
Malic 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 Radix Bupleuri injection agent medicine compositionss, comprises the steps: that (1) weighs crude drug with Radix Bupleuri
Amount of calculation 0.1g～100g, sodium chloride 9.0g, malic acid 1mg～2.0g, natrium malicum 1mg～2.0g；(2) malic acid, Fructus Mali pumilae
Sour sodium is configured to 10%～20% solution respectively, standby.(3) add in less than 40 DEG C of water for injection 500ml, stir to complete
After CL, add the activated carbon of 0.02% (g/ml), stir 15 minutes, filter decarburization.(4) filtrate malic acid or malic acid
It is 3.0～7.0 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:
Malic acid, natrium malicum are configured to 10%～20% solution respectively, standby.Hydrochloric acid Radix Bupleuri, sodium chloride add 40
In water for injection 500ml below DEG C, stir to after be completely dissolved, (i.e. activated carbon dosage is the activated carbon of addition 0.02%
0.02g/100ml), stir 15 minutes, filter decarburization.Filtrate malic acid or natrium malicum solution adjust ph value for 3.8～
4.2, add less than 40 DEG C of water for injection to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 2
Or, a kind of preparation method of Radix Bupleuri injection agent medicine compositionss:
(1) weigh crude drug with Radix Bupleuri amount of calculation 0.1g～100g, malic acid 1mg～2.0g, natrium malicum 1mg～
2.0g；(2) malic acid, natrium malicum are configured to 10%～20% solution respectively, standby.(3) add less than 40 DEG C of injection
With in water 500ml, stirring to after be completely dissolved, add the activated carbon of 0.02% (g/ml), stir 15 minutes, filter decarburization.(4)
It is 3.0～7.0 that filtrate malic acid or natrium malicum solution adjust ph value, adds less than 40 DEG C of water for injection to 1000ml；
(5) medical filtration, to clarification, fill, sterilizing, obtains final product.
Specifically the composition of each component and its content are as follows for the present embodiment:
Hydrochloric acid Radix Bupleuri 20g
Malic acid 1.0g
Natrium malicum 2.0g
Malic acid, natrium malicum are configured to 10%～20% solution respectively, standby.Hydrochloric acid Radix Bupleuri adds less than 40 DEG C
In water for injection 500ml, stir to after be completely dissolved, (i.e. activated carbon dosage is 0.02g/ to the activated carbon of addition 0.02%
100ml), stir 15 minutes, filter decarburization.Filtrate malic acid or natrium malicum solution regulation ph value are 3.8～4.2, add
Less than 40 DEG C of water for injection is to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 3
Radix Bupleuri sodium chloride injection stability comparative test
Visible foreign matters detection using Radix Bupleuri 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 Radix Bupleuri chlorine
Change sodium injection and the problems such as small particles, white block, solution muddiness easily occurs in storage process.Using the Radix Bupleuri 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 Radix Bupleuri 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 Radix Bupleuri 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 Radix Bupleuri drug injection preparation of the present invention can improve the clarity of injection of Radix Bupleuri,
Particularly in the case that Radix Bupleuri 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 Radix Bupleuri 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 (4)
1. a kind of preparation method of Radix Bupleuri injection agent medicine compositionss is it is characterised in that comprise the steps:
(1) salt weighing Radix Bupleuri is with Radix Bupleuri amount of calculation 0.1g～100g, malic acid and/or natrium malicum 2mg～4.0g；
(2) malic acid, natrium malicum are configured to the solution of 10g/100ml～20g/100ml respectively, standby；
(3) salt of Radix Bupleuri, sodium chloride add in 30 DEG C～40 DEG C of water for injection 500ml, stir to after be 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 malic acid and/or natrium malicum solution adjust ph value for 3.0～
7.0, add 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 of Radix Bupleuri injection agent medicine compositionss according to claim 1 is it is characterised in that institute
State in step (1) malic acid consumption be 1mg～2.0g, natrium malicum consumption be 1mg～2.0g.
3. a kind of Radix Bupleuri injection agent medicine compositionss according to claim 1 and 2 preparation method it is characterised in that
Osmotic pressure regulator 9.0g is also included in described step (1).
4. a kind of preparation method of Radix Bupleuri injection agent medicine compositionss according to claim 3 is it is characterised in that described
Osmotic pressure regulator is sodium chloride.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610968030.0A CN106344636A (en) | 2016-11-06 | 2016-11-06 | Preparation method of Chinese thorowax root injection preparation pharmaceutical composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610968030.0A CN106344636A (en) | 2016-11-06 | 2016-11-06 | Preparation method of Chinese thorowax root injection preparation pharmaceutical composition |
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| Publication Number | Publication Date |
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| CN106344636A true CN106344636A (en) | 2017-01-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610968030.0A Withdrawn CN106344636A (en) | 2016-11-06 | 2016-11-06 | Preparation method of Chinese thorowax root injection preparation pharmaceutical composition |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108982387A (en) * | 2018-08-15 | 2018-12-11 | 迪瑞医疗科技股份有限公司 | Full automatic biochemical apparatus specific wavelength reference substance and its application |
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| 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 |
| CN104116768A (en) * | 2013-04-26 | 2014-10-29 | 成都力思特制药股份有限公司 | Polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) containing radix bupleuri injection drug preparation and preparation method thereof |
| CN105125485A (en) * | 2015-09-23 | 2015-12-09 | 成都艾比科生物科技有限公司 | Preparation method of injecting drug improving stability of puerarin drug injection preparation |
| 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 CN201610968030.0A patent/CN106344636A/en not_active Withdrawn
Patent Citations (4)
| 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 |
| CN104116768A (en) * | 2013-04-26 | 2014-10-29 | 成都力思特制药股份有限公司 | Polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) containing radix bupleuri injection drug preparation and preparation method thereof |
| CN105125485A (en) * | 2015-09-23 | 2015-12-09 | 成都艾比科生物科技有限公司 | Preparation method of injecting drug improving stability of puerarin drug injection preparation |
| 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 (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108982387A (en) * | 2018-08-15 | 2018-12-11 | 迪瑞医疗科技股份有限公司 | Full automatic biochemical apparatus specific wavelength reference substance and its application |
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| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20170125 |
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