CN106236840A - Improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati drug injection preparation stability - Google Patents
Improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati drug injection preparation stability Download PDFInfo
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- CN106236840A CN106236840A CN201610646403.2A CN201610646403A CN106236840A CN 106236840 A CN106236840 A CN 106236840A CN 201610646403 A CN201610646403 A CN 201610646403A CN 106236840 A CN106236840 A CN 106236840A
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- illicii lanceolati
- injection
- radix illicii
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- caffeic 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)
- A61K36/57—Magnoliaceae (Magnolia family)
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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 the preparation method of the pharmaceutical composition improving Radix Illicii Lanceolati drug injection preparation stability, comprise the steps: 1) weigh the extracting solution of Radix Illicii Lanceolati, caffeic acid and/or sodium caffeate；2) caffeic acid, sodium caffeate solution are joined respectively；3), during the extracting solution of Radix Illicii Lanceolati adds the water for injection 500ml of 30 DEG C～40 DEG C, stir to after being completely dissolved, the activated carbon of addition, stirring, filter decarburization；4) caffeic acid and/or the sodium caffeate solution regulation pH value of gained filtrate configuration is 4.0～6.0, addition water for injection to 1000ml；5) it is filtered until clear, fill, sterilizing, to obtain final product.The present invention can make this injection pH value more stable, Radix Illicii Lanceolati 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 Injection liquid of red fennel, 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 improve the medicine of Radix Illicii Lanceolati drug injection preparation stability
The preparation method of compositions.
Background technology
Injection liquid of red fennel, subside a swelling dissipating blood stasis, promoting blood circulation and stopping pain.Grieved and the rheumatism for lumbar muscle strain, joint or muscle ligament
Pain etc..
Due to Radix Illicii Lanceolati dissolubility extreme difference in aqueous, therefore it is made into Radix Illicii Lanceolati hydrochlorate or Radix Illicii Lanceolati phosphate
To increase its water solublity.Presently commercially available Injection liquid of red fennel mainly has the phosphatic low capacity of Radix Illicii Lanceolati hydrochlorate, Radix Illicii Lanceolati
Injection, and the Large Copacity that addition glucose or sodium chloride are made as osmotic pressure regulator in Radix Illicii Lanceolati extracting solution solution
Injection.But when preparing above-mentioned injection, it is necessary to be adjusted to the pH value of medicinal liquid be suitable for the certain limit that human injection is administered,
The pH value regulator that document report uses at present is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution, but on using
State Injection liquid of red fennel prepared by pH value regulator under the conditions of long-term storage and winter low temperature, easily separate out tiny white point, white
The precipitate such as block, solution are muddy, the visible foreign matters check item causing product is defective.Prior art is to add poly-mountain in the solution
As cosolvent, there are the sedimentary problems such as small particles, white block, solution are muddy solving product in pear ester 80.But Polysorbate
80 owing to having the effect of haemolysis and blood pressure lowering, and easily becomes sour in storage and autoclaving process, causes containing Polysorbate
The injection clinical practice risk of 80 is higher, makes troubles to clinical application and popularization.
Summary of the invention
The technical problem to be solved is to provide the drug regimen improving Radix Illicii Lanceolati drug injection preparation stability
The preparation method of thing.This medicinal composition for injections employing caffeic acid, sodium caffeate are as pH adjusting agent, and pass through creative labor
When dynamic discovery uses caffeic acid, sodium caffeate as pH adjusting agent, medicinal liquid pH value is more stable, and Radix Illicii Lanceolati 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
Injection liquid of red fennel 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 the medicine improving Radix Illicii Lanceolati drug injection preparation stability
The preparation method of compositions, comprises the steps:
(1) extracting solution 5g～100g of Radix Illicii Lanceolati, caffeic acid and/or sodium caffeate 1mg～10mg are weighed；
(2) caffeic acid, sodium caffeate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
(3), during the extracting solution of Radix Illicii Lanceolati 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 caffeic acid and/or sodium caffeate solution regulation pH value be 6.0～
8.0, 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.
In described step (1) caffeic acid consumption be 1mg～2.0mg, sodium caffeate consumption be 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 caffeic acid and/or sodium caffeate referred to addition can be in caffeic acid, sodium caffeate
Any one, or caffeic acid, sodium caffeate are with arbitrary proportion proportioning；In step (2), the caffeic acid of addition, sodium caffeate
In one, then make a kind of solution, as included caffeic acid, sodium caffeate two kinds, be configured to solution for standby the most respectively；Radix Illicii Lanceolati
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 Radix Illicii Lanceolati drug injection system
In agent, when using caffeic acid, sodium caffeate as pH adjusting agent, medicinal liquid pH value is more stable, and Radix Illicii Lanceolati 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
Injection liquid of red fennel 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 Injection liquid of red fennel 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 Injection liquid of red fennel, 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 caffeate is as pH adjusting agent,
And use caffeic 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:
Improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati drug injection preparation stability, comprise the steps: that (1) weighs former
Material medicine is with Radix Illicii Lanceolati extracting solution amount of calculation 25g, sodium chloride 7.0g, caffeic acid 2g, sodium caffeate 4mg；(2) caffeic acid, caffeic acid
Sodium is configured to the solution of 10%～20% respectively, standby；(3) adding in the water for injection 500ml of less than 40 DEG C, stirring is to the most molten
Xie Hou, add 0.02%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate caffeic acid or sodium caffeate are molten
Liquid regulation pH value is 3.0～7.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clarification, fill, goes out
Bacterium, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Radix Illicii Lanceolati extracting solution 25g
Sodium chloride 7.0g
Caffeic acid 2.0g
Sodium caffeate 4.0g
Caffeic acid, sodium caffeate are configured to the solution of 10%～20% respectively, standby.Radix Illicii Lanceolati 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 0.15%, stir
Mix 15 minutes, filter decarburization.Filtrate caffeic acid or sodium caffeate solution regulation pH value are 4.0～6.0, 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 Radix Illicii Lanceolati drug injection preparation stability
Pharmaceutical composition is prepared according to the following steps:
(1) weighting raw materials is with Radix Illicii Lanceolati amount of calculation 70g, caffeic acid 3g, sodium caffeate 6g；(2) caffeic acid, sodium caffeate are respectively
It is configured to the solution of 10%～20%, standby；(3) add in the water for injection 500ml of less than 40 DEG C, stirring to after being completely dissolved,
Add 0.15%(g/ml) activated carbon, stir 15 minutes, filtration decarburization；(4) filtrate caffeic acid or the regulation of sodium caffeate solution
PH value is 4.0～6.0, adds the water for injection of less than 40 DEG C to 1000ml；(5) medical filtration is to clarifying, fill, sterilizing, i.e.
?.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Radix Illicii Lanceolati extracting solution 70g
Caffeic acid 3g
Sodium caffeate 5g
Caffeic acid, sodium caffeate are configured to the solution of 10%～20% respectively, standby.Hydrochloric acid Radix Illicii Lanceolati 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 0.15g/100ml) of 0.15%, stir
Mix 15 minutes, filter decarburization.Filtrate caffeic acid or sodium caffeate solution regulation pH value are 4.0～6.0, add less than 40 DEG C
Water for injection is to 1000ml.Medical filtration, to clarification, fill, sterilizing, to obtain final product.
Embodiment 3:
Injection liquid of red fennel stability comparative test
The visible foreign matters detection utilizing Injection liquid of red fennel 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 Injection liquid of red fennel and exist
Storage process easily occurs the problems such as small particles, white block, solution are muddy.Utilize Injection liquid of red fennel 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 Injection liquid of red fennel 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 Radix Illicii Lanceolati drug injection preparation of the present invention can improve the clear and bright of Injection liquid of red fennel
Degree, particularly in the case of Radix Illicii Lanceolati 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 Radix Illicii Lanceolati 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 (4)
1. improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati drug injection preparation stability, it is characterised in that include following
Step:
(1) extracting solution 5g～100g of Radix Illicii Lanceolati, caffeic acid and/or sodium caffeate 1g～5g are weighed；
(2) caffeic acid, sodium caffeate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
(3), during the extracting solution of Radix Illicii Lanceolati 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 0.15g/100ml, stirs 15 minutes, filters decarburization；
(4) step (3) gained filtrate step (2) configures caffeic acid and/or sodium caffeate solution regulation pH value be 4.0～
6.0, add 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.
The preparation method of the pharmaceutical composition of raising Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1,
It is characterized in that, in described step (1) caffeic acid consumption be 1g～5g, sodium caffeate consumption be 1g～5g.
The preparation method of the pharmaceutical composition of raising Radix Illicii Lanceolati drug injection preparation stability the most according to claim 1,
It is characterized in that, described step also includes osmotic pressure regulator 7.0g in (1).
The preparation method of the pharmaceutical composition of raising Radix Illicii Lanceolati drug injection preparation stability the most according to claim 3,
It is characterized in that, described osmotic pressure regulator is sodium chloride.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610646403.2A CN106236840A (en) | 2016-08-09 | 2016-08-09 | Improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati drug injection preparation stability |
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| CN201610646403.2A CN106236840A (en) | 2016-08-09 | 2016-08-09 | Improve the preparation method of the pharmaceutical composition of Radix Illicii Lanceolati 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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- 2016-08-09 CN CN201610646403.2A patent/CN106236840A/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 |
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Application publication date: 20161221 |