CN107753876A - A kind of medicinal composition for injections of oil of zedoary turmeric - Google Patents
A kind of medicinal composition for injections of oil of zedoary turmeric Download PDFInfo
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- CN107753876A CN107753876A CN201711252532.4A CN201711252532A CN107753876A CN 107753876 A CN107753876 A CN 107753876A CN 201711252532 A CN201711252532 A CN 201711252532A CN 107753876 A CN107753876 A CN 107753876A
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- Prior art keywords
- oil
- zedoary turmeric
- injections
- medicinal composition
- zedoary
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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)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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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
-
- 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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- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Alternative & Traditional Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicines Containing Plant Substances (AREA)
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Abstract
The invention discloses a kind of medicinal composition for injections of oil of zedoary turmeric, the medicinal composition for injections is mainly dissolved in water for injection by the salt of oil of zedoary turmeric, formic acid and/or sodium formate are added as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the dosage of the formic acid and/or sodium formate is 0.1mg~200.0mg/100ml.The present invention can make the parenteral solution pH value more stable, oil of zedoary turmeric degradation material substantially reduces compared with prior art, in the case where avoiding the cosolvent using other increase clinical practice risks, improve the clarity of Oleum Curcumae injection, particularly solve the problems, such as that Oleum Curcumae injection occurs small particles, white block, solution muddiness in the case where period of storage is longer using prior art products, it can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, be easy to clinical application and popularization.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of medicinal composition for injections of oil of zedoary turmeric.
Background technology
Oil of zedoary turmeric is used to catching a cold, cholera vomitings and diarrhoea, phlegm is senseless in hot summer weather acute filthy disease, apoplexy, falls and flutters mistake gas, head shouting pain, wind
Pyretic toothache, bronchial astehma and various coughs, belly pain due to cold heat, back pain of limbs, pruritus, scabies, nameless sores or boils, bruise damage
Wound, scalds and burns, snakeworm scorpion pike centipede wound, haematemesis, insomnia, traumatism and bleeding.
Due to oil of zedoary turmeric dissolubility extreme difference, therefore be made into oil of zedoary turmeric hydrochloride or oil of zedoary turmeric phosphate in aqueous
It is water-soluble to increase it.Presently commercially available Oleum Curcumae injection mainly has the phosphatic low capacity of oil of zedoary turmeric hydrochloride, oil of zedoary turmeric
Parenteral solution, and glucose or sodium pyrosulfite are added as antioxidant in oil of zedoary turmeric hydrochloride, oil of zedoary turmeric phosphate solution
Manufactured high-capacity injection.But when preparing above-mentioned parenteral solution, it is necessary to adjust the pH value of decoction to suitable human injection and give
The certain limit of medicine, the pH value regulator that document report uses at present are sodium hydroxide solution or use hydrochloric acid solution, phosphoric acid
Solution, but easily separated out under the conditions of long-term storage and winter low temperature using Oleum Curcumae injection prepared by above-mentioned pH value regulator
The sediments such as tiny white point, white block, solution muddiness, cause the visible foreign matters check item of product unqualified.Now it yet there are no preferably
Solution.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of injecting drug use for improving Zedoary oil injecting preparation stability
Compositions.
The medicinal composition for injections finds to adopt using formic acid, sodium formate as pH adjusting agent, and by creative work
During by the use of formic acid, sodium formate as pH adjusting agent, decoction pH value is more stable, and oil of zedoary turmeric degradation material drops significantly compared with prior art
It is low, in the case where avoiding the cosolvent using other increase clinical practice risks, Zedoary oil injecting has been satisfactorily addressed
The problem of liquid easily separates out tiny white point, white block, solution muddiness under the conditions of long-term storage and winter low temperature.
Technical scheme is used by the present invention solves the above problems：One kind improves oil of zedoary turmeric drug injection preparation stability
Medicinal composition for injections, water for injection is mainly dissolved in by the salt of oil of zedoary turmeric, adds antioxidant, and add formic acid and/or first
Sour sodium is as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the dosage of the formic acid and/or sodium formate
For 0.1mg~200.0mg/100ml.
The antioxidant is sodium pyrosulfite.The dosage of antioxidant is prior art, and sodium pyrosulfite dosage is 0.9g/
100ml；Glucose, xylitol, mannitol, fructose dosage are 5g/100ml~10g/100ml.
The salt of the oil of zedoary turmeric includes oil of zedoary turmeric hydrochloride, oil of zedoary turmeric phosphate.
The concentration of the salt of the oil of zedoary turmeric is calculated as 10mg~10g/100ml with oil of zedoary turmeric.
The decoction pH value is 3.0~6.0.
The oil of zedoary turmeric drug injection preparation formulation is parenteral solution.
The preparation method of the medicinal composition for injections of above-mentioned raising oil of zedoary turmeric drug injection preparation stability, including it is following
Step：
(1) salt of oil of zedoary turmeric is weighed with oil of zedoary turmeric amount of calculation 0.1g~100g, formic acid and/or sodium formate 2mg~4.0g；
(2) formic acid, sodium formate are configured to 10g/100ml~20g/100ml solution respectively, standby；
(3) salt of oil of zedoary turmeric, sodium pyrosulfite are added in 30 DEG C~40 DEG C of water for injection 500ml, are stirred to completely molten
Xie Hou, the activated carbon of addition, the activated carbon dosage are 0.02g/100ml, are stirred 15 minutes, filter decarburization；
(4) formic acid of filtrate step (2) configuration obtained by step (3) and/or sodium formate solution regulation pH value be 3.0~
7.0 the water for injection of less than 40 DEG C (30 DEG C~40 DEG C) is added to 1000ml；
(5) it is filling by medical filtration obtained by step (4) to clarification, sterilizing, produce.
In the step (1) formic acid dosage be 1mg~2.0g, sodium formate dosage be 1mg~2.0g.
Also include antioxidant 9.0g in the step (1).
The antioxidant is sodium pyrosulfite.
In such scheme, add that formic acid and/or sodium formate refer to add can be any of formic acid, sodium formate,
Either formic acid, sodium formate are matched with arbitrary proportion；In step (2), one kind in the formic acid of addition, sodium formate, then it is made
A kind of solution, such as include formic acid, two kinds of sodium formate, be then configured to solution for standby respectively；The salt of oil of zedoary turmeric, the dosage of antioxidant can
Using the dosage of prior art, adjusted according to the dosage of prior art.
In summary, the beneficial effects of the invention are as follows：The present invention by experimental studies have found that, in oil of zedoary turmeric drug injection system
In agent, during using formic acid, sodium formate as pH adjusting agent, decoction pH value is more stable, and oil of zedoary turmeric degradation material is compared with prior art
Substantially reduce, in the case where avoiding the cosolvent using other increase clinical practice risks, curcuma zedoary has been satisfactorily addressed
The problem of fat injection easily separates out tiny white point, white block, solution muddiness using prior art products in storage process, can be with
Ensure that the visible foreign matters detection for the holding parenteral solution that Oleum Curcumae injection can be stablized in storage process meets drug quality mark
Accurate regulation, is easy to clinical application and popularization.
The present invention is by creative work, the muddy original of the tiny white point, white block, the solution that are separated out in curcuma zedoary oil parenteral solution
Because being analyzed and being studied, it is mainly raw material free alkali crystallization and a small amount of catabolite to determine deposit, above-mentioned reason occurs
May be relevant with sour, alkali species used in the pH value and pH adjusting agent of solution.Therefore sodium formate is used as pH adjusting agent, and
Using formic acid as pH value counter regulation agent, in the case where avoiding the cosolvent using other increase clinical practice risks, with solution
The problem of certainly this product easily separates out tiny white point, white block, solution muddiness under the conditions of long-term storage and winter low temperature.
Embodiment
With reference to embodiment, the present invention is described in further detail, but the implementation of the present invention is not limited to this.
Embodiment 1
A kind of preparation method for the medicinal composition for injections for improving oil of zedoary turmeric drug injection preparation stability, including it is following
Step：(1) bulk drug is weighed with oil of zedoary turmeric amount of calculation 0.1g~100g, sodium pyrosulfite 9.0g, formic acid 1mg~2.0g, formic acid
Sodium 1mg~2.0g；(2) formic acid, sodium formate are configured to 10%~20% solution respectively, standby.(3) less than 40 DEG C of note is added
Penetrate with water 500ml, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stir 15 minutes, filter decarburization.
(4) filtrate formic acid or sodium formate solution regulation pH value are 3.0~7.0, add less than 40 DEG C of water for injection to 1000ml；
(5) medical filtration is extremely clarified, filling, sterilizing, is produced.
The composition and its content of the specific each component of the present embodiment are as follows：
Formic acid, sodium formate are configured to 10%~20% solution respectively, standby.Hydrochloric acid oil of zedoary turmeric, sodium pyrosulfite add
In less than 40 DEG C of water for injection 500ml, stir to after being completely dissolved, adding 0.02% activated carbon, (i.e. activated carbon dosage is
0.02g/100ml), stir 15 minutes, filter decarburization.Filtrate formic acid or sodium formate solution regulation pH value are 3.8~4.2, are added
Enter less than 40 DEG C of water for injection to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, is produced.
Embodiment 2
Or the medicinal composition for injections of above-mentioned raising oil of zedoary turmeric drug injection preparation stability is made in the steps below
It is standby：
(1) bulk drug is weighed with oil of zedoary turmeric amount of calculation 0.1g~100g, formic acid 1mg~2.0g, sodium formate 1mg~2.0g；
(2) formic acid, sodium formate are configured to 10%~20% solution respectively, standby.(3) less than 40 DEG C of water for injection 500ml is added
In, stir to after being completely dissolved, add 0.02% (g/ml) activated carbon, stir 15 minutes, filter decarburization.(4) filtrate first
Acid or sodium formate solution regulation pH value are 3.0~7.0, add less than 40 DEG C of water for injection to 1000ml；(5) medical filtration is extremely
Clarification, it is filling, sterilizing, produce.
The composition and its content of the specific each component of the present embodiment are as follows：
Hydrochloric acid oil of zedoary turmeric 20g
Formic acid 1.0g
Sodium formate 2.0g
Formic acid, sodium formate are configured to 10%~20% solution respectively, standby.Hydrochloric acid oil of zedoary turmeric adds less than 40 DEG C of note
Penetrate with water 500ml, stir to after being completely dissolved, add 0.02% activated carbon (i.e. activated carbon dosage is 0.02g/100ml),
Stirring 15 minutes, filter decarburization.Filtrate formic acid or sodium formate solution regulation pH value are 3.8~4.2, add less than 40 DEG C of note
Penetrate with water to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, is produced.
Embodiment 3
Oil of zedoary turmeric pyrosulfurous acid sodium injection stability comparative test
Meet drug standard using the visible foreign matters detection of oil of zedoary turmeric pyrosulfurous acid sodium injection obtained by the present invention
Regulation, and stability of solution is fine, in the case where avoiding the cosolvent using other increase clinical practice risks, solves
Easily there is the problems such as small particles, white block, solution muddiness in storage process in oil of zedoary turmeric pyrosulfurous acid sodium injection.Utilize the present invention
Obtained oil of zedoary turmeric pyrosulfurous acid sodium injection is according to the C pharmaceutical preparation stability of two annex of China's coastal port Ⅺ Ⅹ
The related request of test direction principle, investigated respectively 25 DEG C place 24 months, 40 DEG C place 6 months, 60 DEG C place 10 days,
0~5 DEG C of low temperature places 20 days medicine stabilities, and as a result product quality is stable at the conditions of the experiments described above, and every Testing index is equal
Meet the regulation of this product quality standard.
The Pharmacological experiment result shows that：Using the oil of zedoary turmeric pyrosulfurous acid sodium injection of the stabilization obtained by the present invention without haemolysis
Property, without anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
1 25 DEG C of study on the stability results of table
The hydrochloric acid oil of zedoary turmeric pyrosulfurous acid 60 DEG C of study on the stability results of sodium injection of table 2
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
It can be seen from the above results, oil of zedoary turmeric drug injection preparation of the invention can improve the clear and bright of Oleum Curcumae injection
Degree, particularly in the case where Zedoary oil injecting period of storage is longer, the visible foreign matters detection for the holding parenteral solution that can stablize
Meet the regulation of drug standard, solve oil of zedoary turmeric medicine and gone out using existing technical products in the case where period of storage is longer
The problem of existing small particles, white block, solution muddiness, it is ensured that the visible foreign matters inspection of product meets the rule of drug standard
It is fixed, it is easy to clinical application and popularization.
As described above, it can preferably realize the present invention.
Claims (6)
1. a kind of medicinal composition for injections of oil of zedoary turmeric, it is characterised in that water for injection is mainly dissolved in by the salt of oil of zedoary turmeric, added
Enter formic acid and/or sodium formate as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the formic acid and/or
The dosage of sodium formate is 0.1mg~200.0mg/100ml.
2. the medicinal composition for injections of a kind of oil of zedoary turmeric according to claim 1, it is characterised in that also including antioxygen
Agent, the antioxidant are sodium pyrosulfite.
3. the medicinal composition for injections of a kind of oil of zedoary turmeric according to claim 1, it is characterised in that the oil of zedoary turmeric
Salt includes oil of zedoary turmeric hydrochloride, oil of zedoary turmeric phosphate.
A kind of 4. medicinal composition for injections of oil of zedoary turmeric according to claim 1 or 3, it is characterised in that the curcuma zedoary
The concentration of the salt of oil is calculated as 10mg~10g/100ml with oil of zedoary turmeric.
A kind of 5. medicinal composition for injections of oil of zedoary turmeric according to claim 1, it is characterised in that the decoction pH value
For 3.0~6.0.
A kind of 6. medicinal composition for injections of oil of zedoary turmeric according to claim 1, it is characterised in that the oil of zedoary turmeric medicine
Thing ejection preparation formulation is parenteral solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711252532.4A CN107753876A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of oil of zedoary turmeric |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711252532.4A CN107753876A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of oil of zedoary turmeric |
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| Publication Number | Publication Date |
|---|---|
| CN107753876A true CN107753876A (en) | 2018-03-06 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711252532.4A Withdrawn CN107753876A (en) | 2017-12-01 | 2017-12-01 | A kind of medicinal composition for injections of oil of zedoary turmeric |
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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 |
-
2017
- 2017-12-01 CN CN201711252532.4A patent/CN107753876A/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: 20180306 |