CN107970427A - A kind of medicinal composition for injections of gingerol - Google Patents

A kind of medicinal composition for injections of gingerol Download PDF

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Publication number
CN107970427A
CN107970427A CN201711250439.XA CN201711250439A CN107970427A CN 107970427 A CN107970427 A CN 107970427A CN 201711250439 A CN201711250439 A CN 201711250439A CN 107970427 A CN107970427 A CN 107970427A
Authority
CN
China
Prior art keywords
gingerol
injections
medicinal composition
solution
phenylacetic acid
Prior art date
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.)
Withdrawn
Application number
CN201711250439.XA
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Chinese (zh)
Inventor
杨利华
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chengdu Source Technology Co Ltd
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Chengdu Source Technology Co Ltd
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Filing date
Publication date
Application filed by Chengdu Source Technology Co Ltd filed Critical Chengdu Source Technology Co Ltd
Priority to CN201711250439.XA priority Critical patent/CN107970427A/en
Publication of CN107970427A publication Critical patent/CN107970427A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

Abstract

The invention discloses a kind of medicinal composition for injections of gingerol, the medicinal composition for injections is mainly dissolved in water for injection by the salt of gingerol, phenylacetic acid and/or sodium phenylacetate are added as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the dosage of the phenylacetic acid and/or sodium phenylacetate is 0.1mg~200.0mg/100ml.The present invention can be such that the parenteral solution pH value more stablizes, gingerol degradation material is substantially reduced compared with the prior art, in the case where avoiding the cosolvent using other increase clinical practice risks, improve the clarity of gingerol parenteral solution, it is muddy particularly to solve the problems, such as that gingerol parenteral solution using prior art products occurs small particles, white block, solution in the case where period of storage is longer, it can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, easy to clinical application and popularization.

Description

A kind of medicinal composition for injections of gingerol
Technical field
The invention belongs to pharmaceutical technology field, and in particular, to a kind of medicinal composition for injections of gingerol.
Background technology
Gingerol is extracted from ginger comprising gingerol, ginger brain etc. and mixture of the ginger in relation to spicy substance, its Have the function that to resist lipofuscin.It is used to help prevent or treats because of nausea and vomiting caused by carsickness, pregnancy etc..With stomach invigorating Anti-gastric-ulcer, cholagogic, liver protection, cardiac stimulant, suppress platelet aggregation, anti-corona, antitumor, CNS inhibition, strengthen immunity, antibacterial, Desinsection, the effect of anti-inflammatory, also have very strong oxidation resistance.
Due to gingerol, dissolubility is very poor in aqueous, is made into gingerol hydrochloride or gingerol phosphate It is water-soluble to increase it.Presently commercially available gingerol parenteral solution mainly has the phosphatic low capacity of gingerol hydrochloride, gingerol Parenteral solution, and glucose or sodium thiosulfate are added as antioxidant in gingerol hydrochloride, gingerol phosphate solution Manufactured high-capacity injection.But when preparing above-mentioned parenteral solution, it is necessary to adjust the pH value of liquid to suitable human injection and give A certain range of medicine, the pH adjusting agent 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 gingerol parenteral solution prepared by above-mentioned pH adjusting agent 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 gingerol ejection preparation stability Compositions.
The medicinal composition for injections is sent out using phenylacetic acid, sodium phenylacetate as pH adjusting agent, and by creative work During now using phenylacetic acid, sodium phenylacetate as pH adjusting agent, liquid pH value is more stablized, and gingerol degradation material is compared with the prior art Substantially reduce, in the case where avoiding the cosolvent using other increase clinical practice risks, it is peppery that ginger has been satisfactorily addressed The problem of plain parenteral solution easily separates out tiny white point, white block under the conditions of long-term storage and winter low temperature, solution is muddy.
Technical solution is used by the present invention solves the above problems:One kind improves gingerol drug injection preparation stability Medicinal composition for injections, water for injection is mainly dissolved in by the salt of gingerol, adds antioxidant, and add phenylacetic acid and/or Sodium phenylacetate is as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the phenylacetic acid and/or phenylacetic acid The dosage of sodium is 0.1mg~200.0mg/100ml.
The antioxidant is sodium thiosulfate.The dosage of antioxidant is the prior art, and sodium thiosulfate dosage is 0.9g/ 100ml;Glucose, xylitol, mannitol, fructose dosage are 5g/100ml~10g/100ml.
The salt of the gingerol includes gingerol hydrochloride, gingerol phosphate.
The concentration of the salt of the gingerol is calculated as 10mg~10g/100ml with gingerol.
The liquid pH value is 3.0~6.0.
The gingerol drug injection preparation formulation is parenteral solution.
The preparation method of the medicinal composition for injections of above-mentioned raising gingerol drug injection preparation stability, including it is following Step:
(1) weigh the salt of gingerol with gingerol calculation amount 0.1g~100g, phenylacetic acid and/or sodium phenylacetate 2mg~ 4.0g;
(2) phenylacetic acid, sodium phenylacetate are configured to the solution of 10g/100ml~20g/100ml respectively, spare;
(3) salt of gingerol, sodium thiosulfate 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) it is 3.0 that the phenylacetic acid of filtrate step (2) configuration and/or sodium phenylacetate solution obtained by step (3), which adjust pH value, ~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, sterilize, to obtain the final product.
In the step (1) phenylacetic acid dosage be 1mg~2.0g, sodium phenylacetate dosage be 1mg~2.0g.
Antioxidant 9.0g is further included in the step (1).
The antioxidant is sodium thiosulfate.
In such scheme, add that phenylacetic acid and/or sodium phenylacetate refer to add can be in phenylacetic acid, sodium phenylacetate It is any, or phenylacetic acid, sodium phenylacetate match with arbitrary proportion;In step (2), phenylacetic acid, the sodium phenylacetate of addition In one kind, then a kind of solution is made, such as include phenylacetic acid, two kinds of sodium phenylacetate, then be configured to solution for standby respectively;Gingerol Salt, antioxidant dosage can use the prior art dosage, according to prior art dosage adjust.
In conclusion the beneficial effects of the invention are as follows:The present invention by experimental studies have found that, in gingerol drug injection system In agent, during using phenylacetic acid, sodium phenylacetate as pH adjusting agent, liquid pH value is more stablized, and gingerol degradation material is more existing Technology substantially reduces, and in the case where avoiding the cosolvent using other increase clinical practice risks, is satisfactorily addressed Gingerol parenteral solution using the problem of prior art products easily separate out tiny white point, white block in storage process, solution is muddy, It can ensure that the visible foreign matters detection for the holding parenteral solution that gingerol parenteral solution can be stablized in storage process meets medicine matter The regulation of amount standard, easy to clinical application and popularization.
The present invention by creative work, to separated out in gingerol parenteral solution tiny white point, white block, solution muddiness original 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 related with sour, alkali species used in the pH value and pH adjusting agent of solution.Therefore sodium phenylacetate is used as pH adjusting agent, And phenylacetic acid is used as pH value counter regulation agent, in the case where avoiding the cosolvent using other increase clinical practice risks, It is muddy that tiny white point, white block, solution are easily separated out to solve the problems, such as this product 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 gingerol drug injection preparation stability, including it is following Step:(1) bulk pharmaceutical chemicals are weighed with gingerol calculation amount 0.1g~100g, sodium thiosulfate 9.0g, phenylacetic acid 1mg~2.0g, benzene Sodium acetate 1mg~2.0g;(2) phenylacetic acid, sodium phenylacetate are configured to 10%~20% solution respectively, spare.(3) 40 DEG C are added In following water for injection 500ml, stir to after being completely dissolved, add the activated carbon of 0.02% (g/ml), stir 15 minutes, mistake Filter decarburization.(4) it is 3.0~7.0 that filtrate phenylacetic acid or sodium phenylacetate solution, which adjust pH value, adds less than 40 DEG C of water for injection To 1000ml;(5) medical filtration is extremely clarified, filling, sterilizing, to obtain the final product.
The component and its content of the specific each component of the present embodiment are as follows:
Phenylacetic acid, sodium phenylacetate are configured to 10%~20% solution respectively, spare.Hydrochloric acid gingerol, sodium thiosulfate Add in less than 40 DEG C of water for injection 500ml, stir to after being completely dissolved, add 0.02% activated carbon (i.e. activated carbon use Measure as 0.02g/100ml), stir 15 minutes, filter decarburization.It is 3.8 that filtrate phenylacetic acid or sodium phenylacetate solution, which adjust pH value, ~4.2, less than 40 DEG C of water for injection is added to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, to obtain the final product.
Embodiment 2
Alternatively, the medicinal composition for injections of above-mentioned raising gingerol drug injection preparation stability is made in the steps below It is standby:
(1) weigh bulk pharmaceutical chemicals with gingerol calculation amount 0.1g~100g, phenylacetic acid 1mg~2.0g, sodium phenylacetate 1mg~ 2.0g;(2) phenylacetic acid, sodium phenylacetate are configured to 10%~20% solution respectively, spare.(3) less than 40 DEG C of injection is added With in water 500ml, stir to after being 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 phenylacetic acid or sodium phenylacetate solution, which adjust pH value, adds less than 40 DEG C of water for injection to 1000ml; (5) medical filtration is extremely clarified, filling, sterilizing, to obtain the final product.
The component and its content of the specific each component of the present embodiment are as follows:
Hydrochloric acid gingerol 20g
Phenylacetic acid 1.0g
Sodium phenylacetate 2.0g
Phenylacetic acid, sodium phenylacetate are configured to 10%~20% solution respectively, spare.Hydrochloric acid gingerol adds less than 40 DEG C Water for injection 500ml in, 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.It is 3.8~4.2 that filtrate phenylacetic acid or sodium phenylacetate solution, which adjust pH value, is added Less than 40 DEG C of water for injection is to 1000ml.Medical filtration is extremely clarified, filling, sterilizing, to obtain the final product.
Embodiment 3
Gingerol sodium thiosulfate injection stability comparative test
Meet drug standard using the visible foreign matters detection of gingerol sodium thiosulfate 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 is muddy in storage process in gingerol sodium thiosulfate injection.Utilize the present invention Obtained gingerol sodium thiosulfate injection is according to two annex of China's coastal port, Ⅺ Ⅹ C pharmaceutical preparation stability 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 stablized 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 gingerol sodium thiosulfate 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
2 60 DEG C of study on the stability results of hydrochloric acid gingerol sodium thiosulfate injection of table
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, gingerol drug injection preparation of the invention can improve the clear and bright of gingerol parenteral solution Degree, particularly in the case where gingerol injection 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 gingerol medicine and gone out using existing technical products in the case where period of storage is longer Existing small particles, white block, the problem of solution is muddy, it is ensured that the visible foreign matters inspection of product meets the rule of drug standard It is fixed, 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 gingerol, it is characterised in that water for injection is mainly dissolved in by the salt of gingerol, is added Enter phenylacetic acid and/or sodium phenylacetate as medicinal composition for injections made of pH adjusting agent regulating liquid medicine pH value, the benzene second The dosage of acid and/or sodium phenylacetate is 0.1mg~200.0mg/100ml.
2. the medicinal composition for injections of a kind of gingerol according to claim 1, it is characterised in that further include antioxygen Agent, the antioxidant are sodium thiosulfate.
3. the medicinal composition for injections of a kind of gingerol according to claim 1, it is characterised in that the gingerol Salt includes gingerol hydrochloride, gingerol phosphate.
4. the medicinal composition for injections of a kind of gingerol according to claim 1 or 3, it is characterised in that the ginger is peppery The concentration of the salt of element is calculated as 10mg~10g/100ml with gingerol.
A kind of 5. medicinal composition for injections of gingerol according to claim 1, it is characterised in that the liquid pH value For 3.0~6.0.
A kind of 6. medicinal composition for injections of gingerol according to claim 1, it is characterised in that the gingerol medicine Thing ejection preparation formulation is parenteral solution.
CN201711250439.XA 2017-12-01 2017-12-01 A kind of medicinal composition for injections of gingerol Withdrawn CN107970427A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711250439.XA CN107970427A (en) 2017-12-01 2017-12-01 A kind of medicinal composition for injections of gingerol

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Application Number Priority Date Filing Date Title
CN201711250439.XA CN107970427A (en) 2017-12-01 2017-12-01 A kind of medicinal composition for injections of gingerol

Publications (1)

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Country Status (1)

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Citations (1)

* Cited by examiner, † Cited by third party
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
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: 20180501

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