CN106361813A - Drug composition for improving safety of compound ginseng injection - Google Patents
Drug composition for improving safety of compound ginseng injection Download PDFInfo
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- CN106361813A CN106361813A CN201610968044.2A CN201610968044A CN106361813A CN 106361813 A CN106361813 A CN 106361813A CN 201610968044 A CN201610968044 A CN 201610968044A CN 106361813 A CN106361813 A CN 106361813A
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- 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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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Abstract
This invention discloses a drug composition for improving the safety of a compound ginseng injection. The drug composition for injection is mainly prepared from a ginseng extract, salvia miltiorrhiza extract, a euphorbia humifusa extract and polyoxyl 15 hydroxystearate. A cosolvent good in safety and obvious in solubilizing-aiding effect is adopted to replace a cosolvent polysorbate 80 having potential safety hazard and affecting the product quality existing in the compound ginseng injection, the safety of the polyoxyl 15 hydroxystearate is higher than that of the polysorbate 80, the usage amount of the polyoxyl 15 hydroxystearate is lower, the probability and risk of adverse reaction of drugs are reduced, and the safety of clinical medication is improved.
Description
Technical field
A kind of the invention belongs to pharmaceutical technology field, in particular it relates to medicine improving compound ginseng injection safety
Compositionss.
Background technology
Compound ginseng injection standard is recorded and is issued drug standard (Traditional Chinese medicine historical preparation) in Ministry of Public Health, crude drug be Radix Ginseng,
Radix Salviae Miltiorrhizae, Herba Euphorbiae Humifusae, belong to Chinese medicine injection.There is promoting blood circulation to restore menstrual flow, effect of stasis-dispelling and pain-killing.Be clinically used for treat dysmenorrhea, amenorrhea,
Injury from falling down, rheumatic arthralgia etc..
In China in wide clinical application for many years, clinical efficacy has obtained the good of doctor and patient to compound ginseng injection
Comment.But in recent years, the Reporting of harms of Chinese medicine injection clinical practice is on the rise, have impact on and there is Chinese Medicine characteristic
The development of Chinese medicine injection.Domestic experts and scholars have carried out numerous studies to the untoward reaction of Chinese medicine injection, document report its
The generation of untoward reaction is had very with the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) of the presence potential safety hazard of addition in Chinese medicine injection
Big relation.Due to Chinese medicine injection complicated component, solute easily occurs in storage and autoclaving process and separates out and affect clear
The problems such as lightness, solution ph are decreased obviously, therefore adds polyoxyethylene sorbitan monoleate (Tween 80) in such injection and makees hydrotropy
Agent, adds the solubilization-aid effect of other cosolvents then inconspicuous.But polyoxyethylene sorbitan monoleate (Tween 80) is immature due to process for refining,
Easily become sour in storage and autoclaving process, lead to impurity content high it is difficult to reach injection standard, polyoxyethylene sorbitan monoleate (is told
Temperature 80) inherently there are stronger hemolytic and anaphylaxis, apply increased in injection occur untoward reaction probability and
Risk.In addition, in sterilizing and storage process itself, Chinese medicine injection also has that solution ph is decreased obviously, and poly- Pyrusussuriensiss
Ester 80 (Tween 80) and easily becoming sour, more accelerates the decline of the ph value of medicinal liquid.The compound ginseng injection of domestic production at present
In also add polyoxyethylene sorbitan monoleate (Tween 80) and make cosolvent, be faced with same problem.
In view of the foregoing, find the poly- mountain that safety is more preferable, poor stability replaced by the more obvious cosolvent of solubilization-aid effect
Pear ester 80 (Tween 80) is this injection urgent problem.
Content of the invention
The technical problem to be solved is to provide that a kind of safety is more preferable, solubilization-aid effect more obviously improves compound recipe
The pharmaceutical composition of Ginseng Injection safety.
The present invention solves above-mentioned technical problem and be the technical scheme is that a kind of raising compound ginseng injection safety
Pharmaceutical composition, mainly by Radix Ginseng extract, Radix Salviae Miltiorrhizae extract, Herba Euphorbiae Humifusae extract and Polyethylene Glycol ten penta hydroxy group stearic acid
The injection pharmaceutical composition that ester is made.
Specifically, the consumption of Polyethylene Glycol ten penta hydroxy group stearate is 0.005g～5.0g/100ml；Polyethylene Glycol ten
The consumption of penta hydroxy group stearate is preferably 0.05g～1.0g/100ml.
Polyoxyethylene sorbitan monoleate, Polyethylene Glycol ten penta hydroxy group stearate and polyoxyethylene sorbitan monoleate is also included in aforementioned pharmaceutical compositions
Combine by different proportion and make cosolvent, Polyethylene Glycol ten penta hydroxy group stearate is 0.005g with the usage ratio of polyoxyethylene sorbitan monoleate
～5.0g/100ml:0.001g～2.0g/100ml.
Described pharmaceutical composition dosage form is injection, powder pin or lyophilizing.
A kind of preparation method of the pharmaceutical composition of above-mentioned raising compound ginseng injection safety, comprises the steps:
(1) compound ginseng injection raw medicinal material Radix Ginseng 100g, Radix Salviae Miltiorrhizae 100g, Herba Euphorbiae Humifusae 100g, cosolvent 2.0g；Described cosolvent by
Polyethylene Glycol ten penta hydroxy group stearate is formed with polyoxyethylene sorbitan monoleate, and the content of wherein Polyethylene Glycol ten penta hydroxy group stearate is
0.005g～2.0g, balance of polyoxyethylene sorbitan monoleate；(2) Radix Ginseng, Radix Salviae Miltiorrhizae add water to cook secondary, 2 hours every time, collecting decoction, filter
Cross, filtrate reduced in volume to relative density is 1.27～1.30 (80 DEG C), lets cool, plus ethanol makes containing amount of alcohol to be 65%, standing
Overnight, filter, decompression filtrate recycling ethanol is simultaneously concentrated into relative density for 1.30 (80 DEG C), plus 3 times amount water, is sufficiently stirred for, cold
Hide 48 hours, filtration, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Herba Euphorbiae Humifusae adds water to cook two
Secondary, 1 hour every time, collecting decoction, filtration, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, plus ethanol makes
It is 65% containing amount of alcohol, stand overnight, filtration, filtrate reduced in volume to relative density is 1.20 (80 DEG C), plus ethanol makes containing second
Alcohol amount is 70%, stands overnight, filtration, and it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold
Hide 48 hours, filtration, it is 1.15 (80 DEG C) that filtrate is concentrated into relative density, merges with above-mentioned medicinal liquid, plus 2 times amount water, fully stirs
Mix, cold preservation 24 hours, filtration, filtrate adds cosolvent and water for injection to be configured to 1000ml solution.Stir evenly.(3) use 20% hydrogen
Sodium hydroxide solution adjusts solution ph to 6.5-8.5.(4) above-mentioned solution is filtered through microporous filter membrane.(5) fill, sterilizing, that is,
?.
The present invention, by substantial amounts of experimentation, finds a kind of Polyethylene Glycol (peg) 12-hydroxy stearic acid ester
(solutol hs-) it is the preferable substitute products of polyoxyethylene sorbitan monoleate.Polyethylene Glycol (peg) 12-hydroxy stearic acid ester
(solutol hs-) recorded in European Pharmacopoeia (ep5.5), Deutscher Arzneibucses and British Pharmacopoeia, can be used for the increasing of ejection preparation
Solvent.The pharmacological toxicology experimental data of document report shows that its toxicity is significantly lower than polyoxyethylene sorbitan monoleate (Tween 80).In addition we
By substantial amounts of experimental studies have found that, Polyethylene Glycol (peg) 12-hydroxy stearic acid ester when reaching identical solubilization-aid effect
(solutol) amount ratio polyoxyethylene sorbitan monoleate (Tween 80) low, more improve Drug safety.
The pharmacological toxicology experimental data of document report shows Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutol) safety higher than polyoxyethylene sorbitan monoleate (Tween 80), its toxicity (sees below significantly lower than polyoxyethylene sorbitan monoleate (Tween 80)
Table 1-3).Respectively using (0.5g/100ml) Polyethylene Glycol (peg) ten dihydroxy Hard Fat of equivalent in compound ginseng injection
Acid esters (solutol) and polyoxyethylene sorbitan monoleate (Tween 80), safety experiment comparative study result shows, using equivalent
(0.5g/100ml) Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutol) group is in hemolytic, stimulation
Property, anaphylaxis and the toxicity aspect such as reduce blood pressure are all substantially low than being organized using polyoxyethylene sorbitan monoleate (Tween 80), by this
Bright considerably reduce probability and the risk that compound ginseng injection occurs untoward reaction in clinical practice, improve clinical application
Safety.
To sum up, the invention has the beneficial effects as follows: provide that a kind of safety is more preferable, the more obvious cosolvent of solubilization-aid effect is replaced
There is potential safety hazard and the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) of impact product quality in compound ginseng injection；Polyethylene Glycol
(peg) 12-hydroxy stearic acid ester (solutol) safety is higher than polyoxyethylene sorbitan monoleate (Tween 80) and also consumption
Lower, reduce probability and the risk that medicine occurs untoward reaction, improve the safety of clinical application.
Specific embodiment
Embodiment 1
Preparation method: Radix Ginseng, Radix Salviae Miltiorrhizae add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume is extremely
Relative density is 1.27～1.30 (80 DEG C), lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate decompression
Reclaim ethanol and be concentrated into relative density for 1.30 (80 DEG C), plus 3 times amount water, it is sufficiently stirred for, cold preservation 48 hours, filtration, filtrate
It is evaporated to relative density and is about 1.15 (80 DEG C), medicinal liquid is standby；Herba Euphorbiae Humifusae add water to cook secondary, 1 hour every time, merge decoct
Liquid, filtration, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, standing
Overnight, filter, filtrate reduced in volume to relative density is 1.20 (80 DEG C), plus ethanol make containing amount of alcohol to be 70%, stands overnight,
Filtration, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filtration, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, plus 2 times amount water, is sufficiently stirred for, cold preservation 24 hours, filtration, filter
Liquid adds Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutolhs-) make cosolvent and water for injection is configured to
1000ml solution.Stir evenly.With 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.By above-mentioned solution through microporous filter membrane
Filtration.Fill, sterilizing, obtain final product.
Embodiment 2
Preparation method: Radix Ginseng, Radix Salviae Miltiorrhizae add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume is extremely
Relative density is 1.27～1.30 (80 DEG C), lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate decompression
Reclaim ethanol and be concentrated into relative density for 1.30 (80 DEG C), plus 3 times amount water, it is sufficiently stirred for, cold preservation 48 hours, filtration, filtrate
It is evaporated to relative density and is about 1.15 (80 DEG C), medicinal liquid is standby；Herba Euphorbiae Humifusae add water to cook secondary, 1 hour every time, merge decoct
Liquid, filtration, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, standing
Overnight, filter, filtrate reduced in volume to relative density is 1.20 (80 DEG C), plus ethanol make containing amount of alcohol to be 70%, stands overnight,
Filtration, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filtration, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, plus 2 times amount water, is sufficiently stirred for, cold preservation 24 hours, filtration, filter
Liquid adds Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutolhs-) make cosolvent and water for injection with tween 80
It is configured to 1000ml solution.Stir evenly.With 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.By above-mentioned solution through micro-
Hole filter membrane filtration.Fill, sterilizing, obtain final product.
Embodiment 3
Preparation method: Radix Ginseng, Radix Salviae Miltiorrhizae add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume is extremely
Relative density is 1.27～1.30 (80 DEG C), lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate decompression
Reclaim ethanol and be concentrated into relative density for 1.30 (80 DEG C), plus 3 times amount water, it is sufficiently stirred for, cold preservation 48 hours, filtration, filtrate
It is evaporated to relative density and is about 1.15 (80 DEG C), medicinal liquid is standby；Herba Euphorbiae Humifusae add water to cook secondary, 1 hour every time, merge decoct
Liquid, filtration, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, standing
Overnight, filter, filtrate reduced in volume to relative density is 1.20 (80 DEG C), plus ethanol make containing amount of alcohol to be 70%, stands overnight,
Filtration, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filtration, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, plus 2 times amount water, is sufficiently stirred for, cold preservation 24 hours, filtration, filter
Liquid adds Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutolhs-) make cosolvent and water for injection be configured to molten
Liquid.Stir evenly.With 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.Above-mentioned solution is filtered through microporous filter membrane.Subpackage
Become 1000, lyophilization, obtain final product.
Embodiment 4:
The Radix Ginseng extract of the present invention, Radix Salviae Miltiorrhizae extract, Herba Euphorbiae Humifusae extract and Polyethylene Glycol (peg) ten dihydroxy Hard Fat
Acid esters (solutol hs-) the injection pharmaceutical composition made can be achieved through the following technical solutions:
(1) compound ginseng injection raw medicinal material Radix Ginseng 100g, Radix Salviae Miltiorrhizae 100g, Herba Euphorbiae Humifusae 100g, Polyethylene Glycol (peg) ten
Dihydroxystearic acid ester (solutol hs-)2.0g；
(2) Radix Ginseng, Radix Salviae Miltiorrhizae add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume is to relatively close
Spend for 1.27～1.30 (80 DEG C), let cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate decompression reclaims second
Alcohol is simultaneously concentrated into relative density for 1.30 (80 DEG C), plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filtration, filtrate decompression is dense
It is reduced to relative density and is about 1.15 (80 DEG C), medicinal liquid is standby；Herba Euphorbiae Humifusae add water to cook secondary, 1 hour every time, collecting decoction, filter
Cross, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, plus ethanol make containing amount of alcohol to be 65%, stands overnight,
Filtration, filtrate reduced in volume to relative density is 1.20 (80 DEG C), plus ethanol makes containing amount of alcohol to be 70%, stands overnight, filtration,
It is 1.30 (80 DEG C) that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filtration, and filtrate is concentrated into
Relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, plus 2 times amount water, is sufficiently stirred for, cold preservation 24 hours, filtration, and filtrate adds
Enter Polyethylene Glycol (peg) 12-hydroxy stearic acid ester (solutolhs-) make cosolvent and water for injection is configured to 1000ml
Solution.Stir evenly.
(3) with 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.
(4) above-mentioned solution is filtered through microporous filter membrane.
(5) fill, sterilizing, obtain final product.
In the present invention, cosolvent can be Polyethylene Glycol ten penta hydroxy group stearate, and its consumption is 0.005g～5.0g/
Arbitrary value in 100ml, such as 0.005g/100ml, 0.01g/100ml, 0.05g/100ml, 1.0g/100ml, 5.0g/100ml
Deng；Cosolvent can also be made up of with polyoxyethylene sorbitan monoleate Polyethylene Glycol ten penta hydroxy group stearate, and its usage ratio is 0.005g
～5.0g/100ml:0.001g～2.0g/100ml.
Claims (6)
1. a kind of pharmaceutical composition improving compound ginseng injection safety it is characterised in that main by Radix Ginseng extract, pellet
The injection pharmaceutical composition that conopsea extraction, Herba Euphorbiae Humifusae extract and Polyethylene Glycol ten penta hydroxy group stearate are made.
2. the pharmaceutical composition improving compound ginseng injection safety according to claim 1 is it is characterised in that every
100ml solution contains and is equivalent to the Radix Ginseng extract of 5-15g ginseng crude drug, the Radix Salviae Miltiorrhizae extract of 5-15g red rooted salvia, 5-15g ground
The Herba Euphorbiae Humifusae extract of bright and beautiful medical herbs material, Radix Ginseng, Radix Salviae Miltiorrhizae, the usage ratio of Herba Euphorbiae Humifusae medical material are 1:1:1.
3. the pharmaceutical composition improving compound ginseng injection safety according to claim 1 is it is characterised in that described
The consumption of Polyethylene Glycol ten penta hydroxy group stearate is 0.005g～5.0g/100ml.
4. the pharmaceutical composition improving compound ginseng injection safety according to claim 3 is it is characterised in that described
The consumption of Polyethylene Glycol ten penta hydroxy group stearate is 0.05g～1.0g/100ml.
5. the pharmaceutical composition improving compound ginseng injection safety according to claim 1 is it is characterised in that described
Polyoxyethylene sorbitan monoleate is also included, Polyethylene Glycol ten penta hydroxy group stearate and polyoxyethylene sorbitan monoleate press different proportion connection in pharmaceutical composition
Cooperation cosolvent, Polyethylene Glycol ten penta hydroxy group stearate is 0.005g～5.0g/ with the usage ratio of polyoxyethylene sorbitan monoleate
100ml:0.001g～2.0g/100ml.
6. the pharmaceutical composition of the raising compound ginseng injection safety according to claim 1 to 5 any one, it is special
Levy and be, described pharmaceutical composition dosage form is injection, powder pin or lyophilizing.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079067A (en) * | 2015-09-23 | 2015-11-25 | 成都艾比科生物科技有限公司 | Pharmaceutical composition for improving safety of compound gastrodin injection |
| CN105106111A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Safe medicine composition for compound gastrodin injection and preparation method of safe medicine composition |
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2016
- 2016-11-06 CN CN201610968044.2A patent/CN106361813A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079067A (en) * | 2015-09-23 | 2015-11-25 | 成都艾比科生物科技有限公司 | Pharmaceutical composition for improving safety of compound gastrodin injection |
| CN105106111A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Safe medicine composition for compound gastrodin injection and preparation method of safe medicine composition |
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Application publication date: 20170201 |