CN106389322A - Pharmaceutical composition for improving safety of compound Herba Artemisiae Scopariae injection - Google Patents
Pharmaceutical composition for improving safety of compound Herba Artemisiae Scopariae injection Download PDFInfo
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- CN106389322A CN106389322A CN201610968071.XA CN201610968071A CN106389322A CN 106389322 A CN106389322 A CN 106389322A CN 201610968071 A CN201610968071 A CN 201610968071A CN 106389322 A CN106389322 A CN 106389322A
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- 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
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- 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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- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
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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
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- A61K9/00—Medicinal preparations characterised by special physical form
- 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
The invention discloses a pharmaceutical composition for improving safety of a compound Herba Artemisiae Scopariae injection. The pharmaceutical composition is used for injection and is mainly prepared from Herba Artemisiae Scopariae extract, Bupleuri Herba extract, Radix Notoginseng extract and polyoxyl 15 hydroxystearate. A cosolvent which is better in safety and more obvious in dissolving assisting effect replaces polysorbate 80 which is used as a cosolvent, has potential safety hazards and affects quality of products in the compound Herba Artemisiae Scopariae injection, the safety of the polyoxyl 15 hydroxystearate is higher than that of the polysorbate 80, the use amount is lower, probability and risks of adverse reactions of drugs are reduced, and 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 oriental wormwood injection safety
Compositionss.
Background technology
Compound oriental wormwood injection standard is recorded and is issued drug standard (Traditional Chinese medicine historical preparation) in Ministry of Public Health, crude drug be Herba Artemisiae Scopariae,
HERBA BUPLEURL, Radix Notoginseng, 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 oriental wormwood 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 oriental wormwood 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 Herba Artemisiae Scopariae injection safety.
The present invention solves above-mentioned technical problem and be employed technical scheme comprise that：A kind of raising compound oriental wormwood injection safety
Pharmaceutical composition, mainly by Herba Artemisiae Scopariae extract, HERBA BUPLEURL extract, Radix Notoginseng 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 improving compound oriental wormwood injection safety pharmaceutical composition, comprises the steps：
(1) compound oriental wormwood injection raw medicinal material Herba Artemisiae Scopariae 100g, HERBA BUPLEURL 100g, Radix Notoginseng 100g, cosolvent 2.0g；
(2) Herba Artemisiae Scopariae, HERBA BUPLEURL add water to cook secondary, 2 hours every time, collecting decoction, plus ethanol filtering and concentrating, plus 3 times amount
Water, is sufficiently stirred for, cold preservation 48 hours, filtration, and filtrate reduced in volume to relative density is about 1.15, and medicinal liquid is standby；
(3) Radix Notoginseng add water to cook secondary, 1 hour every time, collecting decoction, filtration, concentrate filtrate, let cool, plus ethanol make to contain
Amount of alcohol be 65%, stand overnight, filtration, filtrate reduced in volume to relative density be 1.20, plus ethanol make containing amount of alcohol be
70%, stand overnight, filtration, it is 1.30 that filtrate is concentrated into relative density, plus 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filter
Cross, it is 1.15 that filtrate is concentrated into relative density,
(4) merge with above-mentioned all medicinal liquids, plus 2 times amount water, it is sufficiently stirred for, cold preservation 24 hours, filtration, filtrate adds hydrotropy
Agent and water for injection are configured to 1000ml solution, stir evenly, and the relative density of above-mentioned each filtrate is relative density when 80 DEG C；
(5) with sodium hydroxide solution regulation solution ph to 6.5-8.5；
(6) filter, fill, sterilizing, obtain final product.
In order to the method for the present invention is better achieved, further, in described step (1), cosolvent is by Polyethylene Glycol ten
Penta hydroxy group stearate and polyoxyethylene sorbitan monoleate form, wherein the content of Polyethylene Glycol ten penta hydroxy group stearate be 0.005g～
2.0g, balance of polyoxyethylene sorbitan monoleate.
In order to the method for the present invention is better achieved, further, in described step (2), plus the mistake of ethanol filtering and concentrating
Cheng Wei, first filters to get filtrate, filtrate reduced in volume to relative density be 1.27～1.30, let cool, plus ethanol make containing amount of alcohol be
65%, stand overnight, filtration, decompression filtrate recycling ethanol is simultaneously concentrated into relative density for 1.30.
In order to the method for the present invention is better achieved, further, in described step (3), filtrate is concentrated into relative density
For 1.25～1.30.
In order to the method for the present invention is better achieved, further, in described step (5), the sodium hydroxide solution of use
Mass percent be 20%.
In order to the method for the present invention is better achieved, further, in described step (6), solution uses microporous filter membrane mistake
Filter.
The present invention, by substantial amounts of experimentation, finds a kind of Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester
(Solutol) it is the preferable substitute products of polyoxyethylene sorbitan monoleate.Polyethylene Glycol (PEG) 12-hydroxy stearic acid ester
(Solutol) 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 oriental wormwood 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 oriental wormwood injection occurs untoward reaction in clinical practice, improve clinical application
Safety.
To sum up, the invention has the beneficial effects as follows：There is provided 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 oriental wormwood injection；Polyethylene Glycol
(PEG) 12-hydroxy stearic acid ester (Solutol) safety is higher than polyoxyethylene sorbitan monoleate (Tween 80) and also consumption more
Low, reduce probability and the risk that medicine occurs untoward reaction, improve the safety of clinical application.
Specific embodiment
Embodiment 1
Preparation method：Herba Artemisiae Scopariae, HERBA BUPLEURL add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume
It is 1.27～1.30 (80 DEG C) to relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate subtracts
Push back receipts 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, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Radix Notoginseng 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 (Solutol) 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：Herba Artemisiae Scopariae, HERBA BUPLEURL add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume
It is 1.27～1.30 (80 DEG C) to relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate subtracts
Push back receipts 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, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Radix Notoginseng 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 (Solutol) make cosolvent and injection with tween 80
Water is configured to 1000ml solution.Stir evenly.With 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.By above-mentioned solution warp
Microporous filter membrane filters.Fill, sterilizing, obtain final product.
Embodiment 3
Preparation method：Herba Artemisiae Scopariae, HERBA BUPLEURL add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume
It is 1.27～1.30 (80 DEG C) to relative density, lets cool, plus ethanol makes containing amount of alcohol to be 65%, stands overnight, filtration, filtrate subtracts
Push back receipts 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, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Radix Notoginseng 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 (Solutol) 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 Herba Artemisiae Scopariae extract of the present invention, HERBA BUPLEURL extract, Radix Notoginseng extract and Polyethylene Glycol (PEG) ten dihydroxy Hard Fat
Acid esters (Solutol) the injection pharmaceutical composition made can be achieved through the following technical solutions：
(1) compound oriental wormwood injection raw medicinal material Herba Artemisiae Scopariae 100g, HERBA BUPLEURL 100g, Radix Notoginseng 100g, Polyethylene Glycol (PEG) ten
Dihydroxystearic acid ester (Solutol)2.0g；
(2) Herba Artemisiae Scopariae, HERBA BUPLEURL add water to cook secondary, 2 hours every time, collecting decoction, filtration, filtrate reduced in volume is to relatively
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 reclaims
Ethanol 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
It is concentrated into relative density and is about 1.15 (80 DEG C), medicinal liquid is standby；Radix Notoginseng 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 (Solutol) 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 oriental wormwood injection safety it is characterised in that main by Herba Artemisiae Scopariae extract, spring
The injection pharmaceutical composition that Radix Bupleuri extract, Radix Notoginseng extract and Polyethylene Glycol ten penta hydroxy group stearate are made.
2. the pharmaceutical composition improving compound oriental wormwood injection safety according to claim 1 is it is characterised in that every
100ml solution contains and is equivalent to the Herba Artemisiae Scopariae extract of 5-15g Herba Artemisiae Scopariae medical material, the HERBA BUPLEURL extract of 5-15g HERBA BUPLEURL medical material, 5-
The Radix Notoginseng extract of 15g pseudo-ginseng, Herba Artemisiae Scopariae, HERBA BUPLEURL, the usage ratio of pseudo-ginseng are 1：1：1.
3. the pharmaceutical composition improving compound oriental wormwood 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 oriental wormwood 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 oriental wormwood 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 oriental wormwood 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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| CN201610968071.XA CN106389322A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition for improving safety of compound Herba Artemisiae Scopariae injection |
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| CN201610968071.XA CN106389322A (en) | 2016-11-06 | 2016-11-06 | Pharmaceutical composition for improving safety of compound Herba Artemisiae Scopariae injection |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101524411A (en) * | 2009-03-05 | 2009-09-09 | 常熟雷允上制药有限公司 | High-capacity Kuhuang injection and preparation method thereof |
| 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 |
-
2016
- 2016-11-06 CN CN201610968071.XA patent/CN106389322A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101524411A (en) * | 2009-03-05 | 2009-09-09 | 常熟雷允上制药有限公司 | High-capacity Kuhuang injection and preparation method thereof |
| 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 |
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Application publication date: 20170215 |