CN105920117A - Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection - Google Patents
Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition capable of improving safety of a compound radix polygoni multiflori injection. The pharmaceutical composition is characterized in that the pharmaceutical composition for injection is mainly prepared from a radix polygoni multiflori extract, a herba menthae extract, an Indian kalimeris herb extract and polyglycerol dodecahydroxyl stearate, each 100 ml of solution contains the radix polygoni multiflori extract containing 10-35 g of radix polygoni multiflori, the herba menthae extract containing 20-75 g of herba menthae and the Indian kalimeris herb extract containing 10-35 g of Indian kalimeris herb, and the dosage ratio of radix polygoni multiflori to herba menthae to Indian kalimeris herb is 1:2:1. According to the pharmaceutical composition capable of improving the safety of the compound radix polygoni multiflori injection, cosolvent which is good in safety and obvious in solubilization assisting effect is adopted to replace the cosolvent polysorbate 80 which has potential safety hazards and affects the product quality in the compound radix polygoni multiflori injection, the safety of polyglycerol dodecahydroxyl stearate is higher than that of polysorbate 80, the dosage of polyglycerol dodecahydroxyl stearate is lower than that of polysorbate 80, probability and risks of adverse reactions of drugs are reduced, and the safety of clinical medication is improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of medicine improving Radix Polygoni Multiflori injection safety
Compositions.
Background technology
Radix Polygoni Multiflori injection standard is recorded in health drug standard promulgated by the ministries or commissions of the Central Government (Traditional Chinese medicine historical preparation), and crude drug is the most first
Crow, Herba Menthae, Herba Kalimeridis, belong to Chinese medicine injection.There is promoting blood circulation to restore menstrual flow, effect of stasis-dispelling and pain-killing.It is clinically used for treating dysmenorrhea, warp
Close, 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 Radix Polygoni Multiflori injection
Comment.But in recent years, the Reporting of harms of Chinese medicine injection clinical practice is on the rise, and have impact on and has 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, and it is reported by document
The generation of untoward reaction has very with the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) of the existence potential safety hazard of addition in Chinese medicine injection
Big relation.Due to Chinese medicine injection complicated component, in storage and autoclaving process, easily occur that solute separates out and affects clear
The problems such as lightness, solution ph are decreased obviously, therefore add polyoxyethylene sorbitan monoleate (Tween 80) in such injection and make hydrotropy
Agent, the solubilization-aid effect adding other cosolvents is the most inconspicuous.But polyoxyethylene sorbitan monoleate (Tween 80) is immature due to process for refining,
Storage and autoclaving process are easily become sour, causes impurity content high, it is difficult to reaching injection standard, polyoxyethylene sorbitan monoleate (is told
Temperature 80) inherently there is stronger hemolytic and anaphylaxis, apply add in injection occur untoward reaction probability and
Risk.It addition, Chinese medicine injection there is also, in sterilizing and storage process itself, the problem that solution ph is decreased obviously, and poly-Pyrusussuriensis
Ester 80 (Tween 80) the most easily becomes sour, and more accelerates the decline of the pH value of medicinal liquid.The Radix Polygoni Multiflori injection of domestic production at present
Liquid also adds polyoxyethylene sorbitan monoleate (Tween 80) and makees cosolvent, be faced with same problem.
In view of the foregoing, the poly-mountain that safety is more preferable, poor stability replaced by the more obvious cosolvent of solubilization-aid effect is found
Pear ester 80 (Tween 80) is this injection urgent problem.
Summary 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 Radix Polygoni Multiflori injection safety.
The present invention solves above-mentioned technical problem and be the technical scheme is that a kind of raising Radix Polygoni Multiflori injection safety
Property pharmaceutical composition, mainly stearic by Radix Polygoni Multiflori extract, Folium Menthae extract, Herba Kalimeridis extract and polyglycerol ten dihydroxy
The injection pharmaceutical composition that acid esters is made, every 100ml solution contains the Radix Polygoni Multiflori extract of 10-35g polygonum multiflorum medicinal material, 20-
The Folium Menthae extract of 75g Herba Menthae medical material, the Herba Kalimeridis extract of 10-35g Herba Kalimeridis medical material, Radix Polygoni Multiflori, Herba Menthae, the consumption of Herba Kalimeridis medical material
Ratio is 1:2:1.
For the present invention is better achieved, further, the consumption of described polyglycerol 12-hydroxy stearic acid ester is
0.005g～5.0g/100ml.
For the present invention is better achieved, further, the consumption of described polyglycerol 12-hydroxy stearic acid ester is 0.05g
～1.0g/100ml.
For the present invention is better achieved, further, described pharmaceutical composition also includes polyoxyethylene sorbitan monoleate, polyglycerol
12-hydroxy stearic acid ester and polyoxyethylene sorbitan monoleate are combined by different proportion and are made cosolvent, polyglycerol 12-hydroxy stearic acid ester with
The usage ratio of polyoxyethylene sorbitan monoleate is 0.005g～5.0g/100ml:0.001g～2.0g/100ml.
For the present invention is better achieved, further, described medicine composition dosage form is injection, powder pin or lyophilizing.
The preparation method of the pharmaceutical composition of above-mentioned raising Radix Polygoni Multiflori injection safety, comprises the steps: (1)
Radix Polygoni Multiflori injection raw medicinal material Radix Polygoni Multiflori 100g, Herba Menthae 100g, Herba Kalimeridis 100g, cosolvent 2.0g；Described cosolvent by
Polyglycerol 12-hydroxy stearic acid ester forms with polyoxyethylene sorbitan monoleate, and wherein the content of polyglycerol 12-hydroxy stearic acid ester is
0.005g～2.0g, surplus is polyoxyethylene sorbitan monoleate；(2) Radix Polygoni Multiflori, Herba Menthae boiling secondary, each 2 hours, collecting decoction,
Filtering, filtrate reduced in volume to relative density is 1.27～1.30 (80 DEG C), lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, quiet
Put overnight, filter, decompression filtrate recycling ethanol to be concentrated into relative density be 1.30 (80 DEG C), add 3 times amount water, be sufficiently stirred for,
Cold preservation 48 hours, filters, and filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Herba Kalimeridis boiling two
Secondary, each 1 hour, collecting decoction, filter, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, adds ethanol and make
Being 65% containing amount of alcohol, stand overnight, filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing second
Alcohol amount is 70%, stands overnight, and filters, and it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water, is sufficiently stirred for, cold
Hiding 48 hours, filter, it is 1.15 (80 DEG C) that filtrate is concentrated into relative density, merges with above-mentioned medicinal liquid, adds 2 times amount water, fully stirs
Mixing, cold preservation 24 hours, filter, filtrate adds cosolvent and water for injection is configured to 1000ml solution.Stir evenly.(3) 20% hydrogen is used
Sodium hydroxide solution regulation solution ph is to 6.5-8.5.(4) above-mentioned solution is filtered through microporous filter membrane.(5) fill, sterilizing, i.e.
?.
The present invention, by substantial amounts of experimentation, finds a kind of polyglycerol 12-hydroxy stearic acid ester
It is the preferable substitute products of polyoxyethylene sorbitan monoleate.Polyglycerol 12-hydroxy stearic acid esterRecorded in
European Pharmacopoeia (EP5.5), Deutscher Arzneibucs and British Pharmacopoeia, can be used for the solubilizing agent of ejection preparation.The pharmacological toxicology of document report
Experimental data shows that its toxicity is significantly lower than polyoxyethylene sorbitan monoleate (Tween 80).Additionally we be experimental studies have found that by substantial amounts of,
Reach polyglycerol 12-hydroxy stearic acid ester during identical solubilization-aid effectThe poly-Pyrusussuriensis of amount ratio
Ester 80 (Tween 80) is low, more improves Drug safety.
The pharmacological toxicology experimental data of document report shows polyglycerol 12-hydroxy stearic acid ester
Safety higher than polyoxyethylene sorbitan monoleate (Tween 80), its toxicity is significantly lower than polyoxyethylene sorbitan monoleate (Tween 80) (see table 1-3).?
Radix Polygoni Multiflori injection uses (0.5g/100ml) polyglycerol 12-hydroxy stearic acid ester of equivalent respectively With polyoxyethylene sorbitan monoleate (Tween 80), safety experiment comparative study result shows, uses (the 0.5g/ of equivalent
100ml) polyglycerol 12-hydroxy stearic acid ester Group is in hemolytic, zest, anaphylaxis and reduction
The toxicity aspects such as blood pressure the most substantially ratio uses polyoxyethylene sorbitan monoleate (Tween 80) to organize low, considerably reduces compound recipe by the present invention
There is probability and the risk of untoward reaction in Radix Polygoni Multiflori injection in clinical practice, improves the safety of clinical application.
To sum up, the invention has the beneficial effects as follows: a kind of safety of offer is more preferable, the more obvious cosolvent of solubilization-aid effect is replaced
Radix Polygoni Multiflori injection exists potential safety hazard and affects the cosolvent polyoxyethylene sorbitan monoleate (Tween 80) of product quality；Poly-the third three
Alcohol 12-hydroxy stearic acid esterSafety is higher than polyoxyethylene sorbitan monoleate (Tween 80) and also consumption more
Low, reduce probability and the risk of medicine generation untoward reaction, improve the safety of clinical application.
Detailed description of the invention
Embodiment 1
Preparation method: Radix Polygoni Multiflori, Herba Menthae boiling secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume
Being 1.27～1.30 (80 DEG C) to relative density, let cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight, filtering, filtrate subtracts
Push back receipts ethanol and to be concentrated into relative density be 1.30 (80 DEG C), add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Herba Kalimeridis boiling secondary, each 1 hour, merges and decocts
Liquid, filters, and it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stands
Overnight, filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol to be 70%, stands overnight,
Filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filters, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, adds 2 times amount water, be sufficiently stirred for, cold preservation 24 hours, filters, filter
Liquid adds polyglycerol 12-hydroxy stearic acid esterMake cosolvent and water for injection is configured to
1000ml solution.Stir evenly.By 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.By above-mentioned solution through microporous filter membrane
Filter.Fill, sterilizing, to obtain final product.
Embodiment 2
Preparation method: Radix Polygoni Multiflori, Herba Menthae boiling secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume
Being 1.27～1.30 (80 DEG C) to relative density, let cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight, filtering, filtrate subtracts
Push back receipts ethanol and to be concentrated into relative density be 1.30 (80 DEG C), add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Herba Kalimeridis boiling secondary, each 1 hour, merges and decocts
Liquid, filters, and it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stands
Overnight, filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol to be 70%, stands overnight,
Filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filters, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, adds 2 times amount water, be sufficiently stirred for, cold preservation 24 hours, filters, filter
Liquid adds polyglycerol 12-hydroxy stearic acid esterMake cosolvent with tween 80 and water for injection is joined
Make 1000ml solution.Stir evenly.By 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.By above-mentioned solution through micropore
Filter membrane filters.Fill, sterilizing, to obtain final product.
Embodiment 3
Preparation method: Radix Polygoni Multiflori, Herba Menthae boiling secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume
Being 1.27～1.30 (80 DEG C) to relative density, let cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight, filtering, filtrate subtracts
Push back receipts ethanol and to be concentrated into relative density be 1.30 (80 DEG C), add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filter
Liquid is evaporated to relative density and is about 1.15 (80 DEG C), and medicinal liquid is standby；Herba Kalimeridis boiling secondary, each 1 hour, merges and decocts
Liquid, filters, and it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stands
Overnight, filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol to be 70%, stands overnight,
Filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filters, and filtrate is dense
Being reduced to relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, adds 2 times amount water, be sufficiently stirred for, cold preservation 24 hours, filters, filter
Liquid adds polyglycerol 12-hydroxy stearic acid esterMake cosolvent and water for injection is configured to solution.
Stir evenly.By 20% sodium hydroxide solution regulation solution ph to 6.5-8.5.Above-mentioned solution is filtered through microporous filter membrane.It is distributed into
1000, lyophilization, to obtain final product.
Embodiment 4:
The Radix Polygoni Multiflori extract of the present invention, Folium Menthae extract, Herba Kalimeridis extract and polyglycerol 12-hydroxy stearic acid esterThe injection pharmaceutical composition made can be achieved through the following technical solutions:
(1) Radix Polygoni Multiflori injection raw medicinal material Radix Polygoni Multiflori 100g, Herba Menthae 100g, Herba Kalimeridis 100g, polyglycerol 12
Hydroxy stearic acid ester2.0g；
(2) Radix Polygoni Multiflori, Herba Menthae boiling secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume is to relatively
Density is 1.27～1.30 (80 DEG C), lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stands overnight, and filters, and filtrate decompression reclaims
Ethanol to be concentrated into relative density be 1.30 (80 DEG C), adds 3 times amount water, is sufficiently stirred for, and cold preservation 48 hours filters, filtrate decompression
Being concentrated into relative density and be about 1.15 (80 DEG C), medicinal liquid is standby；Herba Kalimeridis boiling secondary, each 1 hour, collecting decoction, filter
Crossing, it is 1.25～1.30 (80 DEG C) that filtrate is concentrated into relative density, lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stands overnight,
Filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol to be 70%, stands overnight, and filters,
It is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filters, and filtrate is concentrated into
Relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, adds 2 times amount water, is sufficiently stirred for, cold preservation 24 hours, filters, and filtrate adds
Enter polyglycerol 12-hydroxy stearic acid esterMake cosolvent and water for injection to be configured to 1000ml molten
Liquid.Stir evenly.
(3) by 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, to obtain final product.
In the present invention, cosolvent can be polyglycerol 12-hydroxy stearic acid ester, 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 polyglycerol 12-hydroxy stearic acid ester, and its usage ratio is 0.005g
～5.0g/100ml:0.001g～2.0g/100ml.
After the present invention uses polyglycerol 12-hydroxy stearic acid ester as cosolvent, its safety is more preferable, solubilization-aid effect
More obviously being better than polyoxyethylene sorbitan monoleate, concrete data see following table:
Table 1With polyoxyethylene sorbitan monoleate (Tween 80) LD50Toxicity test data compare
Table 2 intravenous injectionWith polyoxyethylene sorbitan monoleate (Tween 80) haemolysis afterwards and serum histamine levels ratio
Relatively
Table 3 intravenous injectionCompare with polyoxyethylene sorbitan monoleate (Tween 80) blood pressure lowering level afterwards
It addition, the present invention is by experimental studies have found that, in Radix Polygoni Multiflori injection, when reaching identical solubilization-aid effect
Polyglycerol 12-hydroxy stearic acid esterConsumption substantially low than polyoxyethylene sorbitan monoleate (Tween 80), more
Add and improve Drug safety.Polyglycerol 12-hydroxy stearic acid ester in pharmaceutical composition's
Consumption is 0.005g-5.0g/100ml, and preferable amount is 0.05g-1.0g/100ml.Pharmaceutical composition it be also possible to use poly-the third three
Alcohol 12-hydroxy stearic acid esterCombine by different proportion with polyoxyethylene sorbitan monoleate (Tween 80) and make cosolvent
To reduce polyoxyethylene sorbitan monoleate (Tween 80) consumption, polyglycerol 12-hydroxy stearic acid esterWith poly-mountain
The usage ratio of pear ester 80 (Tween 80) is 0.005g-5.0g/100ml:0.001g-2.0g/100ml.
Claims (5)
1. the pharmaceutical composition improving Radix Polygoni Multiflori injection safety, it is characterised in that mainly extracted by Radix Polygoni Multiflori
The injection pharmaceutical composition that thing, Folium Menthae extract, Herba Kalimeridis extract and polyglycerol 12-hydroxy stearic acid ester are made, often
100ml solution contains the Radix Polygoni Multiflori extract of 10-35g polygonum multiflorum medicinal material, the Folium Menthae extract of 20-75g Herba Menthae medical material, 10-35g horse
The Herba Kalimeridis extract of blue medical material, Radix Polygoni Multiflori, Herba Menthae, the usage ratio of Herba Kalimeridis medical material are 1:2:1.
The pharmaceutical composition of raising Radix Polygoni Multiflori injection safety the most according to claim 1, it is characterised in that institute
The consumption stating polyglycerol 12-hydroxy stearic acid ester is 0.005g～5.0g/100ml.
The pharmaceutical composition of raising Radix Polygoni Multiflori injection safety the most according to claim 1, it is characterised in that institute
The consumption stating polyglycerol 12-hydroxy stearic acid ester is 0.05g～1.0g/100ml.
The pharmaceutical composition of raising Radix Polygoni Multiflori injection safety the most according to claim 1, it is characterised in that institute
Stating and also include polyoxyethylene sorbitan monoleate in pharmaceutical composition, polyglycerol 12-hydroxy stearic acid ester and polyoxyethylene sorbitan monoleate press different proportion
Combining and make cosolvent, polyglycerol 12-hydroxy stearic acid ester is 0.005g～5.0g/ with the usage ratio of polyoxyethylene sorbitan monoleate
100ml:0.001g～2.0g/100ml.
5. according to the pharmaceutical composition improving Radix Polygoni Multiflori injection safety described in claim 1 to 5 any one, its
Being characterised by, described medicine composition dosage form is injection, powder pin or lyophilizing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610352151.2A CN105920117A (en) | 2016-05-24 | 2016-05-24 | Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610352151.2A CN105920117A (en) | 2016-05-24 | 2016-05-24 | Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection |
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| CN105920117A true CN105920117A (en) | 2016-09-07 |
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| CN201610352151.2A Withdrawn CN105920117A (en) | 2016-05-24 | 2016-05-24 | Pharmaceutical composition capable of improving safety of compound radix polygoni multiflori injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309569A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound codonopsis pilosula injection |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518617A (en) * | 2009-04-02 | 2009-09-02 | 四川升和制药有限公司 | Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101518617A (en) * | 2009-04-02 | 2009-09-02 | 四川升和制药有限公司 | Pharmaceutical composition for improving safety of Shenmai injection and method for preparing same |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309569A (en) * | 2016-11-06 | 2017-01-11 | 成都先先先生物科技有限公司 | Medicine compound for increasing safety of compound codonopsis pilosula injection |
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