CN105943736A - Pharmaceutical composition capable of improving safety of compound manglietia injection - Google Patents
Pharmaceutical composition capable of improving safety of compound manglietia injection Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Abstract
The invention discloses a pharmaceutical composition capable of improving safety of a compound manglietia injection. The pharmaceutical composition for injection is characterized by being mainly prepared from a manglietia extract, an extract of black nightshade herb, a banana extract and polyethylene glycol dodecahydroxyl stearate, wherein each 100ml of the solution (the pharmaceutical composition) consists of the manglietia extract of 10-20g of a manglietia medicinal material, the black nightshade herb extract of 10-20g of a black nightshade herb medicinal material and the banana extract of 1-2g of a banana medicinal material, and the dosage ratio of the manglietia medicinal material to the black nightshade herb medicinal material to the banana medicinal material is 10 to 10 to 1. According to the pharmaceutical composition disclosed by the invention, a cosolvent, namely polysorbate 80, which has safety hidden dangers and has influence on product quality in the compound manglietia injection is replaced by a cosolvent which is better in safety and is more remarkable in dissolve-assisting effect with a lower dosage, so that the probability and risks of adverse reactions of the medicine (the pharmaceutical composition) are reduced, and the safety of clinical administration is improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, improve the injection of compound recipe Fructus Fici Pumilae in particular it relates to a kind of
The pharmaceutical composition of liquid safety.
Background technology
Compound recipe Fructus Fici Pumilae injection standard is recorded in health drug standard promulgated by the ministries or commissions of the Central Government (Traditional Chinese medicine historical preparation),
Crude drug is Fructus Fici Pumilae, Herba Solani Nigri, banana, belongs to Chinese medicine injection.There is promoting blood circulation to restore menstrual flow, blood stasis dispelling
Effect of pain relieving.It is clinically used for treating dysmenorrhea, amenorrhea, injury from falling down, rheumatic arthralgia etc..
In China in wide clinical application for many years, clinical efficacy obtains compound recipe Fructus Fici Pumilae injection
The favorable comment of doctor and patient.But in recent years, the Reporting of harms day of Chinese medicine injection clinical practice
Become serious, have impact on the development of the Chinese medicine injection with Chinese Medicine characteristic.Domestic expert learns
Person has carried out numerous studies to the untoward reaction of Chinese medicine injection, and its untoward reaction reported by document
Occur and the cosolvent polyoxyethylene sorbitan monoleate (tween of the existence potential safety hazard of addition in Chinese medicine injection
80) there is the biggest relation.Due to Chinese medicine injection complicated component, in storage and high temperature sterilize mistake
Journey easily occurs solute separate out and affect clarity, the problem such as solution ph is decreased obviously, because of
This adds polyoxyethylene sorbitan monoleate (Tween 80) in such injection and makees cosolvent, adds other
The solubilization-aid effect of cosolvent is the most inconspicuous.But polyoxyethylene sorbitan monoleate (Tween 80) is due to process for refining
Immature, easily become sour in storage and autoclaving process, cause impurity content high, it is difficult to
Reach injection standard, polyoxyethylene sorbitan monoleate (Tween 80) inherently have stronger hemolytic and
Anaphylaxis, applies and adds probability and the risk that untoward reaction occurs in injection.It addition,
Chinese medicine injection is asking that sterilizing and storage process itself there is also that solution ph is decreased obviously
Topic, and polyoxyethylene sorbitan monoleate (Tween 80) easily becomes sour, and more accelerates under the pH value of medicinal liquid
Fall.The compound recipe Fructus Fici Pumilae injection of domestic production at present also adds polyoxyethylene sorbitan monoleate (Tween 80)
Make cosolvent, be faced with same problem.
In view of the foregoing, find that safety is more preferable, the more obvious cosolvent of solubilization-aid effect is replaced
The polyoxyethylene sorbitan monoleate (Tween 80) of poor stability is this injection urgent problem.
Summary of the invention
The technical problem to be solved be to provide a kind of safety more preferably, solubilization-aid effect more
Significantly improve the pharmaceutical composition of compound recipe Fructus Fici Pumilae injection safety.
The present invention solves above-mentioned technical problem and be the technical scheme is that a kind of raising compound recipe wood
The pharmaceutical composition of lotus injection safety, mainly by Fructus Fici Pumilae extract, Herba Solani Nigri extract, sweet
The injection pharmaceutical composition that any of several broadleaf plants extract and polyethyleneglycol-12-hydroxy stearin are made,
Every 100ml solution is containing the Fructus Fici Pumilae extract of 10-20g Fructus Fici Pumilae medical material, 10-20g Herba Solani Nigri medical material
Herba Solani Nigri extract, the banana extract of 1-2g banana medical material, Fructus Fici Pumilae, Herba Solani Nigri, banana medical material
Usage ratio be 10:10:1.
For the present invention is better achieved, further, described Polyethylene Glycol ten dihydroxystearic acid
The consumption of ester is 0.005g～5.0g/100ml.
For the present invention is better achieved, further, described Polyethylene Glycol ten dihydroxystearic acid
The consumption of ester is 0.05g～1.0g/100ml.
For the present invention is better achieved, further, described pharmaceutical composition also includes poly-mountain
Pear ester 80, polyethyleneglycol-12-hydroxy stearin is combined by different proportion with polyoxyethylene sorbitan monoleate
Making cosolvent, polyethyleneglycol-12-hydroxy stearin 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 be injection,
Powder pin or lyophilizing.
The preparation method of the pharmaceutical composition of above-mentioned raising compound recipe Fructus Fici Pumilae injection safety, including
Following step: (1) compound recipe Fructus Fici Pumilae injection raw medicinal material Fructus Fici Pumilae 100g, Herba Solani Nigri 100g, sweet
Any of several broadleaf plants 100g, cosolvent 2.0g；Described cosolvent by polyethyleneglycol-12-hydroxy stearin with
Polyoxyethylene sorbitan monoleate forms, and wherein the content of polyethyleneglycol-12-hydroxy stearin is
0.005g～2.0g, surplus is polyoxyethylene sorbitan monoleate；(2) Fructus Fici Pumilae, Herba Solani Nigri boiling secondary,
Each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density is 1.27～1.30
(80 DEG C), let cool, and add ethanol and make containing amount of alcohol to be 65%, stand overnight, and filter, filtrate
Decompression recycling ethanol to be concentrated into relative density be 1.30 (80 DEG C), adds 3 times amount water, fully
Stirring, cold preservation 48 hours, filter, filtrate reduced in volume to relative density is about 1.15 (80 DEG C),
Medicinal liquid is standby；Banana boiling secondary, each 1 hour, collecting decoction, filter, filtrate
Being concentrated into relative density is 1.25～1.30 (80 DEG C), lets cool, and adds ethanol and makes and containing amount of alcohol is
65%, stand overnight, filter, filtrate reduced in volume to relative density is 1.20 (80 DEG C),
Adding ethanol and make containing amount of alcohol to be 70%, stand overnight, filter, filtrate is concentrated into relative density
It is 1.30 (80 DEG C), adds 3 times amount water, be sufficiently stirred for that cold preservation 48 hours filters, filtrate
Being concentrated into relative density is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, adds 2 times amount water, fill
Dividing stirring, cold preservation 24 hours, filter, filtrate adds cosolvent and water for injection is configured to
1000ml solution.Stir evenly.(3) by 20% sodium hydroxide solution regulation solution ph extremely
6.5-8.5.(4) above-mentioned solution is filtered through microporous filter membrane.(5) fill, sterilizing, to obtain final product.
The present invention, by substantial amounts of experimentation, finds a kind of Polyethylene Glycol ten dihydroxystearic acid
Ester (Solutol) it is the preferable substitute products of polyoxyethylene sorbitan monoleate.Polyethylene Glycol 12
Hydroxy stearic acid ester (Solutol) recorded in European Pharmacopoeia (EP5.5), Germany's medicine
Allusion quotation and British Pharmacopoeia, can be used for the solubilizing agent of ejection preparation.The pharmacological toxicology experiment of document report
Data show that its toxicity is significantly lower than polyoxyethylene sorbitan monoleate (Tween 80).Additionally we are by a large amount of
Experimental studies have found that, reach polyethyleneglycol-12-hydroxy stearin during identical solubilization-aid effect
(Solutol) amount ratio polyoxyethylene sorbitan monoleate (Tween 80) low, more improve medicine
The safety of thing.
The pharmacological toxicology experimental data of document report shows polyethyleneglycol-12-hydroxy stearin
(Solutol) safety higher than polyoxyethylene sorbitan monoleate (Tween 80), its toxicity is obvious
Less than polyoxyethylene sorbitan monoleate (Tween 80) (see table 1-3).In compound recipe Fructus Fici Pumilae injection respectively
Use (0.5g/100ml) polyethyleneglycol-12-hydroxy stearin (Solutol of equivalent) and polyoxyethylene sorbitan monoleate (Tween 80), safety experiment comparative study result shows,
Use (0.5g/100ml) polyethyleneglycol-12-hydroxy stearin (Solutol of equivalent) group is equal in terms of hemolytic, zest, anaphylaxis and the toxicity such as reduce blood pressure
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 Fructus Fici Pumilae injection in clinical practice, improves clinical application
Safety.
To sum up, the invention has the beneficial effects as follows: provide a kind of safety more preferably, solubilization-aid effect more
Potential safety hazard is there is and affects product quality in significantly cosolvent in replacing compound recipe Fructus Fici Pumilae injection
Cosolvent polyoxyethylene sorbitan monoleate (Tween 80)；Polyethyleneglycol-12-hydroxy stearin (Solutol) safety higher than polyoxyethylene sorbitan monoleate (Tween 80) and consumption is lower, reduce medicine
The probability of thing generation untoward reaction and risk, improve the safety of clinical application.
Detailed description of the invention
Embodiment 1
Preparation method: Fructus Fici Pumilae, Herba Solani Nigri 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, adds second
It is 65% that alcohol makes containing amount of alcohol, stands overnight, and filters, and decompression filtrate recycling ethanol also concentrates
It is 1.30 (80 DEG C) to relative density, adds 3 times amount water, be sufficiently stirred for, cold preservation 48 hours,
Filtering, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Banana
Boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density
It is 1.25～1.30 (80 DEG C), lets cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight,
Filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol
Being 70%, stand overnight, filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds
3 times amount water, are sufficiently stirred for, cold preservation 48 hours, filter, and filtrate is concentrated into relative density and is
1.15 (80 DEG C), merge with above-mentioned medicinal liquid, add 2 times amount water, are sufficiently stirred for, and cold preservation 24 is little
Time, filtering, filtrate adds polyethyleneglycol-12-hydroxy stearin (Solutol)
Make cosolvent and water for injection is configured to 1000ml solution.Stir evenly.Molten with 20% sodium hydroxide
Liquid regulation solution ph is to 6.5-8.5.Above-mentioned solution is filtered through microporous filter membrane.Fill, goes out
Bacterium, to obtain final product.
Embodiment 2
Preparation method: Fructus Fici Pumilae, Herba Solani Nigri 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, adds second
It is 65% that alcohol makes containing amount of alcohol, stands overnight, and filters, and decompression filtrate recycling ethanol also concentrates
It is 1.30 (80 DEG C) to relative density, adds 3 times amount water, be sufficiently stirred for, cold preservation 48 hours,
Filtering, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Banana
Boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density
It is 1.25～1.30 (80 DEG C), lets cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight,
Filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol
Being 70%, stand overnight, filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds
3 times amount water, are sufficiently stirred for, cold preservation 48 hours, filter, and filtrate is concentrated into relative density and is
1.15 (80 DEG C), merge with above-mentioned medicinal liquid, add 2 times amount water, are sufficiently stirred for, and cold preservation 24 is little
Time, filtering, filtrate adds polyethyleneglycol-12-hydroxy stearin (Solutol)
Make cosolvent with tween 80 and water for injection is configured to 1000ml solution.Stir evenly.With 20%
Sodium hydroxide solution regulation solution ph is to 6.5-8.5.Above-mentioned solution is filtered through microporous filter membrane.
Fill, sterilizing, to obtain final product.
Embodiment 3
Preparation method: Fructus Fici Pumilae, Herba Solani Nigri 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, adds second
It is 65% that alcohol makes containing amount of alcohol, stands overnight, and filters, and decompression filtrate recycling ethanol also concentrates
It is 1.30 (80 DEG C) to relative density, adds 3 times amount water, be sufficiently stirred for, cold preservation 48 hours,
Filtering, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Banana
Boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density
It is 1.25～1.30 (80 DEG C), lets cool, add ethanol and make containing amount of alcohol to be 65%, stand overnight,
Filtering, filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol
Being 70%, stand overnight, filtering, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds
3 times amount water, are sufficiently stirred for, cold preservation 48 hours, filter, and filtrate is concentrated into relative density and is
1.15 (80 DEG C), merge with above-mentioned medicinal liquid, add 2 times amount water, are sufficiently stirred for, and cold preservation 24 is little
Time, filtering, filtrate adds polyethyleneglycol-12-hydroxy stearin (Solutol)
Make cosolvent and water for injection is configured to solution.Stir evenly.With 20% sodium hydroxide solution regulation
Solution ph is 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 Fructus Fici Pumilae extract of the present invention, Herba Solani Nigri extract, banana extract and Polyethylene Glycol 12
Hydroxy stearic acid ester (Solutol) the injection pharmaceutical composition made can pass through
Techniques below scheme realizes:
(1) compound recipe Fructus Fici Pumilae injection raw medicinal material Fructus Fici Pumilae 100g, Herba Solani Nigri 100g, banana 100g,
Polyethyleneglycol-12-hydroxy stearin (Solutol)2.0g；
(2) Fructus Fici Pumilae, Herba Solani Nigri boiling secondary, each 2 hours, collecting decoction, filter,
Filtrate reduced in volume to relative density is 1.27～1.30 (80 DEG C), lets cool, and adds ethanol and makes to contain
Amount of alcohol is 65%, stands overnight, and filters, and decompression filtrate recycling ethanol is also concentrated into relatively
Density is 1.30 (80 DEG C), adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filters,
Filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby；Banana adds decocting
Boil secondary, each 1 hour, collecting decoction, filter, filtrate be concentrated into relative density be 1.25～
1.30 (80 DEG C), let cool, and add ethanol and make containing amount of alcohol to be 65%, stand overnight, and filter,
Filtrate reduced in volume to relative density is 1.20 (80 DEG C), adds ethanol and makes containing amount of alcohol to be 70%,
Standing overnight, filter, it is 1.30 (80 DEG C) that filtrate is concentrated into relative density, adds 3 times amount water,
Being sufficiently stirred for, cold preservation 48 hours, filter, it is 1.15 (80 DEG C) that filtrate is concentrated into relative density,
Merge with above-mentioned medicinal liquid, add 2 times amount water, be sufficiently stirred for, cold preservation 24 hours, filter, filter
Liquid adds polyethyleneglycol-12-hydroxy stearin (Solutol) make cosolvent and note
Penetrate and be configured to 1000ml solution with water.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 polyethyleneglycol-12-hydroxy stearin, and its consumption is
Arbitrary value in 0.005g～5.0g/100ml, as 0.005g/100ml, 0.01g/100ml,
0.05g/100ml, 1.0g/100ml, 5.0g/100ml etc.；Cosolvent can also be by poly-second two
Alcohol 12-hydroxy stearic acid ester and polyoxyethylene sorbitan monoleate form, its usage ratio be 0.005g～
5.0g/100ml:0.001g～2.0g/100ml.
After the present invention uses polyethyleneglycol-12-hydroxy stearin as cosolvent, its safety
More preferably, solubilization-aid effect be more obviously better than polyoxyethylene sorbitan monoleate, concrete data see following table:
Table 1SolutolWith polyoxyethylene sorbitan monoleate (Tween 80) LD50Toxicity test data compare
Table 2 intravenous injection SolutolWith polyoxyethylene sorbitan monoleate (Tween 80) haemolysis afterwards and serum
Histamine levels compares
Table 3 intravenous injection SolutolCompare with polyoxyethylene sorbitan monoleate (Tween 80) blood pressure lowering level afterwards
It addition, the present invention is by experimental studies have found that, in compound recipe Fructus Fici Pumilae injection, reach identical
Solubilization-aid effect time polyethyleneglycol-12-hydroxy stearin (Solutol) consumption
Lower than polyoxyethylene sorbitan monoleate (Tween 80), more improve Drug safety.Medicine group
Polyethyleneglycol-12-hydroxy stearin (Solutol in compound) consumption be
0.005g-5.0g/100ml, preferable amount is 0.05g-1.0g/100ml.Pharmaceutical composition also may be used
Use polyethyleneglycol-12-hydroxy stearin (Solutol) (tell with polyoxyethylene sorbitan monoleate
Temperature 80) combine by different proportion and to make cosolvent to reduce polyoxyethylene sorbitan monoleate (Tween 80) consumption, gather
Ethylene glycol 12-hydroxy stearic acid ester (Solutol) and polyoxyethylene sorbitan monoleate (Tween 80)
Usage ratio be 0.005g-5.0g/100ml:0.001g-2.0g/100ml.
Claims (5)
1. the pharmaceutical composition improving compound recipe Fructus Fici Pumilae injection safety, it is characterized in that, the main injection pharmaceutical composition being made up of Fructus Fici Pumilae extract, Herba Solani Nigri extract, banana extract and polyethyleneglycol-12-hydroxy stearin, every 100ml solution is containing the Fructus Fici Pumilae extract of 10-20g Fructus Fici Pumilae medical material, the Herba Solani Nigri extract of 10-20g Herba Solani Nigri medical material, the banana extract of 1-2g banana medical material, and Fructus Fici Pumilae, Herba Solani Nigri, the usage ratio of banana medical material are 10:10:1.
The pharmaceutical composition of raising compound recipe Fructus Fici Pumilae injection safety the most according to claim 1, it is characterised in that the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.005g～5.0g/100ml.
The pharmaceutical composition of raising compound recipe Fructus Fici Pumilae injection safety the most according to claim 1, it is characterised in that the consumption of described polyethyleneglycol-12-hydroxy stearin is 0.05g～1.0g/100ml.
The pharmaceutical composition of raising compound recipe Fructus Fici Pumilae injection safety the most according to claim 1, it is characterized in that, described pharmaceutical composition also includes polyoxyethylene sorbitan monoleate, polyethyleneglycol-12-hydroxy stearin and polyoxyethylene sorbitan monoleate are combined by different proportion and are made cosolvent, and polyethyleneglycol-12-hydroxy stearin is 0.005g～5.0g/100ml:0.001g～2.0g/100ml with the usage ratio of polyoxyethylene sorbitan monoleate.
5. according to the pharmaceutical composition improving compound recipe Fructus Fici Pumilae injection safety described in claim 1 to 5 any one, it is characterised in that described medicine composition dosage form is injection, powder pin or lyophilizing.
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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 |
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| 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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