CN107661290A - A kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security - Google Patents
A kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security Download PDFInfo
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- CN107661290A CN107661290A CN201610995464.XA CN201610995464A CN107661290A CN 107661290 A CN107661290 A CN 107661290A CN 201610995464 A CN201610995464 A CN 201610995464A CN 107661290 A CN107661290 A CN 107661290A
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- A—HUMAN NECESSITIES
- 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)
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- A—HUMAN NECESSITIES
- 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)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61K47/26—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention discloses a kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security.The main injection pharmaceutical composition made of Herba Euphorbiae Humifusae extract, ardisia crispa extract, Herba Abri extract and hydroxypropyl acrylate of the pharmaceutical composition.The present invention uses the glycerol cosolvent that security is more preferable, potential safety hazard and influence product quality in the more obvious cosolvent replacement compound wolf's milk parenteral solution of solubilization-aid effect be present, the security of hydroxypropyl acrylate is higher than glycerine and dosage is lower, adverse reaction occurs for medicine probability and risk are reduced, improves the security of clinical application.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of medicine for improving compound wolf's milk parenteral solution security
Compositions.
Background technology
Compound wolf's milk parenteral solution standard is recorded issues the drug standards (Traditional Chinese medicine historical preparation) in the Ministry of Public Health, and bulk drug is humid euphorbia
Grass, ardisia crispa, Canton love-pea vine, belong to traditional Chinese medicine injection.With invigorate blood circulation, the effect of stasis-dispelling and pain-killing.It is clinically used for treating dysmenorrhoea,
Amenorrhea, injury from falling down, arthralgia pain due to rheumatism etc..
Compound wolf's milk parenteral solution in China in wide clinical application for many years, clinical efficacy has obtained the good of doctor and patient
Comment.But in recent years, the Reporting of harms of traditional Chinese medicine injection clinical practice is on the rise, have impact on Chinese Medicine characteristic
The development of traditional Chinese medicine injection.Adverse reaction of the domestic experts and scholars to traditional Chinese medicine injection has carried out numerous studies, document report its
The glycerol cosolvent of the presence potential safety hazard added in the generation of adverse reaction and traditional Chinese medicine injection has very big relation.Due to
Traditional Chinese medicine injection complicated component, influence clarity, solution ph with easily occurring solute precipitation in autoclaving process storing
The problems such as being decreased obviously, therefore add glycerine in such parenteral solution and make cosolvent, add the hydrotropy effect of other cosolvents
Fruit then unobvious.But glycerine is being stored and easily become sour in autoclaving process, causing impurity because process for refining is immature
Content is high, it is difficult to reaches injection standard, glycerine inherently has stronger hemolytic and anaphylaxis, applied in parenteral solution
Add the probability and risk that adverse reaction occurs.In addition, also there is solution in traditional Chinese medicine injection in itself in sterilizing and storage process
The problem of pH value is decreased obviously, and glycerine easily becomes sour, and more accelerates the decline of the pH value of decoction.Domestic production at present
Glycerine is also added in compound wolf's milk parenteral solution and makees cosolvent, is faced with the problem of same.
In view of the foregoing, find that security is more preferable, the more obvious cosolvent of solubilization-aid effect replaces the third the three of security difference
Alcohol is the parenteral solution urgent problem.
The content of the invention
The technical problems to be solved by the invention are to provide that a kind of security is more preferable, solubilization-aid effect more obviously improves compound
Pharmaceutical composition of wolf's milk parenteral solution security and preparation method thereof.
Technical scheme is used by the present invention solves above-mentioned technical problem：One kind improves compound wolf's milk parenteral solution safety
The pharmaceutical composition of property, is mainly made up of Herba Euphorbiae Humifusae extract, ardisia crispa extract, Herba Abri extract and hydroxypropyl acrylate
Injection pharmaceutical composition.
Specifically, the dosage of hydroxypropyl acrylate is 0.005g~5.0g/100ml；The dosage of hydroxypropyl acrylate is preferred
For 0.05g~1.0g/100ml.
Also include glycerine in aforementioned pharmaceutical compositions, hydroxypropyl acrylate is combined with glycerine by different proportion makees hydrotropy
The usage ratio of agent, hydroxypropyl acrylate and glycerine is 0.005g~5.0g/100ml：0.001g~2.0g/100ml.
Described pharmaceutical composition formulation is parenteral solution, powder pin or lyophilized.
The preparation method of the pharmaceutical composition of above-mentioned raising compound wolf's milk parenteral solution security, comprises the steps：(1)
Compound wolf's milk parenteral solution raw medicinal material wolf's milk 100g, ardisia crispa 100g, Canton love-pea vine 100g, cosolvent 2.0g；The hydrotropy
Agent is made up of hydroxypropyl acrylate and glycerine, and the wherein content of hydroxypropyl acrylate is 0.005g~2.0g, and surplus is the third three
Alcohol；(2) wolf's milk, ardisia crispa add water to cook secondary, 2 hours every time, collecting decoction, and filtration, filtrate decompression is concentrated into relatively close
Spend for 1.27~1.30 (80 DEG C), let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression recovery second
Alcohol and to be concentrated into relative density be 1.30 (80 DEG C), adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate decompression is dense
It is about 1.15 (80 DEG C) to be reduced to relative density, and decoction is standby；Canton love-pea vine add water to cook it is secondary, 1 hour every time, collecting decoction, filter
To cross, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, is stood overnight,
Filtration, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, stands overnight, filters,
It is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate is concentrated into
Relative density is 1.15 (80 DEG C), is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filtration, filtrate adds
Enter cosolvent and water for injection is configured to 1000ml solution.Stir evenly.(3) with 20% sodium hydroxide solution adjust solution ph to
6.5-8.5.(4) above-mentioned solution is filtered through miillpore filter.(5) it is filling, sterilizing, produce.
For the present invention by substantial amounts of experimental study, it is the preferable substitute products of glycerine to find a kind of hydroxypropyl acrylate.
The pharmacological toxicology experimental data of document report shows that its toxicity is significantly lower than glycerine.We pass through substantial amounts of experimental study in addition
It was found that the amount ratio glycerine of hydroxypropyl acrylate is low when reaching identical solubilization-aid effect, Drug safety is more improved.
The pharmacological toxicology experimental data of document report shows that the security of hydroxypropyl acrylate is higher than glycerine, and its toxicity is bright
It is aobvious to be less than glycerine (see the table below 1-3).Use (0.5g/100ml) acrylic acid of equivalent respectively in compound wolf's milk parenteral solution
Hydroxypropyl acrylate and glycerine, safety experiment comparative study result show, use (0.5g/100ml) hydroxypropyl acrylate of equivalent
Group is obvious lower than using glycerine group in terms of hemolytic, excitant, anaphylaxis and the toxicity such as reduce blood pressure, and passes through
Adverse reaction occurs in clinical practice for compound wolf's milk parenteral solution probability and risk are considerably reduced, improves clinical use
The security of medicine.
To sum up, the beneficial effects of the invention are as follows：There is provided that a kind of security is more preferable, the more obvious cosolvent of solubilization-aid effect is replaced
Potential safety hazard in compound wolf's milk parenteral solution be present and influence the glycerol cosolvent of product quality；The safety of hydroxypropyl acrylate
Property and dosage higher than glycerine it is lower, reduce adverse reaction occurs for medicine probability and risk, improve the safety of clinical application
Property.
Embodiment
Embodiment 1
Preparation method：Wolf's milk, ardisia crispa add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was dense
It is 1.27~1.30 (80 DEG C) to be reduced to relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate
It is 1.30 (80 DEG C) that ethanol, which is recovered under reduced pressure, and is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is about 1.15 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and decoction is standby；Canton love-pea vine add water to cook it is secondary, 1 hour every time, close
And decocting liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol,
Stand overnight, filter, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood
Overnight, filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is 1.15 (80 DEG C) that filtrate, which is concentrated into relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours,
Filtration, filtrate addition polyhydroxypropyl acrylate makees cosolvent and water for injection is configured to 1000ml solution.Stir evenly.With 20% hydrogen-oxygen
Change sodium solution and adjust solution ph to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.It is filling, sterilizing, produce.
Embodiment 2
Preparation method：Wolf's milk, ardisia crispa add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was dense
It is 1.27~1.30 (80 DEG C) to be reduced to relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate
It is 1.30 (80 DEG C) that ethanol, which is recovered under reduced pressure, and is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is about 1.15 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and decoction is standby；Canton love-pea vine add water to cook it is secondary, 1 hour every time, close
And decocting liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol,
Stand overnight, filter, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood
Overnight, filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is 1.15 (80 DEG C) that filtrate, which is concentrated into relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours,
Filtration, filtrate adds hydroxypropyl acrylate and glycerine makees cosolvent and water for injection is configured to 1000ml solution, stirs evenly.With
20% sodium hydroxide solution adjusts solution ph to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.It is filling, sterilizing, i.e.,
.
Embodiment 3
Preparation method：Wolf's milk, ardisia crispa add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was dense
It is 1.27~1.30 (80 DEG C) to be reduced to relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate
It is 1.30 (80 DEG C) that ethanol, which is recovered under reduced pressure, and is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is about 1.15 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and decoction is standby；Canton love-pea vine add water to cook it is secondary, 1 hour every time, close
And decocting liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol,
Stand overnight, filter, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood
Overnight, filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration,
It is 1.15 (80 DEG C) that filtrate, which is concentrated into relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours,
Filtration, filtrate addition glycerine makees cosolvent and water for injection is configured to solution.Stir evenly.Adjusted with 20% sodium hydroxide solution molten
Liquid pH value is to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.1000 are distributed into, freeze-drying, is produced.
Embodiment 4：
Herba Euphorbiae Humifusae extract, ardisia crispa extract, Herba Abri extract and the hydroxypropyl acrylate of the present invention are manufactured to be supplied
What medicinal composition for injections can be achieved through the following technical solutions：
(1) compound wolf's milk parenteral solution raw medicinal material wolf's milk 100g, ardisia crispa 100g, Canton love-pea vine 100g, acrylic acid hydroxyl
Propyl ester 2.0g；
(2) wolf's milk, ardisia crispa add water to cook secondary, 2 hours every time, collecting decoction, and filtration, filtrate decompression is concentrated into phase
It is 1.27~1.30 (80 DEG C) to density, lets cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression is returned
It is 1.30 (80 DEG C) to receive ethanol and be concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate subtracts
It is about 1.15 (80 DEG C) that pressure, which is concentrated into relative density, and decoction is standby；Canton love-pea vine add water to cook it is secondary, 1 hour every time, merge decoct
Liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, is stood
Overnight, filtration, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood overnight,
Filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate is dense
It is 1.15 (80 DEG C) to be reduced to relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filter, filter
Liquid addition hydroxypropyl acrylate makees cosolvent and water for injection is configured to 1000ml solution.Stir evenly；
(3) solution ph is adjusted to 6.5-8.5 with 20% sodium hydroxide solution；
(4) above-mentioned solution is filtered through miillpore filter；
(5) it is filling, sterilizing, produce.
In the present invention, cosolvent can be hydroxypropyl acrylate, and its dosage is any in 0.005g~5.0g/100ml
Value, such as 0.005g/100ml, 0.01g/100ml, 0.05g/100ml, 1.0g/100ml, 5.0g/100ml；Cosolvent also may be used
To be made up of hydroxypropyl acrylate and glycerine, its usage ratio is 0.005g~5.0g/100ml：0.001g~2.0g/
100ml。
After the present invention uses hydroxypropyl acrylate as cosolvent, its security is more preferable, solubilization-aid effect is more obviously better than
Glycerine, specific data are referring to following table：
The hydroxypropyl acrylate of table 1 and glycerine LD50Toxicity test data compare
Table 2 is injected intravenously hydroxypropyl acrylate compared with haemolysis after glycerine and serum histamine levels
Table 3 is injected intravenously hydroxypropyl acrylate compared with being depressured level after glycerine
In addition, the present invention by experimental studies have found that, in compound wolf's milk parenteral solution, when reaching identical solubilization-aid effect
The dosage of hydroxypropyl acrylate is substantially lower than glycerine, more improves Drug safety.Acrylic acid hydroxyl in pharmaceutical composition
The dosage of propyl ester is 0.005g-5.0g/100ml, preferable amount 0.05g-1.0g/100ml.Also it can be used in pharmaceutical composition
Hydroxypropyl acrylate is combined with glycerine by different proportion makees cosolvent to reduce glycerine dosage, hydroxypropyl acrylate and the third three
The usage ratio of alcohol is 0.005g-5.0g/100ml：0.001g-2.0g/100ml.
The present invention by experimental studies have found that, the hydroxypropyl acrylate of isoconcentration and glycerin solution comparative study solution
PH value changes, the results showed that hydroxypropyl acrylate does not cause the pH value of parenteral solution to decline in itself, and the stability of solution is more preferable, increase
The stability of medicine, be advantageous to improve the security of clinical application.
The compound wolf's milk parenteral solution hydroxypropyl acrylate of table 4 makees 25 DEG C of study on the stability results of cosolvent
60 DEG C of study on the stability results of the compound wolf's milk parenteral solution of table 5 and 0.2% hydroxypropyl acrylate
| Time | 0 day | 5 days | 10 days | 20 days |
| Character | Brown clear liquid | Brown clear liquid | Brown clear liquid | Brown clear liquid |
| Visible foreign matters | Meet regulation | Meet regulation | Meet regulation | Meet regulation |
| PH value | 6.41 | 5.86 | 5.78 | 5.65 |
| It is sterile | It is qualified | It is qualified | It is qualified | It is qualified |
| Pyrogen | It is qualified | It is qualified | It is qualified | It is qualified |
| Content (μ g) | 21.5 | 21.5 | 21.3 | 21.3 |
Claims (6)
1. a kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security, it is characterised in that mainly extracted by wolf's milk
Thing, ardisia crispa extract, Herba Abri extract and injection pharmaceutical composition made of hydroxypropyl acrylate.
2. the pharmaceutical composition according to claim 1 for improving compound wolf's milk parenteral solution security, it is characterised in that every
100ml solution contain equivalent to the Herba Euphorbiae Humifusae extracts of 5 ~ 15g wolf's milk medicinal materials, 5 ~ 15g ardisia crispa medicinal materials ardisia crispa extract,
The Herba Abri extract of 5 ~ 15g Canton love-pea vine medicinal materials, wolf's milk, ardisia crispa, the usage ratio of Canton love-pea vine medicinal material are 1：1：1.
3. the pharmaceutical composition according to claim 1 for improving compound wolf's milk parenteral solution security, it is characterised in that institute
The dosage for stating hydroxypropyl acrylate is 0.005g ~ 5.0g/100ml.
4. the pharmaceutical composition according to claim 3 for improving compound wolf's milk parenteral solution security, it is characterised in that institute
The dosage for stating hydroxypropyl acrylate is 0.05g~1.0g/100ml.
5. the pharmaceutical composition according to claim 1 for improving compound wolf's milk parenteral solution security, it is characterised in that institute
Stating also includes glycerine in pharmaceutical composition, hydroxypropyl acrylate is combined with glycerine by different proportion makees cosolvent, acrylic acid
The usage ratio of hydroxypropyl acrylate and glycerine is 0.005g~5.0g/100ml：0.001g~2.0g/100ml.
6. the pharmaceutical composition of the raising compound wolf's milk parenteral solution security according to claim 1 to 5 any one, its
It is characterised by, described pharmaceutical composition formulation is parenteral solution, powder pin or lyophilized.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610995464.XA CN107661290A (en) | 2016-11-11 | 2016-11-11 | A kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610995464.XA CN107661290A (en) | 2016-11-11 | 2016-11-11 | A kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107661290A true CN107661290A (en) | 2018-02-06 |
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| CN201610995464.XA Withdrawn CN107661290A (en) | 2016-11-11 | 2016-11-11 | A kind of pharmaceutical composition for improving compound wolf's milk parenteral solution security |
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