CN105878703A - Medicine composition capable of improving safety of compound lily injection - Google Patents

Medicine composition capable of improving safety of compound lily injection Download PDF

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Publication number
CN105878703A
CN105878703A CN201610353139.3A CN201610353139A CN105878703A CN 105878703 A CN105878703 A CN 105878703A CN 201610353139 A CN201610353139 A CN 201610353139A CN 105878703 A CN105878703 A CN 105878703A
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injection
bulbus lilii
extract
safety
stearic acid
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杨素坤
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Chengdu Sibeijia Technology Co Ltd
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Chengdu Sibeijia Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8967Lilium, e.g. tiger lily or Easter lily
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/74Rubiaceae (Madder family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a medicine composition capable of improving the safety of a compound lily injection. The medicine composition used for injection is characterized by being mainly prepared from a lily extract, a parslane herb extract, a small centipeda herb extract and dimeric glycerine dipolyhydroxy stearate, wherein every 100ml of solution contains 10-20g of lily extract, 10-20g of parslane herb extract and 1-2g of small centipeda herb extract; the dosage ratio of lily to parslane herb to small centipeda herb is 10 to 10 to 1. The medicine composition has the beneficial effects that the cosolvent with better safety and more obvious solubilization effects is adopted instead of a cosolvent polysorbate 80, which has potential safety hazards and affects the product quality, in the compound lily injection; dimeric glycerine dipolyhydroxy stearate has higher safety and lower dosage than polysorbate 80, thus reducing the occurrence probability and risk of adverse reactions of the medicines and improving the safety of clinical medication.

Description

A kind of pharmaceutical composition improving compound recipe Bulbus Lilii injection safety
Technical field
The invention belongs to pharmaceutical technology field, improve the injection of compound recipe Bulbus Lilii in particular it relates to a kind of The pharmaceutical composition of liquid safety.
Background technology
Compound recipe Bulbus Lilii 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 Bulbus Lilii, Herba Portulacae, eritrichium pedumculare, belongs 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, amenorrhea, injury from falling down, rheumatic arthralgia etc..
In China in wide clinical application for many years, clinical efficacy obtains compound recipe Bulbus Lilii 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 Bulbus Lilii 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 Bulbus Lilii injection safety.
The present invention solves above-mentioned technical problem and be the technical scheme is that a kind of raising compound recipe hundred Close injection safety pharmaceutical composition, mainly by Bulbus Lilii extract, Herba portulacae extract, The injection medicine group that eritrichium pedumculare extract and two polyglycereol dimerization hydroxy stearic acid esters are made Compound, every 100ml solution contains the Bulbus Lilii extract of 10-20g Bulbus Lilii medical material, 10-20g Dens Equi The Herba portulacae extract of Herba Amaranthi tricoloris medical material, the eritrichium pedumculare extract of 1-2g eritrichium pedumculare medical material, Bulbus Lilii, Herba Portulacae, the usage ratio of eritrichium pedumculare medical material are 10:10:1.
For the present invention is better achieved, further, described two polyglycereol dimerization hydroxy stearic acids The consumption of ester is 0.005g~5.0g/100ml.
For the present invention is better achieved, further, described two polyglycereol dimerization hydroxy stearic acids 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, two polyglycereol dimerization hydroxy stearic acid esters are combined by different proportion with polyoxyethylene sorbitan monoleate Making cosolvent, two polyglycereol dimerization hydroxy stearic acid esters with the usage ratio of polyoxyethylene sorbitan monoleate are 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 Bulbus Lilii injection safety, including Following step: (1) compound recipe Bulbus Lilii injection raw medicinal material Bulbus Lilii 100g, Herba Portulacae 100g, Eritrichium pedumculare 100g, cosolvent 2.0g;Described cosolvent is by two polyglycereol dimerization hydroxy stearic acids Ester forms with polyoxyethylene sorbitan monoleate, and wherein the content of two polyglycereol dimerization hydroxy stearic acid esters is 0.005g~2.0g, surplus is polyoxyethylene sorbitan monoleate;(2) Bulbus Lilii, Herba Portulacae boiling two Secondary, each 2 hours, collecting decoction, filter, filtrate reduced in volume to relative density be 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, Decompression filtrate recycling ethanol to be concentrated into relative density be 1.30 (80 DEG C), adds 3 times amount water, Being sufficiently stirred for, cold preservation 48 hours, filter, filtrate reduced in volume is about 1.15 to relative density (80 DEG C), medicinal liquid is standby;Eritrichium pedumculare boiling secondary, each 1 hour, collecting decoction, Filtering, 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), add ethanol and make containing amount of alcohol to be 70%, stand overnight, and filter, and filtrate is concentrated into Relative density is 1.30 (80 DEG C), adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filter Crossing, 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, is sufficiently stirred for, cold preservation 24 hours, filters, and filtrate adds cosolvent and water for injection It is configured to 1000ml solution.Stir evenly.(3) with 20% sodium hydroxide solution regulation pH value of solution It is worth 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 two polyglycereol dimerization hydroxy stearic acids Ester (Solutol) it is the preferable substitute products of polyoxyethylene sorbitan monoleate.Two polyglycereol dimerization 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 two polyglycereol dimerization hydroxy stearic acid esters 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 two polyglycereol dimerization hydroxy stearic acid esters (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 Bulbus Lilii injection respectively Use (0.5g/100ml) two polyglycereol dimerization hydroxy stearic acid ester (Solutol of equivalent) and polyoxyethylene sorbitan monoleate (Tween 80), safety experiment comparative study result shows, Use (0.5g/100ml) two polyglycereol dimerization hydroxy stearic acid ester (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 Bulbus Lilii 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 Bulbus Lilii injection Cosolvent polyoxyethylene sorbitan monoleate (Tween 80);Two polyglycereol dimerization hydroxy stearic acid ester (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: Bulbus Lilii, Herba Portulacae 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;Intestinum Gallus domesticus Grass boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into the closeest Degree is 1.25~1.30 (80 DEG C), lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stood At night, 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, Add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filtrate is concentrated into relative density It is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, add 2 times amount water, be sufficiently stirred for, cold preservation 24 Hour, filtering, filtrate adds two polyglycereol dimerization hydroxy stearic acid ester (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: Bulbus Lilii, Herba Portulacae 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;Intestinum Gallus domesticus Grass boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into the closeest Degree is 1.25~1.30 (80 DEG C), lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stood At night, 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, Add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filtrate is concentrated into relative density It is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, add 2 times amount water, be sufficiently stirred for, cold preservation 24 Hour, filtering, filtrate adds two polyglycereol dimerization hydroxy stearic acid ester (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: Bulbus Lilii, Herba Portulacae 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;Intestinum Gallus domesticus Grass boiling secondary, each 1 hour, collecting decoction, filter, filtrate is concentrated into the closeest Degree is 1.25~1.30 (80 DEG C), lets cool, and adds ethanol and makes containing amount of alcohol to be 65%, stood At night, 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, Add 3 times amount water, be sufficiently stirred for, cold preservation 48 hours, filter, filtrate is concentrated into relative density It is 1.15 (80 DEG C), merges with above-mentioned medicinal liquid, add 2 times amount water, be sufficiently stirred for, cold preservation 24 Hour, filtering, filtrate adds two polyglycereol dimerization hydroxy stearic acid ester (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 Bulbus Lilii extract of the present invention, Herba portulacae extract, eritrichium pedumculare extract and two polyglycereol Dimerization hydroxy stearic acid ester (Solutol) the injection pharmaceutical composition made can It is achieved through the following technical solutions:
(1) compound recipe Bulbus Lilii injection raw medicinal material Bulbus Lilii 100g, Herba Portulacae 100g, eritrichium pedumculare 100g, two polyglycereol dimerization hydroxy stearic acid ester (Solutol)2.0g;
(2) Bulbus Lilii, Herba Portulacae boiling secondary, each 2 hours, collecting decoction, filter Crossing, filtrate reduced in volume to relative density is 1.27~1.30 (80 DEG C), lets cool, adds ethanol Making containing amount of alcohol is 65%, stands overnight, and filters, and decompression filtrate recycling ethanol is also concentrated into Relative density is 1.30 (80 DEG C), adds 3 times amount water, is sufficiently stirred for, cold preservation 48 hours, filter Crossing, filtrate reduced in volume to relative density is about 1.15 (80 DEG C), and medicinal liquid is standby;Eritrichium pedumculare 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 two polyglycereol dimerization hydroxy stearic acid ester (Solutol) Make cosolvent and water for injection is configured to 1000ml solution.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 two polyglycereol dimerization hydroxy stearic acid esters, 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 sweet by dimerization Oil dimerization 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 two polyglycereol dimerization hydroxy stearic acid esters as cosolvent, its safety More preferably, solubilization-aid effect be more obviously better than polyoxyethylene sorbitan monoleate, concrete data see following table:
Table 1 SolutolWith 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 Bulbus Lilii injection, reach identical Solubilization-aid effect time two polyglycereol dimerization hydroxy stearic acid ester (Solutol) consumption Lower than polyoxyethylene sorbitan monoleate (Tween 80), more improve Drug safety.Medicine group Two polyglycereol dimerization hydroxy stearic acid ester (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 two polyglycereol dimerization hydroxy stearic acid ester (Solutol) (tell with polyoxyethylene sorbitan monoleate Temperature 80) combine by different proportion and to make cosolvent to reduce polyoxyethylene sorbitan monoleate (Tween 80) consumption, two Polyglycereol dimerization 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 Bulbus Lilii injection safety, it is characterized in that, the main injection pharmaceutical composition being made up of Bulbus Lilii extract, Herba portulacae extract, eritrichium pedumculare extract and two polyglycereol dimerization hydroxy stearic acid esters, every 100ml solution is containing the Bulbus Lilii extract of 10-20g Bulbus Lilii medical material, the Herba portulacae extract of 10-20g purslane medicinal material, the eritrichium pedumculare extract of 1-2g eritrichium pedumculare medical material, and Bulbus Lilii, Herba Portulacae, the usage ratio of eritrichium pedumculare medical material are 10:10:1.
The pharmaceutical composition of raising compound recipe Bulbus Lilii injection safety the most according to claim 1, it is characterised in that the consumption of described two polyglycereol dimerization hydroxy stearic acid esters is 0.005g~5.0g/100ml.
The pharmaceutical composition of raising compound recipe Bulbus Lilii injection safety the most according to claim 1, it is characterised in that the consumption of described two polyglycereol dimerization hydroxy stearic acid esters is 0.05g~1.0g/100ml.
The pharmaceutical composition of raising compound recipe Bulbus Lilii injection safety the most according to claim 1, it is characterized in that, described pharmaceutical composition also includes polyoxyethylene sorbitan monoleate, two polyglycereol dimerization hydroxy stearic acid esters and polyoxyethylene sorbitan monoleate are combined by different proportion and are made cosolvent, and two polyglycereol dimerization hydroxy stearic acid esters are 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 Bulbus Lilii 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.
CN201610353139.3A 2016-05-24 2016-05-24 Medicine composition capable of improving safety of compound lily injection Withdrawn CN105878703A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
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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Application publication date: 20160824