CN105943605A - Application of Danhong injection as terfenadine heart adverse effect antagonist - Google Patents
Application of Danhong injection as terfenadine heart adverse effect antagonist Download PDFInfo
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- CN105943605A CN105943605A CN201610498724.2A CN201610498724A CN105943605A CN 105943605 A CN105943605 A CN 105943605A CN 201610498724 A CN201610498724 A CN 201610498724A CN 105943605 A CN105943605 A CN 105943605A
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
The invention discloses an application of a Danhong injection as a terfenadine heart adverse effect antagonist. The application overcomes the technology bias of the prior art on the aspect of application, and experiments show that the Danhong injection has a remarkable effect of improving the heart rhythm change, caused by terfenadine, of a zebra fish. In addition, when the concentration of the Danhong injection is less than or equal to 30muL/mL, the normal zebra fish does not show an obvious teratogenic effect after 6 days of continuous injection. On the basis of the extensive clinical application of the Danhong injection, a theoretical foundation is provided for the drug combination of the terfenadine and the enhancement of the safety of the terfenadine.
Description
Technical field
The present invention relates to the application of a kind of DANHONG ZHUSHEYE, anti-as terfenadine heart condition particularly to a kind of DANHONG ZHUSHEYE
Answer the application of antagonist, belong to technical field of drug development.
Background technology
Along with the acceleration of socioeconomic development, especially aged tendency of population and Development of China's Urbanization, China's cardiovascular disease risk because of
Element fashion trend is in substantially rising situation, and the number of the infected that result in cardiovascular disease continues to increase.According to " China's cardiovascular diseases's report
Accuse 2014 " to announce, there is cardiovascular patient 2.9 hundred million in the whole nation, has 1 to suffer from cardiovascular diseases in every 5 adults.Cardiovascular disease
Mortality rate occupies first of various disease, just has 2 examples to die from cardiovascular diseases in every 5 example dieds.According to " China cardiovascular diseases report 2014 "
Announcing, the Retrospective review to 22 the provincial hospital Cardiological inpatients in the whole nation shows, in Cardiological inpatient, the rhythm of the heart loses
Often account for 26.8%.Implant cardiac pacemaker is for the only effective Therapeutic Method of bradycardia, and success rate of operation is high, complication
Low.Catheter ablation (RFCA) radical cure preexcitation syndrome (WPW) and supraventricular tachycardia (SVT) are as ripe skill
Art is widely used in China.The arrhythmia of China develops healthy and orderly, but still has difficulties with not enough, main table
Present: to carry out pacemaker, ICD, CRT, hospital's deficiency of atrial fibrillation radio-frequency ablation procedure, professional and technology shortage；Medical insurance
The aspects such as deficient payment.
Terfenadine is second filial generation antihistaminic, chemical entitled α-[4-1,1-dimethyl ethyl) phenyl]-4-(hydroxyl-hexichol
Methyl)-1-piperidine butanol.For treating anaphylactic disease.Its great advantage is central nervous system to be produced calmness
Effect, thus without producing the side effect such as drowsiness, sleepy, weak, absent minded.But Clinical practice finds Te Feina
Surely may result in serious arrhythmia, remove city or restriction use the end of the nineties in last century in countries such as America and Europes, this medicine exists at present
China manages with prescription drugs.The medicine of terfenadine itself rather than metabolite have the ARR effect of induction.Terfenadine draws
The accidental torsades de pointes room speed risen betides the patient that those terfenadine metabolism are impaired.Terfenadine induces ARR machine
System can cause the medicine of Torsade de points similar with other, is owing to it has blocked potassium channel.Block ventricular muscle cell
The Delayed Rectifier Potassium Current (IKr) quickly activated on film, makes repolarization time and action potential duration extend, shows as body surface
Q-T interval prolongation, cardiac muscle each several part repolarization dispersion increases, and QT interval prolongation produces early after depolarization (EAD)
And triggered activity, then cause pleiomorphism ventricular arrhythmia and Torsade de points (TdP).
The cardiac toxicity that terfenadine non-rational use of drug causes is clearly present, and terfenadine is implemented prescription drugs management by China,
Description has been carried out to cardiac toxicity equivalent risk prompting, it is proposed that medical worker strictly grasps indication, it is to avoid contraindication is used
Medicine, controls dosage course for the treatment of.Epidemiological study finds that the cardiac toxicity that terfenadine causes is obvious unlike other medicines, as
Fruit is strict controls contraindication and bad drug combination, and the patient for original cardiovascular system diseases weighs the advantages and disadvantages, vigilant clinic
Apply the untoward reaction of this medicine, standardized drug's dosage and merging medicine, to the untoward reaction Preinoc being likely to occur, will
Improve effectiveness and the safety of terfenadine clinical application.
DANHONG ZHUSHEYE be with Radix Salviae Miltiorrhizae as principal agent, the Chinese medicine made for accessory drugs of Flos Carthami, there is blood circulation promoting and blood stasis dispelling, TONGMAI SHULUO
Effect.Through patent and literature search, in terms of not finding that DANHONG ZHUSHEYE is used for antagonism terfenadine heart condition reaction medicine
Research or report.
Summary of the invention
For existing terfenadine clinical adverse present situation, the technical problem to be solved is to provide a kind of DANHONG note
Penetrate the liquid application as terfenadine heart condition reaction antagonist.
Term illustrates:
DANHONG ZHUSHEYE: record in country's standard for traditional Chinese medicines compilation, standard number: WS-11220 (ZD-1220)-2002.
DANHONG ZHUSHEYE formula: Radix Salviae Miltiorrhizae 750 grams, 250 grams of Flos Carthami, sodium chloride for injection 7 grams, make 1000mL.
DANHONG ZHUSHEYE preparation method: Radix Salviae Miltiorrhizae Diluted Alcohol extracts 2 times, takes filtrate.Medicinal residues and Flos Carthami flooding 2 times, takes
Filtrate.Merging filtrate, is concentrated into clear paste, and addition sodium chloride to the most isotonic, regulates pH6-7, filters, cold preservation, inject and use water
To ormal weight, filter, embedding, sterilizing, to obtain final product.
Technical scheme is as follows:
DANHONG ZHUSHEYE is as the application of terfenadine heart condition reaction antagonist.
According to currently preferred, described application, DANHONG ZHUSHEYE clinic usage and dosage is: 1-2ml of intramuscular injection,
1-2 time on the one；Or intravenous injection, a 3-4ml, slow after adding mass concentration 50% glucose injection 20ml dilution
Injection, 1-2 time on the one.
According to currently preferred, described application, the reaction of described heart condition includes torsade de pointes, battle array
The property sent out ventricular tachycardia, sinus bradycardia companion's arrhythmia, complete right bundle branch block and/or atrial fibrillation.
According to currently preferred, described application, DANHONG ZHUSHEYE is to use with the Clinical practice time of terfenadine simultaneously.
Beneficial effect
Instant invention overcomes the technology prejudice of prior art application aspect, DANHONG ZHUSHEYE has preferably alleviation terfenadine heart
The effect of untoward reaction.Being drawn by experiment, the Brachydanio rerio cardiac rhythm change that terfenadine is caused by DANHONG ZHUSHEYE has substantially
Improvement result.And DANHONG ZHUSHEYE is when concentration≤30 μ L/mL, within continuous to normal Brachydanio rerio 6 days, do not demonstrate obvious teratogenesis
Effect.Based on DANHONG ZHUSHEYE extensive application clinically, can be terfenadine drug combination and enhancing its safety offer reason
Opinion foundation.
Hereinafter by concrete experimental example and embodiment, the invention will be further described, but is not limited to the present invention.
Experimental example 1:
DANHONG ZHUSHEYE used by the present embodiment, it is mainly composed of Radix Salviae Miltiorrhizae, Flos Carthami and water for injection, and manufacturer is Heze step
Long pharmaceutical Co. Ltd, product batch number is 15051030, and the quasi-word of traditional Chinese medicines is Z20026866.
Terfenadine used by the present embodiment be purchased from sigma company, tefenadine), original solution be concentration be that 10mM is dissolved in two
The solution of methyl sulfoxide.Must be with cultivating dilute with water during use.
Brachydanio rerio used by this experimental example (is all purchased from Shanghai life section of the Chinese Academy of Sciences for healthy AB strain or wild-type zebrafish
Learn academy's biochemistry and Institute of Cell Biology), raise 28 DEG C, in the fish room of 14 hours photoperiods, and will
Milter and raun separate raising, and the formula of breeding water is shown in Table 1.Fish room is fixed on 9:00 every morning and starts illumination, and feeding
Shrimps, and 16:00 in afternoon feeding shrimps once again is once, the Brachydanio rerio so raised can ensure that fish roe quality and stable yield.
After treating fish feed fish pulled out and be placed in pairing box, containing a pair male and female fish in every box, and insert dividing plate on pairing box upper strata
Male and female is separated, it is to avoid fish laid eggs before the scheduled time.The next day, first by drawing out partition plate before fish roe to be used, make fish permissible
Proceeding by and knock into the back, about after 3～5 minutes, fish will start to lay eggs.Collect fish roe, with clear water careful wash out impurity after,
After clean fish roe is transposed to be marked with the culture dish of embryo medium.
The formula of table 1. breeding water
The acquisition of zebrafish embryo and use:
The Brachydanio rerio utilizing wild type carries out copulation, and pairing need to use dividing plate, to guarantee the concordance of embryonic stage the previous day.Make
Testing with the embryo with a pair, the embryo born controls the time within half an hour, reduces the difference of development time between embryo
Property, is received in embryo in the culture dish added with embryo medium, make embryo be difficult to mouldy outside, also allow water mineral content consistent.
The birth Brachydanio rerio of latter 2 hours is placed under anatomical lens, chooses normotrophic Brachydanio rerio prelarva, put in 6 orifice plates, every hole
15 tails.It is born latter about 2 hours from zebrafish embryo and adds terfenadine and DANHONG ZHUSHEYE, be simultaneously introduced 0.2mmol L-1
Benzene thiourea, prevent pigmentation too much, cardiac shape is observed in impact.
Compound treatment:
6 experimental grouies are set: 1 solvent control group, 1 terfenadine process group, 3 terfenadine+DANHONG ZHUSHEYE
Process group.Removing the breeding water in microwell plate, add 5ml breeding water in blank group, solvent control group adds 5ml and contains
The breeding water solution of volumetric concentration 0.1% dimethyl sulfoxide, terfenadine process group adds 5ml 4 μm ol L-1 terfenadine
Solution, terfenadine+DANHONG ZHUSHEYE process group be separately added into 4 μm ol L-1 terfenadine solution and 4 μ L/mL, 8 μ L/mL,
16 μ L/mL and 30 μ L/mL DANHONG ZHUSHEYE, put into after cultivating 6 days in 28 DEG C of constant incubators, change a fresh drug every day
Liquid, to latter 6 days often 3 parallel holes of group of being born.
Phenotype analytical:
Add the tricaine anesthesia Brachydanio rerio of 0.3 ‰ (mass percents), then with 4% (mass percent) methylcellulose
It is fixed on microscope slide, under inverted microscope, then observes cardiac shape.
Solvent control group and the dirty form of blank group switching centre are normal.There is pericardium edema and yolk sac edema in terfenadine group.With
The increase of DANHONG ZHUSHEYE concentration, pericardium edema and yolk sac edema to fade away (see accompanying drawing 1, the Brachydanio rerio being born latter 6 days
Prelarva).Along with DANHONG ZHUSHEYE concentration increases, tested Brachydanio rerio mortality rate is gradually increased.DANHONG ZHUSHEYE is determined through experimental exploring
The maximum safe concentration shared with terfenadine is 30 μ L/mL.Therefore, can by observe cardiac shape analyze DANHONG ZHUSHEYE (≤
30 μ L/mL) mitigation to terfenadine toxicity.
Quantitative analysis:
Add the tricaine anesthesia Brachydanio rerio that concentration is 0.3 ‰ (mass percents), then with 3% (mass percent) methyl
Cellulose is fixed on microscope slide, in the environment of peace and quiet, keeps room temperature 25 DEG C, the heart beating of Brachydanio rerio in recording 15 seconds
Number, it is the heart rate of Brachydanio rerio per minute that gained beats is multiplied by 4.
Brachydanio rerio atrium under normal condition is consistent with the ventricular beats rhythm and pace of moving things.After terfenadine is administered, Brachydanio rerio AR and ventricle
Rate ratio is about 2.5.DANHONG ZHUSHEYE and the ratio of terfenadine co-administered group, Brachydanio rerio heart AR and Ventricular Rate
Being decreased obviously, ratio is about 1.5.Illustrate that the Brachydanio rerio cardiac rhythm change that terfenadine is caused by DANHONG ZHUSHEYE has substantially
Improvement result (see accompanying drawing 2).
Extract the Messenger RNA of each group of experiment, find multiple genes relevant with cardiac function through transcription group sequencing analysis
Expression there occurs significant change, and DANHONG ZHUSHEYE can recover the expression (being shown in Table 2) of these genes.
The change of table 2 each experimental group cardiac electricity rhythm and pace of moving things related gene expression level
Accompanying drawing explanation
Fig. 1 is the mitigation figure of the pericardium edema that terfenadine is caused by DANHONG ZHUSHEYE；Wherein, A. solvent control group；B.
Terfenadine 4 μm ol L-1；C. terfenadine 4 μm ol L-1+ DANHONG ZHUSHEYE 4 μ L/mL；D. terfenadine 4 μ
Mol L-1+ DANHONG ZHUSHEYE 8 μ L/mL；E. terfenadine 4 μm ol L-1+ DANHONG ZHUSHEYE 16 μ L/mL；
Fig. 2 is the protective effect figure of the Brachydanio rerio rhythm abnormality phenomenon that terfenadine is caused by DANHONG ZHUSHEYE.
Detailed description of the invention
The manufacturer of DANHONG ZHUSHEYE described in the present embodiment is Heze Buchang Pharma Co., Ltd., and product batch number is 15051030,
The quasi-word of traditional Chinese medicines is Z20026866.Terfenadine used by the present embodiment be purchased from sigma company, original solution be concentration be that 10mM is molten
Solution in dimethyl sulfoxide.Must be with cultivating dilute with water during use.
Embodiment 1, DANHONG ZHUSHEYE are as the application of terfenadine heart condition reaction antagonist
DANHONG ZHUSHEYE is as the clinical usage and dosage of terfenadine torsade de pointes untoward reaction antagonist: flesh
A meat 1-2ml of injection, 1-2 time on the one.
Embodiment 2, DANHONG ZHUSHEYE are as the application of terfenadine heart condition reaction antagonist
DANHONG ZHUSHEYE is as the clinical usage and dosage of terfenadine paroxysmal ventricular tachycardia untoward reaction antagonist: vein is noted
Penetrate, a 4ml, slowly inject after adding mass concentration 50% glucose injection 20ml dilution, 1-2 time on the one.
Embodiment 3, DANHONG ZHUSHEYE are as the application of terfenadine heart condition reaction antagonist
DANHONG ZHUSHEYE is as the clinical usage and dosage of terfenadine sinus bradycardia companion's arrhythmia untoward reaction antagonist: flesh
A meat 1-2ml of injection, 1-2 time on the one.
Embodiment 4, DANHONG ZHUSHEYE are as the application of terfenadine heart condition reaction antagonist
DANHONG ZHUSHEYE is as the complete right bundle branch block of terfenadine and the clinical usage of atrial fibrillation untoward reaction antagonist
Consumption: intravenous injection, a 4ml, slowly injects after adding mass concentration 50% glucose injection 20ml dilution, 1-2 on the one
Secondary.
Claims (5)
1. DANHONG ZHUSHEYE is as the application of terfenadine heart condition reaction antagonist.
Apply the most as claimed in claim 1, it is characterised in that DANHONG ZHUSHEYE clinic usage and dosage is: 1-2ml of intramuscular injection, 1-2 time on the one.
Apply the most as claimed in claim 1, it is characterised in that DANHONG ZHUSHEYE clinic usage and dosage is: intravenous injection, a 3-4ml, slowly inject after adding mass concentration 50% glucose injection 20ml dilution, 1-2 time on the one.
Apply the most as claimed in claim 1, it is characterised in that the reaction of described heart condition includes torsade de pointes, paroxysmal ventricular tachycardia, sinus bradycardia companion's arrhythmia, complete right bundle branch block and/or atrial fibrillation.
Apply the most as claimed in claim 1, it is characterised in that DANHONG ZHUSHEYE is to use with the Clinical practice time of terfenadine simultaneously.
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2016
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| CN1520859A (en) * | 2003-01-28 | 2004-08-18 | 黄衍民 | Cerebrovascular and cardiovascular disease treating injection containing red-rooted salvia and safflower |
| CN1589855A (en) * | 2003-08-28 | 2005-03-09 | 天津天士力制药股份有限公司 | Application of red sage root and its prepatation in making medicine for treating aspirin resistance blood vessel disease |
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| CN103940929A (en) * | 2014-05-05 | 2014-07-23 | 山东丹红制药有限公司 | Method for detecting traditional Chinese medicine injection for treating cardiovascular and cerebrovascular diseases |
| CN104666412A (en) * | 2015-02-11 | 2015-06-03 | 济南大学 | Application of taking danhong injection as CYP enzyme inhibitor |
Non-Patent Citations (2)
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