CN104042602A - Application of sodium glutamate in puerarin injection - Google Patents
Application of sodium glutamate in puerarin injection Download PDFInfo
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- CN104042602A CN104042602A CN201410248104.4A CN201410248104A CN104042602A CN 104042602 A CN104042602 A CN 104042602A CN 201410248104 A CN201410248104 A CN 201410248104A CN 104042602 A CN104042602 A CN 104042602A
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Abstract
The invention relates to application of sodium glutamate in puerarin injection. The injection containing puerarin is prepared by combining sodium glutamate and puerarin, or is combined application of a sodium glutamate injection and puerarin injection, so that adverse response of adventitious hemolysis puerarin containing injection can be effectively overcome, the safety of puerarin injection administration can be improved.
Description
Technical field
The present invention relates to the new medical use of sodium glutamate, be specifically related to the application in puerarin injection.Background technology
Sodium glutamate, its chemical constitution and character with in milk, egg, Carnis Gallus domesticus, pig in contained glutamic acid identical, be the important component part that human body is eaten protein, be seasoning good merchantable brand, also belong to amino acid drug, be put into clinically many state-promulgated pharmacopoeia.In the world of medicine, many countries all carried out conscientious research and test aspect toxicology, pharmacology and pharmacodynamics in the world, had drawn compellent conclusion.Sodium glutamate can be combined into the glutamine nontoxic to body with blood ammonia, is conducive to the generation of Aspartic Acid, promotes the synthetic of ornithine cycle and carbamide, thereby reduces too high blood ammonia.Be used for the treatment of clinically hepatic coma, liver dysfunction and be applicable to a variety of causes stupor Resuscitation Period.Participate in brain internal protein and carbohydrate metabolism, promote brain cell oxidizing process, improve central nervous system's function, improve cerebral tissue structure.Cerebral tissue can only be oxidized glutamic acid, and can not be oxidized other aminoacid, and in the time that glucose supplies is not enough, glutamic acid can be used as the energy of cerebral tissue, nutrition cerebral cortex.To neurasthenia, epileptics, the disease auxiliary treatment such as children's's cerebral hypoplasia, successful.Can hypermnesis, stable emotion, inspires enthusiasm, and improves intelligence.Glutamic acid enters after human body, and transamination also can occur, synthetic other aminoacid (seeing " pharmacological action of monosodium glutamate and clinical application " that Ge Wenjin writes, business scientific and technological development, 1995,3,19 pages).
Puerarin is the monomer-isoflavone compounds extracting from the dry root of legume pueraria lobata, 4 ', and 7 one dihydroxy-8-β-D glucone isoflavone.Be widely used in clinically the treatment of cardiovascular disease.Being applied at present the clinical pharmaceutical preparation that contains puerarin is mainly injection.Along with being widely used of puerarin, also more and more about the report of puerarin untoward reaction in recent years, cause the world of medicine's extensive concern.By analyzing nearly 20 years adverse reaction of tcm, puerarin injection ranks the 18th.The untoward reaction of puerarin injection had once been circulated a notice of at national drug adverse reaction monitoring center in the 3rd phase of January in 2003 " adverse drug reaction communication ".Most researchers is thought, puerarin injection be taking 50% propylene glycol as solvent formulated, unavoidably because the difference generation purity of the aspect such as extraction process, technology is inadequate, introduce impurity and cause various reactions (to see " clinical use puerarin injection being occurred to the analysis of untoward reaction " that Xu Xianghui writes, journal of shanghai Chinese medicine, 2006,40 (8): 71-72; " clinical practice of puerarin and the untoward reaction " of writing with Xu Shiguo, time precious traditional Chinese medical science traditional Chinese medicines, 2005,16 (12): 1307-1308).After analyzing, 63 routine puerarin untoward reaction of the domestic main medical journals of Chinese report to 2000-2004 find male 40 examples, female's 23 examples; Year at age 34～81 (57.5 ± 23.5).All cases are intravenous drip administration.Dosage is 0.4～0.6g, and medicine diluent is 5% Glucose Liquid, normal saline, 5% glucose saline etc.The fastest person of reacting generating time is 3min, and the slowest person is 13d, all occurs in administration process.There are responder 47 examples in first administration, responder 16 examples appear in repeat administration.Statistics shows, common adverse reactions has allergy (generate heat, tremble etc., 24 examples), anaphylactic shock (4 example), hemolytic anemia (13 example), hepatic injury, renal damage (7 example), drug fever (10 example), dead (5 example).All cases are all without allergies, and after reaction occurs, drug withdrawal all recovers (except death) through anti symptom treatment.Dosage and used diluent are in package insert prompting range, and institute responds all certainly as due to puerarin.The generation of untoward reaction and suffer from disease independent, have nothing to do with age, sex, contacts without much with drug dilution liquid.Relevant with patient's body constitution difference, particularly elderly and infirm easily occurs.The length of reacting generating time is relevant with the slow degree of Chinese medicine preparation onset (sees flourish " the routine document analysis of puerarin untoward reaction 63 " write whole-heartedly, modern combination of Chinese and Western medicine magazine, 2005,14 (1): 140).Quiet about 10min of puerarin of one patient, appears as acute renal insufficiency, hemolytic anemia (seeing " Puerarin and hemolytic anemia " that Guan Minghua writes, adverse effect magazine, 2003,5:291).Therefore the hemolytic anemia that, puerarin causes is due to puerarin itself.
Summary of the invention
The object of the present invention is to provide the new medicine use of sodium glutamate, i.e. the application of sodium glutamate in puerarin injection, sodium glutamate can effectively be prevented and treated the intravascular hemolysis untoward reaction that puerarin brings out.
In fact, the present invention relates to the application of sodium glutamate in the time preparing puerarin injection compound preparation, also can with puerarin injection with injection and transfusion the interim fit applications of mode, or with injection and transfusion mode application sodium glutamate after then apply again puerarin injection.
For achieving the above object, the technical solution used in the present invention is: sodium glutamate is being prepared the new purposes of puerarin injection.Sodium glutamate and puerarin injection are with the interim fit applications of mode of injection and transfusion.After the mode application sodium glutamate with injection and transfusion, then apply again puerarin injection.
Related content in technique scheme is explained as follows:
1,, in such scheme, described injection, contains following weight portion medicine: 1～50 part of sodium glutamate, 1～50000 part of puerarin.
2,, in such scheme, described injection, also contains adjuvant 1～50 weight portion, water for injection 1～10000 weight portion.Described adjuvant is sodium bicarbonate solution, Glucose Liquid, propylene glycol liquid, glucose saline, sodium chloride injection or normal saline.
3,, in such scheme, described injection can be injection, powder pin or the transfusion of accepting clinically.
4,, in such scheme, the preparation method of described injection is as described below:
Described powder pin, is made by sodium glutamate and puerarin mixing, sterilizing; Or mixed by sodium glutamate, puerarin and sodium chloride, be dissolved in water for injection, then adjust pH value to 5.0-8.5 with hydrochloric acid or sodium bicarbonate solution, filter, after filtrate sterilizing, be potted in powdery ampoule sterilizing again and make;
Described injection.Mixed by sodium glutamate, puerarin and sodium chloride, be dissolved in water for injection, then adjust pH value 5.0-8.5 with hydrochloric acid or sodium bicarbonate solution, filter, filtrate is potted in sterilizing in ampoule and makes.Or sodium glutamate is by 5% Glucose Liquid, 5% glucose saline, propylene glycol liquid (is formed by propylene glycol and normal saline (1: 1) configuration by volume, include propylene glycol 0.5ml/ml), sodium chloride injection or physiological saline solution, mix with puerarin injection, filter, filtrate is potted in sterilizing in ampoule and makes.
Described transfusion, is mixed by sodium glutamate, puerarin and sodium chloride, is dissolved in water for injection, then adjusts pH value 5.0-8.5 with hydrochloric acid or sodium bicarbonate solution, dissolves, and filters, and filtrate is potted in sterilizing in saline vial and makes.Or sodium glutamate is by 5% Glucose Liquid, 5% glucose saline, propylene glycol liquid (is formed by propylene glycol and normal saline (1: 1) configuration by volume, include propylene glycol 0.5ml/ml), sodium chloride injection or physiological saline solution, mix with puerarin injection, filter, filtrate is potted in sterilizing in ampoule and makes.
5,, in such scheme, described interim fit applications refers in hospital, mixes together transfusion or injection in application puerarin injection with sodium glutamate.
6, in such scheme, described then uses puerarin injection after the mode application sodium glutamate with injection and transfusion again, refer in hospital, use after sodium glutamate in the mode of injecting and infuse, then follow the mode application puerarin injection with injection and transfusion.
Puerarin has and has coronary artery dilator and cerebrovascular, reduction myocardial oxygen consumption, improves the effect of microcirculation and antiplatelet aggregation.Clinically for auxiliary treatment coronary heart diseases and angina pectoris, myocardial infarction, retina arteriovenous obstruction, sudden deafness and ischemic cerebrovascular, infantile viral myocarditis, diabetes etc.Puerarin can be made compound puerarin injection for preventing and treating various diseases with sodium glutamate compatibility, as for preventing and treating diabetic peripheral neuropathy, hypertension complicated with diabetes mellitus, diabetic nephropathy, acute cerebral infarction, stable angina pectoris, Lower extremity deep venous thrombosis and vertigo due to vertebrobasilar insufficiency etc.But, very easily cause intravascular hemolysis containing the puerarin in puerarin injection.Sodium glutamate have protect the liver, the multiple physiologically active such as brain-strengthening, slow down aging, present inventor, through studies confirm that sodium glutamate also has the intravascular hemolysis untoward reaction that antagonism is brought out by puerarin, improves the safety of puerarin injection administration.
Below in conjunction with the furthermore bright objects of the present invention of some tests and the effect that can reach.
This laboratory reference " technological guidance's principle of Chinese medicine, natural drug zest and hemolytic research " carries out trial test to hemolytic test, find that 8mM puerarin can cause 1% sheep red blood cell (SRBC) haemolysis 10%, external hemolytic test probability of happening is 100%, hemolytic test result is all reappeared, and illustration method can repeat.The method can be used for finding the potential accidental haemolysis of injection, is the feasible test method of carrying out injection new drug development and judge whether to exist sporadic haemolysis, is conducive to reduce the generation of untoward reaction, improves the safety of injection.
Effect and the effect of the injection haemolysis untoward reaction that, sodium glutamate antagonism contains puerarin
(1) puerarin injection hemolytic test
Research sodium glutamate and puerarin share the impact on sheep red blood cell (SRBC).Get the erythrocyte of the cold sheep (sheep) of 10 little tails, add respectively sodium glutamate and the puerarin of doses, after 10min, observe erythrocytic state and haemolysis incidence rate, analyze experimental result with X2 inspection statistics, seek the antagonism of sodium glutamate to the sporadic haemolysis of puerarin injection.Now that report the test is as follows:
1 experiment material
1.1 tested medicines
1., sodium glutamate is purchased from Beijing Suo Laibao Science and Technology Ltd. for sodium glutamate injection, accurately takes sodium glutamate 6.76mg with electronic balance, be dissolved in normal saline solution, monosodium glutamate solution is settled to 10mL with 10mL volumetric flask, this be injection 1., concentration is 4mmolL
-1.With microporous filter membrane, (m) filtration sterilization of 0.22 μ, 4 DEG C save backup.
Injection is 2.: 1. injection is diluted to 2mmolL with sterile saline
-1, 10mL, 4 DEG C save backup.
Injection is 3.: 1. injection is diluted to 1mmolL with sterile saline
-1, 10mL, 4 DEG C save backup.
Puerarin injection is 4.: provided by Kang Enbei Zhejiang Pharmaceutical Co, and 2mL, batch number 090501, every mL injection is containing puerarin 50mg.
Puerarin injection (250mM) is 5.: accurately take puerarin powder (purchased from Jiangsu Tian Sheng medicine company limited) 1.041g with electronic balance, with 40% dimethyl sulfoxide (DMSO, DZ0231, AMRESCO) dissolve, ultrasonic dissolution assisting, normal saline solution is diluted to 9mL, and volumetric flask is settled to 10mL, and solution colour is colourless (configuration surroundings: carry out in superclean bench).Solvent is 40%DMSO solution.With microporous filter membrane (m) filtration sterilization of 0.22 μ, 4 DEG C of preservations.
Compound puerarin injection is 6.: get 1. 0.04mL of injection, injection is 0.27mL 4., mix, and 0.31mL altogether, composition injection is 6..Every mL injection is containing puerarin 43.55mg, sodium glutamate 0.087mg.
Compound puerarin injection is 7.: get 2. 0.04mL of injection, injection is 0.27mL 4., mix, and 0.31mL altogether, composition injection is 7..Every mL injection is containing puerarin 43.55mg, sodium glutamate 0.044mg.
Compound puerarin injection is 8.: get 3. 0.04mL of injection, injection is 0.27mL 4., mix, and 0.31mL altogether, composition injection is 8..Every mL injection is containing puerarin 43.55mg, sodium glutamate 0.022mg.
Compound puerarin injection is 9.: get 1. 0.04mL of injection, injection is 0.13mL 5., mix, and 0.17mL altogether, composition injection is 9..Every mL injection is containing puerarin 79.61mg, sodium glutamate 0.159mg.
Compound puerarin injection is 10.: get 2. 0.04mL of injection, injection is 0.13mL 5., mix, and 0.17mL altogether, composition injection is 10..Every mL injection is containing puerarin 79.61mg, sodium glutamate 0.08mg.
Compound puerarin injection
: get 3. 0.04mL of injection, injection is 0.13mL 5., mixes 0.17mL altogether, composition injection
.Every mL injection is containing puerarin 79.61mg, sodium glutamate 0.04mg.
1.2 laboratory animal
Little tail 10 of the sheep (20～30Kg) that tremble with fear, are provided by Xibei Univ. of Agricultural & Forest Science & Technology's zoopery center.15～25 DEG C of room temperatures, under relative humidity 50% condition, raise.
1.3 reagent, instrument
Chloride injection agent, lot number: 31213042402, Shiyao Yinhu Pharmaceutical Co., Ltd. produces; Water for injection, self-control; TGL-16B high speed centrifuge, Hunan Xingke Scientific Instrument Co., Ltd.; HPY-01B biochemical cultivation case, Huangshi Hengfeng Medical Devices Co., Ltd.; BIO-RAD680 microplate reader; Enzyme mark bar is purchased by Haimen, Jiangsu three and Xing Ya medical apparatus and instruments factory and is produced, purchased from Yang Ling Bao Xin equipment company limited of Shaanxi Province.
2 methods
The preparation of 2.1 red blood cell suspensions
10 of the cold sheep of little tail, carry out respectively hemolytic experiment.Every sheep is adopted jugular vein blood 10mL, after heparin sodium (Jiangsu Wanbang Biological Pharmaceutical Co., Ltd.) 160IU anticoagulant, be placed in graduated centrifuge tube, centrifugal 10 minutes with 2000 revs/min, discard blood plasma, add appropriate chloride injection agent washing, centrifugal abandoning supernatant and leukocytic cream.Add again appropriate normal saline shake up, centrifugal, so cyclic washing 3 times, till being water white transparency to centrifugal rear supernatant.Gained packed red cells is become to the red cell suspension of 11% (volume ratio) with normal saline dilution.So far, red cell suspension is ready.
The outer hemolytic experiment design of 2.2 puerarin solution bodies
If puerarin solution effects is 8mM (0.00333gmL in erythrocytic concentration
-1).If negative control group, solvent control group (replacing puerarin solution effects in erythrocyte with DMSO), drug treating group and positive controls.The pH value of measuring puerarin solution with the desk-top pH meter of METTLER TOLEDO is 7.16.
Shown in following table 1, in test tube, add corresponding composition respectively, note application of sample order.Often add after a kind of composition, all shake up gently.After all adding in system etc. all the components in system, light shaking mixes, and places the biochemical cultivation case incubation of 37 DEG C, observes haemolysis and aggregation after 10min.Aggregation decision method: if having rufous or brownish red flocculent deposit in solution, not disperseing after jolting, show to have red cell agglutination to occur, if can be uniformly dispersed again after condensation product jolting, is pseudoagglutination, is true coagulation if condensation product does not shake loose person.Follow each pipe centrifugal according to 5000rpm/min condition, interior eye is observed supernatant fluid color. and get supernatant, detect absorbance value (OD value) in 540nm wavelength place.According to 2005 " technological guidance's principle of Chinese medicine, natural drug zest and hemolytic research ", calculate the hemolysis rate (%) of each group of each pipe by formula:
Hemolysis rate (%)=(drug treating group OD value-negative control group OD value)/(positive controls OD value-negative control group OD value)
With reference to evaluation criterion: hemolysis rate >5% shows to have haemolysis to occur, and carries out statistical procedures.
The external hemolytic experiment packet design of table 1 puerarin solution and sodium glutamate
3 results
This test is investigated in the time of puerarin 8mM concentration, and puerarin injection sporadic hemolytic experiment research 4., is 5. carried out in 40 μ M, 20 μ M, 10 impacts of μ M sodium glutamate on 10 sheep red blood cells simultaneously, and experimental result all has itemized record, uses X
2inspection statistics is analyzed, and the results are shown in Table 2.
A table 210 sheep hemolytic test result statistical table
Note: compare a P<0.01 with the negative group of normal saline; With the comparison of puerarin injection group, b P<0.01
Result shows: haemolysis does not appear in normal saline group, the whole haemolysis of water for injection group: with the comparison of normal saline group, puerarin injection 4., 5. haemolysis all appears in group, and haemolysis incidence rate and normal saline group exist utmost point significant difference (P<0.01); Hemolytic test result is all reappeared, and illustrates that this hemolytic experiment method is reliable and stable, and result of the test can repeat.With puerarin injection 4., 5. group relatively, compound puerarin injection 6., 7., 8., 9., 10.,
all there is not haemolysis in each group, compound puerarin injection 6., 7., 8., 9., 10.,
each group haemolysis incidence rate all with puerarin injection 4., there is utmost point significant difference (P<0.01) in group 5.; With the comparison of normal saline group, compound puerarin injection 6., 7., 8., 9., 10.,
each group haemolysis incidence rate all with normal saline group zero difference (P>0.05); Compound puerarin injection 6., 7., 8., 9., 10.,
it is identical that 4., 5. each group and puerarin injection organize puerarin concentration, is 8mM, but compound puerarin injection 6. and 9., 7. and 10., 8. and
contain respectively 40 μ M, 20 μ M, 10 μ M sodium glutamate, and 4., 5. puerarin injection is respectively organized containing sodium glutamate.Above results suggest: the application of the sodium glutamate of variable concentrations and puerarin compatibility, the haemolysis untoward reaction of all can antagonism being brought out by puerarin, and can make incidence rate be reduced to normal saline level.
Above experimental result shows: puerarin can cause haemolysis, and the injection that contains puerarin all likely causes haemolysis, is adding after sodium glutamate, all can eliminate the haemolysis untoward reaction containing puerarin injection.
Above-mentioned result of the test prompting: the injection that puerarin injection and puerarin and sodium glutamate compatibility are made has no the generation of hemolytic reaction.
Therefore, in the time that preparation contains the injection of puerarin or while using puerarin injection, add sodium glutamate, can eliminate the haemolysis untoward reaction that puerarin causes, improved the safety of puerarin injection administration.
Advantage of the present invention is: in the time that preparation contains the injection of puerarin or while using puerarin injection, adds sodium glutamate, there is the intravascular hemolysis untoward reaction that good antagonism is brought out by puerarin, and inexpensive, have no side effect, safety.
Below in conjunction with embodiment, the invention will be further described:
Detailed description of the invention:
The sodium processed of embodiment 1:(compound puerarin injection
Get sodium glutamate 33.8mg, puerarin 10g, adds sodium chloride 9g, adds water to 1000mL, adjusts pH to 5.0-8.5 with 1mol/L hydrochloric acid or sodium bicarbonate solution, filter, filtrate be potted in 2,5 or the ampoule of 10mL in, 100 DEG C of sterilizing 30min, obtain injection.This product can be used for auxiliary treatment coronary heart diseases and angina pectoris, myocardial infarction, artery Venous blocks of retina, sudden deafness and ischemic cerebrovascular, infantile viral myocarditis, diabetes etc.This product can intravenous injection or intramuscular injection, each 1～500mL, and 1～3 time on the one 10～20 days is a course for the treatment of, can use continuously 2～3 courses for the treatment of.
The sodium processed of embodiment 2:(compound puerarin powder pin
Get sodium glutamate 67.6mg, puerarin 1g, is potted in the powder pin ampoule of 10mL, and 100 DEG C of sterilizing 30min, obtain powder pin.This product can be used for auxiliary treatment coronary heart diseases and angina pectoris, myocardial infarction, artery Venous blocks of retina, sudden deafness and ischemic cerebrovascular, infantile viral myocarditis, diabetes etc.When application, will make powder pin 1～5000mg and sodium chloride injection or normal saline solution and mix, can carry out intravenous injection or intramuscular injection, each 1～500mL, 1～3 time on the one 10～20 days is a course for the treatment of, can use continuously 2～3 courses for the treatment of.
The preparation of embodiment 3:(compound puerarin transfusion)
Get sodium glutamate 16.9mg, puerarin 2g, sodium chloride 9g, adds water to 1000mL, adjusts pH to 5.0-8.5 with 1mol/L hydrochloric acid or sodium bicarbonate solution, filters, and filtrate is potted in the saline vial of 250mL, and 100 DEG C of sterilizing 30min, are infused.This product can be used for auxiliary treatment coronary heart diseases and angina pectoris, myocardial infarction, artery Venous blocks of retina, sudden deafness and ischemic cerebrovascular, infantile viral myocarditis, diabetes etc.When application, can directly carry out intravenous injection or intramuscular injection, each 1～500mL, 1～3 time on the one 10～20 days is a course for the treatment of, can use continuously 2～3 courses for the treatment of.
Above-described embodiment is only explanation technical conceive of the present invention and feature, and its object is to allow person skilled in the art can understand content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences that spirit is done according to the present invention change or modify, within all should being encompassed in protection scope of the present invention.
Claims (8)
1. the application of sodium glutamate in puerarin injection.
2. application according to claim 1, it is characterized in that: sodium glutamate can be made compound injection application with puerarin injection, also can apply with interim the cooperation simultaneously of mode of injection and transfusion with puerarin injection, or then use again puerarin injection after the mode application sodium glutamate with injection and transfusion.
3. application simultaneously according to claim 2, is characterized in that: puerarin injection and sodium glutamate injection mix before using for patient, then applies in the mode of injection and transfusion.
4. after the mode application sodium glutamate with injection and transfusion according to claim 2, then apply again puerarin injection, it is characterized in that: first for after patient applies sodium glutamate injection and finish, more then apply puerarin injection.
5. according to the injection described in claim 1,2,3,4 and the application of injection, it is characterized in that: contain following weight portion medicine: 1～50 part of sodium glutamate, 1～50000 part of puerarin.
6. according to the injection described in claim 1,2,3,4,5 and the application of injection, it is characterized in that: can contain adjuvant 1～50 weight portion, water for injection 1～10000 weight portion.
7. according to the injection described in claim 1,2,3,4,5,6 and the application of injection, it is characterized in that: described adjuvant can be sodium bicarbonate solution, Glucose Liquid, glucose saline, propylene glycol liquid, sodium chloride injection or normal saline solution.
8. according to the injection described in claim 1,2,3,4,5,6 or 7 and the application of injection, it is characterized in that: described injection and the application of injection can be injection, powder pin or the transfusions of accepting clinically.
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| CN112336710A (en) * | 2020-12-27 | 2021-02-09 | 西北农林科技大学 | Application of glutamine in preparing medicine for preventing and treating puerarin injection induced intravascular hemolysis |
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