CN1099283A - Injection for treatment of infarction - Google Patents

Injection for treatment of infarction Download PDF

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Publication number
CN1099283A
CN1099283A CN 93116926 CN93116926A CN1099283A CN 1099283 A CN1099283 A CN 1099283A CN 93116926 CN93116926 CN 93116926 CN 93116926 A CN93116926 A CN 93116926A CN 1099283 A CN1099283 A CN 1099283A
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China
Prior art keywords
injection
treatment
ginkgo
present
infarction
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CN 93116926
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Chinese (zh)
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CN1044861C (en
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李宝华
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Shaanxi Academy Of Tcm
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Shaanxi Academy Of Tcm
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Priority to CN93116926A priority Critical patent/CN1044861C/en
Publication of CN1099283A publication Critical patent/CN1099283A/en
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Publication of CN1044861C publication Critical patent/CN1044861C/en
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The injection consists of 5-50g ginkgo leaves or ginkgo, 10-80g radix puerariae, 500 ml physiological saline and 1000 ml water for injection, it is helpful to increase cerebral blood flow, reduce resistance of cerebral blood vessel, reduce blood viscosity, it does not increase myocardial oxygen consumption and heart load, the cure rate for ischemic cerebrovascular diseases is 33.85%, effective rate is 96.92%.

Description

Injection for treatment of infarction
The invention belongs to contain raw material or with the medicinal preparation technical field of the product of fuzzy structure, specifically derive from the material of plant.
The Chinese medicine injection that is used for the treatment of " cerebral infarction " (doctor trained in Western medicine is ischemic cerebrovascular or cerebral infarction) at present clinically has anti-enzyme, Wei Naotonglu, Tolperisone, propylene glycol alginate sodium sulfate, QINGKAILING, the TONGMAI SHULUO liquid of fastening of Agkistrodon halys, and numerous oral liquid formulations and other preparation, these medicines have certain curative effect to the treatment cerebral infarction, but every kind of medicine all has certain indication or limitation, how at some pathology links, the medicine that has is toxic side effect also, and the medication that has is imitated definite not enough.
The objective of the invention is to overcome the shortcoming of above-mentioned treatment cerebral infarction (doctor trained in Western medicine is ischemic cerebrovascular or cerebral infarction) several drugs, provide a kind of treatment cerebral infarction effect remarkable, the injection that has no side effect and adopt Chinese medicine to make.
For achieving the above object, the solution that the present invention adopts is: it is by Chinese medicine Folium Ginkgo or Semen Ginkgo, Radix Puerariae, and injection normal saline, water for injection form, and in mixed composition of the present invention, the content of each component is:
Folium Ginkgo or Semen Ginkgo 5~50 grams
Radix Puerariae 10~80 grams
500 milliliters of injection normal saline
Water for injection adds to 1000 milliliters
In the content of mixed composition of the present invention, the weight ratio of Folium Ginkgo or Semen Ginkgo and Radix Puerariae is 1: 1~2.
The used injection normal saline of the present invention is 0.9% sodium-chloride water solution.
The present invention is through pharmacodynamics test, prove that it has the cerebral blood flow increasing amount, reduces cerebral vascular resistance, increases the lower extremity blood flow amount, and do not increase myocardial oxygen consumption and increase the weight of function such as heart burden, through clinical 119 routine controlled observation tests, cure rate is 33.85%, obvious effective rate is 40%, and total effective rate is 96.92%.
The inventor has provided the first embodiment of the invention prescription:
Folium Ginkgo or Semen Ginkgo 10 grams
Radix Puerariae 15 grams
500 milliliters of injection normal saline
Water for injection adds to 1000 milliliters
Its preparation technology is as follows:
1. pre-treatment of raw material
To the Chinese medicine Folium Ginkgo of prescription or Semen Ginkgo, Radix Puerariae, normal saline, water for injection carry out quality examination, all should meet Chinese Pharmacopoeia related item regulation.Pick up the impurity in the material medicine and the part of going mouldy, sieve dedust bits.
2. extract with refining
1. extract: take by weighing through in pretreated Chinese medicine Folium Ginkgo or Semen Ginkgo, Radix Puerariae and the gauze bag of packing into by prescription, with twice of distilled water Rapid Cleaning, the distilled water that at every turn adds 3~5 times of medical material amounts decocts three times, decocting time 60 minutes for the first time, was respectively 40 minutes for the 3rd, three time, merge three times decoction liquor, be concentrated into 1: 1, it is 65% to containing the alcohol amount that cool back adds 95% ethanol, and deepfreeze 24 hours is standby.
2. refining: get cold preservation liquid, sucking filtration, decompression recycling ethanol to 1: 1.5, cool back adds 95% ethanol makes that to contain the alcohol amount be 75%, the sodium hydroxide solution accent PH to 7 with 40%, deepfreeze 24 hours; Sucking filtration for the second time, decompression recycling ethanol to 1: 2, after the cold, add 95% ethanol and make that to contain the alcohol amount be 85%, deepfreeze 24 hours; Sucking filtration for the third time, decompression recycling ethanol, and wave most ethanol, and add injection water to 1: 1, in the bottle of packing into, with 105 ℃, 30~40 minutes, 0.5 pressure-steam sterilization, after the cold, deepfreeze 24 hours; The 4th sucking filtration transferred PH to 7.5~8 with 40% sodium hydroxide solution, adds 0.1% active carbon, and 80~100 ℃ of hot baths 15 minutes are taken out, and sucking filtration twice while hot, bottling, and with 105 ℃, 30~40 minutes, steam sterilization, after the cold, cold preservation 24 hours; The 5th sucking filtration transferred PH to 7.5~8 with 40% sodium hydroxide solution, adds 0.1% active carbon, and sucking filtration twice is while hot taken out in 80~100 ℃ of hot baths 15 minutes, crosses paper pulp, with 105 ℃, 30 minutes, 0.5 pressure-steam sterilization, and after the cold, cold preservation.
3. dosing and filtration
Get cold preservation liquid, cross paper pulp, add an amount of water for injection in the dense medicinal liquid, add the injection normal saline again, water for injection adds to 1000 milliliters, transfers PH to 7.5~8 with 40% sodium hydroxide, crosses G 3Filter bulb and 0.65 μ m microporous filter membrane, with 0.5 pressure, 105 ℃, 40 minutes, steam sterilization, after the cold, cold preservation.
4. embedding and sterilization
Cold preservation liquid 200ml is packed in the saline bottle of 250ml, and gland is with 0.5 pressure, 105 ℃, 40 minutes, steam sterilization, promptly.
Quality examination: 1. character is for watering pale brown color clear liquid; 2. thin layer chromatography inspection: adopt the thin layer chromatography method to check to Folium Ginkgo in the finished product or Semen Ginkgo, Radix Puerariae, its result must have and detect composition or the corresponding speckle of standard medical material; 3. pH value is 5.5~7; 4. tannin, protein, the oxalates check result should be negative; 5. the potassium ion of heavy metal ignition residue, limiting the quantity of all should be up to specification.
All other all should meet the general injection prescription of Chinese Pharmacopoeia regulation.
The inventor has provided the second embodiment of the invention prescription:
Folium Ginkgo or Semen Ginkgo 20 grams
Radix Puerariae 40 grams
500 milliliters of injection normal saline
Water for injection adds to 1000 milliliters
The preparation technology of its preparation technology and first embodiment is identical, and every milliliter contains crude drug 0.06 gram in this injection.
The inventor adopts first embodiment of the invention, and wherein Folium Ginkgo or Semen Ginkgo are selected Folium Ginkgo for use, and the injection for treatment of infarction of making has carried out pharmacodynamics test, acute toxicity test, long term toxicity test, safety test, clinical trial, and various result of the tests are as follows:
1. pharmacodynamics test
1. the present invention is to the effect of animal brain circulation: to anesthesia Canis familiaris L. and cat significantly expansion of cerebral vascular, cerebral blood flow increasing amount, reduce cerebral vascular resistance, increase the lower extremity blood flow amount, and do not increase myocardial oxygen consumption and increase the weight of the heart burden.
2. the present invention is to the influence of rabbit platelet aggregation: the present invention can significantly resist ADP(Adenosine Diohosphsts.SIGMA product) and the inductive rabbit platelet aggregation of glue unit, and tangible dose-effect relationship is arranged.
3. the present invention is to thrombotic influence in the rat experiment gonosome: the present invention has thrombosis effect in the antibody.
4. the present invention is to the influence of rabbit striomotor: the present invention can significantly strengthen the contractility of rabbit tibialis anterior.
5. resisting oxygen lack of the present invention: the present invention has significant normal pressure resistant anoxia effect.
6. the present invention is to the influence of the acute microcirculation disturbance of rabbit: the present invention has microcirculation improvement, promotes the effect that microcirculation blood flow velocity increases, blood flow state changes, the open quantity of blood capillary increases.
2. acute toxicity test
Give the Kunming mouse lumbar injection with the present invention, the dosage ratio is 1: 0.8, records LD 50Be 88.8g/kg; Give the injection of Kunming mouse tail vein with the present invention, the dosage ratio is 1: 0.7, records LD 50Be 20.03g/kg; The present invention of 200% irritates stomach to Kunming mouse, still can not survey LD 50
3. long term toxicity test
12 of experimental dogs are divided into three groups, and first group is matched group, injects to normal saline; Second group is experimental group, uses intravenous injection of the present invention, and dosage is 10 times of the clinical consumption of 2.2g/kg(); The 3rd group is experimental group, uses intravenous injection of the present invention, and dosage is 10 times of the clinical consumption of 0.22g/kg().Injection every day once, continuously, after medicine stopped for two weeks, put to death each one of male and female for every group, weigh, survey routine blood test, serum transaminase, blood urea nitrogen, and dissect dirty body ratio and the cut sections for microscopic examination of measuring main organs, result and matched group are relatively, the body weight gain of second and third group dog, main dirty body ratio and hepatic and renal function there is no obvious influence.The white content of RBC number of second group of dog and red eggs descends, and can recover after medicine stops, and the 3rd group of dog influence is not obvious.Second and third the group dog each internal organs (heart, liver, spleen, lung, kidney, adrenal gland, ovary, testis) through histological examination, no abnormality seen.
4. safety test
Inventor consignment test unit except that doing toxicity test, also did pyrogenic test, hemolytic test, hemagglutination test, irritant test, hypersensitive test, antibacterial culturing, mtd test, through 13 batches analysis of experiments, all meet the requirements.
5. clinical trial
1. the inventor has carried out the clinical observation test with injection for treatment of infarction treatment acute ischemic cerebrovascular disease 13 examples of first embodiment of the invention making, and all cases are selected the acute ischemic cerebrovascular disease patient of the course of disease within 72 hours for use.Intravenous drip 200ml is once a day adopted in treatment, and seven days is a course of treatment, treats 1~2 course of treatment, and by statistics, cure rate is 47% after the treatment, and total effective rate is 100%.
2. the inventor has carried out amplification clinical observation test with the injection for treatment of infarction and low molecular dextran contrast treatment acute ischemic cerebrovascular disease (acute cerebral infarction) 106 examples of first embodiment of the invention making.
Case is selected: treatment group (treating with the present invention) 65 examples, male 43 examples, women 22 examples; Matched group (treating) 41 examples with low molecular dextran, male 34 examples, women 7 examples.Two groups of patients were morbidity in 7 days, and group cranium brain CT examination is diagnosed as ischemic cerebrovascular.
The Therapeutic Method and the course of treatment: the treatment group is with 200ml intravenous drip of the present invention, once a day or the next day once, seven days is a course of treatment, two courses of treatment of general treatment, is no more than three courses of treatment at most, the three days at interval course of treatment.
Matched group: use low molecular dextran 500ml, or low molecular dextran 500ml+ troxerutin 0.4g, intravenous drip, the Therapeutic Method and the course of treatment and treatment group are identical.
Therapeutic outcome: treatment group cure rate is 33.85%, and obvious effective rate is 40%, and total effective rate is 96.92%, and the matched group cure rate is 21.95%, and obvious effective rate is 14.63%, and total effective rate is 82.93%.
[function with cure mainly] the present invention has blood circulation promoting and blood stasis dispelling, improves cerebral circulation, the cerebral blood flow increasing amount, keep the brain cell effect.Cure mainly acute ischemic cerebrovascular disease and cerebral arteriosclerosis.
[usage and consumption] once a day, each 200ml intravenous drip.
[taboo] acute cerebral hemorrhage patient avoids usefulness.
The storage of [storage] lucifuge shady place reduces jolting as far as possible.
[effect duration] a year and a half.

Claims (2)

1, a kind of injection for treatment of infarction is characterized in that: it is by Chinese medicine Folium Ginkgo or Semen Ginkgo, Radix Puerariae, and injection normal saline, water for injection are formed; In mixed composition, the content of each component is:
Folium Ginkgo or Semen Ginkgo 5~50 grams
Radix Puerariae 10~80 grams
500 milliliters of injection normal saline
Water for injection adds to 1000 milliliters
2,, it is characterized in that in the content of said mixed composition the weight ratio of Folium Ginkgo or Semen Ginkgo and Radix Puerariae is 1: 1~2 according to the described injection for treatment of infarction of claim 1.
CN93116926A 1993-08-21 1993-08-21 Injection for treatment of infarction Expired - Fee Related CN1044861C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN93116926A CN1044861C (en) 1993-08-21 1993-08-21 Injection for treatment of infarction

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN93116926A CN1044861C (en) 1993-08-21 1993-08-21 Injection for treatment of infarction

Publications (2)

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CN1099283A true CN1099283A (en) 1995-03-01
CN1044861C CN1044861C (en) 1999-09-01

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CN93116926A Expired - Fee Related CN1044861C (en) 1993-08-21 1993-08-21 Injection for treatment of infarction

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100427109C (en) * 2002-09-02 2008-10-22 北京大学安康药物研究院 Preparation of compound puerarin
CN108379332A (en) * 2018-05-22 2018-08-10 南华大学 Compound gingkgo gynostemma pentaphylla Trimetazidine injection and preparation method

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100427109C (en) * 2002-09-02 2008-10-22 北京大学安康药物研究院 Preparation of compound puerarin
CN108379332A (en) * 2018-05-22 2018-08-10 南华大学 Compound gingkgo gynostemma pentaphylla Trimetazidine injection and preparation method

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Publication number Publication date
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