CN1528350A - Dispersion tablet containing ginkgo leaf extract - Google Patents

Dispersion tablet containing ginkgo leaf extract Download PDF

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CN1528350A
CN1528350A CNA031254624A CN03125462A CN1528350A CN 1528350 A CN1528350 A CN 1528350A CN A031254624 A CNA031254624 A CN A031254624A CN 03125462 A CN03125462 A CN 03125462A CN 1528350 A CN1528350 A CN 1528350A
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weight
extract
agent
examples
folium ginkgo
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CN1275590C (en
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李崇明
黄志军
翟莉
曾庆恢
徐绍新
王永平
石召华
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JIANGSU CHENPAI PHARMACEUTICAL CO Ltd
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JIANMIN TRADITIONAL CHINESE MEDICINE ENGINEERING Co Ltd WUHAN
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Abstract

The present invention relates to a dispersion tablet preparation containing ginkgo leaf extract and its preparation method, in which for one weight portion of extract said dispersion tablet also contains 0.5-10 weight portions of filling agent, 0.1-5 weight portions of disintegrant, 0.01-0.1 weight portion of lubricant and 0.01-0.1 weight portion of adhesive. Said invented medicine dispersion tablet mainly is used for curing diseases of cardiovascular system, and it is characterized by that it is placed in the warm water with 37 deg.C, it can be completely disintegrated within 3 min.

Description

A kind of dispersible tablet that contains Folium Ginkgo extract
Technical field
The invention belongs to a kind of Chinese herbal medicine extract preparation, is a kind of dispersible tablet that contains Folium Ginkgo extract specifically.
Background technology
Folium Ginkgo has another name called Semen Ginkgo leaves, Folium Ginkgo etc.Dried leaves for Ginkgoaceae plant Ginkgo biloba tree.Compendium of Material Medica is put down in writing its nature and flavor sweetness and bitterness and is puckery, goes into lung, kidney channel.Have that Dingchuan, cough-relieving, leukorrhagia stopping are turbid, the effect of urine reducing, its effective medicinal components is mainly flavone and bilobalide etc., is called for short Folium Ginkgo extract.
Semen Ginkgo extrac is the effective active composition that extracts from the leaf of Ginkgoaceae plant Ginkgo biloba, is the special product plant of China, and according to " book on Chinese herbal medicine " record, Semen Ginkgo has that easypro lung is relievingd asthma, the function of arresting enursis, leucorrhea.In recent years, Chinese scholars is to the chemical constituent of Semen Ginkgo, and research has extensively and profoundly been carried out in aspects such as pharmacological action and application.Find the expansible coronary vasodilator coronary blood flow increasing of Folium Ginkgo extract, acute cerebral ischemia is had protective effect, but the cerebral blood flow increasing amount is improved the energy metabolism of ischemic tissue.In addition, the Folium Ginkgo lactone is the platelet activating factor receptor antagonistic, and antithrombotic, antioxidation, the anti-ageing effect of waiting for a long time are arranged, and the spy obtains certain progress effect to its pharmacological research, is summarized as follows:
One, to the effect of respiratory system
The ethanol extraction of Semen Ginkgo is injected to mouse peritoneal, and the phenol red excretion of respiratory tract is increased, and phlegm-dispelling functions is arranged.Gastric infusion is not obvious to the cough caused antitussive effect of mice amine mist, to the faint relaxation effect of guinea pig tracheal smooth muscle performance that exsomatizes.Rat experiment chronic tracheitis due to the sulfur dioxide is treated with the compound gingkgo spray, with the contrast specific energy tunica mucosa tracheae secretion function is improved, and goblet cell reduces, and mucous secretion reduces, and inflammatory disorders alleviates.
Two, to the effect of smooth muscle
1. to the effect of tracheal smooth muscle
The ethanol extraction of Folium Ginkgo has direct relaxation effect to tracheal smooth muscle, and can remove the convulsion effect that causes of histamine phosphate and acetylcholine to guinea-pig isolated trachea, prevent the property asthma attack of big Cavia porcellus histamine, its contained flavonoid is in Guinea pig lung overflow experiment or histamine's spraying experiment, performance is to the tracheaectasy effect, and how gains in depth of comprehension resist this its effect of effect raising may be with receptor related.
2. to the effect of gastrointestinal smooth muscle
The ethanol extraction of Folium Ginkgo and flavonoid glycosides have spasmolysis to the guinea pig in vitro intestinal tube, can be to the spasm due to antihistaminic, acetylcholine, the barium chloride, and its action intensity is similar to papaverine, but more lasting.Bisflavone has the effect of the excited guinea pig ileum of antagonism Kallidin I.
3. to the effect of ureter smooth muscle
Semen Ginkgo extrac can obviously increase anesthetized rabbit and big ureter action potential frequency, keeps the long period, electrocardiogram is not had obvious influence, and can alleviate ureter tension force, shows ureteral lumen expansion effect, and adding acetylcholine then has the tension force of increasing effect.
Three, to cardiovascular effect
The flavone compound that Folium Ginkgo extracts is used for the guinea pig isolated heart perfusion, can cause coronary vasodilation, injection back limb artery, expansible hind leg blood vessel, can increase rabbit carotid artery and arteria auricularis blood flow, therapeutic dose does not have obvious influence to heart rate, blood pressure and the breathing of rat, Cavia porcellus, cat, rabbit, A, Hel-legonarch etc. have compared Semen Ginkgo extrac and some neurotransmitteies to the contraction of isolated rabbit venous, the result shows, norepinephrine, dopamine, histamine and Semen Ginkgo extrac ED 50, be respectively 2.3 * 10 -7, 6.9 * 10 -6, 2.1 * 10 -6And 86ug/ml, the isolated rabbit tremulous pulse is shunk, Semen Ginkgo extrac (3mg/L) has same purpose with papaverine, suppresses mutually when all being slow.
Four, to the effect of brain system
Folium Ginkgo extract can significantly be expanded the cerebrovascular of anesthesia cat and dog, the cerebral blood flow increasing amount, reduce vascular resistance, also reduce cardiac muscular tension-time index, Folium Ginkgo is similar to the effect of papaverine, but papaverine can significantly increase the heart rate of Canis familiaris L., and Folium Ginkgo does not increase the heart rate of Canis familiaris L., it is reported that the oral or quiet notes of extract formulation of leaf can make parkinson virus patient's cerebral blood flow increase, improve the nutrition of brain, N.BrunelloShi finds that the content of the first-3-0-methylepinephrine in the cerebral cortex has biphasic effect for the oral Semen Ginkgo extrac of rat, long-time low dose of Semen Ginkgo extrac, the activity that can reduce in the cerebral cortex adenosine cyclase under isoproterenol stimulates increases, and big cerebral circulatory disorders patient treats with Semen Ginkgo extrac in West Germany, and its curative effect has been compared significant difference with placebo group.
Five, to hemorheology and the microcirculatory influence of periphery
F.Jung, etall singly educates cross-over experiment by 10 healthy premenopausal volunteers, studied hemorheology and the periphery microcirculatory influence of Semen Ginkgo to human body, per minute is measured shank small artery hemocyte speed capillaceous with the capillaroscope method in 4 hours after giving Semen Ginkgo extrac, before taking Semen Ginkgo extrac, reach 1,2, the in the past vena glutaea blood rheology parameter of taking blood sample to measure respectively after 4 hours, experimental result shows, after taking Semen Ginkgo extrac and placebo, blood pressure and heart rate all there is not influence, take Semen Ginkgo extrac and placebo to packed cell volume, plasma viscosity, erythrocyte fragility, platelet and numeration of leukocyte, platelet aggregation and circulation platelet aggregation number all do not have influence, but effect has appreciable impact to erythrocyte aggregation to take Semen Ginkgo extrac, contrast with placebo group, erythrocyte aggregation effect reduction has significant difference (P<0.0001) for 15.6%, two group after taking Semen Ginkgo extrac; Taking Semen Ginkgo extrac after 1 hour, blood flow speed increases by 57%.
Six, to measured by esr technique
PincenailShi finds that Semen Ginkgo extrac is a stronger free radical scavenger in the test tube test; its easy and OH reaction; also can with 2.2-hexichol bitterness ether together with the reaction of gland diazanyl and Ah mould's acyl group, in the microsome of rat, can lower by what free radical brought out and pass through the NADPH-Fe that the fat peroxidating produces + 3Ion, oral or jugular vein infusion 50mg/kg can effectively prevent cardiac muscle or the brain ischemia in the animal model, measures unreacted superoxide ion o by the reduction or the nitroblue tetrazolium method of cytochrome C - 2, azophenlyene mesylate NADH -Measure super ionic removing degree with electron spin resonance,, prove that Semen Ginkgo extrac truly has the effect of direct removing superoxide ion simultaneously also with the activity of the super oxygen dismutase of polarography determination.
Seven, to the effect of platelet aggregation
Platelet activating factor (Plateletacti-Vating.gactor.PAF) is a kind of endogenous phospholipid that produces with platelet and multiple inflammation tissue secretion, it is the most effective platelet aggregation derivant of finding so far, it and numerous disease are closely related, proof Semen Ginkgo lactone such as Braquet had powerful specificity to suppress active to paf receptor in 1984, be considered to have most the natural PAZ receptor antagonist of potential applicability in clinical practice at present, wherein the activity with Semen Ginkgo lactone B is the strongest, this inhibition is emulative, ginkalide A, B, C, the IC50 of J is respectively 0.74,0.25,7.1 and there is certain structure activity relationship in 54.0um Semen Ginkgo lactone as paf receptor antagonists.
Semen Ginkgo lactone A and B are owing to the existence of 1 and/or 3 OH, and the PAF antagonism is the strongest, and C and J have OH to replace at 7, and inhibitory action weakens.Bilobalide is not owing to there is 1 OH, and activity is minimum.
Eight, to central nervous system's protective effect
Semen Ginkgo lactone A (50mg/kg) and Semen Ginkgo lactone B (100mg/kg) have protective effect to brain in rat brain ischemia focus model, but Semen Ginkgo lactone C and the effect of J unprotect; The Mus Hippocampus nerve injury that Semen Ginkgo lactone B (1umol/l) and white lactone (10umol/l) can protect propylhomoserin salt to cause.
Nine, to the protective effect of ischemic injuries
In ischemic tissue, because platelet aggregation reduces tissue blood flow's amount, thereby the recovery of block cell function, if the blood flow deficiency of tissue, then can cause multiple cerebral ischemia or apoplexy, the arrhythmia that Semen Ginkgo lactone B can stop ischemia to cause, but heart rate, coronary circulation and myocardial function all there is not effect, but thereby prompting Semen Ginkgo lactone B arrhythmia, and do not disturb the normal function of heart, discovery Semen Ginkgo lactone such as Borobiu can improve the recovery of ischemical reperfusion injury liver, improve the hepatic ischemia Rats survival rate, significantly reduce the hepatic ischemia damage.
Ten, Antishock function
Moore etc. studies show that, histamine, thromboxane B in the infusion liquid that Semen Ginkgo lactone B causes kidney vasoconstriction and antigenicity shock 2(TXB 2) and increasing of slow reacting substance-A (SRS-A) level have obvious antagonism also can reduce the release of thromboxane, improve the survival rate of mortality endotoxemia dog, reduce acidosis
11, other effects
There is the bibliographical information ginkgolic acid in test tube, can suppress growth of bacillus tubercle; ginkalide B can disturb multi-form Cavia porcellus active sensitization reaction; can significantly reduce the mortality rate that taurocholic acid is induced the acute pancreatitis in rats of generation; prolong the time-to-live; alleviate the pathological model of pancreas tissue, Semen Ginkgo lactone B also can prolong the survival life-span of heart heteroplastic transplantation in addition.
In a word along with people go deep into the understanding and the further of research of Semen Ginkgo active component, the preparation made from the active component of its extraction has been widely used in clinical, we utilize the dispersible tablet of Semen Ginkgo extrac exploitation, preparation effectively guaranteeing to make under the prerequisite of its active component is used for the treatment of coronary heart disease, myocardial infarction, stiff tongue and retardation in speech, atherosclerosis etc.
Though the preparation made from Folium Ginkgo extract exists already, do not make dispersible tablet so far as yet.Under the situation of dispersible tablet, because its disintegrate rapidly, dispersion in water, therefore help human body effectively, absorb rapidly, for the patient of some hard thing that is difficult to swallow, available water is taken after mixing it with water simultaneously.
Summary of the invention
The purpose of this invention is to provide a kind of human body that helps and absorb effectively, rapidly, for the patient of some hard thing that is difficult to swallow, the dispersible tablet that contains Folium Ginkgo extract that available water is taken after mixing it with water is to overcome above-mentioned shortcoming simultaneously.
To achieve these goals, therefore the present invention relates to the dispersible tablet that contains following composition:
1 part of (weight) Folium Ginkgo extract
0.5---10 parts of (weight) filleies
0.1---5 portions of (weight) disintegrating agents
0.01---0.1 part of (weight) lubricant
0.01---0.1 part of (weight) binding agent
The active substance that the invention still further relates in this dispersible tablet is that Folium Ginkgo extract is to make by oneself or buy from market, accounts for the 5-70% of gross weight, and all the other then are above-mentioned various promoter materials, and each extract with respect to a (weight) of its consumption calculates.
Three kinds of auxiliary agents that relate among the present invention also may exist in conventional tablet, but are their consumption and kind with the difference of conventional tablet.In the present invention, the large usage quantity of disintegrating agent is 0.1~5 times of Folium Ginkgo extract, and in conventional tablet, is generally 0.01~0.1 times; The present invention should select hydrophilic for use, have the filler that helps disintegration concurrently, as microcrystalline Cellulose, starch, lactose etc., and not beneficial use such as bigger filler of lipotropy or viscosity such as cane sugar powder, dextrin, mannitol; Should select for use to help and collapse effective disintegrating agent, as carboxymethyl starch sodium, L-hydroxypropyl cellulose, crospolyvinylpyrrolidone etc.
Characteristics of the present invention are that it is rendered in 37 ℃ the warm water, should be at 3 minutes with interior complete disintegrate.
The present invention also proposes a kind of method for preparing this Folium Ginkgo extract dispersible tablet, this dispersible tablet contains Folium Ginkgo extract (for example weight accounts for the 5-70% of total amount), optional conventional flavoring agent, sweeting agent and spice, and the following material for a (weight) extract.
0.5---10 parts of (weight) filleies
0.1---5 portions of (weight) disintegrating agents
0.01---0.1 part of (weight) lubricant
0.01---0.1 part of (weight) binding agent
At first portion (weight) Folium Ginkgo extract is granulated together with following material in accordance with known methods; these materials comprise 30~70%EtOH; or water and filler; binding agent; disintegrating agent; above-mentioned auxiliary agent uses by the consumption with respect to a (weight) extract; an or only first part that adds this tittle; remaining amount adds after granulation again; gained granule drying; add lubricant then; and optional remaining binding agent that adds; filler and disintegrating agent; also can choose wantonly and add conventional flavoring agent; sweeting agent and spice; with all mixture homogenization, be pressed into tablet then, with the optional according to a conventional method peplos of gained tablet.
Filler of the present invention: starch, microcrystalline Cellulose, lactose.The consumption of filler is 0.5 of an extract weight in the tablet---10 times.
Disintegrating agent: carboxymethyl starch sodium, L-hydroxypropyl cellulose, carboxymethyl cellulose, crospolyvinylpyrrolidone.
Particle size distribution, about 50%>50 micron;
Bulk density: 280-380 grams per liter;
The disintegrating agent consumption is 0.1 of an extract weight in the tablet---5 times.
Binding agent: gelatin, sodium carboxymethyl cellulose, polyvinylpyrrolidone, cellulose ether, pectin, adhesive consumption is 0.01 of an extract weight in the tablet---0.1 times.
Lubricant: magnesium stearate, Pulvis Talci, micropowder silica gel, the consumption of lubricant is 0.01 of an extract weight in the tablet---0.1 times.
The preferred filler that uses is microcrystalline Cellulose and/or starch, and binding agent is polyvinylpyrrolidone and/or gelatin, and disintegrating agent is a carboxymethyl starch sodium, and lubricant is a magnesium stearate.
For example: with a (weight) extract, but adapted 0.5-10 part (weight) microcrystalline Cellulose is good with 1-4, is again best with 2-3.
But adapted 0.1-5 part (weight) carboxymethyl starch sodium is good with 0.5-2, is again best with 0.8-1.5.
But adapted 0.01-0.1 part (weight) polyvinylpyrrolidone is good with 0.03-0.6, is again best with 0.05-0.1.
But adapted 0.01-0.1 part (weight) magnesium stearate is good with 0.03-0.8, is best with 0.05-0.06.
Each auxiliary material ratio is following scope, as:
Microcrystalline Cellulose: carboxymethyl starch sodium: polyvinylpyrrolidone: magnesium stearate 2: 1: 0.1: 0.06.
If the employing polyvinylpyrrolidone is a binding agent, the ethanol of the most handy 10%-50% (with 20-40% is good, and 25-30% is for best) dissolves it, is good with extract and other auxiliary agent mixing granulations then.
If this dispersible tablet is used to take after mixing it with water,, can in tabletting forward direction granule, add an amount of flavoring agent, sweeting agent or spice for covering flavour of a drug.
Admissible spice for example has following these types: Fructus Ananadis comosi, Fructus Mali pumilae, Fructus Pruni, Herba Menthae, milk, Fructus Citri tangerinae, coffee.The spice that is contained in the dispersible tablet should contain the spice of 0.01-0.1 part (weight) for a (weight) extract.
Following material can be used as sweeting agent: mannitol, sorbitol, Icing Sugar, saccharin sodium, dried ammonium oxalate, xylitol.The sweeting agent that is contained in the dispersible tablet is 0.005-10 part to a (weight) extract.
Gingko leaf dispersible tablet is applicable to that the thoracic obstruction that obstruction of collaterals by blood stasis causes, pained, apoplexy, hemiplegia, stiff tongue and retardation in speech, the angina pectoris of coronary heart disease type, breast infraction see above-mentioned patient, also be used for improving memory, treatment clinically to chronic lung regret acute stage hemorheology, unstable angina pectoris, vascular dementia, ischemic cerebrovascular etc., specifically study as follows.
1. aspect the treatment chronic cardiopulmonary disease, Folium Ginkgo treatment chronic cardiopulmonary disease acute patient 92 examples, wherein male's 49 examples, women's 43 examples, with the randomized, double-blind method patient is divided into two groups, matched group 46 examples, 46 examples are organized in the Folium Ginkgo treatment, two groups of state of an illness, the course of disease, pulmonary function are similar, no difference of science of statistics (P>0.05).Matched group adopts conventional treatments, gives antibiotic control infection, oxygen uptake, eliminates the phlegm, spasmolytic is relievingd asthma, improve cardio-pulmonary function etc.; The treatment group adds on the conventional therapy basis uses Folium Ginkgo 80mg, oral, and every day 3 times, 2 weeks were 1 course of treatment, 2 courses of treatment of logotype.Two groups of patients' obvious effective rate treatment group and matched group are respectively 71.7%, 45.6%.Two groups of patients' total effective rate, treatment are organized responder's 41 examples in 46 examples, account for 89.1%; Responder's 33 examples account for 71.7% in matched group 46 examples; The treatment group is better than matched group.The result shows that complication rates such as Folium Ginkgo treatment back arrhythmia, pulmonary encephalopathy, shock descend, and the clinical case fatality rate of patient obviously reduces, and shows that Folium Ginkgo treatment pulmonary heart disease can reduce complication, improve the prognosis of acute stage.
2. Folium Ginkgo treatment unstable angina pectoris (VA): unstable angina pectoris patient 190 examples are treated in the Folium Ginkgo smelting, and wherein male's 102 examples, women's 88 examples, with patients with hypertension 5 examples, are divided into treatment at random and organize 98 examples, matched group 92 examples age 45-72 year.Two groups basic medication is identical, buccal nitroglycerin during pained outbreak, and the treatment group adds with Folium Ginkgo dosage and is 2, is for 4 weeks the course of treatment.Recovery from illness 62 examples in the treatment group, produce effects 18 examples, effective 73 examples, invalid 5 examples, total effective rate 95%.Recovery from illness 38 examples in matched group 92 examples, produce effects 15 examples, effective 22 examples, invalid 17 examples, total effective rate 85%.Two groups of total effective rate significant differences, tangible untoward reaction does not all appear in treatment group and matched group.
3. treat the coronary heart disease aspect, with natural active matter Folium Ginkgo treatment coronary heart disease 110 examples of extracting in the Folium Ginkgo, disease 50 examples, myocardial ischemia 40 examples, angina pectoris merging myocardial ischemia 20 examples are twisted in its center, merge hyperlipidemia 35 examples, hypertension 23 examples, ischemic cerebrovascular 28 examples, type ii diabetes 8 examples, arrhythmia 15 examples, ischemic myocardial infarction 6 examples.Matched group coronary heart disease, angina pectoris and myocardial ischemia 30 examples do not have significant difference at aspects such as age, sex, the course of disease, the state of an illness between two groups, and treatment group 10-30mg/ days, result show that total effective rate is 60-75%, are higher than to take sorbitrate or nifedipine medicine merely.
4. treat the vascular dementia aspect, Sun Li, Wang Ling report is treated vascular dementia with Folium Ginkgo, and 118 examples meet the diagnostic criteria of vascular dementia, are divided into two groups at random, and two groups of patient's primary conditions have harmony.A group Folium Ginkgo 40mg/ time, 3 times/day; B group gives troxerutin 800mg, the last phosphorus choline of born of the same parents 500mg, quiet 1 time/day, totally 10 days, continue with troxerutin 200mg piracetam 810mg, 3 times/day.Two groups of administration times were for 12 weeks, other treatment is identical, and the result shows the simple and easy mental status examination of Folstein of A group, the patient is carried out intelligence measure, has improved 3.3 fens before treating average total points treatment back, and Folium Ginkgo can significantly improve VD patient's cognitive function.
5. treat the ischemic cerebrovascular aspect, with Folium Ginkgo treatment ischemic cerebrovascular 180 routine observation of curative effect, 180 examples are outpatient service and inpatient, male's 104 examples, women's 76 examples, symptom such as the patient has that headache, dizziness, human body are unable, dysmnesia and poor sleep.All patients stop using to influential medicines such as cerebrovascular and blood flows, and list is used Folium Ginkgo, and 2 slices/time, 3 times/day, continuous 5 weeks.Measure hemorheology index and cerebrum blood change in flow before and after the medication.Whole blood viscosity, plasma viscosity, packed cell volume, erythrocyte sedimentation rate after the medication as a result, than obviously reducing before the medication, the back blood flow of middle cerebral artery speed of taking medicine obviously slows down, after treating for 5 weeks, recovery from illness 38 examples in 180 examples, produce effects 73 examples, 65 examples that take a turn for the better, invalid 4 examples.Effective percentage reaches 97%.
6. Folium Ginkgo is treated vascular vertigo, tinnitus.Folium Ginkgo treatment object of study is vascular vertigo patient 60 examples in age 20-70 year, seminar's 29 examples, matched group 31 examples, 40mg/ sheet, 3 times/day.Matched group Betahistine Mesylate (trade name Betahistine) 6mg 3 times/day, in 12 weeks of the course of treatment, forbid taking the vascular medicine in the course of treatment, and other is to dizzy medicative medicine.The result shows in the patient's of seminar the dizzy together symptom, the incidence rate of tinnitus significantly reduces three month of treatment, the incidence rate of feeling sick promptly significantly reduces after one month in medication, and after this two the middle of the month curative effect continue,, tinnitus dizzy at matched group reaches the nauseating symptom that often accompanies after the treatment of 12 weeks, its incidence rate does not significantly reduce, though this symptom of auditory dysesthesia incidence rate after one of medication has remarkable reduction, but curative effect does not continue, continue medication in two middle of the month after this, incidence rate raises again to some extent.
7. treat the chronic cardiopulmonary disease aspect; Folium Ginkgo treatment acute phase of cor pulmonale patient 92 examples are divided into two groups at random, every group 46 example, and two groups of physical data do not have significant difference.Folium Ginkgo 40mg/ sheet, 2 slices/time, 3 times/day.Matched group adopts conventional treatments, and as oxygen uptake, oral salbutamol, quiet notes magnetic therapy, cefotaxime sodium, polarized solution adds aminophylline, is interrupted the utilization cardiac diuretic.The produce effects of treatment group as a result 33 examples, effective 8 examples, invalid 5 examples, total effective rate 89.1%, matched group produce effects 21 examples, effective 12 examples, invalid 13 examples, total effective rate 71.7%.Group two groups of hemorheological indexes in treatment back all have clear improvement, and the treatment group descends more remarkable than matched group.
8. treatment cerebral infarction; Folium Ginkgo is treated 120 routine cerebral infarction and is recovered the patient, treatment group, each 60 example of matched group, and two groups of patient's sexes, age, symptom, sign and CT change through the no significant difference of check.Each 2,3 times/day, 4 all 1 courses of treatment, obey 2 courses of treatment altogether.Matched group is taken Radix Salviae Miltiorrhizae Tabellae, each 3,3 times/day, serve on 2 courses of treatment, the medicine of other treatment cerebral thrombosis of stopping using in the therapeutic process 4 all 1 courses of treatment.19 examples of fully recovering of treatment group as a result, remarkable 26 examples, progressive 13 examples, invalid 2 examples, total effective rate 96.67%; Matched group 13 examples of fully recovering, marked improvement 17 examples, progressive 18 examples, no change 12 examples, total effective rate 80.0%.
9. cerebral infarction acute stage clinical practice; Folium Ginkgo treatment cerebral infarction the time of death patient 67 examples.Be divided into treatment group and matched group at random, 35 examples are organized in treatment, matched group 32 examples.Therapeutic Method: 706 plasma substitute dilatation troxerutins are lived, the treatment of citicoline neurotrophy, and look state of an illness weight and take the circumstances into consideration to be alleviated cerebral edema.The treatment group adds on this basis with the each 40mg of Folium Ginkgo, every day 3 times, serve on for 4 weeks.The total effective rate of treatment group as a result is apparently higher than matched group, and before and after the treatment group patient treatment hemorheological indexes all there were significant differences.
10. the Folium Ginkgo antioxidation reaches the influence to cardiovascular patient; Folium Ginkgo is to the effect and the approach of old cardiovascular disease patient vivo oxidation-antioxidant system.Method: the oral Folium Ginkgo of 43 routine old cardiovascular disease patients, detect malonaldehyde, nitric oxide and superoxide dismutase, activity of glutathione peroxidase in its medication forebody-afterbody.After 8 weeks of medication as a result, geriatric cardiovascular disease patient MDA content decline 25.1%, NO content rise 3.4%, and SOD and GSH-PX activity have risen 34.7% and 40.0% respectively.Conclusion: Folium Ginkgo can be removed interior free yl effectively and improve oxidation resistance.
11. treatment centre blood vessel vertigo; Selecting centre blood vessel vertigo patient 58 examples, is three groups by dizzy generation frequency variation, and Therapeutic Method: 2 slices/time of oral Folium Ginkgos, 3 times/day, 30 days is a course of treatment.Observe 2 courses of treatment, the result is 81.0% to reducing dizzy generation step degree total effective rate, is 75.9% to alleviating dizzy degree total effective rate.
In sum; gingko leaf dispersible tablet is active component flavonoid glycoside and the made tablet of Folium Ginkgo lactone that extracts in the Folium Ginkgo, and its main pharmacological is for removing free radical, antagonism platelet activating factor, improve hemorheology, improve the heart and brain metabolism, improving hypoxia-bearing capability health and regional myocardial ischemia and brain, the heart, lung ischemia are all had protective effect.Treat chronic disease, acute stage hemorheology influence, vascular dementia, cerebrovascular, coronary heart disease clinically, it is obvious that electrocardiogram improves effect, shows that Folium Ginkgo has characteristics in full force and effect, no bright toxic and side effects, confirms that this safety of medicine is effective.
The specific embodiment
Further specify the present invention below in conjunction with embodiment, but following examples should not be construed as limitation of the present invention.
Embodiment 1:
Prepare 4000 dispersible tablets (every contains the 0.1g extract) that contain the Folium Ginkgo medicinal substances extract: 400g extract, microcrystalline Cellulose 560g, carboxymethyl starch sodium 280g, polyvinylpyrrolidone 28g, micropowder silica gel 28g.Extract and microcrystalline Cellulose, carboxymethyl starch sodium and part micropowder silica gel are fully stirred evenly, cross 80 sieves, add 30% alcoholic solution that contains polyvinylpyrrolidone; stir, make granule, back to be dried granulate; add another part micropowder silica gel and granule mixing, use tablet machine compression moulding.Then in suitable device to the continuous spray webbing material of tablet (contain conventional the coating substance that contains polymer), to coating qualified till.
Embodiment 2:
Prepare 4000 dispersible tablets (every contains the 0.025g extract) that contain the Folium Ginkgo medicinal substances extract: 100g extract, starch 840g, L-hydroxypropyl cellulose 120g, gelatin 12g, magnesium stearate 12g.Extract and starch are fully stirred evenly, cross 80 sieves, add the aqueous solution that contains gelatin, stir, make granule, back to be dried granulate adds L-hydroxypropyl cellulose and magnesium stearate and granule mixing, uses tablet machine compression moulding.Then in suitable device to the continuous spray webbing material of tablet (contain conventional the coating substance that contains polymer), to coating qualified till.
The instructions of taking of tablet of the present invention is: oral, one time 4~10,3 times on the one.
Embodiment 3:
Prepare 4000 dispersible tablets (every contains the 0.225g extract) that contain the Folium Ginkgo medicinal substances extract: 900g extract, microcrystalline Cellulose 540g, carboxymethyl starch sodium 200g, polyvinylpyrrolidone 20g, micropowder silica gel 50g, saccharin sodium 50g, coffee aroma 9g.Extract and microcrystalline Cellulose, part of sodium carboxymethyl starch and part micropowder silica gel are fully stirred evenly; cross 80 sieves; add 50% alcoholic solution that contains polyvinylpyrrolidone; stir; make granule; back to be dried granulate adds another part carboxymethyl starch sodium and micropowder silica gel and saccharin sodium, coffee aroma and granule mixing, uses tablet machine compression moulding.Then in suitable device to the continuous spray webbing material of tablet (contain conventional the coating substance that contains polymer), to coating qualified till.
The instructions of taking of tablet of the present invention is: oral or use mixing in water for oral taking, one time 1~3,2 times on the one.
Among above-mentioned three embodiment, tablet of the present invention is rendered to approximately can disintegrate fully about 1 minute and 30 seconds in the warm water.

Claims (4)

1. dispersible tablet that contains Folium Ginkgo extract, wherein also optionally contain conventional flavoring agent, sweeting agent and spice and for the following material of a (weight) extract:
0.5--10 part (weight) filler
0.1--5 portion (weight) disintegrating agent
0.01--0.1 part (weight) lubricant
0.01--0.1 part (weight) binding agent
2. according to the dispersible tablet of claim 1, it is characterized in that, contain the Folium Ginkgo extract of 5-70% (weight) in the dispersible tablet, and listed those materials for a (weight) extract in the claim 1.
3. according to the dispersible tablet of top or several claim, it is characterized in that: this dispersible tablet is plain sheet or the thin film that one deck routine is arranged.
4. manufacture method that contains the Folium Ginkgo extract dispersible tablet, also optionally in the dispersible tablet contain conventional flavoring agent, sweeting agent and spice and for the following material of a (weight) extract:
0.5--10 part (weight) filler
0.1--5 portion (weight) disintegrating agent
0.01--0.1 part (weight) lubricant
0.01--0.1 part (weight) binding agent
The method is characterized in that; at first portion (weight) Folium Ginkgo extract is granulated together with following material in accordance with known methods; these materials comprise 30~70%EtoH; or water and filler; binding agent; disintegrating agent; above-mentioned auxiliary agent uses by the consumption with respect to a (weight) extract; an or only first part that adds this tittle; remaining amount adds after granulation again; gained granule drying; add lubricant then; and optional remaining binding agent that adds; filler and disintegrating agent also can be chosen the flavoring agent that adds routine wantonly; sweeting agent and spice are with all mixture homogenization; be pressed into tablet then, with the optional according to a conventional method peplos of gained tablet.
CN 03125462 2003-09-29 2003-09-29 Dispersion tablet containing ginkgo leaf extract Expired - Lifetime CN1275590C (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063267A1 (en) * 2003-12-31 2005-07-14 Beijing Kexin Bicheng Medical Technology Development Co., Ltd. The oral disintegratable tablet of ginkgo leaves
CN1301108C (en) * 2004-10-15 2007-02-21 山东齐都药业有限公司 Metaducine dispersion tablet and its preparation method
CN106038620A (en) * 2016-07-11 2016-10-26 山西普德药业有限公司 Ginkgo leaf tablet preparing method
CN110721140A (en) * 2019-11-29 2020-01-24 海南女人春天美容有限公司 Uterus warming care membrane powder and preparation method thereof

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005063267A1 (en) * 2003-12-31 2005-07-14 Beijing Kexin Bicheng Medical Technology Development Co., Ltd. The oral disintegratable tablet of ginkgo leaves
CN1301108C (en) * 2004-10-15 2007-02-21 山东齐都药业有限公司 Metaducine dispersion tablet and its preparation method
CN106038620A (en) * 2016-07-11 2016-10-26 山西普德药业有限公司 Ginkgo leaf tablet preparing method
CN106038620B (en) * 2016-07-11 2019-09-17 山西普德药业有限公司 A kind of preparation method of Folium Ginkgo
CN110721140A (en) * 2019-11-29 2020-01-24 海南女人春天美容有限公司 Uterus warming care membrane powder and preparation method thereof

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