CN1555843A - Ginkgoleaf oral cavity disintegrating tablet and its preparation method - Google Patents
Ginkgoleaf oral cavity disintegrating tablet and its preparation method Download PDFInfo
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- CN1555843A CN1555843A CNA2003101238521A CN200310123852A CN1555843A CN 1555843 A CN1555843 A CN 1555843A CN A2003101238521 A CNA2003101238521 A CN A2003101238521A CN 200310123852 A CN200310123852 A CN 200310123852A CN 1555843 A CN1555843 A CN 1555843A
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- folium ginkgo
- ginkgo extract
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- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- 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
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Abstract
A oral disintegating tablet of gingko leaf for treating coronary heart disease, angina pectoris, acute cerebral infaction and cerebral arte riosclerosis is prepared from the extract of gingko leaf, filler, disintegrant, flavouring, flowing aid, lubricant, etc.
Description
[technical field]
The present invention relates to a kind of pharmaceutical preparation that is used for the treatment of diseases of cardiovascular and cerebrovascular systems, especially treat coronary heart disease, angina pectoris, acute cerebral infarction, and a kind of oral cavity disintegration tablet of diseases such as cerebral arteriosclerosis or disturbance of cerebral circulation.
[background technology]
Folium Ginkgo claims Folium Ginkgo again, and Folium Ginkgo is used as medicine and starts from the Ming Dynasty, is used for the treatment of cough and asthma due to lung deficiency and cardiac disorder according to record, clinically at present treatment of diseases such as cardiovascular and cerebrovascular disease, asthma, peripheral blood vessel that are used for more.In recent years mostly with Folium Ginkgo extract as raw material, adopt modern preparation technique to make various different dosage forms, use to make things convenient for extensive patients and medical personnel.
One. pharmacology and drug effect
The chemical constituent kind of Folium Ginkgo extract (GbE) is more.GbE mainly contains 24% flavonoid glycoside and total lactone of 6%.Wherein flavonoid glycoside comprises Quercetin, Flos Camelliae Japonicae phenol and isorhamnetin etc.; Total lactone comprises ginkalide A, B, C, M, J and bilobalide etc.GbE also has 17 seed amino acids and Ca in addition
2 +, Mg
2 +, trace element such as P, Sr, Fe, its pharmacological action is as follows:
1. antagonism platelet activating factor, bilobalide is natural paf receptor antagonists among the anticoagulant GbE, and is wherein the strongest with the ginkalide B activity.People such as Dong Jingcheng confirm with causing that the isolated tracheal bar shrinks strongly behind platelet activating factor (PA) the adding platelet artemia hatching solution quantity of lung tissue β-adrenoreceptor to be reduced; Earlier with after the bilobalide pretreatment, this effect that then can antagonism PAF, diastole bronchus, thereby treatment asthma.People such as Fang Enwei find that in pallasiomy bilateral ligation ischemical reperfusion injury model blood PAF increases, and give can obviously reduce blood PAF behind the bilobalide, thereby alleviate ischemic brain injury, dwindle infarction size, alleviate cerebral edema.
2. antioxidation is eliminated oxygen-derived free radicals ginkgetin class significant elimination oxygen-derived free radicals, regulates multiple activities of antioxidant enzymes and direct antioxidation is arranged.Kose etc. add the Folium Ginkgo extract of variable concentrations in the healthy human red blood cell suspension, add hydrogen peroxide then and cause damage, find that GbE can reduce the generation of membrane lipid peroxidating malonaldehyde, and be time and dose dependent, the result shows that also the antioxidation of GbE is better than water soluble antioxidant (vitamin C, glutathion etc.), and is similar to fat-soluble antioxidation (tocopherol) effect.
3. people's experiment confirm GbE such as blood vessel dilating Li Xu light has the effect of inhibition angiotensin converting enzyme (ACE), angiotensin is generated to be reduced, aldosterone and catecholamine secretion reduce, so the effect of expansion cardiovascular and cerebrovascular vessel, peripheral blood vessel, reduction vascular resistance is arranged.
4. blood fat reducing, reducing the pathologic erythrocyte gathers, significantly improve the unusual Geng Xiu virtue of hemorheology and use the GbE total flavones to 40d behind the rat lumbar injection, the trace element that serum triglycerides content obviously reduces among the experiment confirm GbE such as (P＜0.05), Zhao Zhongjie also can improve atherosclerotic's lipid metabolism.
5. to neural effect GbE the muscarine cholinoceptor of rat hippocampus is increased, and make more increasing newly of rat layer district norepinephrine, can improve and promote the effect of learning and memory.GbE and lactone thereof can also be protected the damage of Mouse Neuron to antiglutamic acid, the Ca that stops glutamic acid to bring out
2 +The rising of interior stream, and the minimizing of the hypothalamus arched nerve unit nuclear area of reverse glutamate induction.
6. other effect Zhou Benhong thinks that GbE has the effect of directly lax tracheal smooth muscle.Deep pool space political affairs clinical trial confirms that GbE has immunoregulation effect, can improve serum immune globulin content, makes periphery blood T lymphocyte CD
3 +/ CD
4 +Ratio raises.Discovery GbE such as Mukhtar can suppress B[a] P metabolism and B[a] formation of ponA addition product, antitumaous effect is arranged.Ginkalide B has anti-allergic effects among the Braquet report GbE.
Two. clinical practice
1. cardiovascular and cerebrovascular disease Folium Ginkgo extract (GbE) all has good efficacy to coronary heart disease and angina pectoris, hypertension, hypotension, hyperlipidemia etc.Clinical practice confirms that its effective percentage can reach more than 90%.Clinical treatment cerebral vasospasm, old cerebrovascular, alzheimer disease, the cerebral trauma sequela etc. of being mainly used in.
2. respiratory system disease Geng Zhi is wide waits with Folium Ginkgo treatment catabasis asthmatic patient 30 examples.The treatment group is compared its airway hyperreactivity after the medication with matched group, and pulmonary function has clear improvement, and difference has significance, confirms that Folium Ginkgo extract can significantly reduce the airway hyperreactivity of asthmatic patient, and improves pulmonary function, and control has positive effect to asthma.
3. diseases of urinary system Semen Ginkgo extrac (GbE) can improve the kidney circulation, and the cellular infiltration that reduces inflammation improves renal damage thereby reduce production of cytokines.It is reported that Yang Wenqing etc. confirm patient's blood glucose 24h urine protein with Folium Ginkgo capsule treatment diabetic nephropathy 31 examples, all improve significantly after the treatment of indexs such as blood β 2-MG, Bun, Cr.
4. digestive system disease Li Wei also confirms that with compound folium ginkgo electuary treatment hepatitis B 86 examples Folium Ginkgo has the liver of improvement microcirculation, alleviates its Fibrotic effect.There is report Semen Ginkgo propyl ester that gastric ulcer is also had certain protective role.
5. other is used one in West Germany and discovers that ginkalide B has the sensitivity of enhancing cancerous cell to chemotherapeutics, can be used for the treatment of metastatic cancer, and Epstein-Barr virus is also had certain effect.GbE has significant ischemia resisting effect, and the intermittent claudication of periphery circulation disorder is also had therapeutic value [1].
Three. the problem of existence
Existing ginkgo leaf extract preparation has injection and multiple traditional oral formulations.
Owing to reasons such as technologies of preparing, exist that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor after most of oral formulations are taken, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect the effect of treatment.In addition, traditional oral formulations needs a large amount of water to send down when taking, and this makes the patient of many old peoples, infant or dysphagia, water intaking inconvenience be difficult to take.
Injection often is easy to generate [2,3] such as anaphylaxis or untoward reaction again, and it is big that the while injection also exists operation easier, and the patient suffering is also big, makes and medical treatment cost high the shortcoming that patient economy burden is heavy.Therefore, be necessary to prepare and take convenient dosage form to satisfy the multiple needs that clinical treatment and family use.
[summary of the invention]
The objective of the invention is to remedy the deficiency of existing ginkgo leaf extract preparation technology of preparing, provide to extensive patients and medical personnel that a kind of absorption is fast, bioavailability is high, intestinal is residual few, side effect is low, avoid liver first-pass effect, and needn't drink water, in the oral cavity, only need tens seconds to get final product rapid disintegrate or dissolving, can finish YINXINGYE KOUQIANGBENGJIE PIAN of taking medicine and preparation method thereof with saliva hypopharynx.
One. the YINXINGYE KOUQIANGBENGJIE PIAN that reaches of the present invention of writing out a prescription, comprise the material medicine Folium Ginkgo extract, need following former, the auxiliary material of 8 classes altogether, wherein: when not making microcapsule or Cotton seeds, then do not use capsule material or coating material, effervescent also can for selecting adjuvant for use as one sees fit.
1. Folium Ginkgo extract 10～50%, and 2. filler 10～80%,
3. disintegrating agent 2～30%, and 4. correctives 1～40%,
5. fluidizer 0.01～5%, and 6. lubricant 0.3～3%,
7. capsule material or coating material 0～60%, 8. effervescent 0～30%.
Wherein:
Any one or two or more mixture such as filler---mannitol, microcrystalline Cellulose, dextrin, lactose, starch.
Disintegrating agent---crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) wait any one or two or more mixture.
Any one or two or more mixture such as correctives---mannitol, stevioside, gelatin, aspartame, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid.
Any one or two or more mixture such as fluidizer---micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate.
Any one or two or more mixture such as lubricant---magnesium stearate, Stepanol MG, Pulvis Talci.
Capsule material or coating material---gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), any one or two or more mixture such as polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol.
The mixture of effervescent---citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Two. the preparation method YINXINGYE KOUQIANGBENGJIE PIAN that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
In view of Folium Ginkgo extract has the stronger bitterness of order, the present invention can adopt three kinds of distinct methods to carry out flavoring or taste masking: adopt the direct flavoring of correctives 1.; 2. in advance Folium Ginkgo extract is made microcapsule with taste masking; 3. in advance Folium Ginkgo extract is carried out powder coating with taste masking, concrete preparation method is as follows:
First step Folium Ginkgo extract give processing method (directly flavoring method need not)
1. directly the flavoring method---this law does not deal with Folium Ginkgo extract, directly enters for second step;
2. prefabricated microcapsule taste masking---get selected capsule material, with dissolved in distilled water and be diluted to debita spissitudo, add fluidizer and mix homogeneously, adopt the uprush laggard line space gas suspension legal system that suspends to be equipped with microcapsule with Folium Ginkgo extract again, gained ginkgo leaf extract powder coated granule, dry back is standby;
3. powder coating taste masking---get selected coating material, with the dissolving of the lyase that adapts with it and to be diluted to debita spissitudo standby, getting Folium Ginkgo extract again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get the ginkgo leaf extract powder coated granule, dry back sieving for standby;
Second step took by weighing correctives and Folium Ginkgo extract or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
[beneficial effect]
Tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take, easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of the tablet extrusion forming, disintegrate is slow, bioavailability is lower, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, meets after saliva separates rapidly or collapse, and borrows and swallows power, and medicine can be gone into the tablet of stomach onset.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, intestinal is residual few, side effect is low, avoid liver first-pass effect etc., therefore, oral cavity disintegration tablet is applicable to onset rapidly, and valid density and poisoning concentration differ bigger medicine, and some war wound emergency treatment medicines, NSAID (non-steroidal anti-inflammatory drug), spasmolytic Bendectin and analgesic etc. all relatively are fit to make oral cavity disintegration tablet.Other medicine such as blood drug level are in for a long time than plateau, then easily produce drug resistance, make oral cavity disintegration tablet and then can overcome this problem, produce excellent curative.
Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate or dissolving, both can swallow by conventional tablet, can be placed in the water again to take after the disintegrate, also can not need to take medicine with water swallow.Especially provide convenience for old man, children's, dysphagia or the inconvenient person that fetches water take medicine,, then can improve the drug compliance of child patient greatly, solved the problem [4] that it is difficult that infant is taken medicine if adopt certain method to improve its mouthfeel in the preparation.
According to the disclosed description introduction of No. 03148531.6 patent " FUFANG DANSHEN KOUQIANG BENGJIEPIAN and preparation method ", oral cavity disintegration tablet has the leap of essence than the disintegration rate of drop pill and ordinary tablet, the disintegrate of oral cavity disintegration tablet generally in 30 seconds, is no more than 1 minute at most.And the dissolve scattered time limit of drop pill Chinese Pharmacopoeia regulation is in 30 minutes, and be all molten loose [5] about 5 minutes the disintegration of conventional tablet Chinese Pharmacopoeia regulation.
The principal indication of Folium Ginkgo extract is a treatment coronary heart disease, angina pectoris, acute cerebral infarction, and diseases such as cerebral arteriosclerosis or disturbance of cerebral circulation, Most patients is an old group, even there wherein have quite a few patient to swallow food to be not very convenient, and that other most of oral formulations also exist dissolve scattered time limit is long, dissolution is low, absorb relatively poor, problems such as liver sausage first pass effect and bioavailability are lower, add injection again and often be easy to generate anaphylaxis or untoward reaction etc. again, it is big simultaneously yet to exist operation easier, the patient suffering is also big, make and the medical treatment cost height, the shortcoming that patient economy burden is heavy, therefore the Ginkago leaf oral disintegrating agent that reaches of the present invention, it is more outstanding that its advantage just seems.
[specific embodiment]
For the better preparation method of explanation YINXINGYE KOUQIANGBENGJIE PIAN of the present invention, in conjunction with direct flavoring method, give make microcapsule taste masking method and powder coating taste masking method as follows for an embodiment respectively:
Embodiment one direct flavoring method
One. prescription
1. raw material---Folium Ginkgo extract 40g;
2. effervescent---citric acid 18g; Sodium bicarbonate 14g;
3. filler---microcrystalline Cellulose 20g, mannitol 79g;
4. fluidizer---micropowder silica gel 4g;
5. disintegrating agent---crospolyvinylpyrrolidone 16g;
6. correctives---aspartame 8g, Herba Menthae essence 0.4g;
7. lubricant---magnesium stearate 0.6g;
Gross weight 200g makes 1000 altogether, 200mg/ sheet, Folium Ginkgo extract content 20%.
Two. preparation method
The first step is got Folium Ginkgo extract, aspartame and Herba Menthae essence, crosses 40 mesh sieves respectively, and mix homogeneously gets the Folium Ginkgo extract raw material for standby of flavoring;
Second step got microcrystalline Cellulose, citric acid, sodium bicarbonate, mannitol, micropowder silica gel, crospolyvinylpyrrolidone and crosses 40 mesh sieves respectively, and mix homogeneously will add and mix homogeneously through the raw material of flavoring again, adds magnesium stearate and mix homogeneously at last;
The 3rd step intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment two gives system microcapsule taste masking method
One. prescription
1. raw material---Folium Ginkgo extract 40g;
2. capsule material---gelatin 15g, Polyethylene Glycol 8g;
3. packing material---mannitol 111.3g;
4. disintegrating agent---cross-linking sodium carboxymethyl cellulose 20g;
5. fluidizer---micropowder silica gel 4.4g;
6. correctives---stevioside 4g, ginseng essence 0.4g;
7. lubricant---magnesium stearate 0.6g;
Gross weight 203.7g makes 1000 altogether, 203.7mg/ sheet, Folium Ginkgo extract content 19.6%.
Two. preparation method
The first step is got gelatin, Polyethylene Glycol and is made into distilled water that to add the micropowder silica gel mixing behind the certain density solution standby as the capsule material;
Second step got Folium Ginkgo extract and is equipped with microcapsule with the uprush laggard line space gas suspension legal system that suspends, gained ginkgo leaf extract powder coated granule, and drying is crossed the 0.5mm sieve, and is standby;
The 3rd step is mannitol, micropowder silica gel, cross-linking sodium carboxymethyl cellulose, stevioside and ginseng essence mix homogeneously, again and the microcapsule after sieving mix and to make evenly, add magnesium stearate, mix making evenly;
The 4th step intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment three powder coating taste masking methods
One. prescription
1. raw material---Folium Ginkgo extract 40g;
2. coating material---ethyl cellulose 12g, Eudragit
E100 8g, Eudragit
NE30D 3.3g;
3. filler---mannitol 111.3g;
4. fluidizer---micropowder silica gel 4.4g;
5. disintegrating agent---crospolyvinylpyrrolidone 16g;
6. correctives---aspartame 4g, fragrant citrus essence 0.4g;
7. lubricant---magnesium stearate 0.6g;
Gross weight 200g makes 1000 altogether, 200mg/ sheet, Folium Ginkgo extract content 20%.
Two. preparation method
The first step is got ethyl cellulose, Eudragit
E100 and Eudragit
NE30D is with the dissolving of the medicinal industrial alcohol more than 95% and to be diluted to finite concentration standby;
Second step got Folium Ginkgo extract and places ebullated bed to seethe with excitement, and sprayed into above-mentioned solution by certain speed and carried out powder coating, made the ginkgo leaf extract powder coated granule, and the 0.6mm sieve is crossed in dry back, and is standby.
The 3rd the step with mannitol, micropowder silica gel, crospolyvinylpyrrolidone, aspartame and fragrant citrus essence mix homogeneously, again and sieve after the coated granule mixing, add magnesium stearate at last, mixing,
The 4th step intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Disintegration of the foregoing description and slice, thin piece hardness numerical value are as follows:
Embodiment disintegration (second) slice, thin piece hardness (newton)
1＜45 second 18-32
2＜60 seconds 18-30
3＜60 seconds 18-27
The partial reference data is as follows:
1. Tang Ling, Su Ke. the pharmacology of Folium Ginkgo extract and Clinical advances. China's medical science 2001,6-14 (3) is P.401-403
2. Wang Hu army, Li Yanhong. gingko leaf extract injection hyperamization pipe redness. adverse effect magazine 2003,1P.54
3. Su Qin, Peng Chaojin, Li Pingsheng, Chu Qinying. quiet of Folium Ginkgo extract causes the allergic cough. adverse effect magazine 2003,1P.54
4. open brightness, Fan Hongcan. the development of oral cavity disintegration tablet. " Hainan medical science 2003,14 (9) is P.88-90
5. open into flying. the production technology of Folium Ginkgo extract. FUFANG DANSHEN KOUQIANG BENGJIEPIAN and preparation method. No. 03148531.6, Chinese patent.
Claims (7)
1. pharmaceutical preparation YINXINGYE KOUQIANGBENGJIE PIAN that is used for the treatment of diseases of cardiovascular and cerebrovascular systems, by supplementary materials such as Folium Ginkgo extract, filler, disintegrating agent, correctives, fluidizer, lubricants, with suitable proportioning, form through specific method for preparing, it is characterized in that the proportioning between each supplementary material is as follows: Folium Ginkgo extract (10～50) %, filler (10～80) %, disintegrating agent (2～30) %, correctives (1～40) %, fluidizer (0.01～5) %, lubricant (0.3～3) %.
2. 5 kinds of adjuvants addressing according to claim 1 is characterized in that selection kind separately is as follows:
Any one or two or more mixture such as filler---mannitol, microcrystalline Cellulose, dextrin, lactose, starch;
Disintegrating agent---crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) wait any one or two or more mixture;
Any one or two or more mixture such as correctives---mannitol, stevioside, gelatin, aspartame, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid;
Any one or two or more mixture such as fluidizer---micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate;
Any one or two or more mixture such as lubricant---magnesium stearate, Stepanol MG, Pulvis Talci.
3. preparation method that is used for the YINXINGYE KOUQIANGBENGJIE PIAN that claim 1 addresses is characterized in that being made up of following steps:
First step Folium Ginkgo extract give processing;
(1) directly flavoring---this law does not deal with Folium Ginkgo extract, directly enters for second step;
(2) prefabricated microcapsule taste masking---get selected capsule material, with dissolved in distilled water and be diluted to debita spissitudo, add fluidizer and mix homogeneously, adopt the uprush laggard line space gas suspension legal system that suspends to be equipped with microcapsule with Folium Ginkgo extract again, gained ginkgo leaf extract powder coated granule, dry back is standby;
(3) powder coating taste masking---get selected coating material, with the dissolving of the lyase that adapts with it and to be diluted to debita spissitudo standby, getting Folium Ginkgo extract again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get the ginkgo leaf extract powder coated granule, dry back sieving for standby;
Second step took by weighing correctives and Folium Ginkgo extract or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
4. the preparation method of addressing according to claim 3 is characterized in that: any method in (2) of the first step and (3) all needs to use in advance capsule material or coating material that Folium Ginkgo extract is carried out taste masking and handles.
5. the preparation method of addressing according to claim 4, it is characterized in that: the capsule material or the coating material that are used for the taste masking processing are gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), any one or two or more mixture such as polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol.
6. any preparation method of addressing according to claim 3 is characterized in that: according to circumstances also can add the adjuvant effervescent.
7. the effervescent of addressing according to claim 6, it is characterized in that: this adjuvant is the mixture of citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101238521A CN1237981C (en) | 2003-12-31 | 2003-12-31 | Ginkgoleaf oral cavity disintegrating tablet and its preparation method |
| PCT/CN2004/001580 WO2005063267A1 (en) | 2003-12-31 | 2004-12-30 | The oral disintegratable tablet of ginkgo leaves |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101238521A CN1237981C (en) | 2003-12-31 | 2003-12-31 | Ginkgoleaf oral cavity disintegrating tablet and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1555843A true CN1555843A (en) | 2004-12-22 |
| CN1237981C CN1237981C (en) | 2006-01-25 |
Family
ID=34338929
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2003101238521A Expired - Lifetime CN1237981C (en) | 2003-12-31 | 2003-12-31 | Ginkgoleaf oral cavity disintegrating tablet and its preparation method |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN1237981C (en) |
| WO (1) | WO2005063267A1 (en) |
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| WO2006000137A1 (en) * | 2004-06-29 | 2006-01-05 | Beijing Kexin Bicheng Medical Technology Development Co., Ltd. | Oral disintegrable tablet of notogingseng total sapoin and the preparation process thereof |
| CN100394917C (en) * | 2005-09-21 | 2008-06-18 | 重庆康刻尔制药有限公司 | Bilobanoate oral-cavity disintegrating tablet and preparation method |
| CN102138672A (en) * | 2010-01-29 | 2011-08-03 | 刘勇 | Fat reducing health care product |
| CN108057027A (en) * | 2018-01-22 | 2018-05-22 | 武汉维奥制药有限公司 | Glimepiride oral disnitegration tablet and preparation method thereof |
| CN108853041A (en) * | 2018-08-20 | 2018-11-23 | 益奇健康科技（上海）有限公司 | A kind of oral quick disintegrating tablet |
| CN111686088A (en) * | 2020-07-03 | 2020-09-22 | 河北医科大学 | Oral quick-release tablet coated with ginkgo biloba extract and preparation method thereof |
| CN112155209A (en) * | 2020-09-11 | 2021-01-01 | 北京瑞草科技有限公司 | Ginkgo extract microcapsule with high flavone content and preparation method and application thereof |
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| ES2958082T3 (en) * | 2019-01-15 | 2024-02-01 | Dr Willmar Schwabe Gmbh & Co Kg | Procedure for the production of easy-to-take tablets with dry extract of Ginkgo biloba leaves |
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| FR2790387B1 (en) * | 1999-03-01 | 2001-05-18 | Prographarm Laboratoires | ORODISPERSIBLE TABLET HAVING LOW FRIABILITY AND PROCESS FOR THE PREPARATION THEREOF |
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| CN1275590C (en) * | 2003-09-29 | 2006-09-20 | 武汉健民中药工程有限责任公司 | Dispersion tablet containing ginkgo leaf extract |
-
2003
- 2003-12-31 CN CNB2003101238521A patent/CN1237981C/en not_active Expired - Lifetime
-
2004
- 2004-12-30 WO PCT/CN2004/001580 patent/WO2005063267A1/en active Application Filing
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2006000137A1 (en) * | 2004-06-29 | 2006-01-05 | Beijing Kexin Bicheng Medical Technology Development Co., Ltd. | Oral disintegrable tablet of notogingseng total sapoin and the preparation process thereof |
| CN100394917C (en) * | 2005-09-21 | 2008-06-18 | 重庆康刻尔制药有限公司 | Bilobanoate oral-cavity disintegrating tablet and preparation method |
| CN102138672A (en) * | 2010-01-29 | 2011-08-03 | 刘勇 | Fat reducing health care product |
| CN108057027A (en) * | 2018-01-22 | 2018-05-22 | 武汉维奥制药有限公司 | Glimepiride oral disnitegration tablet and preparation method thereof |
| CN108853041A (en) * | 2018-08-20 | 2018-11-23 | 益奇健康科技（上海）有限公司 | A kind of oral quick disintegrating tablet |
| CN111686088A (en) * | 2020-07-03 | 2020-09-22 | 河北医科大学 | Oral quick-release tablet coated with ginkgo biloba extract and preparation method thereof |
| CN112155209A (en) * | 2020-09-11 | 2021-01-01 | 北京瑞草科技有限公司 | Ginkgo extract microcapsule with high flavone content and preparation method and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2005063267A1 (en) | 2005-07-14 |
| CN1237981C (en) | 2006-01-25 |
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Owner name: GUIZHOU YIBAI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: KEXIN BICHENG MEDICINE SCIENCE AND TECHNOLOGY DEVELOPMENT CO., LTD., BEIJING Effective date: 20060331 |
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