CN1247202C - Dioscin oral disintegration tablet and its preparing method - Google Patents
Dioscin oral disintegration tablet and its preparing method Download PDFInfo
- Publication number
- CN1247202C CN1247202C CN 200410062279 CN200410062279A CN1247202C CN 1247202 C CN1247202 C CN 1247202C CN 200410062279 CN200410062279 CN 200410062279 CN 200410062279 A CN200410062279 A CN 200410062279A CN 1247202 C CN1247202 C CN 1247202C
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- dioscin
- blood
- essence
- standby
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
- 230000008344 brain blood flow Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 1
- 239000007931 coated granule Substances 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 235000012343 cottonseed oil Nutrition 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 238000009509 drug development Methods 0.000 description 1
- 239000000686 essence Substances 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 201000005577 familial hyperlipidemia Diseases 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229960001031 glucose Drugs 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical class OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 210000003026 hypopharynx Anatomy 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 229960002160 maltose Drugs 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000036284 oxygen consumption Effects 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
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- 230000001737 promoting effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to an oral disintegrating tablet capable of treating and preventing disease symptoms, such as coronary disease, angina pectoris, thoracic obstruction, vertigo, oppression in chest, palmus, short breath, hyperlipoidemia, blood-hyperviscosity and disturbance of cerebral blood circulation, such as cerebral arteriosclerosis, apoplexy sequelae, vertebra-basilar artery blood-supply shortage, etc., wherein thoracic obstruction, vertigo, oppression in chest, palmus, short breath, hyperlipoidemia and blood-hyperviscosity are caused by internal resistance of static blood. The present invention particularly relates to an oral disintegrating tablet preparation containing diosgenin extracted from medicinal plants, such as dioscorea nipponica, etc., and a preparation technology thereof. In the present invention, diosgenin is used as raw materials, and filling agents, disintegrating agents, corrective, glidant, lubricant agents, etc. are used as auxiliary materials; according to different conditions, binding agents or coating materials can be used, and a proper quantity of effervescing agents can be added conditionally; by a specific preparation method, the oral disintegrating tablet is prepared by tabletting with a tabletting machine. The oral disintegrating tablet of the present invention has the advantages of good friability, quick disintegration, good taste, no sand gravel sensation and no need of specific production condition, and has the characteristics of low production cost, portability, convenient storage, convenient transportation and convenient administration, etc.
Description
[technical field] the present invention relates to a kind ofly to be used for the treatment of with the thoracic obstruction, dizzy, uncomfortable in chest, the cardiopalmus of prevention coronary heart disease, angina pectoris and blood-stasis internal-depression, breathes hard, hyperlipemia, high blood viscosity; The dioscin preparation of diseases such as brain blood circulation obstacle such as cerebral arteriosclerosis, apoplexy sequela, vertebral-basilar artery insufficiency relates in particular to a kind of dioscin oral disintegration tablet preparation with rapid release effect.
[background technology]
Dioscin is to extract to obtain from medicinal plants Rhizoma Dioscoreae Nipponicae etc., through the refining pure Chinese medicinal preparation that forms of scientific formula, has the advantages that chemical constitution is clear and definite, oral absorption is good, bioavailability is high.
Dioscin energy coronary blood flow increasing and myocardial nutritional flow amount have obvious protective effect, allevating angina pectoris to myocardial ischemia; Transfer fat, blood viscosity lowering, anticoagulant, microcirculation improvement prevents thrombosis; Alleviate infiltration of arterial wall lipid and speckle and form, prevention of arterial is atherosis; Reduce cardiac load, reduce myocardial oxygen consumption, improve cardiac function.
Existing dioscin preparation has conventional tablet and capsule.The medicine time that needs of patients is long, conventional tablet needs water companion clothes when taking, thereby may cause patient's compliance to reduce.The exploitation dioscin oral disintegration tablet makes the patient carry taking convenience, helps to improve patient's compliance; Also can solve simultaneously the problem of taking medicine of swallowing inconvenient patient.
[summary of the invention]
The objective of the invention is to improve existing dioscin aspect peroral dosage form deficiency, provide a kind of taking convenience, absorption is rapid-action, bioavailability is high dioscin oral disintegration tablet preparation to extensive patients and medical personnel.Needn't drink water when the present invention relates to take, in the oral cavity, only need get final product rapid disintegrate or dissolving in tens seconds, can finish dioscin oral disintegration tablet of taking medicine and preparation method thereof with saliva hypopharynx.The hardness of the tablet that obtains by this preparation method is between 10 to 45 newton, and disintegration time is at 1-60 in second.
One, prescription
The dioscin oral disintegration tablet that reaches of the present invention comprises the material medicine dioscin, needs following former, the auxiliary material of 8 classes altogether, and wherein: when not making Cotton seeds, then do not use coating material, effervescent also can for selecting adjuvant for use as one sees fit.
Dioscin (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
Wherein:
Binding agent includes but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler includes but are not limited to mannitol (granular or powdery), xylitol, glucose, sorbitol, maltose, microcrystalline Cellulose, dextrin, lactose, starch etc., can use separately, also can applied in any combination, and consumption is generally (10-80) %.
Disintegrating agent includes but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) etc., can use use also capable of being combined separately.
Correctives includes but are not limited to mannitol, stevioside, gelatin, aspartame, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material includes but are not limited to 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), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer includes but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant includes but are not limited to magnesium stearate, Stepanol MG, Pulvis Talci etc., can use use also capable of being combined separately.
Effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Two, preparation method
The dioscin oral disintegration tablet that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
Dioscin is distinguished the flavor of little sweet and bitter, and the present invention can adopt two kinds of distinct methods to carry out flavoring or taste masking: 1. adopt the direct flavoring of correctives; 2. in advance dioscin is carried out powder coating with taste masking.
Concrete preparation method is as follows:
The preprocess method of first step dioscin (directly flavoring method need not):
1. directly the flavoring method---this law is granulated to the dioscin raw material or is not dealt with, and directly enters for second step;
2. powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, getting dioscin again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get dioscin powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and dioscin 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, and intestinal is residual few, and side effect is low, avoids liver first-pass effect etc.
According to the requirement of " formulation characteristic of oral cavity disintegration tablet and quality control meeting summary ", oral cavity disintegration tablet has essential leap than the disintegration rate of drop pill and ordinary tablet, and 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 loosing about 5 minutes the disintegration of conventional tablet Chinese Pharmacopoeia regulation.
[specific embodiment]
For the preparation method of dioscin oral disintegration tablet of the present invention better is described, in conjunction with directly flavoring method and powder coating taste masking method are as follows for an embodiment respectively:
Embodiment one direct flavoring method
One. prescription
1. raw material---dioscin 80.0g;
2. binding agent---polyvinylpyrrolidone K-30 1.0g;
3. filler---microcrystalline Cellulose 10.0g;
Mannitol 119.0g;
4. correctives---aspartame 2.5g;
Fragrant citrus essence 2.5g;
5. disintegrating agent---crospolyvinylpyrrolidone 12.0g;
L-HPC 18.0g；
6. fluidizer---micropowder silica gel 2.5g;
7. lubricant---magnesium stearate 2.5g.
Gross weight 250g makes 1000 altogether, 250mg/ sheet, dioscin content 32%.
Two. preparation method
1) get the dioscin raw material pulverizing, granulate, cross 26 mesh sieves with polyvinylpyrrolidone K-30, standby;
2) with micropowder silica gel, aspartame and fragrant citrus essence, cross 40 mesh sieves respectively, mix homogeneously adds the dioscin granule of having granulated again, and mix homogeneously is standby;
3) get microcrystalline Cellulose, mannitol, crospolyvinylpyrrolidone and cross 40 mesh sieves respectively, mix homogeneously will add and mix homogeneously through the raw material of flavoring again, adds magnesium stearate and mix homogeneously at last;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment two powder coating taste masking methods
One. prescription
1. raw material---dioscin 80.0g;
2. coating material---Eudragit
E100 12.0g;
Eudragit
NE30D (doing) 4.0g;
3. filler---mannitol 110.0g;
4. correctives---aspartame 2.5g;
Herba Menthae essence 2.5g;
5. disintegrating agent---crospolyvinylpyrrolidone 10.0g;
L-HPC 15.0g；
6. fluidizer---micropowder silica gel 6.5g;
7. lubricant---magnesium stearate 2.5g.
Gross weight 250g makes 1000 altogether, 250mg/ sheet, dioscin content 32%.
Two. preparation method
1) gets 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;
2) get dioscin and place ebullated bed to seethe with excitement, spray into above-mentioned solution by certain speed and carry out powder coating, make dioscin powder coating granule, dry back is standby;
3) with mannitol, micropowder silica gel, PVPP, L-HPC, aspartame and Herba Menthae essence mix homogeneously, again and sieve after the coated granule mixing, add magnesium stearate at last, mixing, standby;
4) 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 2 | 13-19 12-21 | 18-25 19-27 |
Claims (2)
1 one kinds of dioscin oral disintegration tablets, it is characterized in that its weight consists of dioscin 5-50%, coating material polypropylene acid resin 6.4-40%, disintegrating agent crospolyvinylpyrrolidone 2-35%, filler 10-80%, correctives 1-40%, fluidizer 0.01-5% and lubricant 0.3-3% form, wherein filler is selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, in maltodextrin and the pregelatinized Starch one or more, correctives is selected from mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, in the citric acid one or more, fluidizer is selected from micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, in the hydrated sodium aluminosilicate one or more, lubricant is selected from magnesium stearate, glyceryl monostearate, Stepanol MG, in the Pulvis Talci one or more; After wherein dioscin being carried out powder coating with coating material, the gained granule is pressed into disintegrating tablet with other adjuvant.
The preparation method of 2 dioscin oral disintegration tablets as claimed in claim 1 is characterized in that being made up of following steps:
(1) pretreatment of dioscin; Get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, get dioscin again and place fluid bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get dioscin powder coating granule, dry back sieving for standby;
(2) correctives and the feed particles after first step taste masking is handled are taken by weighing according to quantity, and mix homogeneously is standby;
(3) filler, disintegrating agent, fluidizer are taken by weighing according to quantity also mix homogeneously, make evenly again with through second mixing of materials that goes on foot gained, add the lubricant mixing, standby;
(4) the gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410062279 CN1247202C (en) | 2004-07-05 | 2004-07-05 | Dioscin oral disintegration tablet and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410062279 CN1247202C (en) | 2004-07-05 | 2004-07-05 | Dioscin oral disintegration tablet and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1586493A CN1586493A (en) | 2005-03-02 |
| CN1247202C true CN1247202C (en) | 2006-03-29 |
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ID=34603678
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410062279 Expired - Fee Related CN1247202C (en) | 2004-07-05 | 2004-07-05 | Dioscin oral disintegration tablet and its preparing method |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0329667D0 (en) | 2003-12-22 | 2004-01-28 | King S College London | Core 2 GlcNAc-T inhibitor |
| GB0513881D0 (en) * | 2005-07-06 | 2005-08-10 | Btg Int Ltd | Core 2 GLCNAC-T Inhibitors III |
| TWI422378B (en) * | 2010-11-18 | 2014-01-11 | Univ Chung Shan Medical | Improvement of cognitive deficit associated with menopausal syndrome with diosgenin |
| CN104069312B (en) * | 2013-03-29 | 2018-03-13 | 天津药物研究院 | Treat Chinese medicine composition of apoplexy and preparation method thereof, pharmaceutical preparation and application |
| CN109172590A (en) * | 2018-11-08 | 2019-01-11 | 大连医科大学 | Dioscin inhibits the application in angiosteosis drug in preparation |
| CN110302169A (en) * | 2019-08-01 | 2019-10-08 | 张慧芬 | A kind of sliding film coated tablet and preparation method thereof |
| CN111714509A (en) * | 2020-07-24 | 2020-09-29 | 南通大学 | Application of a diosgenin in the medicine for preventing and treating motion sickness |
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