CN100493494C - American ginseng oral disintegration tablet and its preparing process - Google Patents
American ginseng oral disintegration tablet and its preparing process Download PDFInfo
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- CN100493494C CN100493494C CNB2004100706340A CN200410070634A CN100493494C CN 100493494 C CN100493494 C CN 100493494C CN B2004100706340 A CNB2004100706340 A CN B2004100706340A CN 200410070634 A CN200410070634 A CN 200410070634A CN 100493494 C CN100493494 C CN 100493494C
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- panacis quinquefolii
- radix panacis
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- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 description 1
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- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to oral disintegrated tablet of American ginseng and its extract for treating vital energy deficiency, Yin deficiency, dyspneic cough, blood trace found in phlegm, etc. American ginseng and its extract as main material as well as stuffing, disintegrating agent, corrective, flow assistant, lubricant and other supplementary material are prepared into the oral disintegrated tablet. Into the supplementary material, adhesive, coating material and/or effervescent agent may be added, if necessary. The oral disintegrated tablet of the present invention has excellent crushing degree, fast disintegration, good taste and low cost, and may be taken with no water and high curative effect.
Description
[technical field]
The present invention relates to a kind of have boosting qi and nourishing yin, clearing away heat and promoting production of body fluid, be used for that the deficiency of vital energy cloudy is lost, interior-heat, cough with asthma expectorant blood, deficiency-heat tired tired, quench one's thirst and the preparation of disease Radix Panacis Quinquefolii such as pharyngoxerosis and extract thereof, relate in particular to a kind of the have Radix Panacis Quinquefolii of rapid release effect and the orally disintegrating tablet preparation of extract thereof.
[background technology]
Radix Panacis Quinquefolii has another name called Radix Panacis Quinquefolii, is the dry root of Araliaceae Radix Panacis Quinquefolii (panax guingne folium L.).Wild survivor can claim " wild ginseng " or wild Radix Panacis Quinquefolii ", the grower can claim " seed ginseng " or " Radix Panacis Quinquefolii ".It is a kind of valuable tonification medicine that special medical is worth that has.
Radix Panacis Quinquefolii is former to be wild in the jungle of the Atlantic coast North America, belongs to Araliaceae together with Chinese Radix Ginseng but the root of herbaceos perennial not of the same race.In China's clinical practice the earliest, the applicating history in existing more than 300 year.Quilt China's medicine man is at that time at first regarded as cold tonification seven blood medicines, is to instruct Radix Panacis Quinquefolii is applied to clinical treatment deficiency of YIN heat symptom-complex with the theories of Chinese materia medica, and Radix Panacis Quinquefolii becomes famous and precious tonic gradually thereafter.The clinical practice of Radix Panacis Quinquefolii is recorded in China's medical book the earliest.On the books in clear Kangxu 33 years " complement Bencao Beiyao " and clear Qianrong 30 years " herbal outline is picked up any lost article from the road "." property of medicine is examined " states note, and " Radix Panacis Quinquefolii steeps fourth like the Rhizoma Euonymus of the Liao Dynasty's ginseng, and flavor class Radix Ginseng is only cold in nature, sweetness and bitterness; Nourishing YIN is brought down a fever, and the useful unit of processed with Rhizoma Zingiberis Recens sets upright gas ".As lung stomach two warps, function is tonifying the lung the moon, and born fluid relieves inflammation or internal heat." Records of Tradition Chinese and Western Medicine in Combination " meaning " Radix Panacis Quinquefolii is cool in nature and mend, and allly is not subjected to the temperature compensation person of the Radix Ginseng with Radix Ginseng, all can this generation it "." the complement Bencao Beiyao " of Qing Dynasty medicine scholar Wang Ang work augmented and recorded Radix Panacis Quinquefolii in the item, claim its " cool in nature, bitter in the mouth, sweet thick, gas thin, tonifying the lung pathogenic fire reducing, born fluid, relieving restlessness is tired, empty and have the fiery person suitable ".
Radix Panacis Quinquefolii is cold in nature, the effect of bitter in the mouth, useful lung yin, clear asthenic fire, promoting the production of body fluid to quench thirst, be usually used in treating chronic cough of deficiency lung, diseases such as tired tired, the thirsty few Tianjin of the dry pharynx of losing blood, deficiency-heat, toothache due to stomach-fire, also be applied in the convalescent period of treatment neurasthenia and autonomic nervous dysfunction, pleuritis, infectious polyneuritis and encephalitis b and other acute infectious disease simultaneously, or with other drug matching, curative effect is preferably arranged.
Modern study shows that the pharmacologically active of Radix Panacis Quinquefolii is many-sided, has dual regulation, and main pharmacodynamics can reduce the following aspects:
1. for the central nervous system, have calmness, strengthen learning and memory, promote nerve growth, convulsion, analgesia, antipyretic effect, be applicable to diseases such as neurasthenia, psychosis, hypomnesis, senile disease;
2. for cardiovascular system, have arrhythmia, resist myocardial ischemia and the effect of reperfusion injury etc., be applicable to diseases such as arrhythmia, coronary heart disease, acute myocardial infarction, cerebral thrombosis, coronary artery bypass surgery;
3. for blood system, have the effect of anti-hemolysis, hemostasis, reduction blood coagulation, inhibition platelet aggregation, accent blood fat, atherosclerosis, blood sugar lowering etc., be applicable to diseases such as hyperlipemia atherosclerosis, senile disease, diabetes;
4. for adapting to the former state effect, have resisting fatigue, anti-hypoxia ischemia, shock, anti-ly hunger and thirst, anti-high and low-temp and various chemical factor, be suitable for various shocks;
5. for immune system, have and fall the effect that lipid peroxidation and malonaldehyde etc., enhance SOD vigor, inhibition lymphocyte transformation, spleen heavily wait, be applicable to senile disease and cancer etc.;
6. for hormonal system, act on hypophysis-interrenal system (ACTH sample) and hypophysis-gonad system, promote that serum albumin is synthetic, promote that bone marrow protein is synthetic, promote that organ albumen is synthetic, promote in the brain the synthetic and lipogenesis of albumen, promotion hepatocyte albumen (RNA polymerase vigor) is synthetic, promote effects such as lipid metabolism and carbohydrate metabolism, is applicable to that senile disease, sexual function are low, anemia and cancer etc.;
7. for urinary system, have antidiuretic activity, be applicable to A Disenshi disease and senile disease etc.;
8. for tumor and virus, have the effect of viruses such as anticancer propagation, inhibition herpes simplex, be applicable to various cancers and viral disease.
Radix Panacis Quinquefolii is a medicinal and edible plant, is famous and precious top grade Chinese medicine, is again the high-grade nourishing good merchantable brand.It contains 16 kinds of trace element of needed by human and 17 kinds with upper amino acid and polysaccharide, polypeptide and multivitamin etc., have anticancer, resisting fatigue, anti-hypoxia, radioprotective, the anti-ageing multiple function of waiting for a long time, coronary heart disease, hypertension, anemia, neurosis, diabetes etc. are had good curative effect.Often take Radix Panacis Quinquefolii, but building body, life lengthening.
Radix Panacis Quinquefolii is cold in nature, and all-ages, the four seasons all can nourish.Old or body void person, body constitution chump, brain worker, the uncomfortable person of endocrine, sexual function gastrointestinal disease patient after being ill, and be not suitable for the youngster of nourishing with Radix Ginseng, all be fit to the Radix Panacis Quinquefolii of nourishing.Because the Radix Panacis Quinquefolii drug effect is mild, quite is subjected to patient's welcome.Special China all provinces in south likes using Radix Panacis Quinquefolii (comprising the Radix Panacis Quinquefolii finished product).
The dosage form of Radix Panacis Quinquefolii and extract formulation thereof mainly contains buccal tablet, ordinary tablet and capsule formulation at present.Still find no the orally disintegrating tablet preparation or the relevant document of Radix Panacis Quinquefolii and extract thereof.Radix Panacis Quinquefolii and extract thereof are made oral cavity disintegration tablet, make the patient easy to carry and use, help improving patient's compliance, and then can guarantee Radix Panacis Quinquefolii and extract curative effect thereof.
[summary of the invention]
The objective of the invention is to improve existing Radix Panacis Quinquefolii and extract thereof aspect peroral dosage form deficiency, provide a kind of taking convenience, absorption is rapid-action, bioavailability is high Radix Panacis Quinquefolii and extract ora disintegration tablet preparation thereof to extensive patients and medical personnel.Needn't drink water when the present invention relates to take, in the oral cavity, only need tens seconds can rapid disintegrate or dissolving, the Radix Panacis Quinquefolii that can finish to take medicine with saliva hypopharynx and extract ora disintegration tablet thereof and preparation method thereof.
One, prescription
Radix Panacis Quinquefolii and the extract ora disintegration tablet thereof that reaches of the present invention comprises material medicine Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract, needs following former, the auxiliary material of 9 classes altogether, wherein: when not making Cotton seeds, then do not use coating material, effervescent also can for selecting adjuvant for use as one sees fit.
Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract (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 include but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, microcrystalline Cellulose,
SMCC, polymerization sugar
, glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent include but are not limited to microcrystalline Cellulose,
SMCC, crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide
Deng, can use use also capable of being combined separately.
Correctives includes but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, 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
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, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, magnesium laurylsulfate, Stepanol MG and 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
Radix Panacis Quinquefolii and the extract ora disintegration tablet thereof that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
Radix Panacis Quinquefolii and extract mildly bitter flavor thereof are and sweet, 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 Radix Panacis Quinquefolii and extract thereof are carried out powder coating with taste masking.
Concrete preparation method is as follows:
The pretreatment of first step Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract:
1. directly flavoring---this law is pulverized Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract raw material, granulates in the back of sieving;
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, place ebullated bed to make boiling Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract again through pulverizing, spray into above-mentioned solution with suitable speed then and carry out powder coating, get Radix Panacis Quinquefolii or Radix Panacis Quinquefolii extract powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and the feed particles after the first step is handled 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, after the rapid disintegrate of chance saliva, or 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.
[specific embodiment]
For the preparation method of Radix Panacis Quinquefolii of the present invention and extract ora disintegration tablet thereof 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---Radix Panacis Quinquefolii 500.0g;
2. filler---mannitol 156.0g;
Microcrystalline Cellulose 56.0g;
3. correctives---aspartame 8.0g;
4. disintegrating agent---crospolyvinylpyrrolidone 34.0g;
Cross-linking sodium carboxymethyl cellulose 30.0g;
5. fluidizer---micropowder silica gel 8.0g;
6. lubricant---sodium stearyl fumarate 8.0g.
Gross weight 800g makes 1000 altogether.
Two. preparation method
1) Radix Panacis Quinquefolii is pulverized, crossed 80 mesh sieves, oven dry, standby;
2) with crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the Radix Panacis Quinquefolii powder of having pulverized again, and mix homogeneously is standby;
3) add mannitol and microcrystalline Cellulose mix homogeneously again;
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---Radix Panacis Quinquefolii extract 200.0g;
2. coating material---
E100 20.0g;
3. filler---mannitol 161.0g;
4. correctives---aspartame 5.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 34.0g;
Cross-linking sodium carboxymethyl cellulose 16.0g;
6. fluidizer---micropowder silica gel 9.0g;
7. lubricant---sodium stearyl fumarate 5.0g.
Gross weight 450g makes 1000 altogether.
Two. preparation method
1) gets
E100 is with the dissolving of the medicinal industrial alcohol more than 95% and to be diluted to finite concentration standby;
2) get Radix Panacis Quinquefolii extract and place ebullated bed to seethe with excitement, spray into above-mentioned solution by certain speed and carry out powder coating, make Radix Panacis Quinquefolii and extract powder coated granule thereof, dry back is standby;
3) with mannitol, micropowder silica gel, PVPP, CCNa, aspartame and sodium stearyl fumarate mix homogeneously, again and sieve after the coated granule mixing standby;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Claims (2)
- One kind have boosting qi and nourishing yin, clearing away heat and promoting production of body fluid and be used for that the deficiency of vital energy cloudy is lost, interior-heat, cough with asthma expectorant blood, deficiency-heat tired tired, quench one's thirst or the Radix Panacis Quinquefolii oral cavity disintegration tablet of pharyngoxerosis, wherein, Radix Panacis Quinquefolii 500 grams, mannitol 156 grams, microcrystalline Cellulose 56 grams, crospolyvinylpyrrolidone 34 grams, cross-linking sodium carboxymethyl cellulose 30 grams, aspartame 8 grams, micropowder silica gel 8 grams, sodium stearyl fumarate 8 grams, and make 1000 by the following method:1) Radix Panacis Quinquefolii is pulverized, crossed 80 mesh sieves, oven dry, standby;2) with crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the Radix Panacis Quinquefolii powder of having pulverized again, and mix homogeneously is standby;3) add mannitol and microcrystalline Cellulose mix homogeneously again;4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
- 2. method for preparing the described Radix Panacis Quinquefolii oral cavity disintegration tablet of claim 1 is characterized in that being made up of following steps:The first step is pulverized Radix Panacis Quinquefolii, crosses 80 mesh sieves, and oven dry is standby;Second step crossed 40 mesh sieves respectively with crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate and aspartame, and mix homogeneously adds the Radix Panacis Quinquefolii powder of having pulverized again, and mix homogeneously is standby;The 3rd step added mannitol and microcrystalline Cellulose mix homogeneously again;The 4th step intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
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| CN102631482B (en) * | 2012-05-12 | 2014-01-08 | 赵全成 | Chinese medicinal composition for preventing and treating diabetes and complications |
| CN106420639A (en) * | 2016-08-02 | 2017-02-22 | 吉林省红五味生物技术有限公司 | Multiple-effect American ginseng slices |
| CN108813618A (en) * | 2018-07-10 | 2018-11-16 | 青岛高新区尚达医药研究所 | A kind of oral disintegrating tablet and preparation method thereof with liver-protecting function |
| CN113181132A (en) * | 2021-04-27 | 2021-07-30 | 宁波西敦医药包衣科技有限公司 | Chinese herbal medicine superfine powder composition, preparation method and application of Chinese herbal medicine superfine powder tablet |
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| 口腔崩解片的研制. 张辉等.海南医学，第14卷第9期. 2003 |
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