CN101653587B - Tangerine peel buccal tablets, oral disintegrating tablets and application thereof - Google Patents
Tangerine peel buccal tablets, oral disintegrating tablets and application thereof Download PDFInfo
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- CN101653587B CN101653587B CN2008100302881A CN200810030288A CN101653587B CN 101653587 B CN101653587 B CN 101653587B CN 2008100302881 A CN2008100302881 A CN 2008100302881A CN 200810030288 A CN200810030288 A CN 200810030288A CN 101653587 B CN101653587 B CN 101653587B
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- pericarpium citri
- citri reticulatae
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Abstract
The invention relates to tangerine peel buccal tablets, oral disintegrating tablets and application thereof. 1,000 tangerine peel buccal tablets or 1,000 oral disintegrating tablets are prepared from the following components and pharmaceutically acceptable additives: 120 to 220 grams of tangerine peel and 380 to 480 grams of fresh ginger. The tangerine peel has bidirectional regulation function on gastrointestinal smooth muscles so as to influence the gastrointestinal motility; the ginger can inhibit the central nervous system to release vasopressin so as to relive electrogastric hypsarrhythmia in motion sickness and symptoms such as nausea, vomit and the like; and when the tangerine peel and the ginger are combined, the effect of the combination is superior to that of dimenhydrinate, and the combination has no adverse reaction such as drowsiness, dizziness, headache, thirst, nausea, vomit, epigastric region discomfort and the like.
Description
Technical field
The present invention relates to a kind of Pericarpium Citri Reticulatae buccal tablet, oral cavity disintegration tablet and application thereof.
Background technology
Pericarpium Citri Reticulatae derives from Rutaceae plant Citrus, reticulata, Blanco and carries the mature peel of training mutation, Ming Dynasty's Li Shizhen (1518-1593 A.D.) cloud: " then mend with tonic, then rush down with cathartic, then rise with Hydrargyri Oxydum Rubrum, then fall with falling medicine.Spleen is the mother of Primordial Qi, and lung is label of taking the photograph gas, so Pericarpium Citri tangerinae is two medicines through edema caused by disorder of QI, but with join and the reinforcing and reducing lifting also ".So the Pericarpium Citri Reticulatae preparation is widely used in the disease treatments such as respiratory tract, digestive tract.The Pericarpium Citri Reticulatae preparation also has fine effect aspect cardiovascular, endocrine, anticancer, defying age, skin maintenance, the nutrition tonify deficiency in recent years.
The Pericarpium Citri Reticulatae preparation formulation mainly contains powder, mixture, oral liquid, medicated wine, electuary, tablet, injection etc., and Pericarpium Citri Reticulatae is used as medicine to be had direct pulverize and extract its active ingredient dual mode.
Since social fast-developing, an important component part during the vehicles become the living words of people and work.People's trip be unable to do without the vehicles.These vehicles have brought also for the people who takes and do not accommodate misery when bringing convenience to people.Topmost malaise symptoms when motion sickness is exactly people's riding public transportation means.Motion sickness is a kind of because the syndrome that motion stimulate to cause, and its symptom is based on vestibule vegetative nerve dysfunctions such as dizzy, nauseating, vomitings, and epidemiological study shows that about 80% people experienced motion sickness; In manned space flight, motion sickness appearred in 35%~67% spacefarer.
Modern medicine thinks, the generation of motion sickness and the vehicles are produced when motion jolt, wave or the accelerated motion repeatedly of form such as rotation relevant.Clinical control motion sickness medicine dimenhydrinate commonly used plays a role by suppressing vomiting center, but untoward reaction such as common drowsiness, dizzy, headache, xerostomia, nauseating, vomiting and epigastric region discomfort; Hypertension, hyperthyroidism, cardiopalmus patient avoid usefulness; Glaucoma, neonate, premature infant, newborn woman etc. avoid usefulness.Also have some folk prescriptions among the people to be used to prevent and treat motion sickness, but these method effect instabilities, not remarkable, perhaps medication inconvenience.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art part, a kind of Chinese medicine preparation of preventing and treating motion sickness is provided, this Chinese medicine preparation taking convenience, taste is good, is free from side effects.
Technical scheme of the present invention is: a kind of Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet comprises following each component and pharmaceutically acceptable additives:
Pericarpium Citri Reticulatae 140-200 gram
Fresh ginger 280-400 gram
Make 1000 altogether.
Preferably, Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet of the present invention comprises following each component and pharmaceutically acceptable additives:
Pericarpium Citri Reticulatae 150-190 gram
Fresh ginger 300-380 gram
Make 1000 altogether.
Preferably, Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet of the present invention comprises following each component and pharmaceutically acceptable additives:
Pericarpium Citri Reticulatae 160-180 gram
Fresh ginger 320-360 gram
Make 1000 altogether.
Preferably, Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet of the present invention comprises following each component and pharmaceutically acceptable additives:
Pericarpium Citri Reticulatae 170-175 gram
Fresh ginger 340-350 gram
Make 1000 altogether.
Preferably, Pericarpium Citri Reticulatae buccal tablet of the present invention is made up of following each component:
Pericarpium Citri Reticulatae 173.0 grams
Fresh ginger 346.0 grams
Icing Sugar 200.8
Soluble starch 200.8 grams
Citric acid 16.0 grams
Aspartame 6.0 grams
Flavoring orange essence 3.0 grams
Magnesium stearate is an amount of
Make 1000 altogether.
Preferably, oral cavity disintegration tablet of the present invention is made up of following each component:
Pericarpium Citri Reticulatae 173.0g
Rhizoma Zingiberis Recens 346.0g
Microcrystalline Cellulose 154.0g
Polyvinylpolypyrrolidone 46.1g
Low-substituted hydroxypropyl cellulose 39.2g
Mannitol 51.2g
Citric acid 39.2g
Sodium bicarbonate 39.2g
Aspartame 5.12g
Micropowder silica gel 10.2g
5% 30 POVIDONE K 30 BP/USP
30Ethanol solution is an amount of
Make 1000 altogether.
The preparation method of Pericarpium Citri Reticulatae buccal tablet of the present invention or Orally-disintegrating tablet is as follows: take by weighing the Pericarpium Citri Reticulatae medical material of ormal weight, add suitable quantity of water and decoct secondary, each 1-2 hour, collecting decoction also filtered, and filtrate is condensed into thick paste; The Rhizoma Zingiberis Recens that takes by weighing ormal weight extracts volatile oil, and the aqueous solution after the distillation filters, and filtrate is condensed into thick paste; Pericarpium Citri Reticulatae thick paste and Rhizoma Zingiberis Recens thick paste merge, and drying is ground into fine powder; Add medically acceptable disintegrating agent and/or other additives, mixing is granulated, drying, and granulate sprays into Rhizoma Zingiberis Recens volatile oil, tabletting.
Motion sickness belongs to " vertigo " category in theory of Chinese medical science.Its cause of disease mostly is deficiency of marrow-reservoir, deficiency of qi and blood and stagnation of turbid phlegm in middle-JIAO.When inducements such as rotating, wave, jolt influenced, it was disorderly contrary then to cause mechanism of qi, and lifting is become estranged; Or upward adverse flow of phlegm and falling ill, the symptom of mechanism of qi superinverses such as uncomfortable in chest, nauseating, vomiting, stomach discomfort appears clinically.The Pericarpium Citri tangerinae regulating qi-flowing for harmonizing stomach, the Rhizoma Zingiberis Recens expelling cold to relieve vomiting and and use it, make that sun is logical cold to be gone, gastric qi and falling is then retched, is vomited and the cold spontaneous recovery of fainting.Have experiment to show that symptoms of emesis and gastrointestinal smooth muscle functional status have close ties, and Pericarpium Citri Reticulatae have dual regulation to gastrointestinal smooth muscle, influences gastrointestinal motility; Rhizoma Zingiberis Recens can discharge vasopressin by suppressing the central nervous system, thereby the stomach when alleviating motion sickness electricity arhythmicity and feel sick, symptom such as vomiting, the two synergy, its effect is better than dimenhydrinate, and do not have drowsiness, dizzy, headache, xerostomia, feel sick, untoward reaction such as vomiting and epigastric region discomfort.
The specific embodiment
Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet of the present invention comprises Pericarpium Citri Reticulatae, fresh ginger and/or pharmaceutically acceptable disintegrating agent and other additives, and the consumption of additives is not had special requirement, as long as in the acceptable scope of materia medica.The consumption of disintegrating agent is generally the 10-30% of whole raw material weights, and pharmaceutically Chang Yong disintegrating agent all can use, and preferred polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, citric acid and sodium bicarbonate are mixed to be used.
Embodiment 1: a kind of Pericarpium Citri Reticulatae buccal tablet, composed as follows:
Pericarpium Citri Reticulatae 173.0 grams
Fresh ginger 346.0 grams
Icing Sugar 200.8 grams
Soluble starch 200.8 grams
Citric acid 16.0 grams
Aspartame 6.0 grams
Flavoring orange essence 3.0 grams
Magnesium stearate is an amount of
Take by weighing each component by above-mentioned prescription.The Pericarpium Citri Reticulatae medical material is added suitable quantity of water decoct secondary, each 2 hours, collecting decoction also filtered, and filtrate is condensed into thick paste (60 ℃ of relative density 1.0-1.10); Rhizoma Zingiberis Recens is extracted volatile oil, and the aqueous solution after the distillation filters, and filtrate is condensed into thick paste (60 ℃ of relative density 1.0-1.10); Pericarpium Citri Reticulatae thick paste and Rhizoma Zingiberis Recens thick paste merge, and drying is ground into fine powder; Add Icing Sugar 200.8 grams, soluble starch 200.8 grams, citric acid 16 grams, aspartame 6.0 grams, flavoring orange essence 3.0 grams, mixing is granulated, and cold drying sprays into Rhizoma Zingiberis Recens volatile oil, and it is an amount of to add magnesium stearate, mixing, tabletting.Make 1000 every heavy 0.5 gram altogether.
The invention provides other embodiment following (unit: restrain) of Pericarpium Citri Reticulatae buccal tablet:
Sequence number | Pericarpium Citri Reticulatae | Fresh ginger | Icing Sugar | Soluble starch | Citric acid | Aspartame | Flavoring orange essence | Magnesium stearate |
2 | 140 | 380 | 200 | 200 | 14 | 8 | 1 | In right amount |
3 | 150 | 370 | 210 | 190 | 17 | 5 | 3 | In right amount |
4 | 160 | 355 | 220 | 180 | 18 | 4 | 4 | In right amount |
5 | 162 | 358 | 200 | 200 | 16 | 6 | 2 | In right amount |
6 | 170 | 350 | 225 | 175 | 15 | 7 | 5 | In right amount |
7 | 175 | 345 | 230 | 170 | 14 | 8 | 1 | In right amount |
8 | 176 | 344 | 220 | 180 | 17 | 5 | 3 | In right amount |
The preparation method of last each embodiment of table is with embodiment 1, and each embodiment all makes 1000 in tablet.
Embodiment 9: a kind of Pericarpium Citri Reticulatae oral cavity disintegration tablet, and it is composed as follows:
Pericarpium Citri Reticulatae 173.0g
Rhizoma Zingiberis Recens 346.0g
Microcrystalline Cellulose 154.0g
Polyvinylpolypyrrolidone 46.1g
Low-substituted hydroxypropyl cellulose 39.2g
Mannitol 51.2g
Citric acid 39.2g
Sodium bicarbonate 39.2g
Aspartame 5.12g
Micropowder silica gel 10.2g
5% 30 POVIDONE K 30 BP/USP
30Ethanol solution is an amount of
Make 1000 altogether
Take by weighing each component by above-mentioned prescription.The Pericarpium Citri Reticulatae medical material is added suitable quantity of water decoct secondary, each 2 hours, collecting decoction also filtered, and filtrate is condensed into thick paste (60 ℃ of relative density 1.0-1.10); Rhizoma Zingiberis Recens is extracted volatile oil, and the aqueous solution after the distillation filters, and filtrate is condensed into thick paste (60 ℃ of relative density 1.0-1.10); Pericarpium Citri Reticulatae thick paste and Rhizoma Zingiberis Recens thick paste merge, and drying is ground into impalpable powder; Add microcrystalline Cellulose 154g, polyvinylpolypyrrolidone 46.1g, low-substituted hydroxypropyl cellulose 39.2g, mannitol 51.2g, citric acid 39.2g, sodium bicarbonate 39.2g, aspartame 5.12g, micropowder silica gel 6.8g, mixing adds 5% 30 POVIDONE K 30 BP/USP
30Ethanol solution is an amount of, and 40 mesh sieves are granulated, and drying sprays into Rhizoma Zingiberis Recens volatile oil, adds micropowder silica gel 3.4g, mixing, and tabletting is made 1000 every heavy 0.45 gram altogether.
Other embodiment of Pericarpium Citri Reticulatae oral cavity disintegration tablet provided by the invention following (unit: restrain):
Sequence number | Pericarpium Citri Reticulatae | Fresh ginger | Microcrystalline Cellulose | Polyvinylpolypyrrolidone | Low-substituted hydroxypropyl cellulose | Mannitol | Citric acid | Sodium bicarbonate | Aspartame | Micropowder silica gel | 5% 30 POVIDONE K 30 BP/USP, 30 ethanol solutions |
10 | 140 | 380 | 150 | 47 | 38 | 50 | 41 | 40 | 5 | 12 | In right amount |
11 | 150 | 370 | 154 | 44 | 39 | 52 | 39 | 38 | 6 | 12 | In right amount |
12 | 160 | 355 | 150 | 47 | 38 | 50 | 41 | 40 | 5 | 12 | In right amount |
13 | 165 | 358 | 154 | 44 | 39 | 52 | 39 | 38 | 6 | 12 | In right amount |
14 | 170 | 350 | 150 | 47 | 38 | 50 | 41 | 40 | 5 | 12 | In right amount |
15 | 175 | 345 | 154 | 44 | 39 | 52 | 39 | 38 | 6 | 12 | In right amount |
The preparation method of last each embodiment of table is with embodiment 9, and each embodiment all makes 1000 in tablet, every 0.45 gram.
Be the clinical application research report of Pericarpium Citri Reticulatae oral cavity disintegration tablet of the present invention below:
The chance that the inventor utilizes the student of Jiangxi Chinese medicine higher junior college and Jiangmen, Guangdong Province Chinese medicine school to have a winter vacation and go home and return to school has been carried out the clinical observation of prevention of motion sickness to embodiment 9 described Pericarpium Citri Reticulatae oral cavity disintegration tablets, is reported as follows:
1 object and method
1.1 case is selected:
1. the experimenter must be the passenger of riding public transportation means steamer, automobile.2. the riding public transportation means time is no less than 1h.3. similarly history of attack is previously arranged repeatedly during riding public transportation means.To Meniere's disease, vestibular neuritis, head position vertigo, psychogenic vertigo person and have a heart disease, hypertension, blood patient, do not list range of observation in.
1.2 physical data:
This is organized 113 examples and is this student outside school.Treatment is organized in 71 examples, male 29 examples, women 42 examples; Minimum 15 years old of age, maximum 22 years old, average 18.6 years old.In matched group 42 examples, male 19 examples, women 23 examples; Minimum 14 years old of age, maximum 21 years old, average 18.1 years old.Two groups of physical data are learned processing by statistics, and there was no significant difference has comparability.
1.3 grouping and medication:
All objects of observation all are divided into treatment group, matched group at random.The treatment group gives the Pericarpium Citri Reticulatae buccal tablet of embodiment 1, and (ship) preceding 1h is put 1 import every 20min by bus, swallows after the disintegrate; Car (ship) starts the back put 1 import every 10 minutes, swallowed after the dissolving.
Matched group: dimenhydrinate sheet, each 50mg, decoction being taken at a draught in the by bus preceding 30min.When the vehicles arrived at a station, promptly came to an end the course of treatment.
1.4 curative effect determinate standard:
1. produce effects: whole process is more comfortable, and no dizzy, nauseating, symptoms of emesis has obvious appetite person, or the sense gastral cavilty do not relax, and appetite does not subtract the person slightly.
2. effective: whole process has nauseating symptom, reduces but do not vomit or vomit number of times, and is dizzy, weak, saliva is increased or pale complexion, sx such as uncomfortable in chest, nervous.
3. invalid: carsick (ship) symptom no change.
Observed data adopts the Ridit check to carry out statistical analysis, is that difference has significance with P<0.05.
2 experimental results
2.1 two groups of experimenter's general curative effects relatively see Table 1.
Table 1 liang group experimenter general curative effect is (unit: example, %) relatively
As shown in Table 1, analyze through Ridit, and u=1.486 (P〉0.05), prompting treatment group curative effect and matched group there was no significant difference.Illustrate that said preparation can replace the relatively Western medicine preparation of outstanding anti-motion sickness class of side effect clinically.
2.2 symptoms and therapeutic effect: matched group dizziness, headache, three kinds of doing well,improvings such as weak are not obvious, and the treatment group can effectively alleviate symptoms such as nauseating, dizzy, weak and stomach discomfort, but two groups all can effectively alleviate vomiting, symptom uncomfortable in chest.
2.3 experimenter's medication impression: the matched group medication is convenient, but with after certain untoward reaction such as drowsiness, dizzy, headache, xerostomia etc. are arranged; The treatment group except that indivedual experimenters to the Rhizoma Zingiberis Recens flavor incompatibility, think mostly almost to have no adverse reaction good mouthfeel.
3 conclusions
The Pericarpium Citri Reticulatae buccal tablet can dissolve, disperse after meeting saliva, and the patient need not water can obey medicine down smoothly.Compare with ordinary preparation, taking convenience is arranged, absorb fast, bioavailability is high, to advantages such as digestion mucous membrane zest are little, to medication under the hydropenia condition or to take Bendectin more suitable.
Pericarpium Citri Reticulatae buccal tablet or oral cavity disintegration tablet medicine are eaten same usefulness, have cold expelling and regulate the flow of vital energy, and the effect of regulating the stomach and sending down the abnormal ascending QI is used for the control of motion sickness, have the convenience of taking medicine, taste characteristics good, evident in efficacy, and almost are free from side effects.
Claims (1)
1. Pericarpium Citri Reticulatae buccal tablet/oral cavity disintegration tablet is characterized in that being made up of following each component:
Pericarpium Citri Reticulatae 173.0g
Rhizoma Zingiberis Recens 346.0g
Microcrystalline Cellulose 154.0g
Polyvinylpolypyrrolidone 46.1g
Low-substituted hydroxypropyl cellulose 39.2g
Mannitol 51.2g
Citric acid 39.2g
Sodium bicarbonate 39.2g
Aspartame 5.12g
Micropowder silica gel 10.2g
5% 30 POVIDONE K 30 BP/USP
30Ethanol solution is an amount of
Make 1000 altogether.
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CN108576810A (en) * | 2018-04-20 | 2018-09-28 | 谢寿文 | Dried orange peel process for preparing buccal lozenge |
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