CN1281206C - Orally disintegrating tablet of 'Xinxuekang - Google Patents
Orally disintegrating tablet of 'Xinxuekang Download PDFInfo
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Abstract
The present invention discloses an orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet has the effects of activating blood circulation to dissipate blood stasis and activating Qi to relieve pain. The orally disintegrating tablet is prepared from the extract of yellow yam and dioscorea nipponica, and pharmaceutical adjuvant. The present invention also discloses a composite disintegrating agent for preparing orally disintegrating tablets, which is prepared from 30 to 70 wt% of erythritol and chitin or current frequently-used disintegrating agents. Experimental results show that: compared with the existing preparation, the orally disintegrating tablet prepared by the preparation method of the present invention has the advantages of shorter disintegration time, better stability and stronger pharmacological action.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of oral cavity disintegration tablet and preparation method thereof with blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain effect.Oral cavity disintegration tablet of the present invention is referred to as the Sodium Ferulate oral cavity disintegration tablet again.
Technical background
Oral cavity disintegration tablet is a kind of new pharmaceutical preparation, and it can absorb through hypoglossis mucous membrane, directly enters blood, has avoided first pass effect effectively, so taking dose is little, and safety is good, and effect rapidly.Though be oral formulations, can reach the effect of ejection preparation.Therefore just progressively become the focus that pharmaceutical manufacturer and research and development field are paid close attention to.This dosage form mainly is to select suitable fast disintegrant, by the existing certain rigidity of its tablet of making, certain sedimentation is arranged again.Can not need the water assisting deglutition when taking, can rapid disintegrate become fine grained in the oral cavity, only several swallowing acts can be finished drug administration process.Its more common solid orally ingestible absorbs fast, bioavailability height, and taking convenience.
The preparation oral cavity disintegration tablet will be considered the problem of following critical aspects: 1, the advantage of oral cavity disintegration tablet just is rapid disintegrate, and it is fast to discharge medicine, reaches rapid-action effect, seeks suitable disintegrants, to guarantee oral cavity disintegration tablet disintegrate rapidly in the oral cavity; 2, seek relatively inexpensive pharmaceutic adjuvant, to reduce production cost; 3, only need the just disintegrate fully of water of minute quantity owing to disintegrating tablet, therefore must consider stability, prolongation shelf life and the shelf-life of humidity environment oral cavity disintegration tablet higher relatively in the process of storage, significant to medical manufacturing enterprise.
Disintegrating agent is commonly used in the oral cavity disintegration tablet adjuvant have low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa), crospolyvinylpyrrolidone (PVPP), crosslinked carboxymethylstach sodium (CCMS-Na) etc. [He Jianchang, etc.New oral solid quick releasing formulation-oral cavity quick disintegrating slice.The pharmacy practice magazine, 2000,18 (3): 151].These adjuvants are all water insoluble, but a common characteristic is all arranged, and have hygroscopicity [pharmaceutical preparation portion of Shanghai Institute of Pharmaceutical Industry, Pharmaceutical National Engineering Research Center exactly.Pharmaceutic adjuvant application technology (second edition), Chinese Medicine science and technology publishing house, 2002,73～75].In the higher environment of humidity, oral cavity disintegration tablet is the moisture absorption especially easily, and cracked trend is arranged.So relatively harsher to environment requirement in production, storage and transportation with the oral cavity disintegration tablet that these adjuvants are made, must adopt special packing, seal cover, desiccant bag etc., all can produce considerable influence to production cost.And above-mentioned disintegrating agent all is synthetic through chemical process, and price is higher, for the more relatively oral cavity disintegration tablet of adjuvant content, can cause production cost to increase, and and then can increase patient's financial burden.Therefore, seek disintegrating agent functional, that price is suitable, make that the disintegration time of oral cavity disintegration tablet is shorter, price is more cheap, stability better becomes one of key problem in technology of exploitation oral cavity disintegration tablet.
Application number is 99802175 patent application bibliographical information, and during as disintegrating agent, the hardness of making oral cavity disintegration tablet is identical with disintegration time at the erythritol that uses separately equivalent or low-substituted hydroxypropyl cellulose (L-HPC).The erythritol sweet taste is pure, after eating nice and cool mouthfeel characteristic is arranged, and also can make correctives and use, and reduces the weight of oral cavity disintegration tablet.Erythritol can not influence normal carbohydrate metabolism, is fit to diabetes patient; And be sweet taste material low in calories, be suitable for obese patients, simultaneously caries prevention is also had positive role.
Chitin is the relatively low natural pharmaceutic adjuvant of a kind of price, and it has another name called chitin, chitin, is a kind of biological polysaccharide polymer material, extensively is present in the carapace in the unicellular lower eukaryote.This material can be degraded by lyase, has excellent biological compatibility, avirulence, chemical property quite stable.
Cardiovascular and cerebrovascular disease is the first killer of harm humans health.Containing total steroidal saponin in Dioscoreaceae plant Dioscorea panthaica Prain et Burkill, the Dioscorea nipponica Mak. Ningpo Yam Rhizome, is DIAOXINXUE KANG JIAONANG with its prevention and treatment cardiovascular and cerebrovascular disease ground compound preparation that is effective site is made.
Application number is that the method that 02159077 patent documentation adopts direct water to carry obtains the Rhizoma Dioscoreae total saponins, and it is many that this technology is extracted impurity, and the drug administration amount is big; Application number is that 01100355 patent adopts microwave extracting, concentrating under reduced pressure, supersonic jet technology to extract active substance from the nanometer Dioscorea panthaica Prain et Burkill, and this explained hereafter cycle is long, the expense height; Application number is 93101602 patent documentation employing polar solvent extract, and the technology of resin remove impurity is extracted the Rhizoma Dioscoreae total saponins, uses cyclodextrin inclusion compound, makes oral liquid again.Oral liquid is carrying, is taking, all can make troubles to the patient aspect the dosage.
Summary of the invention
In the selection course that disintegrating agent uses in oral cavity disintegration tablet, we discover that erythritol and disintegrating agent commonly used at present mix by a certain percentage, form a kind of compound disintegrating agent and have more performance, the oral cavity disintegration tablet made from it compares with the simple oral cavity disintegration tablet that uses erythritol or disintegrating agent commonly used at present to make, the disintegration time of oral cavity disintegration tablet was shortened, and because erythritol has very little hygroscopicity, the stability of the feasible oral cavity disintegration tablet of making significantly improves.In the compound disintegrating agent, erythritol is in the amount ranges of 30%-70%, and along with the increase of content, the disintegration time of oral cavity disintegration tablet shortens, and stability strengthens.
We find that in experiment chitin disintegrating agent effect with commonly used at present aspect the disintegrate effect is suitable, even are better than disintegrating agent commonly used.
We have studied compound disintegrating agent in experiment, select the mixture of use erythritol and chitin, disintegrating agent commonly used, are based on many-sided consideration.When making disintegrating agent with single erythritol, though erythritol has very little hygroscopicity, the tablet stability of making is good, and the swelling degree after the single erythritol suction is less, influences the disintegrating property of oral cavity disintegration tablet, and disintegration time is prolonged.Add a certain amount of disintegrating agent commonly used, utilize rapid expansible character after their moisture absorptions, neither influence the stability of oral cavity disintegration tablet, also kept the characteristic of its rapid disintegrate, reached reasonable effect.
The objective of the invention is in order to overcome the deficiency that above-mentioned prior art exists, provide a kind of taking convenience, rapid-action to indication, reach the peak early, curative effect obviously, the Sodium Ferulate orally disintegrating tablet preparation of preparation stabilization.
The present invention is achieved through the following technical solutions:
One, process recipes
(1) with Dioscorea panthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome medical material with twice of the ethanol extraction of 60%-95%; Be equivalent to medical material weight 6-10 solvent doubly each the adding; Extracted 1-3 hour for the first time, extracted 1-2 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, the washing of doubly measuring earlier with 3-6, reuse 30%-80% ethanol elution is collected ethanol elution; Be concentrated into the extractum that relative density is 1.15-1.30 in the time of 50 ℃, spray drying obtains extract;
(2) preparation prescription proportioning of the present invention is: extract 10-25 weight portion, disintegrating agent 10-30 weight portion, filler 50-90 weight portion, correctives 1-10 weight portion, lubricant 0.5-3 weight portion;
(3) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain oral cavity disintegration tablet.
Use the 60%-95% ethanol extraction, the technology of macroporous adsorbent resin remove impurity has been removed impurity effectively, and saponin active ingredient has been played enrichment.
Two, the disintegrating agent performance is investigated experiment
Experimental raw: erythritol, chitin, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, insoluble crospolyvinylpyrrolidone, buy by market.
Experimental technique:
(1) solubility experiment: the saturated aqueous solution at 37 ℃ of preparation samples, utilize membrane filter to filter, obtain filtrate, the filtrate of predetermined of accurately weighing is utilized the freeze-drying drying, thereby is obtained the content of water, calculate water-soluble on the water content basis that obtains thus again, the results are shown in Table 1.
(2) viscosity experiment: the saturated aqueous solutions at 37 ℃ of different disintegrating agents of preparation, utilize membrane filter to filter, obtain filtrate, utilize viscometer to obtain filtrate 37 ℃ viscosity, the results are shown in Table 1.
(3) measurement of wettability: precision takes by weighing above-mentioned disintegrating agent, dry weighs fully, is put into 1 week under 25 ℃ and 75% the damp condition, takes by weighing weight, and the calculating wettability the results are shown in Table 1.
(4) volume increases percent: the volume of moisture absorption fore-and-aft survey disintegrating agent, calculate the percent of the volume increase of disintegrating agent, and see Table 1.
Table 1 disintegrating agent performance is investigated relatively
| Disintegrating agent | Dissolubility W/V (37 ℃) | Viscosity mpa.s (37 ℃) | Wettability (%) | Volume increases (%) |
| The insoluble crospolyvinylpyrrolidone of erythritol chitin low-substituted hydroxypropyl methylcellulose carboxymethyl starch sodium crosslinked carboxymethyl fecula sodium | 45 - - - - - | 3.5 - - - - - | 0.03 11.29 14.09 21.07 22.18 22.64 | 0.02 16.57 20.36 22.89 28.14 27.62 |
Conclusion: the characteristics of investigating experiment and oral cavity disintegration tablet by above-mentioned performance, we can analyze, erythritol has very big advantage as disintegrating agent in wettability, but because its moisture pick-up properties is very little, volume increase degree is also very little, therefore, in disintegrating procedue volumetric expansion slow, can not reach the requirement of the rapid disintegrate of oral cavity disintegration tablet; Erythritol is again good correctives simultaneously, not only can be used as disintegrating agent but also can be used as correctives if choose suitable weight, can significantly reduce consumption, the operation in the formulation preparation process and the cost of preparation of pharmaceutic adjuvant; Other disintegrating agent hygroscopicity are too big, cause oral cavity disintegration tablet very poor aspect stable; By analyzing, erythritol is carried out mixing of proper proportion with other disintegrating agent, the compound disintegrating agent as oral cavity disintegration tablet has good advantages.
Three, the selection of compound disintegrating agent
Experimental raw: choose crosslinked carboxymethyl fecula sodium and carry out different proportion with erythritol and mix, mixed proportion is respectively erythritol: crosslinked carboxymethyl fecula sodium=1: 9 or 2: 8 or 3: 7 or 4: 6 or 5: 5 or 6: 4 or 7: 3 or 8: 2 or 9: 1, totally 9 groups, be respectively experimental group 1-9, with experimental group 1-9 and same filler (in microcrystalline Cellulose, the nano micro crystal cellulose a kind of) and lubricant (in magnesium stearate, Pulvis Talci, the Stepanol MG a kind of), carry out tabletting; Change above-mentioned disintegrating agent into chitin,, be experimental group 10, carry out tabletting with same filler, mix lubricant with weight; Change above-mentioned disintegrating agent into weight crosslinked carboxymethyl fecula sodium, with same filler, mix lubricant, experimental group 11 carries out tabletting.
Experimental technique:
(1) hardness of mensuration tablet: utilize the tablet hardness tester to measure the hardness of tablet, the results are shown in Table 2.
(2) stability experiment: tablet is put into 12 weeks under 25 ℃ and 75% the damp condition, observes the tablet spoilage, the results are shown in Table 2.
(3) disintegrate experiment: according to " the disintegration of tablet method of testing of stipulating in the Chinese pharmacopoeia utilizes the disintegrate tester to measure, and the results are shown in Table 2.
(4) disintegrate test in the oral cavity, disintegration time, grittiness, taste to three health adults have tested experimental group the results are shown in Table 2.
The selection of table 2 experimental group disintegrating agent
| Experimental group | Hardness (kg) | Spoilage (%) | Disintegration time (s) | The Orally disintegrating time (s) | Grittiness | Taste |
| 1 2 3 4 5 6 7 8 9 10 11 | 4.1 3.9 2.1 2.2 2.2 2.1 2.0 1.9 1.8 4.6 4.8 | 22.1 21.6 9.3 8.6 8.1 8.6 9.3 9.6 10.2 33.9 36.5 | 42.1 43.6 26.3 25.2 26.1 26.9 26.8 35.9 35.6 54.1 55.6 | 51.2 52.9 32.9 28.3 26.7 27.4 27.3 38.6 39.1 62.9 62.8 | Having seldom to have much has a lot | Bad generally carefully good carefully very poor |
Change above-mentioned chitin, crosslinked carboxymethyl fecula sodium into low-substituted hydroxypropyl methylcellulose, crosslinked carboxymethyl fecula sodium, crosslinked insoluble polyvinylpyrrolidone, experimentize, the result of experimental result and table 2 is close.
Experimental result shows, erythritol is mixed with into the mixing disintegrating agent with other disintegrating agent, has good effect, simultaneously because erythritol has sweet taste, so can reduce or replace correctives to use, by experiment erythritol: the suitable ratio of other disintegrating agent be 3-7: 7-3.
Four, preparation disintegration time mensuration
In order to prove absolutely that the employed compound disintegrating agent of Sodium Ferulate oral cavity disintegration tablet of the present invention has disintegrate characteristics rapidly than single disintegrating agent, we have carried out following experiment: disintegrating agent is selected in the design by table 3 for use, make into oral cavity disintegration tablet with effective ingredient at identical pressure lower sheeting, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir with 30 rev/mins speed, measure the disintegration of the oral cavity disintegration tablet that contains different disintegrating agents.
Table 3 preparation disintegration time mensuration
| The experiment number | Disintegrating agent | Disintegration (s) | |
| Form | Consumption (g: g) | ||
| 1 2 3 4 5 6 7 8 9 10 | Chitin antierythrite: chitin low-substituted hydroxypropyl methylcellulose antierythrite: low-substituted hydroxypropyl methylcellulose sodium carboxymethyl starch antierythrite: sodium carboxymethyl starch crosslinked carboxymethyl fecula sodium antierythrite: the insoluble PVPP antierythrite of crosslinked carboxymethyl fecula sodium: insoluble PVPP | - 3∶7 - 4∶6 - 5∶5 - 6∶4 - 7∶3 | 31.6 18.5 29.0 18.0 39.3 16.6 41.8 16.0 34.4 14.7 |
The result: the oral cavity disintegration tablet that uses compound disintegrating agent is in 14.7-18.5 all disintegrates and by No. 2 sieves in second; The oral cavity disintegration tablet that uses single disintegrating agent is in 29.0-41.8 all disintegrates and by No. 2 sieves in second.Illustrate that compound disintegrating agent of the present invention has disintegrate characteristics rapidly really.
Five, pharmacology embodiment
1. the influence of anoxia in mice endurance is tested
Get 30 of healthy Kunming mouses, body weight 20～24g.Be divided into matched group at random, DIAOXINXUE KANG JIAONANG group, Sodium Ferulate oral cavity disintegration tablet group.Every group 10, male and female half and half, sub-cage rearing.With the conversion of people's conventional therapy dosage is the dosage of mice.The conversion formula is: tested animal is tried out the body surface area ratio of the body surface area ratio/known animal of dosage=known animals administer amount * tested animal.Control group administered physiological saline, 1 time/d, continuous 13d.1h after the last administration, it is the 150ml port grinding bottle that mice is placed volume respectively, in put the 15g sodica calx, its time-to-live of airtight observation.The results are shown in Table 4.
The influence of table 4 pair mice normobaric hypoxia (X ± SD)
| Group | Mus number (only) | Mean survival time (min) |
| Matched group DIAOXINXUE KANG JIAONANG group Sodium Ferulate oral cavity disintegration tablet group | 10 10 10 | 16.14±1.93 23.68±1.87 * 28.94±1.92 *# |
Annotate: compare with matched group:
*P＜0.01;
Compare with the DIAOXINXUE KANG JIAONANG group: #P＜0.05
DIAOXINXUE KANG JIAONANG, Sodium Ferulate oral cavity disintegration tablet all can improve mice normobaric hypoxia endurance, and mean survival time is than matched group significant prolongation (P＜0.01); The Sodium Ferulate oral cavity disintegration tablet is compared with DIAOXINXUE KANG JIAONANG, mean survival time also variant (P＜0.05).Illustrate: Sodium Ferulate oral cavity disintegration tablet and DIAOXINXUE KANG JIAONANG can both significantly improve mice normobaric hypoxia endurance, and the pharmacological action of Sodium Ferulate oral cavity disintegration tablet is better than DIAOXINXUE KANG JIAONANG.
2. to the anoxybiotic protective effect experiment of mouse cardiac muscle
Get 30 of healthy Kunming mouses, body weight 18～22g is divided into 3 groups at random, matched group, DIAOXINXUE KANG JIAONANG group, Sodium Ferulate oral cavity disintegration tablet group.Every group of male and female half and half, sub-cage rearing.With the conversion of people's conventional therapy dosage is the dosage of mice.The conversion formula is: tested animal is tried out the body surface area ratio of the body surface area ratio/known animal of dosage=known animals administer amount * tested animal.Control group administered physiological saline.Medication: 1 time/d, continuous 6d.1h is with urethane 1.2g/kg intraperitoneal injection of anesthesia after the last administration, and back fixation is separated trachea, with the bulldog clamp folder pipe of holding one's breath, observes electrocardio with electrocardiogram equipment, and writes down the little mousetrap with stopwatch and hold one's breath time of Guan Houzhi electrocardio disappearance.The results are shown in Table 5.
The anoxybiotic influence of table 5 pair mouse cardiac muscle (X ± SD)
| Group | Mus number (only) | Mean survival time (min) |
| Matched group DIAOXINXUE KANG JIAONANG group Sodium Ferulate oral cavity disintegration tablet group | 10 10 10 | 6.77±0.92 9.86±0.84 * 11.45±0.91 *# |
Annotate: compare with matched group:
*P＜0.01;
Compare with the DIAOXINXUE KANG JIAONANG group: #P＜0.05
DIAOXINXUE KANG JIAONANG, Sodium Ferulate oral cavity disintegration tablet all can shield to the mouse cardiac muscle anoxia, and mean survival time is than matched group significant prolongation (P＜0.01); Sodium Ferulate oral cavity disintegration tablet and DIAOXINXUE KANG JIAONANG compare, mean survival time also variant (P＜0.05).Illustrate: Sodium Ferulate oral cavity disintegration tablet and DIAOXINXUE KANG JIAONANG can shield to the mouse cardiac muscle anoxia, and the effect of Sodium Ferulate oral cavity disintegration tablet is better than DIAOXINXUE KANG JIAONANG.
3. to the influence of experimental hyperlipidemia
Get 30 of Wistar kind rat, body weight 220 ± 20g.Be divided into 3 groups at random, hyperlipidemia blank group, DIAOXINXUE KANG JIAONANG group, Sodium Ferulate oral cavity disintegration tablet group.Each group all feeds high lipid food 10 days (1.5% cholesterol adds 10% Adeps Sus domestica and adds 0.30% carbimazole and normal feedstuff), administration every day 1 time, high fat matched group gives 0.5% carboxymethylcellulose sodium solution, after the last administration 1 hour, put to death rat extracting blood, measure T-CHOL (TC) and low density lipoprotein, LDL (LDL) content in the serum with agarose gel electrophoresis method.The results are shown in Table 6.
The influence of table 6 pair experimental hyperlipidemia (X ± SD)
| Group | Mus only | Blood fat (mol/L) | |
| TC | LDL | ||
| High fat matched group DIAOXINXUE KANG JIAONANG group Sodium Ferulate oral cavity disintegration tablet group | 10 10 10 | 217.9±46.3 184.7±44.6 * 156.4±56.9 *# | 194.8±34.7 163.4±36.1 * 140.3±37.9 *# |
Annotate: compare with matched group:
*P＜0.01;
Compare with the DIAOXINXUE KANG JIAONANG group: #P＜0.05
DIAOXINXUE KANG JIAONANG, Sodium Ferulate oral cavity disintegration tablet be obvious hypercholesterolemia reducing of energy and low density lipoprotein, LDL (P＜0.01) all; Sodium Ferulate oral cavity disintegration tablet and DIAOXINXUE KANG JIAONANG compare, also variant (P＜0.05).Illustrate: Sodium Ferulate oral cavity disintegration tablet and DIAOXINXUE KANG JIAONANG be energy hypercholesterolemia reducing and low density lipoprotein, LDL all, and the effect of Sodium Ferulate oral cavity disintegration tablet is better than DIAOXINXUE KANG JIAONANG.
Above pharmacological evaluation proves that the Sodium Ferulate oral cavity disintegration tablet for preparing with new technology has better therapeutic effect.
Six, preparation embodiment
Embodiment 1
(1) with Dioscorea panthaica Prain et Burkill 3000g with twice of 95% ethanol extraction; Each solvent that is equivalent to 8 times of medical material weight that adds; Extracted 2 hours for the first time, extracted 2 hours for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, with the washing of 6 times of amounts, reuse 35% ethanol elution is collected ethanol elution earlier; Be concentrated into relative density in the time of 50 ℃ and be 1.17 extractum, spray drying obtains extract 147.5g;
(2) preparation prescription is:
Extract 147.5g
Nano micro crystal cellulose 640.0g
Erythritol 50.0g
Low-substituted hydroxypropyl methylcellulose 150.0g
Magnesium stearate 12.5g
(3) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 3000 of Orally disintegratings.
Embodiment 2
(1) with Dioscorea nipponica Mak. Ningpo Yam Rhizome medical material 3000g with twice of 85% ethanol extraction; Each solvent that is equivalent to 10 times of medical material weight that adds; Extracted 1 hour for the first time, extracted 2 hours for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, with the washing of 4 times of amounts, reuse 50% ethanol elution is collected ethanol elution earlier; Be concentrated into relative density in the time of 50 ℃ and be 1.23 extractum, spray drying obtains extract 195.4g;
(2) preparation prescription is:
Extract 195.4g
Microcrystalline Cellulose 546.5g
Erythritol 83.3g
Carboxymethyl starch sodium 163.1g
Pulvis Talci 11.7g
(3) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 3000 of Orally disintegratings.
Embodiment 3
(1) with Dioscorea panthaica Prain et Burkill 3000g with twice of 70% ethanol extraction; Each solvent that is equivalent to 6 times of medical material weight that adds; Extracted 3 hours for the first time, extracted 2 hours for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, with the washing of 5 times of amounts, reuse 65% ethanol elution is collected ethanol elution earlier; Be concentrated into relative density in the time of 50 ℃ and be 1.28 extractum, spray drying obtains extract 237.2g;
(2) preparation prescription is:
Extract 237.2g
Nano micro crystal cellulose 529.5g
Erythritol 72.5g
Crosslinked carboxymethyl fecula sodium 119.2g
Stevioside 28.3g
Stepanol MG 13.3g
(3) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 3000 of Orally disintegratings.
Embodiment 4
(1) with Dioscorea nipponica Mak. Ningpo Yam Rhizome medical material 3000g with twice of 60% ethanol extraction; Each solvent that is equivalent to 8 times of medical material weight that adds; Extracted 2 hours for the first time, extracted 1 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, with the washing of 3 times of amounts, reuse 80% ethanol elution is collected ethanol elution earlier; Be concentrated into relative density in the time of 50 ℃ and be 1.20 extractum, spray drying obtains extract 112.5g;
(2) preparation prescription is:
Extract 112.5g
Microcrystalline Cellulose 641.9g
Erythritol 83.3g
Crospolyvinylpyrrolidone 120.6g
Stevioside 25.0g
Magnesium stearate 16.7g
(4) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 3000 of Orally disintegratings.
The once oral 2-4 grain of Sodium Ferulate oral cavity disintegration tablet of the present invention, 3 times on the one.
Claims (2)
1. oral cavity disintegration tablet with blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain effect, it is characterized in that it by Dioscorea panthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome medical material with the 60%-95% ethanol extraction, go up macroporous adsorbent resin, collect extract 10-25 weight portion and the pharmaceutic adjuvant that the 30%-80% ethanol elution obtains and form, disintegrating agent 10-30 weight portion in the pharmaceutic adjuvant, filler 50-90 weight portion, correctives 1-10 weight portion, lubricant 0.5-3 weight portion; Described disintegrating agent is that the weight percentage of its mesoerythrit is 30%-70% by erythritol and a kind of compound disintegrating agent of forming that is selected from chitin, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, the insoluble crospolyvinylpyrrolidone.
2. the preparation method of oral cavity disintegration tablet according to claim 1 is characterized by:
(1) with Dioscorea panthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome medical material with twice of the ethanol extraction of 60%-95%; Be equivalent to medical material weight 6-10 solvent doubly each the adding; Extracted 1-3 hour for the first time, extracted 1-2 hour for the second time; Merge ethanol extract, filter, filtrate is concentrated into does not have the alcohol flavor; Last macroporous adsorbent resin, the washing of doubly measuring earlier with 3-6, reuse 30%-80% ethanol elution is collected ethanol elution; Be concentrated into the extractum that relative density is 1.15-1.30 in the time of 50 ℃, spray drying obtains extract;
(2) extract is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain oral cavity disintegration tablet.
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| CN 200410049621 CN1281206C (en) | 2004-06-22 | 2004-06-22 | Orally disintegrating tablet of 'Xinxuekang |
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| CN1593629A CN1593629A (en) | 2005-03-16 |
| CN1281206C true CN1281206C (en) | 2006-10-25 |
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