CN1253156C - Orally disintegrating tablet of - Google Patents

Orally disintegrating tablet of Download PDF

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CN1253156C
CN1253156C CN 200410049851 CN200410049851A CN1253156C CN 1253156 C CN1253156 C CN 1253156C CN 200410049851 CN200410049851 CN 200410049851 CN 200410049851 A CN200410049851 A CN 200410049851A CN 1253156 C CN1253156 C CN 1253156C
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oral cavity
cavity disintegration
disintegrating agent
disintegration tablet
xuesaitong
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CN1593440A (en
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张晴龙
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Abstract

The present invention discloses an orally disintegrating tablet for treating thromboembolism and a preparation method thereof. The present invention is prepared from notoginseng total saponin 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 existing oral 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; compared with existing injection preparation, the present invention which has identical pharmacological action can be used more conveniently and carried more easily so that the present invention can be accepted by patients merrily.

Description

A kind ofly treat the oral cavity disintegration tablet of cardiovascular and cerebrovascular disease and make each method
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of oral cavity disintegration tablet for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
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, because disintegrating tablet only needs the just disintegrate fully of water of minute quantity, so necessary stability, prolongation shelf life and the shelf-life of considering in the process of storage, to press relatively high humidity environment oral cavity disintegration tablet, 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 one 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.
Two or seven total saponins be the total saponins obtained through refining by certain technology of Radix Notoginseng reed head [Xu Haiqin, etc.Natural extract reference quality standard handbook commonly used.Chemical Industry Press (modern biotechnology and medical sci-tech publishing centre), 2003,109].Total saponin content in the Radix Notoginseng reed head is higher than main root and supporting root (practise and claim " rib ") [Chen Shougao.Radix Notoginseng total arasaponins content relatively in the Radix Notoginseng main root supporting root stem foot.The time precious traditional Chinese medical science traditional Chinese medicines, 1999,10 (4): 249].Radix Notoginseng total arasaponins has blood circulation promoting and blood stasis dispelling, the demountable function of promoting blood circulation, and has blood vessel dilating, the effect of anticoagulant.Be used for the treatment of diseases of cardiovascular and cerebrovascular systems, apoplexy sequela etc.
The preparation that with the Radix Notoginseng total arasaponins is effective ingredient has XUESAITONG PIAN (WS3-B-3207-98), XUESAITONG KELI (WS 3-B-3209-98), XUESAITONG JIAONANG (WS 3-B-3208-98) and XUESAITONG RUANJIAONANG (trade name: reason ditch king); Ejection preparation has XUESAITONG ZHUSHEYE (WS 3-B-3590-98) and XUESAITONG powder pin (trade name: LUOTAI).Effective ingredient Radix Notoginseng total arasaponins in the oral formulations absorbs slow and few at digestive tract, bioavailability is low.Therefore the treatment to cardiovascular and cerebrovascular disease does not reach ideal effect.Though injection has high bioavailability compared with oral formulations, it is convenient not as oral formulations to use clinically, and safety is not as oral formulations, thereby use is very restricted.
In patent retrieval, find no any report that closes the XUESAITONG oral cavity disintegration tablet.
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 XUESAITONG orally disintegrating tablet preparation of preparation stabilization.
The present invention is achieved through the following technical solutions:
One, process recipes
(1) crude drug consists of: Radix Notoginseng total arasaponins fine powder 5 weight portions;
(2) the preparation prescription proportioning is: Radix Notoginseng total arasaponins 5 weight portions, and disintegrating agent 2-6 weight portion, filler 8-15 weight portion is rectified and is hidden agent 0.1-1 weight portion, lubricant 0.05-1 weight portion;
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain oral cavity disintegration tablet.
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 (%)
Erythritol 45 3.5 0.03 0.02
The insoluble crospolyvinylpyrrolidone of chitin low-substituted hydroxypropyl methylcellulose carboxymethyl starch sodium crosslinked carboxymethyl fecula sodium - - - - - - - - - - 11.29 14.09 21.07 22.18 22.64 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, volumetric expansion is slow in disintegrating procedue, 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 XUESAITONG 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 5ml37 ℃ of water, 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
Experimental group 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 31.4 18.7 29.3 18.2 39.1 16.8 41.7 16.2 34.6 14.9
The result: the oral cavity disintegration tablet that uses compound disintegrating agent is in 14.9-18.7 all disintegrates and by No. 2 sieves in second; The oral cavity disintegration tablet that uses single disintegrating agent is in 29.3-41.7 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 that rat suppository is formed
40 of the rat of body weight 300-400g are divided into four groups at random, both matched group, XUESAITONG JIAONANG group, XUESAITONG ZHUSHEYE group, XUESAITONG oral cavity disintegration tablet group.Every group 10.With rat anesthesia (pentobarbital sodium 30-40mg/kg, ip), dorsal position is fixed, separate trachea, insert a plastic bushing, and separation right common carotid artery and left external jugular vein, put into a long silk thread of 6 centimetres in the stage casing of polyethylene tube, with heparin-saline solution, be full of polyethylene tube, after an end of polyethylene tube inserts left external jugular vein, inject anticoagulant heparin accurately by polyethylene tube, and then the other end of polyethylene tube inserted right common carotid artery, and open bulldog clamp, blood flow to polyethylene tube from right common carotid artery, return left external jugular vein, open blood flow Herba Clinopodii after 15 minutes takes out silk thread rapidly and weighs, and gross weight deducts silk thread weight and promptly gets thrombus weight.The animal wet weight of thrombus of blank group and other three groups of administration groups is carried out record, calculate, the result is as shown in table 4:
Table 4 'Xuesaitong ' formulation is to thrombotic influence (X)
Group Mus is (only) only Wet weight of thrombus (mg)
Blank group XUESAITONG JIAONANG group XUESAITONG ZHUSHEYE group XUESAITONG oral cavity disintegration tablet group 10 10 10 10 1.89 1.26# 1.01 * 0.97 *
Annotate: compare with matched group: #P<0.05; *P<0.01
Conclusion: XUESAITONG oral cavity disintegration tablet of the present invention, XUESAITONG ZHUSHEYE and blank group more all have utmost point significant difference (P<0.01); XUESAITONG oral cavity disintegration tablet of the present invention and XUESAITONG ZHUSHEYE compare, zero difference; XUESAITONG JIAONANG and blank group more variant (P<0.05); Illustrate that XUESAITONG oral cavity disintegration tablet of the present invention suppresses thrombotic effect and XUESAITONG ZHUSHEYE is suitable.
2. the influence of anoxia in mice endurance is tested
Get 40 of healthy Kunming mouses, body weight 20~24g.Be divided into matched group at random, XUESAITONG JIAONANG group, XUESAITONG ZHUSHEYE group, XUESAITONG 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 5.
The influence of table 5 pair mice normobaric hypoxia (X ± SD)
Group Mus number (only) Mean survival time (min)
Matched group 10 15.12±1.77
XUESAITONG JIAONANG group XUESAITONG ZHUSHEYE group XUESAITONG oral cavity disintegration tablet group 10 10 10 19.68±1.65# 24.57±1.83 * 24.83±1.76 *
Annotate: compare with matched group: #P<0.05: *P<0.01
XUESAITONG oral cavity disintegration tablet of the present invention and XUESAITONG injection all can improve mice normobaric hypoxia endurance, and mean survival time is than matched group significant prolongation (P<0.01); But XUESAITONG oral cavity disintegration tablet of the present invention is compared zero difference with XUESAITONG ZHUSHEYE.XUESAITONG JIAONANG is compared with matched group, mean survival time also variant (P<0.05).Illustrate: XUESAITONG oral cavity disintegration tablet of the present invention and XUESAITONG injection can both significantly improve mice normobaric hypoxia endurance.
3. to the anoxybiotic protective effect experiment of mouse cardiac muscle
Get 40 of healthy Kunming mouses, body weight 18~22g is divided into 3 groups at random, matched group, XUESAITONG JIAONANG group, XUESAITONG ZHUSHEYE group, XUESAITONG 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 6.
The anoxybiotic influence of table 6 pair mouse cardiac muscle (X ± SD)
Group Mus number (only) Mean survival time (min)
Matched group XUESAITONG JIAONANG group XUESAITONG injection group XUESAITONG oral cavity disintegration tablet group 10 10 10 10 5.88±0.82 7.26±0.93# 11.93±0.76 * 11.88±0.68 *
Annotate: compare with matched group: #P<0.05; *P<0.01
XUESAITONG oral cavity disintegration tablet of the present invention and XUESAITONG ZHUSHEYE all can shield to the mouse cardiac muscle anoxia, and mean survival time is than matched group significant prolongation (P<0.01); But the XUESAITONG oral cavity disintegration tablet is compared both zero differences with XUESAITONG ZHUSHEYE; XUESAITONG JIAONANG and matched group compare, mean survival time also variant (P<0.05).Illustrate: XUESAITONG oral cavity disintegration tablet of the present invention and XUESAITONG ZHUSHEYE all can shield to the mouse cardiac muscle anoxia.
Above pharmacological evaluation explanation, XUESAITONG oral cavity disintegration tablet of the present invention is compared with XUESAITONG ZHUSHEYE, and identical bioavailability and therapeutic effect are arranged.But XUESAITONG oral cavity disintegration tablet patient of the present invention need not any misery when taking, and can happyly accept.More suitable for the patient who takes for a long time.
Six, preparation embodiment
Embodiment 1
(1) crude drug: Radix Notoginseng total arasaponins fine powder 50g;
(2) preparation prescription is:
Radix Notoginseng total arasaponins 50g
Nano micro crystal cellulose 109g
Erythritol 10g
Low-substituted hydroxypropyl methylcellulose 27g
Magnesium stearate 4g
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 1000 of oral cavity disintegration tablets.
Embodiment 2
(1) crude drug: Radix Notoginseng total arasaponins fine powder 50g;
(2) preparation prescription is:
Radix Notoginseng total arasaponins 50g
Microcrystalline Cellulose 87g
Erythritol 24g
Carboxymethyl starch sodium 35g
Pulvis Talci 3g
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 1000 of oral cavity disintegration tablets.
Embodiment 3
(1) crude drug: Radix Notoginseng total arasaponins fine powder 50g;
(2) preparation prescription is:
Radix Notoginseng total arasaponins 50g
Nano micro crystal cellulose 101g
Erythritol 13g
Crosslinked carboxymethyl fecula sodium 29g
Stevioside 5g
Stepanol MG 2g
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 1000 of oral cavity disintegration tablets.
Embodiment 4
(1) crude drug: Radix Notoginseng total arasaponins fine powder 50g:
(2) preparation prescription is:
Radix Notoginseng total arasaponins 50g
Microcrystalline Cellulose 113g
Erythritol 13g
Crospolyvinylpyrrolidone 19g
Stevioside 3g
Magnesium stearate 2g
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain 1000 of oral cavity disintegration tablets.
XUESAITONG oral cavity disintegration tablet specification of the present invention is the 50mg/ sheet, a 1-2 sheet, 3 times on the one.

Claims (5)

1. oral cavity disintegration tablet for the treatment of cardiovascular and cerebrovascular disease is characterized in that it is made up of Radix Notoginseng total arasaponins and pharmaceutic adjuvant; The weight proportion of each composition is: 5 parts of Radix Notoginseng total arasaponinss, disintegrating agent 2-6 part, filler 8-15 part, correctives 0.1-1 part, lubricant 0.05-1 part; Wherein used disintegrating agent is the compound disintegrating agent that contains the 30%-70% erythritol.
2. oral cavity disintegration tablet according to claim 1, its preparation method is:
(1) crude drug consists of: Radix Notoginseng total arasaponins fine powder 5 weight portions;
(2) the preparation prescription proportioning is: Radix Notoginseng total arasaponins 5 weight portions, disintegrating agent 2-6 weight portion, filler 8-15 weight portion, correctives 0.1-1 weight portion, lubricant 0.05-1 weight portion;
(3) Radix Notoginseng total arasaponins is mixed with pharmaceutic adjuvant, granulation, drying, granulate, tabletting, check, packing obtain oral cavity disintegration tablet.
3. oral cavity disintegration tablet according to claim 1 and 2, wherein filler is a kind of in microcrystalline Cellulose, the nano micro crystal cellulose.
4. according to claim 1 or 3 described oral cavity disintegration tablets, wherein correctives is a kind of in mannitol, the stevioside.
5. according to claim 1 or 3 described oral cavity disintegration tablets, wherein lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG.
CN 200410049851 2004-06-25 2004-06-25 Orally disintegrating tablet of Expired - Fee Related CN1253156C (en)

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Publication number Priority date Publication date Assignee Title
CN100337615C (en) * 2005-05-19 2007-09-19 郭鸿旭 Oral disintegration tablet prepared from general saponin of notoginseng for treating thrombosis, and preparing technique

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