CN101564402A - Rehabilitation new dispersing tablet and preparation method thereof - Google Patents
Rehabilitation new dispersing tablet and preparation method thereof Download PDFInfo
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- CN101564402A CN101564402A CNA2009100110890A CN200910011089A CN101564402A CN 101564402 A CN101564402 A CN 101564402A CN A2009100110890 A CNA2009100110890 A CN A2009100110890A CN 200910011089 A CN200910011089 A CN 200910011089A CN 101564402 A CN101564402 A CN 101564402A
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Abstract
The invention discloses a rehabilitation new dispersing tablet used for treating digestive system diseases and a preparation method thereof. The rehabilitation new dispersing tablet is prepared from a major material, namely 10 to 55 weight percent of rehabilitation new dry extract powder, and accessories comprising a disintegrant, a filling agent, a wetting agent and a lubricant through granulation and tabletting by a wet method, wherein the disintegrant can be added internally or externally or internally and externally. Compared with the prior solution, the rehabilitation new dispersing tablet has the advantages of good dispersing state, short disintegration time, quick medicament dissolution, convenient taking, low production cost, no need of special equipment, easy mass production, convenient carrying and transportation, stability and the like.
Description
Technical field
The present invention relates to a kind of dispersible tablets of Chinese medicine for the treatment of peptic ulcer and preparation method thereof
Background technology
Rehabilitation newly is separation from the periplaneta americana herbal extract, the refining extract that forms, and its complicated component contains 18 seed amino acids, and wherein alanine is maximum, also contains animal oil, protein, polyalcohols and peptide class active substance.Rehabilitation is newly oral to have significant protective effect to pyloric ligation ulcers gastric ulcer and dehydrated alcohol type gastric ulcer; can obviously reduce gastric secretion, total acid output and pepsin output; effective in cure to peptic ulcer, can effectively prevent chronic colitis, duodenitis etc.Wheat Protein is newly gone back in rehabilitation, can improve the activity of lymphocyte and serum lysozyme, makes SOD value rise in the body, regulates the physiological equilibrium of body.Rehabilitation newly is applied to clinical existing more than two decades, and the treatment digestive system disease is respond well.Existing dosage form has only the new liquid of rehabilitation, and it is apt to deteriorate in aqueous solution that its composition mostly is amino acids, animal oil, protein, polyalcohols and peptide class, is unfavorable for storage and transportation.Protein-basedly in aqueous solution, be precipitated out easily.General formulation such as tablet, capsule fully absorb because of medicine disintegrate and medicine stripping slowly influence medicine again.Patient for old man, child and dysphagia often brings worry.
Summary of the invention
The present invention is just in order to solve conventional dosage forms appearance precipitation apt to deteriorate, easy, be unfavorable for the shortcoming of transporting, improve curative effect, reduce side effect, close the advantage of tablet and liquid preparation, improve the quality of products, guarantee the product curative effect, according to the selection principle of form of Chinese drug " triple effect, three little, five convenience ", invention chance water disintegrate rapidly forms rehabilitation new dispersing tablet of even suspension and preparation method thereof.
Dispersible tablet has the following advantages:
1, good dispersing state, disintegration time are short, the medicine stripping is rapid;
2, absorption is fast, bioavailability is high
3, taking convenience can be swallowed, chew to contain and suck or with taking after the aqueous dispersion, especially is fit to old man, paralytic and the patient of the difficulty of swallowing takes.
4, dispersible tablet is in external disintegrate, has oral liquid and absorbs fast advantage, has productions simultaneously, carries, convenient transportation and advantage such as stablize.
The technical solution adopted for the present invention to solve the technical problems is:
Rehabilitation new dispersing tablet contains new dried cream powder of rehabilitation and pharmaceutic adjuvant, and its proportioning is:
The new dried cream powder 10-55% of rehabilitation
Adjuvant 45-90%
Preferably:
The new dried cream powder 15-45% of rehabilitation
Adjuvant 55-85%
Wherein adjuvant comprises disintegrating agent, filler, lubricant.
Tabletting method adopts wet granule compression tablet.
Because the key parameter of dispersible tablet is the disintegration rate in water, so the selection of disintegrating agent is extremely important, through experiment repeatedly, final definite preferred disintegrating agent comprises crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), the low light propyl cellulose (L-HPC) that replaces, in carboxymethylcellulose calcium, the cross-linking sodium carboxymethyl cellulose one or more, and disintegrate promoter sodium lauryl sulphate, accounting for total formulation weight percentage ratio is 5-25%.Disintegrating agent can in add or add or inside and outsidely all add.
Filler comprises one or more of lactose, microcrystalline Cellulose (MCC), pregelatinized Starch, starch, dextrin and mannitol, and accounting for total formulation weight percentage ratio is 40-85%
Lubricant comprises one or more of magnesium stearate, Pulvis Talci, micropowder silica gel, stearic acid, Polyethylene Glycol, and accounting for total formulation weight percentage ratio is 0.5-5%.
The process inventor uses wet method and dry granulation is tested repeatedly, determines to adopt wet granule compression tablet, and wetting agent is dehydrated alcohol, ethanol or certain density ethanol water.
The preparation method of described rehabilitation new dispersing tablet is to adopt following technological process preparation:
A, get periplaneta americana and be ground into coarse powder, with 64 ℃ of reflux, extract, of 3 times of amount 70% ethanol 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), and is standby.
B, at 60 ℃ of vacuum dryings, pulverize, cross 100 mesh sieves; Get dry extract.
C, the new dry extract of rehabilitation is mixed with filler, do not add or add earlier part or all of disintegrating agent, add wetting agent system soft material, make wet granular, drying, granulate adds in addition partly or entirely disintegrating agent, add the lubricant mixing again, tabletting promptly gets rehabilitation new dispersing tablet.
Requirement check according to Chinese Pharmacopoeia 2005 editions.
Dispersing uniformity: get two of dispersible tablets, place the jolting of 100ml water, in 20 ℃ ± 1 ℃ water, three minutes all disintegrate and by No. 2 the sieve.
Do not contain sugar in the rehabilitation new dispersing tablet, some are not suitable for taking the patient who contains sugared medicine and use to be appropriate to diabetes etc., and its bioavailability height can be swallowed, chews, contain and suck, take separately after also can placing water to disperse, especially be fit to old man, child and the patient of solid difficulty that swallows.
The invention has the beneficial effects as follows that rehabilitation new dispersing tablet good dispersing state, disintegration time are lacked (less than 3min), the medicine stripping is rapid, bioavailability height, taking convenience.Its preparation technology is simple, and production cost is low, does not compare with solution to add antiseptic and extra package, and the dispersible tablet volume after the production is urinated in storing and transportation.
The specific embodiment
The present invention is further described below in conjunction with embodiment.
Embodiment 1
Periplaneta americana 2000g
Microcrystalline Cellulose (MCC) 542g
Crospolyvinylpyrrolidone (PVPP) 117g
Carboxymethylstach sodium (CMS-Na) 17g
Micropowder silica gel 4g
Magnesium stearate 4g
75% ethanol is an amount of
Method for making: get periplaneta americana and be ground into coarse powder, with 64 ℃ of reflux, extract, of 3 times of amounts, 70% alcohol 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), at 60 ℃ of vacuum dryings, pulverizes, and crosses 100 mesh sieves; Get dry extract,, add an amount of 75% ethanol and make soft material the abundant mixing of dry extract, microcrystalline Cellulose, crospolyvinylpyrrolidone and carboxymethylstach sodium, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add magnesium stearate, micropowder silica gel mixing, tabletting promptly gets rehabilitation new dispersing tablet.This embodiment is a most preferred embodiment of the present invention.The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Embodiment 2:
Periplaneta americana 2000g
Lactose 240g
Pregelatinized Starch 480g
Crospolyvinylpyrrolidone 120g
Ethanol is an amount of
Magnesium stearate 10g
Method for making: get periplaneta americana and be ground into coarse powder, with 3 times of amount 70% ethanol 64 ℃ of reflux, extract, 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), at 60 ℃ of vacuum dryings, pulverizes, and crosses 100 mesh sieves; Get dry extract, with dry extract, lactose, pregelatinized Starch, the abundant mixing of crospolyvinylpyrrolidone, add an amount of ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, and 20 mesh sieve granulate add the magnesium stearate mixing, and tabletting promptly gets rehabilitation new dispersing tablet.The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Embodiment 3:
Periplaneta americana 2000g
Lactose 150g
Pregelatinized Starch 206g
Microcrystalline Cellulose 537g
The light propyl cellulose 79g of low replacement
75% ethanol is an amount of
Magnesium stearate 8g
Method for making: get periplaneta americana and be ground into coarse powder, with 3 times of amount 70% ethanol 64 ℃ of reflux, extract, 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), at 60 ℃ of vacuum dryings, pulverizes, and crosses 100 mesh sieves; Get dry extract, with dry extract, lactose, pregelatinized Starch and the low abundant mixing of light propyl cellulose that replaces add an amount of ethanol and make soft material, and 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, adding magnesium stearate mixing, tabletting promptly gets rehabilitation new dispersing tablet.The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Embodiment 4:
Periplaneta americana 2000g
Microcrystalline Cellulose 54% 450g
Starch 150g
Carboxymethyl starch sodium 5% (in add) 42g
4% (adding) 33g
Ethanol is an amount of
Magnesium stearate 8g
Method for making: get periplaneta americana and be ground into coarse powder, with 3 times of amount 70% ethanol 64 ℃ of reflux, extract, 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), at 60 ℃ of vacuum dryings, pulverizes, and crosses 100 mesh sieves; Get dry extract, dry extract, microcrystalline Cellulose, starch and part of sodium carboxymethyl starch (interior dosage) are added an amount of ethanol make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate add another part carboxymethyl starch sodium (outer dosage) and magnesium stearate, mixing again, tabletting promptly gets rehabilitation new dispersing tablet.The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Embodiment 5:
Periplaneta americana 2000g
Lactose 150g
Microcrystalline Cellulose 450g
Carboxymethyl starch sodium 53g
Crospolyvinylpyrrolidone 58g
Sodium lauryl sulphate 13g
Ethanol is an amount of
Magnesium stearate 9g
Method for making: get periplaneta americana and be ground into coarse powder, with 3 times of amount 70% ethanol 64 ℃ of reflux, extract, 3 times, merge extractive liquid, filters, and reclaims ethanol, is concentrated into the thick paste of relative density 1.35 (70 ℃), at 60 ℃ of vacuum dryings, pulverizes, and crosses 100 mesh sieves; Get dry extract, with dry extract, lactose, microcrystalline Cellulose, carboxymethyl starch sodium (in disintegrating agent) mixing, add an amount of ethanol and make soft material, 20 mesh sieves are granulated, 60 ℃ of oven dry, 20 mesh sieve granulate, add crospolyvinylpyrrolidone (adding disintegrating agent) and sodium lauryl sulphate, add magnesium stearate again, mixing, tabletting promptly gets rehabilitation new dispersing tablet.The dispersible tablet that obtains has following characteristic:
Dispersing uniformity: meet pharmacopeia regulation, promptly in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in three minutes by No. 2.
Claims (10)
1, a kind of dispersible tablet that is used for digestive system disease is characterized in that containing the periplaneta americana ethanol extraction.
2,, it is characterized in that containing the new dried cream powder of rehabilitation that percentage by weight is 10-55% (periplaneta americana ethanol extraction drying, pulverizing back), the adjuvant of 45-90% according to the rehabilitation new dispersing tablet of claim 1.
3,, it is characterized in that containing the new dried cream powder of rehabilitation that percentage by weight is 15-45%, the adjuvant of 55-85% according to the rehabilitation new dispersing tablet of claim 1.
4,, it is characterized in that adjuvant contains disintegrating agent, filler, lubricant according to the rehabilitation new dispersing tablet of claim 1-3.
5, according to the rehabilitation new dispersing tablet of claim 4, it is characterized in that used disintegrating agent comprises one or more in crospolyvinylpyrrolidone, carboxymethyl starch sodium, the light propyl cellulose of low replacement, cross-linking sodium carboxymethyl cellulose, the carboxymethylcellulose calcium, accounting for total formulation weight percentage ratio is 5-25%.And disintegrate promoter sodium lauryl sulphate, accounting for total formulation weight percentage ratio is 5-25%.Disintegrating agent can in add or add or inside and outsidely all add.
6, according to the rehabilitation new dispersing tablet of claim 4, it is characterized in that used filler comprises in lactose, microcrystalline Cellulose, pregelatinized Starch, starch, dextrin and the mannitol one or more, accounting for total formulation weight percentage ratio is 40-85%.
7, according to claim 4 rehabilitation new dispersing tablet, it is characterized in that used lubricant comprises one or more in magnesium stearate, Pulvis Talci, micropowder silica gel, stearic acid, the Polyethylene Glycol, accounting for total formulation weight percentage ratio is 0.5-5%.
8, a kind of method for preparing rehabilitation new dispersing tablet is characterized in that method comprises:
Prescription:
The new dried cream powder 10-55% of rehabilitation (weight)
Adjuvant 45-90% (weight)
Wetting agent is an amount of
Method for making: adopt wet granule compression tablet, be about to new dried cream powder of rehabilitation and filler, do not add or add part or all of disintegrating agent and mix, add wetting agent and make soft material, granulate drying, granulate adds in addition partly or entirely disintegrating agent and lubricant, tabletting behind the mix homogeneously.
9, a kind of method for preparing rehabilitation new dispersing tablet is characterized in that method comprises:
Prescription:
The new dried cream powder 15-45% of rehabilitation (weight)
Adjuvant 55-85% (weight)
Wetting agent is an amount of
Method for making: adopt wet granule compression tablet, be about to new dried cream powder of rehabilitation and filler, do not add or add part or all of disintegrating agent and mix, add wetting agent and make soft material, granulate drying, granulate adds in addition partly or entirely disintegrating agent and lubricant, tabletting behind the mix homogeneously.
The method for making of rehabilitation new dispersing tablet 10, according to Claim 8-9 is characterized in that used wetting agent comprises dehydrated alcohol, ethanol or certain density ethanol water.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100110890A CN101564402A (en) | 2009-04-10 | 2009-04-10 | Rehabilitation new dispersing tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100110890A CN101564402A (en) | 2009-04-10 | 2009-04-10 | Rehabilitation new dispersing tablet and preparation method thereof |
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| CN101564402A true CN101564402A (en) | 2009-10-28 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006590A (en) * | 2011-12-14 | 2013-04-03 | 西安泰科迈医药科技有限公司 | Dispersible tablet for chronic ulcerative colitis and preparation method thereof |
| CN104042635A (en) * | 2013-03-14 | 2014-09-17 | 成都百草和济科技有限公司 | Tablet of cockroach medicine and preparation method thereof |
| CN104644683A (en) * | 2015-02-26 | 2015-05-27 | 王福明 | American cockroach chewable tablet, preparation method and use |
| CN104784214A (en) * | 2014-12-21 | 2015-07-22 | 昆明赛诺制药有限公司 | A periplaneta americana extract micropore osmotic pump tablet and a preparing method thereof |
| CN105878291A (en) * | 2015-09-24 | 2016-08-24 | 陈光健 | Medicine for treating ulcer diseases and preparation method of medicine |
| CN105878292A (en) * | 2015-09-24 | 2016-08-24 | 陈光健 | Periplaneta americana extract and preparation process thereof |
| CN113367182A (en) * | 2021-05-25 | 2021-09-10 | 四川省食品发酵工业研究设计院有限公司 | Method for preserving and preserving cold fresh meat |
-
2009
- 2009-04-10 CN CNA2009100110890A patent/CN101564402A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006590A (en) * | 2011-12-14 | 2013-04-03 | 西安泰科迈医药科技有限公司 | Dispersible tablet for chronic ulcerative colitis and preparation method thereof |
| CN104042635A (en) * | 2013-03-14 | 2014-09-17 | 成都百草和济科技有限公司 | Tablet of cockroach medicine and preparation method thereof |
| CN104042635B (en) * | 2013-03-14 | 2017-09-15 | 成都百草和济科技有限公司 | A kind of cockroach medicinal tablets and preparation method thereof |
| CN104784214A (en) * | 2014-12-21 | 2015-07-22 | 昆明赛诺制药有限公司 | A periplaneta americana extract micropore osmotic pump tablet and a preparing method thereof |
| CN104784214B (en) * | 2014-12-21 | 2019-05-31 | 昆明赛诺制药股份有限公司 | A kind of American-cockroach-extract micro hole seep irrigation and preparation method thereof |
| CN104644683A (en) * | 2015-02-26 | 2015-05-27 | 王福明 | American cockroach chewable tablet, preparation method and use |
| CN105878291A (en) * | 2015-09-24 | 2016-08-24 | 陈光健 | Medicine for treating ulcer diseases and preparation method of medicine |
| CN105878292A (en) * | 2015-09-24 | 2016-08-24 | 陈光健 | Periplaneta americana extract and preparation process thereof |
| CN113367182A (en) * | 2021-05-25 | 2021-09-10 | 四川省食品发酵工业研究设计院有限公司 | Method for preserving and preserving cold fresh meat |
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Open date: 20091028 |