CN101167812A - 'Fengliaochangweikang' dispersible tablet and preparation method thereof - Google Patents
'Fengliaochangweikang' dispersible tablet and preparation method thereof Download PDFInfo
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- CN101167812A CN101167812A CNA2006101434499A CN200610143449A CN101167812A CN 101167812 A CN101167812 A CN 101167812A CN A2006101434499 A CNA2006101434499 A CN A2006101434499A CN 200610143449 A CN200610143449 A CN 200610143449A CN 101167812 A CN101167812 A CN 101167812A
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Abstract
The invention discloses a maple knotweed intestine wei kang dispersible tablet and process for preparation, containing maple knotweed extract and medicinal findings. The proportioning is that maple knotweed extract is 100 parts, the usage of medicinal finding disintegrating agent is 2 to 50 parts, and the usage of medicinal finding filling agent is 5-100 parts, wherein the disintegrating agent is selected from at least one of microcrystal cellulose, cross linked polyvidon, sodium carboxymethylstarch, and low-substituted hydroxypropyl cellulose and cross linked carboxymethyl cellulose sodium. The filling agent is selected from at least one of compressibility starch, starch gum, milk sugar lactose, microcrystal cellulose, and manna sugar. The knotweed intestine wei kang dispersible tablet has the advantages of excellent dispersed state, short disintegration time, quick medicine dissolving, high biology availability, convenient intake, simple medicament arts, low producing cost, and convenient storage and transportation, and does not need vacuum refrigeration, dehumidification, and special package.
Description
Technical field
The present invention relates to a kind of dispersible tablets of Chinese medicine and preparation method thereof.
Background technology
Maple Liao the intestines and stomach health main component is Daphniphyllum calycinum and peppery Liao two flavor Chinese herbal medicine.Daphniphyllum calycinum and the peppery few common drug that is treatment acute gastritis among the people, enteritis, dysentery belong to traditional good medicine of " long-tested ", and through the science compatibility, adopt the refining the intestines and stomach health sheet that forms of modern pharmaceutical technology, and curative effect is even better.As a characteristic Chinese patent medicine, at first require compatibility reasonable, the Daphniphyllum calycinum nature and flavor are destitute, peppery Liao Ze nature and flavor Wen Xin, the two compatibility, using medicines of both cold and hot natures simultaneously is with YIN and YANG balance regulating; Toil is gone forward side by side, with along its lifting, make gastrointestinal must with, lifting is normal again.Thereby eliminate clinical symptoms effectively, recover the gastrointestinal physiological function.Existing tablet, granule, capsule, mixture, oral conventional tablet fully absorbs because of disintegrate and medicine stripping slowly influence medicine, often makes troubles for the patient of old man, child and dysphagia.In this case, preparations such as oral solution, suspensoid are then comparatively superior, but liquid preparation has medicine stability relatively poor and packing, transportation again, stores all inconveniently, and are difficult for grasping shortcoming such as taking dose.
Summary of the invention
The present invention is just in order to solve the shortcoming that the conventional dosage forms onset is slow, bioavailability is low, 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 maple Liao the intestines and stomach healthy dispersion tablet of even suspension and preparation method thereof.
The technical solution adopted for the present invention to solve the technical problems is:
'Fengliaochangweikang' ' dispersible tablet contains maple knotweed extractum and pharmaceutic adjuvant, and its proportioning is: by 100 parts of maple knotweed extractum, pharmaceutic adjuvant disintegrating agent consumption is 2-50 part, and the consumption of pharmaceutic adjuvant filler is 5-100 part; Wherein disintegrating agent is selected from least a of microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose and cross-linking sodium carboxymethyl cellulose; This filler is selected from least a in amylum pregelatinisatum, dextrin, lactose, microcrystalline Cellulose, the mannitol.
The pharmaceutic adjuvant of described 'Fengliaochangweikang' ' dispersible tablet also comprises lubricant, lubricant is selected from least a in stearic acid, magnesium stearate, Pulvis Talci, Polyethylene Glycol, Stepanol MG and the micropowder silica gel, by 100 parts of calculating of maple knotweed extractum, described lubricant quantity is 0.1-20 part.
The pharmaceutic adjuvant disintegrating agent of described 'Fengliaochangweikang' ' dispersible tablet is polyvinylpolypyrrolidone, microcrystalline Cellulose and carboxymethyl starch sodium, filler is a microcrystalline Cellulose, lubricant is magnesium stearate and micropowder silica gel, its proportioning is: by 100 parts of calculating of maple knotweed extractum, disintegrating agent is 2-100 part, and filler is 10-50 part; Lubricant is 0.1-10 part.
Described 'Fengliaochangweikang' ' dispersible tablet by 100 parts of calculating of maple knotweed extractum, wherein disintegrating agent polyvinylpolypyrrolidone, microcrystalline Cellulose and carboxymethyl starch sodium are totally 80 parts, totally 50 parts of filler microcrystalline Cellulose; Lubricant is totally 0.4 part of magnesium stearate and micropowder silica gel.
The preparation method of described 'Fengliaochangweikang' ' dispersible tablet is to adopt following technological process preparation:
A, get recipe quantity Daphniphyllum calycinum, Herba polygoni hydropiperis and add purified water 3000ml and decocted 1.5 hours, it is stand-by to get filtrate, and residue adds purified water 3000ml and decocted 1 hour, gets filtrate and merges decoction liquor for the first time, 60 ℃ of environment decompressions, be concentrated into the thick paste shape;
B, dry below 80 ℃, pulverize, cross 100 mesh sieves;
C, adding crospolyvinylpyrrolidone, microcrystalline Cellulose, sodium carboxymethylstarch and aspartame mixing add 95% ethanol as wetting agent, granulate;
D, dry back granulate add micropowder silica gel, magnesium stearate, and be total mixed, tabletting.
The invention provides a kind of pharmaceutical composition of 'Fengliaochangweikang' ' dispersible tablet, contain maple knotweed extractum and suitable pharmaceutic adjuvant in the said composition, the pharmaceutic adjuvant in the present composition includes but not limited to (maple knotweed extractum is by 100 parts of calculating):
A. disintegrating agent:
Microcrystalline Cellulose: consumption is 2-30 part;
Polyvinylpolypyrrolidone: consumption is 3-30 part;
Carboxymethyl starch sodium: consumption is 3-40 part;
Low-substituted hydroxypropyl cellulose: consumption is 2-30 part;
Cross-linking sodium carboxymethyl cellulose: consumption is 2-15 part.
Preferred polyvinylpolypyrrolidone, microcrystalline Cellulose and carboxymethyl starch sodium 4-50 part.
B. filler:
Amylum pregelatinisatum: consumption is 2-40 part;
Dextrin: consumption is 2-25 part;
Lactose: consumption is 2-40 part;
Microcrystalline Cellulose: consumption is 2-50 part;
Mannitol: consumption is 2-10 part;
Preferably: the shared 4-50 part of microcrystalline Cellulose.
C. lubricant:
Stearic acid: consumption is 0.2-2.5 part;
Polyethylene Glycol: consumption is 0.2-2.0 part (Polyethylene Glycol of multi-purpose solid);
Magnesium stearate: consumption is 0.2-5 part;
Pulvis Talci: consumption is 2-25 part;
Micropowder silica gel: consumption is 0.2-5 part;
Preferred magnesium stearate 0.2-2 part.
In the above-mentioned component, most preferably prescription comprises 100 parts of maple knotweed extractum, 50 parts of disintegrating agents, 80 parts of filleies, 0.4 part of lubricant.
Do not contain sugar in the 'Fengliaochangweikang' ' dispersible tablet, some are not suitable for taking the patient who contains sugared medicine and use to be appropriate to diabetes etc., its bioavailability height, can swallow, chew, contain and suck, take separately after also can placing water to disperse, or be equal to clothes with fruit juice, milk, especially be fit to old man, child and the patient of solid difficulty that swallows.
'Fengliaochangweikang' ' preparation of the present invention has carried out a large amount of clinical experiments at aspects such as treatment acute gastritis, enteritis, dysentery, and experiment shows that to take the 'Fengliaochangweikang' ' dispersible tablet curative effect fast, effective and side effect is little.
The 'Fengliaochangweikang' ' preparation has been selected 60 different sexes, the patient at age in the clinical experiment of treatment acute bacillary dysentery, male's 33 examples wherein, women's 27 examples; The course of disease 3 hours to 7 days, all patients all have abdominal pain diarrhea, and 28 examples have dense hemafecia, and 11 examples have Mucous Stool, and 15 examples have anxious back heavy, and 14 examples have heating, and 25 examples have nausea and vomiting.All patient all takes the 'Fengliaochangweikang' ' preparation, each 16g (two), and 3 times on the 1st, 3 days is a course of treatment.Treat after 3 days, have 48 examples to cure, 9 examples are clearly better, and 3 examples are invalid.Clinical observation finds there is nausea and vomiting person, remission is very fast, and curative effect is better; And with heating person, then curative effect is general.Taking does not have untoward reaction to take place in the process.
The 'Fengliaochangweikang' ' preparation has been selected 268 patients in the clinical experiment of treatment infantile diarrhea, be divided into two group treatments, and wherein matched group 120 examples adopt conventional anti-infectives, anti symptom treatment.Rotavirus enteritis folic acid, virazole; The summer diarrhea cephalosporins.168 examples are organized in treatment, add to use the 'Fengliaochangweikang' ' preparation.Less than 6 months each 2-2.5g of child, 6 months to the 1 years old each 2.5-4g of child, 1 years old to the 2 years old each 4-5g of child, 3 times on the 1st, logotype 3 to 4 days.Therapeutic outcome demonstration: treatment group produce effects (diarrhoea, vomiting and heating paresthesia disappearance, it is normal that stool recovers) 98 examples, effective (symptom is obviously improved, and defecates near normal) 50 examples, invalid (symptom and the nothing of defecating take a turn for the better or increase the weight of) 0 example; Matched group produce effects 75 examples, effective 42 examples, invalid 3 examples.Two groups of effective times that occur of case produce effects are obviously different, average 5 days of matched group, and treatment is organized average 2.4 days.
The 'Fengliaochangweikang' ' preparation has been selected 273 different sexes, the patient at age in the clinical experiment of treatment acute gastroenteritis, male's 131 examples wherein, women's 142 examples; The cause of disease is divided into: eating and drinking too much at one meal person 49 examples, unclean drink trencherman 142 examples, raw food drink trencherman 82 examples.Clinical cardinal symptom: stomachache person's 172 examples, diarrhoea person's 293 examples, vomiter's 157 examples, heating person's 142 examples.Laboratory examination stool routine examination: above person's 198 examples of leukocyte or pus cell (+), no abnormal person's 75 examples.All patient all takes the 'Fengliaochangweikang' ' preparation, each 16g (two), and 3 times on the 1st, 3 days is a course of treatment.Treat after 3 days, 234 example recoveries from illness are arranged, 20 routine produce effects, 12 examples are effective, and 7 examples are invalid.There is not untoward reaction to take place in the therapeutic process, and the hepatic and renal function no abnormality seen.
The invention has the beneficial effects as follows that 'Fengliaochangweikang' ' dispersible tablet good dispersing state, disintegration time are lacked, the medicine stripping is rapid, bioavailability height, taking convenience.Its preparation technology is simple, and production cost is low, does not need vacuum freezing, drying and extra package, is convenient to store and transportation.
The specific embodiment
The present invention is further described below in conjunction with embodiment.
1 1000 consumptions of embodiment
Daphniphyllum calycinum 4000g
Herba polygoni hydropiperis 2000g
Microcrystalline Cellulose (MCC) 240g
Polyvinylpolypyrrolidone (PVPP) 50g
Carboxymethylstach sodium (CMS-Na) 60g
Micropowder silica gel 6g
Magnesium stearate 3g
Aspartame 3g
95% ethanol is an amount of
Its preparation technology is:
Get recipe quantity Daphniphyllum calycinum and Herba polygoni hydropiperis and add purified water 3000ml and decocted 1.5 hours, it is stand-by to get filtrate, and residue adds purified water 3000ml and decocted 1 hour, get filtrate and merge decoction liquor for the first time, 60 ℃ are evaporated to the thick paste shape, dry below 80 ℃, pulverize, cross 100 mesh sieves, add crospolyvinylpyrrolidone, microcrystalline Cellulose, carboxymethylstach sodium and aspartame mixing, 95% ethanol is as wetting agent, granulate, dry back granulate adds micropowder silica gel and magnesium stearate, total mixed, tabletting.
2 1000 consumptions of embodiment
Daphniphyllum calycinum 4000g
Herba polygoni hydropiperis 2000g
Microcrystalline Cellulose (MCC) 230g
Low-substituted hydroxypropyl cellulose 60g
Carboxymethylstach sodium (CMS-Na) 50g
Micropowder silica gel 6g
Magnesium stearate 3g
Aspartame 3g
95% ethanol is an amount of
Its preparation technology is:
Get recipe quantity Daphniphyllum calycinum and Herba polygoni hydropiperis and add purified water 3000ml and decocted 1.5 hours, it is stand-by to get filtrate, and residue adds purified water 3000ml and decocted 1 hour, get filtrate and merge decoction liquor for the first time, 60 ℃ are evaporated to the thick paste shape, dry below 80 ℃, pulverize, cross 100 mesh sieves, add low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, carboxymethylstach sodium and aspartame mixing, 95% ethanol is as wetting agent, granulate, dry back granulate adds micropowder silica gel and magnesium stearate, total mixed, tabletting.
Claims (5)
1. 'Fengliaochangweikang' ' dispersible tablet, contain maple knotweed extractum and pharmaceutic adjuvant, it is characterized in that: the proportioning of described 'Fengliaochangweikang' ' dispersible tablet is: by 100 parts of maple knotweed extractum, pharmaceutic adjuvant disintegrating agent consumption is 2-50 part, and the consumption of pharmaceutic adjuvant filler is 5-100 part; Wherein disintegrating agent is selected from least a of microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose and cross-linking sodium carboxymethyl cellulose; This filler is selected from least a in amylum pregelatinisatum, dextrin, lactose, microcrystalline Cellulose, the mannitol.
2. 'Fengliaochangweikang' ' dispersible tablet according to claim 1, it is characterized in that: wherein pharmaceutic adjuvant also comprises lubricant, lubricant is selected from least a in stearic acid, magnesium stearate, Pulvis Talci, Polyethylene Glycol, Stepanol MG and the micropowder silica gel, by 100 parts of calculating of maple knotweed extractum, described lubricant quantity is 0.1-20 part.
3. 'Fengliaochangweikang' ' dispersible tablet according to claim 1, it is characterized in that: wherein disintegrating agent is polyvinylpolypyrrolidone, microcrystalline Cellulose and carboxymethyl starch sodium, filler is a microcrystalline Cellulose, lubricant is magnesium stearate and micropowder silica gel, its proportioning is: by 100 parts of calculating of maple knotweed extractum, disintegrating agent is 2-100 part, and filler is 10-50 part; Lubricant is 0.1-10 part.
4. 'Fengliaochangweikang' ' dispersible tablet according to claim 3 is characterized in that: by 100 parts of calculating of maple knotweed extractum, wherein disintegrating agent polyvinylpolypyrrolidone, microcrystalline Cellulose and carboxymethyl starch sodium are totally 80 parts, totally 50 parts of filler microcrystalline Cellulose; Lubricant is totally 0.4 part of magnesium stearate and micropowder silica gel.
5. according to the preparation method of claim 1,2, one of 3 or 4 described 'Fengliaochangweikang' ' dispersible tablets, it is characterized in that: 'Fengliaochangweikang' ' dispersible tablet adopts following technological process preparation:
A, get recipe quantity Daphniphyllum calycinum, Herba polygoni hydropiperis and add purified water 3000ml and decocted 1.5 hours, it is stand-by to get filtrate, and residue adds purified water 3000ml and decocted 1 hour, gets filtrate and merges decoction liquor for the first time, 60 ℃ of environment decompressions, be concentrated into the thick paste shape;
B, dry below 80 ℃, pulverize, cross 100 mesh sieves;
C, adding crospolyvinylpyrrolidone, microcrystalline Cellulose, sodium carboxymethylstarch and aspartame mixing add 95% ethanol as wetting agent, granulate;
D, dry back granulate add micropowder silica gel, magnesium stearate, and be total mixed, tabletting.
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CNA2006101434499A CN101167812A (en) | 2006-10-25 | 2006-10-25 | 'Fengliaochangweikang' dispersible tablet and preparation method thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102091049A (en) * | 2011-01-17 | 2011-06-15 | 广东东阳光药业有限公司 | Matrine dispersible tablet and preparation process thereof |
CN102631422A (en) * | 2012-03-20 | 2012-08-15 | 浙江维康药业有限公司 | Drug composite for treating acute gastroenteritis/chronic gastroenteritis |
CN102008552B (en) * | 2009-09-07 | 2013-04-24 | 北京因科瑞斯医药科技有限公司 | Daphniphyllum calycinum and Polygonum hydropiper Linn dispersible tablet for gastrointestinal health and preparation method thereof |
-
2006
- 2006-10-25 CN CNA2006101434499A patent/CN101167812A/en active Pending
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102008552B (en) * | 2009-09-07 | 2013-04-24 | 北京因科瑞斯医药科技有限公司 | Daphniphyllum calycinum and Polygonum hydropiper Linn dispersible tablet for gastrointestinal health and preparation method thereof |
CN102091049A (en) * | 2011-01-17 | 2011-06-15 | 广东东阳光药业有限公司 | Matrine dispersible tablet and preparation process thereof |
CN102091049B (en) * | 2011-01-17 | 2015-12-02 | 广东东阳光药业有限公司 | A kind of matrine dispersible tablet and preparation technology thereof |
CN102631422A (en) * | 2012-03-20 | 2012-08-15 | 浙江维康药业有限公司 | Drug composite for treating acute gastroenteritis/chronic gastroenteritis |
CN102631422B (en) * | 2012-03-20 | 2013-03-13 | 浙江维康药业有限公司 | Drug composition for treating acute gastroenteritis/chronic gastroenteritis |
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Open date: 20080430 |