CN100409899C - Application of pachyman as disintegrating agent in preparation of medicinal tablet - Google Patents
Application of pachyman as disintegrating agent in preparation of medicinal tablet Download PDFInfo
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- CN100409899C CN100409899C CNB2006100181464A CN200610018146A CN100409899C CN 100409899 C CN100409899 C CN 100409899C CN B2006100181464 A CNB2006100181464 A CN B2006100181464A CN 200610018146 A CN200610018146 A CN 200610018146A CN 100409899 C CN100409899 C CN 100409899C
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- pachyman
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Abstract
The present invention relates to an application of pachyman as a medicinal disintegrating agent in a process for preparing pharmaceutical tablets. The pachyman provided by the present invention is a good disintegrating agent with high efficiency and has the advantage of good fluidity; the basic requirements for producing the tablets are satisfied; in addition, the water absorption of the pachyman is strong; the bulk density and the expandability are superior; the tablets are evenly distributed in a powdery shape in the disintegration process so that the disintegration performance of the tablets is increased, and the disintegration efficiency of the tablets is increased; the pachyman not only can be used by mixing other disintegrating agents, but also can be used solely as the disintegrating agent with high efficiency; the tablets can be disintegrated in about 3 minutes by the pachyman.
Description
Technical field:
The present invention relates to pachyman as the application of pharmaceutic adjuvant especially disintegrating agent in the preparation medicinal tablet.
Background technology:
Pharmaceutic adjuvant is the material base that pharmaceutical preparation exists, and is the indispensable material of production pharmaceutical preparation, so countries in the world all take much count of the exploitation new type medicinal stuff.
Tablet is a kind of most popular oral solid formulation, improve the quality of tablet, and the adjuvant of selecting for use is a key.Filler and disintegrating agent are topmost adjuvants in the conventional tablet, and the selection of these adjuvants directly influences the inherent quality of tablet and the curative effect of medicine.Adjuvant commonly used at present mainly contains starch based, cellulose family, Sargassum acids, potter's clay class, PVP class, gummy class etc.
Along with the direction of pharmaceutical preparation towards " triple effect " (efficient, quick-acting, long-acting) and " three is little " (toxicity is little, side effect is little, dosage little) develops, make new adjuvant, especially the exploitation that has the natural pharmaceutic adjuvant of good slow release, controlled-release function has more meaning, wherein noticeable especially to the developmental research of natural macromolecule amylose, have a extensive future.
Poria is the dry sclerotia of Polyporaceae plant Poria poria cocos (Schw.) Wolf.Its structure is that a kind of main chain is the glucosan that linear β (1 → 3) glycosidic bond connects, and side chain is connected by β (1 → 6) glycosidic bond by 9～10 outer glucose residues, has the macromolecule polysaccharide structure of similar starch.Poria is a kind of traditional Chinese medicine, and many scholars have carried out extensive studies to it, but experimental results demonstrate, pachyman is as its pharmacological action of medicines such as antitumor and not obvious.Therefore, attempt pachyman is developed as a kind of natural polymer adjuvant, have very big feasibility, novelty and wide application prospect.
Summary of the invention:
The object of the invention is to provide pachyman as the application of disintegrating agent in the preparation medicinal tablet, and pachyman is Powdered homodisperse as the disintegrating agent of tablet in disintegrating procedue, can increase the disintegrate ability of tablet, improves the disintegrate efficient of tablet.
Technical scheme provided by the invention is: pachyman is as the application of disintegrating agent in the preparation medicinal tablet.
Above-mentioned pachyman can make by the following method, poria cocos sclerotium is worn into 60-200 order powder, be dissolved in the sodium hydroxide or potassium hydroxide solution of 0.5-5wt%, temperature is controlled at 0 ℃～5 ℃, is stirred to thick shape, placed 10-20 hour, sucking filtration, neutralization filtrate leaves standstill, sucking filtration, drying obtains pachyman.
Described pachyman is that structure is to be main chain with β (1 → 3) glycosidic bond, and β (1 → 6) glycosidic bond is the macromolecule polysaccharide of the Polyporaceae plant Poria of side chain, and its preparation method is a sig water lixiviate poria cocos sclerotium powder.Referring to Zhou Yanxia, Tang Minglin, Yin Huian, An Lianying, the extraction of polysaccharide and assay in the Poria, research and development of natural products, 2003, Vol115, Nol4.
The present invention studies its application performance by the investigation to the different aspect of pachyman:
1. investigate the swellability of pachyman.
2. pass through the fixedly flowability of conical bottom method investigation pachyman.
3. investigate the bulk density of pachyman by fixed mount freely falling body method.
4. pachyman is applied to the disintegrating agent of the blank tablet of calcium sulfate, investigates its disintegration properties.
Pachyman can be used for wet granulation in tablet, also can add in the dried granule.Can take outer addition method to the slice, thin piece that hydrophobic drug disintegrate difficulty is bigger; Take interior addition method for the slice, thin piece of easy-formation not; Slice, thin piece for bad disintegrate and don't easy-formation adopts the inside and outside method that both take into account to add.
Above-mentioned experimentation shows that pachyman of the present invention is good efficient disintegrating agent.The pachyman good fluidity can satisfy the fundamental need of tablet manufacturing.In addition, the pachyman water absorption is strong, and has higher bulk density and dilatancy, is Powdered homodisperse in disintegrating procedue, has increased the disintegrate ability of tablet, has improved the disintegrate efficient of tablet.
The specific embodiment:
The following example will further specify the present invention.
Example one: the preparation of pachyman
Commercially available fresh poria cocos sclerotium is clayed into power, cross 60 mesh sieves, get in the NaOH solution that 600g is dissolved in 0.5wt% (the consumption mass ratio of Indian Bread and NaOH solution is 1: 100), temperature is controlled at 0 ℃～5 ℃, be stirred to thick shape, placement is spent the night, and sucking filtration obtains filtrate, use 10% acetic acid neutralization filtrate afterwards, 0 ℃～5 ℃ placements are spent the night, and sucking filtration obtains white precipitate, successively water, ethanol, the washing precipitation of acetone ether, 20 ℃～50 ℃ dryings promptly obtain pachyman.
Example two: the preparation of pachyman
Commercially available fresh poria cocos sclerotium is worn into the powder art, cross 200 mesh sieves, get in the KOH solution that 600g is dissolved in 5wt% (the consumption mass ratio of Indian Bread and NaOH solution is 1: 200), temperature is controlled at 0 ℃～5 ℃, be stirred to thick shape, placement is spent the night, and sucking filtration obtains filtrate, use 10% acetic acid neutralization filtrate afterwards, 0 ℃～5 ℃ placements are spent the night, and sucking filtration obtains white precipitate, successively water, ethanol, the washing precipitation of acetone ether, 20 ℃～50 ℃ dryings promptly obtain pachyman.
The research of pachyman swellability
The research of pachyman swellability
The inventor joins pachyman sample 1g in the 50ml graduated cylinder, adding distil water 50ml, high vibration is suspended in the water powder fully, at interval behind the 10min repetitive vibrations once, leave standstill 48h after, remove supernatant, measure the volume of suction back sample.Characterize the swellability of pachyman with the 1g sample back volume data (5 identical empirical average values) that fully absorbs water.Measurement result sees Table 1.
The comparison of several disintegrating agent flowabilities of table 1
| The sample name | Suction back volume (mL) |
| PVPP | 7.5 |
| CMS-Na | 19.5 |
| L-HPC | 9.5 |
| Starch | Do not have significantly and expand |
| Pachyman | 43.0 |
The research of pachyman flowability
The inventor adopts fixedly conical bottom method, and the diameter 3.5cm of bottom, hopper outlet diameter are 1.3cm, outlet pipe range 5.8cm, and the height of pipe end and bottom is 4.5cm.Flowability to several different disintegrating agents is contrasted, and measurement result sees Table 2.
The comparison of several disintegrating agent flowabilities of table 2
| The sample name | Angle of repose (degree) |
| PVPP | 29.7 |
| CMS-Na | 34.6 |
| L-HPC | 61.7 |
| Starch | 50.8 |
| Pachyman | 31.0 |
The research of the bulk density of pachyman
The inventor adopts the graduated cylinder of 100ml, and each sample is all got 30g, and height of drop is 15.1cm, shakes 5 times by the freely falling body mode and measure in fixed mount, does relatively.(data are 3 times meansigma methods)
The comparison of several disintegrating agent bulk densitys of table 2
| The sample name | Volume (ml) 3 | Bulk density (g/ml) |
| PVPP | 83.0 | 0.36 |
| CMS-Na | 53.3 | 0.56 |
| L-HPC | 68.1 | 0.44 |
| Starch | 53.0 | 0.57 |
| Pachyman | 60.0 | 0.50 |
Pachyman is to the research of blank tablet disintegration properties
The inventor adopts calcium sulfate to prepare blank model sheet.The consumption of disintegrating agent is 5%, with the method for disintegrating agent and equivalent 10%PVP slurry moist granulation, adds 0.5% magnesium stearate in the employing, is pressed into the plain sheet of diameter 10mm with single punch tablet machine.Several different disintegrating agents are contrasted, and measurement result sees Table 3.
The comparison of several disintegrating agent disintegration times of table 3
| Disintegrating agent | Hardness (kg) | Disintegration time (s ± SD) |
| The calcium sulfate blank | 4.50 | ＞1800 |
| PVPP | 4.49 | 193±34.5 |
| CMS-Na | 4.06 | 155±19.9 |
| L-HPC | 5.96 | 393±22.8 |
| Starch | 5.01 | 444±56.7 |
| Pachyman | 4.73 | 153±35.6 |
Above data show, the pachyman good fluidity can satisfy the fundamental need of tablet manufacturing.In addition, the pachyman water absorption is strong, and has higher bulk density and dilatancy, is Powdered homodisperse in disintegrating procedue, has increased the disintegrate ability of tablet, has improved the disintegrate efficient of tablet; Not only can mix and use, also can be used alone as efficient disintegrating agent, and can make tablet disintegrate about 3 minutes with other disintegrating agent.
Claims (2)
1. pachyman is as the application of disintegrating agent in the preparation medicinal tablet.
2. application according to claim 1, it is characterized in that: described pachyman makes by the following method, and poria cocos sclerotium is worn into 60-200 order powder, is dissolved in the sodium hydroxide or potassium hydroxide solution of 0.5-5wt%, temperature is controlled at 0 ℃～5 ℃, be stirred to thick shape, placed sucking filtration 10-20 hour, neutralization filtrate, leave standstill, sucking filtration, drying obtains pachyman.
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| CNB2006100181464A CN100409899C (en) | 2006-01-12 | 2006-01-12 | Application of pachyman as disintegrating agent in preparation of medicinal tablet |
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| CN100409899C true CN100409899C (en) | 2008-08-13 |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103720696B (en) * | 2013-12-27 | 2016-03-30 | 辰欣药业股份有限公司 | A kind of preparation technology improving valsartan and Hydrochlorothiade capsule bioavailability |
| CN106188324B (en) * | 2016-07-13 | 2018-11-23 | 武汉大学 | Hydroxyethyl pachyman preparation and its as sustained release tablets framework material application |
| CN107625852B (en) * | 2017-09-10 | 2021-02-02 | 江西心正药业有限责任公司 | Traditional Chinese medicine composition for clearing heat, promoting diuresis, removing blood stasis and stopping leukorrhagia as well as preparation process and application thereof |
| CN107625925B (en) * | 2017-09-10 | 2020-11-17 | 江西心正药业有限责任公司 | Traditional Chinese medicine composition capable of dispelling wind, relieving exterior syndrome, invigorating stomach and promoting digestion and preparation process and application thereof |
| CN108113968A (en) * | 2018-01-31 | 2018-06-05 | 常州康普药业有限公司 | A kind of Cimitidine Tablets and preparation method thereof |
| CN115521386A (en) * | 2022-08-18 | 2022-12-27 | 安徽中医药大学 | Novel pharmaceutic adjuvant pachyman alkaline solution polysaccharide and preparation method and application thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1686561A (en) * | 2005-04-08 | 2005-10-26 | 武汉大学 | Modified natural polymer medical adjuvant, its preparation method and use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1686561A (en) * | 2005-04-08 | 2005-10-26 | 武汉大学 | Modified natural polymer medical adjuvant, its preparation method and use |
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