CN1927301A - Tongmai Jiangzhi dispersant tablet and method for making same - Google Patents
Tongmai Jiangzhi dispersant tablet and method for making same Download PDFInfo
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Abstract
The invention relates to dispersion antihyperglycemic tablets and preparing process, wherein the raw materials include Equisetum debile, Ligusticum wallichii, lotus leaf, notoginseng, Chinese prickly ash, and right amount of auxiliary materials.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine dispersible tablet, relate in particular to Tongmai Jiangzhi dispersant tablet and preparation method thereof.
Background technology
Dispersible tablet in the Chinese medicine preparation, changes dosage form and manages as new drug according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The existing dosage form of this product is tablets for invigorating circulation and reducing bloodfat and function of invigorating circulation and reducing blood fat capsule, and it is turbid to have blood fat reducingization, the effect of blood circulation and channel invigorating.Be used for the treatment of hyperlipemia, prevent and treat atherosclerosis.List the 9th of " Ministry of Health of the People's Republic of China's standard drug standard " Chinese medicine ministry standard and " national standard for traditional Chinese medicines compilation " (internal medicine is felt concerned about fascicle) respectively in.
The technology features of the tablets for invigorating circulation and reducing bloodfat of existing treatment hyperlipemia be get Radix Notoginseng, Rhizoma Chuanxiong, Pericarpium Zanthoxyli and Folium Nelumbinis, pulverize separately becomes fine powder; Radix Notoginseng powder was steamed 2 hours; Radix Scorzonerae Albicaulis and remaining Folium Nelumbinis decoct twice, filter, and concentrate, and water extract-alcohol precipitation gets thick paste and above-mentioned medicated powder mixing, granulate drying, tabletting, sugar coating.
The capsular technology features of function of invigorating circulation and reducing blood fat of existing treatment hyperlipemia be get Radix Notoginseng, Rhizoma Chuanxiong, Pericarpium Zanthoxyli and Folium Nelumbinis, pulverize separately becomes fine powder; Radix Notoginseng powder was steamed 2 hours; Radix Scorzonerae Albicaulis and remaining Folium Nelumbinis decoct twice, filter, and concentrate, and water extract-alcohol precipitation gets thick paste and above-mentioned medicated powder mixing, granulate, and drying is sieved, and incapsulates, promptly.These two kinds are that the crude drug powder is used as medicine because of its major part, the caking of easily reuniting, and oral back disintegration time is long, and the composition dissolution rate is slow, causes bioavailability low.
Can use for this reason that the modern pharmaceutical technology changes its dosage form into both can be oral, can be scattered in the dispersible tablet that forms fragrant and sweet good to eat solution in the water again rapidly.
Most dispersible tablets of Chinese medicine are because of (1) Chinese medicine principal agent ratio content height, the sticking of macromolecular substances such as (2) pectin, polysaccharide, cause the dispersible tablets of Chinese medicine disintegration rate difficulty reach the requirement that is controlled in 3 minutes, than the more difficult industrialization of Western medicine dispersible tablet.Two medicine dispersible tablet kinds in the industrialization of having reported are more, but the dispersible tablets of Chinese medicine kind of industrialization is considerably less.This is also few because be fit to the herbal species of quick disintegrate dispersible tablet.The dispersible tablets of Chinese medicine kind that particularly can very fast disintegrate about time half a minute finishes is very rare.
Transform the form that existing herbal species makes it to become dispersible tablet, the adjuvant combination that efficiency of selection is higher according to qualifications, very fast disintegrate finishes about time half a minute, so that obtain the better medicament bioavailability certain meaning is arranged.
And according to qualifications the higher adjuvant of efficiency of selection to be combined in about time half a minute that disintegrate finishes be very very difficult, the disintegrate of most herbal species was above 1 minute in a plurality of herbal species of our preparation.
Summary of the invention
The purpose of this invention is to provide a kind of Tongmai Jiangzhi dispersant tablet and preparation method thereof,, improve the quality and the curative effect of product, satisfy needs of medical treatment better to overcome existing dosage form deficiency.The dissolution rate of the total saponins of this Tongmai Jiangzhi dispersant tablet is fast.The disintegration rate of this Tongmai Jiangzhi dispersant tablet is very fast.
The objective of the invention is to be achieved through the following technical solutions:
Tongmai Jiangzhi dispersant tablet, the composition of this dispersible tablet comprise the corresponding medical material powder of function of invigorating circulation and reducing blood fat and extract, adjuvant; Adjuvant comprises disintegrating agent, filler, lubricant, correctives, function of invigorating circulation and reducing blood fat medical material powder and extract are made by the following weight Chinese medicinal raw materials: Tongmai Jiangzhi dispersant tablet, make by the following weight Chinese medicinal raw materials: 250 parts of Radix Scorzonerae Albicaulis, 16.6 parts of Radix Notoginseng, 20 parts of Rhizoma Chuanxiongs, 5 parts in Pericarpium Zanthoxyli, 100 parts on Folium Nelumbinis.
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat crude drug powder and extract 60-90 part, disintegrating agent 10-50 part, filler 0-50 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat crude drug powder and extract 80-85 part, disintegrating agent 30-45 part, filler 30-45 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
The key of dispersible tablet is its disintegration rate in water, so the selection of the disintegrate system in the tablet is extremely important, the disintegrating agent that the present invention chooses is any one or a few in carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na), sodium carboxymethyl cellulose, microcrystalline Cellulose, the pregelatinized Starch.
Filler is in order to increase the weight and volume of dispersible tablet, to be beneficial to molding and divided dose.Because this prescription Central Plains medicated powder is more, molding is difficulty, also need add a certain amount of filler and improve mouldability.The filler that the present invention chooses be in microcrystalline Cellulose, starch, the calcium sulfate any one or a few.
Lubricant is for feeding in raw material smoothly and slice, making the pharmaceutic adjuvant of tablet smooth and beautiful appearance.The lubricant that the present invention chooses be in magnesium stearate, micropowder silica gel, calcium stearate, Pulvis Talci, Stepanol MG, the silicon dioxide any one or a few.
Correctives is that A Siba is sweet, in the glycyrrhizin, citric acid, vanillin any one or a few.
In order to guarantee the stable of principal agent, can also add an amount of antioxidant etc.
Tongmai Jiangzhi dispersant tablet obtains by following concrete steps:
Get Radix Notoginseng, Rhizoma Chuanxiong, Pericarpium Zanthoxyli and 1/6 Folium Nelumbinis 55 ℃ of dryings 1 hour, pulverize separately becomes fine powder; After the Radix Notoginseng fine powder steamed 2 hours, at 55 ℃ of dryings 3 hours, porphyrize, above medical material fine powder sterilization, standby; Radix Scorzonerae Albicaulis and remaining Folium Nelumbinis decoct with water secondary, and each 3 hours, merging filtrate was concentrated into clear paste, again clear paste was carried out precipitate with ethanol, filter, and filtrate is concentrated into the thick paste shape, promptly get Tongmai Jiangzhi dispersant tablet Chinese crude drug prescription.Get former medicated powder, filler and progressively increase method with the mixture mixing of former medicated powder and filler, disintegrating agent, cross 80 mesh sieves by equivalent; Material behind the mixing is put in the appropriate containers, adds thick paste as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds the adjuvant of remainder again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Disintegrating agent add, add in can adopting or in add and add combination.
The dissolution rate of effective ingredient and medicine bioavailability in vivo exists certain dependency, the active ingredient of function of invigorating circulation and reducing blood fat preparation is the ginsenoside Rg1, therefore existing to be index with ginsenoside Rg1 with HPLC method and ultraviolet spectrophotometry respectively compare the stripping situation of Tongmai Jiangzhi dispersant tablet and ordinary tablet, sees whether dispersible tablet has superiority aspect stripping.The result is as follows:
1, ginsenoside Rg1's content is higher than ordinary tablet in the dispersible tablet.
1.1 the preparation of reference substance solution
Precision takes by weighing ginsenoside Rg1's reference substance 21.6mg, puts in the 100ml volumetric flask, adds dissolve with methanol and is diluted to scale, promptly gets the reference substance solution that concentration is 0.216mg/ml
1.2 the preparation of need testing solution
It is an amount of to get Tongmai Jiangzhi dispersant tablet, and porphyrize is got about 2g, and it is an amount of to get the function of invigorating circulation and reducing blood fat ordinary tablet, and porphyrize is got about 1g, each portion.Accurate claim surely, put in the tool plug conical flask that the accurate methanol 50ml that adds claims to decide weight,, put cold in 80 ℃ of reflux of water-bath 3 hours; Weight decided in title again, supplies with methanol to subtract weight loss, shakes up, filter, get subsequent filtrate 25ml, water bath method, residue water 20ml gradation dissolving, be transferred in the separatory funnel, extract 4 times (30ml, 30ml, 20ml, 20ml) with water saturated n-butyl alcohol jolting and merge n-butyl alcohol liquid, the sodium hydroxide solution washing with 1% 2 times, each 25ml, the saturated water washing of reuse n-butyl alcohol 2 times, each 25ml gets n-butyl alcohol liquid evaporate to dryness, the residue dissolve with methanol, be transferred in the 10ml measuring bottle, add methanol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Sample thief is measured by above-mentioned need testing solution preparation method and chromatographic condition, calculates content with external standard method, the results are shown in Table 1
Table 1 sample size measurement result (n=2)
| Sample | Peak area | The ginsenoside Rg 1Content (mg/g) |
| Ordinary tablet (PTP) | 221.1 | 1.3004 |
| Dispersible tablet (FSP) | 1016.7 | 2.9949 |
2, dissolution determination selects for use 75 rev/mins of rotating speeds can embody ordinary tablet and dispersible tablet stripping difference
Hydrochloric acid with 0.1% is dissolution medium, get 2 slices/glass of 8 slices/glass of ordinary tablets and dispersible tablets respectively, adopt little agar diffusion method, under 50 rev/mins, 75 rev/mins, 100 rev/mins rotating speed, test respectively, the result did not almost have stripping at 50 rev/mins of following dispersible tablets in 60 minutes, and close with the accumulation dissolution of dispersible tablet in 60 minutes at 100 rev/mins of following ordinary tablets, this can not show the advantage of dispersible tablet stripping aspect.At 75 rev/mins, the dispersible tablet stripping is significantly better than ordinary tablet.So rotating speed is selected 75 rev/mins.
3, the HPLC method records the dissolution height of dispersible tablet than ordinary tablet
3.1 the preparation of need testing solution
Get this product, " three therapeutic methods of traditional Chinese medicine (appendix XC) device was a dissolution medium with 100ml 0.1% hydrochloric acid under the dissolution determination item of Chinese pharmacopoeia appendix regulation, and bath temperature is (37 ± 0.5) ℃ with version in 2005, rotating speed is 75rmin-1, randomization, accurate title fixed (dispersible tablet is put into two for every glass, and ordinary tablet is put into eight for every glass), respectively at 3,5,15,30,45, the 60min 5ml that takes a sample, add medium 5ml simultaneously, with the filtering with microporous membrane of 0.8 μ m, promptly.
3.2 the preparation of reference substance solution
Precision takes by weighing ginsenoside Rg1's reference substance 4.35mg, puts in the 100ml volumetric flask, adds dissolve with methanol and is diluted to scale, promptly gets the reference substance solution that concentration is 0.0435mg/ml
3.3 ginsenoside Rg1's assay in each sampling time point solution
Get reference substance solution, need testing solution, each 20 μ l of solution, measure under above-mentioned chromatographic condition, the record chromatogram calculates ginsenoside Rg1's content, calculates accumulation stripping percentage rate relatively by the stripping formula: the results are shown in Table 2
Table 2 is accumulation stripping percentage rate relatively
| Sample | Lot number | Cumulative time (min) | ||||||
| 0 | 3 | 5 | 15 | 30 | 45 | 60 | ||
| Common | 1 | 0 | 0 | 0 | 0 | —— | 0.239 | 0.391 |
| 2 | 0 | 0 | 0 | 0 | —— | 0.237 | 0.389 | |
| Sheet | 3 | 0 | 0 | 0 | 0 | —— | 0.221 | 0.373 |
| 4 | 0 | 0 | 0 | 0 | —— | 0.212 | 0.363 | |
| 5 | 0 | 0 | 0 | 0 | —— | 0.203 | 0.352 | |
| 6 | 0 | 0 | 0 | 0 | —— | 0.248 | 0.402 | |
| Dispersible tablet | 1 | 0 | 0.503 | 0.537 | 0.687 | 0.700 | 0.760 | 0.755 |
| 2 | 0 | 0.508 | 0.550 | 0.676 | 0.742 | 0.733 | 0.740 | |
| 3 | 0 | 0.451 | 0.447 | 0.627 | 0.0.629 | 0.627 | 0.653 | |
| 4 | 0 | 0.370 | 0.419 | 0.560 | 0.635 | 0.616 | 0.642 | |
| 5 . | 0 | 0.342 | 0.403 | 0.513 | 0.596 | 0.612 | 0.632 | |
| 6 . | 0 | 0.477 | 0.512 | 0.651 | 0.697 | 0.731 | 0.738 |
3.4 the drafting of stripping curve
Utilization Electronic forms Excel software processes drug dissolution data are abscissa with the sample time, and dissolution is the stripping curve that vertical coordinate is drawn ordinary tablet (TMP) and dispersible tablet (TMF) respectively.
Ordinary tablet and dispersible tablet be (first) relatively.
The result: from top stripping curve as can be seen, dispersible tablet just begins stripping in the time of 30 minutes, just reaches 40% stripping in the time of 60 minutes; And dispersible tablet was uniformly dispersed in 3 minutes and stripping reached about 70% in about 40%, 30 minutes, and begin saturated.Generally speaking, ginsenoside Rg1's stripping, dispersible tablet is better than ordinary tablet.
4, visible spectrophotometry records the dissolution height of ordinary tablet than dispersible tablet
4.1 chromogenic reaction
The accurate respectively sample solution 1ml that draws puts in the 10ml tool plug graduated centrifuge tube, and water-bath (80 ℃) evaporate to dryness is cooled to room temperature, the 5% vanillin glacial acetic acid 0.2 that adds new system, perchloric acid 0.8ml, 60 ℃ of water-baths 15 minutes are put into ice bath immediately, add glacial acetic acid 5ml, shake up, to be measured.
4.2 the preparation of reference substance, need testing solution: the same
4.3 detect the selection of wavelength:
A certain amount of reference substance through chromogenic reaction, is made into certain density solution.With 1% hydrochloric acid is blank, the UV absorption spectrum of scanning reference substance.The selected wavelength that detects.
4.4 determination of dissolution rate:
With above-mentioned two kinds of solution is respectively blank in detecting wavelength mensuration trap down with the dissolution medium, presses the dissolution formula and calculates dissolution.See Table 3
Table 3 is accumulation stripping percentage rate relatively
| Sample | Lot number | Cumulative time (min) | ||||||
| 0 | 3 | 5 | 15 | 30 | 45 | 60 | ||
| Ordinary tablet | 1 | 0 | 0 | 0 | 0.079 | 0.188 | 0.267 | 0.359 |
| 2 | 0 | 0 | 0 | 0.061 | 0.170 | 0.239 | 0.330 | |
| 3 | 0 | 0 | 0 | 0.080 | 0.196 | 0.279 | 0.371 | |
| 4 | 0 | 0 | 0 | 0.069 | 0.179 | 0.248 | 0.343 | |
| 5 | 0 | 0 | 0 | 0.061 | 0.177 | 0.232 | 0.312 | |
| 6 | 0 | 0 | 0 | 0.095 | 0.197 | 0.286 | 0.381 | |
| Dispersible tablet | 1 | 0 | 0.185 | 0.276 | 0.355 | 0.410 | 0.463 | 0.510 |
| 2 | 0 | 0.178 | 0.271 | 0.346 | 0.397 | 0.465 | 0.517 | |
| 3 | 0 | 0.173 | 0.263 | 0.333 | 0.387 | 0.457 | 0.493 | |
| 4 | 0 | 0.181 | 0.273 | 0.351 | 0.401 | 0.462 | 0.523 | |
| 5 | 0 | 0.169 | 0.254 | 0.312 | 0.352 | 0.430 | 0.465 | |
| 6 | 0 | 0.188 | 0.291 | 0.375 | 0.431 | 0.489 | 0.532 | |
4.5 the drafting of stripping curve
Utilization Electronic forms Excel software processes drug dissolution data are abscissa with the sample time, and dissolution is the stripping curve that vertical coordinate is drawn ordinary tablet and dispersible tablet respectively.See Figure:
Ordinary tablet and dispersible tablet be (first) relatively
The result: from top spectrophotography gained stripping curve as can be known, the ordinary tablet total saponins just begins stripping in the time of 5 minutes, and dispersible tablet existing 37% stripping at this moment; The ordinary tablet stripping about 37% in the time of 60 minutes, and dispersible tablet about 50%.So the stripping of total saponins, dispersible tablet is better than ordinary tablet.
Instructions of taking of the present invention is: one time 1～4, took three times in 1st.
Description of drawings:
The specific embodiment:
Embodiment 1:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, polyvinylpyrrolidone 17.44g, carboxymethyl starch sodium 10.36g, microcrystalline Cellulose 33.27g, lactose 5.20g, crospolyvinylpyrrolidone 10.25g, magnesium stearate 0.21g;
Wherein the weight proportion of Tongmai Jiangzhi dispersant tablet raw material of Chinese medicine is: Radix Scorzonerae Albicaulis 250, Radix Notoginseng 16.6, Rhizoma Chuanxiong 20, Pericarpium Zanthoxyli 5, Folium Nelumbinis 100.
Tongmai Jiangzhi dispersant tablet obtains by following concrete steps: the Folium Nelumbinis of getting Radix Notoginseng, Rhizoma Chuanxiong, Pericarpium Zanthoxyli and 1/6 was 55 ℃ of dryings 1 hour, and pulverize separately becomes fine powder A; After Radix Notoginseng powder steamed 2 hours, at 55 ℃ of dryings 3 hours, porphyrize, above medical material fine powder sterilization, standby; Radix Scorzonerae Albicaulis and remaining Folium Nelumbinis decoct with water secondary, and each 3 hours, merging filtrate was concentrated into clear paste, again clear paste was carried out precipitate with ethanol, filter, and filtrate concentrating obtains thick paste B, and the merging material of fine powder A and thick paste B is the function of invigorating circulation and reducing blood fat extract.
Get the mixture mixing of fine powder A in the function of invigorating circulation and reducing blood fat extract and polyvinylpyrrolidone, carboxymethyl starch sodium, microcrystalline Cellulose, crospolyvinylpyrrolidone, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds magnesium stearate, lactose again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 2:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, sodium carboxymethyl cellulose 13.15g, microcrystalline Cellulose 20.16g, crospolyvinylpyrrolidone 17.11g, polyvinylpyrrolidone 16.99g, lactose 3.44g, micropowder silica gel 4.31g, Stepanol MG 0.75g.All the other are with embodiment 1.
Get the mixture mixing of fine powder A in the function of invigorating circulation and reducing blood fat extract and polyvinylpyrrolidone, carboxymethyl starch sodium, microcrystalline Cellulose, crospolyvinylpyrrolidone, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds micropowder silica gel, Stepanol MG again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 3:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, crospolyvinylpyrrolidone 16.26g, low-substituted hydroxypropyl cellulose 16.63g, polyvinylpyrrolidone 11.73g, microcrystalline Cellulose 31.45g, magnesium stearate 0.59g.All the other are with embodiment 1.
Get the mixture mixing of fine powder A in the function of invigorating circulation and reducing blood fat extract and polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, crospolyvinylpyrrolidone, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds magnesium stearate again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 4:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, crospolyvinylpyrrolidone 18.43g, low-substituted hydroxypropyl cellulose 18.43g, microcrystalline Cellulose 36.86g, acesulfame potassium 1.6g, orange flavor 0.16g, magnesium stearate 0.8g.All the other are with embodiment 1.
Get fine powder A in the function of invigorating circulation and reducing blood fat extract and crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline cellulose mixt mixing, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds acesulfame potassium, orange flavor, magnesium stearate again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 5:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, crospolyvinylpyrrolidone 6.96g, low-substituted hydroxypropyl cellulose 6.96g, microcrystalline Cellulose 61.77g, acesulfame potassium 0.12g, fruit essence 0.12g, magnesium stearate 0.08g.All the other are with embodiment 1.
Get fine powder A in the function of invigorating circulation and reducing blood fat extract and crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline cellulose mixt mixing, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds acesulfame potassium, fruit essence, magnesium stearate again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 6:
Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 20.25g, crospolyvinylpyrrolidone 6.08g, microcrystalline Cellulose 10.12g, acesulfame potassium 0.37g, magnesium stearate 0.19g.Make 100, all the other are with embodiment 1.
Get fine powder A in the function of invigorating circulation and reducing blood fat extract and crospolyvinylpyrrolidone, microcrystalline cellulose mixt mixing, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds acesulfame potassium, magnesium stearate again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
Embodiment 7:
The function of invigorating circulation and reducing blood fat extract of percentage by weight and medical material fine powder 83.74g, carboxymethyl starch sodium 19.69g, polyvinylpyrrolidone 22.78g, microcrystalline Cellulose 32.65g, acesulfame potassium 0.62g, magnesium stearate 0.64g.All the other are with embodiment 1.
Embodiment 8:
The function of invigorating circulation and reducing blood fat extract of percentage by weight and medical material fine powder 83.74g, polyvinylpyrrolidone 41.62g, microcrystalline Cellulose 24.87g, acesulfame potassium 3.25g, magnesium stearate 6.64g.All the other are with embodiment 1.
The dispersible tablet made from above embodiment carries out dissolution relatively, as the data of following table 4 and table 5:
Table 4 different auxiliary material comparative test design
The different embodiment comparative test of table 5 result
All about 1 minute, faster than 3 minutes disintegrations of dispersible tablet of version pharmacopeia regulation in 2005, select embodiment 5 is priority scheme of the present invention to the disintegration time of discovery embodiment 4,5,6 far away.The present invention has improved disintegration rate greatly, helps medicine fast Absorption in vivo.
Although what adopt is the disintegrating agent of using always, different disintegrating agent combinations is variant slightly to have caused disintegration rate widely different, can't not screen the Tongmai Jiangzhi dispersant tablet that obtains rapid disintegrate in 51 seconds by a large amount of experiments.
Claims (6)
1, a kind of Tongmai Jiangzhi dispersant tablet is characterized in that: the composition of this dispersible tablet comprises function of invigorating circulation and reducing blood fat extract, adjuvant; Adjuvant comprises disintegrating agent, filler, binding agent, lubricant, correctives.
2, Tongmai Jiangzhi dispersant tablet as claimed in claim 1 is characterized in that: each constituent weight proportion is: function of invigorating circulation and reducing blood fat crude drug powder and extract 60-90 part, disintegrating agent 10-50 part, filler 0-50 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
3, Tongmai Jiangzhi dispersant tablet as claimed in claim 1 is characterized in that: each constituent weight proportion is: function of invigorating circulation and reducing blood fat crude drug powder and extract 80-85 part, disintegrating agent 30-45 part, filler 30-45 part, binding agent 0-10 part, lubricant 0-8 part, correctives 0-5 part.
4, Tongmai Jiangzhi dispersant tablet as claimed in claim 3, it is characterized in that: each constituent weight proportion is: function of invigorating circulation and reducing blood fat crude drug powder and extract 80-85 part, microcrystalline Cellulose 30-45 part, crospolyvinylpyrrolidone 12-20 part, low-substituted hydroxypropyl cellulose 12-20 part, aspartame 0.5-3 part, magnesium stearate 0.5-3 part.
5, Tongmai Jiangzhi dispersant tablet, each constituent weight proportion is: function of invigorating circulation and reducing blood fat extract 83.74g, crospolyvinylpyrrolidone 6.96g, low-substituted hydroxypropyl cellulose 6.96g, microcrystalline Cellulose 61.77g, acesulfame potassium 0.12g, fruit essence 0.12g, magnesium stearate 0.08g; Wherein the weight proportion of Tongmai Jiangzhi dispersant tablet raw material of Chinese medicine is: Radix Scorzonerae Albicaulis 250, Radix Notoginseng 16.6, Rhizoma Chuanxiong 20, Pericarpium Zanthoxyli 5, Folium Nelumbinis 100.
6, the preparation method of the described Tongmai Jiangzhi dispersant tablet of claim 5 is characterized in that: Tongmai Jiangzhi dispersant tablet obtains by following concrete steps: the Folium Nelumbinis of getting Radix Notoginseng, Rhizoma Chuanxiong, Pericarpium Zanthoxyli and 1/6 was 55 ℃ of dryings 1 hour, and pulverize separately becomes fine powder A; After Radix Notoginseng powder steamed 2 hours, at 55 ℃ of dryings 3 hours, porphyrize, above medical material fine powder sterilization, standby; Radix Scorzonerae Albicaulis and remaining Folium Nelumbinis decoct with water secondary, and each 3 hours, merging filtrate was concentrated into clear paste, again clear paste was carried out precipitate with ethanol, filter, and filtrate concentrating obtains thick paste B, and the merging material of fine powder A and thick paste B is the function of invigorating circulation and reducing blood fat extract; Get fine powder A in the function of invigorating circulation and reducing blood fat extract and crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, microcrystalline cellulose mixt mixing, cross 80 mesh sieves; Material behind the mixing is put in the appropriate containers, and the thick paste B in the adding function of invigorating circulation and reducing blood fat extract is as binding agent, and mixing is made soft material; Make wet granular, drying, granulate adds acesulfame potassium, fruit essence, magnesium stearate again, mixing, tabletting promptly gets Tongmai Jiangzhi dispersant tablet.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009005115A1 (en) * | 2007-07-03 | 2009-01-08 | Nisshin Pharma Inc. | Composition for promotion of reduction in size of adipocyte |
| CN102846806A (en) * | 2012-10-11 | 2013-01-02 | 悦康药业集团有限公司 | Vein circulation promoting and fat reducing granule and preparation method thereof |
| CN110448612A (en) * | 2019-09-05 | 2019-11-15 | 长春三德天晟科技有限公司 | A kind of intermediate preparation for the Chinese traditional medicines depressing lipid composition drug effect improving the ingredient containing Radix Notoginseng |
| CN112190557A (en) * | 2020-09-18 | 2021-01-08 | 河北君临药业有限公司 | Compound sulfamethoxazole tablets and preparation method thereof |
-
2006
- 2006-09-05 CN CNA2006101244780A patent/CN1927301A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009005115A1 (en) * | 2007-07-03 | 2009-01-08 | Nisshin Pharma Inc. | Composition for promotion of reduction in size of adipocyte |
| JPWO2009005115A1 (en) * | 2007-07-03 | 2010-08-26 | 日清ファルマ株式会社 | Composition for promoting size reduction of fat cells |
| CN102846806A (en) * | 2012-10-11 | 2013-01-02 | 悦康药业集团有限公司 | Vein circulation promoting and fat reducing granule and preparation method thereof |
| CN102846806B (en) * | 2012-10-11 | 2014-09-17 | 悦康药业集团有限公司 | Vein circulation promoting and fat reducing granule and preparation method thereof |
| CN110448612A (en) * | 2019-09-05 | 2019-11-15 | 长春三德天晟科技有限公司 | A kind of intermediate preparation for the Chinese traditional medicines depressing lipid composition drug effect improving the ingredient containing Radix Notoginseng |
| CN110448612B (en) * | 2019-09-05 | 2021-06-15 | 长春三德天晟科技有限公司 | Preparation method of intermediate for improving drug effect of lipid-lowering traditional Chinese medicine composition containing pseudo-ginseng component |
| CN112190557A (en) * | 2020-09-18 | 2021-01-08 | 河北君临药业有限公司 | Compound sulfamethoxazole tablets and preparation method thereof |
| CN112190557B (en) * | 2020-09-18 | 2022-08-09 | 河北君临药业有限公司 | Compound sulfamethoxazole tablets and preparation method thereof |
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Application publication date: 20070314 |