CN102908325B - Sevelamer carbonate medical tablet composition and preparation method thereof - Google Patents
Sevelamer carbonate medical tablet composition and preparation method thereof Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
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- A61K9/20—Pills, tablets, discs, rods
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- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention discloses a sevelamer carbonate medical tablet composition and a preparation method thereof. The tablet composition comprises the following components in parts by weight: 60-95 parts of sevelamer carbonate, 5-30 parts of crospovidone and 0.1-10.0 parts of silicon dioxide. The preparation method of the tablet composition comprises the following steps: a. sevelamer carbonate is mixed with crospovidone; b. the mixture obtained in step a is pelletized; c. silicon dioxide is mixed with the particles produced in step b to form tablets; d. the tablets obtained is film-coated by water-soluble coating materials. The tablet composition provided by the invention is characterized in that the formability is good, the rigidity is high, the disintegration is quick, and the disintegration is less affected by the rigidity.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate medicinal tablets composition and method of making the same.
Background technology
As everyone knows, End-stage Renal Disease Patients ubiquity hyperphosphatemia, and also hyperphosphatemia can cause hyperparathyroidism and osteodystrophy.Recently research finds that hyperphosphatemia still can bring out soft tissue and angiosteosis, is the key factor that End-stage Renal Disease Patients mortality rate and cardiovascular disease increase.Therefore, effectively control serum paraoxonase level and become the Important Action that reduces End-stage Renal Disease Patients mortality rate and cardiovascular disease incidence rate.The treatment of hyperphosphatemia at present mainly comprises application and the parathyroid excision if desired of diet limit phosphorus, dialysis treatment, phosphate binder.First the absorption of phosphorus in should dietary restriction, but too strict restriction can cause again malnutrition, particularly evident for dialysis patient.Fully dialysis treatment can be removed unnecessary phosphorus in body, but 3 times weekly of current extensive implementation, the hemodialysis mode of each 4h is usually not enough to remove unnecessary phosphorus in body.There is 90%～5% End-stage Renal Disease Patients need to take phosphate binder treatment hyperphosphatemia.
2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate be by Genzyme company of the U.S. former grind for the nonabsorbable ion exchange resin in conjunction with phosphoric acid, commodity are called Renvela
tM, be a kind of crosslinked polyallylamine carbonate, chemistry poly-(pi-allyl amido-altogether-N, N '-diallyl-1,3-diaminourea-2-hydroxy propane) by name carbonate, its molecular structure is similar to mesh resin structure.Structural formula is as follows:
A, the number a+b=9 that b is primary amine group
C is the number c=1 of crosslinked group
M is that a larger number represents the polymer network extending
Research is found, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate has highly hydrophilic, can in gastrointestinal tract, hydration expand into the gel that is several times as much as original volume, multiple amino that under physiological pH, it carries can be in small intestinal inner proton and positively charged, be combined with bile acid with enteral phosphate radical by ion exchange and hydrogen bond, reduce phosphate level in blood of human body.Moreover, the sevelamer hydrochloride of comparing, because the chloride ion containing is little, so can avoid renal failure patient's sour toxemia tendency.2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate treatment hyperphosphatemia has the following advantages: (1) reduces End-stage Renal Disease Patients serum paraoxonase level greatly; (2) with calcic, containing compared with aluminum phosphate binder, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate can not cause hypercalcemia or poisoning by aluminum, thereby can give the calitriol of patient's higher dosage to control better secondary hyperparathyroidism; (3) can avoid using patient to occur blood acidosis tendency.
But the compressibility of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate crude drug is poor, often hardness is low for the plain sheet of compacting, and friability is high, and the plain sheet disintegration time of compacting is also longer, cannot meet the requirement of follow-up coating process, or disintegration of tablet time limit of completing of coating can not meet the General Requirements of tablet.
Although 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate compressibility can be improved by adding more adjuvant, this technical thought is because 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate clinical dosage is compared with large and restricted.2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate clinical treatment dosage is larger, the therapeutic dose of recommending is 2.4-4.8g/ days (2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate sheet description), therefore the specification of its preparation is also corresponding larger, such as its tablet specification is 800mg/ sheet or 400mg/ sheet, the amount of adding adjuvant in the tablet of so large specification will inevitably be subject to larger restriction, otherwise can cause tablet weight and volume too greatly patient to be encountered difficulties in the time taking tablet.
Prior art is attempted the solution of the above-mentioned technical problem in the manufacture of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate tablet.The starting point that its problem solves focuses mostly in the pharmaceutical properties of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate principal agent is limited and optimized, to improve the compressibility of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate.Document CN00814607.1 points out to control in tablet within principal agent water content 3%-10%, even if add little adjuvant also can be by 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate compression forming.The ratio that document EP099714841 prompting particle diameter (is crossed 32 mesh sieves) below 500 μ m accounts for that more than 90.0% sevelamer hydrochloride uses separately or as required with specific additive and make tablet, and gained tablet has that hardness is high, phosphate-binding can excellent, disintegrate advantage rapidly.
We find by research, the solution that above-mentioned 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate compressibility is improved, and the technical scheme of controlling principal agent water content ranges can not realize the effect that it is declared; And the other technologies scheme too harsh to the restriction of principal agent or technique, to 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate raw material require highly, condition is many, uses in and inconvenient, is also not easy to industrialization and production popularization.
Summary of the invention
The object of the invention is the above-mentioned defect for prior art, a kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate medicinal tablets compositions is provided.
Another object of the present invention is to provide the preparation method of this tablet composition.
Object of the present invention can be achieved through the following technical solutions:
2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate tablet composition, the polyvinylpolypyrrolidone of the 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate that contains 60 ~ 95 weight portions, 5 ~ 30 weight portions and the silicon dioxide of 0.1 ~ 10.0 weight portion.
Described tablet composition, preferably contains 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, the polyvinylpolypyrrolidone of 5 ~ 20 weight portions and the silicon dioxide of 0.1 ~ 5.0 weight portion of 60 ~ 90 weight portions.
Described tablet composition also comprises one or more pharmaceutically acceptable lubricants.
The content of described lubricant is 0.5 ~ 5.0 weight portion preferably.
Any one in the preferred magnesium stearate of described lubricant, stearic acid, Glyceryl Behenate, PEG6000, Pulvis Talci or multiple.
The preparation method of tablet composition of the present invention, comprises the following steps:
A, use conventional method that 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate is mixed with polyvinylpolypyrrolidone;
B, by a gained granulating mixture, can be dry granulation, can be also wet granulation, add the water of approximately 6 ~ 13 weight portions, use the conventional equipment such as dry granulating machine or oscillating granulator to granulate;
C, silicon dioxide is mixed with the made granule of b, prepare plain sheet;
D, gained element sheet use water solublity coating material film coating; Described water solublity coating material is the conventional coating material in this area, can make by oneself, also can buy as required easy to be a kind of water solublity coating material of selling on market, as gastric solubility coating material;
In c step, the incorporation time of silicon dioxide and granule is between 30 seconds-360 seconds, preferably between 30 seconds-180 seconds.
Wherein, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate is 60 ~ 95 weight portions, preferably 60 ~ 90 weight portions; Polyvinylpolypyrrolidone is 5 ~ 30 weight portions, preferably 5 ~ 20 weight portions; Silicon dioxide is 0.1 ~ 10.0 weight portion, preferably 0.1 ~ 5.0 weight portion.
Beneficial effect:
The present invention finds in the time adding the pharmaceutic adjuvant polyvinylpolypyrrolidone of certain weight ratio and silicon dioxide by research, in the manufacture of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate tablet, there is beyond thought result, even if that is: 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate raw material is not done to more particular/special requirement, adopt conventional wet granulation technique or dry powder granulation technique just can obtain having and exceed 140N hardness and the 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate element sheet that is less than 1% friability, its gained element sheet can meet the technical requirement of follow-up coating process, and the obtained 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate disintegration of tablet time is not more than 10 minutes.
Detailed description of the invention
Embodiment 1,
Prepare tablet according to prescription and following technique in table 1, tablet is measured hardness and friability, is listed in the table below:
By supplementary material, except silicon dioxide, according to above proportioning wet mixing pelletizer, the mix homogeneously that adds water, with oscillating granulator 20 orders granulations, then adds silicon dioxide in granule, and mix homogeneously, is pressed into plain sheet, measures hardness and the friability of plain sheet.
Table 1
Research is found to use dissimilar adjuvant and 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate mixing granulation tabletting, only has in the time using polyvinylpolypyrrolidone to be main filler, and the hardness of plain sheet and friability can reach the basic demand of tablet.The adjuvant gained element sheet friability of other kinds all can not be less than 1% requirement.
Embodiment 2
Prepare tablet according to table 2 proportioning: 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate and polyvinylpolypyrrolidone are mixed, add purified water to mix, granulate with oscillating granulator 20 orders, granule mixes with silicon dioxide again, is pressed into plain sheet, measures hardness and the friability of plain sheet.
Table 2
Contrast and experiment shows: do not add silicon dioxide to combine use with polyvinylpolypyrrolidone, the friability of the plain sheet of preparation and hardness all can not meet the requirements; And, adding each prescription of the polyvinylpolypyrrolidone of 50-200mg and the silicon dioxide of 1-50mg, the plain sheet of preparation all can reach the requirement of friability and hardness.
Embodiment 3
Prepare tablet according to table 3 proportioning: 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate and polyvinylpolypyrrolidone are mixed; add purified water to mix, use oscillating granulator 20 orders to granulate; granule mixes with silicon dioxide, magnesium stearate, stearic acid, Glyceryl Behenate, PEG6000, Pulvis Talci etc. again; be pressed into plain sheet, measure hardness and the friability of plain sheet.
Table 3
Experimental result shows: on the prescription of basis, increase lubricant and can improve the mobility of midbody particle, and do not affect the index such as hardness and friability of plain sheet.
Embodiment 4,
Prepare tablet according to table 4 proportioning: 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate and polyvinylpolypyrrolidone are mixed; add purified water to mix, use dry granulating machine 20 orders to granulate; granule again with silicon dioxide, magnesium stearate, mix; go sample to be pressed into plain sheet in different incorporation times, measure hardness and the friability of each incorporation time element sheet.
Table 4
Find by test, incorporation time has certain influence for our plain sheet hardness and friability.The hardness that incorporation time extends plain sheet slightly declines, and friability slightly raises.And another aspect, incorporation time is too short, and principal agent 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate and adjuvant mixing can not be even, obtained tablet hardness homogeneity existing problems.Incorporation time 30-360S effect is better.
Embodiment 5:
The preparation of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate 400mg sheet, write out a prescription as shown in table 5:
Table 5
1,2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate was pulverized to 45 mesh sieves.
2,2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, polyvinylpolypyrrolidone are added and in mixer, mix 5min.
3, Jiang Shui adds, wet-mixed 5min.
4,, by granulating mixture, granule is crossed 20 orders.
5, silicon dioxide, magnesium stearate are added, mix 90S.
6, tabletting, specification 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate 400mg/ sheet, 1000 of quantity.
7, slice, thin piece is carried out to hardness, friability, disintegration time mensuration, the results are shown in Table 6.
Table 6
| Prescription | Hardness (N) | Friability (%) | Disintegration (min) |
| Prescription 20 | 230 | 0.45 | 2 |
| Prescription 21 | 212 | 0.57 | 2 |
8, coating
Coating powder consumption, calculates with 4% of plain sheet weight.
Get purified water 255ml, will
gastric solubleness coating powder 20.4g, stirs dissolving in 1 hour.
Plain sheet is added respectively in coating pan to spray coating.
Unilateral uniform and smooth, clothing film is complete.
Coating 4% left and right of increasing weight.
Embodiment 6:
The preparation of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate 800mg sheet, write out a prescription as shown in table 7:
Table 7
1,2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate was pulverized to 45 mesh sieves.
2,2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, polyvinylpolypyrrolidone are added and in mixer, mix 5min.
3, Jiang Shui adds, wet-mixed 5min.
4,, by granulating mixture, granule is crossed 20 orders.
5, silicon dioxide, magnesium stearate are added, mix 180S.
6, tabletting, specification 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate 800mg/ sheet, 1000 of quantity.
7, slice, thin piece is carried out to hardness, friability, disintegration time mensuration, the results are shown in Table 8:
Table 8
| Prescription | Hardness (N) | Friability (%) | Disintegration (min) |
| Prescription 22 | 204 | 0.68 | 2 |
| Prescription 23 | 215 | 0.61 | 2 |
8, coating
Coating powder consumption, calculates with 4% of plain sheet weight.
Get purified water 510ml, will
gastric solubleness coating powder 40.8g, stirs dissolving in 1 hour.
Plain sheet is added respectively in coating pan to spray coating.
Unilateral uniform and smooth, clothing film is complete.
Coating 4% left and right of increasing weight.
Claims (7)
1. 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate tablet composition, it is characterized in that 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate element slice prescription is made up of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, the polyvinylpolypyrrolidone of 5 ~ 30 weight portions and silicon dioxide and the water of 0.1-10.0 weight portion of 60-95 weight portion, or formed by 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, the polyvinylpolypyrrolidone of 5 ~ 30 weight portions and the silicon dioxide of 0.1-10.0 weight portion, water and one or more pharmaceutically acceptable lubricants of 60-95 weight portion.
2. tablet composition according to claim 1, is characterized in that 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate element slice prescription is made up of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate, the polyvinylpolypyrrolidone of 5 ~ 20 weight portions and silicon dioxide and the water of 0.1-5.0 weight portion of 60-90 weight portion.
3. tablet composition according to claim 1, is characterized in that the content of described lubricant is 0.5-5.0 weight portion.
4. tablet composition according to claim 3, is characterized in that described lubricant is one or more in magnesium stearate, stearic acid, Glyceryl Behenate, PEG6000, Pulvis Talci.
5. the preparation method of the tablet composition described in any one in claim 1 ~ 4, comprises the following steps:
A, use conventional method that 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate is mixed with polyvinylpolypyrrolidone,
B, add water to a gained mixture, granulate,
C, silicon dioxide is mixed with the made granule of b, prepares plain sheet,
D, gained element sheet use water solublity coating material film coating;
It is characterized in that: in c step, the incorporation time of silicon dioxide and granule is 30 seconds to 360 seconds.
6. preparation method according to claim 5, is characterized in that in c step that incorporation time is between 30 seconds-180 seconds.
7. preparation method according to claim 5, is characterized in that in prepared tablet, 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate content is 400mg/ sheet or 800mg/ sheet.
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| CN201210448975.1A CN102908325B (en) | 2012-11-12 | 2012-11-12 | Sevelamer carbonate medical tablet composition and preparation method thereof |
| PCT/CN2013/081256 WO2014071757A1 (en) | 2012-11-12 | 2013-08-12 | Sevelamer carbonate medicinal tablet composition and preparation method thereof |
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| CN201210448975.1A CN102908325B (en) | 2012-11-12 | 2012-11-12 | Sevelamer carbonate medical tablet composition and preparation method thereof |
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| CN102908325B true CN102908325B (en) | 2014-07-30 |
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Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908325B (en) * | 2012-11-12 | 2014-07-30 | 南京生命能科技开发有限公司 | Sevelamer carbonate medical tablet composition and preparation method thereof |
| CN104739786B (en) * | 2013-12-25 | 2017-08-15 | 杭州民生滨江制药有限公司 | 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate tablet and preparation method |
| CN104825406B (en) * | 2014-02-09 | 2018-04-13 | 江苏信孚药业有限公司 | Preparation process of sevelamer hydrochloride tablets |
| CN104546781A (en) * | 2014-12-22 | 2015-04-29 | 青岛正大海尔制药有限公司 | Sevelamer carbonate tablet and preparation method thereof |
| CN109715142B (en) * | 2016-06-14 | 2021-10-12 | 苏州韬略生物科技有限公司 | Sevelamer carbonate for tableting |
| CN108338975A (en) * | 2017-01-25 | 2018-07-31 | 北京泰德制药股份有限公司 | A kind of composition and preparation method thereof containing sevelamer or its pharmaceutical salts |
| CN107157947A (en) * | 2017-05-04 | 2017-09-15 | 方达医药技术（苏州）有限公司 | A kind of 2-Propen-1-amine polymer with(chloromethyl)oxirane carbonate piece and preparation method thereof |
| CN107397734B (en) * | 2017-08-24 | 2020-06-30 | 正大制药（青岛）有限公司 | Stable sevelamer carbonate tablet and preparation method thereof |
| CN108904455B (en) * | 2018-07-20 | 2021-04-02 | 汤臣倍健股份有限公司 | A method for preparing tablet containing high-dose oil ester component |
| CN110664772A (en) * | 2019-09-27 | 2020-01-10 | 方达医药技术（苏州）有限公司 | Sevelamer carbonate tablet and preparation method thereof |
| CN111773190A (en) * | 2020-06-24 | 2020-10-16 | 北京瑞迪道森医药科技有限公司 | Sevelamer carbonate tablet for improving safety of preparation and preparation method thereof |
| CN112220762B (en) * | 2020-09-07 | 2022-08-19 | 湖北华世通生物医药科技有限公司 | Sevelamer carbonate coated tablet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1382041A (en) * | 1999-10-19 | 2002-11-27 | 吉尔特药品公司 | Direct comperession polymer tablet core |
| WO2011135591A2 (en) * | 2010-04-29 | 2011-11-03 | Shasun Pharmaceuticals Limited | Novel tablet composition of polyallylamine polymers |
| CN102641251A (en) * | 2012-04-19 | 2012-08-22 | 天津太平洋制药有限公司 | Underwater-dispersible tablet of Sevelamer carbonate |
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| CN102908325B (en) * | 2012-11-12 | 2014-07-30 | 南京生命能科技开发有限公司 | Sevelamer carbonate medical tablet composition and preparation method thereof |
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- 2012-11-12 CN CN201210448975.1A patent/CN102908325B/en active Active
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1382041A (en) * | 1999-10-19 | 2002-11-27 | 吉尔特药品公司 | Direct comperession polymer tablet core |
| WO2011135591A2 (en) * | 2010-04-29 | 2011-11-03 | Shasun Pharmaceuticals Limited | Novel tablet composition of polyallylamine polymers |
| CN102641251A (en) * | 2012-04-19 | 2012-08-22 | 天津太平洋制药有限公司 | Underwater-dispersible tablet of Sevelamer carbonate |
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| WO2014071757A1 (en) | 2014-05-15 |
| CN102908325A (en) | 2013-02-06 |
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