CN1839827A - Strontium ranelate chewing tablet and its preparation process - Google Patents
Strontium ranelate chewing tablet and its preparation process Download PDFInfo
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- CN1839827A CN1839827A CN 200610054032 CN200610054032A CN1839827A CN 1839827 A CN1839827 A CN 1839827A CN 200610054032 CN200610054032 CN 200610054032 CN 200610054032 A CN200610054032 A CN 200610054032A CN 1839827 A CN1839827 A CN 1839827A
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- strontium ranelate
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Abstract
The invention relates to a chewing tablet containing strontium ranelate as the active ingredient and its preparing process, wherein the tablet comprises 10-90% of strontium ranelate, 9-80% of bulking agent, 0.1-10% of flavoring agent, 0.1-10% of glidant or lubricant, and 0-20% of moistening agent or binding agent. The chewing tablet can be used for treating and preventing osteoporosis.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, being specifically related to a kind of Strontium Ranelate (strontium ranelate) that contains is chewable tablet of active ingredient and preparation method thereof.
Background technology
Osteoporosis is a kind of metabolic disease common and that ignored by people easily.Sufferers of osteoporosis face is then sore waist and aching in the waist and the back, limbs fatigue gently, heavy can bow-backed, skeleton pain, its directly harm be that the incidence rate of fracture obviously increases.Particularly occur in fracture of femoral neck, spinal fracture and the radius far-end fracture of hip, wrist, be called as " osteoporosis three is fractured greatly ".Because women's bone loss after menopause obviously quickens, the women in 15～20 years of menolipsis might lose 30% of its whole body skeleton weight, so menopausal women is easy to suffer from women's osteosporosis after menopause disease.
Strontium Ranelate (strontium ranelate), chemical name: 3-thiophene acetic acid-5-[two (carboxymethyl) amino]-2-carboxyl-4-cyano group, strontium salt (1: 2), structural formula is seen (I).U.S. Pat 5128367 (the applying date: 1990.08.37) disclose the osteoporotic purposes of structure, preparation method and treatment of Strontium Ranelate.Strontium Ranelate is developed by French Servier company, gets permission listing in November, 2004 in Britain, is unique osteoporosis agents that promotes bone formation and suppress the double action mechanism of bone resorption that has, and can effectively treat women's osteosporosis after menopause disease.The listing dosage form is a granule, and specification is every bag and contains the 2g Strontium Ranelate.The granule dose is big, and needs boiled water to take, this just to gone out, patient in the travelling process brought inconvenience.Therefore be necessary to design that a kind of volume is less, delicately packed, mouthfeel is good, carry and the strontium ranelate chewing tablet preparation of taking convenience, for this reason, the inventor has finished the present invention through research.
Molecular formula: C12H6N208SSr2 molecular weight: 513.49
(I)
Summary of the invention
The objective of the invention is to overcome existing Strontium Ranelate granule and give and do not possess the inconvenience that patient that boiled water takes condition brings, provide that a kind of volume is less, delicately packed, mouthfeel is good, carry and the strontium ranelate chewing tablet of taking convenience and preparation method thereof.
For this reason, the technical solution used in the present invention is:
A kind of strontium ranelate chewing tablet, comprise following component: weight ratio is 10～90% principal agent Strontium Ranelate, weight ratio is 9～80% filler, weight ratio is 0.1～10% correctives, weight ratio is 0.01～10% fluidizer or lubricant, and weight ratio is 0～20% wetting agent or binding agent.Correctives wherein is in order to improve the mouthfeel of tablet.In addition, can add weight ratio as required is that 0～10% disintegrating agent, weight ratio are 0～1% coloring agent.
Strontium ranelate chewing tablet of the present invention can select every to contain principal agent Strontium Ranelate 0.5～2g, preferentially selects 1g.
Described filler is selected from following one or more: starch, lactose, amylum pregelatinisatum, dextrin, mannitol, xylitol, erithritol, sorbitol, microcrystalline Cellulose, glucose, wherein preferred lactose and mannitol are filler, preferred especially lactose.
Described correctives is in order to improve the mouthfeel of tablet, increase patient's the compliance of taking, can be selected from following one or more: sodium cyclamate, aspartame, glycyrrhizin, sweetleaf centautin, saccharin sodium, sucrose, lactose, fructose, Mel, vitamin C, citric acid, menthol, various milk flavor, fruity essence spice, wherein preferred especially aspartame.
Described fluidizer or lubricant are in order to increase drug flow or lubricate in the tabletting process, can be selected from following one or more: stearic acid, magnesium stearate, calcium stearate, zinc stearate, Polyethylene Glycol, Pulvis Talci, micropowder silica gel, sodium lauryl sulphate, Stepanol MG, wherein preferred micropowder silica gel and magnesium stearate, preferred especially magnesium stearate.
Wetting agent in the prescription or binding agent are selected from following one or more: water, ethanol, gelling starch, sodium carboxymethyl cellulose, polyvinylpyrrolidone, hypromellose, starch slurry, dextrin slurry, wherein preferably polyethylene ketopyrrolidine and hypromellose.
In addition, also can consider to add a certain amount of disintegrating agent, perhaps, add a certain amount of coloring agent in order to improve the outward appearance of this product.
Strontium ranelate chewing tablet described here can be common disk, also can be the special-shaped sheet of different shape, as capsule shape, ellipse, rhombus etc.
Become described strontium ranelate chewing tablet in the preparation, can carry out according to following steps:
(1) supplementary material sieves respectively;
(2) with direct compression behind Strontium Ranelate, filler, correctives mix homogeneously: a. adding fluidizer or the lubricant, perhaps b. adds binding agent or/and wetting agent is made soft material, granulates, 30～100 ℃ of dryings, granulate adds fluidizer or lubricant, then tabletting again.
As adding disintegrating agent, can be chosen in the step (2) and add, particularly, can take interior addition, outer addition adds inside and outside perhaps etc. together.
As adding coloring agent, can be chosen in adding in the step (2), also can behind tabletting, carry out coating to slice, thin piece, coloring agent adds in coating solution.
Strontium ranelate chewing tablet mouthfeel of the present invention is good, chews and takes, and need not use water delivery service, has effectively reduced packaging volume, even to going out and the patient that travels also is easy to carry, is convenient to take.Described strontium ranelate chewing tablet preparation method is stablized feasible, and preparation technology is simple, controllable product quality.
Strontium ranelate chewing tablet of the present invention is used for prevention and treatment osteoporosis, and obey once every day, and principal agent is 2 of the each clothes of the sheet of 1g; Principal agent is 4 of the each clothes of 0.5 sheet.
By way of example
Following embodiment is used for explanation and further explains the present invention but never limit the present invention.
Embodiment 1
Prescription:
Strontium Ranelate 1000g
Mannitol 500g
Aspartame 30g
10% starch slurry is an amount of
Orange flavor 50g
Magnesium stearate 15g
Make 1000
The supplementary material that takes by weighing above-mentioned recipe quantity is crossed 100 mesh sieves respectively, and it is standby starch to be mixed with 10% starch slurry; With Strontium Ranelate, mannitol, aspartame mix homogeneously, add an amount of 10% starch slurry and make soft material, to cross 20 mesh sieves and granulate, 60～80 ℃ of dryings are crossed 20 mesh sieve granulate then.Dry granular is sneaked into orange flavor and magnesium stearate, and mix homogeneously is pressed into the capsule shape slice, thin piece then.
Embodiment 2
Prescription:
Strontium Ranelate 1000g
Lactose 500g
Glycyrrhizin 30g
Sodium cyclamate 15
5% polyvinylpyrrolidone, 50% alcoholic solution is an amount of
Apple essence 50g
Pulvis Talci 20g
Make 1000
The supplementary material that takes by weighing above-mentioned recipe quantity is crossed 100 mesh sieves respectively, polyvinylpyrrolidone is mixed with 5% solution for standby with 50% ethanol; With Strontium Ranelate, lactose, glycyrrhizin, sodium cyclamate mix homogeneously, add an amount of 5% polyvinylpyrrolidone, 50% alcoholic solution and make soft material, to cross 20 mesh sieves and granulate, 60～80 ℃ of dryings are crossed 20 mesh sieve granulate then.Dry granular is sneaked into apple essence and Pulvis Talci, and mix homogeneously is pressed into oval slice, thin piece then.
Embodiment 3
Prescription:
Strontium Ranelate 1000g
Amylum pregelatinisatum 170g
Microcrystalline Cellulose 100g
Xylitol 200g
Sweetleaf centautin 30g
Strawberry essence 50g
Magnesium stearate 20g
Monascorubin 30g
Make 1000
Take by weighing the supplementary material of above-mentioned recipe quantity, cross 100 mesh sieves respectively, with Strontium Ranelate, amylum pregelatinisatum, microcrystalline Cellulose, xylitol, sweetleaf centautin, strawberry essence mix homogeneously,, directly suppress into about 1.6g heavy heart-shaped slice, thin piece then again with magnesium stearate and monascorubin mix homogeneously.
Embodiment 4
Prescription:
Strontium Ranelate 1000g
Lactose 200g
Sorbitol 200g
Aspartame 30g
Carboxymethyl starch sodium 80g
5% hypromellose solution is an amount of
Honey peach essence 50g
Magnesium stearate 20g
Make 1000
Take by weighing the supplementary material of above-mentioned recipe quantity, cross 100 mesh sieves respectively, and prepare 5% hypromellose solution for standby; With Strontium Ranelate, lactose, sorbitol, aspartame, carboxymethyl starch sodium mix homogeneously, add an amount of 5% hypromellose solution and make soft material, to cross 20 mesh sieves and granulate, 60～80 ℃ of dryings are crossed 20 mesh sieve granulate then.Dry granular is sneaked into honey peach essence and magnesium stearate, and mix homogeneously is pressed into oval slice, thin piece then.
Embodiment 5
Prescription:
Strontium Ranelate 500g
Lactose 250g
Microcrystalline Cellulose 100g
Aspartame 20g
5% polyvinylpyrrolidone, 50% alcoholic solution is an amount of
Milk flavour 20g
Magnesium stearate 10g
Make 1000
Take by weighing above-mentioned recipe quantity supplementary material and cross 100 mesh sieves respectively, and it is standby to prepare 5% polyvinylpyrrolidone, 50% alcoholic solution; With Strontium Ranelate, lactose, microcrystalline Cellulose, aspartame mix homogeneously, add an amount of 5% polyvinylpyrrolidone, 50% alcoholic solution and make soft material, to cross 20 mesh sieves and granulate, 60～80 ℃ of dryings are crossed 20 mesh sieve granulate then.Dry granular is sneaked into milk flavour and magnesium stearate, and mix homogeneously is pressed into the rhombus slice, thin piece then.
Claims (11)
1, a kind of strontium ranelate chewing tablet is characterized in that said strontium ranelate chewing tablet comprises:
Weight ratio is 10～90% principal agent Strontium Ranelate,
Weight ratio is 9～80% filler,
Weight ratio is 0.1～10% correctives,
Weight ratio be 0.1～10% fluidizer or lubricant and
Weight ratio is 0～20% wetting agent or binding agent.
2, strontium ranelate chewing tablet is arranged according to claim 1, it is characterized in that also containing in the described chewable tablet disintegrating agent that weight ratio is 0-10%.
3, strontium ranelate chewing tablet as claimed in claim 1 or 2 is characterized in that also containing in the described chewable tablet coloring agent that weight ratio is 0-1%.
4,, it is characterized in that described filler is selected from following one or more: starch, lactose, amylum pregelatinisatum, dextrin, mannitol, xylitol, erithritol, sorbitol, microcrystalline Cellulose and glucose as claim 1,2 or 3 described strontium ranelate chewing tablets.
5, as claim 1,2 or 3 described strontium ranelate chewing tablets, it is characterized in that described correctives is selected from following one or more: sodium cyclamate, aspartame, glycyrrhizin, sweetleaf centautin, saccharin sodium, sucrose, lactose, fructose, Mel, vitamin C, citric acid, menthol, various milk flavor and fruity essence spice.
6,, it is characterized in that described fluidizer or lubricant are selected from following one or more: stearic acid, magnesium stearate, calcium stearate, zinc stearate, Polyethylene Glycol, Pulvis Talci, micropowder silica gel, sodium lauryl sulphate and Stepanol MG as claim 1,2 or 3 described strontium ranelate chewing tablets.
7, as claim 1,2 or 3 described strontium ranelate chewing tablets, it is characterized in that described wetting agent or binding agent are selected from following one or more: water, ethanol, gelling starch, sodium carboxymethyl cellulose, polyvinylpyrrolidone, hypromellose, starch slurry and dextrin slurry.
8, a kind of preparation is as the method for claim 1,2 or 3 described strontium ranelate chewing tablets, it is characterized in that described method operates according to following steps:
(1) takes by weighing supplementary material, sieve respectively;
(2) with direct compression behind Strontium Ranelate, filler, correctives mix homogeneously: a. adding fluidizer or the lubricant, perhaps b. adding binding agent is made soft material, granulate, and 30～100 ℃ of dryings, granulate adds fluidizer or lubricant, then tabletting again.
9, as preparing the method for strontium ranelate chewing tablet as described in the claim 8, it is characterized in that also can adding disintegrating agent in the step (2).
10, the method for preparing strontium ranelate chewing tablet as claimed in claim 8 or 9 also can add coloring agent when it is characterized in that adding correctives in step (2).
11, the method for preparing strontium ranelate chewing tablet as claimed in claim 8 or 9 is characterized in that carrying out coating again behind the tabletting, and coloring agent adds when coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610054032 CN1839827A (en) | 2006-01-16 | 2006-01-16 | Strontium ranelate chewing tablet and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610054032 CN1839827A (en) | 2006-01-16 | 2006-01-16 | Strontium ranelate chewing tablet and its preparation process |
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| CN1839827A true CN1839827A (en) | 2006-10-04 |
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| CN 200610054032 Pending CN1839827A (en) | 2006-01-16 | 2006-01-16 | Strontium ranelate chewing tablet and its preparation process |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101229154B (en) * | 2007-01-26 | 2010-05-12 | 鲁南制药集团股份有限公司 | Medicine compounds for treating osteoporosis |
| CN101204375B (en) * | 2006-12-19 | 2010-09-29 | 北京德众万全药物技术开发有限公司 | Strontium ranelate dry suspension |
| CN101292977B (en) * | 2007-04-28 | 2010-12-08 | 天津药物研究院 | Pharmaceutical combination with stable strontium ranelate and its preparations |
| CN102367247A (en) * | 2011-09-20 | 2012-03-07 | 浙江华海药业股份有限公司 | Method for preparing high purity good stability strontium ranelate |
| CN102391247A (en) * | 2011-09-20 | 2012-03-28 | 浙江华海药业股份有限公司 | Crystalline form K of strontium ranelate hydrate and preparation method thereof |
| CN102525975A (en) * | 2011-12-14 | 2012-07-04 | 天津药物研究院药业有限责任公司 | Strontium ranelate orally disintegrating tablets and preparation method thereof |
| CN102697793A (en) * | 2012-06-11 | 2012-10-03 | 中国人民解放军第四军医大学 | Medicament for inhibiting oral bacterial plaque and preparation method thereof |
| CN102791700A (en) * | 2010-03-05 | 2012-11-21 | 凯梅莱克蒂瓦有限责任公司 | Process for the preparation of a polymorph of strontium ranelate |
| CN103262974A (en) * | 2013-06-03 | 2013-08-28 | 浙江中赢方舟生物工程股份有限公司 | Medlar polysaccharide chewable tablet and preparation method thereof |
| EP2756841A1 (en) | 2013-01-21 | 2014-07-23 | Galenicum Health S.L. | Pharmaceutical compositions comprising an acid salt |
| CN102367247B (en) * | 2011-09-20 | 2016-12-14 | 浙江华海药业股份有限公司 | A kind of method of preparing high purity good stability strontium ranelate |
| CN106344928A (en) * | 2016-08-31 | 2017-01-25 | 安徽逸能生物科技有限公司 | Application of modified starch in medicine |
-
2006
- 2006-01-16 CN CN 200610054032 patent/CN1839827A/en active Pending
Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204375B (en) * | 2006-12-19 | 2010-09-29 | 北京德众万全药物技术开发有限公司 | Strontium ranelate dry suspension |
| CN101229154B (en) * | 2007-01-26 | 2010-05-12 | 鲁南制药集团股份有限公司 | Medicine compounds for treating osteoporosis |
| CN101292977B (en) * | 2007-04-28 | 2010-12-08 | 天津药物研究院 | Pharmaceutical combination with stable strontium ranelate and its preparations |
| CN102791700A (en) * | 2010-03-05 | 2012-11-21 | 凯梅莱克蒂瓦有限责任公司 | Process for the preparation of a polymorph of strontium ranelate |
| CN102367247B (en) * | 2011-09-20 | 2016-12-14 | 浙江华海药业股份有限公司 | A kind of method of preparing high purity good stability strontium ranelate |
| CN102367247A (en) * | 2011-09-20 | 2012-03-07 | 浙江华海药业股份有限公司 | Method for preparing high purity good stability strontium ranelate |
| CN102391247A (en) * | 2011-09-20 | 2012-03-28 | 浙江华海药业股份有限公司 | Crystalline form K of strontium ranelate hydrate and preparation method thereof |
| CN102391247B (en) * | 2011-09-20 | 2016-12-28 | 浙江华海药业股份有限公司 | A kind of Strontium Ranelate hydrated crystalline form K and preparation method thereof |
| CN102525975A (en) * | 2011-12-14 | 2012-07-04 | 天津药物研究院药业有限责任公司 | Strontium ranelate orally disintegrating tablets and preparation method thereof |
| CN102525975B (en) * | 2011-12-14 | 2013-06-19 | 天津药物研究院药业有限责任公司 | Strontium ranelate orally disintegrating tablets and preparation method thereof |
| CN102697793A (en) * | 2012-06-11 | 2012-10-03 | 中国人民解放军第四军医大学 | Medicament for inhibiting oral bacterial plaque and preparation method thereof |
| EP2756841A1 (en) | 2013-01-21 | 2014-07-23 | Galenicum Health S.L. | Pharmaceutical compositions comprising an acid salt |
| CN103262974B (en) * | 2013-06-03 | 2015-07-29 | 杭州中赢科技集团有限公司 | A kind of medlar polysaccharide chewable tablet and preparation method thereof |
| CN103262974A (en) * | 2013-06-03 | 2013-08-28 | 浙江中赢方舟生物工程股份有限公司 | Medlar polysaccharide chewable tablet and preparation method thereof |
| CN106344928A (en) * | 2016-08-31 | 2017-01-25 | 安徽逸能生物科技有限公司 | Application of modified starch in medicine |
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