CN1823764A - Medicinal composition containing strontium fuminate and vitamin D - Google Patents
Medicinal composition containing strontium fuminate and vitamin D Download PDFInfo
- Publication number
- CN1823764A CN1823764A CN 200610054163 CN200610054163A CN1823764A CN 1823764 A CN1823764 A CN 1823764A CN 200610054163 CN200610054163 CN 200610054163 CN 200610054163 A CN200610054163 A CN 200610054163A CN 1823764 A CN1823764 A CN 1823764A
- Authority
- CN
- China
- Prior art keywords
- vitamin
- strontium ranelate
- pharmaceutical composition
- hydrate
- strontium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 235000019202 steviosides Nutrition 0.000 description 1
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- 229910000018 strontium carbonate Inorganic materials 0.000 description 1
- 229910001631 strontium chloride Inorganic materials 0.000 description 1
- AHBGXTDRMVNFER-UHFFFAOYSA-L strontium dichloride Chemical compound [Cl-].[Cl-].[Sr+2] AHBGXTDRMVNFER-UHFFFAOYSA-L 0.000 description 1
- VUWAXXIHYHUOJV-ODZAUARKSA-L strontium;(z)-but-2-enedioate Chemical compound [Sr+2].[O-]C(=O)\C=C/C([O-])=O VUWAXXIHYHUOJV-ODZAUARKSA-L 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229960004793 sucrose Drugs 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 210000000707 wrist Anatomy 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A composite medicine and its packed composition for treating the osteoporosis of the woman after manopause contains strontium ranelate or its hydrate, VD and pharmacologically acceptable additives proportionally.
Description
Technical field
The invention belongs to the drug compound preparation field, be specifically related to a kind of pharmaceutical composition and composite packaging compositions thereof that contains strontium ranelate (strontium ranelate) and vitamin D.The present invention provides enough vitamin D nutritional supplementation for the patient in women's osteosporosis after menopause disease.
Background technology
Osteoporosis is a kind of common and ignored by people easily, be to decrease with osseous tissue microstructure hands, bone ore deposit composition and bone matrix equal proportion ground constantly reduce the sclerotin attenuation, bone trabecula quantity reduces, the disease of a kind of whole body dysostosis that increase of bone fragility and risk of fractures degree raise.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.According to international osteoporosis foundation report, the whole world has 200,000,000 women to suffer from osteoporosis, and it is 1/3 ill that 60-70 year women has, and the women then has 2/3 illly more than 80 years old, surpasses that 50 years old women can suffer once all one's life or more times vertebral fracture person accounts for 30% the age.Though the elderly men osteoporosis incidence will be lower than with the age bracket women, in a single day fracture of femoral neck takes place in elderly men, and mortality rate will be much higher than the women.
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.Being developed by French Servier company, get 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.
Molecular formula: C
12H
6N
2O
8SSr
2Molecular weight: 513.49
(I)
It is vitamin D2 and vitamin D3 that vitamin D has two kinds of important chemical compounds, itself inanimate object activity, but it can generate the calcitriol (1,25-(OH) 2D3) of biologically active in vivo after a series of catalysis.Vitamin D can promote the absorption of small intestinal to calcium, and its metabolic activity thing promotes that renal tubules heavily absorbs phosphorus and calcium, increasing blood calcium, and serium inorganic phosphorus concentration, or keep and regulate plasma calcium phosphorus normal concentration, promote the skeleton calcification.Therefore, when using estrogen antagonist and diphosphonic acid salt Drug therapy osteoporosis, all require to augment vitamin D, and then develop their compound preparation or composite packaging product, as the alendronate of Merck ﹠ Co., Inc.'s listing and the compound tablet of vitamin D.PCT applies for a patent WO2006000224 and discloses organic acid and the strontium salt of mineral acid and the compound preparations of vitamin such as strontium chloride, strontium carbonate, strontium maleate, but does not mention the compound preparation of strontium ranelate and vitamin D.
Equally, during strontium ranelate treatment menopausal women osteoporosis, also require to augment vitamin.D.P.J.Emmanuel etc. (journal of endocrinol.metab.87:2026-2066,2002) treat in the process of osteoporotic curative effect at the research evaluation strontium ranelate, also clearly augment vitamin D and calcium.In the prescription operation instructions of the strontium ranelate granule (Protelos) of European medicine evaluation administration (EMEA) approval listing, disclose strontium ranelate and do not had drug interaction with vitamin D while administration.
When using strontium ranelate treatment menopausal women osteoporosis, the inhibition of bone resorption is caused the slight decline of blood calcium concentration, this patient at vitamin d insufficiency is more outstanding.Therefore when treating, advise vitamin D Can and calcium with strontium ranelate.But take vitamin D when taking strontium ranelate in addition again, instructions of taking is comparatively complicated, is forgotten by the patient easily again, and this has brought very big inconvenience to the patient, and compliance reduces greatly.Therefore want for making things convenient for the patient to obey, improve compliance, be necessary for the patient a kind of pharmaceutical composition that contains strontium ranelate and vitamin D simultaneously is provided, perhaps strontium ranelate and vitamin D are formed composite packaging, for this reason, the inventor has finished the present invention through research.
Summary of the invention
The objective of the invention is to conveniently take the patient that strontium ranelate needs vitamin D Can simultaneously, for it provides a kind of pharmaceutical composition that contains strontium ranelate and vitamin D.
The technical solution used in the present invention is as follows:
A kind of pharmaceutical composition that contains strontium ranelate and vitamin D, said composition is to comprise strontium ranelate or its hydrate, vitamin D and the compound preparation of the adjuvant pharmaceutically accepted, perhaps is the composite packaging of strontium ranelate or its hydrate list component preparation and vitamin D list component preparation.The hydrate of strontium ranelate can be 4 water, 7 water, 8 water, 9 hydrates.
Vitamin D in the pharmaceutical composition of the present invention can be vitamin D2 or vitamin D3.Preferred vitamin D3 wherein.
The compound preparation that strontium ranelate in the pharmaceutical composition of the present invention or its hydrate, vitamin D and the adjuvant of pharmaceutically accepting are formed can be oral formulations such as tablet, capsule, granule, chewable tablet, oral cavity disintegration tablet, oral solution, syrup, suspensoid, effervescent tablet, powder.Preferred particulates agent, chewable tablet, tablet, capsule, suspensoid, powder; More preferably granule, chewable tablet.
Pharmaceutical composition of the present invention, every single agent contain the strontium ranelate or the hydrate 0.5～3g of effective therapeutic dose, preferred 1-2g, contain vitamin D1 00～1000IU, the content of vitamin D is preferably 400-800IU, and wherein, the content of strontium ranelate hydrate is in strontium ranelate weight.
In the pharmaceutical composition of the present invention except that containing strontium ranelate and vitamin D, also contain acceptable accessories, as filler, disintegrating agent, correctives, wetting agent or binding agent, lubricant or fluidizer, suspensoid, cosolvent or solubilizing agent etc., but according to the needs combination in any of different dosage form.Optional in following chemical compound one or more of filler: starch, pregelatinized Starch, lactose, sugar, microcrystalline Cellulose, mannitol and sorbitol, optional in following chemical compound one or more of disintegrating agent: dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone etc., optional in following chemical compound one or more of wetting agent and binding agent: water, ethanol, methylcellulose, sodium carboxymethyl cellulose, polyvidone, hyprolose, hypromellose etc., lubricant is a magnesium stearate, Pulvis Talci or its mixture, correctives can be selected edible or medicinal essence, sucrose, saccharin sodium, aspartame, stevioside or its mixture.
Pharmaceutical composition of the present invention, by the difference of its dosage form, the routine techniques of employing corresponding dosage forms prepares and gets.As granule, with strontium ranelate and the above-mentioned suitable filler of vitamin D, add above-mentioned suitable disintegrants in case of necessity or/and the correctives mixing, add an amount of water again or other binding agent is made soft material, to granulate then, drying is sieved, and in dress generation, is promptly.As chewable tablet, can get by the conventional method preparation of preparation tablets.
Pharmaceutical composition of the present invention also relates to the composite packaging of strontium ranelate or its hydrate list component preparation and vitamin D list component preparation, and wherein said strontium ranelate list component preparation can be granule, chewable tablet or capsule, and every single agent contains strontium ranelate 0.5-2g; Vitamin D list component preparation can be respectively soft gelatin capsule, soft capsule or tablet, and every single agent contains vitamin D2 or D3400-800IU or alfacalcidol 0.5-1.0ug.
Above-mentioned said composite packaging compositions, wherein vitamin D can be vitamin D2, vitamin D3 or alfacalcidol, wherein, vitamin D2 is soft gelatin capsule or tablet; Vitamin D3 is a tablet; Alfacalcidol is tablet and soft gelatin capsule, and specification is 0.5ug or 1.0ug.
Pharmaceutical composition of the present invention, through testing its stability by the Chinese Pharmacopoeia stability testing method, the result proves that compositions of the present invention is stable, strontium ranelate and vitamin D its stability that is independent of each other.
Pharmaceutical composition of the present invention makes the patient at the strontium ranelate of taking effective dose simultaneously, has replenished the vitamin D of effective dose, is very easy to patient's medication.Vitamin D can not influence the bioavailability of strontium ranelate, on the contrary, it can promote the absorption of small intestinal to calcium effectively, and its metabolic activity thing promotes that renal tubules heavily absorbs phosphorus and calcium, increasing blood calcium, serium inorganic phosphorus concentration, or keep and regulate plasma calcium phosphorus normal concentration, and promote the skeleton calcification, help normal bone formation, reduce the generation of the potential complication that causes owing to vitamin d insufficiency, thereby in treatment menopausal women osteoporosis, play positive role.
Pharmaceutical composition of the present invention is used for the treatment of the menopausal women osteoporosis.
By way of example
Following embodiment is used for explanation and further explains the present invention but never limit the present invention.
Embodiment 1---compound recipe strontium ranelate vitamin D chewable tablet
Strontium ranelate 1000g
Vitamin D3 200,000 IU
Mannitol 500g
Aspartame 30g
10% starch slurry is an amount of
Orange flavor 50g
Micropowder silica gel 10g
Make 1000
Above-mentioned recipe quantity strontium ranelate, vitamin D3, mannitol and the aspartame equivalent method mix homogeneously that progressively increases, 10% starch slurry are made soft material after granulate, dry granular, and granulate, again with essence and micropowder silica gel mix homogeneously, compacting is in flakes then.
Use: the above-mentioned pharmaceutical composition that obtains is applied to treat postmenopausal osteoporosis, reduces the risk of vertebra and hip fracture.Chew oral, one day 1 time, one time 2, be preferably in the feed two hours after, take before sleeping.
Embodiment 2---compound recipe strontium ranelate vitamin D granule
Strontium ranelate 2000g
Vitamin D3 800,000 IU
Mannitol 1200g
Dextrin 400
Aspartame 35g
Make 1000 bags
Behind the above-mentioned recipe quantity supplementary material mix homogeneously, granulate with water or 20% alcoholic solution, dry granular, granulate, sub-sieve becomes the suitably granule of size again, is distributed into bag.
Use: the above-mentioned pharmaceutical composition that obtains is applied to treat postmenopausal osteoporosis, reduces the risk of vertebra and hip fracture.Oral, one day 1 time, one time 1 bag, be preferably in the feed two hours after, take before sleeping.Every bag of suspendible of blunging before using is taken then.
Embodiment 3---the composite packaging of strontium ranelate list component preparation and vitamin D list component preparation
(1) preparation of strontium ranelate chewable tablet
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
Above-mentioned recipe quantity strontium ranelate, lactose, glycyrrhizin and sodium cyclamate mix homogeneously, 5% polyvinylpyrrolidone, 50% alcoholic solution are made soft material after granulate, dry granular, and granulate, again with apple essence and Pulvis Talci mix homogeneously, compacting is in flakes then.
(2) the particulate preparation of strontium ranelate
Strontium ranelate 2000g
Mannitol 1200g
Dextrin 400
Aspartame 35g
Make 1000 bags
Behind the above-mentioned recipe quantity supplementary material mix homogeneously, granulate with water or 20% alcoholic solution, dry granular, granulate, sub-sieve becomes the suitably granule of size again, is distributed into bag.
(3) preparation of vitamin D soft gelatin capsule
Vitamin D2 or D3 400,000 IU
Vegetable oil is an amount of
100 parts in gelatin
60 parts of glycerol
120 parts in water
Make 1000
Vitamin D2 or D3 dissolve with vegetable oil, and adjust concentration; G ﹠ W is mixed in proportion and is heated to about 70 degree, stirs and dissolves in gelatin; With the liquid paraffin is that the cooling drop is made ball, washing, oven dry.
(4) preparation of vitamin D sheet
Vitamin D3 400,000 IU
Mannitol 40g
Microcrystalline Cellulose 25g
Sodium carboxymethyl cellulose 10g
The polyvidone alcoholic solution is an amount of
Micropowder silica gel 4g
Sodium lauryl sulphate 1g
Make 1000
Above-mentioned recipe quantity vitamin D3, mannitol, microcrystalline Cellulose and the sodium carboxymethyl cellulose equivalent method mix homogeneously that progressively increases, with the polyvidone alcoholic solution as binding agent system soft material, admixed finepowder silica gel and sodium lauryl sulphate behind granulation, dry granular and granulate, compacting in flakes then.
(5) the capsular preparation of vitamin D
Vitamin D3 400,000 IU
Mannitol 80g
Microcrystalline Cellulose 40g
Sodium carboxymethyl cellulose 20g
The polyvidone alcoholic solution is an amount of
Make 1000
Above-mentioned recipe quantity vitamin D3, mannitol, microcrystalline Cellulose and the sodium carboxymethyl cellulose equivalent method mix homogeneously that progressively increases, incapsulates behind granulation, dry granular and granulate as binding agent system soft material with the polyvidone alcoholic solution.
(5) composite packaging
According to (1) 14+(3) 7, (1) 14+(4) 7, (1) 14+(5) 7, (2) 7 bags+(3) 7, (2) 7 bags+(4) 7, (2) 7 bags+(5) 7 assembly packagings together, promptly get the weekly dose pharmaceutical composition, take the pharmaceutical composition that contains 2g strontium ranelate and 400IU vitamin D every day.
According to (1) 14+(3) 14, (1) 14+(4) 14, (1) 14+(5) 14, (2) 7 bags+(3) 14, (2) 7 bags+(4) 14, (2) 7 bags+(5) 14 assembly packagings together, promptly get the weekly dose pharmaceutical composition, take the pharmaceutical composition that contains 2g strontium ranelate and 800IU vitamin D every day.
Embodiment 4: strontium ranelate and vitamin D compound preparation stability study
With embodiment 1 and embodiment 2 samples is the stability study that example has been carried out strontium ranelate and vitamin D compound preparation.
Sample after placing 5 days, 10 days under 60 ℃ of high temperature, the illumination condition, the sample character, related substance and content evenly do not have significant change.
Accelerated test 6 months, each index of sample does not have significant change yet.
The result has shown that strontium ranelate and vitamin D do not have interaction, the compound preparation steady quality that both form.Verified also simultaneously that strontium ranelate granule description is described and taken no mutual function influence simultaneously with vitamin D.
Claims (10)
1, the pharmaceutical composition of a kind of treatment or prevention of osteoporosis comprises strontium ranelate or its hydrate, vitamin D and the acceptable accessories of effective therapeutic dose, and wherein, every single agent contains strontium ranelate 0.5-3g, vitamin D1 00-1000IU.
2, the described pharmaceutical composition of claim 1, the content of wherein said every single agent strontium ranelate is 1-2g.
3, the described pharmaceutical composition of claim 1, the content of wherein said every single agent vitamin D is 400-800IU.
4, the described pharmaceutical composition of claim 1, wherein said vitamin D is vitamin D2 or vitamin D3.
5, the described pharmaceutical composition of claim 4, wherein said vitamin D is a vitamin D3.
6, the arbitrary described pharmaceutical composition of claim 1-5, its dosage form can be tablet, capsule, granule, chewable tablet, suspensoid or powder.
7, the described compositions of claim 6, its dosage form is granule or chewable tablet.
8, the composite packaging compositions of a kind of treatment or prevention of osteoporosis, form by strontium ranelate or its hydrate and vitamin D or derivatives thereof, it is characterized in that: strontium ranelate or its hydrate and vitamin D or derivatives thereof are independently single component preparation separately, exist with the composite packaging form, wherein, every single agent strontium ranelate preparation contains strontium ranelate 1-2g; Every single agent vitamin D contain vitamin D4 00-800IU.
9, the described composite packaging compositions of claim 8, wherein, said single component preparation, strontium ranelate or its hydrate are granule or chewable tablet, vitamin D or derivant be soft gelatin capsule or.
10, the described composite packaging compositions of claim 9, said vitamin D is vitamin D2, vitamin D3 or alfacalcidol.
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| CN 200610054163 CN1823764A (en) | 2006-03-27 | 2006-03-27 | Medicinal composition containing strontium fuminate and vitamin D |
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| CN 200610054163 CN1823764A (en) | 2006-03-27 | 2006-03-27 | Medicinal composition containing strontium fuminate and vitamin D |
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Cited By (7)
| 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 |
| CN102078620A (en) * | 2009-11-27 | 2011-06-01 | 瑟维尔实验室 | Pharmaceutical composition comprising a strontium salt, vitamine d and a cyclodextrine |
| CN102626420A (en) * | 2012-04-13 | 2012-08-08 | 深圳大学 | Mixed preparation containing strontium, calcium and vitamin D |
| CN103142623A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Calcitriol and strontium ranelate suspension granule and preparation method thereof |
| CN108840811A (en) * | 2018-07-12 | 2018-11-20 | 临沂友康生物科技有限公司 | The method that vegetable oil extracts calciferol in mushroom powder |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| EP2335704A1 (en) | 2009-11-27 | 2011-06-22 | Les Laboratoires Servier | Pharmaceutical composition comprising a strontium salt, vitamine D and a cyclodextrine |
| FR2953139A1 (en) * | 2009-11-27 | 2011-06-03 | Servier Lab | PHARMACEUTICAL COMPOSITION COMPRISING STRONTIUM SALT, VITAMIN D AND CYCLODEXTRIN |
| WO2011064474A1 (en) | 2009-11-27 | 2011-06-03 | Les Laboratoires Servier | Pharmaceutical composition containing strontium salt, vitamin d, and cyclodextrin |
| JP2011111458A (en) * | 2009-11-27 | 2011-06-09 | Lab Servier | Pharmaceutical composition comprising strontium salt, vitamin d and cyclodextrin |
| CN102078620A (en) * | 2009-11-27 | 2011-06-01 | 瑟维尔实验室 | Pharmaceutical composition comprising a strontium salt, vitamine d and a cyclodextrine |
| CN102626420A (en) * | 2012-04-13 | 2012-08-08 | 深圳大学 | Mixed preparation containing strontium, calcium and vitamin D |
| CN102626420B (en) * | 2012-04-13 | 2014-06-25 | 深圳大学 | Mixed preparation containing strontium, calcium and vitamin D |
| CN103142623A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Calcitriol and strontium ranelate suspension granule and preparation method thereof |
| CN103142623B (en) * | 2013-03-21 | 2014-04-16 | 青岛正大海尔制药有限公司 | Calcitriol and strontium ranelate suspension granule and preparation method thereof |
| CN108840811A (en) * | 2018-07-12 | 2018-11-20 | 临沂友康生物科技有限公司 | The method that vegetable oil extracts calciferol in mushroom powder |
| CN110613696A (en) * | 2019-10-24 | 2019-12-27 | 人福普克药业（武汉）有限公司 | Ergocalciferol capsule and preparation method thereof |
| CN110613696B (en) * | 2019-10-24 | 2022-04-22 | 人福普克药业（武汉）有限公司 | Ergocalciferol capsule and preparation method thereof |
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