CN101229177A - Medicine compounds for treating osteoporosis - Google Patents
Medicine compounds for treating osteoporosis Download PDFInfo
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- CN101229177A CN101229177A CNA2007100026726A CN200710002672A CN101229177A CN 101229177 A CN101229177 A CN 101229177A CN A2007100026726 A CNA2007100026726 A CN A2007100026726A CN 200710002672 A CN200710002672 A CN 200710002672A CN 101229177 A CN101229177 A CN 101229177A
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Abstract
The invention provides a medical compound for treating osteoporosis which is characterized in that the invention contains strontium ranelate and bisphosphonate. Animal experiments indicate that the invention achieves the unexpected effect for treating the osteoporosis. The osteoporosis is a bone disease of the whole body characterized by the low bone mass and the degeneration of the micro structure of the bone organization, companying with the enhancement of the bone fragility and easy happened bone broken for which no ideal treatment medicine exists in the clinic. The bisphosphonate of the invention comprises alendronate, risedronate sodium, ibandronate, pamidronate, Etidronate, disodium clodronate and zoledronic acid, etc. In the invention, the dosage of the bisphosphonate is greatly reduced, which can effectively reduce the happening of side effects and is convenient to use the medicine.
Description
Technical field
The invention belongs to new Western medicine compound recipe.
Background technology
Osteoporosis is to be a kind of general skeletal diseases of feature with low bone amount and the regression of osseous tissue micro structure, increases with bone fragility, easily fractures.Osteoporosis can be divided into constitutional and Secondary cases two classes, and wherein primary osteoporosis accounts for about 95% of osteoporosis, and it can be divided into 2 kinds of hypotypes again, i.e. I type and II type.The I type claims postmenopausal osteoporosis again, and the II type is a senile osteoporosis.Secondary osteoporosis can be secondary to other diseases or be caused by medicine.The intensity of bone and complete, depend on from the osteoclast of hemopoietic tissue to the absorption of bone and from the osteoblast of bone marrow matrix to the balance between the reconstruction of bone.Along with age ageing or owing to reasons such as disease, medicines, bone resorption has surpassed bone formation, bone loss will occur, the secondary osteoporosis.
Now in the osteoporosis remedy thing, major part is a bone resorption inhibitor, its determined curative effect, and the mainly generation by reducing osteoclast or reduce the absorption that osteoclast activity suppresses bone prevents that the bone amount from too much losing.At present, still lacking the active bone formation-promoter of stimulating osteoblast, is the focus of the present and the future's osteoporosis treatment to the research association of bone formation-promoter.
Over nearly 30 years, bisphosphonates has developed into the most effective bone resorption inhibitor.Because it can reduce the bone resorption that a variety of causes causes, therefore be used to prevent and treat osteoporosis that primary osteoporosis, braking cause, bone tumor, osteogenesis imperfecta, fibrous dysplasia, inflammatory bone disease etc., also can be used for the secondary osteoporosis that glucocorticoid, thyroxine and heparin etc. cause.In addition, diphosphonate still is the first-line treatment medicine of the hypercalcemia that causes of malignant tumor and paget's disease of bone.
But this class medicine exists the very big problem of taking medicine, because it absorbs extreme difference, stimulates esophagus, thereby the requirement of taking medicine is quite strict and accurately, side effect is very big.
Strontium Ranelate (Strontium Ranelate) is the osteosporosis resistant medicament of new generation by the French Servier of drugmaker development, is first osteosporosis resistant medicament with dual function.This product has the bone formation of stimulation, suppresses the re-absorbed dual function of bone, can significantly reduce the occurrence risk that causes vertebral fracture after the menopause because of osteoporosis, also can significantly reduce simultaneously the generation of hip fracture and other non-vertebral fractures, strengthen bone strength and bone density, overcome the single drawback of drug effect in the past.
Strontium Ranelate is made up of the thunder Buddhist nun acid of two stable strontium atoms and a part.Strontium ion participates in the calcification of bone, and has the function of stimulating osteoblast bone formation and inhibition osteoclast bone resorption, can improve the mechanical resistance of skeleton.Do not influence mineralization of skeleton, do not change the bone structure crystal.Thunder Buddhist nun acid is strong polar organic acid, parmacodynamics-less activity, but can form stable chelate with the bivalence strontium ion.Listing examined and got permission by this medicine by the EMEA of European Union the end of the year 2004.
Because osteoporosis is a kind of chronic, obstinate disease, its pathogeny is not still studied clear fully, so also there is not the osteoporotic medicine of very good treatment now clinically.
Summary of the invention
The present invention is with Strontium Ranelate and bisphosphonates, comprise Alendronate sodium (Alendronate Sodium), risedronate sodium (Risedronate Sodium), ibandronate (Ibandronate Sodium), Pamidronate Disodium (PamidronateDisodium), etidronate disodium (Etidronate Disodium), disodium clodronate (Clodronate Disodium), zoledronic acid (Zoledronic Acid) use in conjunction can reach good therapeutic purposes in osteoporotic treatment, simultaneously the diphosphonate consumption is reduced, evident in efficacy, can effectively reduce the generation of side reaction, make things convenient for medication simultaneously greatly.
The diphosphonate mechanism of action mainly is the bone resorption that suppresses the osteoclast mediation, and the mainly differentiation by suppressing osteoclast precursor and raising suppresses osteoclast and forms; Osteoclast is engulfed diphosphonate, causes the osteoclast apoptosis; Be attached to bone surface, influence osteoclast activity; Disturb osteoclast to accept the bone resorption signal from substrate; By the osteoblast mediation, reduce osteoclast activity.
Compare with diphosphonate, the mechanism of action of Strontium Ranelate is unclear fully as yet at present, but its unique distinction is both to suppress bone resorption, can stimulate bone formation again.Strontium Ranelate is made up of the thunder Buddhist nun acid of two stable strontium atoms and a part.Strontium ion participates in the calcification of bone, and has the function of stimulating osteoblast bone formation and inhibition osteoclast bone resorption, can improve the mechanical resistance of skeleton.Thunder Buddhist nun acid is strong polar organic acid, parmacodynamics-less activity, but can form stable chelate with the bivalence strontium ion.
Hence one can see that, and there is identical place in Strontium Ranelate with diphosphonate on mechanism of action, but Strontium Ranelate is not exclusively identical with diphosphonate again on mechanism of action, and this has determined its mechanism of action to replenish mutually again.
We have done pharmacology's checking to the osteoporosis experimental animal model of different mechanisms in osteoporotic pharmacology's checking, and different experimental results shows that all Strontium Ranelate and diphosphonate use in conjunction have all played very significant effect, is better than single with Strontium Ranelate or diphosphonate.
The present invention is prepared into granule, tablet, capsule, drop pill, oral liquid according to the character of Strontium Ranelate and diphosphonate with its compound recipe.
The specific embodiment
Embodiment 1 Strontium Ranelate and Alendronate sodium compound recipe are to the influence of castration osteoporosis modeling rat
1. experiment material and method
1) experiment medicine
Alendronate sodium (Alendronate Sodium), Strontium Ranelate (Strontium Ranelate).
2) laboratory animal and modeling method
6 month female are not educated 50 of SD rats (providing the SPF level by southern Shandong pharmacy group New Times Pharmaceutical animal center).
Modeling method: at first rat is used the 100g/L chloral hydrate, presses the 300mg/kg intraperitoneal injection of anesthesia, and by median abdominal incision, passivity is separated the laggard abdomen of abdominal muscle peritoneum, finds ovary, and it excision is sewed up the incision in the silk thread ligation, and 1 week of postoperative takes out stitches.
3) grouping
Random packet;
The A group: model control group, 10, anesthesia, the same modeling method of operation pathway, spay, one week of postoperative back filling stomach gives normal saline, and per two days are once, continuous 3 months.
The B group: the associating low dose group, 10, as above-mentioned modeling method, spay.One week of postoperative back filling stomach gives alendronic Acid 1mg/kg+ Strontium Ranelate 200mg/kg, and per two days once, continuous 3 months.
The C group: the associating high dose group, 10, as above-mentioned modeling method, spay.One week of postoperative back filling stomach gives alendronic Acid 3mg/kg+ Strontium Ranelate 600mg/kg, and per two days once, continuous 3 months.
The D group: the alendronic Acid group, 10, as above-mentioned modeling method, spay.One week of postoperative back filling stomach gives alendronic Acid 3mg/kg, and per two days once, continuous 3 months.
The E group: the Strontium Ranelate group, 10, as above-mentioned modeling method, spay.One week of postoperative back filling stomach gives Strontium Ranelate 600mg/kg, and per two days once, continuous 3 months.
Divide cage to feed during postoperative and the administration under the identical conditions, do not limit feedstuff and water.3 months laboratory observation phases of postoperative.
4) index observing of experimental result
Bone density (BMD); Behind the postoperative 3 months,, respectively organize the rat body bone density with dual-energy x-ray borne densitometers mensuration with each group rat anesthesia.
The rat bone weight coefficient; Put to death rat and get the bilateral femur, behind rejecting muscle and the soft tissue,, divided by body weight, get bone weight in wet base coefficient with the bone weight in wet base with electronics Libra weighing bone weight in wet base.Then bone is put into baking box, 120 ℃ were toasted 6 hours, and its dry weight of weighing is calculated key heavy coefficient with quadrat method
Serum calcium, phosphorus content are measured; After experiment finishes, water and chloralization rat, it is standby to adopt the carotid duct drain to get serum, it is to be measured to isolate serum, wherein methylthymol blue (MTB) method is adopted in blood calcium determination, and serium inorganic phosphorus is measured and adopted the molybdic acid method, and the concrete operations step is undertaken by the test kit description.
The serum alkaline phosphatase assay; With p-nitrophenyl disodium hydrogen phosphate method, the concrete operations step is undertaken by the test kit description.
Urinary hydroxyproline/urine creatine ratio measurement; Connect each experimental rat urine with metabolic cage the last week after experiment finishes, and the mensuration of urinary hydroxyproline adopts improvement toluene-sodium-sulfonchloramide oxidizing process to measure, and the concrete operations step is undertaken by the test kit description.
2. respectively organize experimental data and analysis
The influence of table 1 pair experimental rat bone density and bone weight coefficient
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
﹠amp;Compare p＜0.05 with the alendronic Acid group,
﹠amp; ﹠amp;Compare p＜0.01. with the alendronic Acid group
#Compare p＜0.05 with the Strontium Ranelate group,
##Compare p＜0.01. with the Strontium Ranelate group
The influence of table 2 pair experimental rat rat blood serum calcium, phosphorus, content of alkaline phosphatase and urinary hydroxyproline/urine creatine ratio
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
﹠amp;Compare p＜0.05 with the alendronic Acid group,
﹠amp; ﹠amp;Compare p＜0.01. with the alendronic Acid group
#Compare p＜0.05 with the Strontium Ranelate group,
##Compare p＜0.01. with the Strontium Ranelate group
Embodiment 2 Strontium Ranelates and Alendronate sodium compound recipe are to the influence of osteoporosis retinoic acid modeling rat
1. experimental technique
Select 50 of the SD female rat at 6 monthly ages for use, body weight derives from southern Shandong pharmacy group Experimental Animal Center between 180～220g, be divided into 5 groups at random:
The blank group; 10,1% sodium carboxymethyl cellulose normal saline 2ml irritates stomach, every day 1 time.
The osteoporosis model group of Induced by Retinoic Acid; 10, add retinoic acid with 1% carboxymethylcellulose sodium solution and be made into 4% retinoic acid suspension 2ml and irritate stomach, every day 1 time.
Strontium Ranelate and Alendronate sodium compound recipe group; 10, as above molding method adds Strontium Ranelate and Alendronate sodium wiring solution-forming with 1% carboxymethylcellulose sodium solution, presses Strontium Ranelate 700mg/kg+ Alendronate sodium 2mg/kg administration, every day 1 time.
Alendronate sodium treatment group; 10, as above molding method adds the Alendronate sodium wiring solution-forming with 1% carboxymethylcellulose sodium solution, presses Alendronate sodium 2mg/kg administration, every day 1 time.
Strontium Ranelate treatment group; 10, as above molding method adds the Strontium Ranelate wiring solution-forming with 1% carboxymethylcellulose sodium solution, presses Strontium Ranelate 700mg/kg administration, every day 1 time.
Each treated animal was all raised 1 month in 25 ℃ of left and right sides environment, freely drank water, and ingested.
2. the processing of experimental result and observation index
With embodiment 1.
3. experimental data and analysis
Table 3 experiment is to the influence of rat bone density and bone weight coefficient
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
﹠amp;Compare p＜0.05 with the alendronic Acid group,
﹠amp; ﹠amp;Compare p＜0.01. with the alendronic Acid group
#Compare p＜0.05 with the Strontium Ranelate group,
##Compare p＜0.01. with the Strontium Ranelate group
Table 4 experiment is to the influence of rat blood serum calcium, phosphorus, content of alkaline phosphatase and urinary hydroxyproline/urine creatine ratio
*Compare p＜0.05 with model group,
*Compare p＜0.01. with model group
﹠amp;Compare p＜0.05 with the alendronic Acid group,
﹠amp; ﹠amp;Compare p＜0.01. with the alendronic Acid group
#Compare p＜0.05 with the Strontium Ranelate group,
##Compare p＜0.01. with the Strontium Ranelate group
We are in pharmacodynamic experiment, and we find that also bisphosphonate compound such as risedronate sodium, ibandronate, Pamidronate Disodium and Strontium Ranelate all obtained beyond thought synergism.We can't be interpreted as any nearly all bisphosphonates osteosporosis resistant medicament meeting and Strontium Ranelate produces so synergism, may be that the diphosphonate compounds has due to the identical mechanism of action.
The preparation of embodiment 3 Strontium Ranelates and alendronic Acid sodium granules
Strontium Ranelate 2000g
Alendronate sodium 5g
Mannitol 2000g
Corn starch 2000g
Sucrose 8000g
Sodium carboxymethyl cellulose 800g
10% starch slurry is an amount of
Preparation technology:
Strontium Ranelate in the prescription, Alendronate sodium, mannitol, corn starch, sucrose, sodium carboxymethyl cellulose are crossed 100 mesh sieves respectively, take by weighing by recipe quantity, mixing, add 10% starch slurry and make soft material, after granulating with 14 mesh sieves, put 70～80 ℃ of dry backs in 12 mesh sieve granulate, packing gets final product.
The preparation of embodiment 4 Strontium Ranelates and the agent of Alendronate sodium mix suspension grain
Strontium Ranelate 2000g
Alendronate sodium 5g
Sodium carboxymethyl cellulose 500g
Pectin 500g
Sucrose 8000g
Sodium citrate 800g
Beet red 10g
3% polyvinylpyrrolidone alcoholic solution is an amount of
Preparation technology:
With Strontium Ranelate, Alendronate sodium, sodium carboxymethyl cellulose, pectin, sucrose, sodium citrate, beet red in the prescription, cross 100 mesh sieves respectively, take by weighing by recipe quantity, mixing, add 3% polyvinylpyrrolidone alcoholic solution and make soft material, after the granulation of 14 mesh sieves, it is back with 12 mesh sieve granulate to put 70～80 ℃ of dryings, and packing gets final product.
The preparation of embodiment 5 Strontium Ranelates and Pamidronate disodium suspension granule
Strontium Ranelate 20g
Pamidronate Disodium 10g
Sodium carboxymethyl cellulose 350g
Microcrystalline Cellulose 180g
Pectin 350g
Sodium citrate 450g
Sucrose 12500g
10% starch slurry is an amount of
Preparation technology:
With Strontium Ranelate, Pamidronate Disodium, sodium carboxymethyl cellulose, pectin, microcrystalline Cellulose, sodium citrate, sucrose in the prescription, cross 100 mesh sieves respectively, take by weighing by recipe quantity, mixing, add 10% starch slurry and make soft material, after the granulation of 14 mesh sieves, put 70～80 ℃ of dry backs in 12 mesh sieve granulate, packing gets final product.
The preparation of embodiment 6 Strontium Ranelates and the agent of ibandronate mix suspension grain
Strontium Ranelate 3000g
Ibandronate 2.2g
Sodium carboxymethyl cellulose 350g
Microcrystalline Cellulose 200g
Arabic gum 300g
Sodium citrate 450g
Sucrose 12500g
10% starch slurry is an amount of
Preparation technology:
With Strontium Ranelate, ibandronate, sodium carboxymethyl cellulose, arabic gum, microcrystalline Cellulose, sodium citrate, sucrose in the prescription, cross 100 mesh sieves respectively, take by weighing by recipe quantity, mixing, add 10% starch slurry and make soft material, after the granulation of 14 mesh sieves, put 70～80 ℃ of dry backs in 12 mesh sieve granulate, packing gets final product.
The preparation of embodiment 7 Strontium Ranelates and risedronic acid sodium tablet
Strontium Ranelate 400g
Risedronate sodium 1g
Pregelatinized Starch 100g
Sucrose 40g
Sodium carboxymethyl cellulose 8g
Magnesium stearate 3g
10% starch slurry is an amount of
Preparation technology:
With Strontium Ranelate, risedronate sodium, pregelatinized Starch, sucrose, sodium carboxymethyl cellulose mix homogeneously, add 10% starch slurry and make soft material, after granulating with 14 mesh sieves, put 70～80 ℃ of dry backs in 12 mesh sieve granulate, after adding the magnesium stearate mixing, tabletting, promptly.
Embodiment 8 Strontium Ranelates and PREPARATION OF ALENDRONATE SODIUM TABLETS
Strontium Ranelate 400g
Alendronate sodium 1.5g
Microcrystalline Cellulose 200g
Starch 40g
Sodium carboxymethyl cellulose 15g
Magnesium stearate 3g
3% polyvinylpyrrolidone alcoholic solution is an amount of
Preparation technology:
With Strontium Ranelate, Alendronate sodium, microcrystalline Cellulose, starch, sodium carboxymethyl cellulose mix homogeneously, 3% polyvinylpyrrolidone alcoholic solution is made soft material, after granulating with 14 mesh sieves, put 70～80 ℃ of dry backs in 12 mesh sieve granulate, after adding the magnesium stearate mixing, tabletting, promptly.
The preparation of embodiment 9 Strontium Ranelates and Alendronate sodium oral liquid
Strontium Ranelate 1200g
Alendronate sodium 6g
Glycerol 200g
Sucrose 40g
Sodium carboxymethyl cellulose 45g
Sodium benzoate 10g
Add water to 10000ml
Preparation technology:
Strontium Ranelate, Alendronate sodium, glycerol, sucrose, sodium carboxymethyl cellulose are dissolved in earlier in the water of recipe quantity 60%, after the dissolving, add sodium benzoate and add water to full dose, stir, potting, sterilization is promptly.
The preparation of embodiment 10 Strontium Ranelates and alendronic Acid sodium dropping balls
Strontium Ranelate 400g
Alendronate sodium 1.5g
Polyethylene glycol 6000 3500g
Preparation technology:
Taking polyethylene glycol 6000 heating and melting, add Strontium Ranelate and Alendronate sodium then, constantly stir and make its whole fusions, filtered while hot is to reservoir, and insulation, drip system with dropper, drip 90 droplets/minute of speed, splash in liquid paraffin (the outer ice-water bath cooling) liquid coolant that contains 43% kerosene, be cooled to ball, wash ball with liquid paraffin, to there not being the kerosene flavor, promptly.
Claims (5)
1. one kind is used for the treatment of osteoporotic pharmaceutical composition, it is characterized in that it contains Strontium Ranelate and diphosphonate.
2. pharmaceutical composition as claimed in claim 1 is characterized in that described two hydrochlorate of seeing is see sour sodium, Li Sai see sour sodium, ibandronate, Pamidronate Disodium, etidronate disodium, chlorine see acid disodium or a zoledronic acid of A Lun.
3. pharmaceutical composition as claimed in claim 1 is characterized in that it is oral solid formulation or oral liquid.
4. pharmaceutical composition as claimed in claim 3 is characterized in that described oral solid formulation is granule, tablet, capsule or drop pill.
5. pharmaceutical composition as claimed in claim 3 is characterized in that described oral liquid is an oral liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710002672A CN101229177B (en) | 2007-01-26 | 2007-01-26 | Medicine compounds for treating osteoporosis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN200710002672A CN101229177B (en) | 2007-01-26 | 2007-01-26 | Medicine compounds for treating osteoporosis |
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| CN101229177A true CN101229177A (en) | 2008-07-30 |
| CN101229177B CN101229177B (en) | 2010-05-12 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102000094A (en) * | 2010-09-27 | 2011-04-06 | 天津南开允公医药科技有限公司 | Ibandronic acid-containing medicinal composition and preparation process thereof |
| CN104095863A (en) * | 2014-08-06 | 2014-10-15 | 国药集团国瑞药业有限公司 | Pharmaceutical composition containing zoledronic acid and preparation thereof |
| CN105012995A (en) * | 2015-06-04 | 2015-11-04 | 武汉维斯第医用科技股份有限公司 | Collagen sponge containing bone-healing-promoting drug and preparation method thereof |
| CN105213407A (en) * | 2015-07-01 | 2016-01-06 | 南京大学 | Zoledronic acid is for the preparation of the purposes of the medicine for the treatment of fatty liver disease |
| CN105327396A (en) * | 2015-07-27 | 2016-02-17 | 北京大学 | Surface modifying method of orthopedic implanted medical instrument |
| CN112316154A (en) * | 2020-11-27 | 2021-02-05 | 徐州医科大学 | Bone targeting nano material and application thereof |
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2007
- 2007-01-26 CN CN200710002672A patent/CN101229177B/en active Active
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| CN102000094A (en) * | 2010-09-27 | 2011-04-06 | 天津南开允公医药科技有限公司 | Ibandronic acid-containing medicinal composition and preparation process thereof |
| CN102000094B (en) * | 2010-09-27 | 2013-03-27 | 天津南开允公医药科技有限公司 | Ibandronic acid-containing medicinal composition and preparation process thereof |
| CN104095863A (en) * | 2014-08-06 | 2014-10-15 | 国药集团国瑞药业有限公司 | Pharmaceutical composition containing zoledronic acid and preparation thereof |
| CN104095863B (en) * | 2014-08-06 | 2016-03-30 | 国药集团国瑞药业有限公司 | A kind of pharmaceutical composition and preparation thereof comprising zoledronic acid |
| CN105012995A (en) * | 2015-06-04 | 2015-11-04 | 武汉维斯第医用科技股份有限公司 | Collagen sponge containing bone-healing-promoting drug and preparation method thereof |
| WO2016192377A1 (en) * | 2015-06-04 | 2016-12-08 | 武汉维斯第医用科技股份有限公司 | Collagen sponge containing fracture healing promotion drug and preparation method thereof |
| US10046082B2 (en) | 2015-06-04 | 2018-08-14 | Wuhan Vsd Medical Science & Technology Co., Ltd. | Collagen sponge containing a drug for promoting fracture healing and method for preparing the same |
| CN105213407A (en) * | 2015-07-01 | 2016-01-06 | 南京大学 | Zoledronic acid is for the preparation of the purposes of the medicine for the treatment of fatty liver disease |
| CN105213407B (en) * | 2015-07-01 | 2018-01-02 | 南京大学 | Zoledronic acid is used for the purposes for preparing the medicine for the treatment of fatty liver disease |
| CN105327396A (en) * | 2015-07-27 | 2016-02-17 | 北京大学 | Surface modifying method of orthopedic implanted medical instrument |
| CN105327396B (en) * | 2015-07-27 | 2018-08-10 | 北京大学 | A kind of surface modifying method of orthopaedics implantation class medical equipment |
| CN112316154A (en) * | 2020-11-27 | 2021-02-05 | 徐州医科大学 | Bone targeting nano material and application thereof |
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