CN102698281B - Laminarin tablet excipient, medicinal tablets and preparation method for medicinal tablets - Google Patents
Laminarin tablet excipient, medicinal tablets and preparation method for medicinal tablets Download PDFInfo
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Abstract
The invention discloses a laminarin tablet excipient. The laminarin tablet excipient consists of 88 to 96 percent of laminarin, 1 to 5 percent of sucrose stearate, 1 to 5 percent of silicon dioxide and 1 to 5 percent of kaolin, the laminarin tablet excipient has good flowability, and is high in molding degree and demolding property, the laminarin tablet excipient, medicines and water can be mixed and subjected to direct compression to prepare medicinal tablets. The invention also discloses the medicinal tablets; the medicinal tablets are prepared from 75 to 85 percent of medicinal active ingredient, 5 to 15 percent of laminarin tablet excipient and 5 to 15 percent of aqueous raw materials; the laminarin tablet excipient is compatible with the medicinal active ingredient and does not react with the medicinal active ingredient, the laminarin tablet excipient has high dissolubility and good flowability and is suitable for direct compression of various medicines. The invention also discloses a preparation method for medicinal tablets, the medicinal tablets are easy to prepare, and the preparation method is easy to implement, operate and control.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to and a kind ofly prepare laminarin tablet excipient directly compressible, runny, adopt the medicinal tablet of laminarin tablet excipient preparation and the preparation method of medicinal tablet with laminarin.
Background technology
Tablet accounts for more than 1/3rd of all pharmaceutical dosage forms, is a kind of very important pharmaceutical dosage form.Excipient plays crucial effects to stability of drug and absorption efficiency, is the core that medicinal tablet is made.The suitable safety non-toxic of tablet excipient requirement own has no side effect, there are not incompatibility and reaction with principal agent, good fluidity, thereby principal agent is uniformly dispersed and principal agent is had big absorption affinity, be fit to direct compression, advantage such as the tablet of preparation has the bonding force height, forming degree is good, lubricity is good, release property is good and hydrophilic is strong but non-hygroscopic, disintegrate is rapid.
Laminarin be from the Larminaria algae separation and Extraction to some polysaccharide, be to be present in Thallus Laminariae (Thallus Eckloniae) iuntercellular and an intracellular class natural biological macromolecular substances.Laminarin have antitumor, antiviral, antibiotic, improve renal function, eliminate effects such as free radical, antioxidation, resisting fatigue, lipidemia, blood sugar lowering, blood coagulation, plasma substitute, radiation protection.The polysaccharide of finding from Thallus Laminariae (Thallus Eckloniae) at present mainly contains: Algin (algin), fucoidan (fucoidan) and laminaran.Algin refers to the general designation of alginate and alginic acid organic derivative, and mainstream product is sodium alginate (also being sodium alginate).Algin be by α-L-guluronic acid and beta-D-mannuronic acid by the linear polymeric polysaccharide that the 1-4 glycosidic bond is formed by connecting, be a kind of granule or pulverous milky or faint yellow solid of being.Fucoidan, have another name called fucoidan, main component is fucose, it is the polymer of α-L-fucose-4-sulfuric ester, also with a spot of galactose, mannose, xylose, rhamnose, arabinose, alduronic acid etc., be the gang's water solublity heteropolysaccharide with different chemical component, mainly be present in the intercellular substance of Brown algae plant.Fucoidan can be treated chronic kidney hypofunction, and the early stage renal failure of centering is effective, has no side effect, and to improving renal function, it is particularly remarkable to the creatinine clearance rate effect to improve kidney, now gets permission to enter clinical research by national two kind new medicines especially.Laminaran claims laminariose again, is divided into two kinds of water solublity and water-insolubles, mainly is made up of the polymer of glucose, mainly is present in the Cytoplasm, and content seldom in Thallus Laminariae (Thallus Eckloniae).
Sucrose fatty acid ester be by sucrose and fatty acid through simple substance or mixture that esterification generates, be nonionic surfactant.Senior fatty acid (product is Powdered) or lower fatty acids such as acetic acid, isopropylformic acid. (product is the thickness resin-like) preparation sucrose fatty acid ester such as stearic acid commonly used, oleic acid, Palmic acid.FAO (Food and Agriculture Organization of the United Nation) and World Health Organization's approved sucrose fatty acid ester are used for numerous food as food emulsifying agent, can be used as edible surfactant.Sucrose fatty acid ester has the dual function that promotes and hinder crystallization, can prevent that saccharide and lipophilic surfactant are in aqueous crystallization.Sucrose fatty acid ester can be used as confection tabletting lubricant, alternative traditional Pulvis Talci, magnesium stearate, monoglyceride, microcrystalline Cellulose etc.Sucrose fatty acid ester can share as the viscosity modifier of making chocolate, confection with lecithin.Sucrose fatty acid ester can also be used as food foaming agent, antibacterial, antioxidant etc.
In recent years research finds that also sucrose fatty acid ester has obvious aging resistance function.After sucrose fatty acid ester enters in the body, can cholesterol in the blood be taken out of externally with micelle form, therefore, also can prevent and treat and treat multiple cardiovascular disease.In addition, sucrose fatty acid ester has apparent property and the mouthfeel of edible oil and fat, does not produce heat after eating, and is desirable prevention and the fat food of control.As the food additive of desirable fat-reducing and treatment and prevention hypercholesterolemia disease, sucrose fatty acid ester is subjected to many countries and payes attention to also being promoted, and has developed sucrose fatty acid ester-vitamine capsule as the U.S., and the people who recommends each age group takes for a long time.Aspect medical industry, sucrose fatty acid ester not only has the good surface activity, with medicine good compatibility effect is arranged simultaneously, and can accelerate drug releasing rate, promote to be uniformly dispersed, to prevent crystalline deposit, and can the prolong drug quality guarantee period.Therefore, it can be used as emulsifying agent, dispersant, solubilizing agent, stabilizing agent, thickening agent, binding agent, lubricant etc. and is used for multiple pharmaceutical auxiliary agent, makes enteric coating stable in gastric juice, and can dissolve fully in intestinal juice.
Silicon dioxide is a kind of good flow improver additive, can be used as the diluent of tablet, capsule, microcapsule etc. or filler, fluidizer, antitack agent, also can be used as suspensoid or the thickening agent of suspension, ointment, suppository, also can be used as the stabilizing agent of Emulsion, can be used as dispersant, the defoamer of liquid group in the solid preparation again, and the adsorption desiccant that can be used as essence, spice.
Kaolin is hydrated aluminium silicate, and water is eluriated shakeout, washes repeatedly through diluted acid processing and water, removes impurity and makes.In medicine and daily use chemicals industry; kaolin can be used as the carrier of catalyst in adsorbent, excipient, desiccant, softening agent, liquid clarifier and the organic synthesis, and has the poisonous substance of preventing absorb, protect inflamed mucous membranes, drug effects such as treatment dysentery and alimentary toxicosis in gastrointestinal tract.But kaolin also external has the effect of protection skin for removing the cloth agent, can absorb the wound surface exudate, prevents the antibacterial intrusion.
Publication number is that the Chinese invention patent application of CN 1270516A discloses a kind of pharmaceutical preparation that the acceptable dichloromethylene diphosphonate salt of pharmacology is made active substance that contains, and it contains: BONEFOS salt about 60% ~ 80%(weight); About 8% ~ 20%(weight) silicified microcrystalline cellulose; With about 0.5% ~ 10%(weight) lubricant and/or disintegrating agent.Be that excipient carries out clodronic acid two sodium tablet tablettings with the silicified microcrystalline cellulose, record according to embodiment 7, when tabletting speed reaches 30000 slices/hour and 40000 slices/hour, tablet strength is respectively 16kp and 18kp, fragility is respectively 0.11% and 0.20%, and this embodiment does not carry out 50000 slices/hour tablettings.In embodiment 8, be that excipient carries out clodronic acid two sodium tablet tablettings with the ordinary microcrystalline cellulose, when tabletting speed reached 30000 slices/hour, fragility was up to 38%, when tabletting speed reaches 50000 slices/hour, then can not tablet forming, be that excipient carries out clodronic acid two sodium tablet tablettings with the silicified microcrystalline cellulose, when tabletting speed reaches 50000 slices/hour, though tablet still keeps better intensity, but fragility reaches 2.5%, and fragility is still higher.
Summary of the invention
The invention provides a kind of laminarin tablet excipient, good fluidity, forming degree is good, and release property is good, can prepare medicinal tablet with medicine and water direct compression.
A kind of laminarin tablet excipient, formed by following components in weight percentage content:
Laminarin 88% ~ 96%;
Sucrose stearate 1% ~ 5%;
Silica 1 % ~ 5%;
Kaolin 1% ~ 5%.
As preferably, described laminarin tablet excipient, formed by following components in weight percentage content:
Laminarin 91% ~ 94%;
Sucrose stearate 2% ~ 3%;
Silicon dioxide 2% ~ 3%;
Kaolin 2% ~ 3%.
Laminarin is natural cheap material, avirulence, and have good biodegradability and biocompatibility, give laminarin tablet excipient of the present invention with high fluidity, high adhesion, high-hydrophilic, performance such as suitably taste, disintegrate be rapid.Described laminarin is one or more in Algin, fucoidan, the water solublity laminaran, and Algin, fucoidan and water solublity laminaran all extract from Thallus Laminariae (Thallus Eckloniae).
The present invention by sucrose stearate give laminarin tablet excipient of the present invention with high adhesion, high forming degree, preferably lubricity, preferably release property, preserve moisture but non-hygroscopic, hardness is moderate, be fit to performances such as direct compression.
When contacting with dissolve medium, the surface energy of silicon dioxide absorption mass efficient medicine forms powder, has reduced interparticle adsorption function, has avoided agglomeration and the caking of some fine powder shape medicine, has promoted dissolving and the release of medicine.Silicon dioxide is given laminarin tablet excipient of the present invention with high fluidity, high-hydrophilic, to performances such as the high absorption affinities of principal agent.In laminarin tablet excipient prescription of the present invention, add a small amount of silicon dioxide, can improve the homogeneity of hardness, weight and the active drug content of medicinal tablet.
Kaolin can effectively absorb and dissolve oils and fats as natural clay.Kaolin is given laminarin tablet excipient of the present invention with performances such as suitable hardness, absorption principal agent, disintegrate are rapid.
Laminarin tablet excipient of the present invention mixes namely by laminarin, sucrose stearate, silicon dioxide and kaolin, and wherein, laminarin, sucrose stearate, silicon dioxide and kaolin all can adopt the pharmaceutical grade commercially available prod.By four kinds of component interactions, dissolubility is good, good fluidity, during the preparation medicinal tablet, can embody excellent effect, particularly Zhi Bei medicinal tablet and have crushing strength and lower fragility preferably.
The present invention also provides a kind of medicinal tablet, with active constituents of medicine, laminarin tablet excipient and water as feedstock production, laminarin tablet excipient and active constituents of medicine do not have incompatibility and reaction, and dissolubility is good, good fluidity, can make active constituents of medicine be uniformly dispersed and active constituents of medicine is had big absorption affinity, bonding force height, forming degree is good, lubricity is good and release property is good, is fit to the various kinds of drug direct compression.
A kind of medicinal tablet, made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Described laminarin tablet excipient 5% ~ 15%;
Water 5% ~ 15%.
As preferably, described active constituents of medicine is BONEFOS, the crushing strength of the BONEFOS medicinal tablet of preparation is higher, and fragility is lower, and the laminarin tablet excipient is particularly suitable for preparing the BONEFOS medicinal tablet.
As preferably, described medicinal tablet, made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Laminarin tablet excipient 6.5% ~ 13.5%;
Water 5% ~ 15%.
Further preferred, described medicinal tablet, made by following raw materials by weight percent:
Active constituents of medicine 80%;
Laminarin tablet excipient 10%;
Water 10%.
From the characterization data of embodiment as can be known, the medicinal tablet of this raw materials by weight percent has crushing strength and lower fragility preferably.
The present invention also provides a kind of preparation method of medicinal tablet, and preparation is simple, and is easy to implement, and is easy to operate and control.
The preparation method of described medicinal tablet may further comprise the steps:
With crossing 0.5mm ~ 2mm sieve after the laminarin tablet excipient drying and crushing, add active constituents of medicine and water mix homogeneously then, carry out tabletting again, obtain medicinal tablet behind the tabletting.
As preferably, 0.5mm ~ 1mm sieve will be crossed after the laminarin tablet excipient drying and crushing.From the characterization data of embodiment as can be known, cross the medicinal tablet that 0.5mm ~ the 1mm sieve series is equipped with and have crushing strength and lower fragility preferably.Further preferred, cross the 1mm sieve.
Compared with prior art, the present invention has following advantage:
Laminarin tablet excipient of the present invention is formulated with laminarin, sucrose stearate, silicon dioxide, kaolin, wherein, laminarin is natural cheap material, avirulence, and have good biodegradability and biocompatibility, give laminarin tablet excipient of the present invention with high fluidity, high adhesion, high-hydrophilic, performance such as suitably taste, disintegrate be rapid; Sucrose stearate give laminarin tablet excipient of the present invention with high adhesion, high forming degree, preferably lubricity, preferably release property, preserve moisture but non-hygroscopic, hardness is moderate, be fit to performances such as direct compression; Silicon dioxide is given laminarin tablet excipient of the present invention with high fluidity, high-hydrophilic, to performances such as the high absorption affinities of principal agent; Kaolin is given laminarin tablet excipient of the present invention with performances such as suitable hardness, absorption principal agent, disintegrate are rapid.Four kinds of equal safety non-toxics of component have no side effect, do not have incompatibility and reaction with principal agent, by four kinds of component interactions, dissolubility is good, good fluidity, during the preparation medicinal tablet, can embody excellent effect, particularly Zhi Bei medicinal tablet and have crushing strength and lower fragility preferably.
Medicinal tablet of the present invention, with active constituents of medicine, laminarin tablet excipient and water as feedstock production, laminarin tablet excipient and active constituents of medicine do not have incompatibility and reaction, and dissolubility is good, good fluidity, can make active constituents of medicine be uniformly dispersed and active constituents of medicine is had big absorption affinity, bonding force height, forming degree is good, lubricity is good and release property is good, is fit to the various kinds of drug direct compression.
The specific embodiment
Embodiment 1
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 91g;
Sucrose stearate 3g;
Silicon dioxide 3g;
Kaolin 3g;
Water 100g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 2
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 94g;
Sucrose stearate 2g;
Silicon dioxide 2g;
Kaolin 2g;
Water 100g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
The BONEFOS medicinal tablet (sheet A) of preparation embodiment 1 and the BONEFOS medicinal tablet (sheet B) of embodiment 2 under different tabletting speed, and investigate its crushing strength and fragility, concrete test result is as shown in table 1.The test of tablet crushing strength and fragility with reference to Formulaire National (1993 the 10th edition, the V.5.1) method of defined in " fragility of tablet ".
Table 1
| Tabletting speed | The crushing strength of sheet A | The crushing strength of sheet B | The fragility of sheet A | The fragility of sheet B |
| 15000 slices/hour | 19.8kp | 19.6kp | 0.12% | 0.10% |
| 30000 slices/hour | 19.5kp | 18.8kp | 0.11% | 0.11% |
| 50000 slices/hour | 19.6kp | 19.3kp | 0.13% | 0.14% |
Under different tabletting speed, the crushing strength of sheet A and sheet B and fragility all meet the requirements and basic indifference, and when tabletting speed rose, the crushing strength of sheet A and sheet B and fragility still kept stable, so can use 50000 slices/hour of higher tabletting speed on producing.Embodiment 3
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 88g;
Sucrose stearate 4g;
Silicon dioxide 4g;
Kaolin 4g;
Water 100g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 4
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 96g;
Sucrose stearate 1.3g;
Silica 1 .3g;
Kaolin 1.3g;
Water 100g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
The BONEFOS medicinal tablet (sheet C) of preparation embodiment 3 and the BONEFOS medicinal tablet (sheet D) of embodiment 4 under different tabletting speed, and investigate its crushing strength and fragility, concrete test result is as shown in table 2.The test of tablet crushing strength and fragility with reference to Formulaire National (1993 the 10th edition, the V.5.1) method of defined in " fragility of tablet ".
Table 2
| Tabletting speed | The crushing strength of sheet C | The crushing strength of sheet D | The fragility of sheet C | The fragility of sheet D |
| 15000 slices/hour | 18.9kp | 19.0kp | 0.12% | 0.13% |
| 30000 slices/hour | 18.8kp | 18.4kp | 0.13% | 0.13% |
| 50000 slices/hour | 19.0kp | 18.5kp | 0.15% | 0.15% |
Under different tabletting speed, crushing strength and the fragility of sheet C and sheet D all meet the requirements, and when tabletting speed rises, it is stable that the crushing strength of sheet C and sheet D and fragility still keep, so can use 50000 slices/hour of higher tabletting speed in the production, but its crushing strength is starkly lower than embodiment 1, embodiment 2, its fragility is apparently higher than embodiment 1, embodiment 2, as seen, the laminarin tablet excipient set of dispense of embodiment 1 and embodiment 2 is than being the preferred ingredients proportioning.
Embodiment 5
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 91g;
Sucrose stearate 3g;
Silicon dioxide 3g;
Kaolin 3g;
Water 100g;
The 2mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 6
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 91g;
Sucrose stearate 3g;
Silicon dioxide 3g;
Kaolin 3g;
Water 100g;
The 0.5mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
The BONEFOS medicinal tablet (sheet E) of preparation embodiment 5 and the BONEFOS medicinal tablet (sheet F) of embodiment 6 under different tabletting speed, and investigate its crushing strength and fragility, concrete test result is as shown in table 3.The test of tablet crushing strength and fragility with reference to Formulaire National (1993 the 10th edition, the V.5.1) method of defined in " fragility of tablet ".
Table 3
| Tabletting speed | The crushing strength of sheet E | The crushing strength of sheet F | The fragility of sheet E | The fragility of sheet F |
| 15000 slices/hour | 18.8kp | 19.8kp | 0.13% | 0.11% |
| 30000 slices/hour | 18.5kp | 19.5kp | 0.15% | 0.11% |
| 50000 slices/hour | 18.9kp | 19.6kp | 0.14% | 0.12% |
Embodiment 5 and embodiment 1 different being, embodiment 5 adopted the 2mm sieve, as shown in Table 3, compare with embodiment 1, the crushing strength of embodiment 5 reduces, and fragility raises, embodiment 6 and embodiment 1 different being, embodiment 6 adopted the 0.5mm sieve, as shown in Table 3, and its crushing strength and fragility and embodiment 1 basically identical.As shown in Table 3, when tabletting speed rose, the crushing strength of sheet E and sheet F and fragility still kept stable, so can use 50000 slices/hour of higher tabletting speed on producing.
Embodiment 7
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 750g;
Fucoidan 91g;
Sucrose stearate 3g;
Silicon dioxide 3g;
Kaolin 3g;
Water 150g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 8
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 850g;
Algin 91g;
Sucrose stearate 3g;
Silicon dioxide 3g;
Kaolin 3g;
Water 50g;
The 1mm sieve will be crossed behind Algin, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
The BONEFOS medicinal tablet (sheet G) of preparation embodiment 7 and the BONEFOS medicinal tablet (sheet H) of embodiment 8 under different tabletting speed, and investigate its crushing strength and fragility, concrete test result is as shown in table 4.The test of tablet crushing strength and fragility with reference to Formulaire National (1993 the 10th edition, the V.5.1) method of defined in " fragility of tablet ".
Table 4
| Tabletting speed | The crushing strength of sheet G | The crushing strength of sheet H | The fragility of sheet G | The fragility of sheet H |
| 15000 slices/hour | 18.8kp | 18.4kp | 0.13% | 0.13% |
| 30000 slices/hour | 18.9kp | 18.7kp | 0.13% | 0.15% |
| 50000 slices/hour | 18.4kp | 18.5kp | 0.14% | 0.14% |
Embodiment 7 and embodiment 8 difference from Example 1 are, the proportioning of medicinal tablet, and namely the content of BONEFOS and water is different.As shown in Table 4, when tabletting speed rose, the crushing strength of sheet G and sheet H and fragility still kept stable, so can use 50000 slices/hour of higher tabletting speed on producing.
Embodiment 9
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Fucoidan 121.33g;
Sucrose stearate 4g;
Silicon dioxide 4g;
Kaolin 4g;
Water 66.67g;
The 1mm sieve will be crossed behind fucoidan, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 10
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
BONEFOS 800g;
Water solublity laminaran 60.67g;
Sucrose stearate 2g;
Silicon dioxide 2g;
Kaolin 2g;
Water 133.33g;
The 1mm sieve will be crossed behind laminaran, sucrose stearate, silicon dioxide and the kaolin drying and crushing together, add BONEFOS and water mix homogeneously then, in preforming device, use 9 * 20mm stamping machine, make average weight 1175mg(± 2%) the BONEFOS medicinal tablet.
The BONEFOS medicinal tablet (sheet I) of preparation embodiment 9 and the BONEFOS medicinal tablet (sheet J) of embodiment 10 under different tabletting speed, and investigate its crushing strength and fragility, concrete test result is as shown in table 5.The test of tablet crushing strength and fragility with reference to Formulaire National (1993 the 10th edition, the V.5.1) method of defined in " fragility of tablet ".
Table 5
| Tabletting speed | The crushing strength of sheet I | The crushing strength of sheet J | The fragility of sheet I | The fragility of sheet J |
| 15000 slices/hour | 18.7kp | 18.5kp | 0.14% | 0.14% |
| 30000 slices/hour | 18.8kp | 18.2kp | 0.15% | 0.13% |
| 50000 slices/hour | 18.8kp | 18.6kp | 0.15% | 0.15% |
Embodiment 9 and embodiment 10 difference from Example 1 are, the proportioning of medicinal tablet, and namely the content of laminarin tablet excipient and water is different.As shown in Table 5, when tabletting speed rose, the crushing strength of sheet I and sheet J and fragility still kept stable, so can use 50000 slices/hour of higher tabletting speed on producing.
Therefore, adopt laminarin of the present invention to be equipped with sucrose stearate, silicon dioxide, kaolinic laminarin tablet excipient tabletting prepares the BONEFOS medicinal tablet, because each component has been given BONEFOS medicinal tablet fine solubility in this laminarin tablet excipient, mobile, lubricity, forming degree, bonding force and release property, the BONEFOS medicinal tablet can keep stable high strength and low fragility under different tabletting speed, can carry out the tablet tabletting production of tabletting speed up to 50000 slices/hour.
The BONEFOS medicinal tablet is applicable to molten bone bone transfer that cancer causes and osteoporosis, hypercalcemia, and this BONEFOS medicinal tablet meets every standard-required of Chinese Pharmacopoeia defined after testing.
Claims (9)
1. laminarin tablet excipient, formed by following components in weight percentage content:
Laminarin 88% ~ 96%;
Sucrose stearate 1% ~ 5%;
Silica 1 % ~ 5%;
Kaolin 1% ~ 5%.
2. laminarin tablet excipient according to claim 1 is characterized in that, is made up of following components in weight percentage content:
Laminarin 91% ~ 94%;
Sucrose stearate 2% ~ 3%;
Silicon dioxide 2% ~ 3%;
Kaolin 2% ~ 3%.
3. laminarin tablet excipient according to claim 1 and 2 is characterized in that, described laminarin is one or more in Algin, fucoidan, the water solublity laminaran.
4. a medicinal tablet is characterized in that, is made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Claim 1,2 or 3 described laminarin tablet excipients 5% ~ 15%;
Water 5% ~ 15%.
5. medicinal tablet according to claim 4 is characterized in that, is made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Claim 1,2 or 3 described laminarin tablet excipients 6.5% ~ 13.5%;
Water 5% ~ 15%.
6. medicinal tablet according to claim 5 is characterized in that, is made by following raw materials by weight percent:
Active constituents of medicine 80%;
Claim 1,2 or 3 described laminarin tablet excipients 10%;
Water 10%.
7. according to claim 4,5 or 6 described medicinal tablets, it is characterized in that described active constituents of medicine is BONEFOS.
8. according to the preparation method of each described medicinal tablet of claim 4 ~ 7, may further comprise the steps:
With crossing 0.5mm ~ 2mm sieve after the laminarin tablet excipient drying and crushing, add active constituents of medicine and water mix homogeneously then, behind tabletting, obtain medicinal tablet.
9. the preparation method of medicinal tablet according to claim 8 is characterized in that, will cross 0.5mm ~ 1mm sieve after the laminarin tablet excipient drying and crushing.
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| CN1270516A (en) * | 1997-09-19 | 2000-10-18 | 雷若斯公司 | Pharmaceutical preparation comprising colodronate as active ingredient and silicified microcrystalline cellulose as excipient |
| CN1684667A (en) * | 2002-08-02 | 2005-10-19 | 兰贝克赛实验室有限公司 | Storage stable tablets of fosinopril sodium |
| CN102085201A (en) * | 2009-12-08 | 2011-06-08 | 北京双鹤药业股份有限公司 | Atenolol and amlodipine bilayer tablet |
-
2012
- 2012-05-29 CN CN 201210176362 patent/CN102698281B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1270516A (en) * | 1997-09-19 | 2000-10-18 | 雷若斯公司 | Pharmaceutical preparation comprising colodronate as active ingredient and silicified microcrystalline cellulose as excipient |
| CN1684667A (en) * | 2002-08-02 | 2005-10-19 | 兰贝克赛实验室有限公司 | Storage stable tablets of fosinopril sodium |
| CN102085201A (en) * | 2009-12-08 | 2011-06-08 | 北京双鹤药业股份有限公司 | Atenolol and amlodipine bilayer tablet |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102698281A (en) | 2012-10-03 |
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