CN102671200B - Isomaltose hypgather tablet excipient, medicine tablet and preparation method - Google Patents

Isomaltose hypgather tablet excipient, medicine tablet and preparation method Download PDF

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CN102671200B
CN102671200B CN 201210176347 CN201210176347A CN102671200B CN 102671200 B CN102671200 B CN 102671200B CN 201210176347 CN201210176347 CN 201210176347 CN 201210176347 A CN201210176347 A CN 201210176347A CN 102671200 B CN102671200 B CN 102671200B
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tablet
medicine
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oligomeric isomaltose
excipient
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阮晖
李青青
吴慧斌
刘松柏
陈放
诸文颖
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ANJI DONGLAI PHARMACEUTICAL ADJUVANT Co Ltd
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ANJI DONGLAI PHARMACEUTICAL ADJUVANT Co Ltd
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Abstract

The invention discloses isomaltose hypgather tablet excipient, which consists of 88 percent to 96 percent of isomaltose hypgather, 1 percent to 5 percent of starch octenyl succinate anhydride, 1 percent to 5 percent of silicon dioxide and 1 percent to 5 percent of porcellanite in percentage by weight, and has the advantages that the mobility is good, the forming degree is good, the demolding performance is good, and isomaltose hypgather tablet excipient can be directly tableted with medicine and water for preparing medicine tablets. The invention also discloses a medicine tablet, which consists of 75 percent to 85 percent of medicine active ingredients, 5 percent to 15 percent of isomaltose hypgather tablet excipient and 5 percent to 15 percent of water raw materials in percentage by weight, wherein the isomaltose hypgather tablet excipient and the medicine active ingredients do not have incompatibility and reaction, in addition, the solvability is good, the flowability is good, and the medicine tablet is suitable for the direct tableting of various kinds of medicine. The invention also discloses a preparation method of the medicine tablet, which has the advantages that the preparation is simple, the implementation is easy, and the operation and the control are easy.

Description

Oligomeric isomaltose tablet excipient, medicinal tablet and preparation method
Technical field
The present invention relates to field of medicaments, relate in particular to and a kind ofly prepare oligomeric isomaltose tablet excipient directly compressible, runny, adopt the medicinal tablet of oligomeric isomaltose tablet excipient preparation and the preparation method of medicinal tablet with oligomeric isomaltose.
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.
Maltose is the disaccharidase that two glucose molecules couple together with α-1,4 glycosidic bond, and dextrinose is the disaccharidase that two glucose molecules couple together with α-1,6 glycosidic bond.Alpha-glucosidase, have another name called glucosyltransferase, be called for short alpha-glucosidase, can cut α-1 in maltose and the Fructus Hordei Germinatus oligose molecular structure, 6 glycosidic bonds, and a glucose residue that can will dissociate out transfers in another glucose molecule or maltose or the maltotriose equimolecular α-1,6, forms oligomeric isomaltoses such as dextrinose, Isomaltotriose, different maltotetraose, different maltopentaose and panose.Maltose is fermented easily, and dextrinose is non-fermentable oligosaccharide.Oligomeric isomaltose can effectively promote beneficial bacteria bifidobacterium growth breeding in the human body, so be called " positive growth factor for bifidus " again, is called for short " bifidus factor ".Oligomeric isomaltose also has low heat value, dental caries and good moisture retention.Many effect characteristics of oligomeric isomaltose make it suitable to edible for patients such as hypertension, hyperlipidemia, hyperglycemia, coronary heart disease, constipation, dental caries.
The starch octenyl succinate anhydride Chinese name is commonly called as pure glue, and it is to introduce hydrophilic on starch molecular chain simultaneously and the oleophylic amphiprotic group, has unique excellent properties, is widely used in the preparation of food processing and medical auxiliary materials.The starch octenyl succinate anhydride stable in properties can be mated with most drug, can be used as excipient, binding agent, glazing agent, water-retaining agent.It is during as microcapsule wall material, and performance is better than arabic gum and dextrin, and fiber height, heat are low, alleviate the gastrointestinal burden, take the interior blood sugar concentration of back body and obviously reduce, alleviate because of respiratory disorder, the intestines and stomach dyspepsia that blood glucose height in the body causes, reduce the probability of suffering from diabetes.It is during as film former, can prevent medicine at the gastric inactivation or reduce zest to stomach, is conducive to the compound medicine compatibility, improves dissolution rate and the bioavailability of pharmaceutical preparation, makes medicine have targeting, makes tablet have gloss.Certainly, starch octenyl succinate anhydride also can be used as binding agent, adhesive, suspending agent, thickening agent and emulsifying agent, and active component can regularly or slowly discharge, and plays long-acting, effect efficiently.
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 oligomeric isomaltose 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 oligomeric isomaltose tablet excipient, formed by following components in weight percentage content:
Figure BDA00001695056500021
Figure BDA00001695056500031
As preferably, described oligomeric isomaltose tablet excipient, formed by following components in weight percentage content:
Figure BDA00001695056500032
Oligomeric isomaltose is natural cheap material, avirulence, and have good biodegradability and biocompatibility, give oligomeric isomaltose tablet excipient of the present invention with high fluidity, high adhesion, high-hydrophilic, performance such as suitably taste, disintegrate be rapid.The general polymerization degree is 3 ~ 10 to be called oligomericly, and oligomeric isomaltose will meet GB GB/T20881-2007.
Starch octenyl succinate anhydride has good emulsifying stability and thickening power, increases product whiteness and lustrous surface, improves the product flowability, simultaneously, can play good figuration and cementation, guarantee the tablet volume stability, reduce principal agent and become the divided dose deviation, improve the compression forming of medicine.The present invention by starch octenyl succinate anhydride give oligomeric isomaltose tablet excipient of the present invention with high adhesion, high forming degree, better lubricity, better 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 oligomeric isomaltose tablet excipient of the present invention with high fluidity, high-hydrophilic, to performances such as the high absorption affinities of principal agent.In oligomeric isomaltose 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 oligomeric isomaltose tablet excipient of the present invention with performances such as suitable hardness, absorption principal agent, disintegrate are rapid.
Oligomeric isomaltose tablet excipient of the present invention mixes namely by oligomeric isomaltose, starch octenyl succinate anhydride, silicon dioxide and kaolin, wherein, oligomeric isomaltose, starch octenyl succinate anhydride, 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, oligomeric isomaltose tablet excipient and water as feedstock production, oligomeric isomaltose 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 oligomeric isomaltose 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 oligomeric isomaltose 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%;
Oligomeric isomaltose 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%;
Oligomeric isomaltose 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 oligomeric isomaltose 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 oligomeric isomaltose 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:
Oligomeric isomaltose tablet excipient of the present invention is formulated with oligomeric isomaltose, starch octenyl succinate anhydride, silicon dioxide, kaolin, wherein, oligomeric isomaltose is natural cheap material, avirulence, and have good biodegradability and biocompatibility, give oligomeric isomaltose tablet excipient of the present invention with high fluidity, high adhesion, high-hydrophilic, performance such as suitably taste, disintegrate be rapid; Starch octenyl succinate anhydride give oligomeric isomaltose tablet excipient of the present invention with high adhesion, high forming degree, better lubricity, better release property, preserve moisture but non-hygroscopic, hardness is moderate, be fit to performances such as direct compression; Silicon dioxide is given oligomeric isomaltose 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 oligomeric isomaltose 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, oligomeric isomaltose tablet excipient and water as feedstock production, oligomeric isomaltose 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:
Figure BDA00001695056500051
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 2
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
Figure BDA00001695056500061
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 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 ?19.0kp ?0.12% ?0.13%
30000 slices/hour ?19.7kp ?18.7kp ?0.14% ?0.14%
50000 slices/hour ?19.4kp ?19.0kp ?0.13% ?0.13%
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:
Figure BDA00001695056500062
Figure BDA00001695056500071
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 4
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
Figure BDA00001695056500072
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 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 ?18.2kp ?18.5kp ?0.15% ?0.15%
30000 slices/hour ?18.2kp ?18.4kp ?0.13% ?0.15%
50000 slices/hour ?18.1kp ?18.3kp ?0.14% ?0.14%
Under different tabletting speed, the crushing strength of sheet C and sheet D all meets 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 oligomeric isomaltose 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:
Figure BDA00001695056500081
The 2mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 6
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
Figure BDA00001695056500082
The 0.5mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 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 ?19.0kp ?19.8kp ?0.14% ?0.12%
30000 slices/hour ?18.9kp ?19.8kp ?0.15% ?0.14%
50000 slices/hour ?18.9kp ?19.6kp ?0.15% ?0.13%
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:
Figure BDA00001695056500091
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 8
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
Figure BDA00001695056500092
Figure BDA00001695056500101
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 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 ?18.6kp ?18.9kp ?0.13% ?0.14%
30000 slices/hour ?18.5kp ?18.8kp ?0.15% ?0.14%
50000 slices/hour ?18.5kp ?18.8kp ?0.15% ?0.15%
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:
Figure BDA00001695056500102
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 2%) the BONEFOS medicinal tablet.
Embodiment 10
A kind of BONEFOS medicinal tablet, adopt following raw materials by weight percent:
Figure BDA00001695056500111
The 1mm sieve will be crossed behind oligomeric isomaltose, starch octenyl succinate anhydride, 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 1185mg(± 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 ?19.2kp ?19.2kp ?0.15% ?0.13%
30000 slices/hour ?19.0kp ?18.9kp ?0.14% ?0.16%
50000 slices/hour ?18.8kp ?18.8kp ?0.16% ?0.16%
Embodiment 9 and embodiment 10 difference from Example 1 are, the proportioning of medicinal tablet, and namely the content of oligomeric isomaltose 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 oligomeric isomaltose of the present invention to be equipped with starch octenyl succinate anhydride, silicon dioxide, kaolinic oligomeric isomaltose tablet excipient tabletting prepares the BONEFOS medicinal tablet, because each component has been given BONEFOS medicinal tablet fine solubility in this oligomeric isomaltose 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 (8)

1. oligomeric isomaltose tablet excipient, formed by following components in weight percentage content:
Oligomeric isomaltose 88% ~ 96%;
Starch octenyl succinate anhydride 1% ~ 5%;
Silica 1 % ~ 5%;
Kaolin 1% ~ 5%.
2. oligomeric isomaltose tablet excipient according to claim 1 is characterized in that, is made up of following components in weight percentage content:
Oligomeric isomaltose 91% ~ 94%;
Starch octenyl succinate anhydride 2% ~ 3%;
Silicon dioxide 2% ~ 3%;
Kaolin 2% ~ 3%.
3. a medicinal tablet is characterized in that, is made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Claim 1 or 2 described oligomeric isomaltose tablet excipients 5% ~ 15%;
Water 5% ~ 15%.
4. medicinal tablet according to claim 3 is characterized in that, is made by following raw materials by weight percent:
Active constituents of medicine 75% ~ 85%;
Claim 1 or 2 described oligomeric isomaltose tablet excipients 6.5% ~ 13.5%;
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 80%;
Claim 1 or 2 described oligomeric isomaltose tablet excipients 10%;
Water 10%.
6. according to claim 3,4 or 5 described medicinal tablets, it is characterized in that described active constituents of medicine is BONEFOS.
7. according to the preparation method of each described medicinal tablet of claim 3 ~ 6, may further comprise the steps:
With crossing 0.5mm ~ 2mm sieve after the oligomeric isomaltose tablet excipient drying and crushing, add active constituents of medicine and water mix homogeneously then, behind tabletting, obtain medicinal tablet.
8. the preparation method of medicinal tablet according to claim 7 is characterized in that, will cross 0.5mm ~ 1mm sieve after the oligomeric isomaltose tablet excipient drying and crushing.
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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

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