CN1054008A - Be used to make the particulate preparation method of tablet - Google Patents

Be used to make the particulate preparation method of tablet Download PDF

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Publication number
CN1054008A
CN1054008A CN 91100614 CN91100614A CN1054008A CN 1054008 A CN1054008 A CN 1054008A CN 91100614 CN91100614 CN 91100614 CN 91100614 A CN91100614 A CN 91100614A CN 1054008 A CN1054008 A CN 1054008A
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Prior art keywords
tablet
film
kollag
granule
making liquid
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CN 91100614
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Chinese (zh)
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斯蒂恩·卡斯顿·玛蒂尼
布雷安·克努森
本特·帕姆奎斯特
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Ferrosan ApS
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Ferrosan ApS
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Abstract

Be used to make the particulate preparation method of tablet, wherein will contain the cane sugar powder granulating of kollag, to prevent that cane sugar powder changes into caramel in the tablet molding afterwards with a kind of film-making liquid.

Description

Be used to make the particulate preparation method of tablet
The present invention relates to a kind of particulate preparation method that is used to make tablet, said method comprises by film-making liquid makes the sweetening agent powder particlesization, and this granule is modulated at kollag.
Preparing various tablets, as with the vitamin and the mineral tablets that comprise active constituent and sweetening agent (as sorbitol and/or xylitol) granule made, has been technique known.This sweetening agent is used in particular for mouth and chews tablet, chews tablet in particular for the mouth of children taking.This sweetening agent also is used to reduce the reactivity of active constituent except that producing sweet taste.
The major defect of sorbitol and xylitol is that these components cost an arm and a leg, and owing to have only industrialized country to produce basically, so the raw material difficulty of drawing materials.
Attempted in tablet, replacing sorbitol and xylitol with sucrose.Sucrose is by the sugar beet that can grow in the temperate zone or subtropical zone or extracts in the sugar cane of torrid zone growth.Therefore sucrose is a kind of product that most place is buied easily in the world.
Also attempted, at first the powder that is obtained with pulverizing active constituent, Icing Sugar and a kind of film-making liquid (being the mixture of a kind of water, animal glue and ethanol) is made the tablet that contains sucrose.Wherein, Icing Sugar is added in the above-mentioned film-making liquid, dries the moisture content of removing wherein then and obtain granule.
When making tablet with this granule, produce the friction heat-flash, this mould that will cause making tablet is subjected to heat-flash, finally causes occurring first Icing Sugar and be converted into caramel in the time after a while.
Sugar is converted into caramel and not only hinders production, and because pyrogenic sugar is bonded on the metal firmly, institute is so that to make the cleaning of mould of tablet very difficult.
Also attempted, in this granule, added a spot of lubricant or kollag (as various forms of stearate), and be not subjected to local heat-flash and cause Icing Sugar to change into the danger of caramel but also eliminate this granule.
The content that increases kollag can reduce or eliminate the danger that sugar changes into caramel, but this causes the strength characteristics with the tablet difference of this mixtures of material made.
The method according to this invention is characterized in that with sucrose as sweeting agent, and at film-making liquid with before cane sugar powder contacts, kollag is mixed with film-making liquid.
The present invention is based on a kind of like this understanding, promptly by the mixing of kollag in film-making liquid, make kollag uniform distribution on each sucrose granules surface, be not distributed in each particulate surface and do not resemble the said method, distribution after the described improvement has reduced friction significantly, thereby has reduced the suffered heat of film-making mould when making tablet with this granular materials.
The improved distribution of kollag also produces further advantage, and promptly the active constituent of low compressive strength becomes and more easily makes tablet, and the reactivity of active constituent is lowered, and this is because realized the part of these components is sealed in kollag.The part of this active constituent is sealed and has been improved the possible stink of these components and the coverage of foul smell, and has increased the durability of the tablet of making thus.
When making tablet with the prepared according to the methods of the invention granular materials, preparation contains the not production problem of tablet up to the sucrose of 95% weight ratio, and promptly by weight, tablet contains sucrose 40-95%, content of mineral substances 2-55%, vitamin content 0.5-15%.
The particle size of used cane sugar powder is preferably less than 100 μ m in the inventive method.
For preventing cane sugar powder bonding, thereby reduce the distribution of the kollag on each particle surface, should add 1-5% by weight, preferably about 3% caking inhibiter is as starch flour.
Preferably water at will mixes with a kind of component (as ethanol) that reduces the solubility of sucrose in film-making liquid as a kind of film-making liquid.This film-making liquid also can arbitrarily comprise a kind of bonding agent, and as animal glue, its content accounts for 1-20% by weight, and the consumption of this film-making liquid is by weight preferably counting 5-20% with siccative weight.
As a kind of kollag, adopt a kind of ester of acid, especially a kind of fatty acid and a kind of polyhydroxy-alcohol are as a kind of sugar alcohol.The consumption of this kollag is by weight the 0.5-20% that preferably accounts for film-making liquid, and especially the antiseize paste of Tui Jianing is monoglycceride, bisgallic acid glyceride and the triglyceride of fatty acid.Lecithin is a kind of kollag of especially recommending.
The mixture of active constituent and the granulating of cane sugar powder can be finished by known granulation machine, then basin or on a fluid bed granule to 40 of dry gained to 60 ℃ final temperature.The granule of Xing Chenging preferably screened before making tablet therefrom, to isolate the granule of unwanted granularity.
Method of the present invention is particularly useful for making the preparation of containing material of the mineral of tablet, and can be used as mineral contained in the tablet is ferrous fumaric acid, zinc oxide, ammonium molybdate, manganese sulfate, copper oxide, chromic acid, sodium selenate and calcium hydrogen phosphate.Single a kind of mineral, for example ferrous fumaric acid, or the mixture of two or more mineral also can use.
In addition, method of the present invention is particularly useful for making the particulate preparation of the tablet that contains vitamin.
Those vitamin kinds that raw material constituted of being pulverized by needs are vitamin Bs 1, B 2, B 6, C and Folie Acid and vitamin PP.
The vitamin granule that the containing material of the mineral that the present invention is prepared is suitable and the present invention is prepared mixes mutually, to prepare a kind of granulate mixture that comprises the tablet of minerals and vitamins.
Mineral or the vitamin that is comprised in the binding capacity of cane sugar powder and the tablet do not mixed sometimes, but only prepare a kind of part sucrose particles of powder that comprises, and remainder is added in the aforesaid granule with the another kind of sucrose granules form of selecting form.
In addition, preferably only prepare the powder that constitutes by sucrose, and this cane sugar powder was being mixed mutually with one or more active constituents before tablet.
Containing vitamin A, D, E, B in a large number 12And/or known additive, as silicon dioxide, Talcum, corn starch, methylcellulose, stearate, citric acid, the tablet of the synthetic sweetener of odor additive and selection (as aspartame) can add this granule before making.
Below with reference to following example the present invention is explained in detail.
Example 1
A. the preparation of film-making liquid:
The water of 58.6 grams is heated to about 60 ℃, adds the animal glue and the stirring of 13.1 grams then, continuous stirring is dissolved in the water until animal glue.
Mixture 10.1 grams of fatty acid monoglycceride, bisgallic acid glyceride and triglyceride are suspended in the aqueous solvent of preparation, and vigorous stirring.With about the liquid cools to 40 of this preparation ℃, add the ethanol additive and the water of 18.2 grams then, finally obtain the liquid of total amount 100 grams.
The component of representing with percentage ratio below the film-making liquid for preparing has:
Animal glue 13.10% percentage by weight
Ethanol 18.20 percentage by weights
Glyceride 10.10 percentage by weights
Water 58.10 percentage by weights
B. the preparation of sucrose granules
Average particle size stirs in the agitating device of a KA-70 type " happy Wanda's multipotency agitator " (ROwenta Multimixer) with 1400 rev/mins mixing speed less than the cane sugar powders of 500 grams of 100 μ m.In 1 minute, add the above-mentioned film-making liquid of 45 grams, and under 1400 rev/mins rotating speed granulating 1 to 2 minute, resulting granules is injected basin, under the temperature about 60 ℃ dry 4 hours.Dried granule screens to tell coarse grain with the sieve of the wide 1mm of mesh.
The granule of gained has following characteristic:
Mass density (loose) g/cm 30.62
Hausner ratio 1.15
Sand glass 8mm 2), second 14
Screening is analyzed:
>1.25mm,% 0.1
>0.8mm,% 18.5
>0.4mm,% 17.2
>0.2mm,% 20.5
>0.125mm,% 20.2
>0.063mm,% 19.5
<0.063mm,% 4.0
Amount to, % 100
1) the Hausner ratio that drawn of the ratio of the mass density under mass density under the loose condition and closely knit condition is the measured value to particulate flow behavior.
2) with sand glass the method granule that draws specified rate be 8 from the funnel bore MmFunnel in the effusive time, this time is the measured value of this particle flow characteristics.
In a mixing arrangement, the granule and 9.45 that 914 grams are so obtained restrains ground Sio 2(Aerosil
Figure 911006141_IMG1
) mixed 10 minutes, fatty acid monoglycceride, bisgallic acid glyceride and triglyceride (" Boeson VP ") and 5.65 gram stearic acid granules that 15.60 grams are pulverized add in the said mixture, continue to mix 5 minutes again.With the speed of 50 of per minutes the mixture that is obtained is made tablet then, thereby make the molding tablet of heavy 945 grams.
The molding of tablet does not have difficulty, and resulting tablet has following wearability and ultimate strength:
Wearability 3), % 0.70
Ultimate strength, N 88.3
3) wearability with the regulation 25 rev/mins, the relative loss of weight is represented in 4 minutes the abrasion test.
Comparative example:
Repeat example 1 with the film-making liquid that does not contain kollag, resulting granules has following characteristic:
Mass density (loose), g/cm 30.62
Hausner ratio 1.15
Sand glass, 8mm, second 14
Screening is analyzed
>1.25mm,% 1.0
>0.8mm,% 16.0
>0.4mm,% 18.0
>0.2mm,% 21.0
>0.125mm,% 20.0
>0.063mm,% 19.5
<0.063mm,% 4.0
Amount to, % 100.0
This granule has good flow behavior and compression property, promptly must stop rapidly but basically form tablet, because just be bonded on the tablet mould, be caramel thereby cause sucrose inversion first at this tablet after the very short time.
Example 2
Repeat example 1 with lecithin as kollag in film-making liquid, resulting tablet has following characteristic:
Mass density (loose), g/cm 30.66
Hausner ratio 1.11
Sand glass, 8mm, second 8
Screening is analyzed:
>1.25mm,% 0.2
>0.8mm,% 21.9
>0.4mm,% 21.8
>0.2mm,% 29.8
>0.125mm,% 12.8
>0.063mm,% 9.7
<0.063mm,% 3.8
Amount to, % 100.0
The molding of tablet does not have difficulty and the tablet made has following strength characteristics:
Wearability, % 0.60
Ultimate strength, N 92.2
Example 3
Use two kinds of other kollags, as use the glycerol-stearic acid (routine 3a) of 5% concentration that is directly proportional with film-making liquid weight and glycerol three stearic acid (routine 3b) to repeat example 1, the tablet that is obtained has following characteristic:
Example 3a example 3b
Mass density (loose), g/cm 30.61 0.58
Hausner ratio 1.17 1.15
Sand glass, 8mm, second 13 14
Screening is analyzed:
>1.25mm,% 5.7 6.9
>0.8mm,% 27.2 31.3
>0.4mm,% 17.5 18.0
>0.2mm,% 20.9 19.6
>0.125mm,% 12.9 11.3
>0.063mm,% 12.3 10.6
<0.063mm,% 3.4 2.5
Amount to, % 100.0 100.0
The molding of this particulate tablet does not have difficulty and this tablet has following characteristic:
Example 3a example 3b
Wearability, % 0.77 0.35
Ultimate strength, N 85.32 91.20
The water activity, % 40.0 40.0
Example 4
As a kind of sugared granule of example 1 described preparation, and this granule mixed mutually with the vitamin E of doing, the amount of vitamin E should make the tablet made from this mixture contain 00 milligram of vitamin e1.
With resulting mixture make tablet do not have the difficulty and resulting tablet have following characteristic:
Wearability, % 0.7
Ultimate strength, N 108.85
The water activity, % 40.0
Example 5
As a kind of granule of example 1 described preparation, wherein only contain sucrose and Aspirin, pulverize the sucrose of 222.20 grams and the Aspirin of 277.80 grams with the film-making liquid of 35.30 grams, when in tablet, containing a large amount of Aspirins, the molding of tablet will have problem, and this is well-known.
The Sio that the above-mentioned sucrose-salicylic acid granule of 914 grams and 9.45 grams are pulverized 2(Aerosil
Figure 911006141_IMG2
) in a mixing arrangement, mixed about 10 minutes, the stearic acid powder that adds fatty monoglycceride, bisgallic acid glyceride, triglyceride (" Boeson VP ") and 5.69 grams of 15.60 grams then, remix is 5 minutes subsequently, is tablet with this mixture forming with DIAF tablet make-up machine rapidly with 50 of per minutes.
The molding of tablet does not have difficulty and resulting heavy 945 milligrams tablet has following characteristic:
Wearability, % 0.07
Ultimate strength, N 108.85
The water activity, % 40.0
Example 6
Prepare a kind ofly, and have 5 kinds of granules of following component with the preparation of this film-making liquid as example 1 described film-making liquid:
Ⅰ Ⅱ Ⅲ Ⅳ Ⅴ
Film-making liquid, kg 18.6 20.2 16.2 12.0 18.6
The Icing Sugar end, kg 245.7 183.2 183.2 204.4 84.4
Ferrous fumaric acid, kg 62.5
Zinc oxide, kg 62.5
Vitamin B 6, kg 3.75
Vitamin PP, kg 37.5
Dicalcium phosphate, kg 161.3
The alcohol-water mixture, kg 1.9 6.7
In a rotating cylinder mixing arrangement with these solid constituent dry blending 2 minutes; in 3 to 4 minutes, add film-making liquid then; make granule with this; in following table in the listed fixed time; along with the selection of the mixture of ethanol and water is added; with the said mixture granulating, the granule that is obtained is dry under the listed assigned temperature in table, and dried granule is with the mesh screen sorting of the wide 1.2mm of mesh.
Ⅰ Ⅱ Ⅲ Ⅳ Ⅴ
The pulverizing time, divide 234 0.8 2
Dry
Inlet temperature, ℃ 70 70 70 70 70
Outlet temperature, ℃ 60 60 57 50 59
So the granule of preparation has following characteristic:
Ⅰ Ⅱ Ⅲ Ⅳ Ⅴ
Mass density (loose), g/cm 30.84 0.86 0.95 0.75 1.01
Mass density (compacting), g/cm 30.99 1.02 1.10 0.90 1.16
Sand glass, 8mm, second 17 13 12 25 12
Screening is analyzed:
Ⅰ Ⅱ Ⅲ Ⅳ Ⅴ
>1.25mm,% 3.1 2.5 0.9 0.4 2.4
>0.8mm,% 16.4 16.1 8.9 7.6 15.8
>0.4mm,% 19.3 15.9 18.3 13.4 15.3
>0.2mm,% 12.0 9.4 21.5 10.7 17.5
>0.125mm,% 10.9 18.1 20.7 12.4 21.4
>0.063mm,% 25.2 31.9 24.3 37.7 18.9
<0.063mm,% 13.0 6.0 5.4 17.9 8.8
Amount to, % 100.0 100.0 100.0 100.0 100.0
With above-mentioned granule and some not granular compositions, prepare a kind of mixture, have following composition with the tablet of its made:
Dried vitamin A * * 6.64kg
Dried vitamin D 3100** 4.73kg
Ferrum granule (granule II) * * 103.36kg
Zinc granule (granule III) * * 49.88kg
Vitamin granule (granule IV) * * 79.47kg
Sugar granule (granule I) * * 5.40kg
Calcium granule (granule V) * * 666.67kg
Cherry flavor * * 12.00kg
Thiamine mononitrate * 1.16kg
Vitamin B 2* 1.20kg
Vitamin C * 30.00kg
Silicon dioxide * 10.00kg
Aspartame* 1.00kg
Citric acid water compound * * * 6.00kg
Fatty acid monoglycceride, bisgallic acid glyceride
Triglyceride (" Boeson VP ") * * * 16.5kg
Stearic acid * * * 6.00kg
Amount to 1000.00kg
The component that indicates * is represented the sieve that it has passed through the wide 1mm of mesh and was mixed 15 minutes with the component that indicates * * in a garden awl mixer.
The component that indicates * * * represents that it has passed through the sieve of the wide 1mm of mesh and mixed 30 minutes with said mixture.
With about per hour speed of 300.000, the mixture that is obtained is made tablet with a Manesty Ratapress MK IV type tablet make-up machine.
The molding of tablet does not have difficulty, and resulting tablet has following characteristic:
Weight change 1%
Ultimate strength 78-98N
Wearability<1%
Various vitamins stability are packed tablet by polyvinyl-chloride foam material, it is stored under 25 ℃ of temperature, and checks that after official hour remaining vitamin content measures.
The result of aforementioned stable test is as shown in the table:
The vitamin addition, the % surplus, % is after the month
0 month 6 months March, December was 18 months 24 months
A 140 137 130 119 120 118 109
D 130 127 127 133 132 120 119
B 1110 106 111 103 101 106 96
B 2100 99 97 91 91 100 97
B 6100 104 96
Vitamin PP 100 90 104
C 100 102 101 100 100 98 102
Outward appearance carefully
Aroma and flavor carefully
Find out that from top detected tablet this tablet has gratifying durability.

Claims (10)

1, a kind of particulate preparation method that is used to make tablet; said method comprises utilizes a kind of film-making liquid with a kind of sweetening agent powder particlesization; this granule is in harmonious proportion mutually with a kind of kollag; it is characterized in that with cane sugar powder as sweetening agent, and film-making liquid with earlier kollag is sneaked in the film-making liquid before the sucrose powder contacts.
2, according to the method for claim 1, the granularity that it is characterized in that used cane sugar powder is less than 100 μ m.
3,, it is characterized in that containing in the used cane sugar powder 1% to 5% anti-bonding agent by weight percentage according to the method for claim 1 or 2.
4, according to each method in the claim 1 to 3, it is characterized in that used film-making liquid contains bonding agent.
5, according to the method for above-mentioned each claim, it is characterized in that with lecithin as kollag.
6,, it is characterized in that fatty acid ester with polyhydric alcohol is as kollag according to the method for above-mentioned each claim.
7, according to the method for above-mentioned each claim, the consumption that it is characterized in that kollag is the 0.5-20% percentage by weight of film-making liquid.
8,, it is characterized in that before pulverizing, cane sugar powder being mixed with one or more mineral according to the method for above-mentioned each claim.
9,, it is characterized in that before pulverizing, the sucrose powder being mixed with one or more vitamin according to each method in the claim 1 to 7.
10,, it is characterized in that before pulverizing, cane sugar powder being mixed with at least a mineral and at least a vitamin according to the method for above-mentioned each claim.
CN 91100614 1989-12-22 1990-12-21 Be used to make the particulate preparation method of tablet Pending CN1054008A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK659389A DK162506C (en) 1989-12-22 1989-12-22 PROCEDURE FOR THE PREPARATION OF A TABLETABLE GRANULATE
DK6593/89 1989-12-22

Publications (1)

Publication Number Publication Date
CN1054008A true CN1054008A (en) 1991-08-28

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DK (1) DK162506C (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI101039B (en) * 1992-10-09 1998-04-15 Eeva Kristoffersson Method for preparing medicated pellets

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Publication number Publication date
DK162506C (en) 1992-03-30
DK659389A (en) 1991-07-09
DK659389D0 (en) 1989-12-22
DK162506B (en) 1991-11-11

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