CN1066780A - Capsule filling small, micro tablet producing technology - Google Patents
Capsule filling small, micro tablet producing technology Download PDFInfo
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- CN1066780A CN1066780A CN 91107391 CN91107391A CN1066780A CN 1066780 A CN1066780 A CN 1066780A CN 91107391 CN91107391 CN 91107391 CN 91107391 A CN91107391 A CN 91107391A CN 1066780 A CN1066780 A CN 1066780A
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- small
- tablet
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- sized
- capsule
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Abstract
The present invention relates to the preparation technology of a kind of capsule filling small, micro chip.Bioactive ingredients is added adjuvant, and directly to be pressed into or to be pressed into diameter with special drift punch die behind wet granulation be 0.5～7.5mm, and sheet weighs small-sized, the micro chip of 1～500mg, thin membrane coated tablet.Be separated by in certain sequence with small-sized, miniature plain sheet, coated tablet, coating sustained-release tablet, matrix type controlled release tablet or the film coating framework controlled release tablets made or with powdered drug, adjuvant and granule preparation or mixing is packed in the capsule.This technology can be divided the compound preparation that is separated with incompatibility, gets rid of to analyze and disturbs, and preparation is specious, and patient takes medicine conveniently, and the ratio between rapid release and slow release is easily regulated.
Description
The invention relates to capsule fill process, particularly capsule filling small, micro tablet producing technology that health care is used.
Drug therapy is normally filled in gelatin glue shell with capsule and is contained medicine powder, piller, granule or other granule preparation.Yet the compound preparation that is filled with incompatibility will interact, and the mutual interference of medicine phase often takes place content analysis.Current, preparation medicament slow release, Extencap preparation technology are packed in the glue shell after normally medicine being made controlled release piller or granule, and medicine is lossy during production, and the response rate is not high, and the ways and means of regulating rate of releasing drug is less.
The objective of the invention is to overcome the deficiency that above-mentioned capsule preparation technology exists, provide a kind of and divide the bioactive ingredients that is separated with incompatibility, phase mutual interference and control bioactive ingredients effectively and in a period of time, continue the capsule fill process that discharges when getting rid of compound preparation bioactive ingredients assay.
The present invention implements by following method.Get one or more bioactive ingredients respectively or grouping add diluent and absorbent (as starch, Icing Sugar, lactose, glucose, mannitol, calcium sulfate, calcium hydrogen phosphate and tricalcium phosphate etc.), disintegrating agent is (as microcrystalline Cellulose, cellulose derivative such as low-substituted hydroxypropyl cellulose and hydroxypropyl emthylcellulose, modified starch, surfactant, silicide and polyvinylpyrrolidone etc.), dry adhesives (as dextrin and amylum pregelatinisatum etc.), lubricant is (as stearic acid and salt or ester, fatty acid ester and hydrogenated vegetable wet goods hydrophobic auxiliary, water soluble adjuvant such as Polyethylene Glycol and sodium benzoate), fluidizer (as inorganic matters such as Pulvis Talci and micropowder silica gels) and do not add as required or add other additive (as the pigment of different colours, buffer agent and effervescent etc.) directly be pressed into special drift punch die respectively, or add wetting agent (as water, ethanol or rare machine solvent) or wet binder (as starch slurry, 0.1～30% polyvinyl alcohol, polyvinylpyrrolidone or Gonak, concentration with 2～10% for good) adding fluidizer behind wet granulation, to be pressed into diameter respectively be that 0.5～7.5mm(is good with 3～6.5mm), it is good with 15～150mg that sheet weighs 1～500mg() small-sized, micro chip.By weight, contain bioactive ingredients in the tablet and account for 0.01～99%, adjuvant and additive are 99.99～1%.Small-sized, the micro chip list kind dosage form made contain with a kind of bioactive ingredients, or make the single dosage form of planting that contains multiple different bioactive ingredients respectively.With the gastric solubility thin film coating material of one or more same concentration or variable concentrations (as methylcellulose, cellulose derivative such as hydroxypropyl cellulose and hydroxypropyl emthylcellulose stomach function regulating soluble acrylic resin), insoluble micropore or enteric film coating material are (as cellulose acetate, ethyl cellulose, Cellulose Acetate Phthalate, cellulose derivatives such as hydroxypropyl methylcellulose phthalate, enteric solubility acrylic resin or latex aqueous dispersion separately) to small-sized, one or more layers thin film of micro chip bag.Can contain one or more and the intracardiac contained identical or different bioactive ingredients of sheet in the coating solution.
Discharge for delaying bioactive ingredients, can adopt above-mentioned coating material and coating method control coating thickness and (or) add film porogen (as soluble high molecular polymers such as methylcellulose and low molecular polies) amount.Also can in sheet heart prescription, add waxiness (alcohol, acid, ester (salt) or the amide that contain C8～C30 as stearic acid, Cera Flava, castor wax, octadecanol and Brazil wax etc.) one or more mixed matrix materials of insoluble (as high molecular polymers such as ethyl cellulose, polyethylene, polypropylene and polysiloxanes) or hydrophilic gel matrix material (as pectin and natural gel such as alginic acid and salt thereof, methylcellulose, carboxymethyl cellulose or cellulose derivatives such as its salt and hydroxypropyl emthylcellulose, polyvinyl alcohol, carbopol, modified starch and acrylic resin etc.)., micro chip film coating small-sized to matrix type can further be controlled the bioactive ingredients rate of release.
With above-mentioned contain with one or more small-sized, miniature plain sheets, coated tablet, coating sustained-release tablet, matrix type controlled release tablet or the film coating matrix tablet of one or more different bioactive ingredients by weight 1～10: 10～1 or 1～10: 10～1: 1～10 or 1～10: 10～1: 1～10: 10～1 or 1～10: 10～1: 1～10: 10～1: 1～10 be separated by or mix after be packed in the capsule.Also can with various small-sized, micro tablets and granule preparations such as powdered drug, adjuvant, powder or piller by weight 1～100: 100～1 be separated by or mix after be packed in the capsule.Medicine phase mutual interference when being separated with incompatibility eliminating assay for branch, existing immediate release section has purposes such as the sustainable delivery of biologically active composition of slow-released part and convenient drug administration again, in certain sequence successively with true qualities or have the implant of different colours to be packed into No. 5 to No. 000 or the capsule of special size (with No. 0 for good) in.The glue shell is made with macromolecular materials such as gelatin, alginic acid or its salt or acrylic resin or its mixture.
Capsule filling small, micro chip except that above-mentionedly divide the compound preparation that is separated with incompatibility, when getting rid of assay the mutual interference of bioactive ingredients phase, also can make hospital multiple medicine be put into a capsules by prescription, by the individual administration patient of state of an illness taking convenience, preparation is specious.One capsules is filling miniature, miniature plain sheet, coated tablet and various types of controlled release preparation simultaneously, makes that bioactive ingredients is long-time in gastrointestinal tract to continue release, and bioavailability height, individual variation are little, and the ratio between rapid release and slow release is easily regulated.Capsule is filled micro chip bioactive ingredients content height, and preparation yield height is easier than the production of granule preparations such as filler particles and piller, has also increased several different methods means such as control bioactive ingredients rate of release such as adjustment sheet amount and diameter.
Example one capsule is filled multidimensional gold minitablets
The grouping of 16 kinds of bioactive ingredients is pressed into 6 kinds of minitablets that diameter is 5.5mm and 6.5mm (dividing another name I, II, III, IV, V and VI sheet) respectively, is packed into No. 0 capsule successively by the order of I～VI.
1. the I minitablets is write out a prescription and technology
(1) prescription: potassium iodide 200mg, vitamin B
125mg, calcium pantothenate 20g, sodium chloride 37g.
(2) film-making technology: potassium iodide is added the low amounts of water dissolving; Vitamin B
12With the small amount of ethanol dissolving, add calcium pantothenate and sodium chloride behind the mixing, granulate behind the mixing.In 60 ℃ of baking ovens, dry, cross 40 mesh sieves, be pressed into the pink tablet that 1000 diameters are 5.5mm.
2. the II minitablets is write out a prescription and technology
(1) prescription: vitamin B
15.15g, vitamin B
25.0g, vitamin B
62.05g, nicotiamide 50g, dextrin 0.25g, starch 0.75g.
(2) film-making technology: with the material mixing, granulate with 50% alcoholic solution, dry in 60 ℃ of baking ovens, being pressed into 1000 diameters is the yellow tablet of 6.5mm.
3. the III minitablets is write out a prescription and technology
(1) prescription: Catergen 00g, dextrin 20g and Pulvis Talci are an amount of.
(2) film-making technology: behind above-mentioned material mixing, sieve, directly being pressed into 1000 diameters is 6.5mm white tablet.
4. the IV minitablets is write out a prescription and technology
(1) prescription: ferrous fumarate 36.5g, magnesium oxide 108g, copper sulfate 7.8g, zinc sulfate 6.6g, manganese sulfate 3.1g and starch 20.0g.
(2) tablet technology: with the material mixing, granulate with 1% poly-vinyl alcohol solution, after the oven dry, being pressed into 1000 diameters is 6.5mm light gray tablet in 60 ℃ of baking ovens.
5. the V minitablets is write out a prescription and technology
(1) granule prescription: 82 parts of vitamin Es, 100 parts in gelatin, 200 parts of sucrose, 300 parts in water and corn starch are an amount of.
(2) granulating process: gelatin expanded in water spend the night, next day, heating in water bath made whole dissolvings, added after sucrose makes its dissolving, and vitaminize E makes granule.
(3) tablet formulation: vitamin e1 5g, Celluloasun Microcrystallisatum 12g, dextrin 8g and Pulvis Talci are an amount of.
(4) film-making technology: with the above-mentioned raw materials mixing, being pressed into 1000 diameters after sieving is 6.5mm off-white color tablet.
6. the VI minitablets is write out a prescription and technology
(1) granule prescription: 40 parts of vitamin A, 0.13 part of vitamin D, 100 parts in gelatin, 300 parts of sucrose and corn starch are an amount of.
(2) granulating process: gelatin expanded in water spend the night, next day, heating in water bath made dissolving, with sucrose, stirred and made dissolving back vitaminize A and D, made granule then.
(3) tablet formulation: vitamin A granule 3g, vitamin D granule 10mg, dextrin 8g, microcrystalline Cellulose 12g and Pulvis Talci are an amount of.
(4) film-making technology: with above-mentioned material mixing, cross 20 mesh sieves, the ecru tablet that to be pressed into 1000 diameters be 5.5mm.
Example two capsules are filled cefalexin controlled micro sheet
Get cefalexin powder 8g, starch 1g, hydroxypropyl cellulose 1g and an amount of mixing of Pulvis Talci, behind starch slurry wet granulation drying, granulate, being pressed into diameter is the miniature plain sheet of the heavily about 18mg of 3mm, sheet.With 2～5% Cellulose Acetate Phthalate solution coatings, get miniature enteric coatel tablets.By weight, get 30% miniature plain sheet and 70% miniature enteric coatel tablets mixing is packed in the hard capsule, every capsules contains principal agent 250mg.
The miniature coating sustained-release tablet of the filling chlorinated potassium of example three capsules
An amount of mixing direct compression of potassium chloride 1g and Pulvis Talci, diameter is 3mm, the heavily about 20mg of sheet.Be packed in the hard capsule add the acetone soln coating of 10% Macrogol 4000 with 5～10% cellulose acetate after, every capsules contains potassium chloride 250mg.
Example four capsules are filled the miniature framework controlled release tablets of ibuprofen
Get ibuprofen 7g, stearic acid 0.5g and an amount of mixing of magnesium stearate, granulate with 2% polyvinyl alcohol liquid, drying adds the micro tablet that magnesium stearate is pressed into diameter 3mm, and sheet weighs 10～20mg, is packed in the hard capsule.Every capsules contains ibuprofen 100mg.Adjustment sheet heavily reaches stearic acid dosage may command drug release time.
Example five capsules are filled the miniature controlled release tablet of pyrazinamide
Get pyrazinamide 14g and stearic acid 1g mixing, granulate with 2% poly-vinyl alcohol solution, drying adds the micro tablet that magnesium stearate is pressed into diameter 3mm, and sheet weighs 10～30mg, is packed in the capsule, and every capsules contains medicine 200mg.
Claims (10)
1, a kind of capsule filling small, micro tablet producing technology, it is characterized in that with bioactive ingredients respectively or grouping add diluent, absorbent, disintegrating agent, dry adhesives, lubricant, fluidizer and (or not adding) other additive, directly be pressed into special drift punch die respectively or add wetting agent or wet binder and behind wet granulation, add fluidizer and be pressed into small-sized, micro chip, use the thin-film material coating, discharge in order to delay bioactive ingredients, can adopt the thin-film material coating or in sheet heart prescription, add framework material, make further sustained release speed of film coating matrix tablet, with above-mentioned make small-sized, miniature plain sheet, coated tablet, coating sustained-release tablet, matrix type controlled release tablet or the agent of film coating framework controlled release tablets list kind are in certain sequence successively, or it is each dosage form is mixed in certain sequence successively or mutually by weight, or various types of small-sized, micro chip and powdered drug, adjuvant, granule preparation such as powder or piller is separated by or mixing is packed in the capsule.
2, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that small-sized, the micro chip diameter that are pressed into are that 0.5～7.5mm(is good with 3～6.5mm), it is good with 15～150mg that sheet weighs 1～500mg().Small-sized, micro chip list kind dosage form contains with a kind of bioactive ingredients or makes the single dosage form of planting that contains the biological being composition of multiple difference respectively.By weight, bioactive ingredients accounts for 0.01～99% in small-sized, the micro tablet, and adjuvant and additive are 99.99～1%.
3, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that one or more small-sized, miniature plain sheets, coated tablet, coating sustained-release tablet, matrix type controlled release tablet or film coating matrix tablet be separated by or mix after be packed in the capsule, each dosage form is 1～10: 10～1 or 1～10: 10～1: 1～10 or 1～10: 10～1: 1～10 by weight: 10～1 or 1～10: 10～1: 1～10: 10～1: 1～10.Various small-sized, micro tablets and granule preparations such as powdered drug, adjuvant, powder or piller are 1～100: 100～1 by weight.
4, by the described the sort of capsule filling small of claim 3, micro tablet producing technology, it is characterized in that for branch is separated with incompatibility, medicine phase mutual interference when getting rid of assay, existing immediate release section has purposes such as the sustainable delivery of biologically active composition of slow-released part and convenient drug administration again, in certain sequence successively with true qualities or have the implant of different colours to insert in the capsule
5, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that the capsule size that is packed into is No. 5 to No. 000 or special size, is good with No. 0.The glue shell is made with macromolecular materials such as gelatin, alginic acid or its salt or acrylic resin or its mixture.
6, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that it is solution of cellulose derivatives such as starch slurry, poly-vinyl alcohol solution, polyvinylpyrrolidonesolution solution or hydroxypropyl emthylcellulose that institute adds wet binder, high molecular polymer solution concentrations such as polyvinyl alcohol are 0.1～30%, are good with 2～10%.
7, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that discharging for delaying bioactive ingredients, in sheet heart prescription, can add waxiness, insoluble or one or more mixed matrix materials of hydrophilic gel.The waxiness framework material is alcohol, acid, ester (salt) or the amide that stearic acid, Cera Flava, castor wax, octadecanol and Brazil wax etc. contain C8～C30.Insoluble framework material is high molecular polymers such as ethyl cellulose, polyethylene, polypropylene and polysiloxanes.Hydrophilic gel matrix material is pectin and natural gel such as alginic acid and salt thereof, methylcellulose, carboxymethyl cellulose or cellulose derivatives such as its salt and hydroxypropyl emthylcellulose, polyvinyl alcohol, carbopol, modified starch and acrylic resin etc.
8, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that with the gastric solubility of one or more same concentration or variable concentrations, insoluble micropore or enteric film coating material small-sized, one or more layers thin film of micro chip bag.The gastric solubility thin film coating material is cellulose derivative stomach function regulating soluble acrylic resins such as methylcellulose, hydroxypropyl cellulose and hydroxypropyl emthylcellulose etc.Insoluble micropore or enteric film coating material are cellulose derivative, enteric solubility acrylic resin or latex aqueous dispersions separately such as cellulose acetate, ethyl cellulose, Cellulose Acetate Phthalate, hydroxypropyl methylcellulose phthalate.
9,, it is characterized in that to contain in the coating solution one or more and the intracardiac contained identical or different bioactive ingredients of sheet by claim 1 and 8 described the sort of capsule filling smalls, micro tablet producing technology.
10, by the described the sort of capsule filling small of claim 1, micro tablet producing technology, it is characterized in that discharging for delaying bioactive ingredients, the control coating thickness and (or) amount of adding the film porogen.The film porogen adopts soluble high molecular polymers such as methylcellulose and low molecular poly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 91107391 CN1066780A (en) | 1991-05-13 | 1991-05-13 | Capsule filling small, micro tablet producing technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 91107391 CN1066780A (en) | 1991-05-13 | 1991-05-13 | Capsule filling small, micro tablet producing technology |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1066780A true CN1066780A (en) | 1992-12-09 |
Family
ID=4908734
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 91107391 Pending CN1066780A (en) | 1991-05-13 | 1991-05-13 | Capsule filling small, micro tablet producing technology |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1066780A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011103789A1 (en) * | 2010-02-23 | 2011-09-01 | 天津天士力制药股份有限公司 | Capsule of complex danshen drop pill |
| CN114344159A (en) * | 2021-12-27 | 2022-04-15 | 康道生物（南通）有限公司 | Processing technology of reducing coenzyme Q10 capsule |
-
1991
- 1991-05-13 CN CN 91107391 patent/CN1066780A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011103789A1 (en) * | 2010-02-23 | 2011-09-01 | 天津天士力制药股份有限公司 | Capsule of complex danshen drop pill |
| US9205123B2 (en) | 2010-02-23 | 2015-12-08 | Tasly Pharmaceutical Group Co., Ltd. | Capsule of compound danshen dripping pills |
| EA026761B1 (en) * | 2010-02-23 | 2017-05-31 | Тасли Фармасьютикал Груп Ко., Лтд. | Capsule of compound danshen dripping pills |
| CN114344159A (en) * | 2021-12-27 | 2022-04-15 | 康道生物（南通）有限公司 | Processing technology of reducing coenzyme Q10 capsule |
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|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C01 | Deemed withdrawal of patent application (patent law 1993) | ||
| WD01 | Invention patent application deemed withdrawn after publication |