CN103445965A - Method for preparing tablets containing high-dose oily components - Google Patents
Method for preparing tablets containing high-dose oily components Download PDFInfo
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Abstract
The invention discloses a method for preparing tablets containing high-dose oily components and aims to provide the method for preparing the tablets containing the high-dose oily components, which has high production safety performance and is suitable for industrialized production. The method has the technical key points that the method for preparing the tablets sequentially comprises the following steps of 1, weighing each component; 2, placing an adsorbent which is weighed in step 1 into a high-speed mixing granulator for uniformly mixing, adding oil as an active component, granulating at a high speed, and sieving to prepare oily granules; 3, dissolving a granule coating agent which is weighed in step 1 into water to prepare a granule coating-agent serous fluid, placing the oily granules which are prepared in step 2 into a one-step granulator, spraying the granule coating-agent serous fluid, drying, and sieving to prepare coating granules; 4, adding lubricating substances or other auxiliary materials into the coating granules prepared in step 3, uniformly mixing, and tabletting through a rotary tabletting machine to prepare plain tablets. The method belongs to the technical fields of medicine and health-care foods.
Description
Technical field
The present invention relates to a kind of method for preparing tablet thereof, specifically, is a kind of method for preparing tablet thereof that contains high dose oily composition, belongs to medicine, health food technology field.
Background technology
In the technology of preparing of tablet, for composition be generally the solids of non-oily.Because the existence of oily composition can cause in the tabletting process producing a series of problem, as: can not molding, sliver, plain sheet hardness be low, can not tolerate coating operation etc.Certainly, existing tabletting technology still likely accomplishes for the oily composition of some low dosages (<20%), but is inconvenient for the film-making of the oily composition of high dose (>20%).
For these reasons, for the product containing oily composition (as: Fructus Schisandrae oil, Oleum Curcumae, cod-liver oil etc.), be generally to make soft capsule.Generally to use a large amount of organic solvents in the production process of soft capsule, as: after the soft capsule thermoforming, need with liquid paraffin or dimethyl-silicon wet goods cooling forming, after cooling forming, need again with eluting coolants such as tetrachloroethylene or petroleum ether, need again after eluting with ethanol, eluant to be washed away, then ethanol is removed.Above-mentioned organic solvent major part is all some volatile, explosive, inflammable materials.So, not only danger but also not environmental protection of the production of soft capsule.
Chinese patent CN1518418A discloses a kind of " hard bouillon tablet " patent, and it comprises, in tablet weight %, the oil of 1-20% and may be fat.Patent that Chinese patent CN1518419A discloses a kind of " soft bouillon tablet ", it comprises, in tablet weight %, 3-60%, preferred 10-60%, the more preferably oil of 15-60% and may be fat.But the method for making of its tablet is: with a piston, thus obtained paste is metered into wherein and folds and have in the tablet form cavity of wrapping paper, this wrapping paper is sealed and tablet is released to cavity.The machine that carries out this operation can be for example the Corazza type.The preparation of this tablet is a kind of special preparation method, and the equipment of use is not the rotary tablet machine that conventional tabletting is used, and has used special equipment, and can not carry out coating.
Chinese patent CN1288731A discloses " slow-releasing concentrated fish oil tablet and method for making thereof " patent, each component that comprises following weight ratio: fish oil 50, clathrate β-CD, cyclodextrin 2-10, slow releasing tablet ethyl cellulose 5-10, excipient starch 5-10, the two hydrogen wood acid 0.05-0.1 more processed of the lucky methyl of antioxidant, correctives 0.1-0.2.This patent has been used beta-schardinger dextrin-(β-CD) to carry out enclose to fish oil.Patent CN1139551A, CN1078908A, CN103041294A all disclose with β-CD oil have been carried out to enclose.In fact, the relative molecular weight of β-CD reaches 1135, the chamber volume of the every gram β-CD 0.14mL that only has an appointment.Due to the restriction that is subject to the cavity size of β-CD own, the molecular size by clathrate, molecular shape etc. are had to certain selectivity.So being not all oil can be by β-cdinclusion.A β-CD molecule can only molecule of enclose.Need to be with 5-10 β-CD enclose completely of (weight) doubly to fish oil.Add other excipient etc., oil does not reach 20% with the content of the tablet of β-cdinclusion.And β-cdinclusion is a kind of technique of more complicated, efficiency is low, also needs to use the special installations such as Ultrasound Instrument or colloid mill, and these all bring certain puzzlement to production.
Summary of the invention
For above-mentioned deficiency, the object of the present invention is to provide a kind of production safety performance high, be applicable to the method for preparing tablet thereof that contains high dose oily composition of suitability for industrialized production.
For solving the problems of the technologies described above, a kind of method for preparing tablet thereof that contains high dose oily composition provided by the invention, technical scheme comprises the steps: successively
1) weighing
Take each raw material by following mass percent: active component oil 21～60%; Adsorbent 10%～45%; Granule coating agent 1%～10%; Lubricating substance 0.1%～1.0%; Disintegrating agent 0～10%; Filler 0～60%; Element coating tablets agent 2～6%;
2) granulate
The adsorbent that step 1) is taken is placed in the high-speed mixing granulating machine mix homogeneously, adds active component oil, granulates at a high speed, sieves, and makes containing oil particles;
3) granule coating
Granule coating agent that step 1) is taken disperses or the granule coating agent serosity that makes soluble in water, by step 2) prepare be placed in one-step-granulating method containing oil particles, spray into granule coating agent serosity, drying, sieve, and makes coated granule;
4) tabletting
Coated granule to step 3) adds lubricating substance or other adjuvants, puts in mixer, and mix homogeneously, carry out tabletting with rotary tablet machine, makes plain sheet.
5) coating
Granule coating agent that step 1) is taken disperses or soluble in waterly makes plain coating tablets agent serosity, and the described plain sheet of step 4) is placed in to high-efficiency coating machine, sprays into plain coating tablets serosity, coating, and drying, make coated tablet.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, step 2) described active component oil is to be at room temperature liquid hydrophobicity material.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, described hydrophobicity material is vegetable oil or animal oil or artificial oil or combination in any.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, one of them or combination in any that described adsorbent is microcrystalline Cellulose, micropowder silica gel, corn starch, dextrin, inorganic salt.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, one of them or combination in any that described granule coating agent is hypromellose, hyprolose, copolyvidone, Polyethylene Glycol, pregelatinized Starch, dextrin.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, described lubricating substance is magnesium stearate, calcium stearate, Pulvis Talci, Glyceryl Behenate, stearic one of them or combination in any.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, one of them or combination in any that described disintegrating agent is starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone, crosslinked carboxymethyl fecula sodium, cross-linked carboxymethyl fiber sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, described filler is microcrystalline Cellulose, starch, dextrin, lactose, mannitol, sorbitol, inorganic salt in case of necessity one of them or combination in any.
Further, the above-mentioned method for preparing tablet thereof that contains high dose oily composition, one of them or combination in any that described tablet coating agent is coating pre-mixing agent, hypromellose, hyprolose, copolyvidone, Polyethylene Glycol, titanium dioxide, Pulvis Talci, pigment
Compared with prior art, technical scheme provided by the invention, active component oil and suitable adjuvant are set high to the granule that fast mixer-granulator is made suitable size, again by this granule or and suitable adjuvant put one-step-granulating method and make suitable coated granule with suitable coating adjuvant, and add suitable adjuvant, mix homogeneously, tabletting, coating (or not coating); The oily composition of some high doses (as: Fructus Schisandrae oil, Oleum Curcumae, cod-liver oil etc.) can be made to tablet (plain sheet or coated tablet).The equipment that whole preparation process is used is conventional high-speed mixing granulating machine, one-step-granulating method, mixer, rotary tablet machine, high-efficiency coating machine etc.; And whole preparation process only needs the coating operation to use a small amount of water just can complete as solvent, it is the technology of a kind of safety, environmental protection, effective, applicable suitability for industrialized production.
The specific embodiment
Below in conjunction with the specific embodiment; claim of the present invention is described in further detail; but do not form any limitation of the invention, the modification of any limited number of time of making in the claims in the present invention scope, still within claim protection domain of the present invention.
Embodiment 1
A kind of method for preparing tablet thereof that contains high dose Fructus Schisandrae oil composition provided by the invention, comprise the steps: successively
1) plain tablet recipe:
Fructus Schisandrae oil 60.0g(granulates)
Corn starch 20.0g(granulates)
DEXTRIN .0g(granulates)
Pregelatinized Starch 8.0g(granule coating)
Pulvis Talci 8.0g(is always mixed)
Microcrystalline Cellulose 64.0g(is always mixed)
Make 1000
2) take material by prescription;
3) by step 2) the adsorbent corn starch, the dextrin that take be placed in high-speed mixing granulating machine and mix 3～6 minutes, adds Fructus Schisandrae oil, high-speed stirred (100～900rpm), chopping (1000～3000rpm) at a high speed, granulate 10～200 seconds, discharging, cross 30 mesh sieves, makes granule;
4) by step 2) pregelatinized Starch that takes is scattered in appropriate water and makes granule coating agent serosity, the granule that step 3) is crossed after 30 mesh sieves is placed in one-step-granulating method, (technological parameter: air quantity is as the criterion with granule energy active fluidization, 50～80 ℃ of inlet temperature, 30～60 ℃ of temperature of charge to spray into granule coating agent serosity, atomisation pressure 1～4bar, spouting velocity 20～200rpm), drying, discharging, cross 20 mesh sieves, make coated granule;
5) add Pulvis Talci, microcrystalline Cellulose to the step 4) coated granule, put mixer and mix 5～30 minutes, discharging, with rotary tablet machine, the stamping of Ф 8.0mm scrobicula, the heavy 200mg/ sheet of sheet (containing Fructus Schisandrae oil 60mg/ sheet, oil content 30%), hardness 8～40kgf, make plain sheet.
Embodiment 2
A kind of method for preparing tablet thereof that contains high dose Fructus Schisandrae oil, Zedoary turmeric oil provided by the invention, comprise the steps: successively
1) plain tablet recipe:
Fructus Schisandrae oil 50.0g(granulates)
Oleum Curcumae 50.0g(granulates)
Microcrystalline Cellulose 100.0g(granulates)
Copolyvidone 12.0g(granule coating)
Low-substituted hydroxypropyl cellulose 9.4g(is always mixed)
Magnesium stearate 0.6g(is always mixed)
Make 1000
2) coating prescription:
Element sheet 1000.0g
Hypromellose 30.0g(film former)
Polyethylene Glycol 6.0g(plasticizer)
Pulvis Talci 6.0g(antiplastering aid)
Titanium dioxide 6.0g(coloring agent)
Pigment appropriate (developer)
3) take material by prescription;
4) adsorbent microcrystalline Cellulose step 3) taken is placed in high-speed mixing granulating machine to be mixed 3～6 minutes, adds Fructus Schisandrae oil, Oleum Curcumae, high-speed stirred (100～900rpm), chopping (1000～3000rpm) at a high speed, granulate 10～200 seconds, discharging, cross 40 mesh sieves, makes granule;
5) copolyvidone step 3) taken is dissolved in appropriate water and makes granule coating agent serosity, the granule that step 4) is crossed after 40 mesh sieves is placed in one-step-granulating method, (technological parameter: air quantity is as the criterion with granule energy active fluidization, 50～80 ℃ of inlet temperature, 30～60 ℃ of temperature of charge to spray into granule coating agent serosity, atomisation pressure 1～4bar, spouting velocity 20～200rpm), drying, discharging, cross 24 mesh sieves, make coated granule;
6) add magnesium stearate, the low-substituted hydroxypropyl cellulose of recipe quantity to the step 5) coated granule, putting mixer mixes 5～30 minutes, with rotary tablet machine, the stamping of Ф 8.5mm scrobicula, the heavy 222mg/ sheet of sheet (containing Fructus Schisandrae oil 50mg/ sheet, Oleum Curcumae 50mg/ sheet, total oil content amount 45%), hardness 8～40kgf, make plain sheet;
7) the plain coating tablets agent hypromellose, Polyethylene Glycol, Pulvis Talci, titanium dioxide, the pigment that step 3) are taken make plain coating tablets serosity with appropriate water, by the described plain sheet of step 6) put with high-efficiency coating machine in, spray into plain coating tablets serosity (technological parameter: cylinder negative pressure-0.1～-1.0KPa, drum rotation speed 5～15rpm, 60～100 ℃ of inlet temperature; 30～60 ℃ of leaving air temps; Atomisation pressure 1～4bar; Spouting velocity 30～150rpm), drying, slice, make coated tablet.
Embodiment 3
A kind of method for preparing tablet thereof that contains high dose cod-liver oil composition provided by the invention, comprise the steps: successively
1) plain tablet recipe:
Cod-liver oil 208.0g(granulates)
Micropowder silica gel 104.0g(granulates)
Hypromellose 17.5g(granule coating)
Carboxymethyl starch sodium 17.5g(is always mixed)
Calcium stearate 1.0g(is always mixed)
Make 1000
2) coating prescription:
Element sheet 1000.0g
Coating pre-mixing agent 40.0g
3) take material by prescription;
4) adsorbent micropowder silica gel step 3) taken is placed in high-speed mixing granulating machine and mixes 3～10 minutes, adds cod-liver oil, high-speed stirred (100～900rpm), chopping (1000～3000rpm) at a high speed, granulate 10～200 seconds, discharging, cross 60 mesh sieves, makes granule;
5) by step 2) hypromellose that takes is dissolved in appropriate water and makes granule coating agent serosity, step 4) is crossed to granule after 60 mesh sieves to be placed in one-step-granulating method and to mix 5～15 minutes, (technological parameter: air quantity is as the criterion with granule energy active fluidization, 50～80 ℃ of inlet temperature, 30～60 ℃ of temperature of charge to spray into granule coating agent serosity, atomisation pressure 1～4bar, spouting velocity 20～200rpm), drying, discharging, cross 24 mesh sieves, make coated granule;
6) add calcium stearate, the carboxymethyl starch sodium of recipe quantity to the step 5) coated granule, put mixer and mix 5～30 minutes, with rotary tablet machine, the stamping of Ф 10.0mm scrobicula, the heavy 348mg/ sheet of sheet (containing cod-liver oil 208mg/ sheet, oil content 60%), hardness 8～40kgf, make plain sheet;
7) coating pre-mixing agent step 3) taken is scattered in appropriate water and makes plain coating tablets serosity, by the described plain sheet of step 6) put with high-efficiency coating machine in, spray into plain coating tablets serosity (technological parameter: cylinder negative pressure-0.1～-1.0KPa, drum rotation speed 5～15rpm, 60～100 ℃ of inlet temperature; 30～60 ℃ of leaving air temps; Atomisation pressure 1～4bar; Spouting velocity 30～150rpm), drying, slice, make coated tablet.
The equipment that the bright technical scheme provided of this law is used is conventional high-speed mixing granulating machine, one-step-granulating method, mixer, rotary tablet machine, high-efficiency coating machine, without using other special installation; And whole preparation process only needs the coating operation to use a small amount of water just can complete as solvent, safety, environmental protection, efficient, applicable suitability for industrialized production.
Claims (10)
1. a method for preparing tablet thereof that contains high dose oily composition, is characterized in that, comprises the steps: successively
1) weighing
Take each raw material by following mass percent: active component oil 21～60%; Adsorbent 10%～45%; Granule coating agent 1%～10%; Lubricating substance 0.1%～1.0%; Disintegrating agent 0～10%; Filler 0～60%; Element coating tablets agent 2～6%;
2) granulate
The adsorbent that step 1) is taken is placed in the high-speed mixing granulating machine mix homogeneously, adds active component oil, granulates at a high speed, sieves, and makes containing oil particles;
3) granule coating
Granule coating agent that step 1) is taken disperses or the granule coating agent serosity that makes soluble in water, by step 2) prepare be placed in one-step-granulating method containing oil particles, spray into granule coating agent serosity, drying, sieve, and makes coated granule;
4) tabletting
Add lubricating substance or other adjuvants to the step 3) coated granule, put in mixer, mix homogeneously, carry out tabletting with rotary tablet machine, makes plain sheet.
2. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, is characterized in that, the described plain sheet of step 4) is placed in to high-efficiency coating machine, sprays into plain coating tablets serosity, coating, and drying, make coated tablet.
3. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, is characterized in that, the described active component oil of step 1) is to be at room temperature liquid hydrophobicity material.
4. the method for preparing tablet thereof that contains high dose oily composition according to claim 3, is characterized in that, described hydrophobicity material is vegetable oil or animal oil or artificial oil or combination in any.
5. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, is characterized in that, one of them or combination in any that described adsorbent is microcrystalline Cellulose, micropowder silica gel, starch, dextrin, inorganic salt.
6. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, it is characterized in that one of them or combination in any that described granule coating agent is hypromellose, hyprolose, copolyvidone, Polyethylene Glycol, starch, dextrin.
7. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, is characterized in that, described lubricating substance is magnesium stearate, calcium stearate, Pulvis Talci, Glyceryl Behenate, stearic one of them or combination in any.
8. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, it is characterized in that one of them or combination in any that described disintegrating agent is starch, carboxymethyl starch sodium, polyvinylpolypyrrolidone, crosslinked carboxymethyl fecula sodium, cross-linked carboxymethyl fiber sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose.
9. the method for preparing tablet thereof that contains high dose oily composition according to claim 1, is characterized in that, one of them or combination in any that described filler is microcrystalline Cellulose, starch, dextrin, lactose, mannitol, sorbitol, inorganic salt.
10. the method for preparing tablet thereof that contains high dose oily composition according to claim 2, it is characterized in that one of them or combination in any that described tablet coating agent is coating pre-mixing agent, hypromellose, hyprolose, copolyvidone, Polyethylene Glycol, titanium dioxide, Pulvis Talci, pigment.
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Cited By (4)
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| CN106177131A (en) * | 2016-07-21 | 2016-12-07 | 李时珍医药集团有限公司 | A kind of preparation method of Kanggu-Zengsheng tablet |
| CN108042583A (en) * | 2017-12-22 | 2018-05-18 | 浙江康恩贝制药股份有限公司 | A kind of Folium Ginkgo production process |
| CN108608668A (en) * | 2018-05-23 | 2018-10-02 | 夏文才 | A kind of device producing tablet |
| CN112544947A (en) * | 2020-12-23 | 2021-03-26 | 浙江华康药业股份有限公司 | Method for preparing pigment-containing sorbitol tabletting matrix |
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Cited By (4)
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| CN106177131A (en) * | 2016-07-21 | 2016-12-07 | 李时珍医药集团有限公司 | A kind of preparation method of Kanggu-Zengsheng tablet |
| CN108042583A (en) * | 2017-12-22 | 2018-05-18 | 浙江康恩贝制药股份有限公司 | A kind of Folium Ginkgo production process |
| CN108608668A (en) * | 2018-05-23 | 2018-10-02 | 夏文才 | A kind of device producing tablet |
| CN112544947A (en) * | 2020-12-23 | 2021-03-26 | 浙江华康药业股份有限公司 | Method for preparing pigment-containing sorbitol tabletting matrix |
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| CN103445965B (en) | 2015-03-18 |
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Address after: Three road 528300 in Guangdong province Foshan city Shunde District of Ronggui high tech Park Keyuan cross No. 2 Patentee after: SINOPHARM GUANGDONG GLOBAL PHARMACEUTICAL CO., LTD. Address before: Three road 528300 in Guangdong province Foshan city Shunde District of Ronggui high tech Park Keyuan cross No. 2 Patentee before: Huanqiu Pharmaceutical Co., Ltd., Guangdong |