CN105535986B - The cementing composite auxiliary material of multifilament tablet sheet body and its application - Google Patents
The cementing composite auxiliary material of multifilament tablet sheet body and its application Download PDFInfo
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- CN105535986B CN105535986B CN201510998169.5A CN201510998169A CN105535986B CN 105535986 B CN105535986 B CN 105535986B CN 201510998169 A CN201510998169 A CN 201510998169A CN 105535986 B CN105535986 B CN 105535986B
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- zein
- chinese medicine
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- crospovidone
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- 239000000463 material Substances 0.000 title claims description 6
- 239000002131 composite material Substances 0.000 title description 4
- 239000000843 powder Substances 0.000 claims abstract description 49
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 25
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 21
- 229920002494 Zein Polymers 0.000 claims abstract description 20
- 239000005019 zein Substances 0.000 claims abstract description 19
- 229940093612 zein Drugs 0.000 claims abstract description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 15
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 15
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 15
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 15
- 239000003814 drug Substances 0.000 claims abstract description 14
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229960000913 crospovidone Drugs 0.000 claims abstract description 13
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims abstract description 13
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims abstract description 13
- 239000000203 mixture Substances 0.000 claims abstract description 12
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 239000002671 adjuvant Substances 0.000 claims abstract description 8
- 239000002245 particle Substances 0.000 claims abstract description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 238000002360 preparation method Methods 0.000 claims description 6
- 150000002576 ketones Chemical class 0.000 claims description 3
- 238000005469 granulation Methods 0.000 claims description 2
- 230000003179 granulation Effects 0.000 claims description 2
- 108010055615 Zein Proteins 0.000 claims 9
- 235000019441 ethanol Nutrition 0.000 claims 3
- 235000020985 whole grains Nutrition 0.000 claims 2
- 230000001476 alcoholic effect Effects 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 claims 1
- 239000011122 softwood Substances 0.000 claims 1
- 238000005303 weighing Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 6
- 238000001125 extrusion Methods 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 description 10
- 239000000284 extract Substances 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000007689 inspection Methods 0.000 description 8
- 241000233866 Fungi Species 0.000 description 6
- 241001248610 Ophiocordyceps sinensis Species 0.000 description 5
- 239000000853 adhesive Substances 0.000 description 4
- 230000001070 adhesive effect Effects 0.000 description 4
- 230000004580 weight loss Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- 244000028550 Auricularia auricula Species 0.000 description 2
- 235000000023 Auricularia auricula Nutrition 0.000 description 2
- 241000222336 Ganoderma Species 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- OIRDTQYFTABQOQ-KQYNXXCUSA-N adenosine Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O OIRDTQYFTABQOQ-KQYNXXCUSA-N 0.000 description 2
- 238000000748 compression moulding Methods 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 229960004793 sucrose Drugs 0.000 description 2
- DCXXMTOCNZCJGO-UHFFFAOYSA-N tristearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 description 2
- 241000208340 Araliaceae Species 0.000 description 1
- 239000002126 C01EB10 - Adenosine Substances 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 240000008397 Ganoderma lucidum Species 0.000 description 1
- 235000001637 Ganoderma lucidum Nutrition 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 241000180649 Panax notoginseng Species 0.000 description 1
- 235000003143 Panax notoginseng Nutrition 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 206010000059 abdominal discomfort Diseases 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 229960005305 adenosine Drugs 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 239000008236 heating water Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229940024898 povidone k30 Drugs 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 1
- 239000008678 sanqi Substances 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 150000007949 saponins Chemical class 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- -1 triterpene compound Chemical class 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/066—Clavicipitaceae
- A61K36/068—Cordyceps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a kind of adjuvant composition, this composition is made of microcrystalline cellulose, zein, crospovidone, silica, magnesium stearate, and weight ratio is（30~80）:(5~15):(4~10):(0.5~2):(0.1~1.5).The adjuvant composition of the present invention can be used for most of herb powders for being difficult to excipient and particle be made, and mobility of particle is good, and compressibility is strong, and lubricant effect is good, and the slice, thin piece of extrusion is unilateral smooth, and hardness is good, and disintegration solves the problems, such as that rapidly most traditional Chinese medicine powders are difficult to tabletting.
Description
Technical field
The present invention provides a kind of cementing composite auxiliary material of multifilament tablet sheet body.Belong to biomedicine field.
Background technology
It is all worn into fine powder, added by the complicated component of Chinese medicine if the property to Chinese medicine is not made a concrete analysis of
Adhesive excipient will bring difficulty to tabletting, more outstanding to have following two situations:The cellulose of first traditional Chinese medicine fine powder contains
Amount is excessively and the institutional framework feature of itself makes medicinal powder have certain elasticity.It just can not bonded when tabletting, cause
Existing loose pieces, sliver phenomenon.Fibre-bearing is not extracted into medicinal extract all to fine medicinal material powder in second preparation, will be ground into after extract dry
Extract powder, and the very strong ingredient of the viscosity such as most resinous, gummy, carbohydrate, protein in these extract powders, by such medicinal extract
After powder granulation, in tabletting, viscosity just will appear sticking phenomenon very much greatly.And the hardness of tablet is too big, and disintegration is also unqualified.
However the herb powder more rare to some extracts and virtually improves prodigious cost, and make its complex process.
The molding of herb powder tabletting difficulty is the universal problem that tablet manufacturing encounters in the process in tablet.It is commonly used in tablet formulation
Adhesive have starch, dextrin, sodium carboxymethylcellulose, povidone-k30 etc..The ratio occupied in formula due to herb powder
Example is larger, and with above-mentioned adhesive, pelleting carries out tabletting, and the friability of slice, thin piece is very low when tabletting, and it is existing sliver loose pieces occur
As.Use the cane sugar powder of higher concentration as adhesive, particle obtained is harder, and slice, thin piece should not be disintegrated, and flower piece phenomenon occurs, simultaneously
Since the addition of sucrose limits the consumer groups of product.
Common herb powder has in the market, auricularia auriculajudae powder, white fungus powder, ginseng pulverate, cordyceps sinensis mycelium powder, ganoderma lucidum wall-broken
There is the problem of being difficult to compression molding since herb powder fiber is more in conidia powder etc., due to can not tabletting, it is all most of
Herb powder all exists with the dosage form of pulvis, granule, capsule, and there are inconvenient to carry, hardly possible clothes compared with tablet for powders and granules
With, be not easy to be acceptable to the market the problem of.Capsule easily causes stomach when taking due to the introducing of the additives such as gelatin pigment
The discomfort in portion increases extraction process in order to which herb powder is carried out excipient, and increased production cost, keeps part in Chinese medicine effective
Component damages bring huge warp so can solve the problems, such as herb powder tabletting in technique productions under common process
Ji benefit.
The present invention is supplied to a kind of adjuvant composition and preparation method thereof for the easy sliver of multifilament.Tablet can be used
It prepares.And what be can be very good solves the problems, such as the unsuitable compression molding of tablet herb powder.Zein, the poly- dimension of crosslinking in prescription
The reasonable employment of ketone, microcrystalline cellulose keeps the slice, thin piece pressed smooth, and disintegration is rapid, and friability is good.And preparation process simply may be used
Row is suitable for big production.Reduce rare Chinese medicine need extract medicinal extract after could excipient the problem of, reduce production in cost.
In addition, tablet safety higher, stability made from adjuvant composition are more preferable, for a wider population.
Invention content
The present invention provides the cementing composite auxiliary material of multifilament tablet sheet body, it can be used for solving the difficulty of herb powder difficulty tabletting
Topic.
The present invention can be used for being difficult to the auricularia auriculajudae powder of tabletting, white fungus powder, cordyceps sinensis mycelium powder, lucidum spore powder in the market
In the production process of equal herb powders, solve the problems, such as can not tabletting, reduce rare Chinese medicine and need to extract ability after medicinal extract
The problem of excipient, reduces the cost in production.In addition, tablet safety higher, stability made from adjuvant composition are more
It is good, for a wider population.
Herb powder tabletting can be solved herb powder because that pulvis, granule production can not be made due to tabletting by the present invention
Life is inconvenient to carry, it is difficult to which the problem of taking solves the problems, such as that the softgel shell of capsule easily causes and have a stomach upset.
Usefulness of the present invention is realized by following scheme：
A kind of adjuvant composition, by following weight proportion at being grouped as：30-60 parts of microcrystalline cellulose；Zein 5-15
Part；4-10 parts of crospovidone；0.5-2 parts of silica；0.1-1.5 parts of magnesium stearate
As preferred following weight proportion at being grouped as：40-60 parts of microcrystalline cellulose；5-10 parts of zein；Crosslinking is poly-
Tie up 5-6 parts of ketone；0.5-1 parts of silica；0.5-1 parts of magnesium stearate
Method prepared by zein is as follows, and zein crushed 80 mesh sieve, be dissolved in the ethanol solution of 80%-95%
In, heating water bath makes it dissolve, and the zein ethanol solution for being made into 15%-25% is spare.
Crospovidone need to take half to be uniformly mixed with microcrystalline cellulose with the herb powder of pre-add, for pelletizing, take one
Half is mixed evenly with silica and microcrystalline cellulose, and tabletting is used for after being particle mixing.
Example is embodied
It is further illustrated the present invention below in conjunction with several embodiments and innovation.It should be appreciated that listed implementation
Example is only used for illustrating the present invention rather than limitation of the invention further, those skilled in the art can after fully understanding
Suitably to be adjusted to embodiment, these are still within protection scope of the present invention.
Embodiment 1
Cordyceps sinensis tablet takes 35 parts of microcrystalline cellulose, aweto mycelium fine powder 50g, 7 parts of zein, 5 parts of crospovidone
0.5 part of of silica 1 part magnesium stearate is made 1000,0.6g/ pieces take the Cordyceps sinensis tablet finished product of above-described embodiment according to《China
Pharmacopeia》Described in versions in 2010, the quality examination project of tablet is carried out：Appearance character, tablet weight variation, hardness and friability, disintegration
Degree, uniformity of dosage units.
Inspection result is as follows
Inspection result
1. appearance character：Complete bright and clean, uniform color, foreign, no miscellaneous spot.
2. tablet weight variation：20 are taken to weigh, by every piece again compared with being averaged piece again, without the tablet for exceeding difference limit.
3. hardness and friability：Using Monsanto durometer method measure the hardness of tablet more than 4kg meet ideal indicator and
Permitted friability instrument with sieve and be detected 10 minutes wear weight loss to meet States Pharmacopoeia specifications less than 1%.
4. disintegration：With lift disintegration tester, it is detected all disintegrations at 30 minutes
5. uniformity of dosage units：Take 10 adenosine contents for measuring every respectively qualified.
2 wall-broken ganoderma spore piece of embodiment
Take 50 parts of microcrystalline cellulose, 40 parts of lucidum spore powder, 6 parts of zein, 6 parts of crospovidone silica 1 .5
1 part of magnesium stearate is made 1000,0.6g/ pieces take the wall-broken ganoderma spore piece finished product of above-described embodiment according to《Chinese Pharmacopoeia》
Described in versions in 2010, the quality examination project of tablet is carried out：Appearance character, tablet weight variation, hardness and friability, contain disintegration
Measure the uniformity.
Inspection result is as follows
Inspection result
2. appearance character：Complete bright and clean, uniform color, foreign, no miscellaneous spot.
3. tablet weight variation：20 are taken to weigh, by every piece again compared with being averaged piece again, without the tablet for exceeding difference limit.
4. hardness and friability：Using Monsanto durometer method measure the hardness of tablet more than 4kg meet ideal indicator and
Permitted friability instrument with sieve and be detected 10 minutes wear weight loss to meet States Pharmacopoeia specifications less than 1%.
5. disintegration：With lift disintegration tester, it is detected all disintegrations at 30 minutes
6. uniformity of dosage units：Take 10 triterpene compound contents for measuring every respectively qualified
3 sanqi tablets of embodiment
Take 38 parts of microcrystalline cellulose, 48 parts of Radix Notoginseng powder, 7 parts of zein, 6 parts of crospovidone silica 1 part tristearin
0.6 part of sour magnesium is made 1000,0.7g/ pieces take the Cordyceps sinensis tablet finished product of above-described embodiment according to《Chinese Pharmacopoeia》Version institute in 2010
It states, carries out the quality examination project of tablet：Appearance character, tablet weight variation, hardness and friability, disintegration, uniformity of dosage units.
Inspection result is as follows
Inspection result
1. appearance character：Complete bright and clean, uniform color, foreign, no miscellaneous spot.
2. tablet weight variation：20 are taken to weigh, by every piece again compared with being averaged piece again, without the tablet for exceeding difference limit.
3. hardness and friability：Using Monsanto durometer method measure the hardness of tablet more than 4kg meet ideal indicator and
Permitted friability instrument with sieve and be detected 10 minutes wear weight loss to meet States Pharmacopoeia specifications less than 1%.
4. disintegration：With lift disintegration tester, it is detected all disintegrations at 30 minutes
5. uniformity of dosage units：Take 10 total saponin contents for measuring every respectively qualified.
4 agaric white fungus piece of embodiment
Take 42 parts of microcrystalline cellulose, 28 parts of white fungus powder, 114 parts of black fungus powder, 15 parts of zein, 4 part two of crospovidone
Silica 7g magnesium stearates 3g. is made 1000,0.73g/ pieces take the agaric white fungus piece finished product of above-described embodiment according to《China
Pharmacopeia》Described in versions in 2010, the quality examination project of tablet is carried out：Appearance character, tablet weight variation, hardness and friability, disintegration
Degree, uniformity of dosage units.
Inspection result is as follows
Inspection result
1. appearance character：Complete bright and clean, uniform color, foreign, no miscellaneous spot.
2. tablet weight variation：20 are taken to weigh, by every piece again compared with being averaged piece again, without the tablet for exceeding difference limit.
3. hardness and friability：Using Monsanto durometer method measure the hardness of tablet more than 4kg meet ideal indicator and
Permitted friability instrument with sieve and be detected 10 minutes wear weight loss to meet States Pharmacopoeia specifications less than 1%.
4. disintegration：With lift disintegration tester, it is detected all disintegrations at 30 minutes
5. uniformity of dosage units：Take 10 polyoses contents for measuring every respectively qualified.
By the technological parameter belonging to the present invention program it can be seen from the above testing result, adjuvant composition is provided and is made
Tablet hardness qualification friability it is good, be suitable for herb powder excipient, solve the problems, such as that herb powder is difficult to tabletting, technique
It is mature and stable, it is suitable for big production.
Claims (3)
1. a kind of adjuvant composition for the easy sliver of multifilament, it is characterised in that be made of the raw material of following weight parts：
30-60 parts of microcrystalline cellulose
5-15 parts of zein
5-10 parts of crospovidone
0.5-2 parts of silica
0.1~1.5 part of magnesium stearate.
2. a kind of preparation method of the easy sliver of multifilament, which is characterized in that it is comprised the steps of
The weighing of a supplementary materials：Microcrystalline cellulose is crossed into 80-100 mesh sieve, the traditional Chinese medicine powder of pre-add crosses 80-200 mesh sieve, zein powder
It is broken to cross 80-100 mesh sieve, 30-80 parts of microcrystalline cellulose, 20-80 parts of the traditional Chinese medicine powder of pre-add are weighed, 5-15 parts of zein is crosslinked poly-
5-10 parts of ketone of dimension, 0.5-2 parts of silica, 0.1-1.5 parts of magnesium stearate are spare；
The preparation of b zein alcoholic solutions：25-75 parts of water-baths of ethyl alcohol of load weighted zein 5-15 parts plus 80%-95% are added
Heat is stirred continuously, and is configured to the zein ethanol solution of 10%-35%, is waited for that zein dissolving stops water-bath in brown color, is crossed 100
Mesh screens out undissolved impurity, spare；
C is mixed：By load weighted microcrystalline cellulose 30-80 parts and 20-80 parts of the traditional Chinese medicine fine powder of pre-add, half crospovidone
2.5-5 parts uniformly mixed spare, by 2.5-5 parts of the other half crospovidone and 0.5-2 parts of magnesium stearate 0.1-1.5 of silica
Part is uniformly mixed spare；
D pelletizes：Microcrystalline cellulose, crospovidone, in pre-add is added in prepared 10%-35% zeins ethanol solution
In the mixture of medicinal powder, softwood processed crosses the sieve granulation of 14-20 mesh；
E is dried：The particle made is put into air dry oven, is dried at a temperature of 40 DEG C -80 DEG C；
F whole grains：The particle dried is crossed into 14-20 mesh sieve, whole grain；
G is always mixed：By crospovidone, silica, magnesium stearate mixture is always mixed with the particle prepared；
H tablettings：The particle that will be mixed in g, progress tabletting piece weight are 0.25-2.5g.
3. a kind of preparation method of the easy sliver of multifilament according to claim 2, which is characterized in that crystallite is fine in step a
Tie up 30-80 parts of element, 20-80 parts of the traditional Chinese medicine powder of pre-add, 5-15 parts of zein, 5-10 parts of crospovidone, silica 0.5-2
Part, 0.1-1.5 parts of magnesium stearate；Wherein the traditional Chinese medicine powder of pre-add is a kind of traditional Chinese medicine powder or two or more Chinese medicine powder mixtures.
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| "归芪多糖颗粒制备工艺";陈虎虎等;《中国实验方剂学杂志》;20120228;第18卷(第4期);第32-34页 * |
| "星点设计-效应面法优化发酵虫草菌粉全粉末压片工艺";陈丽华等;《中国现代应用药学》;20131130;第30卷(第11期);第1192-1196页 * |
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