CN109602711A - A kind of oryzanol tablets and preparation method thereof - Google Patents
A kind of oryzanol tablets and preparation method thereof Download PDFInfo
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- CN109602711A CN109602711A CN201910122441.1A CN201910122441A CN109602711A CN 109602711 A CN109602711 A CN 109602711A CN 201910122441 A CN201910122441 A CN 201910122441A CN 109602711 A CN109602711 A CN 109602711A
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- oryzanol
- tablets
- starch
- dextrin
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- 238000002360 preparation method Methods 0.000 title claims abstract description 32
- 229920002472 Starch Polymers 0.000 claims abstract description 51
- 235000019698 starch Nutrition 0.000 claims abstract description 51
- 239000008107 starch Substances 0.000 claims abstract description 51
- 229920001353 Dextrin Polymers 0.000 claims abstract description 33
- 239000004375 Dextrin Substances 0.000 claims abstract description 33
- 235000019425 dextrin Nutrition 0.000 claims abstract description 33
- 235000021552 granulated sugar Nutrition 0.000 claims abstract description 33
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 32
- 239000004094 surface-active agent Substances 0.000 claims abstract description 25
- 239000011734 sodium Substances 0.000 claims abstract description 19
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 19
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 16
- 239000000853 adhesive Substances 0.000 claims abstract description 8
- 230000001070 adhesive effect Effects 0.000 claims abstract description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 43
- 238000001035 drying Methods 0.000 claims description 19
- 238000005469 granulation Methods 0.000 claims description 19
- 230000003179 granulation Effects 0.000 claims description 19
- 239000002245 particle Substances 0.000 claims description 19
- 239000011122 softwood Substances 0.000 claims description 18
- 235000020985 whole grains Nutrition 0.000 claims description 18
- 238000002156 mixing Methods 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 13
- 238000003860 storage Methods 0.000 claims description 13
- 239000002994 raw material Substances 0.000 claims description 11
- 239000007779 soft material Substances 0.000 claims description 10
- 239000000126 substance Substances 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 9
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 239000000843 powder Substances 0.000 claims description 9
- 238000007781 pre-processing Methods 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- -1 Sodium alkyl sulfate Chemical class 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 abstract description 11
- 230000000052 comparative effect Effects 0.000 description 31
- 239000000243 solution Substances 0.000 description 19
- 235000019441 ethanol Nutrition 0.000 description 13
- 239000000203 mixture Substances 0.000 description 12
- 238000000034 method Methods 0.000 description 8
- 239000003814 drug Substances 0.000 description 6
- 230000033228 biological regulation Effects 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 238000012360 testing method Methods 0.000 description 4
- CONKBQPVFMXDOV-QHCPKHFHSA-N 6-[(5S)-5-[[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]methyl]-2-oxo-1,3-oxazolidin-3-yl]-3H-1,3-benzoxazol-2-one Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)C[C@H]1CN(C(O1)=O)C1=CC2=C(NC(O2)=O)C=C1 CONKBQPVFMXDOV-QHCPKHFHSA-N 0.000 description 3
- WTFUTSCZYYCBAY-SXBRIOAWSA-N 6-[(E)-C-[[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]methyl]-N-hydroxycarbonimidoyl]-3H-1,3-benzoxazol-2-one Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)C/C(=N/O)/C1=CC2=C(NC(O2)=O)C=C1 WTFUTSCZYYCBAY-SXBRIOAWSA-N 0.000 description 3
- 238000010348 incorporation Methods 0.000 description 3
- 150000002632 lipids Chemical class 0.000 description 3
- KZEVSDGEBAJOTK-UHFFFAOYSA-N 1-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)-2-[5-[2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidin-5-yl]-1,3,4-oxadiazol-2-yl]ethanone Chemical compound N1N=NC=2CN(CCC=21)C(CC=1OC(=NN=1)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)=O KZEVSDGEBAJOTK-UHFFFAOYSA-N 0.000 description 2
- YJLUBHOZZTYQIP-UHFFFAOYSA-N 2-[5-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]-1,3,4-oxadiazol-2-yl]-1-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethanone Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C1=NN=C(O1)CC(=O)N1CC2=C(CC1)NN=N2 YJLUBHOZZTYQIP-UHFFFAOYSA-N 0.000 description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 2
- 241000209094 Oryza Species 0.000 description 2
- 235000007164 Oryza sativa Nutrition 0.000 description 2
- 235000021355 Stearic acid Nutrition 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000007797 corrosion Effects 0.000 description 2
- 238000005260 corrosion Methods 0.000 description 2
- 239000011777 magnesium Substances 0.000 description 2
- 229910052749 magnesium Inorganic materials 0.000 description 2
- 210000004165 myocardium Anatomy 0.000 description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 2
- 235000009566 rice Nutrition 0.000 description 2
- 239000008117 stearic acid Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- KSEBMYQBYZTDHS-HWKANZROSA-M (E)-Ferulic acid Natural products COC1=CC(\C=C\C([O-])=O)=CC=C1O KSEBMYQBYZTDHS-HWKANZROSA-M 0.000 description 1
- HMUNWXXNJPVALC-UHFFFAOYSA-N 1-[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethanone Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)C(CN1CC2=C(CC1)NN=N2)=O HMUNWXXNJPVALC-UHFFFAOYSA-N 0.000 description 1
- JQMFQLVAJGZSQS-UHFFFAOYSA-N 2-[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]-N-(2-oxo-3H-1,3-benzoxazol-6-yl)acetamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)CC(=O)NC1=CC2=C(NC(O2)=O)C=C1 JQMFQLVAJGZSQS-UHFFFAOYSA-N 0.000 description 1
- DFGKGUXTPFWHIX-UHFFFAOYSA-N 6-[2-[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]acetyl]-3H-1,3-benzoxazol-2-one Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)CC(=O)C1=CC2=C(NC(O2)=O)C=C1 DFGKGUXTPFWHIX-UHFFFAOYSA-N 0.000 description 1
- AFCARXCZXQIEQB-UHFFFAOYSA-N N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CCNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 AFCARXCZXQIEQB-UHFFFAOYSA-N 0.000 description 1
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical group OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 description 1
- 235000019774 Rice Bran oil Nutrition 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 150000001336 alkenes Chemical class 0.000 description 1
- 230000003288 anthiarrhythmic effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000002567 autonomic effect Effects 0.000 description 1
- 210000000467 autonomic pathway Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 210000002451 diencephalon Anatomy 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000002124 endocrine Effects 0.000 description 1
- 229940114124 ferulic acid Drugs 0.000 description 1
- KSEBMYQBYZTDHS-UHFFFAOYSA-N ferulic acid Natural products COC1=CC(C=CC(O)=O)=CC=C1O KSEBMYQBYZTDHS-UHFFFAOYSA-N 0.000 description 1
- 235000001785 ferulic acid Nutrition 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000008165 rice bran oil Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- QURCVMIEKCOAJU-UHFFFAOYSA-N trans-isoferulic acid Natural products COC1=CC=C(C=CC(O)=O)C=C1O QURCVMIEKCOAJU-UHFFFAOYSA-N 0.000 description 1
- 150000003648 triterpenes Chemical class 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/06—Free radical scavengers or antioxidants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Diabetes (AREA)
- Toxicology (AREA)
- Hospice & Palliative Care (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
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Abstract
The present invention provides a kind of oryzanol tablets and preparation method thereof, it include following components: 10 parts of oryzanol, 38-42 parts of starch, 13 ~ 15 parts of white granulated sugar, 4 ~ 6 parts of dextrin, 1.2 ~ 1.8 parts of sodium carboxymethyl starch, 13 ~ 15 parts of adhesive, 0.4 ~ 0.6 part of magnesium stearate, 0.3 ~ 0.4 part of surfactant according to weight ratio, pass through the control of three kinds of component proportion parameters such as Surfactant and white granulated sugar, starch, dextrin, so that the dissolution rate of oryzanol tablets meets the requirements, quality is stablized.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, more specifically to a kind of oryzanol tablets and preparation method thereof.
Background technique
Oryzanol (Oryzanol) is present in rice bran oil, is the mixing of the ferulic acid ester based on triterpene (alkene) alcohol
Object.The autonomic nerves system and endocrine maincenter for mainly acting on diencephalon, can adjust autonomic nervous function, reduce incretion balance
Obstacle improves spiritual nervous disorder symptom.Also having simultaneously reduces blood lipid, reduces liver lipids, prevent lipid oxidation, is anti-oxidant
Etc. different physiological roles.In addition, cardiac muscle can be kept emerging by adjusting vegetative nerve function there are also antiarrhythmic effect is supported
Putting forth energy property reduces.The effect for reducing fat of oryzanol can also improve the blood supply of cardiac muscle, play the role of improving sleep.
Oryzanol is natural materials, and safety is very high.Existing research shows that the Asia that oryzanol is carried out to mouse, rat is anxious
Property, the toxicological tests such as chronic, LD50 of passing through mouth value is all larger than 25g/kg, and without any abnormal phenomenon during testing, to its into
Row antigenicity, allergenicity test also show without exception.
China is View of World Rice big producer, paddy annual output in 2015 up to 200,000,000 tons, rice bran annual output up to 14,000,000 tons,
Raw material sources for extracting oryzanol are extremely abundant, and oryzanol has vast potential for future development in China.
In view of this, needing a kind of oryzanol tablets that quality is stable in the prior art.
Summary of the invention
For the deficiencies in the prior art, the object of the present invention is to provide the paddy that a kind of quality stabilization, curative effect are stable
Tie up plain piece and preparation method thereof.
To achieve the goals above, the present invention provides the following technical scheme that
A kind of oryzanol tablets, which is characterized in that according to weight ratio include following components: 10 parts of oryzanol, 38-42 parts of starch, white
13 ~ 15 parts of granulated sugar, 4 ~ 6 parts of dextrin, 1.2 ~ 1.8 parts of sodium carboxymethyl starch, 13 ~ 15 parts of adhesive, 0.4 ~ 0.6 part of magnesium stearate,
0.3 ~ 0.4 part of surfactant.
The adhesive is the ethanol solution of 45-55%, preferably 50% ethanol solution.
The surfactant is lauryl sodium sulfate.
In one embodiment of the invention, a kind of oryzanol tablets include following components: oryzanol 10 according to weight ratio
Part, 38 parts of starch, 13 parts of white granulated sugar, 4 parts of dextrin, 1.2 parts of sodium carboxymethyl starch, 45% 13 parts of ethanol solution, magnesium stearate
0.4 part, 0.3 part of surfactant.
In another embodiment of the present invention, a kind of oryzanol tablets include following components: oryzanol according to weight ratio
10 parts, 42 parts of starch, 15 parts of white granulated sugar, 6 parts of dextrin, 1.8 parts of sodium carboxymethyl starch, 55% 15 parts of ethanol solution, stearic acid
0.6 part of magnesium, 0.4 part of surfactant.
In another embodiment of the present invention, a kind of oryzanol tablets include following components: oryzanol according to weight ratio
10 parts, 40 parts of starch, 14 parts of white granulated sugar, 5 parts of dextrin, 1.5 parts of sodium carboxymethyl starch, 50% 14 parts of ethanol solution, stearic acid
0.5 part of magnesium, 0.36 part of surfactant.
The present invention also provides a kind of preparation method of oryzanol tablets, this method include raw material auxiliary material pulverize and sieve, mix,
Soft material granulation processed, particle drying, tabletting.
Above-mentioned oryzanol tablets, preparation method the following steps are included:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin addition mixing machine is 10-15 minutes dry-mixed, add starch, surface
Activating agent is 10-15 minutes dry-mixed；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: it takes the particle made to be dried, after dry, sodium carboxymethyl starch, magnesium stearate is added, into
Row whole grain produces uniform particle.
5. tabletting: white tablets are pressed into, are examined, are packed, storage.
In above-mentioned oryzanol tablets:
The step 4. in, drying temperature be 55-60 DEG C, drying time 80-100min.
The step 5. in, the pressure of tabletting is 55 ~ 65KN, preferably 60KN.
The uniformity of tablet refers to that every content deviates the degree of labelled amount, that is, refers to that main ingredient is distributed uniform in tablet
Degree.The present invention is reduced between piece and piece by the control to supplementary material incorporation time so that supplementary material mixing is more uniform
Difference, ensure that the uniformity of dosage units of oryzanol tablets, further ensure the performance of the quality and curative effect of oryzanol tablets.
Tablet friability is the index for reflecting tablet antivibration wear resistant ability, can not be kept away during production, transport of tablet etc.
It will receive vibration or rubbing action with exempting from, these factors may cause the breakage of tablet, influence to apply.The present invention passes through to bonding
The selection of agent concentration and the control of tableting pressure, ensure that the friability of oryzanol tablets, further ensure the matter of oryzanol tablets
Amount.
Tablet must be absorbed into blood circulation upon administration, can generate treatment effect after reaching certain blood concentration
Fruit, so that it is absorbed premise that drug, which releases out of preparation and is dissolved in body fluid, if drug is not easy to discharge from preparation
Out or the solution rate of drug is extremely slow, then may influence the therapeutic effect of drug, and the dissolution rate of oryzanol directly affects
The therapeutic effect of product, the present invention is by three kinds of component proportion parameters such as Surfactant and white granulated sugar, starch, dextrin
Control, so that the dissolution rate of oryzanol tablets meets the requirements.
Specific embodiment
The invention discloses oryzanol tablets and preparation method thereof, those skilled in the art can use for reference the contents of the present invention,
Prescription is suitably modified with when realization of process parameters.In particular, it should be pointed out that all similar substitutions and modifications are to this field
It is it will be apparent that they are considered as being included in the scope of the present invention for technical staff.Application of the invention has passed through
Preferred embodiment is described, related personnel obviously can not depart from the content of present invention, in spirit and scope to described herein
Methods and applications be modified or appropriate changes and combinations, carry out implementation and application the technology of the present invention.
Next by the following examples the present invention is further explained, but embodiment does not do any restriction to the present invention.
Test method in following embodiments is unless otherwise specified conventional method, original as used in the following examples
Material, reagent material etc. are commercially available products unless otherwise specified.
According to the standard requirements of " the Sanitation Ministry medicine standard (chemicals and first, preparation) " oryzanol tablets, carry out each
The detection of item index.
Content: this product should be the 95.0~105.0% of labelled amount containing oryzanol.
Uniformity of dosage units: content is measured according to the method under content determination item, regulation (general rule 0941) should be met.
Inner quality standard: if A+2.2S≤15, the uniformity of dosage units of test sample meets regulation.
Friability: it is detected according to 2015 editions four 0923 methods of general rule of Chinese Pharmacopoeia.
Inner quality standard: less loss weight must not cross 1%, and must not detect the piece of fracture, cracking and crushing.
Dissolution rate: taking this product, according to dissolution rate and drug release determination method (0,931 second method of general rule)
Inner quality standard: every the amount of dissolution is calculated by labelled amount, is not less than 75%；To meet regulation.
Embodiment 1: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 10 minutes, add starch, surface is lived
Property agent dry-mixed 15 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, drying temperature is 55 DEG C, and drying time is 100 minutes, is done
After dry, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 55KN is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 1 detect, and as a result see the table below:
Embodiment 2: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 15 minutes, add starch, surface is lived
Property agent dry-mixed 10 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 60 DEG C of drying temperature, drying time is 80 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 65N is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 2 detect, and as a result see the table below:
Embodiment 3: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 12 minutes, add starch, surface is lived
Property agent dry-mixed 12 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 58 DEG C of drying temperature, drying time is 90 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 60N is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 3 detect, and as a result see the table below:
Embodiment 4: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 12 minutes, add starch, surface is lived
Property agent dry-mixed 12 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 58 DEG C of drying temperature, drying time is 90 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 60N is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 4 detect, and as a result see the table below:
Embodiment 5: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 12 minutes, add starch, surface is lived
Property agent dry-mixed 12 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 58 DEG C of drying temperature, drying time is 90 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 60N is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 5 detect, and as a result see the table below:
Embodiment 6: oryzanol tablets (1000)
Composition:
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 13 minutes, add starch, surface is lived
Property agent dry-mixed 13 minutes；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 58 DEG C of drying temperature, drying time is 90 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 58N is examined, and is packed, storage.
The oryzanol tablets prepared to embodiment 6 detect, and as a result see the table below:
Comparative example 1: oryzanol tablets (1000)
Composition:
Preparation method: with embodiment 3.
The oryzanol tablets prepared to comparative example 1 detect, and as a result see the table below:
Comparative example 2: oryzanol tablets (1000)
Composition:
Preparation method: with embodiment 3.
The oryzanol tablets prepared to comparative example 2 detect, and as a result see the table below:
Analyze comparative example 1-2 and embodiment 1-6, starch, white granulated sugar, three kinds of components of dextrin proportion, influence the molten of oryzanol tablets
Out-degree, in specific ratio range, the oryzanol tablets dissolution rate being prepared meets regulation.
Comparative example 3: oryzanol tablets (1000)
Comparative example 3-1 ~ comparative example 3-5 composition:
Using the ethanol solution of various concentration as adhesive:
95% ethanol solution is the aqueous solution that ethyl alcohol weight ratio is 95%, similarly hereinafter.
Preparation method: with embodiment 3.
Oryzanol tablet is prepared to comparative example 3 to detect, and as a result see the table below:
Comparative example 3 and embodiment 1-6 are analyzed, when adhesive is ethanol solution, the concentration of ethanol solution influences oryzanol tablets
Friability and dissolution rate comprehensively consider the influence to friability and dissolution rate, the ethyl alcohol of concentration of alcohol preferred weight ratio 45%-55%
Solution.
Comparative example 4: oryzanol tablets (1000)
Preparation method:
1. preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, 120 meshes are crossed,
It is spare；
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 12 minutes, add dry-mixed 12 points of starch
Clock；
3. soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 mesh
Sieve granulation.
4. dry, whole grain: taking the particle made to be dried, 58 DEG C of drying temperature, drying time is 90 minutes, dry
Afterwards, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain, produces uniform particle.
5. tabletting: being pressed into white tablets, tableting pressure 60N is examined, and is packed, storage.
The oryzanol tablets prepared to comparative example 4 detect, and as a result see the table below:
Analyze 4 embodiment 1-6 of comparative example, the dissolved corrosion of Surfactant Effect oryzanol tablets, when being added without surfactant
When, significant changes have occurred in the dissolved corrosion of oryzanol tablets, against regulation.
Comparative example 5: oryzanol tablets (1000)
Comparative example 5-1 ~ comparative example 5-4 composition (1000):
Preparation method: comparative example 5-1 ~ comparative example 5-4 preparation method: step 1., 2., 3., 4. with embodiment 3.
The preparation method of comparative example 5-1:
5. tabletting: being pressed into white tablets, tableting pressure 40N is examined, and is packed, storage.
The preparation method of comparative example 5-2:
5. tabletting: being pressed into white tablets, tableting pressure 45N is examined, and is packed, storage.
The preparation method of comparative example 5-3:
5. tabletting: being pressed into white tablets, tableting pressure 70N is examined, and is packed, storage.
The preparation method of comparative example 5-4:
5. tabletting: being pressed into white tablets, tableting pressure 75N is examined, and is packed, storage.
The oryzanol tablets prepared to comparative example 5 detect, and as a result see the table below
Comparative example 5 and embodiment 1-6 are analyzed, the tableting pressure of step 5. influences the indexs such as friability, the dissolution rate of oryzanol tablets,
Comprehensively consider the influence to friability and dissolution rate etc., the tableting pressure of step 5. preferably 55 ~ 65KN.
Comparative example 6: oryzanol tablets (1000)
Composition:
Preparation method: comparative example 6-1 ~ comparative example 6-2 preparation method: step 1., 3., 4., 5. with embodiment 3.
The preparation method of comparative example 6-1:
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 5 minutes, add dry-mixed 9 points of starch
Clock；
The preparation method of comparative example 6-2:
2. supplementary material mixes: oryzanol, white granulated sugar, dextrin being added mixing machine dry-mixed 6 minutes, add dry-mixed 17 points of starch
Clock；
The oryzanol tablets prepared to comparative example 6 detect, and as a result see the table below
Comparative example 6 and embodiment 1-6 are analyzed, the supplementary material incorporation time of step 2. influences paddy and ties up piece uniformity of dosage units index, when
Incorporation time cannot reach and be mixed thoroughly, although the oryzanol tablets being prepared lower than 10 minutes or when being higher than 15 minutes
Content meets the requirements, but uniformity of dosage units difference is big, undesirable.Therefore step 2. answer are as follows: by oryzanol, white granulated sugar,
Dextrin addition mixing machine is 10-15 minutes dry-mixed, and it is 10-15 minutes dry-mixed to add starch, surfactant.
Embodiment 7: stability study
The embodiment 1-6 oryzanol tablets prepared are placed in 40 DEG C ± 2 DEG C of temperature, in 75% ± 5% climatic chamber of relative humidity,
It was sampled respectively at 0,1,2,3,6 month, measures indices, as a result see the table below:
As can be seen from the above table: oryzanol tablets quality provided by the invention is stablized.
Claims (10)
1. a kind of oryzanol tablets, which is characterized in that according to weight ratio include following components: 10 parts of oryzanol, 38-42 parts of starch,
13 ~ 15 parts of white granulated sugar, 4 ~ 6 parts of dextrin, 1.2 ~ 1.8 parts of sodium carboxymethyl starch, 13 ~ 15 parts of adhesive, magnesium stearate 0.4 ~ 0.6
Part, 0.3 ~ 0.4 part of surfactant, the adhesive are the ethanol solution of 45-55%；The surfactant is 12
Sodium alkyl sulfate.
2. oryzanol tablets as described in claim 1, which is characterized in that according to weight ratio include following components: 10 parts of oryzanol,
38 parts of starch, 13 parts of white granulated sugar, 4 parts of dextrin, 1.2 parts of sodium carboxymethyl starch, 45% 13 parts of ethanol solution, magnesium stearate 0.4
Part, 0.3 part of surfactant.
3. oryzanol tablets as described in claim 1, which is characterized in that according to weight ratio include following components: 10 parts of oryzanol,
42 parts of starch, 15 parts of white granulated sugar, 6 parts of dextrin, 1.8 parts of sodium carboxymethyl starch, 55% 15 parts of ethanol solution, magnesium stearate 0.6
Part, 0.4 part of surfactant.
4. oryzanol tablets as described in claim 1, which is characterized in that according to weight ratio include following components: 10 parts of oryzanol,
40 parts of starch, 14 parts of white granulated sugar, 5 parts of dextrin, 1.5 parts of sodium carboxymethyl starch, 50% 14 parts of ethanol solution, magnesium stearate 0.5
Part, 0.36 part of surfactant.
5. oryzanol tablets as described in claim 1, which is characterized in that the ethanol solution that the adhesive is 50%.
6. any oryzanol tablets as described in claim 1 to 5, which is characterized in that preparation method the following steps are included:
Preprocessing raw material and auxiliary material: oryzanol bulk pharmaceutical chemicals, white granulated sugar, starch, dextrin, surfactant are crushed, and cross 120 meshes, standby
With；
Supplementary material mixes: oryzanol, white granulated sugar, dextrin addition mixing machine is 10-15 minutes dry-mixed, add starch, surface is lived
Property agent is 10-15 minutes dry-mixed；
Soft material granulation processed: binder solution is added in the powder of step 2., and stirring prepares softwood；The softwood made is taken to cross 23 meshes
Net granulation；
Dry, whole grain: taking the particle made to be dried, and after dry, sodium carboxymethyl starch, magnesium stearate is added, carries out whole grain,
Produce uniform particle；
Tabletting: being pressed into white tablets, examines, and packs, storage.
7. oryzanol tablets as claimed in claim 6, which is characterized in that the step 4. in, drying temperature be 55-60 DEG C.
8. oryzanol tablets as claimed in claim 6, which is characterized in that the step 4. in, drying time 80-
100min。
9. oryzanol tablets as claimed in claim 6, which is characterized in that the step 5. in, the pressure of tabletting is 55 ~
65KN。
10. oryzanol tablets as claimed in claim 6, which is characterized in that the step 5. in, the pressure of tabletting is 60KN.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111529500A (en) * | 2020-06-28 | 2020-08-14 | 江西谷物源食品有限公司 | Pharmaceutical composition for improving solubility of oryzanol and preparation method thereof |
| WO2021258683A1 (en) * | 2020-06-24 | 2021-12-30 | 宜春万申制药机械有限公司 | Application of berberine-oryzanol tablet in treatment of diabetes |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839850A (en) * | 2006-01-18 | 2006-10-04 | 马志梅 | Dispersion tablet medicine containing oryzanol and its preparation method |
| CN105769790A (en) * | 2016-03-15 | 2016-07-20 | 山东仁和堂药业有限公司 | Oryznol tablets for treating premenstrual tension and climacteric syndromes and preparation process thereof |
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2019
- 2019-02-18 CN CN201910122441.1A patent/CN109602711B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839850A (en) * | 2006-01-18 | 2006-10-04 | 马志梅 | Dispersion tablet medicine containing oryzanol and its preparation method |
| CN105769790A (en) * | 2016-03-15 | 2016-07-20 | 山东仁和堂药业有限公司 | Oryznol tablets for treating premenstrual tension and climacteric syndromes and preparation process thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021258683A1 (en) * | 2020-06-24 | 2021-12-30 | 宜春万申制药机械有限公司 | Application of berberine-oryzanol tablet in treatment of diabetes |
| CN111529500A (en) * | 2020-06-28 | 2020-08-14 | 江西谷物源食品有限公司 | Pharmaceutical composition for improving solubility of oryzanol and preparation method thereof |
| CN111529500B (en) * | 2020-06-28 | 2021-09-24 | 江西谷物源食品有限公司 | Pharmaceutical composition for improving solubility of oryzanol and preparation method thereof |
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