CN106619546A - Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets - Google Patents
Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets Download PDFInfo
- Publication number
- CN106619546A CN106619546A CN201610898083.XA CN201610898083A CN106619546A CN 106619546 A CN106619546 A CN 106619546A CN 201610898083 A CN201610898083 A CN 201610898083A CN 106619546 A CN106619546 A CN 106619546A
- Authority
- CN
- China
- Prior art keywords
- simvastatin
- stirring
- material casting
- blood lipid
- simvastatin tablets
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
-
- 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
- A61K9/2013—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
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
- B01F27/19—Stirrers with two or more mixing elements mounted in sequence on the same axis
- B01F27/191—Stirrers with two or more mixing elements mounted in sequence on the same axis with similar elements
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
- B01F27/85—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis with two or more stirrers on separate shafts
Abstract
The invention relates to simvastatin tablets capable of lowering blood lipid, and belongs to the technical field of western medicine preparations. The simvastatin tablets are prepared from the following components: 5 to 15 parts of simvastatin, 20 to 40 parts of ethyl cellulose, 30 to 50 parts of cereal starch and the like; the components are mixed by adopting a specific grain stirrer. The tablets provided by the invention are stably and slowly released.
Description
Technical field
The invention belongs to Western medicine preparation technical field, more particularly to a kind of Simvastatin Tablets of reducing blood lipid.
Background technology
Simvastatin (simvastatin) is the blood lipid-lowering medicine of Statins (statin), for controlling blood in courage consolidate
The content and prevention of cardiovascular disease of alcohol.Simvastatin is the synthesis of derivatives of Aspergillus terreus tunning.Existing Simvastatin
Piece increases the stability of preparation using compressing dry granulation technique or using methods such as inclusions, and dissolution is unstable, clinically patient's clothes
Used time usually produces some side effects.
The content of the invention
In order to overcome the deficiencies in the prior art, the present invention to change to auxiliary material screening, process optimization and equipment by lot of experiments
Enter, there is provided a kind of Simvastatin Tablets.The tablet sustained release, gastrointestinal side-effect are little, preparation process is simple.
The object of the present invention is achieved like this：
A kind of Simvastatin Tablets of reducing blood lipid, by total weight of tablet percentages, consist of the following composition:Simvastatin 5-
15 parts, ethyl cellulose 20-30 parts, cereal starch 30-40 parts, D-mannital 10-30 parts, guar gum 5-25 parts, ethanol
Acid-starch sodium 5-20 parts, magnesium stearate 0.5-3.0 parts.
The Simvastatin Tablets of the reducing blood lipid, the formula of Simvastatin Tablets is as follows：Simvastatin 10g, ethyl cellulose
25g, cereal starch 35g, D-mannital 20g, guar gum 15g, Sodium Carboxymethyl Starch 15g, magnesium stearate 2g.
The Simvastatin Tablets of the reducing blood lipid, preparation method comprises the following steps:Simvastatin bulk drug is taken, is cut down pungent
Statin bulk drug is placed in disintegrating apparatus and crushes；The Simvastatin bulk drug after crushing is stirred with above-mentioned auxiliary material in particle according to quantity
It is well mixed in machine, pelletizes according to a conventional method, compressing tablet packs to obtain finished product.
The Simvastatin Tablets of the reducing blood lipid, Particle mixer in preparation method, including base, are arranged on the base
Stirring cylinder, stirring motor is provided with the base, in the main shaft of the stirring motor and the diapire of the stirring cylinder
The heart is connected, and on the diapire in the mixing drum body stirring mast is provided with, vertical uniform in the side wall of the stirring cylinder
At least two cavitys are provided with, L-type material casting plate is provided with the cavity, the corner of the L-type material casting plate is connected by rotary shaft
It is connected in cavity and the outboard end of the L-type material casting plate is stretched in the mixing drum body, material casting driving is provided with the cavity
Motor, is provided with the main shaft of the material casting motor and compresses eccentric wheel, medial extremity and the cavity of the L-type material casting plate
Side wall between be provided with stress spring, the wheel side for compressing eccentric wheel be pressed on L-type material casting plate medial extremity and cavity side walls it
Between, support rod is additionally provided with the base, regulation vertical slot is provided with the support rod, it is provided with liter in the regulation vertical slot
Drop block, between the elevator and the regulation vertical slot lift cylinder is provided with, and in the elevator electric rotating machine is provided with,
The main shaft of the electric rotating machine is provided with column spinner, the column spinner stretch into when the elevator declines in the mixing drum and
The column spinner staggers setting with stirring mast.
Sealing gasket is provided with the opening of the cavity, the rotary shaft is wrapped in the sealing gasket.
The column spinner is provided with stirring palpus, and on the roof of the stirring cylinder charging aperture and feeding detection mouth are provided with.
Compared with prior art, Simvastatin Tablets according to the present invention have following beneficial technique effect：
(1) discharge steady.(2) preparation process is simple, simple structure is provided with L-type material casting plate, and it is when in use by compressing
Eccentric wheel coordinates stress spring that L-type material casting plate can be made to rotate centered on rotary shaft, so as to mixing drum interior part medicine be thrown
To the center of mixing drum, and column spinner is additionally provided with, by the reverse rotation of column spinner and mixing drum, can be thrown in L-type
The bottom medicine agitation of flitch, the medicine decline such that it is able to make L-type material casting back is stirred by column spinner, so as to greatly improve
Stirring efficiency, and it is not easy stirring dead angle occur, solving the stirring of conventional art medicine agitating device has dead angle and stirring
The low technical deficiency of efficiency, stability in use is good and strong applicability.
Description of the drawings
Fig. 1 is the structural representation of Particle mixer
Specific embodiment
By the following examples form is described in further detail again to the above of the present invention, but should not manage this
Solve the scope for above-mentioned theme of the invention and be only limitted to Examples below, all technologies realized based on the above of the present invention are belonged to
In the scope of the present invention.
Embodiment 1
Weigh Simvastatin 10g, ethyl cellulose 25g, cereal starch 35g, D-mannital 20g, guar gum 15g,
Sodium Carboxymethyl Starch 15g, magnesium stearate 2g.
Preparation technology：Simvastatin bulk drug is placed in disintegrating apparatus and is crushed；It is according to quantity that the Simvastatin after crushing is former
Material medicine is well mixed with above-mentioned auxiliary material in Particle mixer, pelletizes according to a conventional method, and compressing tablet packs to obtain finished product.
Above-mentioned Particle mixer, is shown in Fig. 1, including including base 1, the stirring cylinder 2 being arranged on the base 1, in institute
State and stirring motor 3 is provided with base 1, the main shaft of the stirring motor 3 is connected with the bottom wall central of the stirring cylinder 2,
Diapire in the stirring cylinder 2 is provided with stirring mast 4, is vertically uniformly provided with least in the side wall of the stirring cylinder 2
Two cavitys 5, in the cavity 5 L-type material casting plate 6 is provided with, and the corner of the L-type material casting plate 6 is connected to by rotary shaft 7
In cavity 5 and the outboard end of the L-type material casting plate 6 is stretched in the stirring cylinder 2, material casting is provided with the cavity 5 and is driven
Motor 8, is provided with the main shaft of the material casting motor 8 and compresses eccentric wheel 9, the medial extremity of the L-type material casting plate 6 with it is described
Be provided with stress spring 10 between the side wall of cavity 5, the wheel side for compressing eccentric wheel 9 be pressed on the medial extremity of L-type material casting plate 6 with it is recessed
Between the side wall of chamber 5, when in use, the wheel side activity for compressing eccentric wheel is pressed on the end of L-type material casting plate, so that L-type material casting
The end of plate is rotated centered on rotary shaft and stretching stress spring makes it store power, when the concave edge for compressing eccentric wheel is rotated to, L
The end of type material casting plate resets under the pulling of stress spring, so that medicinal material is thrown to and stirred by the plate body movement in mixing drum
The center of cylinder is mixed, support rod 11 is additionally provided with the base 1, regulation vertical slot 12 is provided with the support rod 11, described
Adjust in vertical slot 12 and be provided with elevator 13, between the elevator 13 and the regulation vertical slot 12 lift cylinder 14 is provided with,
Electric rotating machine 15 is provided with the elevator 13, column spinner 16, the column spinner are provided with the main shaft of the electric rotating machine 15
16 stretch in the mixing drum 2 and the column spinner 16 and stirring mast 4 stagger setting when the elevator 13 declines.In order to
Facilitate column spinner to enter mixing drum, the top cover of mixing drum can be opened and be loaded after column spinner, then top cover is covered.
Sealing gasket 17 is provided with the opening of the cavity 5, the rotary shaft is wrapped in the sealing gasket.
The column spinner is provided with stirring palpus 18, and charging aperture 19 and feeding detection are provided with the roof of the stirring cylinder
Mouth 20.Using stirring palpus, because it is flexible material, so do not interfere with the normal material casting operation of L-type material casting plate.
Embodiment 2
Weigh Simvastatin 5g, ethyl cellulose 30g, cereal starch 30g, D-mannital 30g, guar gum 5g, second
Alkyd sodium starch 20g, magnesium stearate 0.5g.
Preparation technology is ibid.
Embodiment 3
Weigh Simvastatin 15g, ethyl cellulose 20g, cereal starch 40g, D-mannital 10g, guar gum 25g,
Sodium Carboxymethyl Starch 5g, magnesium stearate 3.0g.
Preparation technology is ibid.
Comparative example 4
Weigh Simvastatin 10g, ethyl cellulose 25g, cereal starch 35g, D-mannital 20g, guar gum 15g,
Sodium Carboxymethyl Starch 15g, magnesium stearate 2g.
Plain particles mixer is adopted in preparation technology, other steps are ibid.
The release research of the Simvastatin Tablets of embodiment 5
Embodiment of the present invention 1-3, the tablet of the preparation of comparative example 4 are taken respectively, according to drug release determination method [version 5 in 2005
Chinese Pharmacopoeia (two) methods of annex XD first], with 0.5% sodium dodecyl sulfate solution 1000mL as solvent, rotating speed is 50r/
Min, operates in accordance with the law, and respectively at 2,4,6,8,10,12,14,16,18,20,22,24h solution 10mL is taken, filtration, and supplements in time
Above-mentioned solvent 10mL；Subsequent filtrate is taken, according to AAS (Chinese Pharmacopoeia of version 5 (two) annex IVA in 2005) in 274nm wavelength
Place determines trap；Another precision weighs 105 degree of Jing and is dried the Simvastatin reference substance of 2h in right amount, plus 0.5% dodecyl sulphate
The ultrasonically treated dissolving of sodium solution heating is simultaneously quantitatively diluted to the solution containing 10ug medicines in every 1mL, is measured in the same method trap, and divides
Do not calculate the burst size in different time.Dissolution determination result such as table 1
Dissolution of sustained-release tablets measurement result prepared by each embodiment of table 1
| Sample source | 1h (%) | 3h (%) | 6h (%) | 9h (%) | 12h (%) | 24h (%) |
| Embodiment 1 | 22.8 | 52.3 | 75.4 | 82.6 | 94.7 | 100.3 |
| Comparative example 2 | 29.2 | 42.5 | 62.7 | 84.7 | 92.4 | 98.7 |
| Comparative example 3 | 24.6 | 31.8 | 45.3 | 61.9 | 96.2 | 98.4 |
| Comparative example 4 | 59.5 | 92.4 | 95.8 | 100.2 | 98.4 | 98.5 |
It can be seen from the result of the test of table 1, Simvastatin Tablets release prepared by embodiment of the present invention 1-3 is steady；Contrast is real
Apply example 4 to mix Simvastatin using plain particles mixer, because Simvastatin is not fully wrapped by auxiliary material in the particle of preparation
Wrap up in, therefore discharge too fast.
Claims (6)
1. a kind of Simvastatin Tablets of reducing blood lipid, it is characterised in that by total weight of tablet percentages, consist of the following composition:It is pungent
Cut down statin 5-15 part, ethyl cellulose 20-30 parts, cereal starch 30-40 parts, D-mannital 10-30 parts, guar gum 5-25
Part, Sodium Carboxymethyl Starch 5-20 parts, magnesium stearate 0.5-3.0 parts.
2. Simvastatin Tablets of reducing blood lipid as claimed in claim 1, it is characterised in that the formula of Simvastatin Tablets is as follows：It is pungent to cut down him
It is spit of fland 10g, ethyl cellulose 25g, cereal starch 35g, D-mannital 20g, guar gum 15g, Sodium Carboxymethyl Starch 15g, hard
Fatty acid magnesium 2g.
3. Simvastatin Tablets of reducing blood lipid as claimed in claim 1, it is characterised in that preparation method comprises the following steps:Take pungent
Cut down statin bulk drug and be placed in crushing in disintegrating apparatus；The Simvastatin bulk drug after crushing and above-mentioned auxiliary material are stirred in particle according to quantity
Mix in machine and be well mixed, pelletize according to a conventional method, compressing tablet packs to obtain finished product.
4. Simvastatin Tablets of reducing blood lipid as claimed in claim 3, it is characterised in that Particle mixer in preparation method, including bottom
Seat, the stirring cylinder being arranged on the base is provided with stirring motor, the main shaft of the stirring motor and institute in the base
The bottom wall central for stating stirring cylinder is connected, and stirring mast is provided with the diapire in the mixing drum body, in the mixing drum
At least two cavitys are vertically uniformly provided with the side wall of body, L-type material casting plate is provided with the cavity, the L-type material casting plate
Corner is connected in cavity by rotary shaft and the outboard end of the L-type material casting plate is stretched in the mixing drum body, described
Material casting motor is provided with cavity, is provided with the main shaft of the material casting motor and is compressed eccentric wheel, the L-type material casting plate
Medial extremity and the side wall of the cavity between be provided with stress spring, the wheel side for compressing eccentric wheel is pressed on L-type material casting plate
Between medial extremity and cavity side walls, support rod is additionally provided with the base, regulation vertical slot is provided with the support rod, in institute
State in regulation vertical slot and be provided with elevator, lift cylinder is provided between the elevator and the regulation vertical slot, in the lifting
Electric rotating machine is provided with block, column spinner is provided with the main shaft of the electric rotating machine, the column spinner declines in the elevator
When stretch in the mixing drum and the column spinner and stirring mast stagger setting.
5. Simvastatin Tablets of reducing blood lipid according to claim 4, it is characterised in that sealing is provided with the opening of the cavity
Pad, the rotary shaft is wrapped in the sealing gasket.
6. Simvastatin Tablets of reducing blood lipid according to claim 4, it is characterised in that the column spinner be provided with stirring must,
The roof of the stirring cylinder is provided with charging aperture and feeding detection mouth.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610898083.XA CN106619546A (en) | 2016-10-14 | 2016-10-14 | Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610898083.XA CN106619546A (en) | 2016-10-14 | 2016-10-14 | Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106619546A true CN106619546A (en) | 2017-05-10 |
Family
ID=58856418
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610898083.XA Withdrawn CN106619546A (en) | 2016-10-14 | 2016-10-14 | Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106619546A (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105943514A (en) * | 2016-06-22 | 2016-09-21 | 南京华宽信息咨询中心 | Glipizide tablets for treating diabetes and preparation method thereof |
-
2016
- 2016-10-14 CN CN201610898083.XA patent/CN106619546A/en not_active Withdrawn
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105943514A (en) * | 2016-06-22 | 2016-09-21 | 南京华宽信息咨询中心 | Glipizide tablets for treating diabetes and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 吴旖主编: "《药物制剂生产》", 30 June 2015, 广东高等教育出版社 * |
| 石雷、钱俊青: "辛伐他汀缓释片制备及体外释放研究", 《中国现代应用药学》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN107875136B (en) | Amoxicillin medicinal preparation and preparation method thereof | |
| CN109261250A (en) | A kind of pharmaceutical purpose medicine particle is pulverized and mixed device | |
| CN1798796A (en) | Cellulose powder | |
| CN105943514A (en) | Glipizide tablets for treating diabetes and preparation method thereof | |
| CN1946426A (en) | Sustained release formulation for oral administration of HMG-CoA reductase inhibitor and method for the preparation thereof | |
| CN111588701B (en) | Metformin hydrochloride sustained release tablet and preparation method thereof | |
| CN208612718U (en) | A kind of medicament production smashing and grinding equipment | |
| CN103877051B (en) | A kind of preparation method of Ezetimibe sheet | |
| CN109126589A (en) | A kind of biological medicine raw material integration mixing arrangement | |
| CN107511208B (en) | A kind of grinding device for veterinary drug drug | |
| CN106619546A (en) | Simvastatin tablets capable of lowering blood lipid and preparation method of simvastatin tablets | |
| CN106619707A (en) | Compound reserpine tablet for treating hypertension and preparation method thereof | |
| CN106619554A (en) | Adenosine triphosphate disodium tablet and preparation method thereof | |
| EP3020395A1 (en) | Preparation method for traditional chinese medicine micro drop pill and traditional chinese medicine micro drop pill prepared by using the method | |
| CN209362251U (en) | A kind of lepidolite ingredient agitating device | |
| CN206295904U (en) | A kind of medicine Mixing Machine | |
| CN208213354U (en) | A kind of pharmacy pulverizer preventing drug deposition | |
| CN106420642A (en) | Cefixime chewable tablet and preparation method thereof | |
| CN209697397U (en) | A kind of brewed Chinese medicine production raw material seed soaking and screening device | |
| CN103566281B (en) | A kind of Traditional Chinese medicine composition with anti-tumor effect and preparation method | |
| CN111759820B (en) | Oxcarbazepine tablet and preparation method thereof | |
| CN211384757U (en) | Pharmacy is with dispensing device | |
| CN216322391U (en) | Chemical medicine raw materials is with dry reducing mechanism who has screening effect | |
| RU2236859C2 (en) | Preparation "fitoomolazhivajuschie" | |
| CN109331915A (en) | A kind of insecticide pulvis continuous producing apparatus |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20170510 |
|
| WW01 | Invention patent application withdrawn after publication |