CN108324695A - Le Sinida tablets and preparation method thereof - Google Patents
Le Sinida tablets and preparation method thereof Download PDFInfo
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- CN108324695A CN108324695A CN201810189582.0A CN201810189582A CN108324695A CN 108324695 A CN108324695 A CN 108324695A CN 201810189582 A CN201810189582 A CN 201810189582A CN 108324695 A CN108324695 A CN 108324695A
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- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
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- 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
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- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of Le Sinida tablets and preparation method thereof.The Le Sinida tablets include the component of following parts by weight：800 1200 parts of Le Sinida；270 330 parts of lactose；500 600 parts of microcrystalline cellulose；54 66 parts of hydroxypropyl methylcellulose；54 66 parts of crospovidone；18 22 parts of magnesium stearate；54 66 parts of gastric solubility coating powder.The dissolution rate and bioavilability of the Le Sinida tablets are good, dosage is accurate, and interior medicament contg difference is smaller, stable quality, take, carry, transporting etc. more convenient, are suitble to mechanization production, yield is big, at low cost, and sanitary standard is easy to reach.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of Le Sinida tablets and preparation method thereof.
Background technology
In human body, there are two kinds of approach of external source and endogenous in the source of uric acid, exogenous uric acid mainly based on food intake,
Endogenous uric acid is the final product that purine substrate generates under the action of yellow fast cry of certain animals oxidizing ferment in human body, and endogenous uric acid accounts for total urine
The 80% of sour source.The uric acid of most of filtrations can be by kidney proximal tubule reabsorption, wherein about 10% through homaluria.And it is most of
The uric acid of patient with gout cannot ultimately form hyperuricemia effectively by kidney excretion.Lithate transport protein 1
(URAT1) it is considered as the major protein being present in kidney for transporting lithate, uric acid can be transferred to nearly song from tube chamber
Tubular epithelial cell is simultaneously converted into monocarboxylate.Generation, the development of the defect and gout of the albumen are closely related, therefore, can lead to
The excretion for overregulating URAT1 activity to increase kidney to uric acid, to achieve the purpose that treat gout.In addition, during being somebody's turn to do
URAT4 can convert uric acid to two shuttle hydrochlorate U1.Glucose transporter 9 (GLUT9) is a kind of raw electric type hexose transport egg
In vain, splicing variants can adjust uric acid reabsorption, and uric acid, glucose and fructose are passed through basolateral membrane in teleblem region
It transports into cycle.In addition, probenecid, Sulfinpyrazone and Benzbromarone are the uricosuric eccritics applied in traditional gout treatment,
Inhibit uric acid reabsorption by URAT1 and GLUT9.
Le Sinida (also known as carrying out Si Nida, English is Lesinurad), chemical name：2- [the bromo- 4- of 5-] 4- cyclopropyl-
1- naphthalene -4H-1,2,4- triazole -3- sulfanyls] sodium acetate；Molecular formula：C17H13BrN3NaO2S；Molecular weight：426.263；
No. CAS：878672-00-5；Yuan Yan producers：Ardea Biosciences(AstraZeneca plc).The public affairs on the 13rd of August in 2014
The cloth positive top line of 3 key III clinical trial phases (CLEAR1, CLEAR2, CRYSTAL) of experimental drug lesinurad
Data.These research combination treatment containing lesinurad is used for the treatment of gout (gout).Lesinurad is a kind of choosing
Selecting property uric acid reuptake inhibithors (SURI) can inhibit URAT1 transporters, increase uric acid excretion, to reduce blood uric acid
(sUA)。
Invention content
It is an object of the invention to overcome the above-mentioned deficiency of the prior art, a kind of Le Sinida tablets and its preparation side are provided
Method, it is intended to solve existing Le Sinida prescriptions and select limited technical problem.
For achieving the above object, the technical solution adopted by the present invention is as follows：
One aspect of the present invention provides a kind of Le Sinida tablets, and the Le Sinida tablets include the group of following parts by weight
Point：800-1200 parts of Le Sinida；270-330 parts of lactose；500-600 parts of microcrystalline cellulose；54-66 parts of hydroxypropyl methylcellulose；
54-66 parts of crospovidone；18-22 parts of magnesium stearate；54-66 parts of gastric solubility coating powder.
Another aspect of the present invention provides a kind of preparation method of Le Sinida tablets, includes the following steps：
After the Le Sinida, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose are mixed, wet granulation is carried out, is obtained
Wet granulation；
After the wet granulation is dried, mixed with the crospovidone and magnesium stearate, tabletting obtains plain piece；
The gastric solubility coating powder is coated on the plain piece surface, the Le Sinida tablets are obtained.
Le Sinida tablets provided by the invention are a kind of thin membrane coated tablet, the dissolution rate of the Le Sinida tablets and life
Object availability is good, dosage is accurate, and interior medicament contg difference is smaller, stable quality, takes, carries, transporting etc. more convenient, is suitble to machine
Tool metaplasia is produced, and yield is big, at low cost, and sanitary standard is easy to reach.
The preparation method of Le Sinida tablets provided by the invention, by wet granulation, tabletting, be coated again it is obtained；Film
Art for coating can be widely used for tablet, pill, granule, it is high-quality, pollution is small, at low cost the advantages that, it is happy made from the technique
Si Nida tablets, satisfactory quality, and technique is relatively stable, is suitble to commodity production.
Specific implementation mode
In order to make technical problems, technical solutions and advantageous effects to be solved by the present invention be more clearly understood, below in conjunction with
Embodiment, the present invention will be described in further detail.It should be appreciated that specific embodiment described herein is only used to explain
The present invention is not intended to limit the present invention.
On the one hand, an embodiment of the present invention provides a kind of Le Sinida tablets, the Le Sinida tablets include following weight
Measure the component of part：800-1200 parts of Le Sinida；270-330 parts of lactose；500-600 parts of microcrystalline cellulose；Hydroxypropyl methylcellulose
54-66 parts；54-66 parts of crospovidone；18-22 parts of magnesium stearate；54-66 parts of gastric solubility coating powder.
The structure of Le Sinida is as follows, and Le Sinida is different from traditional uricosuric eccritic, only inhibit DRAT1 and
The substrate transport protein in outside is had no effect on, therefore there is good effect to treatment gout, hyperuricemia (3 phases are clinical).
Le Sinida tablets provided by the invention are a kind of thin membrane coated tablet, the dissolution rate and bioavilability of the Le Sinida tablets
It is good, dosage is accurate, interior medicament contg difference is smaller, stable quality, takes, carries, transport etc. more convenient, is suitble to mechanical metaplasia
Production, yield is big, at low cost, and sanitary standard is easy to reach.
Further, which includes the component of following parts by weight：800-1200 parts of Le Sinida；Lactose
270-330 parts；500-600 parts of microcrystalline cellulose；54-66 parts of hydroxypropyl methylcellulose；54-66 parts of crospovidone；Magnesium stearate
18-22 parts；54-66 parts of gastric solubility coating powder.
Further, grain size≤40 μm of the Le Sinida in the Le Sinida tablets.Le Sini in the particle size range
Up to bulk pharmaceutical chemicals, into human body in have good adsorption effect.In addition, the lactose is the lactose for sieving screening process through 80 mesh；
The microcrystalline cellulose is the microcrystalline cellulose that screening process is sieved through 80 mesh；The hydroxypropyl methylcellulose is to be sieved at screening through 80 mesh
The hydroxypropyl methylcellulose of reason.
On the other hand, the embodiment of the present invention additionally provides the preparation method of above-mentioned Le Sinida tablets, includes the following steps：
S01：After the Le Sinida, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose are mixed, wet granulation is carried out,
Obtain wet granulation；
S02：After the wet granulation is dried, mixed with the crospovidone and magnesium stearate, tabletting obtains
Plain piece；
S03：The gastric solubility coating powder is coated on the plain piece surface, the Le Sinida tablets are obtained.
The preparation method of the above-mentioned Le Sinida tablets of the embodiment of the present invention, by wet granulation, tabletting, is coated system again
；Film coating procedure can be widely used for tablet, pill, granule, it is high-quality, pollution is small, at low cost the advantages that, the technique system
The Le Sinida tablets obtained, satisfactory quality, and technique is relatively stable, is suitble to commodity production.
Further, in above-mentioned steps S01, grain size≤40 μm of Le Sinida.Le Sinida in the particle size range
Bulk pharmaceutical chemicals, into human body in have good adsorption effect.In addition, the lactose is the lactose for sieving screening process through 80 mesh；Institute
It is the microcrystalline cellulose that screening process is sieved through 80 mesh to state microcrystalline cellulose；The hydroxypropyl methylcellulose is to sieve screening process through 80 mesh
Hydroxypropyl methylcellulose.
Further, the step of wet granulation includes：Add under conditions of speed of agitator is 500-600rpm first
Water stirs, and then pelletizes under conditions of speed of agitator is 500-600rpm, cutter rotating velocity 2000-2500rpm.Above-mentioned steps exist
It is carried out in wet granulator.
Further, in above-mentioned steps S02, the wet granulation is dried using fluidized drying method.Fluidisation is dry
The drying effect of dry method is more preferable, and specifically, the fluidized drying method carries out in a fluidized bed, and the parameter of the fluid bed is：Into
50-60 DEG C of air temperature, wind turbine frequency 20Hz.
Further, tabletting rotary pelleting machine tabletting.And control sheet weight 400mg, control tablet weight variation ± 5% it
It is interior.
Further, in above-mentioned steps S03, the gastric solubility coating powder is coated and is wrapped in the step of plain piece surface
It includes：The gastric solubility coating powder is configured to coating solution, the coating solution and the plain piece are completed into coating work in coating pan
Skill.Specifically, the parameter of the coating pan is：Coating pan rotating speed is 4-12rpm, and inlet air temperature is 50-60 DEG C, and piece bed tempertaure is
40-50 DEG C, hydrojet rotating speed is 2.0-10.0rpm, atomizing pressure 0.1-0.3Mpa.
The present invention successively carried out test of many times, and it is further detailed to invention progress as reference now to lift A partial experiment result
Thin description, is described in detail with reference to specific embodiment.
Embodiment 1
A kind of preparation method of the tablet of Le Sinida：
Prescription raw material is：Come Si Nida 1000g, lactose 300g, microcrystalline cellulose 560g, hydroxypropyl methylcellulose 60g, crosslinking
Povidone 60g, magnesium stearate 20g, gastric solubility coating powder 60g；Preparation method includes the following steps：
1. taking recipe quantity Le Sinida to set in Universalpulverizer to crush, grain size after crushing is measured, it is desirable that grain size is less than or equal to
40μm。
2. the lactose of recipe quantity, microcrystalline cellulose, hydroxypropyl methylcellulose is taken to cross 80 mesh sieve.
3. taking coming in Si Nida, lactose, microcrystalline cellulose, hydroxypropyl methylcellulose to three-dimensional mixer for recipe quantity, mix
30min。
4. taking after mixing in material 384g to wet granulator, unlatching stirring, rotating speed 600rpm add water 100g, stir
30s shuts down clear material and opens stirring and cutter, speed of agitator 600rpm, cutter rotating velocity 2500rpm, Granulation time 1min.
5. wet granular is set in fluid bed, device parameter：60 DEG C of inlet air temperature, wind turbine frequency 20Hz, control moisture is only
2%.
6. crospovidone, magnesium stearate are added in material to three-dimensional mixer after will be dry, mix 5 minutes, mixing is frequently
Rate uses 45Hz.
7. carry out tabletting to the particle prepared with rotary pelleting machine, piece weight 400mg, the control grain method of double differences it is different ± 5% it
It is interior.
8. taking the coating powder of plain piece weight 3%, stirring is dissolved in gauge water, is configured to 12.5% coating solution, is persistently stirred
45min is mixed, is sieved with 100 mesh sieve before use.
9. coating：4-12 revs/min of coating pan rotating speed, 50-60 DEG C of inlet air temperature, 40-50 DEG C of piece bed tempertaure, hydrojet rotating speed
2.0-10.0rpm atomizing pressure 0.1-0.3Mpa.
10. packaging.
Embodiment 2
By the preparation method of embodiment 1, the tablet of three crowdes of Le Sinida is prepared, carries out dissolution rate, content, related substance etc.
Sample quality detects, and correlated results is as shown in table 1 below：First (lot number：25201404；Scale 1.5 ten thousand)；Second batch (batch
Numbers 25201405；；Scale 1.5 ten thousand)；Third batch (lot number：25201406；Scale 1.5 ten thousand).
Table 1
Can be seen that from above-mentioned three batches scale up test result datas can produce satisfactory quality using this technique
Product, and technique is relatively stable, is suitble to commodity production.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
All any modification, equivalent and improvement etc., should all be included in the protection scope of the present invention made by within refreshing and principle.
Claims (10)
1. a kind of Le Sinida tablets, which is characterized in that the Le Sinida tablets include the component of following parts by weight：Le Sini
Up to 800-1200 parts；270-330 parts of lactose；500-600 parts of microcrystalline cellulose；54-66 parts of hydroxypropyl methylcellulose；Crospovidone
54-66 parts；18-22 parts of magnesium stearate；54-66 parts of gastric solubility coating powder.
2. Le Sinida tablets as described in claim 1, which is characterized in that grain size≤40 μm of the Le Sinida.
3. Le Sinida tablets as described in claim 1, which is characterized in that the lactose is the breast for sieving screening process through 80 mesh
Sugar；And/or
The microcrystalline cellulose is the microcrystalline cellulose that screening process is sieved through 80 mesh；And/or
The hydroxypropyl methylcellulose is the hydroxypropyl methylcellulose that screening process is sieved through 80 mesh.
4. the preparation method of Le Sinida tablets as described in any one of claims 1-3, which is characterized in that including walking as follows
Suddenly：
After the Le Sinida, lactose, microcrystalline cellulose and hydroxypropyl methylcellulose are mixed, wet granulation is carried out, obtains wet
Grain object；
After the wet granulation is dried, mixed with the crospovidone and magnesium stearate, tabletting obtains plain piece；
The gastric solubility coating powder is coated on the plain piece surface, the Le Sinida tablets are obtained.
5. the preparation method of Le Sinida tablets as claimed in claim 4, which is characterized in that the grain size of the Le Sinida≤
40μm；And/or
The lactose is the lactose that screening process is sieved through 80 mesh；And/or
The microcrystalline cellulose is the microcrystalline cellulose that screening process is sieved through 80 mesh；And/or
The hydroxypropyl methylcellulose is the hydroxypropyl methylcellulose that screening process is sieved through 80 mesh.
6. the preparation method of Le Sinida tablets as claimed in claim 4, which is characterized in that the step of wet granulation wraps
It includes：
Add water stirring under conditions of speed of agitator is 500-600rpm first, is then 500-600rpm, cuts in speed of agitator
It pelletizes under conditions of swivel speed 2000-2500rpm.
7. the preparation method of Le Sinida tablets as claimed in claim 4, which is characterized in that will be described using fluidized drying method
Wet granulation is dried.
8. the preparation method of Le Sinida tablets as claimed in claim 7, which is characterized in that the fluidized drying method is fluidizing
It is carried out in bed, the parameter of the fluid bed is：50-60 DEG C of inlet air temperature, wind turbine frequency 20Hz.
9. the preparation method of Le Sinida tablets as claimed in claim 4, which is characterized in that by the gastric solubility coating powder packet
Clothing includes in the step of plain piece surface：The gastric solubility coating powder is configured to coating solution, by the coating solution and described
Plain piece completes art for coating in coating pan.
10. the preparation method of Le Sinida tablets as claimed in claim 9, which is characterized in that the parameter of the coating pan is：
Coating pan rotating speed is 4-12rpm, and inlet air temperature is 50-60 DEG C, and piece bed tempertaure is 40-50 DEG C, and hydrojet rotating speed is 2.0-
10.0rpm, atomizing pressure 0.1-0.3Mpa.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810189582.0A CN108324695A (en) | 2018-03-08 | 2018-03-08 | Le Sinida tablets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810189582.0A CN108324695A (en) | 2018-03-08 | 2018-03-08 | Le Sinida tablets and preparation method thereof |
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| CN108324695A true CN108324695A (en) | 2018-07-27 |
Family
ID=62930636
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| CN201810189582.0A Pending CN108324695A (en) | 2018-03-08 | 2018-03-08 | Le Sinida tablets and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112057429A (en) * | 2019-06-11 | 2020-12-11 | 上海京新生物医药有限公司 | Controlled release pharmaceutical compositions of rasinades |
| CN113368032A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Pharmaceutical composition, oral solid preparation and preparation method and application thereof |
| CN113368073A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Method for producing a pharmaceutical preparation for reducing blood uric acid levels |
| CN113368067A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Method for preparing oral medicine tablet for reducing blood uric acid level |
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| CN104814957A (en) * | 2015-03-31 | 2015-08-05 | 北京阜康仁生物制药科技有限公司 | Lesinurad-containing compound composition and preparation method thereof |
| CN105175348A (en) * | 2015-10-16 | 2015-12-23 | 北京康立生医药技术开发有限公司 | Preparation method for lesinurad |
| CN105456211A (en) * | 2015-12-11 | 2016-04-06 | 香港九华华源集团滁州药业有限公司 | Empagliflozin tablet and preparation method thereof |
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2018
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| CN104814957A (en) * | 2015-03-31 | 2015-08-05 | 北京阜康仁生物制药科技有限公司 | Lesinurad-containing compound composition and preparation method thereof |
| CN105175348A (en) * | 2015-10-16 | 2015-12-23 | 北京康立生医药技术开发有限公司 | Preparation method for lesinurad |
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| Title |
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| ASTRAZENECA PHARMACEUTICALS LP: "ZURAMPIC® (lesinurad) tablets, for oral use", 《HIGHLIGHTS OF PRESCRIBING INFORMATION》 * |
| 李威等主编: "《药剂学》", 28 February 2014, 湖北科学技术出版社 * |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112057429A (en) * | 2019-06-11 | 2020-12-11 | 上海京新生物医药有限公司 | Controlled release pharmaceutical compositions of rasinades |
| CN113368032A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Pharmaceutical composition, oral solid preparation and preparation method and application thereof |
| CN113368073A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Method for producing a pharmaceutical preparation for reducing blood uric acid levels |
| CN113368067A (en) * | 2020-07-23 | 2021-09-10 | 太阳升(亳州)生物医药科技有限公司 | Method for preparing oral medicine tablet for reducing blood uric acid level |
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