CN106619555A - Diacerein quick-release pellet preparation and preparation method - Google Patents
Diacerein quick-release pellet preparation and preparation method Download PDFInfo
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- CN106619555A CN106619555A CN201710077354.XA CN201710077354A CN106619555A CN 106619555 A CN106619555 A CN 106619555A CN 201710077354 A CN201710077354 A CN 201710077354A CN 106619555 A CN106619555 A CN 106619555A
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- diacerein
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- medicine
- fast release
- fluid bed
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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
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
-
- 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
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a diacerein quick-release pellet preparation and a preparation method, and relates to the field of pharmaceutical preparations and application. A drug-delivery way of the quick-release pellet preparation is oral medication, a core pellet is utilized as a carrier, and diacerein water solution containing a cosolvent and adhesive serves as a medicine applying solution. The diacerein quick-release pellet preparation has the characteristics of high medicine applying rate, good content evenness, quick drug release, quick effect in abirritation and the like. Meanwhile, the quick-release pellet preparation has the characteristics of good clinical use adaptability, high safety and the like. In addition, a fluidized bed medicine applying method of the core pellet is suitable for preparing extremely-low-standard diacerein oral preparation.
Description
Technical field
The present invention relates to drug preparation technique and application, specifically related to a kind of diacerein fast release micropill preparation, system
Preparation Method and its application.
Background technology
1st, pharmacological action and clinical effect
Primary inhibitor of the diacerein for osteoarthritis IL-1.Jing cell experiments and zoopery confirm that the pharmacology of this product is made
With mainly having（1）This product can induce Chondrogenesis, with pain relieving, antiinflammatory and antipyretic effect；（2）Do not suppress prostaglandin and into；
（3）Osteoarthritis are played the role of to delay disease process.Pharmacokinetic shows, in animal and human body, oral is double
Vinegar is auspicious because of the Viability metabolite chrysophanic acid of Jing deacetylations before into body circulation.Health adult's single oral administration reaches
Peak time about 2.4 hours, plasma protein binding rate are more than 99%, and plasma half-life about 4.2 hours, this product are apparent biological sharp
Expenditure is 35%-56%.The main Jing renal excretion of metabolite chrysophanic acid, fraction also Jing bile excretions.
The toxicological effect test of this product shows that the maximum tolerated dose of mice and rat single-dose exceedes people's dosage
190 and 410 times, the maximum tolerated dose of Canis familiaris L. exceedes 600 times of people's dosage（Calculate by body surface area dosage）.It is subacute, slow
Property and fetotoxicity experiment, fertility test, perinatal stage and toxicity test in puerperal, carcinogenic and teratology testing show diacerein
With good safety.
This product indication clinically is for treating degenerative joint disease（Osteoarthritis and relevant disease）；State
Interior research shows that this product can significantly improve the symptoms such as the pain that osteoarthritis and relevant disease cause and joint function disturbance.Clothes
With 2-4 it is all after start effective, 4-6 week performances are obvious.If continuous treatment is discontinued for 3 months later, curative effect is at least sustainable 1 month
（Carry-over effect）.
2nd, clinical practice
Usage and dosage is, orally.240mg-480mg (1-2), 3 times a day, or follows the doctor's advice.According to patient's state of an illness, connect
It is continuous to take 4-12 all, if necessary in doctor's long-term treatment（It is not shorter than 3 months）：It is daily 1-2 time, 1 every time, take after the meal.By
Laxativeness may be caused within 2 weeks in the head for taking diacerein, it is therefore proposed that in daily 1 of the head 4 weeks for the treatment of, clothes after dinner
With.After patient is to medicine adaptation, dosage just should increase to that 2 times a day, after the meal orally.When doctor should determine treatment according to curative effect
Between, but the course for the treatment of should not be shorter than 3 months.In clinical experiment, patient once continuously took this product 2 years and without any safety problem.If controlling
Needing to share other medicines in treatment carries out long-term treatment, should carry out per 6 months once including the comprehensive blood including liver biochemistry enzyme
Liquid and urine test.As this product works slowly（After treatment, 2-4 weeks are effective）And good gastrointestinal toleration, it is proposed that giving
The first 2-4 weeks of medicine can be with other analgesic or nonsteroidal antiinflammatory drug use in conjunction.
Diacerein is not useable for less than 15 years old child, because this age group does not carry out any clinical experiment.More than 70 years old,
And with serious renal insufficiency（CCr rate 10-30ml/min）Gerontal patient, must dosage halve or follow the doctor's advice.
Take improve intestinal transport and（Or）During the medicine of intestinal contents property, taboo takes this medicine.To improve the biology profit of diacerein
Expenditure should avoid and meanwhile take containing aluminium hydroxide and（Or）The medicine of magnesium hydroxide.Can increase after taking diacerein using anti-
Raw element and（Or）Chemotherapeutic patient suffers from the probability of enterocolitiss, because antibiotic and chemotherapy can affect intestinal
Flora.Unexpected or spontaneous excessive use diacerein can cause diarrhoea.Without special solution.If diarrhoea continues, doctor need to be asked
Process.Internal fluid and electrolyte balance need to be repeatedly detected during emergent management.
The content of the invention
The purpose of the present invention one is the diacerein fast release micropill preparation for providing a kind of Orally-administrable.The mesh of the present invention
Two be that a kind of preparation method of diacerein fast release micropill preparation is provided.
For achieving the above object, solution of the invention is：A kind of diacerein fast release micropill preparation is provided, it is described
Fast release micropill preparation administering mode is oral administration, with celphere as carrier, the diacerein water containing cosolvent and binding agent
Solution be upper drug solns, described diacerein consumption, according to weight ratio, diacerein consumption be the capsule core 5%～
25%.
Further, described celphere is sucrose capsule core or Microcrystalline Cellulose capsule core.
Further, one or more in citric acid, acetic acid, hydrochloric acid, ascorbic acid of the cosolvent.
Further, according to weight ratio, cosolvent consumption for diacerein 20%～300%.
Further, described binding agent selected from hypromellose (HPMC), polyvidone (PVP), syrup, starch slurry,
One or more in carmethose, gelatin, arabic gum, methylcellulose.
Further, according to weight ratio, binder dosage for celphere 0.18%～1.68%.
Further, described any one diacerein fast release micropill preparation also includes overcoat membrane material；Described protection
One or more in acrylic resin, hypromellose of tunic material.
Further, described diacerein fast release micropill preparation, according to weight ratio, the consumption of overcoat membrane material is sky
The 1.0%～5.0% of white capsule core.
Further, described fast release micropill be pressed into after tablet after can filling in capsule or addition proper auxiliary materials orally to
Medicine.
For achieving the above object, solution of the invention is：A kind of preparation of diacerein fast release micropill preparation is provided
Method, with celphere as carrier, with the diacerein aqueous solution containing cosolvent and binding agent as upper drug solns, using fluid bed
Bottom is sprayed prescription method and prepares load medicine micropill, adds overcoat membrane material solution Jing fluidized bed coatings to obtain diacerein fast release micropill system
Agent.
A kind of preparation method of diacerein fast release micropill preparation, including：
Step one：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After be dried.
Further, the step one is specially and weighs diacerein by formula, adds the citron acid solution of formula ratio molten
Solution, is configured to quantitatively go up drug solns in being then dissolved in the pure water solution for include binding agent.
Further, the step 2 is specially and the celphere of formula ratio is placed in fluid bed, starts fluid bed, to
The upper drug solns prepared in quantitative input step one in fluid bed.
Further, fluid bed medicine-feeding parameter is set by the process conditions of optimization during drug solns in the input, including
150～180m3h-1 of fan delivery, feed flow 2～7rmin-1 of revolution speed, 25～40 DEG C of temperature of charge, atomizing pressure
0.16MPa。
Further, the step 3 is specially and presses formula ratio 5% overcoat membrane material solution of preparation, and fluidized bed coating parameter sets
Be set to 150～180m3h-1 of fan delivery, feed flow 5～15rmin-1 of revolution speed, temperature of charge control at 25～30 DEG C, mist
Change pressure 0.3MPa.Further, after the completion of the step 4 is specially coating, fluid bed parameter is adjusted, coated micropill is in 30
～40 DEG C of 15～45min of fluidized drying.
Specific embodiment
The above of the present invention is described in detail below in conjunction with specific embodiment, but this should not be interpreted as this
Bright technical scheme is only limitted to following examples.
1 formula 1 of embodiment
| Diacerein | 50mg |
| Microcrystalline Cellulose celphere | 3000g |
| 0.3% acetum | 200ml |
| Hypromellose (HPMC) | 300g |
| Pulvis Talci | 50g |
| Water | 4500g |
Preparation method：
(1) preparation of drug solns on：Diacerein 10mg is weighed by formula, 0.3% acetum 200mL dissolvings is added, then
Drug solns on 1500g are configured in being dissolved in the aqueous solution for include hypromellose (HPMC) 100g.
(2) medicine is sprayed at fluid bed bottom：Microcrystalline Cellulose celphere 3000g is placed in fluid bed, starts fluid bed, if
Put fluid bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge are controlled 30～40
DEG C, atomizing pressure 0.16MPa, added medicine under fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water 3100g is weighed by formula, stirring lower addition is added into hydroxypropyl under stirring
Methylcellulose (HPMC) 200g, stirs molten clear, and prepared concentration is 5% overcoat membrane material solution, adds Pulvis Talci 50g, at a high speed
Emulsifying homogeneous 10 minutes, cross 60 mesh sieves and must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-
1, feed flow revolution speed 15rmin-1, temperature of charge are controlled at 25～35 DEG C, and atomizing pressure 0.3MPa is prevented under fluidized state
Cuticular layer coating.
(4) it is dried afterwards：After the completion of coating, coated micropill is in 30～40 DEG C of fluidized drying 30min.
2 formula 2 of embodiment
| Diacerein | 25mg |
| Sucrose celphere | 3000g |
| 0.1% citron acid solution | 300ml |
| Polyvidone (PVP) | 8g |
| Acrylic resin | 200g |
| Water | 3000g |
Preparation method：
(1) preparation of drug solns on：Diacerein 20mg is weighed by formula, 0.1% citron acid solution 300mL dissolvings is added, so
Drug solns on 1500g are configured in being dissolved in the aqueous solution for include polyvidone (PVP) 8g afterwards.
(2) medicine is sprayed at fluid bed bottom：Sucrose celphere 3000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30～40 DEG C, atomization
Added medicine under pressure 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 2600g is weighed by formula, is added into acrylic resin under stirring
200g, stirs molten clear, and prepared concentration is 5% overcoat membrane material solution, and stirring is lower to add Pulvis Talci 50g, high-speed emulsifying homogeneous
10 minutes, cross 60 mesh sieves and must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, solution feed pump
Rotating speed 15rmin-1, at 25～35 DEG C, atomizing pressure 0.3MPa carries out protecting film layer bag under fluidized state for temperature of charge control
Clothing.(4) it is dried afterwards：After the completion of coating, coated micropill is in 30～40 DEG C of fluidized drying 30min.
3 formula 3 of embodiment
| Diacerein | 20mg |
| Sucrose celphere | 3000g |
| 0.6% hydrochloric acid solution | 700ml |
| Syrup | 70g |
| Acrylic resin | 200g |
| Water | 3500g |
Preparation method：
(1) preparation of drug solns on：Diacerein 40mg is weighed by formula, 0.6% hydrochloric acid solution 700mL dissolvings is added, then
Drug solns on 1500g are configured in being dissolved in the aqueous solution for include syrup 70g.
(2) medicine is sprayed at fluid bed bottom：Sucrose celphere 3000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30～40 DEG C, atomization
Added medicine under pressure 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 2000g is weighed by formula, is added into acrylic resin under stirring
200g, stirs molten clear, and prepared concentration is 5% overcoat membrane material solution, addition Pulvis Talci 60g, high-speed emulsifying homogeneous 10 minutes,
Cross 60 mesh sieves and must protect film layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed
15rmin-1, at 25～35 DEG C, atomizing pressure 0.3MPa carries out protecting film layer coating under fluidized state for temperature of charge control.
(4) it is dried afterwards：After the completion of coating, coated micropill is in 30～40 DEG C of fluidized drying 30min.
4 formula 4 of embodiment
| Diacerein | 10mg |
| Sucrose celphere | 300g |
| 6% ascorbic acid solution | 100ml |
| Starch slurry | 0.8g |
| HPMC | 20g |
| Water | 400g |
Preparation method：
(1) preparation of drug solns on：Diacerein 10mg is weighed by formula, 6% ascorbic acid solution 100mL dissolvings is added, so
Drug solns on 150g are configured in being dissolved in the aqueous solution for include starch slurry 0.8g afterwards.
(2) medicine is sprayed at fluid bed bottom：Sucrose celphere 300g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 2rmin-1, temperature of charge control are in 30～40 DEG C, atomization
Added medicine under pressure 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 250g is weighed by formula, stirring is lower to add HPMC 20g, stirs molten
Clearly, prepared concentration is 5% overcoat membrane material solution, adds Pulvis Talci 6g, high-speed emulsifying homogeneous 10 minutes to cross 60 mesh sieves and must prevent
Cuticular layer coating solution.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 5rmin-1, material temperature
At 25～35 DEG C, atomizing pressure 0.3MPa carries out protecting film layer coating under fluidized state for degree control.
(4) it is dried afterwards：After the completion of coating, coated micropill is in 30～40 DEG C of fluidized drying 30min.
5 formula 5 of embodiment
| Diacerein | 5mg |
| Sucrose celphere | 3000g |
| 0.1% citric acid soln | 200ml |
| Carmethose | 70g |
| HPMC | 200g |
| Water | 4000g |
Preparation method：
(1) preparation of drug solns on：Diacerein 20mg is weighed by formula, 0.1% citric acid soln 200mL dissolvings is added, so
Drug solns on 1500g are configured in being dissolved in the aqueous solution for include carmethose 70g afterwards.
(2) medicine is sprayed at fluid bed bottom：Sucrose celphere 3000g is placed in fluid bed, starts fluid bed, fluidisation is set
Bed medicine-feeding parameter:Fan delivery 150m3h-1, feed flow revolution speed 5rmin-1, temperature of charge control are in 30～40 DEG C, atomization
Added medicine under pressure 0.16MPa, fluidized state, after the completion of medicine-feeding, fluidized drying 15min.
(3) fluidized bed coating-protection film layer：Pure water about 2500g is weighed by formula, stirring is lower to add HPMC 200g, stirring
Molten clear, prepared concentration is 5% overcoat membrane material solution, adds Pulvis Talci 20g, high-speed emulsifying homogeneous 10 minutes to cross 60 mesh sieves
Film layer coating solution must be protected.Fluidized bed coating parameter is set：Fan delivery 180m3h-1, feed flow revolution speed 12rmin-1,
At 25～35 DEG C, atomizing pressure 0.3MPa carries out protecting film layer coating under fluidized state for temperature of charge control.
(4) it is dried afterwards：After the completion of coating, coated micropill is in 30～40 DEG C of fluidized drying 30min.
Claims (10)
1. a kind of diacerein fast release micropill preparation, it is characterised in that described fast release micropill preparation administering mode is orally to give
Medicine, with celphere as carrier, the diacerein aqueous solution containing cosolvent and binding agent be upper drug solns, described diacerein
Consumption, according to weight ratio, diacerein consumption is the 5～25% of the capsule core.
2. diacerein fast release micropill preparation as claimed in claim 1, it is characterised in that described celphere is sucrose ball
Core or Microcrystalline Cellulose capsule core；One or more in citric acid, acetic acid, hydrochloric acid, ascorbic acid of the cosolvent is pressed
According to weight ratio, cosolvent consumption for diacerein 20～300%.
3. diacerein fast release micropill preparation as claimed in claim 1, it is characterised in that described binding agent is selected from hydroxypropyl first
One kind or many in cellulose, polyvidone, syrup, starch slurry, carmethose, gelatin, arabic gum, methylcellulose
Kind, according to weight ratio, binder dosage for celphere 0.18～1.68%.
4. any one diacerein fast release micropill preparation as described in claims 1 to 3, it is characterised in that also including overcoat
Membrane material；One or more in acrylic resin, hypromellose of described overcoat membrane material；According to weight ratio, prevent
The consumption of sheath membrane material for celphere 1.0～5.0%.
5. any one diacerein fast release micropill preparation as described in Claims 1 to 4, it is characterised in that described rapid release is micro-
Ball is pressed into oral administration after tablet after filling in capsule or addition proper auxiliary materials.
6. a kind of preparation method of diacerein fast release micropill preparation, it is characterised in that with celphere as carrier, with containing hydrotropy
The diacerein aqueous solution of agent and binding agent is upper drug solns, sprays prescription method using fluid bed bottom and prepares load medicine micropill, adds
Overcoat membrane material solution Jing fluidized bed coatings obtain diacerein fast release micropill preparation.
7. a kind of preparation method of diacerein fast release micropill preparation, including：
Step one：The preparation of upper drug solns；
Step 2：Spray medicine in fluid bed bottom；
Step 3：Fluidized bed coating-protection film layer；
Step 4：After be dried.
8. preparation method as claimed in claim 7, it is characterised in that the step one is specially that to weigh double vinegar by formula auspicious
Cause, adds the citron acid solution dissolving of formula ratio, is configured to quantitatively add medicine to molten in being then dissolved in the aqueous solution for include binding agent
Liquid.
9. preparation method as claimed in claim 7, it is characterised in that the step 2 is specially the celphere of formula ratio
It is placed in fluid bed, starts fluid bed, the upper drug solns prepared in quantitative input step one in fluid bed, the input medicine-feeding
Fluid bed medicine-feeding parameter is set by the process conditions of optimization during solution, including 150～180m3h-1 of fan delivery, solution feed pump turn
2～7rmin-1 of speed, 25～40 DEG C of temperature of charge, atomizing pressure 0.16MPa.
10. preparation method as claimed in claim 7, it is characterised in that the step 3 is specially press formula ratio to prepare 5% anti-
Sheath membrane material solution, fluidized bed coating parameter are set to 150～180m3h-1 of fan delivery, feed flow 5～15rmin- of revolution speed
1, temperature of charge control at 25～30 DEG C, atomizing pressure 0.3MPa；After the completion of the step 4 is specially coating, fluid bed is adjusted
Parameter, coated micropill is in 30～40 DEG C of 15～45min of fluidized drying.
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| CN201710077354.XA CN106619555A (en) | 2017-02-14 | 2017-02-14 | Diacerein quick-release pellet preparation and preparation method |
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| CN201710077354.XA CN106619555A (en) | 2017-02-14 | 2017-02-14 | Diacerein quick-release pellet preparation and preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107982258A (en) * | 2017-12-08 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Febustat releases pellet preparations, preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1395484A (en) * | 2000-01-12 | 2003-02-05 | 梅迪多姆实验室股份有限公司 | Substances for use in treating psoriasis |
| CN106063780A (en) * | 2016-06-28 | 2016-11-02 | 国家海洋局第三海洋研究所 | A kind of tetradoxin fast release micropill preparation, preparation method and applications |
-
2017
- 2017-02-14 CN CN201710077354.XA patent/CN106619555A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1395484A (en) * | 2000-01-12 | 2003-02-05 | 梅迪多姆实验室股份有限公司 | Substances for use in treating psoriasis |
| CN106063780A (en) * | 2016-06-28 | 2016-11-02 | 国家海洋局第三海洋研究所 | A kind of tetradoxin fast release micropill preparation, preparation method and applications |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107982258A (en) * | 2017-12-08 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of Febustat releases pellet preparations, preparation method |
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