CN106943363A - A kind of preparation method of bendroflumethiazide piece - Google Patents
A kind of preparation method of bendroflumethiazide piece Download PDFInfo
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- CN106943363A CN106943363A CN201710118066.4A CN201710118066A CN106943363A CN 106943363 A CN106943363 A CN 106943363A CN 201710118066 A CN201710118066 A CN 201710118066A CN 106943363 A CN106943363 A CN 106943363A
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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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
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/2004—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
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Abstract
The present invention discloses a kind of preparation method of bendroflumethiazide piece, belongs to technical field of medicine, comprises the following steps：Bendroflumethiazide, microcrystalline cellulose PH 102 are mixed with water, suspension one is obtained；Suspension one is subjected to wet pulverizing, suspension two is obtained；Suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；By particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, produces.Present invention effectively avoids the high temperature problem that existing crushing process runs into, uniform content after compressing tablet, dissolution is rapid.
Description
Technical field
The present invention relates to technical field of medicine, more particularly to a kind of preparation method of bendroflumethiazide piece.
Background technology
Bendroflumethiazide is 3- benzyl -6- trifluoromethyl -7- sulfonamido -3,4- dihydro -2H-1,2,4- benzothiadiazines -
1,1- dioxide.
Effect：1st, edema disease, excretion internal excessive sodium and water, reduces ECFV, eliminates oedema.
Common includes congestive heart failure, cirrhotic ascites, nephrotic syndrome, acute and chronic nephritis oedema, chronic renal failure
In early days, adrenal gland matter cortin and sodium caused by estrin treatment, water retention.2nd, hypertension.It can be depressured individually or with other
Medicine use in conjunction.It is mainly used in treating essential hypertension.3rd, central or nephrogenic diabetes insipidus.4th, nephrolith disease.It is mainly used in pre-
The calculus of anti-calcic salt component formation.
Pharmacological action：
1st, to the influence of water, electrolyte excretion.1. diuresis, urinates sodium, potassium, chlorine, phosphorus and the excretion increase of magnesium plasma, and
Urinary calcium excretion is reduced.This class mechanism of drug action mainly suppresses distal tubule leading portion and proximal tubule (effect is lighter) to chlorination
The reabsorption of sodium, so that the Na+-K+ for increasing distal tubule and concetrated pipe is exchanged, K+ secretions increase.Its mechanism of action is not yet complete
Understand.This class medicine can suppress carbonic anhydrase activity to some extent, therefore can explain its effect to proximal tubule.This class medicine
Phosphodiesterase activity can also be suppressed, intake and mitochondria oxygen consumption of the renal tubule to aliphatic acid are reduced, so as to suppress renal tubule pair
Na+, Cl- active reabsorption.2. antihypertensive effect.In addition to diuresis row's sodium effect, there may be the outer mechanism of action of kidney to participate in step-down,
It is probably the excretion for increasing intestines and stomach to Na+.
2nd, to the influence of renal hemodynamics and detection of glomeruli filtration function.Because renal tubule is reduced to water, Na+ reabsorptions,
Pressure rise in renal tubule, and flow through the water and Na+ of distal convoluted tubule and increase, stimulate macula densa to be reflected by pipe-ball, make in kidney
Feritin, angiotensins secretion increase, cause Renal vascular to shrink, renal blood flow declines, glomerulus goal and efferent glomerular arteriole are received
Contracting, glomerular filtration rate(GFR also declines.Renal blood flow and glomerular filtration rate(GFR decline, and are this class medicines to Heng Shi loops without effect
Thing diuresis can not show a candle to the main cause of loop diuretics.
The common flow of existing bendroflumethiazide piece preparation technology is first to fill out lactose, cornstarch and pre-paying starch etc.
Fill agent and use wet granulation, compressing tablet is carried out after then other auxiliary materials such as bendroflumethiazide, glidant are mixed with particle.The technique will
Compressing tablet is carried out after the particle that bendroflumethiazide and filler are made directly mixing, due to the particle diameter and the grain of particle of bendroflumethiazide raw material
Footpath difference is big, easily causes content difference between tablet.
Micronizing is generally required because bendroflumethiazide is insoluble drug, therefore when pharmaceutical preparation is made, to ensure medicine
Thing absorption in vivo and the clinical efficacy of medicine.Conventional method of micronization has ball mill grinding, air-flow crushing and spray drying
Method, this several method easily causes the relevant material of bendroflumethiazide exceeded the problem of can all run into high temperature during crushing.
In addition, in terms of existing bendroflumethiazide piece auxiliary material selection, due to selecting substantial amounts of insoluble auxiliary material.Surveyed in dissolution rate
During fixed, even if disintegration of tablet, water-insoluble auxiliary material is easily deposited in stripping rotor bottom, hinders the scattered of medicine, so that
Make drug-eluting poor；In addition, it is ensured that micronized medicine is good with auxiliary material mixing uniformity, to auxiliary material requirement should granularity it is small, again
There is good mobility and compressibility.
The content of the invention
The invention provides a kind of bendroflumethiazide piece and preparation method thereof, the tablet of existing bendroflumethiazide piece having is solved
Between content difference is larger and the problem of exceeded relevant material.
In order to solve the above technical problems, the technical scheme is that：
A kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, produces.
Wherein it is preferred to, the wet pulverizing in the step (2) is entered by the way of colloid mill and high-speed stirred bead mill
OK, wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is less than 15 DEG C, benzyl fluorine after wet grinding
The particle diameter D90 of thiazine is less than 30 μm.
Wherein it is preferred to, the bendroflumethiazide is that 0.25~0.5 parts by weight, the microcrystalline cellulose PH-102 are 2~6
Parts by weight, the lactose are that 4~8 parts by weight, the cornstarch are that 4~8 parts by weight, the carboxyrnethyl starch sodium are 0.2~0.6
Parts by weight, the magnesium stearate are 0.02~0.04 parts by weight.
Wherein it is preferred to, the bendroflumethiazide is that 0.25~0.5 parts by weight, the microcrystalline cellulose PH-102 are 3~5
Parts by weight, the lactose are that 5~7 parts by weight, the cornstarch are that 5~7 parts by weight, the carboxyrnethyl starch sodium are 0.3~0.5
Parts by weight, the magnesium stearate are 0.02~0.04 parts by weight.
Beneficial effect of the present invention：
1. the present invention reduces the temperature of grinding using wet grinding using water at low temperature circulating cooling, circulating water temperature is less than 15
DEG C, the high temperature problem that existing crushing process runs into, and the wherein efficiency high of high-speed stirred bead mill are efficiently avoid, is industrialized
It is convenient for production.
2. the present invention suspension will be sprayed into cornstarch and lactose bulking agents after wet pulverizing, wet method system is carried out
Grain, uniform content after compressing tablet effectively solves to have showed the problem of content difference between the tablet of existing bendroflumethiazide piece is larger.
3. the microcrystalline cellulose PH-102 density that the present invention is selected is small, cellulose rapid flotation after disintegration of tablet, not only not
Medicine can be made to be deposited in stripping rotor bottom, and medicine can be driven to be suspended in dissolution medium, promote bendroflumethiazide dissolution, simultaneously
Drug-eluting is rapider in 5min.
Embodiment
Below in conjunction with the specific embodiment of the invention, the technical scheme to the present invention carries out clear, complete description, institute
The example of description is only the section Example of the present invention, rather than whole embodiments.Based on the embodiment in the present invention, sheet
Field those of ordinary skill, the every other embodiment obtained under the premise of creative work is not made, belongs to this hair
Bright protection domain.
Embodiment 1
The present embodiment provides a kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；The wet pulverizing uses colloid mill and high-speed stirred
The mode of bead mill is carried out, and wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is wet less than 15 DEG C
The particle diameter D90 of bendroflumethiazide is less than 30 μm after method grinding；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, is in batches 100,000, rule
Lattice are 2.5mg/ pieces.
Wherein, the inventory of supplementary material is respectively in above-mentioned preparation method：Bendroflumethiazide 0.25Kg, microcrystalline cellulose PH-
102 4Kg, lactose 6Kg, cornstarch 6Kg, carboxyrnethyl starch sodium 0.4Kg, magnesium stearate 0.03Kg.
Embodiment 2
The present embodiment provides a kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；The wet pulverizing uses colloid mill and high-speed stirred
The mode of bead mill is carried out, and wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is wet less than 15 DEG C
The particle diameter D90 of bendroflumethiazide is less than 30 μm after method grinding；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, is in batches 100,000, rule
Lattice are 2.5mg/ pieces.
Wherein, the inventory of supplementary material is respectively in above-mentioned preparation method：Bendroflumethiazide 0.25Kg, microcrystalline cellulose PH-
102 6Kg, lactose 4Kg, cornstarch 8Kg, carboxyrnethyl starch sodium 0.6Kg, magnesium stearate 0.02Kg.
Embodiment 3
The present embodiment provides a kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；The wet pulverizing uses colloid mill and high-speed stirred
The mode of bead mill is carried out, and wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is wet less than 15 DEG C
The particle diameter D90 of bendroflumethiazide is less than 30 μm after method grinding；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, is in batches 100,000, rule
Lattice are 2.5mg/ pieces.
Wherein, the inventory of supplementary material is respectively in above-mentioned preparation method：Bendroflumethiazide 0.25Kg, microcrystalline cellulose PH-
102 2Kg, lactose 8Kg, cornstarch 4Kg, carboxyrnethyl starch sodium 0.2Kg, magnesium stearate 0.04Kg.
Embodiment 4
The present embodiment provides a kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；The wet pulverizing uses colloid mill and high-speed stirred
The mode of bead mill is carried out, and wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is wet less than 15 DEG C
The particle diameter D90 of bendroflumethiazide is less than 30 μm after method grinding；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, is in batches 100,000, rule
Lattice are 5mg/ pieces.
Wherein, the inventory of supplementary material is respectively in above-mentioned preparation method：Bendroflumethiazide 0.5Kg, microcrystalline cellulose PH-
102 3Kg, lactose 7Kg, cornstarch 5Kg, carboxyrnethyl starch sodium 0.3Kg, magnesium stearate 0.04Kg.
Embodiment 5
The present embodiment provides a kind of preparation method of bendroflumethiazide piece, comprises the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；The wet pulverizing uses colloid mill and high-speed stirred
The mode of bead mill is carried out, and wet grinding reduces the temperature of grinding using water at low temperature circulating cooling, and circulating water temperature is wet less than 15 DEG C
The particle diameter D90 of bendroflumethiazide is less than 30 μm after method grinding；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, is in batches 100,000, rule
Lattice are 5mg/ pieces.
Wherein, the inventory of supplementary material is respectively in above-mentioned preparation method：Bendroflumethiazide 0.5Kg, microcrystalline cellulose PH-
102 5Kg, lactose 5Kg, cornstarch 7Kg carboxyrnethyl starch sodiums 0.5Kg, magnesium stearate 0.02Kg.
Bendroflumethiazide piece and uniformity of dosage units made from the various embodiments described above are measured.
(1) dissolution rate is detected：Inspection method is《Chinese Pharmacopoeia》Second method, slurry processes, rotating speed as defined in 2015 editions：50rpm,
900ml pH6.8 phosphate buffers, 5min sampling detections.
(2) uniformity of dosage units is detected：This product 1 is taken, is put in mortar, it is finely ground, plus 0.4% sodium hydroxide solution is in right amount, grinds
Mill, is transferred in 25ml measuring bottles, shake well dissolves bendroflumethiazide, uses 0.4% hydrogen-oxygen by several times with 0.4% sodium hydroxide solution
Change sodium solution and be diluted to scale, shake up, filter, precision measures subsequent filtrate 2ml, puts in 25ml measuring bottles, be diluted with water to scale, shake
It is even, according to the method mensuration absorbance under assay, and content is calculated, regulation (general rule 0941) should be met.
(3) fragrant first amine：Inspection method is《Chinese Pharmacopoeia》In the bendroflumethiazide quality standard of 2015 editions two records
The inspection method of fragrant first amine.
The bendroflumethiazide piece drug-eluting that it can be seen from above-mentioned experimental result prepared by the embodiment of the present invention 1~5 is rapid,
Complete dissolution in 5min, and uniformity of dosage units numerical value is small, relevant material meets regulation.After accelerated test, dissolution rate is basically unchanged,
Relevant material is substantially unchanged.And sample made from above-described embodiment 0 day and acceleration are pressed for 6 months《Chinese Pharmacopoeia》Version in 2015
Two bendroflumethiazide tablet quality standard detections, meet standard regulation.
Presently preferred embodiments of the present invention is the foregoing is only, is not intended to limit the invention, all essences in the present invention
God is with principle, and any modifications, equivalent substitutions and improvements made etc. should be included within the scope of the present invention.
Claims (4)
1. a kind of preparation method of bendroflumethiazide piece, it is characterised in that comprise the following steps：
(1) bendroflumethiazide, microcrystalline cellulose PH-102 are mixed with water, obtain suspension one；
(2) suspension one is subjected to wet pulverizing, obtains suspension two；
(3) suspension two is added in lactose and cornstarch by the way of spraying into, using wet granulation；
(4) by particle drying, 30 mesh sieves are crossed, carboxyrnethyl starch sodium and magnesium stearate, compressing tablet is added, produces.
2. a kind of preparation method of bendroflumethiazide piece according to claim 1, it is characterised in that：In the step (2)
Wet pulverizing is carried out by the way of colloid mill and high-speed stirred bead mill, and wet grinding reduces grinding using water at low temperature circulating cooling
Temperature, circulating water temperature be less than 15 DEG C, after wet grinding the particle diameter D90 of bendroflumethiazide be less than 30 μm.
3. a kind of preparation method of bendroflumethiazide piece according to claim 1, it is characterised in that：The bendroflumethiazide is
0.25~0.5 parts by weight, the microcrystalline cellulose PH-102 are that 2~6 parts by weight, the lactose are 4~8 parts by weight, the jade
Rice starch is that 4~8 parts by weight, the carboxyrnethyl starch sodium are that 0.2~0.6 parts by weight, the magnesium stearate are 0.02~0.04 weight
Measure part.
4. a kind of preparation method of bendroflumethiazide piece according to claim 1, it is characterised in that：The bendroflumethiazide is
0.25~0.5 parts by weight, the microcrystalline cellulose PH-102 are that 3~5 parts by weight, the lactose are 5~7 parts by weight, the jade
Rice starch is that 5~7 parts by weight, the carboxyrnethyl starch sodium are that 0.3~0.5 parts by weight, the magnesium stearate are 0.02~0.04 weight
Measure part.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118066.4A CN106943363A (en) | 2017-03-01 | 2017-03-01 | A kind of preparation method of bendroflumethiazide piece |
Applications Claiming Priority (1)
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| CN201710118066.4A CN106943363A (en) | 2017-03-01 | 2017-03-01 | A kind of preparation method of bendroflumethiazide piece |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4327080A (en) * | 1981-07-13 | 1982-04-27 | E. R. Squibb & Sons, Inc. | Novel Bendroflumethiazide formulations and method |
| CN103705510A (en) * | 2013-12-27 | 2014-04-09 | 华润赛科药业有限责任公司 | Method for preparing azilsartan solid composition |
-
2017
- 2017-03-01 CN CN201710118066.4A patent/CN106943363A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4327080A (en) * | 1981-07-13 | 1982-04-27 | E. R. Squibb & Sons, Inc. | Novel Bendroflumethiazide formulations and method |
| CN103705510A (en) * | 2013-12-27 | 2014-04-09 | 华润赛科药业有限责任公司 | Method for preparing azilsartan solid composition |
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Application publication date: 20170714 |
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