CN108721240A - A kind of 25mg amitriptylines film coating tablet recipe and technological procedure - Google Patents
A kind of 25mg amitriptylines film coating tablet recipe and technological procedure Download PDFInfo
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- CN108721240A CN108721240A CN201810589878.1A CN201810589878A CN108721240A CN 108721240 A CN108721240 A CN 108721240A CN 201810589878 A CN201810589878 A CN 201810589878A CN 108721240 A CN108721240 A CN 108721240A
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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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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P25/24—Antidepressants
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Abstract
A kind of 25mg amitriptylines film coating tablet recipe and technological procedure, the present invention relates to pharmaceutical technology fields, are made of following parts by weight of component, label：85.49 parts by weight of dicalcium phosphate dihydrate, 1.84 parts by weight of cornstarch, 15.56 parts by weight of purified water, 25 parts by weight of Amitriptyline Hydrochloride, 6 parts by weight of lactose, 9.9 parts by weight of cornstarch, 6.5 parts by weight of microcrystalline cellulose, 1.3 parts by weight of anhydrous silica gel, 1 parts by weight of stearic acid, 0.5 parts by weight of magnesium stearate, coating：5.54 parts by weight of coating powder, 30 parts by weight of isopropanol, 30 parts by weight of purified water.The granulation solution being made into, pelletizes, and dry, is sieved, whole mesh；Dry granulation；It is always mixed, and tabletting forms label；Label is preheated, and is coated processing, is dried.The present invention adjusts bitter taste by cornstarch, and improves outer surface color and luster by coating, is conducive to improve patient heart, and make it more easily decompose absorption by anhydrous silica gel, is conducive to patient health.
Description
Technical field
The present invention relates to pharmaceutical technology field, specially a kind of 25mg amitriptylines film coating tablet recipe and Process Planning
Journey.
Background technology
Amitriptyline is often colourless crystallization or white, off-white powder with its hydrochloride；Odorless or almost odorless, bitter,
There is burn feeling, then there is feeling of numbness.It is readily soluble in water, methanol, ethyl alcohol or chloroform, it is almost insoluble in ether.Fusing point 195~
199℃.Amitriptyline is clinical most common tricyclic antidepressant, and pharmacological action is to block norepinephrine, 5- hydroxyls
Tryptamines promotes cynapse transfer function and plays anti-in the reuptake of nerve endings to make the mediator concentration of synaptic cleft increase
Depression effect.Its antidepressant effect is similar to imipramine, and patients with depression mood can be made to improve, to think slow, behavior it is slow and
The symptoms such as loss of appetite can make moderate progress.Obvious curative effects can be generated after general medication within 7th~10.Its sedation is made with cholinolytic
With stronger than imipramine.This product oral absorption is complete, and blood concentration reaches peak within 8-12 hours.In blood 90% with plasma protein knot
It closes.Part is nortriptyline through liver metabolism, this product still has antidepressant effect.It is discharged by kidney and enteron aisle, excretion is slow, and 24 is small
When be about discharged 40%, discharge 60% in 72 hours.Being discontinued 3 weeks can still detect in urine.Half-life period is 32-40 hours general.Without water silicon
Glue is nonirritant to tissue, non-toxic, few without allergic reaction, body rejection；With good physicochemical property, with
Its original elasticity and pliability can be kept in body fluid and tissue contact process, is not degraded, and be a kind of the lazy of quite stable
Property substance.Microcrystalline cellulose is white or canescence fine crystalline powder, odorless, tasteless.Dicalcium phosphate dihydrate white monocline
Crystallographic system crystalline powder.It is odorless, tasteless.Another important use of starch is as pharmaceutical excipient, the production of early stage various countries pharmaceutical factory
The tablet overwhelming majority the use of cornstarch is filler and adhesive, cornstarch contains a certain amount of sugared part.Existing Ah
Rice is in blocks for the condensation of dense growth of plants and trees film coating piece drug, it is difficult to decompose, and bitter, color is single, is unfavorable for patient's absorption, and mouth
Taste and color are unfavorable for adjusting patient heart, are unfavorable for patient's physical and mental health.
Invention content
(1) the technical issues of solving
In view of the deficiencies of the prior art, the present invention provides a kind of 25mg amitriptylines film coating tablet recipe and Process Plannings
Journey it is in blocks to solve existing amitriptyline thin membrane coated tablet drug condensation, it is difficult to decompose, and bitter, color is single, unfavorable
It is absorbed in patient, and taste and color are unfavorable for adjusting patient heart, are unfavorable for the problem of patient's physical and mental health.
(2) technical solution
In order to achieve the above object, the present invention is achieved by the following technical programs：A kind of 25mg amitriptylines film packet
Garment piece prescription is made, label of following parts by weight of component：84~87 parts by weight of dicalcium phosphate dihydrate, 1~3 weight of cornstarch
Part, 15~16 parts by weight of purified water, 20~30 parts by weight of Amitriptyline Hydrochloride, 5~7 parts by weight of lactose, 9~11 weight of cornstarch
Measure part, 6~7 parts by weight of microcrystalline cellulose, 0.8~1.8 parts by weight of anhydrous silica gel, 0.5~1.5 parts by weight of stearic acid, stearic acid
0.2~0.8 parts by weight of magnesium, coating：5~6 parts by weight of coating powder, 25~35 parts by weight of isopropanol, 25~35 parts by weight of purified water.
Preferably, it is made of following parts by weight of component, label：85.49 parts by weight of dicalcium phosphate dihydrate, cornstarch 1.84
Parts by weight, 15.56 parts by weight of purified water, 25 parts by weight of Amitriptyline Hydrochloride, 6 parts by weight of lactose, 9.9 parts by weight of cornstarch,
6.5 parts by weight of microcrystalline cellulose, 1.3 parts by weight of anhydrous silica gel, 1 parts by weight of stearic acid, 0.5 parts by weight of magnesium stearate, coating：Packet
5.54 parts by weight of clothing powder, 30 parts by weight of isopropanol, 30 parts by weight of purified water.
A kind of technological procedure of 25mg amitriptylines film coating tablet recipe, includes the following steps,
(1), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is weighed on weighing and burden platform；
(2), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is sieved；
(3), the granulation solution that dicalcium phosphate dihydrate, purified water and cornstarch are made into, pelletizes, and dry；
(4), dicalcium phosphate dihydrate particle is sieved, whole mesh；
(5), dicalcium phosphate dihydrate, Amitriptyline Hydrochloride, lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, tristearin
Acid, magnesium stearate are pre-mixed；
(6), dry granulation is carried out, 10mg amitriptyline thin membrane coated tablets is generated and is pre-mixed particle；
(7), 10mg amitriptylines thin membrane coated tablet, stearic acid, magnesium stearate are always mixed, and 25mg amitriptylines are made
Thin membrane coated tablet；
(8), tabletting is carried out, label is formed；
(9), label is preheated, and the coating solution that isopropanol, purified water and coating powder are formed is coated processing, into
Row drying, piece to inlet air temperature of drying in the air reach room temperature；
(10), semi-finished product detect, packaging, finished product detection.
Preferably, step (3) loss on drying should be less than or equal to 2 percent points five, and the step (4) uses 30
Mesh shaking screen, whole grain size are 1mm.
Preferably, step (5) incorporation time is set as 10 minutes, and speed-frequency is set as 35Hz.
Preferably, step (6) the pressure roller extruding force is 45 (30-60) Kp/cm2, feeding frequency：25HZ, tabletting frequency：
30HZ crushes frequency：25HZ, frequency of being sieved：30HZ carries out dry granulation with 1.0mm sieves.
Preferably, step (7) incorporation time is set as 5 minutes, and speed-frequency is set as 35HZ.
Preferably, step (8) punch die：Mould in diameter 6.5mm circles；Upper punching：Diameter 6.5mm, scrobicula is round, is carved with
" MP50 " printed words；Undershoot：Diameter 6.5mm, scrobicula is round, is carved with " 25mg " printed words.
Preferably, step (9) the coating solution hydrojet speed is 160-240g/ minutes, after Coating Solution sprays,
It is 2-4 revs/min by seed-coating machine adjustment of rotational speed, it is about 30 minutes dry, it is then shut off heating valve, piece to inlet air temperature of drying in the air reaches
Room temperature, temperature of outgoing air are less than 30 DEG C.
Preferably, the step (10) sets bubble-cap machine and is punched set of frequency as 20HZ-30HZ；The temperature of profiled sheeting is set
It it is 135 DEG C ± 10 DEG C, when the temperature of heat sealing plate is set as 20-25HZ：220℃±10℃；When 25-30HZ：230℃±10℃.
(3) advantageous effect
The present invention provides a kind of 25mg amitriptylines film coating tablet recipe and technological procedures, have following
Advantageous effect：
The present invention adjusts the bitter taste of amitriptyline thin membrane coated tablet by cornstarch so that amitriptyline thin membrane coated tablet
Taste improves, and improves amitriptyline thin membrane coated tablet outer surface color and luster by coating so that amitriptyline thin membrane coated tablet color
Pool is conducive to improve patient heart, and make amitriptyline thin membrane coated tablet more easily decompose by anhydrous silica gel not single
It absorbs, is conducive to patient's physical and mental health.
Specific implementation mode
The following is a clear and complete description of the technical scheme in the embodiments of the invention, it is clear that described embodiment
Only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, the common skill in this field
The every other embodiment that art personnel are obtained without making creative work belongs to the model that the present invention protects
It encloses.
Example one
A kind of 25mg amitriptylines film coating tablet recipe, it is characterised in that：It is made of following parts by weight of component, label：
84 parts by weight of dicalcium phosphate dihydrate, 1 parts by weight of cornstarch, 15 parts by weight of purified water, 20 parts by weight of Amitriptyline Hydrochloride, lactose
5 parts by weight, 9 parts by weight of cornstarch, 6 parts by weight of microcrystalline cellulose, 0.8 parts by weight of anhydrous silica gel, 0.5 parts by weight of stearic acid,
0.2 parts by weight of magnesium stearate, coating：5 parts by weight of coating powder, 25 parts by weight of isopropanol, 25 parts by weight of purified water.
A kind of technological procedure of 25mg amitriptylines film coating tablet recipe, includes the following steps,
(1), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is weighed on weighing and burden platform；
(2), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is sieved；
(3), the granulation solution that dicalcium phosphate dihydrate, purified water and cornstarch are made into, pelletizes, and dry；
(4), dicalcium phosphate dihydrate particle is sieved, whole mesh；
(5), dicalcium phosphate dihydrate, Amitriptyline Hydrochloride, lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, tristearin
Acid, magnesium stearate are pre-mixed；
(6), dry granulation is carried out, 10mg amitriptyline thin membrane coated tablets is generated and is pre-mixed particle；
(7), 10mg amitriptylines thin membrane coated tablet, stearic acid, magnesium stearate are always mixed, and 25mg amitriptylines are made
Thin membrane coated tablet；
(8), tabletting is carried out, label is formed；
(9), label is preheated, and the coating solution that isopropanol, purified water and coating powder are formed is coated processing, into
Row drying, piece to inlet air temperature of drying in the air reach room temperature；
(10), semi-finished product detect, packaging, finished product detection.
Preferably, step (3) loss on drying should be less than or equal to 2 percent points five, and the step (4) uses 30
Mesh shaking screen, whole grain size are 1mm.
Preferably, step (5) incorporation time is set as 10 minutes, and speed-frequency is set as 35Hz.
Preferably, step (6) the pressure roller extruding force is 45 (30-60) Kp/cm2, feeding frequency：25HZ, tabletting frequency：
30HZ crushes frequency：25HZ, frequency of being sieved：30HZ carries out dry granulation with 1.0mm sieves.
Preferably, step (7) incorporation time is set as 5 minutes, and speed-frequency is set as 35HZ.
Preferably, step (8) punch die：Mould in diameter 6.5mm circles；Upper punching：Diameter 6.5mm, scrobicula is round, is carved with
" MP50 " printed words；Undershoot：Diameter 6.5mm, scrobicula is round, is carved with " 25mg " printed words.
Preferably, step (9) the coating solution hydrojet speed is 160-240g/ minutes, after Coating Solution sprays,
It is 2-4 revs/min by seed-coating machine adjustment of rotational speed, it is about 30 minutes dry, it is then shut off heating valve, piece to inlet air temperature of drying in the air reaches
Room temperature, temperature of outgoing air are less than 30 DEG C.
Preferably, the step (10) sets bubble-cap machine and is punched set of frequency as 20HZ-30HZ；The temperature of profiled sheeting is set
It it is 135 DEG C ± 10 DEG C, when the temperature of heat sealing plate is set as 20-25HZ：220℃±10℃；When 25-30HZ：230℃±10℃.
Example two
A kind of 25mg amitriptylines film coating tablet recipe, it is characterised in that：It is made of following parts by weight of component, label：
85.5 parts by weight of dicalcium phosphate dihydrate, 2 parts by weight of cornstarch, 15.5 parts by weight of purified water, 25 parts by weight of Amitriptyline Hydrochloride,
6 parts by weight of lactose, 10 parts by weight of cornstarch, 6.5 parts by weight of microcrystalline cellulose, 1.3 parts by weight of anhydrous silica gel, 1 weight of stearic acid
Measure part, 0.5 parts by weight of magnesium stearate, coating：5.5 parts by weight of coating powder, 30 parts by weight of isopropanol, 30 parts by weight of purified water.
A kind of technological procedure of 25mg amitriptylines film coating tablet recipe, includes the following steps,
(1), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is weighed on weighing and burden platform；
(2), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is sieved；
(3), the granulation solution that dicalcium phosphate dihydrate, purified water and cornstarch are made into, pelletizes, and dry；
(4), dicalcium phosphate dihydrate particle is sieved, whole mesh；
(5), dicalcium phosphate dihydrate, Amitriptyline Hydrochloride, lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, tristearin
Acid, magnesium stearate are pre-mixed；
(6), dry granulation is carried out, 10mg amitriptyline thin membrane coated tablets is generated and is pre-mixed particle；
(7), 10mg amitriptylines thin membrane coated tablet, stearic acid, magnesium stearate are always mixed, and 25mg amitriptylines are made
Thin membrane coated tablet；
(8), tabletting is carried out, label is formed；
(9), label is preheated, and the coating solution that isopropanol, purified water and coating powder are formed is coated processing, into
Row drying, piece to inlet air temperature of drying in the air reach room temperature；
(10), semi-finished product detect, packaging, finished product detection.
Preferably, step (3) loss on drying should be less than or equal to 2 percent points five, and the step (4) uses 30
Mesh shaking screen, whole grain size are 1mm.
Preferably, step (5) incorporation time is set as 10 minutes, and speed-frequency is set as 35Hz.
Preferably, step (6) the pressure roller extruding force is 45 (30-60) Kp/cm2, feeding frequency：25HZ, tabletting frequency：
30HZ crushes frequency：25HZ, frequency of being sieved：30HZ carries out dry granulation with 1.0mm sieves.
Preferably, step (7) incorporation time is set as 5 minutes, and speed-frequency is set as 35HZ.
Preferably, step (8) punch die：Mould in diameter 6.5mm circles；Upper punching：Diameter 6.5mm, scrobicula is round, is carved with
" MP50 " printed words；Undershoot：Diameter 6.5mm, scrobicula is round, is carved with " 25mg " printed words.
Preferably, step (9) the coating solution hydrojet speed is 160-240g/ minutes, after Coating Solution sprays,
It is 2-4 revs/min by seed-coating machine adjustment of rotational speed, it is about 30 minutes dry, it is then shut off heating valve, piece to inlet air temperature of drying in the air reaches
Room temperature, temperature of outgoing air are less than 30 DEG C.
Preferably, the step (10) sets bubble-cap machine and is punched set of frequency as 20HZ-30HZ；The temperature of profiled sheeting is set
It it is 135 DEG C ± 10 DEG C, when the temperature of heat sealing plate is set as 20-25HZ：220℃±10℃；When 25-30HZ：230℃±10℃.
Example three
A kind of 25mg amitriptylines film coating tablet recipe, it is characterised in that：It is made of following parts by weight of component, label：
87 parts by weight of dicalcium phosphate dihydrate, 3 parts by weight of cornstarch, 16 parts by weight of purified water, 30 parts by weight of Amitriptyline Hydrochloride, lactose
7 parts by weight, 11 parts by weight of cornstarch, 7 parts by weight of microcrystalline cellulose, 1.8 parts by weight of anhydrous silica gel, 1.5 parts by weight of stearic acid,
0.8 parts by weight of magnesium stearate, coating：6 parts by weight of coating powder, 35 parts by weight of isopropanol, 35 parts by weight of purified water.
A kind of technological procedure of 25mg amitriptylines film coating tablet recipe, includes the following steps,
(1), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is weighed on weighing and burden platform；
(2), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two
Water calcium monohydrogen phosphate is sieved；
(3), the granulation solution that dicalcium phosphate dihydrate, purified water and cornstarch are made into, pelletizes, and dry；
(4), dicalcium phosphate dihydrate particle is sieved, whole mesh；
(5), dicalcium phosphate dihydrate, Amitriptyline Hydrochloride, lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, tristearin
Acid, magnesium stearate are pre-mixed；
(6), dry granulation is carried out, 10mg amitriptyline thin membrane coated tablets is generated and is pre-mixed particle；
(7), 10mg amitriptylines thin membrane coated tablet, stearic acid, magnesium stearate are always mixed, and 25mg amitriptylines are made
Thin membrane coated tablet；
(8), tabletting is carried out, label is formed；
(9), label is preheated, and the coating solution that isopropanol, purified water and coating powder are formed is coated processing, into
Row drying, piece to inlet air temperature of drying in the air reach room temperature；
(10), semi-finished product detect, packaging, finished product detection.
Preferably, step (3) loss on drying should be less than or equal to 2 percent points five, and the step (4) uses 30
Mesh shaking screen, whole grain size are 1mm.
Preferably, step (5) incorporation time is set as 10 minutes, and speed-frequency is set as 35Hz.
Preferably, step (6) the pressure roller extruding force is 45 (30-60) Kp/cm2, feeding frequency：25HZ, tabletting frequency：
30HZ crushes frequency：25HZ, frequency of being sieved：30HZ carries out dry granulation with 1.0mm sieves.
Preferably, step (7) incorporation time is set as 5 minutes, and speed-frequency is set as 35HZ.
Preferably, step (8) punch die：Mould in diameter 6.5mm circles；Upper punching：Diameter 6.5mm, scrobicula is round, is carved with
" MP50 " printed words；Undershoot：Diameter 6.5mm, scrobicula is round, is carved with " 25mg " printed words.
Preferably, step (9) the coating solution hydrojet speed is 160-240g/ minutes, after Coating Solution sprays,
It is 2-4 revs/min by seed-coating machine adjustment of rotational speed, it is about 30 minutes dry, it is then shut off heating valve, piece to inlet air temperature of drying in the air reaches
Room temperature, temperature of outgoing air are less than 30 DEG C.
Preferably, the step (10) sets bubble-cap machine and is punched set of frequency as 20HZ-30HZ；The temperature of profiled sheeting is set
It it is 135 DEG C ± 10 DEG C, when the temperature of heat sealing plate is set as 20-25HZ：220℃±10℃；When 25-30HZ：230℃±10℃.
The embodiment of the present invention and the common amitriptyline thin membrane coated tablet table of comparisons
From above table as can be seen that compared with common amitriptyline thin membrane coated tablet in the market, present invention tool
The case where mouthfeel that improves significantly and taste are deteriorated, and do not have excessive sugar, and also outer surface color and luster is various bright-coloured,
Be conducive to mood when patient's medication, and be suitable for most of crowds, and its internal drug is easily decomposes, is easy to absorb,
Be conducive to patient health.
It should be noted that herein, relational terms such as first and second and the like are used merely to a reality
Body or operation are distinguished with another entity or operation, are deposited without necessarily requiring or implying between these entities or operation
In any actual relationship or order or sequence.Moreover, the terms "include", "comprise" or its any other variant are intended to
Non-exclusive inclusion, so that the process, method, article or equipment including a series of elements is not only wanted including those
Element, but also include other elements that are not explicitly listed, or further include for this process, method, article or equipment
Intrinsic element.In the absence of more restrictions.By sentence " an including element limited, it is not excluded that including
There is also other identical elements in the process, method, article or equipment of element ".
It although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
Understanding without departing from the principles and spirit of the present invention can carry out these embodiments a variety of variations, modification, replace
And modification, the scope of the present invention is defined by the appended.
Claims (10)
1. a kind of 25mg amitriptylines film coating tablet recipe, it is characterised in that：It is made of following parts by weight of component, label：Two
84~87 parts by weight of water calcium monohydrogen phosphate, 1~3 parts by weight of cornstarch, 15~16 parts by weight of purified water, Amitriptyline Hydrochloride 20~
30 parts by weight, 5~7 parts by weight of lactose, 9~11 parts by weight of cornstarch, 6~7 parts by weight of microcrystalline cellulose, anhydrous silica gel 0.8
~1.8 parts by weight, 0.5~1.5 parts by weight of stearic acid, 0.2~0.8 parts by weight of magnesium stearate, coating：5~6 weight of coating powder
Part, 25~35 parts by weight of isopropanol, 25~35 parts by weight of purified water.
2. a kind of 25mg amitriptylines film coating tablet recipe according to claim 1, it is characterised in that：By following weight
Part component is made, label：85.49 parts by weight of dicalcium phosphate dihydrate, 1.84 parts by weight of cornstarch, 15.56 parts by weight of purified water,
25 parts by weight of Amitriptyline Hydrochloride, 6 parts by weight of lactose, 9.9 parts by weight of cornstarch, 6.5 parts by weight of microcrystalline cellulose, no water silicon
1.3 parts by weight of glue, 1 parts by weight of stearic acid, 0.5 parts by weight of magnesium stearate, coating：5.54 parts by weight of coating powder, 30 weight of isopropanol
Measure part, 30 parts by weight of purified water.
3. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 1, it is characterised in that：
Include the following steps,
(1), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two water phosphorus
Sour hydrogen calcium is weighed on weighing and burden platform；
(2), lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, magnesium stearate, Amitriptyline Hydrochloride, two water phosphorus
Sour hydrogen calcium is sieved；
(3), the granulation solution that dicalcium phosphate dihydrate, purified water and cornstarch are made into, pelletizes, and dry；
(4), dicalcium phosphate dihydrate particle is sieved, whole mesh；
(5), dicalcium phosphate dihydrate, Amitriptyline Hydrochloride, lactose, cornstarch, microcrystalline cellulose, anhydrous silica gel, stearic acid, hard
Fatty acid magnesium is pre-mixed；
(6), dry granulation is carried out, 10mg amitriptyline thin membrane coated tablets is generated and is pre-mixed particle；
(7), 10mg amitriptylines thin membrane coated tablet, stearic acid, magnesium stearate are always mixed, and 25mg amitriptyline films are made
Coating tablet；
(8), tabletting is carried out, label is formed；
(9), label is preheated, and the coating solution that isopropanol, purified water and coating powder are formed is coated processing, is done
Dry, piece to inlet air temperature of drying in the air reaches room temperature；
(10), semi-finished product detect, packaging, finished product detection.
4. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (3) loss on drying should be less than or equal to 2 percent points five, and the step (4) uses 30 mesh shaking screens, whole grain big
Small is 1mm.
5. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (5) incorporation time is set as 10 minutes, and speed-frequency is set as 35Hz.
6. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (6) the pressure roller extruding force is 45 (30-60) Kp/cm2, feeding frequency：25HZ, tabletting frequency：30HZ crushes frequency：
25HZ, frequency of being sieved：30HZ carries out dry granulation with 1.0mm sieves.
7. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (7) incorporation time is set as 5 minutes, and speed-frequency is set as 35HZ.
8. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (8) punch die：Mould in diameter 6.5mm circles；Upper punching：Diameter 6.5mm, scrobicula is round, is carved with " MP50 " printed words；Under
Punching：Diameter 6.5mm, scrobicula is round, is carved with " 25mg " printed words.
9. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, it is characterised in that：
Step (9) the coating solution hydrojet speed is 160-240g/ minutes, after Coating Solution sprays, by seed-coating machine rotating speed tune
Whole is 2-4 revs/min, about 30 minutes dry, is then shut off heating valve, piece to inlet air temperature of drying in the air reaches room temperature, temperature of outgoing air
Less than 30 DEG C.
10. a kind of technological procedure of 25mg amitriptylines film coating tablet recipe according to claim 2, feature exist
In：The step (10) sets bubble-cap machine and is punched set of frequency as 20HZ-30HZ；The temperature of profiled sheeting is set as 135 DEG C ± 10
DEG C, when the temperature of heat sealing plate is set as 20-25HZ：220℃±10℃；When 25-30HZ：230℃±10℃.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114028369A (en) * | 2021-11-22 | 2022-02-11 | 常州市第四制药厂有限公司 | Amitriptyline hydrochloride preparation composition and preparation method thereof |
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| CN104684550A (en) * | 2012-06-15 | 2015-06-03 | 通尼克斯制药有限公司 | Compositions and methods for transmucosal absorption |
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| CN104684550A (en) * | 2012-06-15 | 2015-06-03 | 通尼克斯制药有限公司 | Compositions and methods for transmucosal absorption |
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| R.H. MANZO等: "Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amitriptyline Hydrochloride", 《JOURNAL OF PHARMACEUTICAL SCIENCES》 * |
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| CN114028369A (en) * | 2021-11-22 | 2022-02-11 | 常州市第四制药厂有限公司 | Amitriptyline hydrochloride preparation composition and preparation method thereof |
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