CN109833301A - A kind of dog cat terbinafine HCl flavor piece and its preparation process - Google Patents
A kind of dog cat terbinafine HCl flavor piece and its preparation process Download PDFInfo
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- CN109833301A CN109833301A CN201711224269.8A CN201711224269A CN109833301A CN 109833301 A CN109833301 A CN 109833301A CN 201711224269 A CN201711224269 A CN 201711224269A CN 109833301 A CN109833301 A CN 109833301A
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- Prior art keywords
- terbinafine hcl
- piece
- dog cat
- terbinafine
- flavor
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- DOMXUEMWDBAQBQ-WEVVVXLNSA-N terbinafine Chemical compound C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 DOMXUEMWDBAQBQ-WEVVVXLNSA-N 0.000 title claims abstract description 55
- 229960002722 terbinafine Drugs 0.000 title claims abstract description 55
- 239000000796 flavoring agent Substances 0.000 title claims abstract description 34
- 241000282326 Felis catus Species 0.000 title claims abstract description 25
- 235000019634 flavors Nutrition 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 20
- 235000019640 taste Nutrition 0.000 claims abstract description 13
- 239000008139 complexing agent Substances 0.000 claims abstract description 12
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 10
- 239000000470 constituent Substances 0.000 claims abstract description 4
- 239000008187 granular material Substances 0.000 claims description 12
- 238000010438 heat treatment Methods 0.000 claims description 12
- 239000003094 microcapsule Substances 0.000 claims description 12
- 239000002245 particle Substances 0.000 claims description 12
- 239000000725 suspension Substances 0.000 claims description 12
- 230000009967 tasteless effect Effects 0.000 claims description 9
- 239000007921 spray Substances 0.000 claims description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- 241000287828 Gallus gallus Species 0.000 claims description 6
- 229920002472 Starch Polymers 0.000 claims description 6
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 235000012054 meals Nutrition 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- 239000011122 softwood Substances 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- RFVNOJDQRGSOEL-UHFFFAOYSA-N 2-hydroxyethyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCO RFVNOJDQRGSOEL-UHFFFAOYSA-N 0.000 claims description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 238000004108 freeze drying Methods 0.000 claims description 5
- 229940100242 glycol stearate Drugs 0.000 claims description 5
- 229920013747 hydroxypolyethylene Polymers 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 229920000059 polyethylene glycol stearate Polymers 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 235000021355 Stearic acid Nutrition 0.000 claims description 4
- 235000014121 butter Nutrition 0.000 claims description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 4
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 4
- 239000008117 stearic acid Substances 0.000 claims description 4
- 235000015278 beef Nutrition 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 3
- 229920002521 macromolecule Polymers 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 229920002125 Sokalan® Polymers 0.000 claims 1
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 claims 1
- 239000004584 polyacrylic acid Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 16
- 210000004369 blood Anatomy 0.000 abstract description 11
- 239000008280 blood Substances 0.000 abstract description 11
- 230000000536 complexating effect Effects 0.000 abstract description 2
- 241000282472 Canis lupus familiaris Species 0.000 description 23
- 229940079593 drug Drugs 0.000 description 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 238000005469 granulation Methods 0.000 description 5
- 230000003179 granulation Effects 0.000 description 5
- 238000005507 spraying Methods 0.000 description 5
- 241001465754 Metazoa Species 0.000 description 4
- UFWIBTONFRDIAS-UHFFFAOYSA-N Naphthalene Chemical compound C1=CC=CC2=CC=CC=C21 UFWIBTONFRDIAS-UHFFFAOYSA-N 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000004321 preservation Methods 0.000 description 3
- 229940121375 antifungal agent Drugs 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 235000020985 whole grains Nutrition 0.000 description 2
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241001480043 Arthrodermataceae Species 0.000 description 1
- 206010017533 Fungal infection Diseases 0.000 description 1
- 208000031888 Mycoses Diseases 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 230000001857 anti-mycotic effect Effects 0.000 description 1
- 239000003429 antifungal agent Substances 0.000 description 1
- 239000002543 antimycotic Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 230000037304 dermatophytes Effects 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229940084434 fungoid Drugs 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 229940075529 glyceryl stearate Drugs 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 235000019629 palatability Nutrition 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention provides a kind of dog cat terbinafine HCl flavor piece, its constituent proportion count by weight percentage are as follows: terbinafine HCl piece 5%-10%, polymeric complexing agent 25%-50%, agreeable to the taste dose of 5%-10%, polyacrylic resinⅡ type 10%-20%, flavoring agent 50%-70% and magnesium stearate 2%-5%, the present invention carries out complexing processing using polymeric complexing agent and terbinafine HCl piece, improve the stability of terbinafine HCl, improve its blood medicine effective concentration time, adding agreeable to the taste dose and flavoring agent simultaneously makes dog cat be easier to take, the present invention also provides a kind of preparation processes of dog cat terbinafine HCl flavor piece.
Description
Technical field
The invention belongs to pet pharmaceutical technology field, more particularly, to a kind of dog cat terbinafine HCl flavor piece and its
Preparation process.
Background technique
In veterinary clinic practice, dog cat fungoid disease is a kind of very common and multiple disease, and average attack rate is about
For 10%-40%, the course of disease is long, it is difficult, easy to recur to cure, and can mutually pass on from one to another between animal and animal, person to person, people and animal
Broadcast, cause serious public health problem, terbinafine HCl has a broad antifungal spectrum, sterilizing power is strong, minimum bactericidal concentration (MFC) with
Minimum inhibitory concentration (MIC) is almost equal, and particularly sensitive to dermatophyte, clinical application is increasingly extensive, list since 1991 with
Come, through nearly 20 years Human clinical's practical proofs, curative effect really, adverse reaction is few, and toxicity is low, is that extraordinary one kind is antimycotic
Medicine, but on the one hand due to its taste hardship, dog cat is reluctant to take, at present veterinary clinic based on spray and ointment external application, but
It is very poor to deep skin and enteron aisle, ear's fungal infection effect；On the other hand, the terbinafine HCl piece of existing dog cat
Stability is poor, causes blood medicine effective concentration low, and cure time is long, and the time for needing to take drugs and metering are larger, therefore animal doctor
Clinic needs the Oral antifungal agents object that a kind of dog cat is willing to accept and bioavilability is high.
Summary of the invention
The problem to be solved in the present invention is to provide a kind of bitter taste for effectively reducing raw medicine, blood medicine effective concentration times to grow
Dog cat terbinafine HCl flavor piece.
The present invention also provides a kind of preparation processes of dog cat terbinafine HCl flavor piece.
In order to solve the above technical problems, the technical solution adopted by the present invention is that: a kind of dog cat terbinafine HCl flavor
Piece, constituent proportion count by weight percentage are as follows: terbinafine HCl piece 5%-10%, polymeric complexing agent
25%-50%, agreeable to the taste dose of 5%-10%, polyacrylic resinⅡ type 10%-20%, flavoring agent 50%-70% and magnesium stearate
2%-5%.
Further, the polymeric complexing agent is 15-hydroxy polyethylene glycol stearate or polyvinylpyrrolidone.
Further, described agreeable to the taste dose is stearic acid, tristerin or pure butter.
Further, the flavoring agent includes one of lactose, chicken meal, powdered beef and sodium carboxymethyl starch or more
Kind.
A kind of preparation process of dog cat terbinafine HCl flavor piece, comprising the following steps:
(1) suspension is made in addition terbinafine HCl piece after weighing polymeric complexing agent heating fusing；
(2) it after by agreeable to the taste dose of heating fusing in the liquid of clear, is added in suspension, is protected at 90 DEG C -100 DEG C
Temperature is spraying, and freeze-drying obtains the microcapsule granule of 40 mesh；
(3) polyacrylic resinⅡ type is dissolved with dehydrated alcohol, the microcapsule granule in step (2) is placed in fluidized bed and is carried out
Bottom spray is coated to obtain tasteless terbinafine HCl particle；
(4) it takes the tasteless terbinafine HCl particle in step (3) that flavoring agent is added, mixes, softwood is made, cross 20 meshes
Granulation after dry, crosses 24 mesh sieves, and magnesium stearate is added and mixes, tabletting.
Compared with prior art, the present invention has the advantage that is with beneficial effect:
The present invention carries out macromolecule complexing using polymeric complexing agent and terbinafine HCl piece, improves hydrochloric acid spy and compares naphthalene
The stability of fragrant piece, effective extended period blood medicine effective concentration time reduce the number and medication quantity of the medication of dog cat, while benefit
Technology is covered with solid dispersion packet and adds agreeable to the taste dose and flavoring agent, can be effectively reduced the bitter taste of raw medicine, is more willing to dog cat
It takes.
Specific embodiment
It elaborates below to a specific embodiment of the invention.
A kind of dog cat terbinafine HCl flavor piece, constituent proportion count by weight percentage are as follows: salt
Sour terbinafine 5%-10%, polymeric complexing agent 25%-50%, agreeable to the taste dose of 5%-10%, polyacrylic resinⅡ type
10%-20%, flavoring agent 50%-70% and magnesium stearate 2%-5%.
Further, the polymeric complexing agent is 15-hydroxy polyethylene glycol stearate or polyvinylpyrrolidone, is divided
Sub- weight is big, can be good at being complexed with terbinafine HCl piece, to improve its stability.
Further, described agreeable to the taste dose is stearic acid, tristerin or pure butter, and oil substances can be fine
Raising dog cat pet palatability.
Further, the flavoring agent includes one of lactose, chicken meal, powdered beef and sodium carboxymethyl starch or more
Kind, make dog cat be more willing to take.
A kind of preparation process of dog cat terbinafine HCl flavor piece, comprising the following steps:
(1) weigh polymeric complexing agent heating fusing after be added terbinafine HCl piece suspension is made, by with high score
The fusion of sub- complexing agent improves terbinafine HCl stability, blood medicine effective concentration time extended period；
(2) it after by agreeable to the taste dose of heating fusing in the liquid of clear, is added in suspension, is protected at 90 DEG C -100 DEG C
Temperature is spraying, and freeze-drying obtains the microcapsule granule of 40 mesh；
(3) polyacrylic resinⅡ type is dissolved with dehydrated alcohol, the microcapsule granule in step (2) is placed in fluidized bed and is carried out
Bottom spray is coated to obtain tasteless terbinafine HCl particle；
(4) it takes the tasteless terbinafine HCl particle in step (3) that flavoring agent is added, mixes, softwood is made, cross 20 meshes
Granulation after dry, crosses 24 mesh sieves, and magnesium stearate is added and mixes, tabletting.
Embodiment 1
Step 1: add terbinafine HCl that suspension is made after weighing 15-hydroxy polyethylene glycol stearate heating fusing,
Extend effective blood drug concentration；Step 2: adding first step suspension, in 90-100 after taking stearic acid heating to be fused into clear liquid
DEG C heat preservation is spraying, and freeze-drying obtains the microcapsule granule of 40 mesh or so；Third step dissolves polyacrylic resin with dehydrated alcohol
Step (2) microcapsule granule is placed in fluidized bed progress bottom spray and is coated to obtain tasteless terbinafine HCl particle by II type；4th step, takes
Particle adds lactose, chicken meal in step (3), and sodium carboxymethyl starch mixes, softwood processed, crosses the granulation of 20 meshes, dry, 24 meshes
Whole grain；Magnesium stearate is added to mix, tabletting.
Embodiment 2
Step 1: add terbinafine HCl that suspension is made after weighing 15-hydroxy polyethylene glycol stearate heating fusing,
Extend effective blood drug concentration；Step 2: add first step suspension after taking glyceryl stearate heating to be fused into clear liquid,
90-100 DEG C of heat preservation is spraying, and freeze-drying obtains the microcapsule granule of 40 mesh or so；Third step dissolves polypropylene with dehydrated alcohol
Step (2) microcapsule granule is placed in fluidized bed progress bottom spray and is coated to obtain tasteless terbinafine HCl particle by II type of acid resin；4th
Step takes step (3) particle to add lactose, chicken meal, and sodium carboxymethyl starch mixes, softwood processed, crosses the granulation of 20 meshes, dry, 24 mesh
Sieve whole grain；Magnesium stearate is added to mix, tabletting.
Embodiment 3
Step 1: adding terbinafine HCl that suspension is made after weighing vinylpyrrolidone heating fusing, extend effective blood
Concentration；Step 2: add first step suspension after taking butter heating to be fused into clear liquid, and it is spraying in 90-100 DEG C of heat preservation, it is cold
It is lyophilized dry, obtains the microcapsule granule of 40 mesh or so；Third step dissolves polyacrylic resinⅡ type with dehydrated alcohol, by step (2)
Microcapsule granule is placed in fluidized bed progress bottom spray and is coated to obtain tasteless terbinafine HCl particle；4th step takes step (3) particle to add cream
Sugar, chicken meal, sodium carboxymethyl starch mix, softwood processed, cross the granulation of 20 meshes, dry, 24 mesh sieves；Magnesium stearate is added
It mixes, tabletting.
Feeding experiment is carried out to the terbinafine HCl flavor piece produced by above embodiments method, the flavor piece
Terbinafine HCl flavor piece has voluntarily been taken in 8 test dogs with the feeding that is mixed of dog grain.
The pharmacokinetics for having carried out dog to the long-acting flavor piece of the terbinafine HCl produced by the above implementation method is ground
Study carefully.8 healthy beasle dogs are taken to be randomly divided into A and bis- groups of B (every group 4, male and female is fifty-fifty), single dose intravenous hydrochloric acid spy compares naphthalene respectively
Fragrant sterile solution 10mg/kg and the long-acting flavor piece 10mg/kg of single oral dose terbinafine HCl and take general technology hydrochloric acid
Terbinafine.
Terbinafine content is tested and analyzed using HPLC UV detector in blood plasma, and the actual measurement blood medicine of Terbinafine is dense
Degree-time data use WinNonlin5.2 editions pharmacokinetic analysis softwares, calculate pharmacokinetic parameter, as a result as follows:
Bolos intravenous administration Terbinafine T1/2 β be (15.158 ± 8.558) h, Tmax and Cmax be respectively (0.083 ±
0.000) h and (3.334 ± 0.185) μ g/mL, MRT are (2.443 ± 1.132) h, and AUC0~t is (1.803 ± 0.374) μ g
H/mL, Vd are (49.778 ± 25.594) L/kg, and CLB is (2.415 ± 0.577) L/ (kgh)；
After the long-acting flavor piece piece of dog single oral dose 10mg//kg bw terbinafine HCl, Terbinafine T1/ in dog body
2 β are (22.150 ± 10.557) h；Tmax(1.875±0.791)h；Cmax is (0.157 ± 0.087) μ g/ml；MRT is
(5.019±1.591)h；AUC0~t is (1.094 ± 0.588) μ gh/mL；It is estimated by AUC0~t, absolute bioavailability
(F0~t) is (16.589 ± 11.495) %；
Terbinafine HCl common process piece, Terbinafine T1/2 β in dog body is (16.250 ± 6.557) h；Tmax
(1.945±0.781)h；Cmax is (0.196 ± 0.102) μ g/ml；MRT is (5.310 ± 1.528) h；AUC0~t is
(1.066±0.548)μg·h/mL；By AUC0~t estimate, absolute bioavailability (F0~t) be (19.589 ±
13.463) %.
Therefore, effective blood drug concentration can be reached by the long-acting dispersible tablet of the terbinafine HCl of this process implementing, blood medicine is effective
Concentration is held time extends more than 6 hours than common process.
One embodiment of the present invention has been described in detail above, but the content is only preferable implementation of the invention
Example, should not be considered as limiting the scope of the invention.It is all according to all the changes and improvements made by the present patent application range
Deng should still be within the scope of the patent of the present invention.
Claims (5)
1. a kind of dog cat terbinafine HCl flavor piece, it is characterised in that: its constituent is shared count by weight percentage
Ratio are as follows: terbinafine HCl piece 5%-10%, polymeric complexing agent 25%-50%, agreeable to the taste dose of 5%-10%, polyacrylic acid tree
II type 10%-20% of rouge, flavoring agent 50%-70% and magnesium stearate 2%-5%.
2. a kind of dog cat terbinafine HCl flavor piece according to claim 1, it is characterised in that: the macromolecule network
Mixture is 15-hydroxy polyethylene glycol stearate or polyvinylpyrrolidone.
3. a kind of dog cat terbinafine HCl flavor piece according to claim 1, it is characterised in that: described agreeable to the taste dose is
Stearic acid, tristerin or pure butter.
4. a kind of dog cat terbinafine HCl flavor piece according to claim 1, it is characterised in that: the flavoring agent packet
Include one of lactose, chicken meal, powdered beef and sodium carboxymethyl starch or a variety of.
5. a kind of preparation process of dog cat terbinafine HCl flavor piece, it is characterised in that: the following steps are included:
(1) suspension is made in addition terbinafine HCl piece after weighing polymeric complexing agent heating fusing；
(2) it after by agreeable to the taste dose of heating fusing in the liquid of clear, is added in suspension, spray is kept the temperature at 90 DEG C -100 DEG C
Mist, freeze-drying obtain the microcapsule granule of 40 mesh；
(3) polyacrylic resinⅡ type is dissolved with dehydrated alcohol, the microcapsule granule in step (2) is placed in fluidized bed and carries out bottom spray
It is coated to obtain tasteless terbinafine HCl particle；
(4) it takes the tasteless terbinafine HCl particle in step (3) that flavoring agent is added, mixes, softwood is made, cross 20 mesh Shai Zhi
Grain after dry, crosses 24 mesh sieves, and magnesium stearate is added and mixes, tabletting.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115869273A (en) * | 2022-10-31 | 2023-03-31 | 修正药业集团长春高新制药有限公司 | A kind of terbinafine hydrochloride tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115869273A (en) * | 2022-10-31 | 2023-03-31 | 修正药业集团长春高新制药有限公司 | A kind of terbinafine hydrochloride tablet and preparation method thereof |
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Application publication date: 20190604 |