CN104523690A - Topiroxostat oral preparation and preparation method thereof - Google Patents
Topiroxostat oral preparation and preparation method thereof Download PDFInfo
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- CN104523690A CN104523690A CN201510062975.1A CN201510062975A CN104523690A CN 104523690 A CN104523690 A CN 104523690A CN 201510062975 A CN201510062975 A CN 201510062975A CN 104523690 A CN104523690 A CN 104523690A
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- Engineering & Computer Science (AREA)
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Abstract
The invention provides a topiroxostat oral preparation and a preparation method thereof. The topiroxostat oral preparation is composed of an active ingredient topiroxostat as well as a filling agent, a disintegrating agent, a binding agent and a lubricating agent. The prepared topiroxostat oral preparation has no special requirement on particle size on the active ingredient, superfine grinding does not need to be carried out, energy consumption is low, dissolution rate reaches more than 95%, bioavailability is high, the defects of low dissolution rate and low bioavailability of the active ingredient are overcome, quality is stable and reliable, and a market development prospect is broad.
Description
Technical field
The invention belongs to technical field of medicine, relate to a kind of holder his oral formulations of department and preparation method thereof, invention also provides his oral formulations of a holder department of a kind of quality safety, good stability.
Background technology
Gout be due to produce in body uric acid too much and kidney Scavenging activity decline, uric acid body accumulation, causes urate crystal in joint and each internal organs deposition.Along with improving constantly of people's living standard, the change of dietary structure and living habit (food being rich in nucleoprotein increases), the prolongation of average life, the understanding of the mankind to gout and the raising of diagnostic level, no matter be in American-European countries or in countries in Asia, the prevalence of gout has the trend increased year by year, current China Patients with Hyperuricemia number is more than 1.5 hundred million, wherein patient with gout is more than 7,500 ten thousand people, and increase with annual 0.97% annual rate of growth, gout has become China with the same second largest metabolism class disease of diabetes, and the life and health of people in serious threat.
The conventional current kind of antigout drug is few clinically at present, and clinical treatment is mainly based on colchicine, nonsteroidal antiinflammatory drug, hormone, promotion urate excretion medicine (as probenecid, sulfinpyrazone and benzbromarone) and suppression uric acid synthetic drug (allopurinol).These medicines are all defectiveness in treatment.Weak curative effect, side effect become greatly the bottleneck of its clinical practice.
Holder department he (Topirixostat)) by Fuji of Amada Co., Ltd. medicine in June, 2013 obtain Japanese MHLW ratify listing, for gout, hyperuricemia.This medicine, by suppressing xanthine oxidoreductase enzyme, suppresses uric acid to produce.
A kind of 1,2,4-triazole class compounds and preparation method thereof is disclosed in CN1561340B.A kind of 1,2,4-triazole compounds manufacture method and its intermediate is disclosed in CN1826335A.CN104230891A discloses a kind of holder his preparation method of department.CN104042577A discloses a kind of stable holder his sheet of department and preparation method thereof, described holder his sheet of department is made up of principal agent, lactose, microcrystalline Cellulose, cross-linked carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and magnesium stearate, by always mixing after principal agent and adjuvant respectively micronization processes, direct powder compression is adopted to obtain.
Due to a holder department, he is an almost water-fast medicine, and existing holder his preparation of department exists the not high defect of quality instability, dissolution.
Summary of the invention
The present invention aims to provide high, the stay-in-grade holder of a kind of dissolution his oral formulations of department and preparation method thereof.
His oral formulations of holder prepared by a present invention department is made up of pharmaceutic adjuvants such as an active component holder department he and filler, disintegrating agent, binding agent, lubricants.
Above-mentioned active component is that his (Topiroxostat) or the acceptable salt of its pharmacy, solvate are taken charge of in holder.
The acceptable salt of pharmacy that above-mentioned active component takes charge of he (Topiroxostat) for holder is the inorganic acid salt such as its sodium salt, potassium salt, calcium salt, magnesium salt, lithium salts and hydrochloric acid, hydrobromic acid, hydroiodic acid, the acylates such as succinic acid, maleic acid, fumaric acid, lactic acid, tartaric acid, benzenesulfonic acid, the acidic amino acid salt such as proline, aspartic acid, glutamic acid; Described solvate is hydrate, alcohol adduct, ethanolates.
Above-mentioned holder his oral formulations of department consists of the following composition by weight percentage: active component 30% ~ 70%, filler 20% ~ 60%, disintegrating agent 3% ~ 20%, binding agent 1% ~ 5%, lubricant 0.2% ~ 5.0%.
Above-mentioned filler is one or more the mixture in lactose, microcrystalline Cellulose, pre-paying starch, mannitol, preferred lactose; Disintegrating agent is one or more the mixture in carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, preferred polyvinylpolypyrrolidone; Binding agent is one or more the mixture in hypromellose, hyprolose, sodium carboxymethyl cellulose, the aqueous solution of polyvidone or alcoholic solution and starch slurry etc., the aqueous solution of preferred hyprolose; Lubricant is one or more the mixture in magnesium stearate, stearic acid, zinc stearate, micropowder silica gel, Pulvis Talci, preferred magnesium stearate.
Prepare above-mentioned holder his oral formulations of department and comprise following steps:
1. supplementary material process: mixed homogeneously with filler by active component, ultra micro efflorescence, crosses more than 200 orders
Standard screen, for subsequent use; Disintegrating agent with 60 orders with upper screen cloth sieving for standby;
2. take the above-mentioned active component of recipe quantity to mix all with filler ultra micro efflorescence mixture, appropriate disintegrating agent
Even, add suitable amount of adhesive, make soft material;
3. the wet grain of system: get above-mentioned soft material granulation;
4. dry: wet granular is dry under optimum conditions;
5. granulate: by dried particles granulate;
6. always mix: granulate granule is added the lubricant of recipe quantity and appropriate disintegrating agent, mixing, intermediate inspection is carried out in sampling;
7. intermediate carries out tabletting or capsule charge according to different sizes such as 20mg, 40mg and 60mg after the assay was approved.
treat that Bao Pin packs after the assay was approved and get final product.
In above-mentioned holder his an oral formulations preparation process of department, granulation and granulate mesh size used are 16 order ~ 40 orders, preferably 18 order ~ 30 orders; It is 40 DEG C ~ 65 DEG C that dry materials temperature controls, preferably 45 DEG C ~ 60 DEG C; Pellet moisture controls 1% ~ 3%, and preferably less than 2%; Always doing time is 15 ~ 45 minutes, preferably 20 ~ 30 minutes.
Coating after above-mentioned holder his an oral formulations tabletting of department, coating material is stomach dissolution type film coating liquid, and film-coat layer gain in weight is 2% ~ 4%.
Above-mentioned one holder his oral formulations of department and preparation method thereof, it is characterized in that, stomach dissolution type thin film coating material is formed by polyvinyl alcohol, Polyethylene Glycol, Pulvis Talci, titanium dioxide, plain color or is directly selected from stomach dissolution type Opadry.
Tool of the present invention has the following advantages:
1, supplementary material of the present invention is through strict proportioning, and adjuvant selects kind few, and drug dissolution is high, good stability, and safety is high;
2, ultra micro efflorescence altogether after adopting effective ingredient to mix homogeneously with filler, significantly accelerates dissolution rate, improves dissolution, effectively increases bioavailability;
3, production technology is simple, is applicable to suitability for industrialized production;
4, not containing surfactant, unnecessary risk can not be brought to patient.
Detailed description of the invention
Enforcement below can illustrate in greater detail the present invention, but does not limit the present invention in any form.
embodiment 1
His tablet recipe (specification: 20mg) is taken charge of in holder:
His 20.0 g are taken charge of in holder
Lactose 42.0 g
Polyvinylpolypyrrolidone 7.0 g
4% hyprolose (HPC-SL) aqueous solution is appropriate
magnesium stearate 0.7 g
Make 1000 altogether
Preparation method:
1. supplementary material process: he mixs homogeneously with lactose by a recipe quantity holder department, and ball milling takes out for 1 to 2 hour in ball mill, crosses 200 mesh standard sieves for subsequent use; Polyvinylpolypyrrolidone 80 eye mesh screen sieving for standby;
2. by an above-mentioned holder department, he mixs homogeneously with 5g polyvinylpolypyrrolidone with the ultra micro efflorescence mixture of lactose;
3. add 4% hyprolose aqueous solution appropriate, mix homogeneously, makes soft material;
4. the wet grain of system: get above-mentioned soft material 24 eye mesh screens and granulate;
5. dry: by above-mentioned wet grain drying, controlling temperature of charge is 50 ~ 55 DEG C;
6. granulate: by dried particles 24 eye mesh screen granulate;
7. always mix: granulate granule is added magnesium stearate and the 2.0g polyvinylpolypyrrolidone of recipe quantity, mixing, intermediate inspection is carried out in sampling;
intermediate carries out tabletting after the assay was approved, and packaging, to obtain final product.
embodiment 2
His sheet Core formulation (specification: 40mg) is taken charge of in holder:
Holder he 40.0 g(of department give money as a gift pure)
Lactose 45.0 g
Microcrystalline Cellulose 45.0 g
Cross-linking sodium carboxymethyl cellulose 12.0 g
4% hypromellose E15 aqueous solution is appropriate
micropowder silica gel 1.5 g
Make 1000 altogether
Coating fluid prescription:
Opadry 85,F42,129 7.0 g
75% ethanol 93.0 g
Preparation method:
1, the preparation of pastille label
1. supplementary material process: he mixs homogeneously with lactose, microcrystalline Cellulose by a recipe quantity holder department, after ultra micro efflorescence, crosses 400 mesh standard sieves for subsequent use; Cross-linking sodium carboxymethyl cellulose 80 eye mesh screen sieving for standby;
2. by an above-mentioned holder department, he mixs homogeneously with 8g cross-linking sodium carboxymethyl cellulose with the ultra micro efflorescence mixture of lactose, microcrystalline Cellulose;
3. add 4% hypromellose E15 aqueous solution appropriate, mix homogeneously, makes soft material;
4. the wet grain of system: get above-mentioned soft material 24 eye mesh screens and granulate;
5. dry: by above-mentioned wet grain drying, controlling temperature of charge is 55 ~ 60 DEG C;
6. granulate: by dried particles 24 eye mesh screen granulate;
7. always mix: granulate granule is added micropowder silica gel and the 4.0g cross-linking sodium carboxymethyl cellulose of recipe quantity, mixing, intermediate inspection is carried out in sampling;
intermediate carries out tabletting after the assay was approved.
2, the preparation of coated tablet:
Recipe quantity Opadry 85F42129 is dissolved in 75% ethanol prepare into about 7% solution as film-coat liquid, by pastille label coating, controlling temperature of charge in coating process is 40 DEG C ~ 42 DEG C, after this operation completes label weightening finish about 3%.
3, treat that Bao Pin packs after the assay was approved and get final product.
embodiment 3
His sheet Core formulation (specification: 60mg) is taken charge of in holder:
Holder he 60.0 g(of department give money as a gift pure)
Lactose 90.0 g
Microcrystalline Cellulose 30.0 g
Carboxymethylstach sodium 20.0 g
8% PVP K30 aqueous solution is appropriate
magnesium stearate 2.0 g
Make 1000 altogether
Coating fluid prescription:
Opadry 85,F18,422 14.0 g
75% ethanol 186.0 g
Preparation method:
1, the preparation of pastille label
4. supplementary material process: he mixs homogeneously with lactose, microcrystalline Cellulose by a recipe quantity holder department, after ultra micro efflorescence, crosses 400 mesh standard sieves for subsequent use; Cross-linking sodium carboxymethyl cellulose 80 eye mesh screen sieving for standby;
5. by an above-mentioned holder department, he mixs homogeneously with 16g cross-linking sodium carboxymethyl cellulose with the ultra micro efflorescence mixture of lactose, microcrystalline Cellulose;
6. add 8% PVP K30 aqueous solution appropriate, mix homogeneously, makes soft material;
4. the wet grain of system: get above-mentioned soft material 24 eye mesh screens and granulate;
5. dry: by above-mentioned wet grain drying, controlling temperature of charge is 50 ~ 55 DEG C;
6. granulate: by dried particles 24 eye mesh screen granulate;
7. always mix: granulate granule is added magnesium stearate and the 4.0g cross-linking sodium carboxymethyl cellulose of recipe quantity, mixing, intermediate inspection is carried out in sampling;
intermediate carries out tabletting after the assay was approved.
2, the preparation of coated tablet:
Recipe quantity Opadry 85F42129 is dissolved in 75% ethanol prepare into about 7% solution as film-coat liquid, by pastille label coating, controlling temperature of charge in coating process is 40 DEG C ~ 42 DEG C, after this operation completes label weightening finish about 3%.
3, treat that Bao Pin packs after the assay was approved and get final product.
embodiment 4
His capsule prescription (specification: 40mg) is taken charge of in holder:
His 40.0 g are taken charge of in holder
Lactose 90.0 g
Polyvinylpolypyrrolidone 15.0 g
4% hyprolose (HPC-L) aqueous solution is appropriate
magnesium stearate 1.5 g
Make 1000 altogether
Preparation method:
1. supplementary material process: supplementary material process: he mixs homogeneously with lactose, at ball milling by a recipe quantity holder department
In machine, ball milling takes out for 1 to 2 hour, crosses 200 mesh standard sieves for subsequent use; Polyvinylpolypyrrolidone 80 eye mesh screen sieving for standby;
2. by an above-mentioned holder department, he mixs homogeneously with 10g polyvinylpolypyrrolidone with the ultra micro efflorescence mixture of lactose;
3. add 4% hyprolose aqueous solution appropriate, mix homogeneously, makes soft material;
4. the wet grain of system: get above-mentioned soft material 24 eye mesh screens and granulate;
5. dry: by above-mentioned wet grain drying, controlling temperature of charge is 50 ~ 55 DEG C;
6. granulate: by dried particles 24 eye mesh screen granulate;
7. always mix: granulate granule is added magnesium stearate and the 5g polyvinylpolypyrrolidone of recipe quantity, mixing, intermediate inspection is carried out in sampling;
intermediate carries out capsule-filling after the assay was approved, and packaging, to obtain final product.
Test example 1
The sample of embodiment 1,2,3,4 is placed in relative humidity (RH) is 75%, temperature is that 40 DEG C of incubators are placed 6 months continuously, respectively at the 0th, 1,2,3, June time pick test.Result all samples all conforms with the regulations, and shows that products obtained therefrom of the present invention has good stability, reliable in quality, and wherein content, related substance (always mixing), dissolution results are in table 1.
Table 1 accelerated test investigates result
Claims (10)
1. holder department's his oral formulations and preparation method thereof, is characterized in that, his oral formulations of the method holder department of preparing is made up of an active component holder department he and filler, disintegrating agent, binding agent, lubricant.
2. holder department's his oral formulations and preparation method thereof, is characterized in that, prepares his oral formulations of a described holder department obtained by supplementary material process, soft material processed, granulation, drying, granulate, total mixed, tabletting or capsule charge.
3. a kind of holder according to claim 1 his oral formulations of department and preparation method thereof, is characterized in that, described active component is that his (Topiroxostat) or the acceptable salt of its pharmacy, solvate are taken charge of in holder.
4. one holder according to claim 1 his oral formulations of department and preparation method thereof, it is characterized in that, described active component is holder his an acceptable salt of pharmacy of department is the inorganic acid salt such as its sodium salt, potassium salt, calcium salt, magnesium salt, lithium salts and hydrochloric acid, hydrobromic acid, hydroiodic acid, the acylates such as succinic acid, maleic acid, fumaric acid, lactic acid, tartaric acid, benzenesulfonic acid, the acidic amino acid salt such as proline, aspartic acid, glutamic acid; Described solvate is hydrate, alcohol adduct, ethanolates.
5. one holder according to claim 1 his oral formulations of department and preparation method thereof, it is characterized in that, his oral formulations of described holder department consists of the following composition by weight percentage: an active component holder department he 30% ~ 70%, filler 20% ~ 60%, disintegrating agent 3% ~ 20%, binding agent 1% ~ 5%, lubricant 0.2% ~ 5.0%.
6. one holder according to claim 1 his oral formulations of department and preparation method thereof, it is characterized in that, described filler is one or more the mixture in lactose, microcrystalline Cellulose, pre-paying starch, mannitol, preferred lactose; Disintegrating agent is one or more the mixture in carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, preferred polyvinylpolypyrrolidone; Binding agent is one or more the mixture in hypromellose, hyprolose, sodium carboxymethyl cellulose, the aqueous solution of polyvidone or alcoholic solution and starch slurry etc., the aqueous solution of preferred hyprolose; Lubricant is one or more the mixture in magnesium stearate, stearic acid, zinc stearate, micropowder silica gel, Pulvis Talci, preferred magnesium stearate.
7. one holder according to claim 2 his oral formulations of department and preparation method thereof, it is characterized in that, in described holder his an oral formulations preparation process of department, supplementary material is treated to the mixture ultra micro efflorescence by active component and filler, crosses 200-400 mesh sieve, for subsequent use.
8. one holder according to claim 2 his oral formulations of department and preparation method thereof, is characterized in that, in described holder his an oral formulations preparation process of department, granulation and granulate mesh size used are 16 order ~ 40 orders, preferably 18 order ~ 30 orders; It is 40 DEG C ~ 65 DEG C that dry materials temperature controls, preferably 45 DEG C ~ 60 DEG C; Pellet moisture controls 1% ~ 3%, and preferably less than 2%; Always doing time is 15 ~ 45 minutes, preferably 20 ~ 30 minutes.
9. one holder according to claim 2 his oral formulations of department and preparation method thereof, is characterized in that, coating after holder his an oral formulations tabletting of department, coating material is stomach dissolution type film coating liquid, and film-coat layer gain in weight is 2% ~ 4%.
10. one holder according to claim 9 his oral formulations of department and preparation method thereof, it is characterized in that, described stomach dissolution type thin film coating material is formed by polyvinyl alcohol, Polyethylene Glycol, Pulvis Talci, titanium dioxide, plain color or is directly selected from stomach dissolution type Opadry.
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105769766A (en) * | 2016-03-24 | 2016-07-20 | 长沙佰顺生物科技有限公司 | Topiroxostat nano-emulsion and preparation method of topiroxostat nano-emulsion |
CN105919968A (en) * | 2016-06-12 | 2016-09-07 | 佛山市腾瑞医药科技有限公司 | Topiroxostat preparation and application thereof |
CN105997906A (en) * | 2016-03-16 | 2016-10-12 | 江苏悦兴药业有限公司 | Topiroxostat tablets and preparation method thereof |
CN106880603A (en) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | A kind of oral disnitegration tablet containing Topiroxostat and preparation method thereof |
CN107224430A (en) * | 2016-03-25 | 2017-10-03 | 江苏奥赛康药业股份有限公司 | A kind of pharmaceutical composition of hydrochloric Ramosetron |
CN112516094A (en) * | 2019-09-17 | 2021-03-19 | 杭州百诚医药科技股份有限公司 | Topiroxostat tablet and preparation method thereof |
CN114796161A (en) * | 2022-03-09 | 2022-07-29 | 南京唯创远医药科技有限公司 | Topiroxostat oral instant film agent and preparation method thereof |
-
2015
- 2015-02-08 CN CN201510062975.1A patent/CN104523690A/en active Pending
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106880603A (en) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | A kind of oral disnitegration tablet containing Topiroxostat and preparation method thereof |
CN105997906A (en) * | 2016-03-16 | 2016-10-12 | 江苏悦兴药业有限公司 | Topiroxostat tablets and preparation method thereof |
CN105769766A (en) * | 2016-03-24 | 2016-07-20 | 长沙佰顺生物科技有限公司 | Topiroxostat nano-emulsion and preparation method of topiroxostat nano-emulsion |
CN107224430A (en) * | 2016-03-25 | 2017-10-03 | 江苏奥赛康药业股份有限公司 | A kind of pharmaceutical composition of hydrochloric Ramosetron |
CN105919968A (en) * | 2016-06-12 | 2016-09-07 | 佛山市腾瑞医药科技有限公司 | Topiroxostat preparation and application thereof |
CN112516094A (en) * | 2019-09-17 | 2021-03-19 | 杭州百诚医药科技股份有限公司 | Topiroxostat tablet and preparation method thereof |
CN112516094B (en) * | 2019-09-17 | 2022-08-19 | 杭州百诚医药科技股份有限公司 | Topiroxostat tablet and preparation method thereof |
CN114796161A (en) * | 2022-03-09 | 2022-07-29 | 南京唯创远医药科技有限公司 | Topiroxostat oral instant film agent and preparation method thereof |
CN114796161B (en) * | 2022-03-09 | 2024-04-26 | 南京唯创远医药科技有限公司 | Topiroxostat oral instant film agent and preparation method thereof |
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Application publication date: 20150422 |