CN110898022A - Isoniazid composition and preparation method thereof - Google Patents
Isoniazid composition and preparation method thereof Download PDFInfo
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- CN110898022A CN110898022A CN201911414307.5A CN201911414307A CN110898022A CN 110898022 A CN110898022 A CN 110898022A CN 201911414307 A CN201911414307 A CN 201911414307A CN 110898022 A CN110898022 A CN 110898022A
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- isoniazid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—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
- A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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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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- 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
- A61K9/2813—Inorganic compounds
-
- 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
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
- A61P31/06—Antibacterial agents for tuberculosis
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Pulmonology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
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Abstract
The application provides an isoniazid composition, which comprises the following raw materials: isoniazid, starch, a binder, a disintegrant and polyethylene glycol. The composition has good stability, can effectively reduce the generation of related substances, and the auxiliary materials used by the composition are conventional auxiliary materials, and are low in cost and easy to obtain. In addition, the invention also provides a method for preparing the isoniazid composition, which has simple steps and simple and convenient operation and is beneficial to saving the production cost.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to an isoniazid composition and a preparation method thereof.
Background
Tuberculosis is a chronic infectious disease caused by infection of tubercle bacillus, which mainly invades the lung and is called as pulmonary tuberculosis, and is clinically in a chronic process, and has general symptoms of low fever, hypodynamia and the like and respiratory system manifestations of cough, hemoptysis and the like. Isoniazid is an anti-tubercular drug used in the treatment and prevention of various forms of tuberculosis, including tubercular meningitis and other mycobacterial infections. Isoniazid was invented in 1952, and the invention of isoniazid has made a fundamental change in the treatment of tuberculosis.
Isoniazid is colorless crystal or white to off-white crystalline powder, odorless, slightly sweet and bitter, and gradually deteriorates when exposed to light. It is readily soluble in water, slightly soluble in ethanol, and very slightly soluble in diethyl ether. The melting point of the product is 170-173 ℃, and the chemical structural formula is as follows:
the existing isoniazid tablet often has the defect of poor stability, is easy to discolor, deteriorate and the like, and has influence on the safety of the isoniazid tablet.
Therefore, how to provide an isoniazid composition with high quality and good stability becomes a technical problem to be solved urgently by the technical personnel in the field.
Disclosure of Invention
In order to solve the technical problems, the invention provides the isoniazid composition which has good stability, can effectively reduce the generation of related substances, and has the advantages of low cost and easy obtainment because all auxiliary materials used by the composition are conventional auxiliary materials. In addition, the invention also provides a method for preparing the isoniazid composition, which has simple steps and simple and convenient operation and is beneficial to saving the production cost.
The invention provides an isoniazid composition, which comprises the following raw materials: isoniazid, starch, a binder, a disintegrant and polyethylene glycol.
The existing isoniazid composition contains more types of auxiliary materials, and the safety of the isoniazid composition is influenced by incompatibility between some auxiliary materials and main medicines, impurity introduction in the auxiliary materials and the like.
For example, magnesium stearate and isoniazid can undergo maillard reactions which adversely affect the stability of the product. Glyceryl behenate as a lubricant also reacts with isoniazid under certain conditions to affect the stability of the product.
Compared with the prior art, the scheme does not use lactose and magnesium stearate which react with isoniazid, but adopts starch as a filling agent and polyethylene glycol as a lubricating agent; the selected auxiliary materials and the isoniazid have no incompatibility, so that the stability of the isoniazid composition is enhanced.
Preferably, the isoniazid composition comprises the following raw materials in parts by weight: 50-55 parts of isoniazid, 35-40 parts of starch, 1-3 parts of adhesive, 3-8 parts of disintegrating agent and 0.5-3 parts of polyethylene glycol.
Preferably, the isoniazid composition is a tablet.
Preferably, the starch is corn starch.
Preferably, the polyethylene glycol is polyethylene glycol 4000.
Preferably, the isoniazid composition comprises 52-54 parts by weight of isoniazid, 37-39 parts by weight of starch and 5-6 parts by weight of disintegrant.
Preferably, the disintegrating agent is one or more of croscarmellose sodium, sodium carboxymethyl starch, crospovidone, low-substituted hydroxypropyl cellulose, hydroxypropyl starch, sodium alginate, surfactant, silicon dioxide, sodium dodecyl sulfate, magnesium dodecyl sulfate, methylcellulose, glycine, modified starch, malic acid, citric acid, alginic acid, sodium alginate, pregelatinized starch, colloidal silicon dioxide, hydroxyethyl methyl cellulose, magnesium aluminum silicate, microcrystalline cellulose, potassium bicarbonate, sodium bicarbonate, potassium carbonate, sucrose fatty acid ester, sucrose monolaurate, sucrose monopalmitate, potassium dihydrogen phosphate and sodium dihydrogen phosphate;
preferably, the binder is one or more of microcrystalline cellulose, povidone, hypromellose, powdered sugar, dextrin, white dextrin, starch slurry, sucrose, sodium carboxymethyl starch, polyethylene glycol 4000, polyethylene glycol 6000, ethyl cellulose, ethyl methyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, polymethyl methacrylate, cellulose acetate, polypropylene, polyisobutylene, polyvinyl acetate, sucrose fatty acid ester, sucrose monolaurate, sucrose monopalmitate, acrylic resin, methyl methacrylate, tragacanth, poloxamer, alginic acid, sodium/potassium/calcium alginate, sucrose, acacia slurry, gelatin slurry and carbopol.
Preferably, the adhesive is starch slurry, and the disintegrant is sodium carboxymethyl starch.
According to the isoniazid composition provided by the invention, starch is reasonably selected as a filling agent, starch slurry is used as an adhesive, sodium carboxymethyl starch is used as a disintegrating agent, polyethylene glycol is used as a lubricant, and selected auxiliary materials and isoniazid have no incompatibility, so that the stability of the isoniazid composition is enhanced.
In addition, as isoniazid gradually changes in quality when being exposed to light, the content of effective components is reduced under the condition of light, related substances are increased, and the safety of the isoniazid composition is also affected. In addition to the problem that the stability of the product is affected by the increase of related substances caused by the possible reaction of raw and auxiliary materials, the prior art does not improve the characteristics that isoniazid gradually deteriorates when being exposed to light and has bitter taste, and the quality and the medicine taking compliance of the product are affected.
In order to solve the problem, the isoniazid composition also comprises a coating material.
Preferably, the coating material is 2-5 parts by weight.
Preferably, the weight ratio of the film-forming material to the opacifier to the plasticizer in the coating material is 3-5:2-5: 1.
The invention adopts the film forming material, the opacifier and the plasticizer as the coating material, reduces the degradation of isoniazid by light, reduces the growth of related substances in the isoniazid composition, also effectively covers the bitter taste of isoniazid and improves the taste of the medicine taking. The product stability can be ensured and the generation of related substances can be reduced under the condition of not reducing the bioavailability. In addition, the film coating can reduce the growth of the related substances under non-lighting conditions, probably because the film coating acts as a barrier to oxygen and inhibits the Maillard reaction to some extent.
Preferably, the film forming material is hypromellose, and/or the opacifier is titanium dioxide, and/or the plasticizer is polyethylene glycol.
In addition, the invention also provides a method for preparing the isoniazid composition, which comprises the following steps:
weighing isoniazid according to a proportion, crushing, and sieving by a 40-80 mesh sieve;
mixing the screened isoniazid with starch uniformly,
adding adhesive to granulate, drying and straightening to obtain mixture granules;
adding disintegrating agent and polyethylene glycol, mixing, and tabletting to obtain tablet core.
Preferably, the present invention also provides another method for preparing the isoniazid composition, comprising the steps of:
weighing isoniazid according to a proportion, crushing, and sieving by a 40-80 mesh sieve;
mixing the screened isoniazid with starch uniformly,
adding adhesive to granulate, drying and straightening to obtain mixture granules;
adding disintegrating agent and polyethylene glycol, mixing, and tabletting to obtain tablet core;
uniformly mixing the coating material and purified water;
the tablet cores are coated.
The preparation method of the isoniazid tablet provided by the invention has the advantages that the preparation process is simple, the large-scale production can be realized, the used auxiliary materials are common auxiliary materials, the price is low, and the production cost is favorably saved.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the present application, the present application will be clearly and completely described below with reference to specific embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
Example 1:
the tablet core formula is as follows:
coating:
the preparation method comprises the following steps:
weighing 100g of isoniazid, crushing, sieving by a 40-80 mesh sieve, adding 76.5g of corn starch, placing in a stirrer, stirring for 10-15 minutes, and mixing uniformly. Adding starch slurry as binder into a stirrer, stirring for 15-20 min, granulating, drying, and grading to obtain mixture granule. Adding carboxymethyl starch sodium disintegrant and polyethylene glycol lubricant in the proportion of the prescription, mixing uniformly, and tabletting to obtain the tablet core. Adding a proper amount of purified water into the film forming material, the opacifier and the plasticizer according to the prescription amount, uniformly mixing, and coating the tablet core to obtain the tablet with the specification of 0.10g of isoniazid.
Example 2:
the tablet core formula is as follows:
coating:
the preparation method comprises the following steps: the preparation method is the same as example 1.
Example 3:
the tablet formula comprises:
the procedure was as in example 1, but without coating the cores.
Example 4
Determination of related substances
20 tablets of this product were taken, ground, mixed well, and precisely weighed 50mg (about equivalent to 25-27.5mg of isoniazid) in a 100mL volumetric flask. Adding phosphate buffer solution-methanol (95: 5)70ml, dissolving by ultrasonic, cooling and calibrating to scale, shaking, and filtering to obtain filtrate as sample solution. Sampling, injecting into a liquid chromatograph, recording a chromatogram, and calculating related substances by an area normalization method.
The following table shows the accelerated substance test results of 0 month, 1 month, 2 months, 3 months and 6 months for comparative examples 1, 2 and 3.
From the above results, it is clear that the stability of the coated isoniazid tablet is apparently due to the stability of the uncoated isoniazid tablet. The impurity content of the coated isoniazid tablet does not change obviously within 6 months.
The following table shows the results of the photostability test for the substances of comparative examples 1 and 2.
The results show that under the illumination condition, the impurity content of the isoniazid tablet meets the regulation, and the increase of the impurity content is not obvious, which shows that the isoniazid tablet has better stability.
Example 5
Dissolution rate comparative test
Taking 6 tablets of commercial isoniazid tablets and 6 tablets of isoniazid coated tablets prepared in example 1 and example 2, taking dissolved liquids at 5min, 15min, 20min, 30min and 60min respectively according to a determination method in Chinese pharmacopoeia 2015 edition by taking 900ml of water as a dissolution medium and 100 revolutions per minute as a rotating speed, measuring absorbance at 263nm wavelength by an ultraviolet-visible spectrophotometry after filtering and diluting, and taking an average value of the obtained dissolution rates as shown in the following table:
dissolution curves were made for three groups of samples.
The results show that the dissolution curves of the three groups of samples are similar and have consistent trends, the dissolution rate of the isoniazid tablet reaches more than 60 percent within 30 minutes according to the quality standard of the isoniazid tablet in Chinese pharmacopoeia, but the embodiment of the invention reaches the standard within 30 minutes, and the dissolution rates are all higher than those of the commercially available varieties and accord with the standard of the Chinese pharmacopoeia. Namely, the isoniazid tablet provided by the invention can effectively ensure the drug effect of the isoniazid tablet while improving the stability of isoniazid.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. An isoniazid composition, which is characterized by comprising the following raw materials: isoniazid, starch, a binder, a disintegrant and polyethylene glycol.
2. The isoniazid composition according to claim 1, characterized by comprising the following raw materials in parts by weight: 50-55 parts of isoniazid, 35-40 parts of starch, 1-3 parts of adhesive, 3-8 parts of disintegrating agent and 0.5-3 parts of polyethylene glycol.
3. Isoniazid composition according to claim 1 or 2 characterized in that,
the disintegrating agent is one or more of croscarmellose sodium, sodium carboxymethyl starch, crospovidone, low-substituted hydroxypropyl cellulose, hydroxypropyl starch, sodium alginate, surfactant, silicon dioxide, sodium dodecyl sulfate, magnesium dodecyl sulfate, methylcellulose, glycine, modified starch, malic acid, citric acid, alginic acid, sodium alginate, pregelatinized starch, colloidal silicon dioxide, hydroxyethyl methylcellulose, magnesium aluminum silicate, microcrystalline cellulose, potassium bicarbonate, sodium bicarbonate, potassium carbonate, sucrose fatty acid ester, sucrose monolaurate, sucrose monopalmitate, potassium dihydrogen phosphate and sodium dihydrogen phosphate;
the adhesive is one or more of microcrystalline cellulose, polyvidone, hydroxypropyl methylcellulose, powdered sugar, dextrin, white dextrin, starch slurry, sucrose, sodium carboxymethyl starch, polyethylene glycol 4000, polyethylene glycol 6000, ethyl cellulose, ethyl methyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, polymethyl methacrylate, cellulose acetate, polypropylene, polyisobutylene, polyvinyl acetate, sucrose fatty acid ester, sucrose monolaurate, sucrose monopalmitate, acrylic resin, methyl methacrylate, tragacanth, poloxamer, alginic acid, sodium/potassium/calcium alginate, sucrose, acacia slurry, gelatin slurry and carbopol.
4. The isoniazid composition of claim 3 wherein the binder is a starch slurry and the disintegrant is sodium carboxymethyl starch.
5. The isoniazid composition of claim 3 further comprising a coating.
6. The isoniazid composition according to claim 5, characterized in that the coating material is present in an amount of 2 to 5 parts by weight.
7. The isoniazid composition according to claim 6, characterized in that the coating material comprises the following raw materials in weight ratio,
film-forming material, opacifier and plasticizer in the ratio of 3-5 to 2-5 to 1.
8. The isoniazid composition according to claim 7, characterized in that the film-forming material is hypromellose, and/or the opacifier is titanium dioxide, and/or the plasticizer is polyethylene glycol.
9. A process for the preparation of the isoniazid composition according to any one of claims 1 to 4, characterized in that it comprises the following steps:
weighing isoniazid according to a proportion, crushing, and sieving by a 40-80 mesh sieve;
mixing the screened isoniazid with starch uniformly,
adding adhesive to granulate, drying and straightening to obtain mixture granules;
adding disintegrating agent and polyethylene glycol, mixing, and tabletting to obtain tablet core.
10. A process for the preparation of the isoniazid composition according to any one of claims 5 to 8, characterized in that it comprises the following steps:
weighing isoniazid according to a proportion, crushing, and sieving by a 40-80 mesh sieve;
mixing the screened isoniazid with starch uniformly,
adding adhesive to granulate, drying and straightening to obtain mixture granules;
adding disintegrating agent and polyethylene glycol, mixing, and tabletting to obtain tablet core;
uniformly mixing the coating material and purified water;
the tablet cores are coated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911414307.5A CN110898022A (en) | 2019-12-31 | 2019-12-31 | Isoniazid composition and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911414307.5A CN110898022A (en) | 2019-12-31 | 2019-12-31 | Isoniazid composition and preparation method thereof |
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| CN110898022A true CN110898022A (en) | 2020-03-24 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1611218A (en) * | 2003-10-31 | 2005-05-04 | 沈阳药科大学 | Fixed dose compound preparation of antitubercular drug and its preparing method |
| WO2008030469A2 (en) * | 2006-09-07 | 2008-03-13 | Merial Limited | Soft chewable, tablet, and long-acting injectable veterinary antibiotic formulations |
| CN102727496A (en) * | 2011-04-12 | 2012-10-17 | 上海双健现代药物技术咨询有限公司 | Compound antituberculosis drug oral solid preparation and its preparation method |
| CN102920707A (en) * | 2012-11-02 | 2013-02-13 | 沈阳药科大学 | Process for preparing compound antituberculous preparation |
| CN104274453A (en) * | 2013-07-02 | 2015-01-14 | 安徽贝克生物制药有限公司 | Bigeminal compound preparation of anti-tuberculosis medicines and preparation method thereof |
-
2019
- 2019-12-31 CN CN201911414307.5A patent/CN110898022A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1611218A (en) * | 2003-10-31 | 2005-05-04 | 沈阳药科大学 | Fixed dose compound preparation of antitubercular drug and its preparing method |
| WO2008030469A2 (en) * | 2006-09-07 | 2008-03-13 | Merial Limited | Soft chewable, tablet, and long-acting injectable veterinary antibiotic formulations |
| CN102727496A (en) * | 2011-04-12 | 2012-10-17 | 上海双健现代药物技术咨询有限公司 | Compound antituberculosis drug oral solid preparation and its preparation method |
| CN102920707A (en) * | 2012-11-02 | 2013-02-13 | 沈阳药科大学 | Process for preparing compound antituberculous preparation |
| CN104274453A (en) * | 2013-07-02 | 2015-01-14 | 安徽贝克生物制药有限公司 | Bigeminal compound preparation of anti-tuberculosis medicines and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 倪根珊: "《药物临床应用撷萃》", 31 August 1994, 八一出版社 * |
| 国家基本药物领导小组: "《国家基本药物》", 31 August 1999, 人民卫生出版社 * |
| 钱春梅: "久贮异烟肼片的溶出度研究", 《西北药学杂志》 * |
| 韩存年: "《抗菌药物的临床合理应用》", 31 January 2000, 南方出版社 * |
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Application publication date: 20200324 |