CN111643485A - Preparation process of emedastine fumarate sustained-release capsule - Google Patents
Preparation process of emedastine fumarate sustained-release capsule Download PDFInfo
- Publication number
- CN111643485A CN111643485A CN202010578122.4A CN202010578122A CN111643485A CN 111643485 A CN111643485 A CN 111643485A CN 202010578122 A CN202010578122 A CN 202010578122A CN 111643485 A CN111643485 A CN 111643485A
- Authority
- CN
- China
- Prior art keywords
- solution
- coating
- release
- emedastine fumarate
- slow
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pulmonology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Otolaryngology (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses the technical field of medicine preparation, and particularly relates to a preparation process of an emedastine fumarate slow-release capsule, which comprises the steps of solution preparation, main medicine layer coating, isolation coating, slow-release layer coating, total mixing and filling in sequence, so that the emedastine fumarate slow-release capsule can be obtained, wherein four different solutions are prepared in the solution preparation step, wherein the solution 1 is used for preparing the solution 2, the rest 3 solutions are respectively used for the steps of main medicine layer coating, isolation coating and slow-release layer coating, and the emedastine fumarate slow-release capsule obtained by the preparation process is stably controlled to have a release rate of 1.5 hours of 25-45%, a release rate of 4 hours of 50-75% and a release rate of 8 hours of more than 80% in 0.1mol/L hydrochloric acid solution; the release rate of the composition in water is controlled to be 10-40% in a release rate standard of 0.5 hour, 35-65% in a release rate standard of 1.5 hour and more than 75% in a release rate standard of 6 hours, which also meets the requirements of the Japanese pharmacopoeia.
Description
Technical Field
The invention relates to the technical field of medicine preparation, in particular to a preparation process of emedastine fumarate sustained-release capsules.
Background
Emedastine fumarate is a second generation histamine H1 receptor antagonist with specific affinity for the H1 receptor; the emedastine fumarate is mainly used for treating allergic rhinitis and chronic urticaria clinically, and compared with similar medicines, the emedastine fumarate has the characteristics of high curative effect, few side effects, good tolerance, no cardiotoxicity and the like, and is particularly low in central sedation effect, free of side effects such as lethargy and the like after use, so that the emedastine fumarate is deeply popular with patients who take medicines.
The sustained-release preparation belongs to the third-generation preparation in the existing pharmaceutical preparation, and because the absorption characteristic of the common preparation causes the blood concentration valley bee phenomenon, the blood concentration is easy to exceed the toxic dose of the medicament when the blood concentration is larger or the physiological condition is changed, and serious toxic and side effects are generated; the sustained release preparation has slow drug release, stable blood concentration, longer action time and less toxic and side effects.
An epostine fumarate Sustained-release capsule (Emedestine Difumarate stabilized-ReleaseCs) is a relatively selective Hl receptor antagonist jointly developed by Kowa corporation in Japan, Kanebo, and is firstly marketed in Japan at 4/2.1993 under the trade name REMICUT (R), and is marketed only in Japan, Korea and China at the past, and is used for allergic rhinitis, respected measles and dampness of adults. Dermatitis, skin pruritus, prurigo, with formulation sizes of 1mg and 2mg in japan.
The literature on the relevant preparation processes that are currently available is as follows:
1) emedastine fumarate sustained release tablet and its preparation method/North China pharmaceutical products, Inc.; CN102018680B discloses an emedastine fumarate sustained release tablet, which is prepared from the following raw materials in parts by weight: 2mg of emedastine fumarate, 40mg of carbopol resin, povidone K3075mg and 50mg of cyclodextrin. The preparation method comprises the following steps: a. firstly, mixing emedastine fumarate and carbopol resin according to an equivalent gradual addition method; b. mixing the above mixture with polyvidone K30, adding ethanol, and stirring to dissolve; c. adding cyclodextrin to prepare a soft material, granulating by a 20-mesh sieve, and drying at 50-70 ℃; d. finishing the grains; e. and (6) tabletting. The invention selects the carbopol resin and the povidone K30 cyclodextrin as framework materials, and obtains the emedastine fumarate sustained release tablet which has smooth tablet surface, good hardness, no shedding during coating and good release stability by a wet granulation and tabletting process.
2) Preparation of emedastine fumarate sustained release tablet and determination of release rate/Wang ZUZUOQILI preparation-2005, 24 (6);
the method comprises the steps of taking hydroxypropyl methylcellulose and lactose as excipients, adopting an ultraviolet spectrophotometry to screen release solvents, carrying out methodology researches such as release degree recovery rate, precision, stability determination and the like, determining the release degree recovery rate of three batches of emedastine fumarate by using water as the release solvents, wherein the average of the release degree recovery rates is 98.12%, the RSD is 1.12/% (n is 9), and determining the release degree of emedastine fumarate by using the ultraviolet spectrophotometry, so that the repeatability and the uniformity are good, and the conclusion is that the ultraviolet spectrophotometry can be used for determining the release degree of emedastine fumarate. Preparing the sustained release tablets of the fumaric acid epostine: uniformly mixing emedastine fumarate, hydroxypropyl methylcellulose and lactose, adding an appropriate amount of ethanol, granulating, ventilating and drying at 65 ℃, granulating, adding magnesium stearate, uniformly mixing, and tabletting, wherein each tablet contains 2mg of emedastine fumarate.
Stability of emedastine fumarate aqueous solution: the resulting mixture was left at room temperature for 24 hours, and the absorbances were measured at 0, 2, 6, 12 and 24 hours and were 0.509, 0.508, 0.509, 0.506 and 0.507, respectively.
3) An emedastine fumarate aqueous pharmaceutical composition and its preparation method are provided;
CN107875119A relates to the technical field of ophthalmic medication, in particular to an emedastine fumarate aqueous pharmaceutical composition and a preparation method thereof. Comprises the following components in parts by weight: 15-18 parts of emedastine fumarate, 50-55 parts of osmotic pressure regulator, 50-55 parts of thickener, 8-11 parts of pH regulator and 0.01-0.02 part of preservative; the pH value of the components is 7.0 to 7.8, and the osmotic pressure molar concentration is 250mosmo/kg to 290mosmol/kg, so that the problem of the compatibility of benzalkonium chloride and a plastic bottle in the existing emedastine fumarate eye drops is effectively solved, related substances are obviously superior to the existing emedastine fumarate eye drops, and the long-term stability is better; the consumption of the preservative is less, the environment is protected, and the consumption is low; the use population of contact lens patients is increased, and the medication compliance is increased. The preparation method comprises the following steps: (1) firstly, sequentially adding a pH regulator, an osmotic pressure regulator and emedastine fumarate into a proper amount of water, and continuously stirring until the pH regulator, the osmotic pressure regulator and the emedastine fumarate are dissolved; (2) adding the thickening agent into a proper amount of water, continuously stirring until the thickening agent is uniformly dispersed, and adding the preservative; (3) mixing the two solutions and then continuously stirring; dropwise adding sodium hydroxide to adjust the pH of the solution to 7.45, and then supplementing enough water for injection; (4) and (5) performing hot-pressing sterilization after subpackaging.
4) The improvement of the synthesis process of emedastine fumarate bulk drug and the structural representation thereof/Liyanqin application chemistry-2013, 30 (11);
o-phenylenediamine is used as an initial raw material, a method of adding a phase transfer catalyst is adopted to synthesize the fumaric acid-type statin (1) through 5-step reaction, the synthesis process of 2 key intermediates, namely 2-nitrogen-1- (2-ethoxyethyl) benzimidazole (4) and the fumaric acid-type statin (5) is improved, moisture does not need to be controlled in the reaction, the yields of the intermediates 4 and 5 are respectively improved to 67.9 percent and 74.9 percent, and the structure of a product is verified by IR, lHNMR, 13CNMR, mass spectrometry, element analysis, differential thermal analysis and X-ray powder beam diffraction.
5) Synthesis of emedastine fumarate, a novel antihistaminic drug, Yanjinsong, China journal of pharmaceutical chemistry-2003, 13 (2);
the aim is to research the synthesis method of a novel antihistaminic drug emedastine fumarate, which takes o-phenylenediamine as a starting raw material to synthesize emedastine fumarate (8) through 6 steps of reactions of acidification, condensation, chlorination, substitution and salification, the emedastine fumarate is synthesized with the total yield of 10%, and the synthesis processes of important intermediates 1- (2-ethoxyethyl) -2-chlorobenzimidazole (5) and emedastine (7) are improved.
6) Preparation and stability study of emedastine fumarate eye drop/Yandonghuannan pharmacy-2018, 16 (7);
the aim is to optimize the prescription of the emedastine fumarate eye drops and prepare samples with qualified quality and stable properties, and the method takes sodium chloride as an osmotic pressure regulator; hydroxypropyl methylcellulose is used as a thickening agent; the benzalkonium chloride is used as a bacteriostatic agent for preparing samples, and compared with the sample of 0 month, the results show that the indexes of appearance, pH, osmotic pressure, related substances, content and the like of the self-made sample after being placed for 9 months have no obvious change, and the conclusion is that the self-made eye drop prescription has reasonable design, qualified quality and stable property.
At present, there are many clinical application studies on emedastine fumarate preparations, but there are very few reports related to the preparation process thereof.
Disclosure of Invention
The invention aims to provide a preparation process of emedastine fumarate slow-release capsules, wherein the emedastine fumarate slow-release capsules obtained by the preparation process are stably controlled to have the release degree of 25-45% in a 0.1mol/L hydrochloric acid solution within 1.5 hours, 50-75% in 4 hours, and more than 80% in 8 hours, and also stably controlled to have the release degree of 10-40% in 0.5 hour, 35-65% in 1.5 hours, and more than 75% in 6 hours according with the release degree standard in water required by the Japanese pharmacopoeia.
The technical scheme provided by the invention is a preparation process of emedastine fumarate sustained-release capsules, which comprises the steps of solution preparation, main medicine layer coating, isolation coating, sustained-release layer coating, total mixing and filling in sequence, thus obtaining the emedastine fumarate sustained-release capsules.
According to the technical scheme, the high-purity emedastine fumarate is used as a raw material, a sucrose blank pellet core (the particle size is 710-; and then a vacuum material-sucking capsule automatic filling machine is adopted for filling, so that the safety, effectiveness, uniformity and stability of the product are ensured, and the product meets the registration standard and the preset application.
Further, the solution preparation process specifically comprises the following steps:
(1) preparation of solution 1: taking 1 part of hydroxypropyl methyl cellulose, adding 10-20 parts of purified water, and stirring to completely dissolve the hydroxypropyl methyl cellulose to obtain a solution 1;
(2) preparation of solution 2: dissolving 1 part of emedastine fumarate raw material medicine in 4-10 parts of purified water, stirring and dissolving completely, then adding 5-10 parts of solution 1, and stirring uniformly to obtain solution 2;
(3) preparation of solution 3: taking 1 part of talcum powder, adding 10-26 parts of purified water, stirring to uniformly disperse the talcum powder, adding 14-26 parts of solution 1, and stirring to uniformly disperse the talcum powder to obtain solution 3;
(4) preparation of solution 4: and (3) taking 1 part of ethyl cellulose aqueous dispersion, adding 2-5 parts of purified water, and uniformly stirring to obtain a solution 4.
Further, the method for the main medicine layer coating process comprises the following steps: taking a proper amount of sucrose blank pellet cores, placing the sucrose blank pellet cores in a fluidized bed, starting a fan of the fluidized bed, and atomizing the solution 2 prepared in the solution preparation procedure; the atomization pressure is 0.30-0.40 MPa; the air inlet temperature is 55-60 ℃; the pill temperature is 45-50 ℃, the spraying speed is 10-25 r/min, and the drying is continued for 5-30 min after the spraying is finished.
Further, the method of the process of coating and isolating the coating comprises the following steps: and after the working procedure of coating the medicine layer is finished, continuously spraying the solution 3 prepared in the working procedure of preparing the solution, and continuously drying for 5-30 minutes after the spraying is finished.
Further, the method for coating the slow release layer comprises the following steps: continuously spraying the solution 4 prepared in the solution preparation process after the isolation coating process is finished, continuously drying for 5-30 minutes after the spraying is finished, and then aging at 40 ℃; the dosage of the coating is increased by the weight of the medicine, and the weight increase range is 15-30%.
Further, the method of the total mixing process comprises the following steps: preparing solution, coating main medicine layer, coating isolation coating, coating slow release layer to obtain pellet, adding talcum powder, mixing for 5-30 min, and collecting.
Further, the filling process comprises the following steps: and automatically filling and polishing the pellets after the total mixing procedure to obtain the emedastine fumarate sustained-release capsule.
Based on the above explanation, the technical scheme of the application has the beneficial effects that: the prepared emedastine fumarate slow-release capsule is stably controlled to be 25-45% in the release degree of 1.5 hours, 50-75% in the release degree of 4 hours and more than 80% in the release degree of 8 hours in 0.1mol/L hydrochloric acid solution; the release rate of the composition in water is controlled to be 10-40% in a release rate standard of 0.5 hour, 35-65% in a release rate standard of 1.5 hour and more than 75% in a release rate standard of 6 hours, which also meets the requirements of the Japanese pharmacopoeia.
Drawings
Fig. 1 is a flow chart of a preparation process of emedastine fumarate sustained-release capsules.
Detailed Description
Example 1
Referring to fig. 1, a preparation process of emedastine fumarate slow-release capsules specifically comprises the following steps:
preparation of solution 1: taking 1 part of hydroxypropyl methylcellulose, adding 10 parts of purified water, and stirring to completely dissolve the hydroxypropyl methylcellulose to obtain a solution 1;
preparation of solution 2: dissolving 1 part of emedastine fumarate raw material medicine in 4 parts of purified water, stirring and dissolving completely, then adding 5 parts of solution 1, and stirring uniformly to obtain solution 2;
preparation of solution 3: taking 1 part of talcum powder, adding 10 parts of purified water, stirring to uniformly disperse the talcum powder, adding 14 parts of solution 1, and stirring to uniformly disperse the talcum powder to obtain solution 3;
preparation of solution 4: taking 1 part of ethyl cellulose aqueous dispersion, adding 2 parts of purified water, and uniformly stirring to obtain a solution 4;
packaging a main medicine layer: taking a proper amount of sucrose blank pellet cores, placing the sucrose blank pellet cores in a fluidized bed, starting a fan of the fluidized bed, and atomizing the prepared solution 2 at the atomizing pressure of 0.30-0.40 MPa; the air inlet temperature is 55-60 ℃; the pill temperature is 45-50 ℃, the spraying speed is 10-25 r/min, and the drying is continued for 5-30 min after the spraying is finished;
coating an isolation coating: continuing spraying the solution 3 according to the operation parameters, and continuing drying for 5-30 minutes after spraying;
coating a slow release layer: continuing spraying the solution 4 according to the operation parameters, continuing drying for 5-30 minutes after spraying, and then performing aging treatment at 40 ℃; the coating amount is increased by weight of the medicine, and the weight increase range is 15%.
Total mixing: and (3) taking the pellets, adding 0.001 part of talcum powder, mixing for 5-30 minutes, and collecting.
Filling: and (4) automatically filling and polishing the totally mixed pellets to obtain the emedastine fumarate sustained-release capsule.
After the preparation of the emedastine fumarate slow-release capsule is finished, the emedastine fumarate slow-release capsule can be packaged and sold.
Example 2
Referring to fig. 1, a preparation process of emedastine fumarate slow-release capsules specifically comprises the following steps:
preparation of solution 1: taking 1 part of hydroxypropyl methylcellulose, adding 20 parts of purified water, and stirring to completely dissolve the hydroxypropyl methylcellulose to obtain a solution 1;
preparation of solution 2: dissolving 1 part of emedastine fumarate raw material medicine in 10 parts of purified water, stirring and dissolving completely, then adding 10 parts of solution 1, and stirring uniformly to obtain solution 2;
preparation of solution 3: taking 1 part of talcum powder, adding 26 parts of purified water, stirring to uniformly disperse the talcum powder, adding 26 parts of solution 1, and stirring to uniformly disperse the talcum powder to obtain solution 3;
preparation of solution 4: taking 1 part of ethyl cellulose aqueous dispersion, adding 5 parts of purified water, and uniformly stirring to obtain a solution 4:
packaging a main medicine layer: taking a proper amount of sucrose blank pellet cores, placing the sucrose blank pellet cores in a fluidized bed, starting a fan of the fluidized bed, and atomizing the prepared solution 2 at the atomizing pressure of 0.30-0.40 MPa; the air inlet temperature is 55-60 ℃; the pill temperature is 45-50 ℃, the spraying speed is 10-25 r/min, and the drying is continued for 5-30 min after the spraying is finished;
coating an isolation coating: continuing spraying the solution 3 according to the operation parameters, and continuing drying for 5-30 minutes after spraying;
coating a slow release layer: continuing spraying the solution 4 according to the operation parameters, continuing drying for 5-30 minutes after spraying, and then performing aging treatment at 40 ℃; the coating amount is increased by weight of the medicine, and the weight increase range is 30%.
Total mixing: and (3) taking the pellets, adding 0.001 part of talcum powder, mixing for 5-30 minutes, and collecting.
Filling: and (4) automatically filling and polishing the totally mixed pellets to obtain the emedastine fumarate sustained-release capsule.
After the preparation of the emedastine fumarate slow-release capsule is finished, the emedastine fumarate slow-release capsule can be packaged and sold.
The above is only a preferred embodiment of the present invention, and it should be noted that the above preferred embodiment should not be considered as limiting the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. It will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the spirit and scope of the invention, and these modifications and adaptations should be considered within the scope of the invention.
Claims (8)
1. A preparation process of emedastine fumarate slow-release capsules is characterized by comprising the steps of preparing a solution, coating a main medicine layer, coating an isolation coating, coating a slow-release layer, totally mixing and filling in sequence to obtain the emedastine fumarate slow-release capsules.
2. The preparation process of emedastine fumarate slow-release capsules according to claim 1, wherein the solution preparation process specifically comprises the following steps:
(1) preparation of solution 1: taking 1 part of hydroxypropyl methyl cellulose, adding 10-20 parts of purified water, and stirring to completely dissolve the hydroxypropyl methyl cellulose to obtain a solution 1;
(2) preparation of solution 2: dissolving 1 part of emedastine fumarate raw material medicine in 4-10 parts of purified water, stirring and dissolving completely, then adding 5-10 parts of solution 1, and stirring uniformly to obtain solution 2;
(3) preparation of solution 3: taking 1 part of talcum powder, adding 10-26 parts of purified water, stirring to uniformly disperse the talcum powder, adding 14-26 parts of solution 1, and stirring to uniformly disperse the talcum powder to obtain solution 3;
(4) preparation of solution 4: and (3) taking 1 part of ethyl cellulose aqueous dispersion, adding 2-5 parts of purified water, and uniformly stirring to obtain a solution 4.
3. The process for preparing emedastine fumarate slow-release capsules according to claim 1, wherein the method for the main drug layer coating process comprises: taking a proper amount of sucrose blank pellet cores, placing the sucrose blank pellet cores in a fluidized bed, starting a fan of the fluidized bed, and atomizing the solution 2 prepared in the solution preparation procedure.
4. The process for preparing emedastine fumarate slow-release capsules according to claim 3, wherein the atomization pressure is 0.30 to 0.40 MPa; the air inlet temperature is 55-60 ℃; the pill temperature is 45-50 ℃, the spraying speed is 10-25 r/min, and the drying is continued for 5-30 min after the spraying is finished.
5. The process for preparing emedastine fumarate slow-release capsules according to claim 1, wherein the coating and isolation procedure comprises the following steps: and after the working procedure of coating the medicine layer is finished, continuously spraying the solution 3 prepared in the working procedure of preparing the solution, and continuously drying for 5-30 minutes after the spraying is finished.
6. The process for preparing emedastine fumarate slow-release capsules according to claim 1, wherein the process for coating the slow-release layer comprises: and continuously spraying the solution 4 prepared in the solution preparation process after the coating and isolation process is finished, continuously drying for 5-30 minutes after the spraying is finished, and then aging at 40 ℃.
7. The process for preparing emedastine fumarate slow-release capsules according to claim 1, wherein the total mixing procedure comprises: preparing solution, coating main medicine layer, coating isolation coating, coating slow release layer to obtain pellet, adding talcum powder, mixing for 5-30 min, and collecting.
8. The process for preparing emedastine fumarate slow-release capsules according to claim 1, wherein the filling process comprises: and automatically filling and polishing the pellets after the total mixing procedure to obtain the emedastine fumarate sustained-release capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010578122.4A CN111643485A (en) | 2020-06-23 | 2020-06-23 | Preparation process of emedastine fumarate sustained-release capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010578122.4A CN111643485A (en) | 2020-06-23 | 2020-06-23 | Preparation process of emedastine fumarate sustained-release capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111643485A true CN111643485A (en) | 2020-09-11 |
Family
ID=72343593
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010578122.4A Pending CN111643485A (en) | 2020-06-23 | 2020-06-23 | Preparation process of emedastine fumarate sustained-release capsule |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111643485A (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862297A (en) * | 2009-04-14 | 2010-10-20 | 上海医药工业研究院 | Water-insoluble medicine sustained-release pellet, sustained-release orally disintegrating tablet thereof and preparation method thereof |
-
2020
- 2020-06-23 CN CN202010578122.4A patent/CN111643485A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862297A (en) * | 2009-04-14 | 2010-10-20 | 上海医药工业研究院 | Water-insoluble medicine sustained-release pellet, sustained-release orally disintegrating tablet thereof and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 日本橙皮书数据库: "Emedastine Difumarate", 《HTTPS://WWW.DRUGFUTURE.COM/JPORANGEBOOK/DISSVIEW.ASPX?DRUGNAME=DAREN%2BCAP.%2B1MG&SEQ=3965》 * |
| 日本药局方: ""过敏性疾病治疗"", 《HTTPS://PINS.JAPIC.OR.JP》 * |
| 谢秀琼主编: "《现代中药制剂新技术》", 30 June 2004, 化学工业出版社 * |
| 颜耀东主编: "《缓释控释制剂的设计与开发》", 30 June 2006, 中国医药科技出版社 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP5401327B2 (en) | Tablets with improved dissolution | |
| CN105213346B (en) | A kind of pharmaceutical composition and preparation method thereof containing cinacalcet hydrochloride | |
| KR101977785B1 (en) | Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof | |
| EP4233847A1 (en) | A tablet comprising a methoxyurea derivative and mannitol particles | |
| CN109875972B (en) | Olmesartan medoxomil and amlodipine pharmaceutical composition | |
| EP3653603A1 (en) | Fenlean (flz) crystal g form, preparation method, and composition and use thereof | |
| WO2022148053A1 (en) | Purification method for metformin hydrochloride, metformin hydrochloride sustained release tablet and preparation method therefor | |
| CN106924237B (en) | It is a kind of containing En Gelie is net and the pharmaceutical composition of Metformin hydrochloride | |
| CN109481412A (en) | A kind of II crystal linezolid piece and its preparation process | |
| CN117562900A (en) | New apixaban preparation composition with obvious clinical advantage and preparation method thereof | |
| CN111643485A (en) | Preparation process of emedastine fumarate sustained-release capsule | |
| CN117159555A (en) | Pharmaceutical composition, preparation method and application thereof | |
| CN109010298A (en) | A kind of melbine glipizide compound and preparation method thereof | |
| EP2810656A1 (en) | Agomelatine formulations comprising agomelatine in the form of co-crystals | |
| CN106692070A (en) | Trelagliptin succinate solid dispersion preparation and preparation method thereof | |
| CN113908153A (en) | Buvalracetam pharmaceutical composition, preparation method and application thereof | |
| CN109125278B (en) | Iloperidone medicinal oral preparation and preparation method thereof | |
| CN110742868A (en) | Mirogabalin Besilate orally disintegrating tablet | |
| CN106265559B (en) | Olanzapine oral disnitegration tablet and preparation method thereof | |
| CN110237097A (en) | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof | |
| CN115227660B (en) | Metformin hydrochloride sustained release tablet and preparation method thereof | |
| CN113893222B (en) | Pharmaceutical composition and preparation method and application thereof | |
| WO2023173460A1 (en) | Pharmaceutical composition of sglt-2 inhibitor | |
| CN114948969B (en) | Pharmaceutical composition comprising a crystalline form of a compound and fumaric acid, process for the preparation thereof and use thereof | |
| CN114053235B (en) | Theophylline sustained release tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20200911 |