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Valaciclovir hydrochloride tablet and preparation method thereof

A technology of valacyclovir hydrochloride and Lovir tablets, which is applied in the field of medicine and can solve the problems of many fine powders, complex procedures, and poor molding

Inactive Publication Date: 2021-04-23
澳美制药(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of this application is to provide a kind of valacyclovir hydrochloride and its preparation method, aiming to solve the complex procedure of the existing valacyclovir hydrochloride preparation method to a certain extent, is unfavorable for large-scale production, and the product stability of preparation is poor, Too much fine powder and poor molding

Method used

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  • Valaciclovir hydrochloride tablet and preparation method thereof
  • Valaciclovir hydrochloride tablet and preparation method thereof
  • Valaciclovir hydrochloride tablet and preparation method thereof

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preparation example Construction

[0028] The first aspect of the embodiment of the present application provides a method for preparing valacyclovir hydrochloride tablets, comprising the following steps:

[0029] S10. Adding valacyclovir hydrochloride, the first filler and the binder into the fluidized bed for fluidized bed granulation to obtain core granules;

[0030] S20. After mixing the inner core granules with the second filler, disintegrating agent and lubricant, the tablet is compressed to prepare the valacyclovir hydrochloride tablet core.

[0031] The preparation method of valacyclovir hydrochloride tablets provided in the first aspect of the application adopts the principle of fluidized bed granulation, utilizes high-speed hot air flow to suspend valacyclovir hydrochloride and fillers into a fluidized state, and passes through the adhesive The solution is sprayed and dried to form a liquid bridge, so that the fluidized material powder is combined into porous particles to obtain core particles. Then, ...

Embodiment 1

[0074] A kind of valacyclovir hydrochloride sheet, its preparation comprises steps:

[0075] Take by weighing valacyclovir hydrochloride 556g (D 90183 μm), microcrystalline cellulose 30g, added to the fluidized bed, weighed 24g of povidone, made into a solution, and carried out fluidized bed granulation with a fluidized bed, set the inlet air temperature: 60 ℃, material temperature 30 ℃, fan frequency 15-25Hz, start fluidization, set the peristaltic pump speed at 5-12rpm, spray slurry, after drying, the final moisture content is 2.65% MC, pass through a 24-mesh sieve for granulation. The ratio of obtained particles above 100 mesh to fine powder below 100 mesh is 67.2:32.8.

[0076] Take microcrystalline cellulose 30g, crospovidone 14g, colloidal silicon dioxide 4g, magnesium stearate 2g, add in the three-dimensional mixer together with granule, mix 10min, granule fluidity is good, carry out tabletting, pack coating, valacyclovir hydrochloride tablets can be obtained.

Embodiment 2

[0078] A kind of valacyclovir hydrochloride sheet, its preparation comprises steps:

[0079] Weigh valacyclovir hydrochloride 571g (D 90 258μm), 30g of lactose was added to the fluidized bed, 20g of cornstarch was weighed, and made into a starch slurry solution, and the fluidized bed was used for fluidized bed granulation. The fan frequency is 15-25Hz, fluidization is started, the speed of the peristaltic pump is set at 5-12rpm, and the slurry is sprayed. After drying, the final moisture content is 3.16% MC, and the granules are sieved through a 24-mesh sieve. The ratio of obtained particles above 100 mesh to fine powder below 100 mesh is 53.7:46.3.

[0080] Weigh 30g of lactose, 40g of dextrin, 26g of carboxymethyl cellulose, 4g of silicon dioxide, and 8g of sodium lauryl sulfate, and add them into a three-dimensional mixer together with the granules, and mix for 10 minutes. Valacyclovir hydrochloride tablets can be obtained.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a valaciclovir hydrochloride tablet and a preparation method of the valaciclovir hydrochloride tablet. The preparation method comprises the following steps of adding valaciclovir hydrochloride, a first filler and an adhesive into a fluidized bed for fluidized bed granulation to obtain core particles; and mixing the core particles with a second filler, a disintegrating agent and a lubricant, and performing tabletting to obtain a valaciclovir hydrochloride tablet core. According to the preparation method of the valaciclovir hydrochloride tablet, the fluidized bed granulation is adopted; compared with a wet granulation process, the fluidized bed granulation has the advantages that the process steps are reduced, and the production efficiency is improved; and moreover, the whole process is completed in the fluidized bed, so that continuous industrial production is facilitated, excessive contact between raw material components such as the valaciclovir hydrochloride and the like and water is reduced, the influence of excessive water on the crystal form of the valaciclovir hydrochloride is avoided, and the stability of the valaciclovir hydrochloride is improved.

Description

technical field [0001] The application belongs to the technical field of medicine, and in particular relates to a valacyclovir hydrochloride tablet and a preparation method of the valacyclovir hydrochloride tablet. Background technique [0002] Valacyclovir hydrochloride, its chemical name is:: L-valine-2-[6-2-amino-1,6 dihydro-9H-purin-9-yl] ethyl ester hydrochloride, its molecular formula For: C 13 h 20 N 6 o 4 • HCl. Valacyclovir is the prodrug of acyclovir, which is absorbed rapidly after oral administration and is quickly converted into acyclovir in the body. Its antiviral effect is exerted by acyclovir, and acyclovir enters herpes-infected cells After that, it competes with deoxynucleoside for viral thymidine kinase or cellular kinase, and the drug is phosphorylated into activated acycloguanosine triphosphate, which acts as a substrate for viral DNA replication and competes with deoxyguanine triphosphate for viral DNA polymerase, thereby inhibiting Synthesis of v...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/36A61K47/38A61K31/522A61P31/22
CPCA61K9/2054A61K9/2059A61K9/2866A61K31/522A61P31/22
Inventor 陈燕雯魏建华孟中斌李海华
Owner 澳美制药(苏州)有限公司
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