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Valaciclovir hydrochloride granules and preparation method thereof

A technology of valacyclovir hydrochloride and granules, which is applied in the field of drug preparation, can solve the problems of slight bitterness and irritation when taking granules, and achieve the effects of simple process, improving therapeutic effect, and overcoming excessive humidity or agglomeration

Pending Publication Date: 2021-08-20
LIVZON GROUP LIVZON PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to overcome the deficiencies in the prior art, the object of the present invention is to provide a valacyclovir hydrochloride granule and a preparation method thereof. stimulating question

Method used

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  • Valaciclovir hydrochloride granules and preparation method thereof
  • Valaciclovir hydrochloride granules and preparation method thereof
  • Valaciclovir hydrochloride granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A valacyclovir hydrochloride granule, which comprises the following components:

[0032]

[0033] Make 1000 bags. Among them, the internal disintegrant is crospovidone CL-M, and the external disintegrant is croscarmellose sodium.

[0034] Its preparation method is as follows:

[0035] S1, sieve valacyclovir hydrochloride, mannitol, povidone k30, and crospovidone CL-M and add them to a wet granulator and mix evenly;

[0036] S2. Add 100-130 g of ethanol with a concentration of 80% to granulate, dry, granulate, and sieve the 20-80 mesh granules;

[0037] S3, adding croscarmellose sodium, aspartame, strawberry essence, and talc powder, mixing evenly, and subpackaging to obtain valacyclovir hydrochloride granules.

Embodiment 2

[0039] A valacyclovir hydrochloride granule, which comprises the following components:

[0040]

[0041] Make 1000 bags. Among them, the internal disintegrant is crospovidone CL-M, and the external disintegrant is crospovidone XL.

[0042] Its preparation method is as follows:

[0043] S1, sieve valacyclovir hydrochloride, lactose, povidone k30, and crospovidone CL-M and add them to a wet granulator and mix evenly;

[0044] S2, adding 150-200 g of ethanol with a concentration of 95% to granulate, dry, granulate, and sieve the 20-80 mesh granules;

[0045] S3. Add crospovidone XL, stevioside, milk essence, and magnesium stearate, mix evenly, and divide into packages to obtain valacyclovir hydrochloride granules.

Embodiment 3

[0047] A valacyclovir hydrochloride granule, which comprises the following components:

[0048]

[0049] Make 1000 bags. Among them, the internal disintegrant is crospovidone CL-M, and the external disintegrant is crospovidone XL.

[0050] Its preparation method is as follows:

[0051] S1, sieve valacyclovir hydrochloride, mannitol, povidone k90, and crospovidone CL-M and add them to a wet granulator and mix evenly;

[0052] S2. Add 250-350 g of absolute ethanol to granulate, dry, granulate, and sieve the 20-80 mesh granules;

[0053] S3. Add crospovidone XL, stevioside, sweet orange essence, and fumed silica, mix evenly, and divide into packages to obtain valacyclovir hydrochloride granules.

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Abstract

The invention discloses valaciclovir hydrochloride granules and a preparation method thereof, and belongs to the technical field of medicine preparation. The valaciclovir hydrochloride granules provided by the invention take 80-95% ethanol or absolute ethanol as a wetting agent, and is prepared from the following components through wet granulation: 500 mg-1000 mg of valaciclovir hydrochloride, 90 mg-180 mg of a water-soluble filling agent, 10 mg-50 mg of an adhesive, 110 mg-180 mg of a disintegrating agent, 5 mg-25 mg of a flavoring agent and 2 mg-25 mg of a flow aid or a lubricating agent, wherein the water-soluble filling agent is lactose or mannitol, the disintegrating agent is divided into an internally-added disintegrating agent and an externally-added disintegrating agent, and the mass ratio of the internally-added disintegrating agent to the externally-added disintegrating agent is (6: 1)-(4: 1). According to the invention, the disintegration performance of the granules can be effectively improved, the granules are not prone to being too wet or caking, the granules disintegrate rapidly, the medicine release speed is high, bitter irritation is small, and the taking compliance is high.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a valacyclovir hydrochloride granule and a preparation method thereof. Background technique [0002] Valacyclovir hydrochloride is L-valine-2-[(6-oxo-2-amino-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl ester hydrochloride , the English name is Valaciclovir Hydrochloride, which is the prodrug of Acyclovir. After oral administration, valacyclovir hydrochloride is rapidly absorbed and quickly converted into acyclovir in the body. After acyclovir enters cells infected by herpes virus, it is phosphorylated into activated aciclovir by viral deoxynucleoside thymidine and cellular kinases. Lowe triphosphate, as a substrate for viral DNA replication, competes with deoxyguanine triphosphate for viral DNA polymerase, and under the action of viral DNA polymerase, binds to the growing DNA chain to terminate the extension of viral DNA, thereby inhibiting Viral DNA synthesis, showing...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/522A61K47/10A61K47/32A61K47/38A61K47/26A61K47/18A61P31/22
CPCA61K9/1617A61K9/1623A61K9/1635A61K9/1652A61K31/522A61P31/22
Inventor 覃开芳钟贞徐晓范文峰何裕赞毛万祥廖洁宇李玥颖曹珺王亚龙
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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