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Adefovir dipivoxil tablet and preparation method thereof

A technology for adefovir dipivoxil and ester tablets, which is applied in the field of adefovir dipivoxil tablets and its preparation, can solve the problems of increasing the production cost of preparation production enterprises, complicated process flow, etc., and achieve the reduction of product quality risk and process Simplicity and the effect of reducing production costs

Pending Publication Date: 2022-03-25
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

On the other hand, the wet granulation process is complicated, which increases the production cost of preparation manufacturers

Method used

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  • Adefovir dipivoxil tablet and preparation method thereof
  • Adefovir dipivoxil tablet and preparation method thereof
  • Adefovir dipivoxil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Prescription (mass percentage): adefovir dipivoxil 6.67% (D90≤149.5μm), lactose 80%, pregelatinized starch 10%, croscarmellose sodium 0.3%, talc 2%, magnesium stearate 1%.

[0014] The preparation method is as follows: (1) adding adefovir dipivoxil, 50% lactose, pregelatinized starch, croscarmellose sodium, talcum powder, and remaining lactose into a mixer in sequence and mixing uniformly; (2) mixing the above mixture (3) transfer the above mixed powder to the mixer and mix evenly; (4) add magnesium stearate to the above mixed powder and mix evenly; (5) add the above mixed powder into the press Tablets can be obtained by pressing in a tablet machine.

Embodiment 2

[0016] Prescription: adefovir dipivoxil 6.67% (D90≤149.5μm), lactose 85%, pregelatinized starch 5%, croscarmellose sodium 0.3%, talc 2%, magnesium stearate 1%.

[0017] The preparation method is as follows: (1) mix adefovir dipivoxil, about 50% lactose, pregelatinized starch, croscarmellose sodium, talcum powder, and remaining lactose in a mixer; (2) mix the above (3) transfer the above mixed powder to the mixer and mix evenly; (4) add magnesium stearate to the above mixed powder and mix evenly; (5) add the above mixed powder into the press Tablets can be obtained by pressing in a tablet machine.

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Abstract

The invention discloses an adefovir dipivoxil tablet and a preparation method thereof. The adefovir dipivoxil tablet is prepared from the following components in parts by mass: 5 to 10 parts of adefovir dipivoxil, 75 to 90 parts of lactose, 3 to 10 parts of pregelatinized starch, 0.1 to 0.5 part of disintegrating agent, 0.5 to 2 parts of lubricating agent and 1 to 3 parts of flow aid. The adefovir dipivoxil tablet is prepared by adopting a direct powder tabletting process, a wet adhesive does not need to be added, moisture is prevented from being introduced in the tablet preparation process, so that the product quality risk is reduced, and compared with a wet granulation process, the adefovir dipivoxil tablet has the advantages that the product stability is higher, the direct powder tabletting process is simple, and the production cost of the adefovir dipivoxil tablet is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an adefovir dipivoxil tablet and a preparation method thereof. Background technique [0002] Adefovir dipivoxil is an acyclic nucleoside analog of adenosine monophosphate, which is phosphorylated into an active metabolite, adefovir diphosphate, under the action of cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) in the following two ways; one is to compete with the natural substrate deoxyadenosine triphosphate, and the other is to cause DNA chain elongation and termination after being integrated into viral DNA. This product is suitable for the treatment of adult chronic hepatitis B patients with active replication of hepatitis B virus and hepatic function compensation with continuous elevation of serum amino acid transferase. [0003] Adefovir dipivoxil tablets are marketed by original manufacturers in Chi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/675A61P1/16A61P31/20
CPCA61K9/2095A61K9/2059A61K31/675A61P1/16A61P31/20
Inventor 赵元文郑琳琳
Owner CISEN PHARMA
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