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Stable compound preparation valsartan amlodipine recipe and preparation method thereof

A technology of valsartan amlodipine tablets and amlodipine besylate, which is applied in the field of preparation of valsartan amlodipine tablets, can solve problems such as high temperature instability of raw materials, achieve improved bioavailability, and solve content problems, the effect of improving safety

Inactive Publication Date: 2019-03-22
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] This application provides a method for preparing valsartan and amlodipine tablets using a stable formula ratio and dry granulation process. This application can effectively improve the bioavailability, and at the same time solve the problem of easy introduction of impurities in the wet granulation process and high temperature instability of raw materials problems, improving the safety of medication

Method used

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  • Stable compound preparation valsartan amlodipine recipe and preparation method thereof
  • Stable compound preparation valsartan amlodipine recipe and preparation method thereof
  • Stable compound preparation valsartan amlodipine recipe and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] plain tablet prescription

[0025]

[0026] Preparation:

[0027] Weigh the prescribed amount of amlodipine besylate and microcrystalline cellulose PH102, and premix them in an equal-volume incremental mixing method. Weigh the prescribed amount of other raw materials and all excipients, and mix for about 3 minutes.

[0028] Fill the mixed material into the dry granulator, set the tableting pressure to 2.5MPa, the feeding frequency to 10.0Hz, the tableting frequency to 10.0Hz, and the granulation frequency to 10.0Hz, use a 30-mesh sieve for granulation, add The additional materials in the prescribed amount are mixed evenly and compressed with a tablet machine.

[0029] Coating in a coating pan with 10% coating solution, and increasing the weight by 3%, to obtain a finished product.

Embodiment 2

[0031]

[0032] Preparation:

[0033] Weigh the prescribed amount of amlodipine besylate and microcrystalline cellulose PH102, and premix them in an equal-volume incremental mixing method. Weigh the prescribed amount of other raw materials and all excipients, and mix for about 3 minutes.

[0034] Fill the mixed material into a wet granulator, add 10% sodium carboxymethyl cellulose aqueous solution to make a soft material, granulate with a 24-mesh sieve, dry, granulate with a 30-mesh sieve, and compress with a tablet machine.

[0035] Coating in a coating pan with 10% coating solution, and increasing the weight by 3%, to obtain a finished product.

Embodiment 3

[0037]

[0038] Preparation:

[0039] Weigh the prescribed amount of amlodipine besylate and microcrystalline cellulose PH102, and premix them in an equal-volume incremental mixing method. Weigh the prescribed amount of other raw materials and all excipients, and mix for about 3 minutes.

[0040] Fill the mixed material into the dry granulator, set the tableting pressure to 2.5MPa, the feeding frequency to 10.0Hz, the tableting frequency to 10.0Hz, and the granulation frequency to 10.0Hz, use a 30-mesh sieve for granulation, and Tablet press tablet.

[0041] Coating in a coating pan with 10% coating solution, and increasing the weight by 3%, to obtain a finished product.

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Abstract

The invention provides a stable compound preparation valsartan amlodipine tablet and a preparation method thereof. The stable compound preparation valsartan amlodipine tablet is a thin film coating tablet, and comprises a plain tablet and a thin film coating layer, wherein the plain tablet comprises raw medicine and auxiliary materials; the raw medicine includes valsartan and amlodipine besylate;the auxiliary materials comprise filling agents, disintegrating agents, lubricating agents and flow aids; the raw medicine and all auxiliary materials are prepared into the plain tablet; a thin film coating is wrapped at the outside; the stable compound preparation valsartan amlodipine tablet is prepared. The valsartan amlodipine tablet is prepared by using a stable recipe proportion and a dry method granulating process; the medicine disintegration can be effectively accelerated; meanwhile, the problem that the unqualified content of relevant substances of the medicine due to impurity caused by a wet method granulating process is solved; the use safety of medicine is improved.

Description

technical field [0001] The application relates to the technical field of biomedicine, and is a researched and verified preparation method of valsartan and amlodipine tablets. Background technique [0002] Valsartan Amlodipine Tablets is the world's first ARB / CCB single-chip compound preparation developed by Swiss Novartis Pharmaceuticals. It was approved by the European Union in January 2007; it was launched in Switzerland in February; On March 23, it was approved by the US FDA for the first-line treatment of hypertension; at the end of 2009, this product of Novartis was approved in China, and it was launched in June 2010 under the trade name of Bebot. [0003] This product is a compound preparation of valsartan and amlodipine, used for essential hypertension. [0004] Valsartan is an angiotensin II receptor antagonist. It can selectively act on AT1 receptor subtypes known to be related to the action of angiotensin II, selectively block the binding of angiotensin II to AT1...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/41A61K9/28A61K47/38A61P9/12
CPCA61K9/2054A61K9/28A61K31/41A61K31/4422A61K2300/00
Inventor 李月彤马莉王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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