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Valsartan amlodipine pharmaceutical composition and preparation method thereof

A technology of amlodipine besylate and composition, which is applied in the field of pharmaceutical composition containing valsartan and amlodipine besylate and its preparation, and can solve the problems of low bioavailability, large difference in tablet weight, and drug disintegration. Solve the problems such as unsatisfactory dissolution and dissolution, achieve the effect of simple production process, improve dissolution, and reduce investment in equipment and workshops

Inactive Publication Date: 2015-02-25
JIANGXI SHIMEI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the problems in the above-mentioned prior art, the first object of the present invention is to provide a new valsartan and amlodipine besylate pharmaceutical composition, by optimizing the composition and ratio of auxiliary materials, it solves the problem of drug disintegration In order to solve technical problems such as unsatisfactory dissolution, large tablet weight differences, and low bioavailability, valsartan amlodipine tablets with relatively simple prescription and process were obtained, which improved drug stability and dissolution speed and were more suitable for industrialized mass production.

Method used

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  • Valsartan amlodipine pharmaceutical composition and preparation method thereof
  • Valsartan amlodipine pharmaceutical composition and preparation method thereof
  • Valsartan amlodipine pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] 1. Prescription

[0075] Tablet prescription:

[0076]

[0077] Coating Solution Prescription:

[0078] Opadry II 5g

[0079] Purified water 28ml

[0080] 2. Preparation process

[0081] (1) Pass the valsartan raw material and the amlodipine besylate raw material through an 80-mesh sieve respectively.

[0082] (2) Bake lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide and sodium stearyl fumarate at 80°C for 2 hours, and pass through a 60-mesh sieve.

[0083] (3) Weighing valsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, and fully mixing to obtain a mixed powder.

[0084] (4) Weigh the prescribed amount of amlodipine besylate and mix with the above-mentioned mixed powder according to the method of equal increase.

[0085] (5) Determine the content of the main drug, calculate the weight of the tablet, press the tablet ...

Embodiment 2

[0089] 1. Prescription

[0090] Tablet prescription:

[0091]

[0092] Coating Solution Prescription:

[0093] Opadry II 5g

[0094] Purified water 28ml

[0095] 2. Preparation process

[0096] (1) Pass the valsartan raw material and the amlodipine besylate raw material through a 100-mesh sieve respectively.

[0097] (2) Bake lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide and sodium stearyl fumarate at 60°C for 3 hours, and pass through a 60-mesh sieve.

[0098] (3) Weighing valsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, and fully mixing to obtain a mixed powder.

[0099] (4) Weigh the prescribed amount of amlodipine besylate and mix with the above-mentioned mixed powder according to the method of equal increase.

[0100] (5) Determine the content of the main drug, calculate the weight of the tablet, press the tablet ...

Embodiment 3

[0104] 1. Prescription

[0105] Tablet prescription:

[0106]

[0107] Made into 1000 pieces

[0108] Coating Solution Prescription:

[0109] Opadry II 5g

[0110] Purified water 22ml

[0111] 2. Preparation process

[0112] (1) Pass the valsartan raw material and the amlodipine besylate raw material through a 100-mesh sieve respectively.

[0113] (2) Bake lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide and sodium stearyl fumarate at 70°C for 3 hours, and pass through an 80-mesh sieve.

[0114] (3) Weighing valsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, and fully mixing to obtain a mixed powder.

[0115] (4) Weigh the prescribed amount of amlodipine besylate and mix with the above-mentioned mixed powder according to the method of equal increase.

[0116] (5) Determine the content of the main drug, calculate the weight...

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Abstract

The invention relates to a valsartan amlodipine pharmaceutical composition and a preparation method thereof. The pharmaceutical composition is composed of the following formula: 5 parts by weight of amlodipine besylate, 80 parts by weight of valsartan, 20-50 parts by weight of lactose, 10-40 parts by weight of microcrystalline cellulose, 3-6 parts by weight of low substituted hydroxypropyl cellulose, 0.3-2 parts by weight of silica and 0.5-5 parts by weight of sodium stearyl fumarate. The pharmaceutical composition is prepared from a direct powder compression process. The invention adopts a small amount of disintegrating agent to reach dissolution of more than 90%, and the composition has the advantages of good stability and fast disintegration. The preparation method provided by the invention has simple production process, reduces the corresponding investment in equipment factory, and saves the production cost. The tablet produced by the direct powder compression has faster disintegration, and helps to improve the dissolution of the drug; and through test, the tablet prepared by the method of the invention has dissolution above 90% in 15 min.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition containing valsartan and amlodipine besylate and a preparation method thereof. Background technique [0002] Hypertension (hypertensive disease) is a chronic disease characterized by continuous increase in arterial blood pressure, which often causes lesions in the heart, brain, kidney and other important organs with corresponding consequences. Hypertension is the most common cardiovascular disease and a major public health problem worldwide. [0003] At present, the clinically used antihypertensive drugs alone can achieve less than 50% of the antihypertensive target (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg) rate, and most patients need to use combination drugs. The results of the study confirmed that the clinical demand for single use of antihypertensive drugs is decreasing, and the combination of drugs for ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/36A61P9/12A61K31/41
CPCA61K31/4422A61K9/2866A61K31/41A61K47/38A61K2300/00
Inventor 江鸿杨大龙
Owner JIANGXI SHIMEI PHARM CO LTD
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