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Compound solid preparation of valsartan and hydrochlorothiazide, and preparation method thereof

A technology of tan hydrochlorothiazide and solid preparations, which is applied in the field of medicine, can solve problems such as the dissolution of valsartan, and achieve the effects of good industrial production value, high dissolution rate, and simple operation

Active Publication Date: 2012-11-28
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, we found that hydrochlorothiazide has a great influence on the dissolution of valsartan during the process of formula development

Method used

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  • Compound solid preparation of valsartan and hydrochlorothiazide, and preparation method thereof
  • Compound solid preparation of valsartan and hydrochlorothiazide, and preparation method thereof
  • Compound solid preparation of valsartan and hydrochlorothiazide, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] The prescription is (specification 80mg / 12.5, per 1000 tablets);

[0052] A: Valsartan 80g

[0053] B: Hydrochlorothiazide 12.5g

[0054] C: Microcrystalline cellulose 158.3g

[0055] D: Crospovidone 15g

[0056] E: micronized silica gel 1.5g

[0057] F: Magnesium stearate 2.7g

[0058] Materials A, B, C and D were passed through a 30-mesh sieve, and mixed uniformly to obtain mixture I; silicon dioxide and magnesium stearate were added to mixture I, and mixed uniformly to obtain mixture II, and the measured angle of repose was 43.7°. It is not suitable for direct compression of dry powder; Sinopharm Longli ZP-10 Rotary Tablet Press hopper feeding is not smooth, tablet cannot be pressed smoothly, and the difference in tablet weight is greater than 7.5%.

[0059] The powder with a tablet weight of 270 mg was manually weighed, and the dissolution rate was measured after tablet compression (1000 ml dissolution medium, paddle method 50 rpm). The results show that the d...

Embodiment 2

[0061] The prescription is (specification 80mg / 12.5, per 1000 tablets);

[0062] A: Valsartan 80g

[0063] B: Hydrochlorothiazide 12.5g

[0064] C: Microcrystalline Cellulose 150.2g 55.6%

[0065] D: Partially pregelatinized starch 8.1g 3%

[0066] E: Crospovidone 15g

[0067] F: Micropowder silica gel 1.5g

[0068] G: Magnesium stearate 2.7g

[0069] Materials A, B, C and D were passed through a 30-mesh sieve, and mixed uniformly to obtain mixture I; silicon dioxide and magnesium stearate were added to mixture I, and mixed uniformly to obtain mixture II, and the measured angle of repose was 44.8°. It is not suitable for direct compression of dry powder; Sinopharm Longli ZP-10 rotary tablet press does not discharge smoothly from the hopper and cannot press tablets smoothly. Tablet weight differences were greater than 7.5%.

[0070] The powder with a tablet weight of 270 mg was manually weighed, and the dissolution rate was measured after tablet compression (1000 ml diss...

Embodiment 3

[0071] Embodiment 3, tablet of the present invention

[0072] The prescription is (specification 80mg / 12.5, per 1000 tablets);

[0073] A: Valsartan 80g

[0074] B: Micropowder silica gel 1.5g

[0075] C: Hydrochlorothiazide 12.5g

[0076] D: Microcrystalline cellulose 150.2g

[0077] E: Partially pregelatinized starch 8.1g

[0078] F: Crospovidone 15g

[0079] G: Magnesium stearate 2.7g

[0080] Pass materials A and B through a 30-mesh sieve, and mix well to obtain mixture I; add half of the amount of microcrystalline cellulose to mixture I and mix for about 5 minutes, then add the remaining microcrystalline cellulose, partially pregelatinized starch and hydrochlorothiazide Mix for about 5 minutes to obtain mixture II, finally add magnesium stearate into mixture II, mix evenly to obtain mixture III, measure the angle of repose to be 40.3°, and feed smoothly in the hopper of Sinopharm Longli ZP-10 rotary tablet press, The tableting went well. Tablet weight variance was...

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Abstract

The invention belongs to the field of pharmaceutical preparation, and relates to a compound solid preparation of valsartan or pharmaceutically acceptable salts thereof and hydrochlorothiazide, and a preparation method thereof. The pharmaceutical composition provided by the invention is processed from the following raw and auxiliary materials in percentage by weight: 25-35% of valsartan or pharmaceutically acceptable salts thereof, 2-20% of hydrochlorothiazide, 25-71.4% of microcrystalline cellulose, 1-5.3% of partially pregelatinized starch, 0-20% of disintegrant, 0.5-5% of flow aid and 0.1-5% of lubricant, wherein the weight ratio of the microcrystalline cellulose to the partially pregelatinized starch is requested not to be less than 5:1.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a compound solid preparation and a preparation method thereof, in particular to a compound valsartan-hydrochlorothiazide solid preparation and a preparation method thereof. Background technique [0002] Cardiovascular and cerebrovascular diseases are the second largest "killer" that endangers human health after tumors. Hypertension is a common cardiovascular disease and can induce or aggravate other related diseases. At present, about 2 / 3 of hypertensive patients need to take two or more antihypertensive drugs to control blood pressure. The compound valsartan hydrochlorothiazide solid preparation provides two antihypertensive substances, which can effectively lower blood pressure and reduce blood pressure at the same time. Adverse reactions, and convenient to take, improve people's compliance. [0003] Valsartan is an orally effective and highly specific angiotensin (AT) II receptor antago...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/549A61K31/41A61K9/28A61P9/12
Inventor 蒋玲敏沈泽刘蕴秀杨炎王文峰
Owner CHINA RESOURCES SAIKE PHARMA
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