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A preparation process for improving the bioavailability of valsartan hydrochlorothiazide capsules

A technology for tan hydrochlorothiazide and hydrochlorothiazide, which is applied in the field of preparation technology for improving the bioavailability of valsartan hydrochlorothiazide capsules, can solve the problems of affecting drug efficacy, low bioavailability, poor solubility, etc., and achieve improved bioavailability and dissolution rate , the effect of increasing solubility

Active Publication Date: 2016-03-30
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the large particle size of valsartan and hydrochlorothiazide, their poor solubility in water, and the strong adsorption capacity of polyethylene oxide, the loss of valsartan and hydrochlorothiazide is relatively large, and their bioavailability is low. The effect of medicine

Method used

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  • A preparation process for improving the bioavailability of valsartan hydrochlorothiazide capsules
  • A preparation process for improving the bioavailability of valsartan hydrochlorothiazide capsules
  • A preparation process for improving the bioavailability of valsartan hydrochlorothiazide capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: Valsartan Hydrochlorothiazide Capsules

[0018]

[0019]

[0020] Preparation method:

[0021] 1) Micronize valsartan and hydrochlorothiazide so that the average particle size is 15 μm, pass pregelatinized starch, sodium carboxymethyl starch, dextrin, hypromellose, and sodium lauryl sulfate through a 80-mesh sieve, Magnesium stearate is passed through a 40-mesh sieve, for subsequent use;

[0022] 2) Weigh the prescribed amount of valsartan, hydrochlorothiazide, pregelatinized starch, dextrin, sodium carboxymethyl starch, lauryl sulfate, and mix them evenly in a high-speed granulator;

[0023] 3) Granulate the mixed powder with a dry granulator, add the prescribed amount of magnesium stearate for granulation and mix well.

[0024] 4) Fill the capsule.

Embodiment 2

[0025] Embodiment 2: Valsartan Hydrochlorothiazide Capsules

[0026]

[0027] Preparation method:

[0028] 1) Micronize valsartan and hydrochlorothiazide so that the average particle size is 10 μm, microcrystalline cellulose, black fungus polysaccharide MHA (molecular weight 3×10 4 -4×10 4 ), hypromellose, sodium lauryl sulfate through a 80-mesh sieve, and talcum powder through a 40-mesh sieve, and set aside;

[0029] 2) Weigh the prescribed amount of valsartan, hydrochlorothiazide, microcrystalline cellulose, croscarmellose sodium, hypromellose, and sodium lauryl sulfate, and mix them evenly in a high-speed granulator;

[0030] 3) Granulate the mixed powder with a dry granulator, add the prescribed amount of talcum powder and mix well.

[0031] 4) Fill the capsule.

Embodiment 3

[0032] Embodiment 3: Valsartan Hydrochlorothiazide Capsules

[0033]

[0034]

[0035] Preparation method:

[0036] 1) Micronize valsartan and hydrochlorothiazide so that the average particle size is 5 μm, microcrystalline cellulose, dextrin, croscarmellose sodium, hydroxypropyl cellulose, and sodium lauryl sulfate pass through 80 mesh Sieve, pass talcum powder through a 40-mesh sieve, set aside;

[0037] 2) Weigh the prescribed amount of valsartan, hydrochlorothiazide, microcrystalline cellulose, croscarmellose sodium, dextrin, and sodium lauryl sulfate, and mix them evenly in a high-speed granulator;

[0038] 3) Granulate the mixed powder with a dry granulator, add the prescribed amount of talcum powder and mix well.

[0039] 4) Fill the capsule.

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to a preparation process for improving bioavailability of valsartan and hydrochlorothiazid capsules. The process provided by the invention comprises the following specific steps: 1) processing valsartan and hydrochlorothiazid by means of micronization, sieving a filler, a disintegrating agent, an adhesive and a solubilizer with a 80-mesh sieve, and sieving a lubricating agent with a 40-mesh sieve for later use; 2) weighing a prescribed dose of the valsartan, the hydrochlorothiazid, the filler, the disintegrating agent, the adhesive and the solubilizer, and uniformly mixing in a high-speed mixing granulator; 3) granulating the uniformly-mixed powder by using a dry type granulator, adding a prescribed dose of the lubricating agent for strengthening granules and then uniformly mixing the lubricating agent with the powder; 4) filling capsules. Compared with the prior art, the preparation process for improving the bioavailability of valsartan and hydrochlorothiazid capsules can improve the dissolution rate and increase the solubility by processing the raw materials by means of micronization, adding special auxiliary materials and adopting dry granulation, thus the bioavailability of the valsartan and hydrochlorothiazid capsules is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a preparation process for improving the bioavailability of valsartan hydrochlorothiazide capsules. Background technique [0002] According to the ESH / ESC guidelines for the prevention and treatment of hypertension, the target blood pressure of patients with uncomplicated hypertension should be controlled at <140 / 90mmHg; Control at <130 / 80mmHg. In order to achieve the above treatment target value, most of the current guidelines for the prevention and treatment of hypertension recommend the combined use of two different types of antihypertensive drugs in the initial treatment. However, many studies have shown that only 1 / 3 of hypertensive patients can achieve the goal under the combined treatment of two antihypertensive drugs. [0003] Valsartan / hydrochlorothiazide compound preparation is a safe and orally effective antihypertensive drug widely used...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/549A61K9/48A61P9/12A61K31/41
Inventor 成瑞明李大涛卢秀莲杜振新
Owner CISEN PHARMA