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Valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity

A technology for hydrochlorothiazide and solid preparation, applied in the field of pharmaceutical preparations and preparation thereof, can solve the problems of large dosage form and inconvenience for patients to take, and achieve the effects of good product stability, improved production efficiency and simple process

Inactive Publication Date: 2012-07-04
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is that the dosage form of oral solid preparation of valsartan hydrochlorothiazide in the prior art is too large, and it is inconvenient for patients to take it.

Method used

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  • Valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity
  • Valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity
  • Valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation of Valsartan Hydrochlorothiazide Tablets, the material composition is shown in Table 1

[0039] Table 1 Material Composition Ratio

[0040]

[0041] Preparation of tablet cores: the prescribed amount of valsartan was granulated by roller compaction (Alexander WP120V), pressure: 70bar, roller speed: 3rpm. Mix the prepared granules with hydrochlorothiazide, optimized microcrystalline cellulose, low-substituted hydroxypropyl cellulose or sodium carboxymethyl starch, crospovidone, and silicon dioxide in a total mixing tank, then add magnesium stearate and mix Evenly, prepare 80 / 12.5mg valsartan-hydrochlorothiazide tablets according to the tablet weight, or double the tablet weight to prepare 160 / 25mg valsartan-hydrochlorothiazide tablets.

[0042] Preparation of coated tablets: Weigh Opadry prepared coating liquid, and coat the plain tablets. Until the sheet has gained about 3% in weight. Product quality is inspected, and the results are shown in Table 2 ...

Embodiment 2

[0046] Preparation of Valsartan Hydrochlorothiazide Tablets

[0047] The material composition is shown in Table 3

[0048] Table 3 Material Composition Ratio

[0049]

[0050] Preparation of tablet cores: the prescribed amount of valsartan was granulated by roller compaction (Alexander WP120V), pressure: 70bar, roller speed: 3rpm. Mix the prepared granules with hydrochlorothiazide, optimized microcrystalline cellulose, low-substituted hydroxypropyl cellulose or sodium carboxymethyl starch, crospovidone, and silicon dioxide in a total mixing tank, then add magnesium stearate and mix Evenly, according to the weight of the tablet, prepare 160 / 12.5 mg or 320 / 12.5 mg of valsartan hydrochlorothiazide tablets, or double the prescription 4-5 tablets and prepare 320 / 25 mg of valsartan and hydrochlorothiazide tablets.

[0051] Preparation of coated tablets: Weigh Opadry prepared coating liquid, and coat the plain tablets. Until the sheet has gained about 3% in weight. Product qua...

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PUM

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Abstract

The invention relates to a valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity. The oral solid preparation contains valsartan and hydrochlorothiazide which serve as active ingredients and a pharmaceutically acceptable additive which is suitable for preparing a solid oral preparation form by a pressing method. The oral solid preparation is characterized in that: the quantity of the active ingredients of the preparation is 65 to 80 percent of the total weight of the oral solid preparation, preferably 65 to 75 percent. The invention also relates to a preparation method for the oral solid preparation. The preparation method has the characteristics of simple process, low cost, good product stability and the like, improves the production efficiency to a certain extent, and is suitable for industrialized production. By detecting the produced sample according to the quality standards, various indexes accord with the specification.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a compound preparation of valsartan or a pharmaceutically acceptable salt thereof and hydrochlorothiazide and a preparation method thereof. Background technique [0002] Valsartan is a highly specific angiotensin (AT) II receptor antagonist that acts selectively on the AT1 receptor subtype, which responds to the known actions of angiotensin II , AT2 receptor subtypes are not related to cardiovascular effects, and valsartan does not have any partial agonist activity on AT1 receptors. Valsartan has a 20,000-fold stronger affinity for AT1 receptors than for AT2 receptors. The peak time of valsartan after oral administration is 2 to 4 hours, and the absolute bioavailability is about 25%. [0003] Structural formula: [0004] [0005] The original research company of Valsartan Hydrochlorothiazide Tablets is Swiss Novartis, and the trade name is Fud...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K9/20A61K9/48A61K9/28A61P9/12A61K31/41
Inventor 彭俊清葛光华魏芳胡李斌李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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