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Preparation method of compound preparation for treating high blood pressure

A compound and co-solvent technology, used in pill delivery, cardiovascular system diseases, drug combinations, etc., can solve problems such as reducing bioavailability and reducing drug dissolution rate.

Inactive Publication Date: 2013-01-23
CHANGZHOU PHARMA FACTORY
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Problems solved by technology

But telmisartan and hydrochlorothiazide compound preparation adopts this method and is not feasible, because hydrochlorothiazide and alkaline substance react to form a salt (such as meglumine, a conventional component in telmisartan preparation), so the dissolution rate of the drug will be greatly reduced , reducing the bioavailability

Method used

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  • Preparation method of compound preparation for treating high blood pressure
  • Preparation method of compound preparation for treating high blood pressure
  • Preparation method of compound preparation for treating high blood pressure

Examples

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Embodiment Construction

[0029]

[0030] Preparation:

[0031] 1. Preparation of the final mixture of the first sheet.

[0032] At 20°C, add 200.0kg of purified water, 3.0kg of sodium hydroxide, 6.0kg of sodium salicylate, 45.0kg of telmisartan, 14.0kg of povidone K, and 13.5kg of meglumine into a stainless steel container. Dubbed into a light yellow solution, set aside.

[0033] The above solution is sprayed into a suitable spray dryer and spray dried to obtain white to off-white fine particles, which are sieved to obtain the final mixture of the above first sheet.

[0034] 2. The final mixture of the second sheet.

[0035] Mix 9.0kg of purified water at 70°C, 6.0kg of starch, 112.0kg of lactose monohydrate, 12.5kg of hydrochlorothiazide, 64.0kg of microcrystalline cellulose sodium, and 0.330kg of red iron oxide until homogeneous to obtain the final product of the second sheet. mixture.

[0036] 3. Preparation of bilayer tablet.

[0037] Using a suitable tablet press, 240 kg of the final blen...

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Abstract

The invention relates to a double-layer tablet for treating high blood pressure and a preparation method of the double-layer tablet. The double-layer tablet comprises a first layer which contains angiotensin II receptor antagonist telmisartan and complex solubilizer, and a second layer which contains diuretic hydrochlorothiazide and disintegrant. The invention also discloses the preparation method of the double-layer tablet.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a double-layer tablet preparation containing angiotensin II receptor antagonist telmisartan and diuretic hydrochlorothiazide. The present invention also provides a method for preparing the bilayer tablet. technical background: [0002] Telmisartan is a novel angiotensin II receptor inhibitor, which was first disclosed in EP-A-50231. The chemical name of Telmisartan is 4'-[2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazol-1-ylmethyl]- Biphenyl-2-carboxylic acid, its structural formula is as follows: [0003] [0004] Telmisartan was originally developed by the German Boehringer Ingelheim pharmaceutical company. It was first approved for marketing in the United States in November 1998, and then in Germany, the Philippines, Australia, Belgium, the United Kingdom, China and other countries. Compared with other sartan drugs, telmisartan has an outstanding...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/549A61P9/12A61K31/4184
Inventor 殷学治郭乙杰计莹张艳
Owner CHANGZHOU PHARMA FACTORY
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