Compound preparation containing losartan potassium and preparation method of compound preparation

Abstract

The present invention discloses a compound preparation containing losartan potassium and a preparation method of the compound preparation. The compound preparation is prepared by the following method:dissolving losartan potassium and kollicoat IR in a methanol aqueous solution and conducting granulation on auxiliary materials to obtain losartan potassium granules wrapped by the kollicoat IR; dissolving hydrochlorothiazide in acetone and conducting granulation on the auxiliary materials; mixing the two granules and conducting tableting to obtain a finished product. The prepared compound preparation containing the losartan potassium can fully isolate the losartan potassium and hydrochlorothiazide, and besides, the drug is added in a state of the solution and fully dispersed on the surfacesof the auxiliary materials and dissolves rapidly. The compound preparation containing the losartan potassium prepared by the process steps has a simple and feasible process, stable quality, improved product quality, and guaranteed product stability during long-term storage.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a compound preparation containing losartan potassium and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world today. It is a chronic disease characterized by continuous elevation of arterial blood pressure. The treatment of hypertension requires long-term medication. Generally, it starts with a small dose and gradually increases the dose. For patients whose blood pressure cannot be controlled after receiving one drug treatment, a combination of drugs can be selected. Studies have shown that 2 / 2 of the patients with good blood pressure control 3 is combined medication. There is a synergistic effect between the drugs when the drug is used in combination, which increases the effect of lowering blood pressure, and can also avoid the increase of adverse reactions caused by excessive dosage of...

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Problems solved by technology

[0005] Chinese patent CN103505460A discloses a preparation method for losartan potassium hydrochlorothiazide composition, which adopts dry granulation, but it is easy to cause uneven particle size, large difference in tablet weight, and difference in dissolution

However, the use of wet granulation can easily lead to the degradation of hydrochlorothiazide, which increases the number of related substances and affects the stability of the preparation.

[0006] Because hydrochlorothiazide is prone to degradation, the main degradation product: 4-amino-6-chloro-1,3-benzenedisulfonamide (DSA), wet granulation cannot obtain stable hydrochlorothiazide; In the process of long-term contact with other excipients, it is easy to react and increase the related substances of the drug; dry granulation, the particle size is uneven, and the dissolution is different; the fluidity of direct compression is poor

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