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Compound preparation containing losartan potassium and hydrochlorothiazide and preparation method for compound preparation

A technology of hydrochlorothiazide and losartan potassium, which is applied in the field of medicine, can solve problems such as the increase of related substances, and achieve the effects of high bioavailability, fast dissolution and good stability

Inactive Publication Date: 2012-07-04
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Related substances increase even when the two drugs are granulated separately

Method used

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  • Compound preparation containing losartan potassium and hydrochlorothiazide and preparation method for compound preparation
  • Compound preparation containing losartan potassium and hydrochlorothiazide and preparation method for compound preparation
  • Compound preparation containing losartan potassium and hydrochlorothiazide and preparation method for compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Prescription

[0032] (Based on 1000 pieces)

[0033]

[0034] Coating Composition

[0035] Opadry (stomach dissolving type) 7g

[0036] water 100ml

[0037] (2) Preparation method

[0038] 1) Pulverize losartan potassium and hydrochlorothiazide respectively, sieve, and set aside; sieve microcrystalline cellulose, lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate, respectively, and set aside;

[0039] 2) Weigh the raw and auxiliary materials according to the prescription quantity;

[0040] 3) Mix the raw and auxiliary materials in 2) evenly, and press into tablets;

[0041] 4) Put the sample obtained in 3) into a coating pan, and coat it to obtain.

Embodiment 2

[0042] Embodiment 2 (comparative example)

[0043] (1) Prescription

[0044] (Based on 1000 pieces)

[0045]

[0046] Coating Composition

[0047] Opadry (stomach dissolving type) 7g

[0048] water 100ml

[0049] (2) Preparation method

[0050] 1) Pulverize losartan potassium and hydrochlorothiazide respectively, sieve, and set aside; sieve microcrystalline cellulose, lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate, respectively, and set aside;

[0051] 2) Weigh the raw and auxiliary materials according to the prescription quantity and mix them evenly;

[0052] 3) dissolving hypromellose in 80% aqueous ethanol;

[0053] 4) Mix the product obtained in step 2) and step 3) uniformly, granulate with a 20-mesh screen, dry at 60°C, granulate with a 18-mesh screen, add magnesium stearate, and tablet;

[0054] 5) Put the sample obtained in 4) into a coating pan, and coat it to obtain.

[0055] Example 1 was prepared by the direct powder compression ...

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PUM

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Abstract

The invention relates to a compound preparation containing losartan potassium and hydrochlorothiazide and a preparation method for the compound preparation. The compound preparation containing the losartan potassium and the hydrochlorothiazide comprises a tablet core and a film coating, wherein the tablet core comprises active pharmaceutical ingredients of the losartan potassium and the hydrochlorothiazide, and minor pharmaceutical ingredients such as microcrystalline cellulose, lactose, low substituted hydroxyprepyl cellulose and magnesium stearate. The prepared compound preparation has high dissolubility, is simple in preparation process and can be easily produced in large scale; and moreover, the degradation speed and degree of the hydrochlorothiazide can be remarkably lowered, and impurities 4-amino-6-chloro-1,3-benzenedisulfonamide (DSA) and chlorothiazide can be prevented from increasing.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a compound preparation composed of losartan potassium and hydrochlorothiazide and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world, often causing complications in the heart, brain, kidney and other organs, seriously endangering human health. According to my country's statistical data, the prevalence of hypertension in my country has increased by about 25% every 10 years, and the estimated number of patients in the country has exceeded 100 million at present. my country has become one of the countries with the most severe hypertension hazards in the world. [0003] The main pathogenesis of hypertension is the hyperfunction of the sympathetic adrenergic system and the renin-angiotensin-aldosterone system caused by various reasons, resulting in strong contraction of small arteries i...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K31/4178A61K9/36A61P9/12
Inventor 尹莉芳刘秀敏周建平张陆勇王广基朱春莉
Owner CHINA PHARM UNIV
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