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Medicinal composition containing enalapril or genazepril and sotalol

A technology of sotalol hydrochloride and its composition, which is applied in the field of pharmaceutical compositions, can solve the problems of poor compliance of elderly patients, limited antihypertensive efficacy, and decline in sales, so as to reduce medical expenses and improve patient compliance , enhance the effect of antihypertensive effect

Active Publication Date: 2007-01-10
SHENZHEN AUSA PHARM CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The ACE inhibitor enalapril was first developed by Merck in the United States, and it was launched in the Federal Republic of Germany in 1984. It was once one of the best-selling prescription drugs in the European and American markets, but sales began to decline after 2001. The main reasons are: enalapril The patent expired in 2000, and countries imitated it one after another; new products of the same kind appeared continuously; there were some problems in itself: (1) the antihypertensive curative effect had a certain limit, and a large number of literature reports had a total effective rate of only about 60%, and 40% were ineffective or had no curative effect. Significantly; (2) Target
The 3-year epidemiological monitoring showed that nearly 30% of the patients who insisted on taking benazepril still did not reach the target, and the elderly patients showed poor performance, which may be related to the higher baseline systolic blood pressure level of the elderly patients In addition, on the whole, the control of systolic blood pressure is more difficult than diastolic blood pressure (Lv Jun. Chinese Journal of Epidemiology, 2004; 25(5): 412~6)
[0027] Patent and scientific literature searches did not find any report on the combined application of enalapril / benazepril and sotalol

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1. preparation contains the compound enalapril sotalol sheet of 10mg enalapril and 20mg sotalol

[0050] Prescription Enalapril Maleate 10.0g

[0051] Sotalol Hydrochloride 20.0g

[0052] Starch 45.0g

[0053] Microcrystalline Cellulose 45.0g

[0054] Sodium carboxymethyl starch (CMS Na) 5.0g

[0055] 5% povidone k-30 (solvent is absolute ethanol) QS

[0056] Magnesium stearate (MS) QS

[0057] Made into 1000 pieces

[0058] Preparation process: Take the prescribed amount of enalapril maleate and sotalol hydrochloride through a 100-mesh sieve and mix them uniformly by the method of equal increments; other excipients are passed through a 100-mesh sieve and dried at 75°C for 2 hours; according to the prescription A certain amount of starch, microcrystalline cellulose, and CMS·Na are mixed evenly, and then mixed with the mixed raw materials in equal increments; adding a...

Embodiment 2

[0059] Example 2. Preparation of compound enalapril sotalol tablets containing 10mg enalapril and 40mg sotalol

[0060] Prescription: Enalapril Maleate 10.0g

[0061]Sotalol Hydrochloride 40.0g

[0062] Starch 45.0g

[0063] Microcrystalline Cellulose 45.0g

[0064] Sodium carboxymethyl starch (CMS Na) 5.0g

[0065] 5% povidone k-30 (solvent is absolute ethanol) QS

[0066] Magnesium stearate (MS) QS

[0067] Made into 1000 pieces

[0068] The preparation method is the same as implementation 1.

Embodiment 3

[0069] Example 3. Preparation of Compound Enalapril Sotalol Tablets Containing 10mg Enalapril and 80mg Sotalol

[0070] Formula: Enalapril Maleate 10g

[0071] Sotalol Hydrochloride 80g

[0072] Microcrystalline Cellulose 50g

[0073] Starch 20g

[0074] Sodium carboxymethyl starch 20g

[0075] 10% starch slurry appropriate amount

[0076] Micropowder silica gel amount

[0077] Made into 1000 pieces

[0078] Preparation method: crush the original and auxiliary materials through a 120-mesh sieve, weigh the prescription amount of enalapril maleate, sotalol hydrochloride, microcrystalline cellulose, starch and sodium carboxymethyl starch, crush and sieve, mix evenly, Use an appropriate amount of 10% starch slurry to make a soft material, granulate, dry at 40°C to 60°C until the water content is about 3%, take it out, granulate, mix the granules with an appropriate amount of talcum powder, and press ...

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PUM

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Abstract

The present invention relates to a medicine composition containing enalapril or benazepril and sotalol. It is a new type hypotensor medicine composition. The content of enalapril or benazepril is 5-40 mg and the sotalol content is 20-160mg.

Description

technical field [0001] The invention relates to a novel pharmaceutical composition, in particular to a chemical pharmaceutical composition containing enalapril or benazepril and sotalol and its application in preparing medicine. belongs to the field of pharmacy. Background technique [0002] Enalapril (Enalapril) was first developed by Merck Company of the United States and was listed in the Federal Republic of Germany in 1984. It is an angiotensin-converting enzyme (ACE) inhibitor. After oral administration, it is hydrolyzed into Enalaprilat in the body. The latter strongly inhibits ACE, reduces the content of angiotensin II, causes systemic vasodilation, and lowers blood pressure. It has obvious antihypertensive effect on two-kidney-one-clip hypertensive rats, one-kidney-one-clip hypertensive rats and spontaneously hypertensive rats. For the treatment of essential hypertension. [0003] Benazepril (Benazepril, Benazepril, Luotingxin) was researched and developed by Nova...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/55A61K38/55A61K38/05A61K31/401A61K9/08A61K9/10A61K9/16A61K9/20A61K9/22A61K9/48A61P9/12A61P9/10A61P9/04A61P13/12A61P27/02A61P3/10A61K31/18
Inventor 陈光亮王琳琳段炎炎李莉徐希平
Owner SHENZHEN AUSA PHARM CO LTD
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