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Perindopril amlodipine tablet and production process thereof

A technology for indopril amlodipine tablet and production process, applied in the field of perindopril amlodipine tablet and its production process, can solve the problems of increasing the risk of myocardial infarction, etc., and achieve the control and prevention of renal disease occurrence and the development and control of blood pressure

Active Publication Date: 2014-06-18
SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Recent studies have suggested that the use of short-acting calcium antagonists may increase the risk of death from myocardial infarction, but there is no evidence that the use of long-acting preparations has a similar risk

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A perindopril amlodipine tablet, comprising the following components:

[0035] Perindopril tert-butylamine salt 4mg

[0036] Amlodipine besylate (calculated as amlodipine) 5mg

[0037] Microcrystalline Cellulose 55mg

[0038] Lactose 15mg

[0039] Pregelatinized starch 5 mg

[0040] Sodium carboxymethyl starch 5 mg

[0041] Magnesium stearate 0.8mg

[0042] Silica 0.4mg

[0043] Talc powder 0.4mg

[0044] Finally, the tablet with a total tablet weight of 90.6 mg is obtained, and its preparation process comprises the following steps:

[0045] Perindopril tert-butylamine salt and amlodipine besylate were mixed with microcrystalline cellulose and lactose in equal amounts respectively. After the mixing, the above two mixtures, pregelatinized starch, sodium carboxymethyl starch, silicon dioxide 1. Put the talcum powder into the mixer and mix for 30 minutes. After stopping the machine, add magnesium stearate and mix for 15 minutes. Sampling to test the content and...

Embodiment 2

[0047] A perindopril amlodipine tablet, comprising the following components:

[0048] Perindopril tert-butylamine salt 4mg

[0049] Amlodipine besylate (calculated as amlodipine) 5mg

[0050] Microcrystalline Cellulose 30mg

[0051] Lactose 50mg

[0052] Pregelatinized starch 5 mg

[0053] Sodium carboxymethyl starch 5 mg

[0054] Magnesium stearate 0.8mg

[0055] Silica 0.4mg

[0056] Talc powder 0.4mg

[0057] Finally, a tablet with a total tablet weight of 90.6 mg was obtained, and its preparation process was the same as in Example 1.

Embodiment 3

[0059] A perindopril amlodipine tablet, comprising the following components:

[0060] Perindopril tert-butylamine salt 4mg

[0061] Amlodipine besylate (calculated as amlodipine) 5mg

[0062] Microcrystalline Cellulose 60mg

[0063] Lactose 15mg

[0064] Pregelatinized starch 10 mg

[0065] Sodium carboxymethyl starch 10 mg

[0066] Magnesium stearate 0.8mg

[0067] Silica 0.4mg

[0068] Talc powder 0.4mg

[0069] Finally, a tablet with a total tablet weight of 90.6 mg was obtained, and its preparation process was the same as in Example 1.

[0070] Below in conjunction with specific clinical use the present invention will be further described:

[0071] A total of 46 patients with essential hypertension combined with stable angina pectoris were selected and randomly divided into two groups for a double-blind randomized controlled study. 24 patients in the treatment group were given amlodipine (5 mg / d) and perindopril ( 4mg / d), and 22 cases in the control group were giv...

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PUM

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Abstract

The invention discloses a perindopril amlodipine tablet and a production process thereof. The tablet comprises the following components: perindopril tert-butylamine salt, amlodipine besylate, microcrystalline cellulose, lactose, pregelatinized starch, sodium carboxymethyl starch, magnesium stearate, silicon dioxide and talc powder. The perindopril amlodipine tablet is an effective, safe and convenient treatment medicament for hypertension patients, and has important meaning in controlling blood pressure of patients, preventing occurrence and development of heart and cerebral vessel diseases, controlling kidney diseases occurrence of hypertension patients with with diabetes, improving heart functions of the patients, and reducing occurrence rate of myocardial infarction and other serious incidents.

Description

[0001] technical field [0002] The invention belongs to the technical field of medicine manufacturing, and in particular relates to a perindopril amlodipine tablet and a production process thereof. Background technique [0003] Hypertension refers to an abnormal increase in arterial blood pressure, and patients are often asymptomatic; increased arterial blood pressure increases the risk of stroke, aneurysm, heart failure, myocardial infarction, and kidney damage. [0004] According to the 1991 census, the prevalence of hypertension in my country has reached 11.26%, which is 25% higher than that in the 10 years from 1979 to 1980. In the early 1990s, there were 95 million hypertensive patients in my country. According to the 1996 survey, this rising trend is still continuing. Current statistics show that the number of hypertensive patients in my country has reached 120 million, with an increase of more than 3 million each year. In 1998, cerebrovascular disease was the secon...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/20A61P9/12A61P9/10A61K31/4422
Inventor 陈丽薛焰张耀华王坚姜允菊张秋
Owner SHANGHAI PHARMA DONGYING JIANGSU PHARMA CO LTD
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