Stable perindopril indapamide tablet and preparation technology

A technology for indapamide tablets and perindapamide, which is applied in the field of perindopril indapamide tablets and the preparation technology thereof, can solve the problem of insufficiency to ensure that perindopril tert-butylamine and indapamide are stable and clinically stable. It can solve the problems of curative effect, inter-batch variation, etc., to achieve the effect of solving the problem of content uniformity, excellent inter-batch variation, and excellent intra-batch variation.

Active Publication Date: 2017-05-10
杭州新诺华医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Research and analysis on the marketed perindopril indapamide tablets, which are packaged in aluminum-plastic blisters and stored in aluminum foil bags with desiccant, and are required to be stored below 30°C. However, the research results show that the conditions of the preparation are not enough to ensure the stability of perindopril tert-butylamine and indapamide, that is, there is also high temperature degradation, and the packaging also greatly increases the cost
On the other hand, the dissolution profile of indapamide in its more serious problem marketed products shows that there are obvious differences between batches and within batches, which will have an impact on clinical efficacy

Method used

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  • Stable perindopril indapamide tablet and preparation technology
  • Stable perindopril indapamide tablet and preparation technology
  • Stable perindopril indapamide tablet and preparation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] A kind of perindopril indapamide tablet, described perindopril indapamide tablet is made up of following components according to parts by weight:

[0065] Alpha crystal form perindopril tert-butylamine: 4 parts;

[0066] Indapamide: 1.25 parts;

[0067] Lactose monohydrate: 79.65 parts;

[0068] 3.6 parts of hydroxypropyl cellulose;

[0069] 1.5 parts of sodium carboxymethyl starch;

[0070] 0.5 parts of colloidal silicon dioxide;

[0071] Magnesium stearate: 1 part; indapamide crystal form and literature Phamazie 2006, 61(12):99-1004

[0072] The reported crystal forms are the same;

[0073] The tablet weighing about 90mg of last system, its preparation process comprises the following steps:

[0074] (1) Take the lactose and dry it until the moisture content is lower than 5.5%, pass through a 50-mesh sieve together with colloidal silicon dioxide, and mix;

[0075] (2) adding sieved hydroxypropyl cellulose (passing 50 mesh), sodium carboxymethyl starch (passing 5...

Embodiment 2

[0092] A kind of perindopril indapamide tablet, described perindopril indapamide tablet is made up of following components according to parts by weight:

[0093] Alpha crystal form perindopril tert-butylamine: 2 parts;

[0094] Indapamide: 0.625 parts;

[0095] Lactose monohydrate: 82.275 parts;

[0096] SSL hydroxypropyl cellulose 3.6 parts;

[0097] 1.5 parts of sodium carboxymethyl starch;

[0098] 0.5 parts of colloidal silicon dioxide;

[0099] Magnesium stearate: 1 part;

[0100] The crystal form of indapamide is the same as that reported in the literature Phamazie 2006, 61(12):99-1004.

[0101] The tablet weighing about 90mg of last system, its preparation process comprises the following steps:

[0102] (1) After drying the lactose until the water content is lower than 5.5%, pass through a 50-mesh sieve with colloidal silicon dioxide and mix;

[0103] (2) Do not add sieved hydroxypropyl cellulose (over 50 mesh) and sodium carboxymethyl starch (over 50 mesh) to mi...

Embodiment 3

[0127] A kind of perindopril indapamide tablet, described perindopril indapamide tablet is made up of following components according to parts by weight:

[0128] Alpha crystal form perindopril tert-butylamine: 4 parts;

[0129] Indapamide: 1.25 parts;

[0130] Lactose monohydrate: 76.25 parts;

[0131] SSL hydroxypropyl cellulose 1.5 parts;

[0132] 4.5 parts of sodium carboxymethyl starch;

[0133] 1 part of colloidal silicon dioxide;

[0134] Magnesium stearate: 1.5 parts; the crystal form of indapamide is the same as the crystal form reported in the document Phamazie 2006, 61 (12): 99-1004. Finally, a tablet weighing about 90 mg is made, and its preparation process is as in Example 1 As mentioned above, the crystal form of the product obtained in the embodiment is consistent with that of the marketed product, and the key quality attributes such as properties, related substances, dissolution rate, content uniformity, moisture content, and content are all consistent.

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Abstract

The invention discloses a stable perindopril indapamide tablet and a preparation technology. The pharmaceutical composition is composed of the following components: perindopril tert-butylamine, indapamide, lactose, hydroxypropyl cellulose, sodium carboxymethyl starch, silicon dioxide, and magnesium stearate. Powder is directly pressed to prepare the pharmaceutical composition. The properties, dissolution rate, water content, content, crystal form, and dissolving-out behavior in different medium with different pH values of the prepared perindopril indapamide tablet are similar with those of commercial products. Furthermore, the dissolution curve shows that the difference of tablets in a batch and the difference of tablets in different batches is prominently less than that of commercial products. Compared with the commercial products, the stability of the provided tablet is better in production and storage. The clinical effectiveness and safety are guaranteed. Moreover, the preparation technology is simple, and the production cost is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a stable perindopril indapamide tablet and a preparation process thereof. Background technique [0002] Hypertension refers to a clinical syndrome characterized by elevated systemic arterial pressure and peripheral arteriolar resistance accompanied by varying degrees of increased cardiac output and blood volume. Hypertension is the most common chronic disease and the most important risk factor for cardiovascular and cerebrovascular diseases. Its main complications are stroke, myocardial infarction, heart failure and chronic kidney disease. At present, the prevalence of hypertension in my country is increasing. According to statistics, the number of hypertensive patients in my country has reached 250 million, the prevalence of hypertension in adults is 25%-30%, and 3.5 million people die from cardiovascular and cerebrovascular diseases every year. More than half of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K9/20A61K47/26A61K47/36A61K47/38A61K47/04A61K47/12A61P9/12A61K31/404
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/404A61K38/05A61K2300/00
Inventor 石晓宝余永华
Owner 杭州新诺华医药有限公司
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