Pimobendan sustained-release tablets for pet and preparation method thereof

A technology for pimobendan and sustained-release tablets, applied in the field of pimobendan sustained-release tablets for pets and its preparation, can solve the problems of excessive fluctuation of blood drug concentration, great influence on therapeutic effect, and lack of preparation process , to reduce the risk of injury, improve the effect of clinical treatment, and improve palatability

Inactive Publication Date: 2014-03-26
RINGPU TIANJIN BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Patent (CN100546568C, published on October 7, 2009) provides a pharmaceutical composition containing pimobendan, mainly composed of pimobendan, citric acid, starch, lactose, artificial beef flavoring agent, povidone, colloid Composed of anhydrous silicon dioxide and magnesium stearate, the main advantage is that it enhances the palatability of pimobendan and facilitates clinical administration, but frequent administration can easily cause excessive fluctuations in blood drug concentration, which is harmful to clinical treatment. The effect of treatment is greater
The patent (CN1929845B, published on July 28, 2010) provides the use of a PDEⅢ inhibitor in the preparation of drugs for reducing the heart size of mammals with heart failure, and mainly introduces the application of pimobendan in clinical treatment The use in this patent does not provide a specific preparation process

Method used

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  • Pimobendan sustained-release tablets for pet and preparation method thereof
  • Pimobendan sustained-release tablets for pet and preparation method thereof
  • Pimobendan sustained-release tablets for pet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Party:

[0022]

[0023] Preparation:

[0024] A, firstly prepare the solid dispersion of pimobendan and citric acid, dissolve pimobendan and citric acid in water together, carry out vacuum drying, pulverize the dried solid powder, pass through a 200 mesh sieve, and set aside;

[0025] B, the sieved pimobendan solid dispersion, slow and controlled release auxiliary material, filler, 80% flavoring agent and 30% binder are mixed uniformly;

[0026] C. Add the ethanol / water (30 / 70) solution of the remaining 70% of the adhesive and mix evenly to make a soft material;

[0027] D. Carry out wet granulation of the prepared soft material, dry at 60°C for 1 hour, and granulate;

[0028] E, add lubricant and remaining 20% ​​correctives to the prepared granule and mix evenly;

[0029] F, tablet pressing, finished product.

Embodiment 2

[0030] Embodiment 2 stability test

[0031] 1 Materials and methods

[0032] 1.1 Material test drugs: the pimobendan sustained-release tablets prepared according to Example 1-A, Example 1-B, and Example 1-C respectively; control drugs: according to the patent (CN100546568C, issued on October 7, 2009 Published in Japan) homemade Pimobendan Tablets, the content is 5mg.

[0033] 1.2 Methods Take 25 tablets of the test drug and the control drug respectively, and carry out the accelerated test of the drug for six months according to the "Technical Specifications for Stability Test of Veterinary Drugs (Trial)". Sampling for content determination.

[0034] 2 Test results: See Table 1.

[0035] Table 1 Drug Stability Test Results (n=4)

[0036]

[0037] The results show that the drug stability of the pimobendan sustained-release tablets prepared in Example 1-A, Example 1-B, and Example 1-C is obviously better than that of the reference drug. It shows that the preparation is st...

Embodiment 4

[0038] Example 4 Clinical Trials

[0039] 1. Materials and Methods

[0040] 1.1 Test material

[0041] 1.1.1 Test drug Test drug: Example 1-C, used continuously for seven days; control drug: self-made pimobendan tablets according to the patent (CN100546568C, published on October 7, 2009), with a content of 5 mg.

[0042] 1.1.2 Experimental animals Tianjin Pet Hospital has diagnosed dogs with heart disease, and 80 dogs have been diagnosed with clinical disease in the third and fourth stages of heart disease. The age of onset is 3-10 years old.

[0043] 1.2 Test method: Divide 80 naturally occurring dogs into five groups of I, II, III, IV and V, with 16 dogs in each group. Group I is the infection-free group; Group II is the group treated with low-dose test drugs (2.5mg per kilogram of body weight orally, once a day, for seven consecutive days); Group III was treated with a medium dose of the test drug (5 mg per kg of body weight, once a day, for seven consecutive days); Group...

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Abstract

The invention discloses pimobendan sustained-release tablets for a pet and a preparation method thereof. The pimobendan sustained-release tablets disclosed by the invention are stable and safe to use and consist of a solid dispersion of pimobendan, a sustained-release material, a filling agent, an adhesive, a lubricant and a flavoring agent. The pimobendan sustained-release tablets disclosed by the invention have the characteristics of convenience in administration, lasting action and stable curative effect.

Description

technical field [0001] The invention belongs to the field of veterinary drug preparations, in particular to a pimobendan sustained-release tablet for pets and a preparation method thereof. Background technique [0002] Pimobendan is a cardiac dilator compound with calcium sensitization and type III phosphatase inhibitory effects. Calcium sensitizers achieve their positive cardiac contractility by changing the binding of calcium to troponin-C, making contractile proteins sensitive to existing intracellular calcium, rather than by increasing calcium into cardiomyocytes to achieve calcium effects. Therefore, the positive myocardial contractility produced by calcium sensitization can avoid some side effects caused by intracellular calcium overload. Increased intracellular calcium levels are associated with an increased tendency to arrhythmia and sudden death. Clinical trials have shown that long-term oral administration of pimobendan in patients with heart failure can improve ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/501A61P9/04
Inventor 魏德宝张静高芳
Owner RINGPU TIANJIN BIOLOGICAL PHARMA
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