Felodipine sustained-release tablet and method for controlling sustained-release of Felodipine sustained-release tablet

A gentle and filodipine technology, applied to non-active ingredient medical preparations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve problems such as retention and no release patents for felodipine slow-release controlled-release preparations , to achieve the effect of reducing rework, reducing energy consumption, and saving production costs

Active Publication Date: 2009-11-11
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the patents on felodipine sustained-release preparations only stay on the prepar...

Method used

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  • Felodipine sustained-release tablet and method for controlling sustained-release of Felodipine sustained-release tablet
  • Felodipine sustained-release tablet and method for controlling sustained-release of Felodipine sustained-release tablet
  • Felodipine sustained-release tablet and method for controlling sustained-release of Felodipine sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Take by weighing Felodipine sustained release tablet granule 15.2g (wherein the total amount of HPMC K15M CR, HPMC K4M CR and HPMC K100LV CR accounts for 33% of granule gross weight; The weight ratio of the three is: HPMCK15M CR: HPMC K4M CR: HPMC K100LV CR=2:1:4), add 50g of hot distilled water, stir with a glass rod to disperse it, add 434.8g of distilled water, and fully stir for 40 minutes with a high-shear mixing emulsifier to prepare an aqueous solution containing 1% HPMC, using Brookfield LVDV -C digital display viscometer, choose #1 rotor, the measured viscosity under the condition of rotating speed 30rpm is 7040 centipoise. The release rate of felodipine sustained-release tablets prepared at this time is shown in Table 1, and the dissolution curve similarity f2 factor method evaluation is shown in Table 1. figure 1 .

[0034] The release degree of table 1 embodiment 1

[0035]

[0036] Conclusion: Example 1 is evaluated according to the dissolution ...

Embodiment 2

[0038] Take felodipine sustained-release tablet granule 12.1g (wherein the total amount of HPMC K4M CR and HPMC K100LVCR accounts for 41.4% of granule gross weight; The weight ratio of the two is: HPMC K4M CR: HPMCK100LV CR=4: 25), add 50g of hot distilled water, stirred with a glass rod to disperse, add 437.9g ​​of distilled water, and fully stir for 40 minutes with a high-shear mixer emulsifier to prepare an aqueous solution containing 1% HPMC, using a Brookfield LVDV-C digital display viscometer, and select the #1 rotor , The measured viscosity under the condition of rotating speed 30rpm is 2820 centipoise. The release rate of felodipine sustained-release tablets prepared at this time is shown in Table 2, and the dissolution curve similarity f2 factor method evaluation is shown in Table 2. figure 2 .

[0039] The release degree of table 2 embodiment 2

[0040] time

[0041] Conclusion: Example 2 is evaluated according to the dissolution curve similarity f2 facto...

Embodiment 3

[0043] Take by weighing Felodipine sustained-release tablet granule 12.5g (wherein the total amount of HPMC K15M CR, HPMC K100LVCR and HPMC E15LV accounts for 40.1% of the granule gross weight; The weight ratio of the three is: HPMCK15M CR: HPMC K100LV CR: HPMC E15LV= 3:8:6), add 50g of hot distilled water, stir with a glass rod to disperse it, add 437.5g of distilled water, and fully stir for 40 minutes with a high-shear mixing emulsifier to prepare an aqueous solution containing 1% HPMC, using Brookfield LVDV-C Apparent viscometer, choose #1 rotor, the measured viscosity of rotating speed 30rpm condition is 2200 centipoises. The release rate of the felodipine sustained-release tablets prepared at this time is shown in Table 3, and the dissolution curve similarity f2 factor method evaluation is shown in Table 3. image 3 .

[0044] The release degree of table 3 embodiment 3

[0045]

[0046] Conclusion: Example 3 is evaluated according to the dissolution curve sim...

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Abstract

The invention discloses a Felodipine sustained-release tablet and a method for controlling the sustained-release of the Felodipine sustained-release tablet. The Felodipine sustained-release tablet comprises Felodipine and HPMC high polymer material, the Felodipine accounts for 2.0-7.0% of the total sum of the granules or the powder, wherein, the viscosity range of the granules or the powder of the prepared Felodipine sustained-release tablet is respectively 2000-2400 centipoise and 6840-7240centipoise. The Felodipine sustained-release tablet has quality conforming to the standard and similar release property with the preparation of the same type sold in markets, and the quality control is carried out before production, thus reducing re-doing, saving production cost, reducing energy consumption and improving productivity.

Description

technical field [0001] The invention relates to a felodipine sustained-release tablet and a method for controlling the release of the felodipine sustained-release tablet. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. With the improvement of our people's living standards and the improvement of medical and health standards, cardiovascular and cerebrovascular diseases have replaced infectious diseases as the number one killer of human health. And high blood pressure is the chief culprit of cardiovascular and cerebrovascular diseases. According to the national statistical data: the existing hypertensive patients in my country have reached 120 million, and more than 3 million are added every year, and the blood pressure of about 60% of them is in the range of 140-160 / 90-95mmHg. The number of deaths due to hypertension and its complications exceeds 1 million every year in the country. Therefore, ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61K47/38A61P9/12
Inventor 谢称石王金超张兰廖广华
Owner GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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