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A kind of felodipine sustained-release tablet and preparation method thereof

A felodipine, gentle technology, applied in non-active ingredients medical preparations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problems of patient use risk, sudden release, uneven tablet coating, etc., achieve the effect of security

Active Publication Date: 2021-01-05
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Generally, the solid preparation is prepared by coating the slow-release material to control the release of the main pellets. This is due to the uneven coating of individual tablets during the coating process or the occasional sticking of the tablets during the process. This may cause tablet The sudden release in the body brings great risks to patients

Method used

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  • A kind of felodipine sustained-release tablet and preparation method thereof
  • A kind of felodipine sustained-release tablet and preparation method thereof
  • A kind of felodipine sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025]

[0026] Preparation:

[0027] In step a, the raw material felodipine, the antioxidant propyl gallate, and the solubilizer polyoxyethylene hydrogenated castor oil are added to 95% ethanol solution to dissolve [felodipine: 95% ethanol=1:20 (g / ml)] to obtain Raw material solution; the binder hydroxypropyl cellulose was dissolved in 95% ethanol solution [binder: 95% ethanol = 1:15 (g / ml)] to obtain a binder solution;

[0028] In step b, the slow-release materials Hypromellose K15M and Hypromellose E50 are premixed uniformly by an equal amount addition method, and then mixed evenly with the excipient magnesium trisilicate by an equal amount addition method to obtain a mixture I; Lactose water and microcrystalline cellulose are premixed uniformly by equal addition method to obtain mixture II;

[0029] Step c, mix I and II in a three-dimensional mixer and mix evenly; transfer to a wet granulator after mixing, start mixing, add the raw material solution in step a, and shea...

Embodiment 2

[0041] Raw materials Prescription amount mg 2000 tablets g Felodipine 5.0 mg 10g Hypromellose LF 10mg 20g Hypromellose E50 100mg 200g Hypromellose K15M 25mg 50g anhydrous lactose 20mg 40g Polyoxyethylene Hydrogenated Castor Oil 5.0 mg 10g microcrystalline cellulose 3mg 6g Propyl gallate 0.06mg 0.12g Magnesium trisilicate 40mg 80g Sodium stearate fumarate 3.9mg 8.4g

[0042] Preparation method: with embodiment 1

[0043] Taking the matching degree (F2) and related substances of the self-made sustained-release tablet in this embodiment and the release degree of the original preparation as the investigation index, the investigation results are shown in the following tables 3 and 4:

[0044] Table 3 Example 2 Sustained Release Tablets and the release of the original formulation compared to the results (specification 5.0mg)

[0045]

[0046] Table 4 Example 2 Sustained-release Tablet...

Embodiment 3

[0050] Raw materials Prescription amount mg 2000 tablets g Felodipine 10mg 20g Hypromellose LF 10mg 20g Hypromellose E50 100mg 200g Hypromellose K15M 25mg 50g anhydrous lactose 20mg 40g Polyoxyethylene Hydrogenated Castor Oil 10mg 20g microcrystalline cellulose 3mg 6g Propyl gallate 0.06mg 0.12g Magnesium trisilicate 40mg 80g Sodium stearate fumarate 4mg 8.4g

[0051] Preparation method: with embodiment 1

[0052] Taking the matching degree (F2) and related substances of the sustained-release tablets made in this embodiment and the release of the original preparation as the investigation indicators, the investigation results are shown in the following tables 5 and 6:

[0053] Table 5 Example 3 Sustained Release Tablets and the release result comparison of the original preparation (specification 10mg)

[0054]

[0055] Table 6 Example 3 Sustained Release Tablets and the comparison ...

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Abstract

The invention relates to a felodipine sustained-release tablet, wherein the percentages of raw and auxiliary materials of the sustained-release tablet in the total weight of the tablet core are: 1%-5%of felodipine, 30-80% of matrix material, 1-20% of filler, 1-10% of solubilizer, 10-30% of excipient, 1-10% of adhesive and 0.01-0.1% of antioxidant.

Description

technical field [0001] The invention relates to a felodipine sustained-release tablet and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Felodipine is a third-generation dihydropyridine calcium antagonist, which is used to treat hypertension by inhibiting the influx of extracellular calcium in arteriolar smooth muscle and reducing peripheral vascular resistance. [0003] Felodipine is a dihydropyridine calcium channel antagonist, which was first launched in Denmark in 1988. It is an efficient, safe and well-tolerated drug for treating hypertension. Patients with insufficiency, asthma, peripheral vascular disease, gout or diabetes are relatively safe, and have been used in the treatment of hypertension in many countries. [0004] Scientific research has found that simple high blood pressure can cause damage to organs, but blood pressure fluctuations are particularly harmful to organs. Ordinary tablets of felodipine need to be...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K47/38A61K31/4422A61P9/12
CPCA61K9/0002A61K9/2054A61K9/2095A61K31/4422
Inventor 张建立李瑞兰汪连弟陈婧石丽王立芹解玉红陈红燕方贤罗
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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