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Verapamil hydrochloride delayed-release tablet and its preparation method

A delayed-release technology for verapamil hydrochloride, which is applied in pill delivery, pharmaceutical formulations, medical preparations with non-active ingredients, etc., can solve the problems of unfavorable industrial production, long production cycle, and many operation steps, and prevent serious Cardiovascular accidents, efficacy optimization, and compliance enhancement effects

Inactive Publication Date: 2012-08-01
YUANHE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The coating process of the above two patented preparations requires special coating equipment and precise process control, and there are many operating steps, long production cycle, poor reproducibility and high cost, which is not conducive to the realization of industrial production

Method used

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  • Verapamil hydrochloride delayed-release tablet and its preparation method
  • Verapamil hydrochloride delayed-release tablet and its preparation method
  • Verapamil hydrochloride delayed-release tablet and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prescription:

[0027]

[0028]

[0029] Preparation:

[0030] (1) preparation of tablet core: take prescription quantity verapamil hydrochloride and sodium carboxymethyl starch, mix, make soft material with 5% PVP ethanol solution as binding agent, cross 20 mesh sieve granulation, Dry at 40-50°C for 2 hours, pass through a 18-mesh sieve for granulation, add 1% magnesium stearate, mix well, and compress in a shallow concave die to obtain tablet cores.

[0031] (2) Preparation of coated granules: Weigh the prescription amount of HPMC E15, add 5% PVP alcohol solution as a binder to make a soft material, pass through a 40-mesh sieve for granulation, dry at 50°C for 2 hours, pass through the same mesh Sieve the whole grain, add 1% magnesium stearate, mix well, set aside.

[0032] (3) Compression coating: use a core-coating tablet machine, place half of the coated granules in the die hole of the tablet machine, then place the tablet core obtained in step (1) in the ...

Embodiment 2

[0038] Prescription:

[0039]

[0040] Preparation:

[0041] (1) Preparation of tablet core: take by weighing auxiliary materials such as prescription amount of verapamil hydrochloride, croscarmellose sodium, mix evenly, make soft material with 10% starch slurry as binding agent, cross 20 mesh sieves Granulate, dry at 50°C for 2 hours, sieve through a 18-mesh sieve for granulation, add magnesium stearate and talc, mix well, and compress in a shallow concave die to obtain tablet cores.

[0042] (2) Preparation of coated granules: take the prescription amount of ethyl cellulose and PEG4000, add 5% HPMC alcohol solution as a binder, make soft material, pass through a 20 mesh sieve and granulate, dry at 50°C for 1 hour, Sieve through the same mesh size for granulation, add 1% sodium lauryl sulfate, mix well, and set aside.

[0043] (3) Compression coating: use a core-coating tablet machine, place half of the coated granules in the die hole of the tablet machine, then place t...

Embodiment 3

[0049] Prescription:

[0050]

[0051]

[0052] Preparation:

[0053] (1) Preparation of tablet core: take by weighing prescription quantity verapamil hydrochloride, PVPP, MCC, mix, make soft material with 50% ethanol solution as binding agent, cross 20 mesh sieves and granulate, in 40 ~ Dry at 50°C for 2 hours, sieve through a 20-mesh sieve for granulation, add magnesium stearate, mix well, and compress into tablets in a shallow concave die to obtain tablet cores.

[0054] (2) Preparation of coated granules: Take stearyl alcohol, hydrogenated castor oil, and mannitol in the prescribed amount and mix them evenly. After heating and melting, place them at room temperature to cool and solidify, grind and pulverize, pass through a 40-mesh sieve, add magnesium stearate, and Alkyl sodium sulfate mixed, set aside.

[0055] (3) Compression coating: use a core-coating tablet machine, place half of the coated granules in the die hole of the tablet machine, then place the tablet...

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Abstract

The invention provides a preparation method of a verapamil hydrochloride delayed-release tablet. The method comprises the steps of: (1) preparation of a tablet core containing drug verapamil hydrochloride; (2) preparation of a coated granule; and (3) coating pressing. The invention also provides a verapamil hydrochloride delayed-release tablet provided by the method. Based on the variation law of blood pressure circadian rhythm in hypertensive patients, the tablet can rapidly release the active drug after taken and delayed for a proper period of time in vivo. The verapamil hydrochloride delayed-release tablet of the invention has the advantages of simple prescription and process, fewer operation step, short production cycle, low equipment requirement, good reproducibility and low cost, thus being very conducive to the realization of industrial mass production.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition of verapamil hydrochloride, in particular to a delayed-release preparation of verapamil hydrochloride and a preparation method thereof. technical background: [0002] Verapamil hydrochloride, alias verapamil, verapamil, English name: Verapamil hydrochloride, chemical name: α-[3-[[2-(3,4-dimethoxyphenyl) ethyl] methylamino] Propyl]-3,4-dimethoxy-α-isopropylphenylacetonitrile hydrochloride, the structural formula is as follows: [0003] [0004] Molecular formula: C 27 h 38 N 2 o 4 HCl, molecular weight: 491.07 [0005] This product is white or off-white crystal or crystalline powder, odorless, bitter taste, soluble in water, methanol or chloroform, insoluble in ether or benzene. Verapamil hydrochloride is a calcium channel blocker, which can be used clinically to treat essential hypertension, variant angina, unstable angina and arrhy...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/30A61K9/32A61K9/34A61K9/36A61K31/275A61K47/38A61P9/06A61P9/10A61P9/12
Inventor 邬林祥王玉文常绍琴古福根温爱平
Owner YUANHE PHARMA CO LTD
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