Benidipine hydrochloride tablet and preparation method thereof

A technology of benidipine hydrochloride and benidipine hydrochloride, applied in the field of biomedicine, can solve the problems of inhibiting bone anabolism and the like

Pending Publication Date: 2021-05-18
山东华素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is known that low or intermittently high concentrations of parathyroid hormone in the blood can promote bone anabolism

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Weigh 10g of polyethylene glycol in a beaker, heat and melt in a water bath; dissolve 1g of benidipine hydrochloride in 20% ethanol solution, add to the melted polyethylene glycol, stir and mix, and continue to stir until anhydrous The ethanol is evaporated, rapidly cooled, and pulverized to obtain the solid dispersion powder of the drug.

[0024] (2) Proportion according to the following weight components:

[0025] Benidipine Hydrochloride Tablet Dispersion Powder 10g

[0026] Lactose 30g

[0027] Sodium Lauryl Sulfate 0.5g

[0028] Sodium carboxymethyl starch 3g

[0029] Povidone K30 2.5g

[0030] Magnesium Stearate 1g

[0031] Mix benidipine hydrochloride dispersion powder, lactose, sodium lauryl sulfate, and sodium carboxymethyl starch evenly, and granulate the mixture under the spraying of povidone K30 ethanol solution, and then add Magnesium stearate was mixed evenly, and compressed in a single-punch tablet machine, with a hardness of 50N and a tablet we...

Embodiment 2

[0033] (1) Weigh 200g of polyethylene glycol in a beaker, heat and melt in a water bath; dissolve 20g of benidipine hydrochloride through 85% ethanol solution, add to the melted polyethylene glycol, stir until the drug dissolves, and cool quickly. Pulverize to obtain the solid dispersion powder of the drug.

[0034] (2) Proportion according to the following weight components:

[0035] Benidipine Hydrochloride Tablet Dispersion Powder 30g

[0036] Microcrystalline Cellulose 40g

[0037] Sodium Lauryl Sulfate 6g

[0038] Sodium carboxymethyl starch 15g

[0039] Povidone K30 4g

[0040] Magnesium Stearate 3g

[0041] Mix benidipine hydrochloride dispersion powder, microcrystalline cellulose, sodium lauryl sulfate, and sodium carboxymethyl starch evenly, granulate the mixture under the spraying of povidone K30 ethanol solution, and dry the granules Add magnesium stearate and mix evenly, and compress in a single-punch tablet machine, with a hardness of 50N and a tablet weight...

Embodiment 3

[0043] (1) Weigh 100g of polyethylene glycol in a beaker, heat and melt in a water bath; dissolve 10g of benidipine hydrochloride through 52% ethanol solution, add to the melted polyethylene glycol, stir until the drug dissolves, and cool quickly. Pulverize to obtain the solid dispersion powder of the drug.

[0044] (2) Proportion according to the following weight components:

[0045] Benidipine Hydrochloride Tablet Dispersion Powder 50g

[0046] Dextrin 20g

[0047] Benzaze-35 3.2g

[0048] Crospovidone 15g

[0049] Hypromellose 3.2g

[0050] Talc powder 2g

[0051] Mix benidipine hydrochloride dispersion powder, dextrin, benzaze-35, and crospovidone evenly, and granulate the mixture under the spraying of hydroxypropyl methylcellulose aqueous solution, and then add it after the granules are dried The talcum powder was mixed evenly, and compressed in a single-punch tablet machine with a hardness of 40N and a tablet weight of 100mg.

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PUM

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Abstract

The invention relates to a benidipine hydrochloride tablet and a preparation method thereof. Thus, the technical problems that existing benidipine hydrochloride tablets are low in dissolution and dissolution rate can be solved. The tablet consists of, by weight, 1-20% of benidipine hydrochloride, 20-60% of a hydrophilic filler, 0.5-6.0% of a wetting agent, 25-50% of a disintegrating agent, 2.5-4.0% of an adhesive, and 1-3% of a flow aid, with the balance being solid dispersion carriers. The preparation method of the tablet is also provided. The tablet can be widely applied to the field of drug preparation.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a benidipine hydrochloride tablet and a preparation method thereof. Background technique [0002] Benidipine hydrochloride is a new type of dihydropyridine calcium ion antagonist. It binds to dihydropyridine receptors that block cell membrane potential-dependent calcium ion channels, preventing calcium ions from flowing into cells and dilating blood vessels. Benidipine hydrochloride is widely used as a therapeutic drug for hypertension, renal hypertension, angina pectoris, etc. because of its safety and effectiveness. [0003] In the process of treating essential hypertension, calcium antagonists, as a class of core drugs, play a very important role, especially for elderly patients with essential hypertension. Studies have shown that osteoporosis is a common symptom of elderly patients with essential hypertension. It is known that benidipine can improve osteoporosis in the elderly, in...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K47/32A61K31/4545A61P9/12
CPCA61K9/0056A61K9/2018A61K9/2027A61K9/2059A61K31/4545A61P9/12
Inventor 王熙红滕世涛张凯林淑霞
Owner 山东华素制药有限公司
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