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Alendronate sodium enteric-coated tablet and preparation method thereof

A technology of alendronate sodium and enteric-coated tablets, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, etc., can solve the problems of expensive calcitonin, inability to restore bone tissue, and side effects, and achieve The effect of rapid drug dissolution, convenient administration and low production cost

Inactive Publication Date: 2010-06-30
BEIJING HOPE HUGE PHARM SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Calcitonin is expensive and difficult to promote in China; long-term use of estrogen has certain side effects, and estrogen cannot restore lost bone tissue

Method used

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  • Alendronate sodium enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Tablet prescription:

[0026] Alendronate Sodium 10g

[0027] Lactose 45g

[0028] Microcrystalline Cellulose 40g

[0029] Micronized silica gel 2.5g

[0030] Magnesium Stearate 2.5g

[0031] 30% ethanol solution appropriate amount

[0032]

[0033] 1000 pieces

[0034] Coating Solution Prescription

[0035] Hypromellose 5g

[0036] Acrylic resin 2.5g

[0037] 30% ethanol solution appropriate amount

[0038] Tween-80 5g

[0039] Talc powder 2g

[0040]

[0041] 100ml

[0042] The alendronate sodium, microcrystalline cellulose, lactose, micropowder silica gel that takes by weighing recipe quantity crosses 24 mesh sieves and makes it mix homogeneously. Mix in 30% ethanol solution, then add the solution into the mixed fine powder of raw and auxiliary materials, and stir to make a soft material. Pass the soft material through a 20-mesh sieve to make granules. Dry at 70°C for 4 hours, pass throu...

Embodiment 2

[0044] Tablet prescription:

[0045] Alendronate Sodium 10g

[0046] 35g pregelatinized starch

[0047] Microcrystalline Cellulose 40g

[0048] Sodium carboxymethyl starch 13g

[0049] Micronized silica gel 0.5g

[0050] Magnesium Stearate 1.5g

[0051] 30% ethanol solution appropriate amount

[0052]

[0053] 1000 pieces

[0054] Coating Solution Prescription

[0055] Hypromellose 2.5g

[0056] Acrylic resin 2.5g

[0057] 30% ethanol solution appropriate amount

[0058] Tween-80 2.5g

[0059] Talc powder 2.0g

[0060]

[0061] 100ml

[0062]The alendronate sodium, pregelatinized starch, microcrystalline cellulose, carboxymethyl starch sodium of prescription quantity are taken by weighing 24 mesh sieves and make it mix homogeneously. Add 30% ethanol solution and mix well, stir to make soft material. Pass the soft material through a 20-mesh sieve to make granules. Dry at 70°C for 4 hours, pass through a 2...

Embodiment 3

[0063] Embodiment 3: tablet core prescription

[0064] Alendronate Sodium 10g

[0065] 30g pregelatinized starch

[0066] Microcrystalline Cellulose 40g

[0067] Sodium carboxymethyl starch 15g

[0068] Micronized silica gel 2.5g

[0069] Magnesium Stearate 2.5g

[0070] 30% ethanol solution appropriate amount

[0071]

[0072] 1000 pieces

[0073] Coating Solution Prescription

[0074] Hypromellose 2g

[0075] Acrylic resin 1.5g

[0076] 30% ethanol solution appropriate amount

[0077] Tween-80 1.25g

[0078] Talc powder 1.25g

[0079]

[0080] 100ml

[0081] The alendronate sodium, pregelatinized starch, microcrystalline cellulose, carboxymethyl starch sodium of prescription quantity are taken by weighing 24 mesh sieves and make it mix homogeneously. Add the prescribed amount of sodium chloride into 30% ethanol solution of 8% povidone and mix evenly, then add the solution into the mixed fine powder o...

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Abstract

The invention relates to an alendronate sodium enteric-coated tablet and a preparation method thereof. The method comprises the following steps of: uniformly mixing alendronate sodium with an auxiliary material in a given proportion and screening; then adding adhesive to prepare a soft material; granulating, drying, straightening and pressing into tablets; preparing enteric-coated liquid for standby; spraying and drying according to conventional coating and packaging respectively to obtain the product. By using the enteric-coated tablet formulation, the defects of the traditional preparation technology are overcome, the simulation of the alendronate sodium to the alimentary canal mucosa in the process of oral administration is reduced or eliminated, and a medicament which can be selected, is relatively safe and is convenient for taking is supplied to patients.

Description

technical field [0001] The invention discloses an alendronate sodium enteric-coated tablet and a preparation method thereof, which are used for treating osteoporosis. Background technique [0002] Osteoporosis is a worldwide health problem that attracts more and more attention. At present, about 200 million people in the world suffer from osteoporosis, and its incidence rate has leapt to the seventh among common diseases and frequently-occurring diseases. At present, my country has entered an aging society, and the prevention and treatment of geriatric diseases, especially osteoporosis, has become an important research topic. Senile osteoporosis is a common and frequently-occurring disease among the elderly, especially postmenopausal women. Therefore, drugs for the treatment of osteoporosis have also attracted attention and attention. [0003] The existing drugs for the prevention and treatment of senile osteoporosis basically fall into two categories, namely calcitonin d...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/663A61P19/10
Inventor 王翰斌王丹
Owner BEIJING HOPE HUGE PHARM SCI
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