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Alendronate sodium vitamine D3 enteric-coated tablet and preparation method thereof

A technology of sodium alendronate and vitamins, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, and can solve problems such as poor patient compliance, strong corrosion, and peptic ulcers

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

[0011] However, since the two hydrogen atoms connected to a carbon atom in the structure of alendronate are replaced by two phosphoric acid groups, this type of compound can release more hydrogen atoms, which makes it more corrosive , it is generally believed that when taking this type of drug, some active ingredients will be dissolved, and a higher concentration will be produced on the mucosal surface of the esophagus, resulting in damage to the epithelium and mucosa of the upper gastrointestinal tract, and the patient will feel pain when swallowing, esophagus Burning heat, heartburn, and severe peptic ulcers can occur; in addition, because these compounds are extremely polar, it is difficult to penetrate the epithelial cells of the alimentary canal into the blood, so the bioavailability is low. According to foreign clinical statistics, Alen Compared with aspirin, the incidence of gastrointestinal adverse reactions of sodium phosphonate is even higher than that of aspirin, resulting in poor patient compliance and affecting the efficacy of the drug

Method used

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  • Alendronate sodium vitamine D3 enteric-coated tablet and preparation method thereof
  • Alendronate sodium vitamine D3 enteric-coated tablet and preparation method thereof
  • Alendronate sodium vitamine D3 enteric-coated tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Tablet prescription:

[0029]

[0030] Coating Solution Prescription

[0031] Hypromellose 5g

[0032] Acrylic resin 2.5g

[0033] 30% ethanol solution appropriate amount

[0034] Tween-80 5g

[0035] Talc powder 2g

[0036]

[0037] 100ml

[0038] Take alendronate sodium, vitamin D3, and one or more of pregelatinized starch, microcrystalline cellulose, and lactose, as well as sodium carboxymethyl starch, hydroxypropyl cellulose, and hypromellose One or more of croscarmellose sodium, cross-linked polyvinylpyrrolidone, and cross-linked carmellose sodium, after sieving the above raw materials, mix them evenly, add ethanol solution to the above mixture to make a soft material, pass through 14-30 mesh Sieve to granulate, dry at 50-80°C for 4-6 hours, pass through a 14-30 mesh sieve to granulate, add micronized silica gel or talcum powder and magnesium stearate, mix evenly, and press into tablets. The enteric-coated solution is prepar...

Embodiment 2

[0040] Tablet prescription:

[0041]

[0042] Coating Solution Prescription

[0043] Hypromellose 2.5g

[0044] Acrylic resin 2.5g

[0045]30% ethanol solution appropriate amount

[0046] Tween-80 2.5g

[0047] Talc powder 2.0g

[0048]

[0049] 100ml

[0050] Take alendronate sodium, vitamin D3, and one or more of pregelatinized starch, microcrystalline cellulose, and lactose, as well as sodium carboxymethyl starch, hydroxypropyl cellulose, and hypromellose One or more of croscarmellose sodium, cross-linked polyvinylpyrrolidone, and cross-linked carmellose sodium, after sieving the above raw materials, mix them evenly, add ethanol solution to the above mixture to make a soft material, pass through 14-30 mesh Sieve to granulate, dry at 50-80°C for 4-6 hours, pass through a 14-30 mesh sieve to granulate, add micronized silica gel or talcum powder and magnesium stearate, mix evenly, and press into tablets. The enteric-coated solution i...

Embodiment 3

[0051] Embodiment 3: tablet core prescription

[0052]

[0053]

[0054] Coating Solution Prescription

[0055] Hypromellose 2g

[0056] Acrylic resin 1.5g

[0057] 30% ethanol solution appropriate amount

[0058] Tween-80 1.25g

[0059] Talc powder 1.25g

[0060]

[0061] 100ml

[0062] Take alendronate sodium, vitamin D3, and one or more of pregelatinized starch, microcrystalline cellulose, and lactose, as well as sodium carboxymethyl starch, hydroxypropyl cellulose, and hypromellose One or more of croscarmellose sodium, cross-linked polyvinylpyrrolidone, and cross-linked carmellose sodium, after sieving the above raw materials, mix them evenly, add ethanol solution to the above mixture to make a soft material, pass through 14-30 mesh Sieve to granulate, dry at 50-80°C for 4-6 hours, pass through a 14-30 mesh sieve to granulate, add micronized silica gel or talcum powder and magnesium stearate, mix evenly, and press into ...

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PUM

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Abstract

The invention relates to an alendronate sodium vitamine D3 enteric-coated tablet and a preparation method thereof. The method comprises the following steps of: uniformly mixing alendronate sodium, vitamine D3 and an auxiliary material in a given proportion and screening; then adding adhesive to prepare a soft material; granulating, drying, straightening and pressing into tablets; then preparing enteric-coated liquid for standby; spraying and drying according to conventional coating and packaging respectively to obtain the product. The invention provides the treating selection of a medicament which is dissolved and released in the intestines to prevent gastrointestinal tract influence for a patient with osteoporosis, can meet the clinical requirement of long-term medicament use and achieve the aims of reducing taking frequency and toxic and side effect, generating synergistic effect and improving bioavailability and is suitable for industrialized production.

Description

technical field [0001] The invention discloses an alendronate sodium vitamin D3 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 c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/663A61K31/593A61P19/10
Inventor 王翰腾王翰斌
Owner BEIJING HOPE HUGE PHARM SCI
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