Alendronate sodium intestine-sol capsule and preparation method thereof

A technology of alendronate sodium and enteric-coated capsules, applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of hindering osteoporosis patients and inconvenient taking, and achieve good economic and Social benefits, simplifying the production process, and ensuring the effect of drug quality

Active Publication Date: 2011-08-31
JIANGSU SHENLONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] It can be seen that the taking of alendronate sodium preparations under the current conditions is very inconvenient, which hinders the drug from serving the vast number of osteoporosis patients to a certain extent.

Method used

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  • Alendronate sodium intestine-sol capsule and preparation method thereof
  • Alendronate sodium intestine-sol capsule and preparation method thereof
  • Alendronate sodium intestine-sol capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Enteric-coated capsules of alendronate sodium without adding protective agent, hereinafter referred to as capsule 1 #

[0029] The prescription is as follows (1000 capsules):

[0030] Alendronate Sodium 10g

[0031] Starch 80g

[0032] 2% HPMC solution (prepared with 50% ethanol) 30ml

[0033] Magnesium stearate 0.5g

[0034] Preparation process: Alendronate Sodium is passed through a 100-mesh sieve, starch and magnesium stearate are passed through an 80-mesh sieve, and the Alendronate Sodium and starch of the formula quantity are fully mixed; with 2% HPMC solution (with 50% ethanol Preparation) Wet granulation, passing through a 24-mesh sieve to obtain wet granules, drying at 55°C to obtain dry granules; sizing the dry granules through a 20-mesh sieve, adding magnesium stearate, mixing evenly, and filling into enteric-coated capsules , to obtain alendronate sodium enteric-coated capsules.

Embodiment 2

[0035] Example 2 Enteric-coated capsules of alendronate sodium using common technology, hereinafter referred to as capsule 2 #

[0036] The prescription is as follows (1000 capsules):

[0037] Alendronate Sodium 10g

[0038] Microcrystalline Cellulose 80g

[0039] 2% HPMC solution (prepared with 50% ethanol) 30ml

[0040] Acrylic II 9g

[0041] Magnesium stearate 0.5g

[0042] Preparation process: Alendronate sodium is passed through a 100-mesh sieve, microcrystalline cellulose and magnesium stearate are passed through a 80-mesh sieve, and the alendronate sodium and microcrystalline cellulose in the prescribed amount are fully mixed; The solution (prepared with 50% ethanol) is wet granulated, passed through a 24-mesh sieve to obtain wet granules, dried at 55°C to obtain dry granules; coated in a granule coating machine, and the enteric coating solution is polypropylene resin II (made into an aqueous solution with a mass percent concentration of 5%), uniformly sprayed on ...

Embodiment 3

[0043] Embodiment 3 Alendronate sodium enteric-coated capsules of the present invention, hereinafter referred to as capsule 3 #

[0044] The prescription is as follows (1000 capsules):

[0045] Alendronate Sodium 10g

[0046] Starch 80g

[0047] Carbomer 934P 1g

[0048] 2% HPMC solution (prepared with 50% ethanol) 30ml

[0049] Magnesium stearate 0.5g

[0050] Preparation process: pass alendronate sodium through a 100-mesh sieve, starch, carbomer 934P, and magnesium stearate through a 80-mesh sieve, take the formula amount of alendronate sodium and starch and mix well; use 2% HPMC solution (Prepared with 50% ethanol) Wet granulation, passing through a 24-mesh sieve to obtain wet granules, drying at 55°C to obtain dry granules; sizing the dry granules with 20-mesh sieve, adding Carbomer 934P and magnesium stearate , mixed evenly, filled into enteric-coated capsules to obtain alendronate sodium enteric-coated capsules

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Abstract

The invention discloses an alendronate sodium intestine-sol capsule and a preparation method thereof; the intestine-sol capsule comprises the following compositions by weight parts: 10-20 parts of alendronate sodium, 70-100 parts of diluents, 0.5-5 parts of protective agents and 0.5-2 parts of lubricants. The alendronate sodium intestine-sol capsule is particularly added in the protective agents,so as to effectively prevent basic remedy from being released in oral cavity, esophagus and esophagus before reaching the absorption site of the intestinal canal, thereby improving the medicine quality, reducing the adverse reaction and improving the compliance of a patient; the preparation process is simple, the pollution to the environment is reduced by energy consumption and social cost is saved.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to an alendronate sodium enteric-coated capsule and a preparation method thereof. Background technique [0002] Osteoporosis is a common and frequently-occurring disease in middle-aged and elderly people, especially in postmenopausal women. Its prevention and treatment drugs have become the focus of new drug development. Alendronate sodium is a new type of osteoporosis treatment and prevention drug, which belongs to the third generation of bisphosphonate bone resorption inhibitors. [0003] Alendronate Sodium (Alendronate Sodium) chemical name: (4-amino-1-hydroxybutylene)-1,1-diphosphonic acid monosodium salt trihydrate, molecular structure: [0004] [0005] Alendronate was first developed by Istituto Gentili of Italy, and then transferred to Merck of the United States for further development. The foreign trade name is Fosamax. Since the tablet was first launched in Italy i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/663A61K47/38A61K47/36A61K47/32A61P19/10
Inventor 徐成胡传良秦勇金春周自桂景瑞
Owner JIANGSU SHENLONG PHARMA
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