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Hydrochloride loratadine enteric-coated formulation composition and method for preparing the same

A technology for loratadine hydrochloride and enteric-coated preparations, applied in the field of medicine, can solve problems such as no reports on the composition of enteric-coated preparations of loratadine hydrochloride, achieve the controllability and stability of the preparation process, avoid disgusting effect

Inactive Publication Date: 2009-08-12
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] According to the search results of relevant patents and prior art literature, there are no relevant reports on the composition of loratadine hydrochloride enteric-coated preparations

Method used

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  • Hydrochloride loratadine enteric-coated formulation composition and method for preparing the same
  • Hydrochloride loratadine enteric-coated formulation composition and method for preparing the same
  • Hydrochloride loratadine enteric-coated formulation composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Enteric-coated tablets

[0023] prescription:

[0024]

[0025] Preparation Process:

[0026] Pass loratadine hydrochloride, lactose, sodium carboxymethyl starch, microcrystalline cellulose, and magnesium stearate through an 80-mesh sieve respectively for later use, weigh lactose, sodium carboxymethyl starch, and microcrystalline cellulose according to the prescription After mixing in a mixer, mix with loratadine hydrochloride in equal increments, add an appropriate amount of 5% polyvinylpyrrolidone aqueous solution, granulate, granulate, dry at 50°C for 30 minutes, and add prescription amount of magnesium stearate to the dry granules Mix evenly, pass through a 16-mesh sieve with a swinging granulator, measure the content of the granules, determine the weight range of the tablet, press the tablet, and prepare the enteric material polyvinyl acetate phthalate with 65% ethanol acetone solution The coating powder of ester is used for preparing enteric-coating solution,...

Embodiment 2

[0029] Enteric-coated capsules

[0030] prescription:

[0031]

[0032] Preparation Process:

[0033] Pass loratadine hydrochloride, microcrystalline cellulose and starch through 80-mesh sieve respectively, weigh microcrystalline cellulose and starch according to the prescription amount, mix them in a mixer, and then mix them with loratadine hydrochloride in equal increments , add an appropriate amount of 50% ethanol solution to make soft materials, granulate in a granulator, dry the granules at 45°C for 30 minutes, and then pass through a swing granulator and granulate with a 20-mesh screen. The content of the mixed granules is determined, and the filling capacity of the enteric-coated capsule shell is determined. After passing the inspection, pack.

[0034] The loratadine hydrochloride enteric-coated capsules prepared by the above-mentioned method meet the requirements of the relevant testing items specified in the "Chinese Pharmacopoeia 2005 Edition Part Two" "General...

Embodiment 3

[0036] Enteric-coated pellets and capsules

[0037] Prescription: Su Micropills

[0038]

[0039] Prescription: enteric coating solution

[0040] 4 parts talcum powder

[0041] Titanium dioxide 6 parts

[0042] Polyacrylic resin II 20 parts

[0043] Polyacrylic resin III 10 parts

[0044] Tween 80 1.5 parts

[0045] 3 parts propylene glycol

[0046] 50% ethanol solution appropriate amount

[0047] Preparation Process:

[0048] Pass loratadine hydrochloride, lactose, microcrystalline cellulose, and magnesium stearate through a 120-mesh sieve respectively, weigh lactose, microcrystalline cellulose, and magnesium stearate according to the prescription amount of vegetarian pellets, put them in a mixer and mix them. Mix with loratadine hydrochloride in equal increments, place in a centrifugal granulator, spray an appropriate amount of 50% ethanol solution to make plain pellets, and prepare a coating solution for the plain pellets according to the enteric coating solution...

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PUM

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Abstract

The invention discloses a lorapadine hydrochloride enteric preparation combination and a preparation method thereof. The lorapadine hydrochloride enteric preparation combination is mainly prepared from lorapadine hydrochloride bulk drugs and appropriate auxiliary materials. Compared with the common lorapadine hydrochloride preparations, the lorapadine hydrochloride enteric preparation provided by the invention has the advantages that the lorapadine hydrochloride enteric preparation is less irritant to the stomach, thereby reducing the adverse reactions. The lorapadine hydrochloride enteric preparation combination is particularly suitable for patients with stomach-upset diseases. The invention provides a novel form of drug featuring higher safety and better curative effect and having the advantages of high quality controllability and stability of the preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a loratadine hydrochloride enteric-coated preparation composition and a preparation method thereof. Background technique [0002] Loratadine hydrochloride is a long-acting tricyclic antihistamine, which can relieve nasal or non-nasal symptoms of seasonal allergic rhinitis by selectively antagonizing peripheral H1 receptors. It is currently in the category of non-prescription drug management. According to reports, loratadine hydrochloride is rapidly absorbed orally and takes effect in 45 minutes. It is currently the fastest-acting antihistamine, and the action time is as long as 18 to 24 hours. The protein binding rate is 97-99%. It is a powerful and long-acting new type of antihistamine with high affinity to peripheral H1 receptors and is difficult to penetrate the blood-brain barrier, so it has no central inhibitory effect. [0003] This product is used to relieve symptoms asso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545A61K9/00A61K9/48A61P37/08A61P11/02
Inventor 贺同庆贾法强安英张慧英张玲玲
Owner 山东淄博新达制药有限公司
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