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Dirithromycin enteric-coated formulation

A technology of dirithromycin and enteric-coated preparations, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., which can solve the problem of drug dissolution rate decline, increased process difficulty, and damaged process. issues of continuity

Inactive Publication Date: 2009-08-12
SHANDONG INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Patent 200510136661.8 discloses a dirithromycin enteric-coated pellet and its preparation method, wherein the disclosed enteric layer coating material is acrylic resin, the main disadvantage of this technical solution is that special attention should be paid to the dosage when using the coating material , once the coating is excessive, it will easily lead to a decrease in the drug dissolution rate, and in order to make the coating amount suitable, not only rely on experience alone, but also conduct acid resistance tests to determine the appropriate coating amount, which increases the difficulty of the process and destroys the process. continuity
[0004] Patent 200810069467.6 discloses an enteric-coated capsule of erythromycin and its preparation method, wherein acrylic resins are still used in the disclosed coating liquid, and this technical solution also has the same problem as patent 200510136661.8

Method used

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  • Dirithromycin enteric-coated formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Dirithromycin core prescription:

[0030] Raw material name dosage

[0031] Dirithromycin 125g

[0032] HPMCP 5g

[0033] 80% ethanol 100ml

[0034] Gown Prescription:

[0035] HPMC (3cap) 2.5g

[0036] Triethyl citrate 0.25g

[0037] 80% ethanol 100ml

[0038] Enteric coating prescription:

[0039] HPMCP 7.5g

[0040] Diethyl phthalate 0.75g

[0041] 80% ethanol 125ml

[0042] The preparation method of dirithromycin enteric-coated pellets is as follows:

[0043] Preparation of drug-containing pellet cores:

[0044] Slowly add HPMCP into 100ml of 80% ethanol with a stirring device, and keep stirring until it dissolves into a clear solution as a binder.

[0045] Grind and sieve 125 g of dirithromycin, and use the solution as a binder to make a suitable soft material. Start the extrusion and spheronization equipment, select the aperture of the sieve plate to be 0.8 mm, and rotate at 4000 rpm, extrude and spheronize, and dry the obtained pellets. Pass the obt...

Embodiment 2

[0052] Dirithromycin core prescription:

[0053] Name Dosage

[0054] Dirithromycin 250g

[0055] HPMCP 8g

[0056] 80% ethanol 160ml

[0057] Gown Prescription:

[0058] HPMC (5cap) 2.5g

[0059] PEG400 2.5g

[0060] Talc powder 7.5g

[0061] 80% ethanol 250ml

[0062] Enteric coating prescription:

[0063] HPMCP 20g

[0064] Triethyl citrate 2g

[0065] 80% ethanol 330ml

[0066] The preparation method of dirithromycin enteric-coated pellets is as follows:

[0067] Preparation of drug-containing pellet cores:

[0068] Take 8g of HPMCP and slowly add it into 160ml of 80% ethanol with a stirring device, and keep stirring until it dissolves into a clear solution, as a binder.

[0069] 250g of dirithromycin was crushed and sieved, and the solution was used as a binder to make a suitable soft material. Start the extrusion and spheronization equipment, select the aperture of the sieve plate to be 1mm, and the rotating speed is 4000 rpm, extrude and spheronize, and dry ...

Embodiment 3

[0075] Dirithromycin core prescription:

[0076] Raw material name dosage

[0077] Dirithromycin 250g

[0078] HPMCP 8g

[0079] 80% ethanol 150ml

[0080] Gown Prescription:

[0081] HPMC (3cap) 2.5g

[0082] Propylene glycol 2.5g

[0083] 80% ethanol 100ml

[0084] Enteric coating prescription:

[0085] HPMCP 25g

[0086] Diethyl phthalate 2.5g

[0087] 80% ethanol 416ml

[0088] The preparation method of dirithromycin enteric-coated pellets is as follows:

[0089] Preparation of drug-containing pellet cores:

[0090] Take 8g of HPMCP and slowly add it into 150ml of 80% ethanol with a stirring device, and keep stirring until it dissolves into a clear solution, as a binder.

[0091] 250g of dirithromycin was crushed and sieved, and the solution was used as a binder to make a suitable soft material. Start the extrusion and spheronization equipment, select the aperture of the sieve plate to be 0.8 mm, and rotate at 4000 rpm, extrude and spheronize, and dry the obta...

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Abstract

The invention relates to a dirithromycin (DRM) enteric preparation with hydroxypropyl methylcellulose phthalate (HPMCP) being the framework material of drug-containing core and the coating material of an enteric coating layer. The enteric preparation has the advantages that the drug content is higher, the drug dissolution rate is less affected by the coating material, the preparation cost is low and the preparation process is simple.

Description

technical field [0001] The invention relates to an enteric-coated preparation of macrolide antibiotic dirithromycin. Background technique [0002] Dirithromycin is a derivative of erythromycin, which belongs to macrolide antibiotics. It is suitable for patients over 12 years old with various infections caused by sensitive bacteria. It has excellent curative effect and is safe and reliable. Dirithromycin was originally listed in the form of ordinary tablets, but because it is very sensitive to acidic media, it is destroyed in a short period of time in gastric juice, and dirithromycin and its decomposition products are easy to cause gastrointestinal reactions. In the alkaline environment of intestinal fluid, dirithromycin is relatively stable and easy to absorb. In order to solve this problem, domestic manufacturers have successively developed dirithromycin enteric-coated tablets, enteric-coated capsules and other varieties. [0003] Patent 200510136661.8 discloses a dirithro...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/48A61K31/706A61K47/38A61P31/04
Inventor 张曼红张文张岱州王功霞
Owner SHANDONG INST OF PHARMA IND
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