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Medicinal pantoprazole sodium composition granules for treating digestive system diseases

A technology for digestive system diseases and pantoprazole sodium, which is applied in the field of medicine, can solve the problems of unsatisfactory dissolution rate and stability of liquid enteric-coated capsule preparations, and achieve simple components, high bioavailability and good stability Effect

Inactive Publication Date: 2015-10-07
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] ZL201310093503.3 Pantoprazole sodium crystalline compound, pharmaceutical composition and preparation method thereof The present invention provides a new pantoprazole sodium crystalline compound, its pharmaceutical preparations, especially enteric-coated capsules, and their preparation methods, the present invention The chemical stability of the pantoprazole sodium crystal compound is better, the solubility is better, the safety of the drug is improved, the long-term storage of the drug is beneficial, and the clinical application of the drug provides a safety guarantee, but its pantoprazole sodium crystal The fluidity of the compound and the dissolution rate and stability of the prepared enteric-coated capsule preparation are not ideal

Method used

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  • Medicinal pantoprazole sodium composition granules for treating digestive system diseases
  • Medicinal pantoprazole sodium composition granules for treating digestive system diseases
  • Medicinal pantoprazole sodium composition granules for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Preparation of Pantoprazole Sodium Crystals

[0030] (1) Add the crude product of pantoprazole sodium to a mixed solution of water and acetonitrile whose volume is 4 times the weight of pantoprazole sodium, the volume ratio of water and acetonitrile is 3:1, heat up to 30°C, and stir until completely dissolved;

[0031] (2) Under a sound field with a frequency of 30KHz and an output power of 45W, add a mixed solution of ethanol, chloroform and cyclohexane whose volume is 8 times the weight of pantoprazole sodium while stirring, ethanol, chloroform, The volume ratio of cyclohexane is 1:4:1, the stirring speed is 150 rpm, and the addition speed is 100 ml / min;

[0032] (3) After adding the mixed solution of ethanol, chloroform, and cyclohexane, under a sound field with a frequency of 25KHz and an output power of 40W, cool down to -5°C at 10°C / hour, grow crystals for 2 hours, and wash. Vacuum-dried to obtain pantoprazole sodium compound.

[0033] The X-ray po...

Embodiment 2

[0034] Example 2: The preparation of pantoprazole sodium granules:

[0035] Prescription: in parts by weight, 0.4 parts of pantoprazole sodium crystal form compound prepared in Example 1, 1.7 parts of mannitol, 0.5 part of sorbitol, 0.02 part of polacrilin potassium, 0.07 part of potassium bicarbonate, 0.005 part of sodium saccharin parts, 0.8 parts of absolute ethanol.

[0036] Preparation:

[0037] 1) Processing of raw and auxiliary materials: use a pulverizer to pulverize pantoprazole sodium through a 100-mesh sieve;

[0038] 2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0039] 3) Mixing and granulation: add the prescribed amount of pantoprazole sodium, mannitol, sorbitol, polacrilin potassium, potassium bicarbonate, and sodium saccharin into the wet mixing granulator, and turn on the stirring motor to dry mix for 10 minutes , add the prescribed amount of absolute ethanol, wet mix for 100-130 seconds to make soft m...

Embodiment 3

[0043] Example 3: The preparation of pantoprazole sodium granules:

[0044]Prescription: in parts by weight, 0.4 parts of pantoprazole sodium crystal form compound prepared in Example 1, 1.8 parts of mannitol, 0.7 part of sorbitol, 0.03 part of polacrilin potassium, 0.08 part of potassium bicarbonate, 0.01 part of sodium saccharin part, 1 part of absolute ethanol.

[0045] Preparation:

[0046] 1) Processing of raw and auxiliary materials: use a pulverizer to pulverize pantoprazole sodium through a 100-mesh sieve;

[0047] 2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0048] 3) Mixing and granulation: add the prescribed amount of pantoprazole sodium, mannitol, sorbitol, polacrilin potassium, potassium bicarbonate, and sodium saccharin into the wet mixing granulator, and turn on the stirring motor to dry mix for 10 minutes , add the prescribed amount of absolute ethanol, wet mix for 100-130 seconds to make soft materia...

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Abstract

The invention relates to medicinal pantoprazole sodium composition granules for treating digestive system diseases, and belongs to the technical field of medicaments. The medicinal composition granules are prepared from pantoprazole sodium, mannitol, sorbitol, polacrilin potassium, potassium hydrogen carbonate, saccharin sodium and anhydrous ethanol. The pantoprazole sodium is a new crystal compound, the X-ray powder diffraction diagram obtained by Cu-Ka ray measurement is shown as Figure. 1, the pantoprazole sodium is different from the one reported in the prior art, tests discover that the new crystal compound has good flowability and stability, and the granules prepared from the new crystal pantoprazole sodium compound are simple in component, greatly reduce adverse response and are good in stability and high in bioavailability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pantoprazole sodium composition granule for treating digestive system diseases. Background technique [0002] Pantoprazole sodium is a proton pump inhibitor, through H + -K + The covalent binding of two sites in the ATPase system inhibits the final step in gastric acid production. This effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. h + -K + The binding of ATPase can cause its antisecretory effect to last for more than 24 hours. Pantoprazole sodium is the third proton pump inhibitor listed after omeprazole and lansoprazole. Because the substituent groups of pantoprazole sodium on the pyridine ring and benzimidazole ring are different from those of omeprazole and lansoprazole, thus determining the difference in its biochemical, pharmacokinetic and pharmacological properties , making it more selective and specific. [0003] In the pr...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4439A61P1/04C07D401/12
Inventor 王贵宾
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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