Enteric coated omeprazole pellets capsule and the preparing method thereof

A technology for omeprazole enteric and omeprazole, which is applied in the field of omeprazole enteric-coated micropill capsules and its preparation field, can solve the problems of unsatisfactory stability, accelerated stability test and long-term stability test, and problems. And other issues

Active Publication Date: 2007-09-19
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, it is still not very satisfactory in terms of stability, and there are deficiencies in accelerated stability tests and long-term stability tests

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] This preparation formula is made up of following components: (make 1000 altogether, other embodiment and comparative example all make 1000)

[0042] a. 72.0g of sucrose starch ball core

[0043] b, active drug layer (suspension)

[0044]Omeprazole 20g

[0045] Sodium carboxymethyl starch 0.8g

[0046] Hypromellose 6.3g

[0047] Sodium dihydrogen phosphate 0.9g

[0048] Sodium hydroxide 0.54g

[0049] Polysorbate 80 1.4g

[0050] Talc powder 0.8g

[0051] Purified water 200g

[0052] c, isolation layer (coating solution)

[0053] Hypromellose 10.0g

[0054] Magnesium oxide 4.8g

[0055] Titanium dioxide 2.5g

[0056] Talc powder 9.0g

[0057] Purified water 220g

[0058] d. Enteric coating layer (coating liquid)

[0059] Udrake L30-D55 100.5g

[0060] Talc powder 11.0g

[0061] Triethyl citrate 3.9g

[0062] Purified water 177g

[0063] Preparation:

[0064] 1) Preparation of sucrose starch pellet core: adopt centrifugal coating machine or extrusion sp...

Embodiment 2

[0070] The formulation of this preparation consists of the following components:

[0071] a. Microcrystalline cellulose ball core 55.0g

[0072] b, active drug layer (suspension)

[0073] Omeprazole 10g

[0074] Low-substituted hydroxypropyl methylcellulose 3g

[0075] Sodium Carboxymethyl Cellulose 1.0g

[0076] Sodium Phosphate 2.2g

[0077] Sodium Lauryl Sulfate 3.0g

[0078] Purified water 200g

[0079] c, isolation layer (coating solution)

[0080] Polyvinyl alcohol 4.0g

[0081] Magnesium oxide 2.5g

[0082] Titanium dioxide 1.0g

[0083] Talc powder 8.0g

[0084] Purified water 100g

[0085] d. Enteric coating layer (coating liquid)

[0086] Udrake L30-D55 150g

[0087] Talc powder 23.0g

[0088] Polyethylene glycol 6000 8.0g

[0089] Purified water 300g

[0090] Preparation:

[0091] 1) Preparation of microcrystalline cellulose pellet core: Use centrifugal coating machine or extrusion spheronizer or fluidized bed coating granulator (side spray mode) to...

Embodiment 3

[0097] The formulation of this preparation consists of the following components:

[0098] a. Starch blank ball core 40.0g

[0099] b, active drug layer (suspension)

[0100] Omeprazole 40.0g

[0101] Sodium carboxymethyl starch 0.3g

[0102] Low-substituted hydroxypropyl cellulose 0.3g

[0103] Hypromellose 12.0g

[0104] Disodium hydrogen phosphate 6.0g

[0105] Polysorbate 80 2.4g

[0106] Talc powder 4.0g

[0107] Purified water 250g

[0108] c, isolation layer (coating solution)

[0109] Hypromellose 19.0g

[0110] Magnesium oxide 12.0g

[0111] Titanium dioxide 6.0g

[0112] Talc powder 22.0g

[0113] Purified water 400g

[0114] d. Enteric coating layer (coating solution)

[0115] Udrake L30-D55 135g

[0116] Talc powder 22.0g

[0117] Ethyl citrate 4.5g

[0118] Purified water 270g

[0119]Preparation:

[0120] 1) Preparation of blank starch ball cores: use centrifugal coating machine or extrusion spheronizer or fluidized bed coating granulator (side ...

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Abstract

The invention relates to an omeprazole enteric micropill capsule and a process for preparing the same. The content of the capsule is omeprazole enteric micropill including a blank pill core; an activity medicine layer having an alkaline component; a separator containing magnesia and titanium pigment; and an enteric coat layer. According to synergistic reaction, stability of the medicine is distinctly improved. The omeprazole enteric micropill capsule of the invention has period of validity of the preparation to three years or more.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, in particular to an omeprazole enteric-coated pellet capsule and a preparation method thereof. Background technique [0002] Omeprazole is a proton pump inhibitor anti-ulcer drug, which can treat duodenal ulcer, gastric ulcer and esophagitis, and can eliminate refractory ulcer crisis. Proton pump inhibitors vs histamine H 2 Receptor blockers (such as ranitidine, famotidine) have more powerful and long-lasting acid-suppressing effects, and have excellent curative effect on peptic ulcers and severe esophageal reflux ulcers that cannot be effectively treated by conventional therapy, and the side effects rarely seen. [0003] Omeprazole is not stable and is easily degraded in acidic and neutral media. Its stability is also affected by light, humidity, heat, organic solvents (even in trace amounts). Therefore, it is very important to overcome the weakness of the raw material itself by prescription te...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/36A61K47/38A61K47/30A61K47/02A61P1/04
Inventor 张文伟郭殿武谢纲吴春霞杜九龄郑文
Owner HANGZHOU MINSHENG PHARM CO LTD
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