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Compound omeprazole capsule and preparation method thereof

A technology of omeprazole and capsules, which is applied in the field of compound omeprazole capsule preparations and its preparation, can solve the problems of insignificant therapeutic effect, easy rebound, large toxic and side effects, etc., and achieve good therapeutic effect, easy absorption and effective effect fast effect

Active Publication Date: 2014-05-21
仁和堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its purpose is to solve the problem of treating gastric ulcer, overcoming the problem that the Western medicine omeprazole is easy to rebound, has large toxic and side effects, and the treatment effect is not significant, and achieves the purpose of treating both symptoms and root causes

Method used

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  • Compound omeprazole capsule and preparation method thereof
  • Compound omeprazole capsule and preparation method thereof
  • Compound omeprazole capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A compound omeprazole capsule, which is prepared from omeprazole, sodium bicarbonate, croscarmellose sodium, sodium stearyl fumarate and concentrated Chinese herbal medicine paste; the preparation method is as follows:

[0022] 1) Preparation of material A: Weigh 40 g of omeprazole, 1100 g of sodium bicarbonate, and 34 g of croscarmellose sodium, and mix to obtain material A;

[0023] 2) Preparation of Chinese herbal medicine concentrated ointment: Take 100g of tangerine peel, 80g of Codonopsis pilosula, 65g of pinellia, and 45g of Atractylodes macrocephala, mix them, then heat and reflux with 70% ethanol for 3 hours, control the temperature at 80°C, filter, recover ethanol from the filtrate, and then concentrate to obtain a concentrated ointment , the temperature of the concentration process is controlled at 60°C, and the density of the concentrated paste is controlled at 1.2g / ml;

[0024] 3) Granulation: Stir and mix the material A and the concentrated paste evenly, t...

Embodiment 2

[0026] Example 2 Compatibility study:

[0027] Type: ① Omeprazole

[0028] ② Compound raw materials (omeprazole + sodium bicarbonate + traditional Chinese medicine)

[0029] ③ Croscarmellose Sodium

[0030] ④Sodium stearyl fumarate

[0031] ⑤Excipient blank (croscarmellose sodium + sodium stearyl fumarate 1:1)

[0032] Stakeout: (1) ① Omeprazole

[0033] (2) ② Compound raw materials (omeprazole + sodium bicarbonate + traditional Chinese medicine)

[0034] (3) ② compound raw material + ③ croscarmellose sodium (20:1)

[0035] (4) ② compound raw material + ④ sodium stearyl fumarate (20:1)

[0036] (5) ② compound raw material + ⑤ auxiliary material blank (20:1)

[0037] (6)⑤Auxiliary material blank

[0038] Stakeout conditions: Place 1 to 6 samples in strong light (4500±500Lux), high temperature (60°C) and high humidity (90%) for 10 days, and use HPLC to check the content and presence of related substances before and after placement Changes, while observing changes in app...

Embodiment 3

[0047] 1. Acute Toxicity Study

[0048] 20 Kunming female mice were selected and administered the drug of Example 1 of the present invention by oral gavage once, and the gavage dose was 50 times of the intended clinical dosage. After the administration, the mice showed a slight decrease in activity and returned to normal in about 1 hour. After the administration was observed continuously for 7 days, no animal died. Their general conditions, diet, water intake, urination and weight growth were normal, and no obvious acute symptoms appeared. Toxic reactions did not cause animal death. The above experimental results suggest that the drug has low acute toxicity and is safe for clinical use.

[0049] 2. Pharmacological research

[0050] Take 45 healthy Wistar rats, weighing 180±20g, 26 females and 19 males. Divide into 3 groups at random according to body weight, gender, the medicine group of embodiment 1 of the present invention, omeprazole group (Zhejiang Asia-Pacific Pharmace...

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Abstract

The invention relates to a compound omeprazole capsule and a preparation method thereof. The capsule is prepared from omeprazole, sodium bicarbonate, crosslinked sodium carboxymethylcellulose, sodium stearyl fumarate, and traditional Chinese medicinal herbal concentrated extracts. The invention also discloses a preparation method of the compound omeprazole capsule. The compound omeprazole capsule can treat both symptoms and root causes of gastric ulcer, and has advantages of good dissolution and powder fluidity, has low toxic and adverse effects, is easily absorbed by human body, and has wide application prospects.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a compound omeprazole capsule preparation and a preparation method thereof Background technique [0002] Peptic ulcer refers to the tissue damage of the gastrointestinal mucosa beyond the muscularis mucosa caused by the digestion of gastric digestive juice itself. It can occur in any part of the digestive tract, among which the stomach and duodenum are the most common, namely gastric ulcer and duodenum The etiology, clinical symptoms and treatment methods of digital ulcers are basically similar, and the definite diagnosis mainly depends on gastroscopy. Gastric ulcer is the most common type of peptic ulcer. It mainly refers to the tissue damage beyond the muscularis mucosa caused by the gastric mucosa being digested by the gastric digestive juice itself. About 6% of people in the world have suffered from this disease. [0003] Omeprazole has opened up a new way of action for the t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8888A61K9/48A61P1/04A61K31/4439
Inventor 林凡友
Owner 仁和堂药业有限公司
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