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Drug composition containing lansoprazole compound and preparation method of drug composition

A technology of lansoprazole and composition, which is applied in the field of pharmaceutical compositions containing lansoprazole compounds and their preparation, can solve the problems such as inability to prevent pH, and achieves the solution of pH drop, good solubility, and synergistic increase. obvious effect

Active Publication Date: 2013-04-17
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Therefore, the method of adding EDTA complexing agent in the prior art cannot fundamentally solve the problem of insoluble particles being separated out when the lansoprazole injection is redissolved, and adding macromolecular substances such as polyethylene glycol cannot fundamentally solve the problem of lansoprazole injection. The problem of precipitation of insoluble particles during the reconstitution of prazole injection, because these substances cannot prevent the pH drop of the strongly alkaline lansoprazole solution during production or use

Method used

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  • Drug composition containing lansoprazole compound and preparation method of drug composition
  • Drug composition containing lansoprazole compound and preparation method of drug composition
  • Drug composition containing lansoprazole compound and preparation method of drug composition

Examples

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Effect test

Embodiment 1

[0022] Formulation: the lansoprazole pharmaceutical composition of the present invention includes components: 15 g of lansoprazole; 5 g of disodium edetate; 5 g of mannitol; 8 g of sodium sulfite; and 15 g of sodium citrate.

[0023] Weigh the above weight of lansoprazole, disodium edetate, mannitol and sodium sulfite, mix with sterile water for injection, adjust the pH value to 12.0 with sodium citrate, decolorize and filter with 0.1% activated carbon, use 0.22 μm Filter through the filter membrane, pack it into glass bottles according to the preparation specifications under sterile parts, send it to a freeze dryer for freeze drying, pre-freeze at -40°C for 8 hours, and then slowly heat up and dry at low temperature for 20 hours to -20°C. °C, continue to heat up to 10 °C, vacuum dry for 5 hours, and press the lid to get it.

Embodiment 2

[0025] Formulation: the lansoprazole pharmaceutical composition of the present invention includes components: 10 g of lansoprazole; 10 g of disodium edetate; 15 g of mannitol; 5 g of sodium sulfite; and 20 g of sodium citrate.

[0026] Weigh the above weight of lansoprazole, disodium edetate, mannitol and sodium sulfite, mix with sterile water for injection, adjust the pH value to 11.5 with sodium citrate, decolorize and filter with 0.1% activated carbon, use 0.22 μm Filtered through the filter membrane, packed in glass bottles according to the preparation specifications under sterile parts, sent to a freeze dryer for freeze-drying, pre-freeze at -45°C for 7 hours, and then slowly heated up at low temperature for vacuum drying for 30 hours to -20°C °C, continue to heat up to 10 °C, vacuum dry for 3 hours, and press the lid.

Embodiment 3

[0028] Formulation: the lansoprazole pharmaceutical composition of the present invention includes components: 15 g of lansoprazole; 8 g of disodium edetate; 1 g of mannitol; 10 g of sodium sulfite; and 30 g of sodium citrate.

[0029] Weigh the above weight of lansoprazole, disodium edetate, mannitol and sodium sulfite, mix with sterile water for injection, adjust the pH value to 11.8 with sodium citrate, decolorize and filter with 0.1% activated carbon, use 0.22 μm Filtered through the filter membrane, packed in glass bottles according to the preparation specifications under sterile parts, sent to a freeze dryer for freeze-drying, pre-frozen at -35°C for 8 hours, and then slowly heated up at low temperature for vacuum drying for 30 hours to -20°C °C, continue to heat up to 10 °C, vacuum dry for 4 hours, and press the lid to obtain.

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Abstract

The invention discloses a drug composition containing a lansoprazole compound, which comprises the following raw materials in parts by weight: 10-20 parts of lansoprazole, 1-10 parts of edetate disodium, 1-20 parts of mannitol, 5-10 parts of sodium sulfite and 10-30 parts of sodium citrate. According to the drug composition, a pH regulator sodium citrate is screened out by a large number of tests and compounded with a stabilizing agent edetate disodium, the synergistic interaction is obvious; decrease of a pH value of strongly basic lansoprazole solution during production or a lyophilized agent during storage can be avoided well; therefore, re-dissolution of the lansoprazole lyophilized agent can be well avoided; and the solubility is good. The drug composition does not go bad and is not oxidized in a storage process, and the administration safety is ensured.

Description

technical field [0001] The invention belongs to the technical field of medicine, and particularly relates to a pharmaceutical composition containing a lansoprazole compound and a preparation method thereof. Background technique [0002] Lansoprazole is the second proton pump inhibitor-type anti-ulcer drug after omeprazole, similar in structure to omeprazole, due to the introduction of fluorine atoms, its chemical stability and therapeutic effect. are better than omeprazole. After entering the parietal cells from the blood, this product is activated under acidic conditions and binds to the base of the (H+ / K+)-ATPase of the proton pump, inhibiting the activity of the enzyme and thus inhibiting acid secretion. Mainly used in clinical: ① peptic ulcer bleeding, anastomotic ulcer bleeding. ② Acute gastric mucosal damage complicated by stress state, and acute gastric mucosal damage caused by non-steroidal anti-inflammatory drugs. [0003] The chemical name of the lansoprazole (f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/4439A61K47/18A61K47/12A61P1/04
Inventor 罗诚
Owner 罗诚
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