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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 the preparation thereof, can solve the problems such as the inability to prevent pH, and achieves the solution of pH drop, good solubility, and complex problems. The effect of dissolution problems

Active Publication Date: 2014-06-18
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] Prescription: the lansoprazole pharmaceutical composition of the present invention comprises components: lansoprazole 15g; edetate disodium 5g; mannitol 5g; sodium sulfite 8g; sodium citrate 15g.

[0023] Weigh the lansoprazole, edetate disodium, mannitol and sodium sulfite of the above weight, mix them with sterile water for injection, adjust the pH value to 12.0 with sodium citrate, decolorize and filter with 0.1% activated carbon, and use 0.22 μm Filtered through a filter membrane, packed in glass bottles according to the preparation specifications under sterile conditions, sent to a freeze dryer for freeze-drying, pre-frozen at -40°C for 8 hours, and then slowly heated up and dried in a low-temperature vacuum for 20 hours to -20°C ℃, continue to heat up to 10 ℃, vacuum-dry for 5 hours, press the cap, and obtain.

Embodiment 2

[0025] Prescription: Lansoprazole pharmaceutical composition of the present invention comprises components: Lansoprazole 10g; Edetate disodium 10g; Mannitol 15g; Sodium sulfite 5g; Sodium citrate 20g.

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

Embodiment 3

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

[0029] Weigh the lansoprazole, edetate disodium, mannitol and sodium sulfite of the above weight, mix them with sterile water for injection, adjust the pH value to 11.8 with sodium citrate, decolorize and filter with 0.1% activated carbon, and use 0.22 μm Filtered through a filter membrane, packed in glass bottles according to the specifications of the preparation under sterile conditions, sent to a freeze dryer for freeze-drying, pre-frozen at -35°C for 8 hours, and then slowly heated up and dried in a low-temperature vacuum for 30 hours to -20°C ℃, continue to heat up to 10 ℃, vacuum-dry for 4 hours, press the cap, and 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, in particular to a pharmaceutical composition containing lansoprazole compound and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug after omeprazole. It is structurally similar to omeprazole. Due to the introduction of fluorine atoms, its chemical stability and therapeutic effect are superior to omeprazole. After the product enters the parietal cells from the blood, it is activated under acidic conditions and binds to the (H+ / K+)-ATPase base of the proton pump, inhibiting the activity of the enzyme and thereby inhibiting acid secretion. Mainly used clinically: ① peptic ulcer bleeding, anastomotic ulcer bleeding. ② Acute gastric mucosal injury complicated by stress state, and acute gastric mucosal injury caused by non-steroidal anti-inflammatory drugs. [0003] The chemical name of Lansoprazole (foreign ...

Claims

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Application Information

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