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A kind of lansoprazole freeze-dried emulsion and preparation method thereof

A lansoprazole freeze-dried emulsion and a technology for lansoprazole are applied in the field of medicine and can solve the problems of low solubility, large blood vessel irritation and the like, and achieve the effects of simple preparation process, low irritation and improved body tolerance

Active Publication Date: 2018-10-02
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the low solubility of lansoprazole in water, the clarity of the preparation of the drug solution and the redissolution of the preparation pose a challenge, lansoprazole is stable under alkaline conditions, so that the pH of the drug solution is higher, and it is less irritating to blood vessels. Big

Method used

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  • A kind of lansoprazole freeze-dried emulsion and preparation method thereof
  • A kind of lansoprazole freeze-dried emulsion and preparation method thereof
  • A kind of lansoprazole freeze-dried emulsion and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] A kind of lansoprazole freeze-dried emulsion, comprises the raw material of following quality: lansoprazole: 30g, mannitol: 45g, glycerol: 300g, poloxamer: 6g, lecithin: 3g, soybean lecithin: 10g, large Soybean oil: 100g.

[0033] A preparation method of lansoprazole freeze-dried emulsion, comprises the steps:

[0034] (1) Dissolve poloxamer, mannitol, and glycerin in 2000ml of water for injection in proportion, stir and mix, and adjust the pH to 10.0 with sodium hydroxide;

[0035] (2) Lecithin, soybean lecithin, and lansoprazole are dissolved in soybean oil in proportion to form an oil phase.

[0036] (3) Slowly add the oil phase into the high-speed stirring water phase, mix evenly with a magnetic stirrer, and then repeatedly homogenize the emulsion to a white uniform emulsion through a high-pressure homogenizer;

[0037] (4) Add 0.1% (w / v) medicinal activated carbon, stir and adsorb for 20 minutes, decarbonize and filter, fill,

[0038] (5) After the filled produc...

Embodiment 2

[0041] A kind of lansoprazole freeze-dried emulsion, comprises the raw material of following quality: lansoprazole: 30g, lactose: 30g, glycerol: 450g, poloxamer: 3g, egg yolk phospholipid: 40g, olive oil: 200g.

[0042] A preparation method of lansoprazole freeze-dried emulsion, comprises the steps:

[0043] (1) Dissolve poloxamer, lactose, and glycerin in 2000ml of water for injection in proportion, stir and mix well, and adjust the pH to 9.2 with potassium hydroxide;

[0044] (2) egg yolk phospholipid and lansoprazole are dissolved in olive oil in proportion to form an oil phase;

[0045] (3) Slowly add the oil phase into the high-speed stirring water phase, mix evenly with a magnetic stirrer, and then repeatedly homogenize the emulsion to a white uniform emulsion through a high-pressure homogenizer;

[0046] (4) Add 0.1% (w / v) medicinal activated carbon, stir and adsorb for 20 minutes, decarbonize and filter, fill,

[0047] (5) After the filled product is put into the fre...

Embodiment 3

[0050] A kind of lansoprazole freeze-dried emulsion, comprises the raw material of following quality: lansoprazole: 30g, sorbitol: 60g, mannitol: 60g, glycerol: 500g, sodium oleate: 30g, egg yolk phospholipid: 20g, soybean lecithin : 40g, castor oil: 200g, fish oil: 100g.

[0051] A preparation method of lansoprazole freeze-dried emulsion, comprises the steps:

[0052] (1) Dissolve sodium oleate, sorbitol, mannitol, and glycerin in 2000ml of water for injection in proportion, stir and mix, and adjust the pH to 8.5 with sodium bisulfite and sodium thiosulfate;

[0053] (2) egg yolk phospholipid, soybean lecithin, lansoprazole are dissolved in castor oil and fish oil in proportion, form oily phase;

[0054](3) Slowly add the oil phase into the high-speed stirring water phase, mix evenly with a magnetic stirrer, and then repeatedly homogenize the emulsion to a white uniform emulsion through a high-pressure homogenizer;

[0055] (4) Add 0.1% (w / v) medicinal activated carbon, sti...

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Abstract

The invention discloses lansoprazole freeze-dried emulsion and a preparation method thereof. The lansoprazole freeze-dried emulsion comprises the following raw materials: lansoprazole, freeze-drying supporting agent, equal expansion agent, aqueous phase surfactant, oil phase surfactant and injection oil in a mass ratio of 1: (1-4): (10-20): (0.1-2): (0.1-2): (3-10). According to the lansoprazole freeze-dried emulsion and the preparation method thereof, the product is high in re-dissolution speed, can be mixed with injection water, NaCl solution, glucose solution or other aqueous solution in a random ratio without precipitation or crystallization, and has good clarity; the preparation is stable, and the stability of the product can be guaranteed under any preservation condition; and the alkalinity of the product is lower than that of similar products, so that the product has low stimulation to blood vessels and can improve the tolerance of the body.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a lansoprazole freeze-dried preparation and a preparation method thereof. Background technique [0002] Lansoprazole [0003] Chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]-sulfinyl]-1H-benzimidazole. [0004] Structural formula: [0005] [0006] Lansoprazole is a proton pump inhibitor. It reduces gastric acid secretion in vivo by acting on the acid pumps of the gastric parietal (oxyntic) cells. For gastric ulcer, duodenal ulcer, acute stress ulcer and acute gastric mucosal lesion with bleeding for which oral therapy is not applicable [1] , Zollinger-Ellison syndrome (gastrinoma), etc., have unique curative effects on stomach diseases such as gastric ulcer and duodenal ulcer. Due to the development of society and the accelerated pace of life, the incidence of gastrointestinal diseases is still increasing year by year, and the drug market for such disease...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/107A61K31/4439A61P1/04
Inventor 吕旭幸王丽云陈洁冯超敏戴兴祥周亚健
Owner ZHEJIANG YATAI PHARMA