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Lansoprazole medicine composition used for injection

A technology of lansoprazole and composition, applied in the field of lansoprazole pharmaceutical composition for injection and preparation thereof, can solve the problems of low bioavailability, slow oral absorption, inability to high temperature sterilization and the like

Inactive Publication Date: 2012-06-27
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Lansoprazole is unstable under acidic conditions, is easily destroyed in gastric acid, and oral absorption is slower after making tablet or capsule, and bioavailability is low, thereby needs to be prepared into injection, but because lansoprazole The solution has poor stability and cannot be sterilized at high temperature, so its injection can only be prepared by freeze-drying

Method used

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  • Lansoprazole medicine composition used for injection
  • Lansoprazole medicine composition used for injection
  • Lansoprazole medicine composition used for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Lansoprazole 30g

[0069] Mannitol 30g

[0070] Sodium hydroxide 5g

[0071] Water for injection up to 2L

[0072] Made into 1000

[0073] The preparation process is:

[0074] 1) Add the prescription amount of sodium hydroxide and mannitol to 80% of the prepared amount of water for injection. The water for injection must be cooled to below 20°C in advance. While stirring, slowly add the prescription amount of lansoprazole to make it completely dissolved. Make its pH value between 10.0-11.5;

[0075] 2) Add medicinal charcoal to the prepared solution in step 1) according to the volume of the drug solution at 0.05-0.1% g / ml, stir for 15 minutes, and filter;

[0076] 3) Determination of intermediate content;

[0077] 4) According to the determination result of the intermediate content, adjust the filling quantity, filling and semi-stopping;

[0078] 5) Put the filled glass bottle into a freeze-drying box that has been cooled to 0°C, quickly cool to -40°C, keep warm and freeze for 3 hour...

Embodiment 2

[0081] Lansoprazole 60g

[0082] Mannitol 60g

[0083] Sodium hydroxide 10g

[0084] Water for injection up to 3L

[0085] Made into 1000

[0086] The preparation process is:

[0087] 1) Add the prescription amount of sodium hydroxide and mannitol to 80% of the prepared amount of water for injection. The water for injection must be cooled to below 20°C in advance. While stirring, slowly add the prescription amount of lansoprazole to make it completely dissolved. Make its pH value between 10.0-11.5;

[0088] 2) Add medicinal charcoal to the prepared solution in step 1) according to the volume of the drug solution at 0.05-0.1% g / ml, stir for 15 minutes, and filter;

[0089] 3) Determination of intermediate content;

[0090] 4) According to the determination result of the intermediate content, adjust the filling quantity, filling and semi-stopping;

[0091] 5) Put the filled glass bottle into a freeze-drying box that has been cooled to 0°C, quickly cool to -40°C, keep warm and freeze for 3 hou...

experiment example 1

[0094] This test example is a screening experiment of preparation temperature. The component process parameters are the same as in Example 1. Different concentrations of injection preparation temperature are selected for preparation. The related substances of esomeprazole sodium and the color of the solution are used as the inspection indicators:

[0095] Process: Different temperatures are used in the dissolution process and placed at a constant temperature for 4 hours to investigate the changes in related substances:

[0096]

[0097] It can be seen from the test results that as the preparation temperature increases, the single largest impurity and total impurities both increase significantly. Only when the preparation temperature is 15±5℃, it meets the requirements.

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Abstract

The invention aims at providing a lansoprazole lyophilized medicine composition used for injection. According to the invention, lansoprazole is dissolved in a solution of sodium hydroxide and mannitol; the obtained solution is lyophilized, such that the medicine composition is obtained. In the medicine composition, a weight ratio of lansoprazole:mannitol:sodium hydroxide is 2-8.5:2-8.5:1, and preferably 6:6:1. The medicine composition is advantaged in simple formula and small amount of auxiliary materials. Therefore, side effects caused by excess dosages of auxiliary materials are overcome; a lyophilization time is greatly reduced, such that unnecessary energy consumption is saved. Therefore, the lansoprazole medicine composition has certain competitive strength in markets.

Description

[0001] Technical field [0002] The present invention is a pharmaceutical technology field, which involves the specifically for injection and preparation methods. Background technique [0003] The average incidence of gastrointestinal diseases in my country is 11.43%, and the incidence of residents in Shanghai is as high as 30.23%, accounting for the second place for common diseases and extra occurrences of residents in Shanghai; the incidence of gastrointestinal diseases in the United States is 10%, and women are 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%; Japan is 5%. ~ 10%; Germany is 12.3%. [0004] Lanzozole is a proton pump inhibitor.After the acidic environment of the gastric mucosal wall cells is distributed, it transforms into an active metabolites.This metabolites are combined with the binding of the H+, K+-TP enzymes that exist in the acid generated site to inhibit acid secretion by inhibiting the activity...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4439A61P1/04
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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