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A kind of famotidine freeze-dried powder injection

A technology for freeze-dried powder injection and famotidine, which is applied in the field of famotidine freeze-dried powder for injection, can solve the problems of non-compliance with pharmacopoeia regulations, high medication risk, and high cost, and achieves avoiding adsorption influence, good solid forming, and high cost. The effect of reducing water content

Active Publication Date: 2022-07-19
开封康诺药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the cost is also very important. The longer the freeze-drying time and the freeze-drying cycle, the higher the cost, the more excipients are added, the more complicated, the higher the cost, and the greater the risk of medication
[0005] The inspection items of the conventional preparations of famotidine, such as clarity, visible foreign matter and incompatible particles, and related substances, often do not meet the requirements of the Pharmacopoeia during the stability inspection.

Method used

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  • A kind of famotidine freeze-dried powder injection
  • A kind of famotidine freeze-dried powder injection
  • A kind of famotidine freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A famotidine freeze-dried powder for injection, the famotidine freeze-dried powder for injection is prepared by a method comprising the following steps:

[0026] S1. Add 0.44g of aspartic acid to 110.0g of water for injection with a temperature of 70-80°C, keep stirring for 15min to complete dissolution, add famotidine 1.1g and stir to complete dissolution for 15min, then add mannitol 1.1g After stirring for 5min to complete dissolution, add aqueous hydrochloric acid solution with a concentration of 1mol / L to adjust pH=5.0-5.6, then add water for injection to 110ml, and then filter and sterilize through 0.45μm and 0.22μm filters to obtain solution 1;

[0027] S2. Pack the solution 1 into a vial, then quickly freeze to -35°C, and keep the temperature for 120min; then perform sublimation once, and then perform secondary drying, and finally adjust the pressure to 4-5.5MPa for tamponade to obtain famotir Ding freeze-dried powder for injection, wherein, the procedure of one ...

Embodiment 2

[0030] A famotidine freeze-dried powder for injection, the famotidine freeze-dried powder for injection is prepared by a method comprising the following steps:

[0031] S1. Add 0.44g of aspartic acid to 110.0g of water for injection with a temperature of 70-80°C, keep stirring for 15min until completely dissolved, add 1.1g of famotidine and stir until completely dissolved, then add 1.045g of mannitol After stirring for 5min to complete dissolution, add aqueous hydrochloric acid solution with a concentration of 1mol / L to adjust pH=5.0-5.6, then add water for injection to 110ml, and then filter and sterilize through 0.45μm and 0.22μm filters to obtain solution 1;

[0032] S2. Pack the solution 1 into a vial, then quickly freeze it to -37°C, and keep the temperature for 120min; then perform sublimation once, then perform secondary drying, and finally adjust the pressure to 4-5.5MPa for tamponade to obtain famotir Ding freeze-dried powder injection, wherein, the procedure of one s...

Embodiment 3

[0035] A famotidine freeze-dried powder for injection, the famotidine freeze-dried powder for injection is prepared by a method comprising the following steps:

[0036] S1. Add 0.44g of aspartic acid to 110.0g of water for injection with a temperature of 70-80°C, keep stirring for 15min until completely dissolved, add 1.1g of famotidine and stir until completely dissolved, then add 1.155g of mannitol After stirring for 5min to complete dissolution, add aqueous hydrochloric acid solution with a concentration of 1mol / L to adjust pH=5.0-5.6, then add water for injection to 110ml, and then filter and sterilize through 0.45μm and 0.22μm filters to obtain solution 1;

[0037] S2. Pack the solution 1 into a vial, then quickly freeze to -33°C, and keep the temperature for 120 minutes; then perform sublimation once, and then perform secondary drying, and finally adjust the pressure to 4-5.5MPa for tamponade to obtain famotir Ding freeze-dried powder for injection, wherein, the procedur...

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Abstract

The invention discloses a famotidine freeze-dried powder injection, which is prepared according to a method comprising the following steps: S1, taking aspartic acid, famotidine, mannitol, water for injection and pH adjuster to prepare and filter to obtain Solution 1 with pH=5.0-5.6; S2, divide solution 1 into a container, perform quick freezing, then perform sublimation once, then perform secondary drying, and finally press the plug to obtain famotidine freeze-dried powder injection, wherein once The procedure of sublimation is as follows: adjust the degree of vacuum to 20±1Pa, heat up to ‑30±2℃, and keep the temperature for 72min; then heat up to ‑20±2℃, and keep the temperature for 240min; then heat up to ‑10±2℃, and keep the temperature for 120min; finally increase the temperature To ‑5±2℃, keep warm for 120min. The present invention obtains stable, safe and effective famotidine freeze-dried powder injection by selecting a suitable preparation method and combining with a suitable sublimation procedure and secondary drying procedure.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a famotidine freeze-dried powder injection. Background technique [0002] Sterile powder for injection refers to the sterile powder or sterile block of raw drug or with appropriate excipients that can be prepared into injection solution with sterile solution before use, generally prepared by aseptic subpackaging or freeze-drying. have to. It can be prepared by suitable solvent for injection and then injected, or by intravenous infusion and then intravenous drip. The sterile powder for injection prepared by freeze-drying method can also be called lyophilized preparation for injection. [0003] Famotidine has poor solubility and is insoluble in cold water, and its preparations are mostly tablets, rarely sterile injections, and mostly water injections. There are many problems in the water injection of this variety, and its clarity and color are difficult to control; the stabili...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/18A61K31/426
CPCA61K9/19A61K9/0019A61K47/26A61K47/183A61K31/426
Inventor 王伟贾和平王志刚王卓明张倩王沙沙
Owner 开封康诺药业有限公司
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