A kind of lansoprazole freeze-dried agent for injection and preparation method thereof

A technology of lansoprazole freeze-dried agent and lansoprazole, applied in freeze-dried transportation, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of affecting compatibility stability and reducing product Safety, insoluble particles and other issues, to achieve the effect of improving stability and resolubility, short freeze-drying time, and simple preparation process

Active Publication Date: 2020-06-23
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention can improve the stability and reconstitution of misoprazole freeze-dried preparations, but too many excipients are added in this invention, which increases the risk of clinical use and reduces the safety of the product
[0007] CN105878193A discloses a kind of lansoprazole lyophilized powder for injection, and this lyophilized powder comprises lansoprazole, hydroxyethyl starch, acetamide, sodium hydroxide and water for injection, wherein lansoprazole: hydroxyethyl starch : the weight ratio of acetamide is 2-4: 4-6: 1-3; CN10 9394706A discloses a kind of lyophilized powder of lansoprazole for injection, comprises lansoprazole, mannitol, meglumine, hydroxide Sodium and water for injection, wherein, the mass ratio of lansoprazole, mannitol and meglumine is 3:6:1, and the composition of the lansoprazole fre

Method used

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  • A kind of lansoprazole freeze-dried agent for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0041] The invention also provides a preparation method of the above-mentioned lansoprazole freeze-dried agent for injection, which comprises the following steps:

[0042] S1. Liquid preparation: add water for injection to the formulated amount of lansoprazole, pullulan, histidine and hydroxypropyl-β-cyclodextrin, stir and dissolve, the utilization concentration is 0.2-0.3mol / L Adjust the pH value of the sodium hydroxide solution to 10-11 to obtain a solution;

[0043] S2. Sterilization filtration: pass the dissolved solution with a concentration of 16-20 mg / ml obtained in step S1 through a 0.22 μm filter membrane,

[0044] Filter sterilization to obtain a sterile solution;

[0045] S3. Filling the semi-tightening stopper: filling the sterile solution obtained in step S2 into the vial, half-pressing the stopper to obtain a sample liquid;

[0046] S4. Freeze drying: freeze-drying the sample solution obtained in step S3 to obtain a freeze-dried sample;

[0047] The freeze-drying is: cooli...

Example Embodiment

[0051] The preparation method of Examples 1-9 includes the following steps:

[0052] S1. Liquid preparation: add water for injection to the formulated amount of lansoprazole, pullulan, histidine and hydroxypropyl-β-cyclodextrin, stir and dissolve, and use hydrogen with a concentration of 0.2mol / L Adjust the pH value of sodium oxide solution to 10 to obtain a solution;

[0053] S2. Sterilization filtration: pass the dissolved solution with a concentration of 18mg / ml obtained in step S1 through a 0.22μm filter membrane,

[0054] Filter sterilization to obtain a sterile solution;

[0055] S3. Filling the semi-tightening stopper: filling the sterile solution obtained in step S2 into the vial, half-pressing the stopper to obtain a sample liquid;

[0056] S4. Freeze-drying: freeze-dry the sample solution obtained in step S3, cool the sample solution at 27°C to -42°C within 0.5h, and keep it for 0.5h, warm up to -5°C within 1h, and keep it for 4h, Raise the temperature to 0°C in 12min and ke...

Example Embodiment

[0087] Experimental example one, basic performance

[0088] The basic performance of the freeze-dried lansoprazole powder for injection prepared in each example and comparative example was tested. The appearance of the freeze-dried lansoprazole powder was observed by the observation method, and the freeze-dried powder was dissolved in water for injection. Prepare an injection with a concentration of 3.5 mg / mL, observe the color, clarity and reconstitution time of the injection, and freeze-dry lansoprazole according to the high performance liquid chromatography method in Appendix V D of Part Two of the Chinese Pharmacopoeia 2010 The lansoprazole content and impurity content in the powder were measured; the moisture content in the lansoprazole freeze-dried powder was measured according to the moisture measurement method of the Chinese Pharmacopoeia 2010 edition two appendix Ⅷ M method one. At the same time, the freeze-dried powder injection produced by Takeda Pharmaceutical Industr...

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Abstract

The present invention discloses a lansoprazole freeze-dried agent for injection. The lansoprazole freeze-dried agent comprises the following components: lansoprazole, pullulan, histidine and hydroxypropyl-beta-cyclodextrin. A preparation method comprises the following steps: S1, preparing a solution: adding water for injection into lansoprazole, pullulan, histidine and hydroxypropyl-beta-cyclodextrin according to a formula amount, and after stirring and dissolving, adjusting a pH value by using a sodium hydroxide solution to obtain a dissolved solution; S2, conducting sterilizing and filtering: filtering and sterilizing the dissolved solution obtained in the step S1 to obtain sterile solution; S3, conducting filling and semi-plug-pressing; S4, conducting freeze-drying: freeze-drying the sample solution obtained in the step S3 to obtain a freeze-dried sample; and S5, conducting plug-pressing and capping. The prepared lansoprazole freeze-dried agent for injection fully exerts synergisticinteraction effects among the raw materials, improves stability and re-solubility of the lansoprazole, and improves stability of infusion compatibility in clinical use.

Description

technical field [0001] The invention belongs to the technical field of proton pump inhibitor drugs, relates to a proton pump inhibitor drug and a preparation method thereof, and more particularly relates to a lansoprazole freeze-dried agent for injection and a preparation method thereof. Background technique [0002] Lansoprazole is a representative drug of proton pump inhibitors, the chemical name is 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl] Sulfuryl]-1H-benzimidazole, which can combine with the sulfhydryl group of H+-K+-ATPase at the site of gastric acid generation, inhibit gastric acid secretion by inhibiting the activity of H+-K+-ATPase, and has a negative effect on basic gastric acid secretion and the production of histamine , pentagastrin, dibutylcycloadenoic acid, cholic acid and food, etc. have a strong and lasting inhibitory effect on the formation and secretion of gastric acid, and at the same time have a protective effect on the gastrointestinal mu...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/40A61K47/36A61K47/18A61K31/4439A61P1/04
CPCA61K9/0019A61K9/19A61K31/4439A61K47/18A61K47/36A61K47/40A61P1/04
Inventor 周培育张羽强伍巧吉
Owner 双鹤药业(海南)有限责任公司
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