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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  • Abstract
  • Description
  • Claims
  • Application Information

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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 freeze-dried powder of above-mentioned invention is simple, has no potential safety hazards such as hemolysis, but this kind The reconstitution of the invented product is poor, and visible foreign matter or insoluble particles are produced after reconstitution, which affects the stability of compatibility with infusion in clinical use
[0008] At present, the formula and process of lansoprazole freeze-dried powder do not solve the problems of visible foreign matter and insoluble particles after product reconstitution, which leads to the appearance of a large number of fine particles during clinical infusion compatibility, which can cause Embolism, formation of phlebitis, granuloma, allergic reaction, etc., the risk of clinical application is relatively high, which poses a great threat to the safety of patients' medication

Method used

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

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preparation example Construction

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

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

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

[0044] Sterilize by filtration to obtain a sterile solution;

[0045]S3. Filling and half-tamping: filling the aseptic solution obtained in step S2 into a vial, and half-tightening to obtain a sample solution;

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

[0047] The freeze-drying method is as follows: cool the sample li...

Embodiment 1-9

[0051] The preparation method of embodiment 1-9, comprises the following steps:

[0052] S1. Dosing: 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 The sodium oxide solution adjusts the pH value to 10 to obtain a solution;

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

[0054] Sterilize by filtration to obtain a sterile solution;

[0055] S3. Filling and half-tamping: filling the aseptic solution obtained in step S2 into a vial, and half-tightening to obtain a sample solution;

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

experiment example 1

[0087] Experimental example 1, basic performance

[0088] The lansoprazole freeze-dried powder for injection that each embodiment and comparative example make carries out basic performance detection, adopts observation method to observe the outward appearance character of lansoprazole freeze-dried powder, freeze-dried powder is dissolved in the water for injection Make the injection that concentration is 3.5mg / mL, observe the color of injection, clarity and reconstitution time, and according to the high performance liquid chromatography of Chinese Pharmacopoeia 2010 edition two appendix V D, to lansoprazole freeze-drying Lansoprazole content, impurity content in the powder are measured; According to the moisture determination method of the Chinese Pharmacopoeia 2010 edition two appendix VIII M first method, the moisture in the lansoprazole freeze-dried powder is measured. Simultaneously, buy the freeze-dried powder injection of trade name " lansoprazole for injection " produce...

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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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