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Composition of proton pump inhibitor, and preparation method of composition

A technology for injections and osmotic pressure regulators, which can be used in drug combinations, drug delivery, pharmaceutical formulations, etc., and can solve problems such as increasing safety risks

Pending Publication Date: 2021-09-07
广东东阳光药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above literature, in order to increase the solubility of the active ingredient Vonorasan fumarate, a variety of excipients are added to the formulation to increase the stability of the solution, or reconstitution is required in clinical use, which increases the safety risk of the drug

Method used

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  • Composition of proton pump inhibitor, and preparation method of composition
  • Composition of proton pump inhibitor, and preparation method of composition
  • Composition of proton pump inhibitor, and preparation method of composition

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Experimental program
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Embodiment Construction

[0020] The invention aims to provide an injection that can be used directly without reconstitution and has good stability.

[0021] Based on the deficiencies in the prior art, the present invention directly dissolves Vonopraxan or its salt in water through in-depth investigation and research, adding osmotic pressure regulator and controlling the pH range of the resulting liquid without adding other auxiliary materials, and the resulting solution is stable. Good, meeting the solubility requirements for preparation of injections; and high bioavailability, fast onset of action, good safety, and good drug compliance for special groups of people. On the other hand, during the process of preparing the vonolasan composition of the present invention into an injection, the solution has strong stability, can be sterilized by terminal sterilization, and can be sterilized thoroughly.

[0022] In the first aspect of the present invention, a composition is provided, the active ingredient is...

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Abstract

The invention relates to a proton pump inhibitor composition, and a preparation method of the composition The composition comprises the proton pump inhibitor and an osmotic pressure regulator, does not need to be redissolved, can be directly used, and is good in stability and safety. Meanwhile, the invention further provides a method for preparing the above proton pump inhibitor composition, and the method is simple, economic and suitable for industrial production.

Description

technical field [0001] The invention relates to a composition of a proton pump inhibitor and a preparation method thereof, in particular to a safe and stable composition of a proton pump inhibitor and a preparation method thereof, and belongs to the technical field of pharmacy. Background technique [0002] Vonoprazan fumarate, once code-named TAK-438, is a new type of proton pump inhibitor developed by Takeda Corporation of Japan. In the final step of secretion, by inhibiting the K + to H + -K + - The combination of ATPase (proton pump) stops the secretion of gastric acid and achieves the effect of acid suppression. Vonola fumarate was first launched in Japan in 2014 under the trade name Takecab. [0003] The chemical name of Vonolasan fumarate is 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylformazan Amine fumaric acid monosalt, the structural formula is as follows: [0004] [0005] At present, the dosage form of vonorasan fumarate on the...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4439A61K47/02A61P1/04
CPCA61K9/08A61K9/0019A61K31/4439A61K47/02A61P1/04
Inventor 吴莹赵步文游劲松黄芳芳
Owner 广东东阳光药业股份有限公司