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Injection and preparation process thereof

A technology for injections and solutions, applied in medical preparations of non-active ingredients, non-effective ingredients of polymer compounds, pharmaceutical formulations, etc., can solve the problems of poor safety and body adaptability, high cost, and complicated injection development and production processes, etc. problems, to achieve the effects of high drug dissolution utilization, high stability, convenience and safety

Pending Publication Date: 2021-04-13
李锋
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injection acts quickly and reliably, is not affected by pH, enzymes, food, etc., has no first-pass effect, and can exert a systemic or localized effect. It is suitable for patients who are not suitable for orally taking drugs, but the development and production process of injections is complicated, and the safety and Poor body adaptability and high cost

Method used

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  • Injection and preparation process thereof
  • Injection and preparation process thereof
  • Injection and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0027] An injection comprising 200mg of API, 1ml of ethanol, 6ml of propylene glycol, 9ml of PEG400, 4ml of water for injection, and an appropriate amount of HCL solution with a concentration of 2mol / L.

Embodiment 2

[0029] An injection comprising 250mg of API, 1.5ml of ethanol, 9ml of propylene glycol, 12ml of PEG400, 4ml of water for injection, and an appropriate amount of 2mol / L HCL solution.

Embodiment 3

[0031] An injection comprising 400mg of API, 2ml of ethanol, 12ml of propylene glycol, 18ml of PEG400, 4ml of water for injection, and an appropriate amount of HCL solution with a concentration of 2mol / L.

[0032] A method for preparing injection, comprising the steps of:

[0033] Step 1: Solvent configuration, according to the ratio of each component in the above solubilizer, mix ethanol, propylene glycol, and PEG400 evenly, and then use 2mol / L HCL to adjust the pH value of the solution to 1.5 to prepare solvent A;

[0034] Step 2: API dilution, adding water for injection to 50ml of the solvent A prepared in the above step 1, and then diluting the API powder to obtain a mixture B with an API concentration of 12.5mg / ml;

[0035] Step 3: Prepare the suspension, place the mixture B prepared in the above step 2 in a 50ml sterile glass injection bottle, stir until suspended, and prepare the suspension D;

[0036] Step 4: Prepare a solution, place the suspension D prepared in Step...

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Abstract

The invention discloses an injection, and relates to the field of chemical preparations. The injection comprises the following components in parts by weight: 1-2 parts of API, 70-90 parts of a solubilizer, 10-30 parts of water and the balance of a pH regulator, and has the advantages of high drug dissolution utilization rate and high stability.

Description

technical field [0001] The invention relates to the field of injection preparations, in particular to an injection and a preparation process thereof. Background technique [0002] Injection (injection) refers to sterile solutions (including emulsions and suspensions) made of drugs for injection into the body, as well as sterile powders or concentrated solutions for making solutions or suspensions before use. Injection acts quickly and reliably, is not affected by pH, enzymes, food, etc., has no first-pass effect, and can exert a systemic or localized effect. It is suitable for patients who are not suitable for orally taking drugs, but the development and production process of injections is complicated, and the safety and The adaptability of the body is poor and the cost is high. Contents of the invention [0003] The object of the present invention is to overcome the deficiencies in the prior art, and provide an injection, which has the advantages of high drug dissolution...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/10A61K47/40
CPCA61K9/08A61K9/0019A61K47/10A61K47/40
Inventor 刘晓力李锋
Owner 李锋
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