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Anisodamine freeze drying preparations for injections and preparation method

A technology of freeze-dried preparations and anisodamine, which can be used in freeze-dried transportation, anti-toxic agents, anti-inflammatory agents, etc., and can solve problems such as poor stability, inconvenient transportation and storage

Inactive Publication Date: 2008-03-12
张为群
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the injection is in liquid form, which has poor long-term storage stability and inconvenience in transportation and storage.

Method used

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  • Anisodamine freeze drying preparations for injections and preparation method
  • Anisodamine freeze drying preparations for injections and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Screening of anisodamine freeze-dried preparation formulation process for injection

[0025] 1. Solubility of anisodamine:

[0026] Anisodamine is white crystal or crystalline powder, odorless and bitter. This product is soluble in ethanol or hydrochloric acid and dissolved in water.

[0027] 2. Determination of pH range

[0028] According to the quality standard of racemic anisodamine hydrochloride injection, the pH value range of the drug solution before freeze-drying of the product of this research is determined to be 4.0-6.0.

[0029] 3. Dissolution and investigation of the volume of the drug solution before freeze-drying

[0030] Weigh 89 mg of anisodamine, add water for injection to 10 ml, stir to dissolve, adjust the pH value to 4.87 with 1 mol / L hydrochloric acid, and the liquid medicine is colorless and clear. According to the dissolving situation of medicine, in order to make sub-dosing accurate, so determine that the filling volume is 2ml.

[0...

Embodiment 2

[0064] Embodiment 2 preparation technology of anisodamine freeze-dried preparation for injection

[0065] 1. Determination of the lowest eutectic point

[0066] Prepare the liquid medicine according to the preliminarily determined formula, and measure its minimum eutectic point temperature by resistance method. Results Specification I was -19.0°C to -18.3°C; Specification II was -18.0°C to -17.5°C.

[0067] 2. Determination of freeze-drying process

[0068] According to the minimum eutectic point and the volume of the liquid medicine, we investigated the freeze-drying process, and determined the freeze-drying process conditions of the two specifications as shown in Table 9 according to the investigation results:

[0069] Table 9 freeze-drying process conditions

[0070] Freeze-drying conditions

freeze drying time

Pre-freezing period: start the freeze dryer, set the shelf temperature to -45

℃, after the shelf temperature drops to about -45℃, respect...

Embodiment 3

[0097] Example 3 Stability Test of Anisodamine Freeze-dried Preparation for Injection

[0098] The anisodamine freeze-dried preparation for injection was subjected to the influence factor test under the conditions of light (4500Lx), high temperature (60°C) and low temperature (4°C) for 10 days, and no significant change was seen in each investigation item; accelerated test (40°C) for 6 months , the properties of the sample, the clarity and color of the solution, clarity, acidity, related substances, and content have no obvious changes; , related substances, and content have no significant changes, and the results show that the quality is stable.

[0099] 1. Influencing factor test

[0100] Take a certain number of samples (batch number: 040301; 040307), remove the outer packaging, place them under the conditions of light (4500Lx), high temperature (60°C) and low temperature (4°C), take samples on 5 days and 10 days, and follow the quality standards ( Draft) method to measure...

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Abstract

The present invention discloses a freezing stem preparation of the anisodamine and a preparation method, which is produced by concentrated preparation, carbon adsorption, crude filtration, dilution, intermediate good measurement, refined filtration, filling, half compression and plugging, freezing and drying with the active component of the nisodamine, the salt formation agent, the acid regulator, the isoosmotic adjusting agent, the excipient or the water for the injection.

Description

technical field [0001] The invention relates to anisodamine freeze-dried preparation and preparation method Background technique [0002] At present, racemic anisodamine hydrochloride injection has been produced. It has peripheral anti-M choline receptor effect and is suitable for relieving smooth muscle spasm, gastrointestinal colic, biliary tract spasm, acute microcirculation disturbance and organophosphate poisoning. However, the injection is in liquid form, which has poor long-term storage stability and inconvenience in transportation and storage. Contents of the invention [0003] In order to meet market demand and clinical needs, improve the stability of racemic anisodamine hydrochloride injection, and facilitate transportation and storage, the inventor has developed a freeze-dried formulation of racemic anisodamine hydrochloride for injection. [0004] According to the specifications of the existing marketed racemic anisodamine hydrochloride injection and the clini...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/439A61P29/00A61P39/02
Inventor 杨放张为群
Owner 张为群
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