Amisulpride injection

A technology of amisulpride and injection, applied in the field of medicine, can solve problems such as reducing the content of finished products, long stirring time, and unqualified products

Pending Publication Date: 2022-07-12
BEIJING PUDEKANGLI PHARMA TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Since amisulpride is difficult to dissolve in water, it takes a long time to stir when it is prepared as an intravenous injection, and the content of the finished product may be reduced due to the insufficient dissolution of the raw material drug, resulting in unqualified products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 The effect of different preparation temperatures on the dissolution time of amisulpride.

[0026] Amisulpride injection was prepared with the following formula:

[0027] ingredients Content per ml Amisulpride 2.5mg citric acid monohydrate 9.35mg Sodium citrate dihydrate 16.32mg Sodium chloride 1.8mg Hydrochloric acid / sodium hydroxide Adjust pH to 4.0-7.0

[0028] Preparation method 1:

[0029] (1) at room temperature, in 1L purified water, add citric acid monohydrate, sodium citrate dihydrate and sodium chloride of the formula amount, and stir until completely dissolved;

[0030] (2) adding amisulpride in the solution of step (1) and stirring, the rotating speed is 60r / min, record the time from adding the bulk drug to the complete dissolution of the bulk drug, and the rotating speed is 60r / min;

[0031] (3) use hydrochloric acid / sodium hydroxide in the solution of step (2), adjust pH to 6.0;

[0032] (4) Use...

Embodiment 2

[0040] Example 2 The influence of the particle size of the bulk drug on the dissolution time of amisulpride

[0041] Raw material drug recrystallization: add amisulpride into isopropanol, heat and dissolve to make a saturated solution, filter and cool it at 2-8℃ until crystals separate out, filter and dry at 50℃ to obtain the recrystallized amisulpride raw material .

[0042] The amisulpride raw material of the above-mentioned recrystallization was passed through a 40-mesh sieve (450 μm), and the amisulpride that did not pass through the 40-mesh sieve was sample 1, and its particle size was greater than 450 μm; Pass through an 80-mesh sieve (200 μm) to obtain amisulpride with a particle size between 200 μm and 450 μm as sample 2; continue to pass the sample that has passed through an 80-mesh sieve (200 μm) through a 120-mesh sieve (125 μm) to obtain a particle size of 125 μm- Amisulpride between 200 μm is sample 3; the sample passed through a 120-mesh sieve (125 μm) continues...

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Abstract

The invention provides an amisulpride injection and a preparation method thereof, the particle size of the used bulk drug amisulpride is not less than 20 [mu] m; preferably not less than 74 [mu] m; further, preferably, the particle size is 74-450 [mu] m; furthermore, the particle size of the particles is preferably 125-450 [mu] m. According to the amisulpride injection and the preparation method thereof provided by the invention, the preparation efficiency can be improved, and the content of a finished product is more stable.

Description

technical field [0001] The invention relates to an amisulpride injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Postoperative nausea and vomiting (PONV) is the most common adverse reaction in the perioperative period, which can cause varying degrees of discomfort in patients, making it impossible to take oral drugs, food or liquids. In severe cases, it may cause wound dehiscence, incisional hernia formation, and aspiration. Pneumonia, water-electrolyte and acid-base balance disturbances were the second most important factors in prolonging hospital stay in patients undergoing day surgery (influencing factors were postoperative drowsiness 31%, PONV 25%, and adverse cardiovascular events 24%). PONV has a serious adverse effect on the recovery quality of patients, and is an important reason for the low satisfaction of patients with surgery. Although many preventive measures have been taken in recent years, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/40A61P1/08
CPCA61K9/08A61K9/0019A61K31/40A61P1/08A61K2300/00
Inventor 王鹏马雪娇
Owner BEIJING PUDEKANGLI PHARMA TECH DEV CO LTD
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