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A kind of metoclopramide hydrochloride injection and preparation method thereof

A technology for metoclopramide hydrochloride and metoclopramide, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. The problems of poor stability of sodium content and many residues have achieved the effect of good stability and stable and controllable quality of liquid medicine.

Active Publication Date: 2018-10-16
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablet Disadvantages: Slow onset of action
Disadvantages of nasal spray: fewer effective sprays, more residues, more waste, and increased economic burden on patients
The content of metal ions in the metoclopramide hydrochloride injection on the market is relatively high, and the stability of sodium bisulfite content in the liquid is poor, which affects the stability of the liquid and is not conducive to safe drug use.

Method used

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  • A kind of metoclopramide hydrochloride injection and preparation method thereof
  • A kind of metoclopramide hydrochloride injection and preparation method thereof
  • A kind of metoclopramide hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Prescription: Metoclopramide: 0.77kg

[0019] Hydrochloric acid: 410ml (equivalent to 0.49kg)

[0020] Sodium acetate: 0.30kg

[0021] Sodium bisulfite: 0.10kg

[0022] Preparation Process:

[0023] (1) Preparation: Dissolve 0.77kg of metoclopramide in a beaker with 410ml of 36.5% hydrochloric acid with a mass fraction of 36.5% which has been diluted for later use. Use a beaker to dissolve 0.10 kg of sodium bisulfite with an appropriate amount of water for injection. Use a beaker to dissolve 0.30 kg of sodium acetate with an appropriate amount of water for injection for later use. Add 40L of water for injection with a specified amount of process into the preparation tank, open the nitrogen valve, and start stirring; add 40L of water for injection with a specified amount of process into the preparation tank, open the nitrogen valve, and start stirring; The standby solution of metoclopramide is added in the preparation tank, and then the standby solution of dissolved...

Embodiment 2

[0027] Prescription: Metoclopramide: 0.77kg

[0028] Citric acid: 1.58kg

[0029] Sodium bicarbonate: 0.40kg

[0030] Sodium sulfite: 0.12kg

[0031] Preparation Process:

[0032] (1) Preparation: Dissolve 0.77kg of metoclopramide in a beaker with 1.58kg of citric acid that has been dissolved in the prescribed amount for later use. Dissolve 0.12 kg of sodium sulfite with an appropriate amount of water for injection in a beaker for subsequent use. Use a beaker to dissolve 0.40 kg of sodium bicarbonate with an appropriate amount of water for injection. Add 40L of water for injection with a specified amount of process into the preparation tank, open the nitrogen valve, and start stirring; first add the reserve solution of metoclopramide dissolved in the citric acid solution into the preparation tank, and then add the dissolved Add the standby solution of sodium sulfite to the preparation tank; finally add the dissolved sodium bicarbonate solution to the preparation tank to a...

Embodiment 3

[0036] Prescription: Metoclopramide: 0.77kg

[0037] Tartaric acid: 1.50kg

[0038] Sodium acetate buffer: 400ml (equivalent to 0.75kg)

[0039] Sodium metabisulfite 0.18kg

[0040] Preparation Process:

[0041] (1) Preparation: Dissolve 0.77kg of metoclopramide with 1.50kg of diluted tartaric acid in a beaker for later use. Use a beaker to dissolve 0.18 kg of sodium metabisulfite with an appropriate amount of water for injection. Use a beaker to dilute 400ml of sodium acetate buffer solution with an appropriate amount of water for injection for later use. Add 40L of water for injection as specified in the process into the preparation tank, open the nitrogen valve, and start stirring; first add the reserve solution of metoclopramide that has been dissolved in the tartaric acid solution into the preparation tank, and then add the dissolved Add the standby solution of sodium metabisulfite to the preparation tank; finally add the dissolved sodium acetate solution to the prep...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a metoclopramide hydrochloride injection and a preparation method thereof. The metoclopramide hydrochloride injection comprises metoclopramide, cosolvent, pH regulator and antioxidant. The metoclopramide hydrochloride injection is characterized in that a ratio of metoclopramide, cosolvent, pH regulator and antioxidant is 1:0.6-2:0.3-1:0.1-0.3. The metoclopramide hydrochloride injection is reasonable in prescription, simple in process and high in stability and has the advantages of safety, stability and quality controllability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a metoclopramide hydrochloride injection and a preparation method thereof. Background technique [0002] Metoclopramide is a potent central antiemetic drug. Metoclopramide is a dopamine D2 receptor antagonist, and it also has 5-HT4 receptor agonistic effects, and 5-HT3 receptors. Mild inhibitory effect. It can act on dopamine receptors in the medullary emetic chemoreceptor zone (CTZ) to increase the threshold of CTZ, and has a strong central antiemetic effect. The drug mainly acts on the upper gastrointestinal tract, promoting the movement of the stomach and upper intestinal segment; increasing the tension of the gastrointestinal sphincter in the resting state, increasing the tension and contraction of the lower esophageal sphincter, increasing the pressure at the lower end of the esophagus, and blocking the stomach- Esophageal reflux, strengthen gastric and esophageal ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/12A61K31/166A61P1/08
CPCA61K9/08A61K31/166A61K47/02A61K47/12
Inventor 徐飞董旭李后涛郭元志宋彩香
Owner SHANDONG QIDU PHARMA