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Atropine sulfate injection with improved stability

A technology for the stability of atropine sulfate, which is applied in the field of atropine sulfate injection, can solve the problems of reduced stability, high impurity content, and high risk of injection, and achieve the effect of improving stability and reducing impurity content

Pending Publication Date: 2022-03-04
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Existing atropine sulfate injection includes: atropine sulfate, sodium chloride and hydrochloric acid, and the balance is water for injection; its disadvantage is that atropine sulfate injection introduces metal ions during the production process, which has a high risk, resulting in existing prescriptions, The high content of impurities, especially the high content of impurity A and impurity C, leads to a decrease in the stability of atropine sulfate injection

Method used

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  • Atropine sulfate injection with improved stability
  • Atropine sulfate injection with improved stability
  • Atropine sulfate injection with improved stability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] For atropine sulfate injection (specification: 1ml: 0.5mg), the prescription is shown in Table 1 below:

[0026] Table 1

[0027] name single dose prescription effect Atropine sulfate 0.5mg active ingredient Sodium chloride 9mg osmotic regulator Edetate disodium 0.1mg complexing agent 0.1% hydrochloric acid solution 0.02ml pH regulator Water for Injection Dilute to 1ml solvent

[0028] Preparation method: Measure 80% water for injection (the dosing temperature is 40°C), add the prescribed amount of edetate disodium, atropine sulfate, and sodium chloride in sequence, stir to dissolve, and use 0.1% (V / V) hydrochloric acid solution , adjust the pH value of the medicinal solution to 4.1±0.1, add water for injection to the full amount, filter through a 0.22 μm filter membrane, fill in ampoules, seal, and sterilize at 121°C for 15 minutes.

Embodiment 2

[0030] The prescription of atropine sulfate injection (specification: 1ml: 0.5mg) is shown in Table 2 below:

[0031] Table 2

[0032] name single dose prescription effect Atropine sulfate 0.5mg active ingredient Sodium chloride 9mg osmotic regulator Edetate disodium 0.15mg complexing agent 0.1% hydrochloric acid solution 0.02ml pH regulator Water for Injection Dilute to 1ml solvent

[0033] Preparation method: Measure 80% water for injection (the dosing temperature is 40°C), add the prescribed amount of edetate disodium, atropine sulfate, and sodium chloride in sequence, stir to dissolve, and use 0.1% (V / V) hydrochloric acid solution , adjust the pH value of the medicinal solution to 4.1±0.1, add water for injection to the full amount, filter through a 0.22 μm filter membrane, fill in ampoules, seal, and sterilize at 121°C for 15 minutes.

Embodiment 3

[0035] The prescription of atropine sulfate injection (specification: 1ml: 0.5mg) is shown in Table 3 below:

[0036] table 3

[0037] name single dose prescription effect Atropine sulfate 0.5mg active ingredient Sodium chloride 9mg osmotic regulator Edetate disodium 0.05mg complexing agent 0.1% hydrochloric acid solution 0.02ml pH regulator Water for Injection Dilute to 1ml solvent

[0038] Preparation method: Measure 80% water for injection (the dosing temperature is 40°C), add the prescribed amount of edetate disodium, atropine sulfate, and sodium chloride in sequence, stir to dissolve, and use 0.1% (V / V) hydrochloric acid solution , adjust the pH value of the medicinal solution to 4.1±0.1, add water for injection to the full amount, filter through a 0.22 μm filter membrane, fill in ampoules, seal, and sterilize at 121°C for 15 minutes.

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Abstract

The invention provides an atropine sulfate injection with improved stability, which belongs to the technical field of pharmaceutical preparations and comprises 0.5 mg / ml of atropine sulfate, 9mg / ml of sodium chloride, 0.1-0.15 mg / ml of edetate disodium, a proper amount of hydrochloric acid and the balance of water for injection. According to the atropine sulfate injection with the improved stability, the problem that the stability of a traditional prescription is poor is solved, the impurity content can be greatly reduced, and the stability of the atropine sulfate injection is greatly improved.

Description

technical field [0001] The invention relates to an atropine sulfate injection with improved stability, belonging to the technical field of pharmaceutical preparations. [0002] technical background [0003] Atropine sulfate is an anticholinergic drug that binds to M-choline receptors and antagonizes the muscarinic effects of acetylcholine and other cholinomimetic drugs. It mainly relieves the spasm of smooth muscle, inhibits the secretion of glands, relieves the inhibition of the vagus nerve on the heart, accelerates the heartbeat, dilates the pupils, increases intraocular pressure, and excites the respiratory center. It is clinically used for: rescuing infectious toxic shock, relieving organophosphorus pesticide poisoning, Aspen syndrome and visceral colic. Combined with morphine to treat hepatic and renal colic. [0004] Atropine sulfate injection, indications include: 1. Various visceral colic, such as gastrointestinal colic and bladder irritation symptoms. The curative...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/18A61K47/02A61P29/00A61P9/06A61P43/00A61P39/02A61P7/08
CPCA61K9/08A61K9/0019A61K47/183A61K47/02A61P29/00A61P9/06A61P43/00A61P39/02A61P7/08
Inventor 张雪梅吴素林叶飞燕齐宁宁范玲玲蒲平立熊静
Owner HENAN RUNHONG PHARMA
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