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Levogyration sulpiride injection and its preparation method

A technology for levosulpiride and injection, which is applied in the field of preparation of levosulpiride injection, can solve the problems of difficulty in preparing injections, levosulpiride is insoluble in water, etc., and achieves the effects of expanding the scope of medicine, improving water solubility and good stability

Inactive Publication Date: 2006-09-27
SHANGHAI HUATUO MEDICAL SCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows for better administration of drugs by injecting them through veins without causing pain on their own hands (which could cause complications). It also makes it easier to prepare small doses that are safe but still effective at treating certain medical disorders effectively.

Problems solved by technology

This patents describes how certain compounds can help relieve symptoms caused due to gastrointestinal issues like stomach pain when given alone without causing nausea or heartburn during long periods after treatment with drugs called sulfonexides. However, these substances have low soluble strengths making them hard to administer through conventional methods that require either injecting liquid solutions containing this drug at once or spray dry powders onto mucosa tissue.

Method used

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  • Levogyration sulpiride injection and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1 Preparation of Levosulpiride Small Volume Sodium Chloride Injection

[0018] Raw materials

[0019] Preparation:

[0020] (1) Take the prescribed amount of levosulpiride, 1mol / L hydrochloric acid, and sodium chloride and add them to about 1500ml of water for injection. After levosulpiride is completely dissolved, add water for injection to 2000ml, and use 0.1M hydrochloric acid and 0.1M sodium hydroxide solution Adjust the pH value to the set value;

[0021] (2) Add the gac of prescription quantity and stir and adsorb for 15 minutes, after rough filtration with sand rod, fine filter with the microporous membrane of 0.45um, check the clarity of medicinal liquid;

[0022] (3) Fill and seal the medicinal solution in ampoules, 2ml / support;

[0023] (4) Steam sterilization at 115°C for 30 minutes, leak detection, light inspection, printing and packaging.

[0024] The injections prepared by each prescription are colorless and clear solutions, and the p...

Embodiment 2

[0027] Example 2 Preparation of Levosulpiride Sodium Chloride Infusion

[0028] Prescription: Levosulpiride 25.0g

[0029] 1mol / L sulfuric acid 73.2ml

[0030] Sodium chloride 900.0g

[0031] Water for injection 100000ml

[0032] A total of 1000 bottles were made

[0033] Preparation:

[0034] (1) Take levosulpiride and 1mol / L hydrochloric acid according to the prescription amount, add them to about 4500ml water for injection, stir to dissolve them completely, then add the solution to about 250000ml water for injection, stir and mix evenly;

[0035] (2) Add the sodium chloride of recipe quantity, stir and make dissolving;

[0036] (3) adjust the pH to 4.5 with hydrochloric acid or sodium hydroxide of 0.1mol / L;

[0037] (4) Add 0.03% (w / v) activated carbon and stir for adsorption for 15 minutes, remove the activated carbon by filtration, and measure the content of levosulpiride;

[0038] (5) Add water for injection to the full amount;

[0039] (6...

Embodiment 3

[0041] Example 3 Preparation of Levosulpiride Freeze-dried Powder Injection

[0042] Prescription: Levosulpiride 25.0g

[0043] 1mol / L benzenesulfonic acid 73.2ml

[0044] Mannitol 250.0g

[0045] Water for injection 1000ml

[0046] Activated carbon 0.5g

[0047] A total of 1000 bottles were made

[0048] Preparation:

[0049] (1) Take the prescribed amount of levosulpiride and add it to about 800ml of water for injection, add the prescribed amount of 1mol / L methanesulfonic acid, stir to dissolve it completely, add the prescribed amount of mannitol, add water for injection to 1000ml, stir and mix evenly , add 1M hydrochloric acid or sodium hydroxide to adjust the pH value to 4.5±0.5;

[0050] (2) add the gac of recipe quantity, after sand stick coarse filtration, by fine filtration with the microporous membrane of 0.45um, check the clarity of medicinal liquid;

[0051] (3) The medicinal liquid is divided into vials, 1ml / bottle;

[0052] (4...

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Abstract

The preparation process of levosulpiride injection features that levosulpiride is dissolved with injection water containing pharmaceutically acceptable acid of the same molar amount to regulate the pH value of the injection to 4-6. The said process can prepare water injection and frozen powder for injection with less side effect and high stability.

Description

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Claims

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Application Information

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Owner SHANGHAI HUATUO MEDICAL SCI CO LTD
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