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Preparation method of sodium nitroprusside injection

A technology of sodium nitroprusside injection and sodium nitroprusside, which is applied in the field of preparation of freeze-dried injections, can solve the problems of complex auxiliary agent process and increased risk of pollution, reduce the risk of impurity introduction, improve production efficiency, avoid The effect of reabsorbing moisture

Inactive Publication Date: 2014-05-07
YOUCARE PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of additives also brings about problems such as complicated process and increased risk of pollution.

Method used

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  • Preparation method of sodium nitroprusside injection
  • Preparation method of sodium nitroprusside injection
  • Preparation method of sodium nitroprusside injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Process such as figure 1 . Aseptic control process measures include: materials entering the filling process are passed in after disinfection; sterile clean clothes are used after being sterilized by pulsating vacuum pure steam at 121°C for 30 minutes; moisture-resistant equipment for receiving and filling sterile liquid medicine All containers and utensils are sterilized by pulsating vacuum pure steam at 121°C for 30 minutes. Dry heat-resistant equipment and containers are all sterilized by dry heat at 220°C for 2 hours.

[0030] 1) Accurately weigh sodium nitroprusside according to the mass-volume ratio of adding 50g of sodium nitroprusside to 1000mL with water for injection, add water for injection to dissolve into a 20%-30% concentrated solution, add 0.1-0.2% activated carbon, and stir for 15 -25min, diatomaceous earth coarse filtration decarbonization;

[0031] 2) Add water for injection to 950-980mL, check the pH value, and make up the amount of water for injecti...

Embodiment 2

[0039] The aseptic control process is the same as in Example 1.

[0040] 1) Accurately weigh sodium nitroprusside according to the mass-volume ratio of adding 50g of sodium nitroprusside to 1000mL with water for injection, add water for injection to dissolve into a 30% concentrated solution, add 0.1wt% activated carbon, stir for 20min, diatomaceous earth Coarse filtration and decarbonization;

[0041] 2) Add water for injection to 980mL, check the pH value, and make up the amount of water for injection. Then pass through a 0.22μm microporous membrane filter. After fine filtration, samples were taken to detect content, pH, and bacterial endotoxin.

[0042] 3) The finely filtered solution is filled in sterile vials, half stoppered, placed in a freeze-drying device, and freeze-dried according to the freeze-drying curve:

[0043]Put the solution to be frozen after fine filtration in the freeze-drying equipment, the temperature of the equipment is reduced to -45 ° C, and then ke...

experiment example 1

[0057] Experimental Example 1 Routine physical and chemical performance testing

[0058] According to "Chinese Pharmacopoeia" 2000 edition two "sodium nitroprusside for injection" (P838), use ascorbic acid to react with sodium nitroferricyanide and sodium hydroxide to produce blue color, and inspect the product. Through the inspection to embodiment 1, embodiment 2, each four batches of samples of comparative example, the result is all in positive reaction. Conforms to the provisions of "Sodium Nitroprusside for Injection" in the 2000 edition of the Chinese Pharmacopoeia.

[0059] According to the provisions of "Sodium Nitroprusside for Injection" in Part Two of the "Chinese Pharmacopoeia" in 2000: take a sample, add water to make a solution containing 10 mg of Sodium Nitroprusside per 1 ml, and perform spectrophotometry (Appendix IV A in Part Two of the Chinese Pharmacopoeia in 2000) Measure, embodiment 1, embodiment 2, each four batches of samples of comparative example 1, 2...

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Abstract

The invention provides a preparation method of sodium nitroprusside injection. The preparation method comprises the following steps: (1) accurately weighing sodium nitroprusside according to a mass volume ratio of each 50g of sodium nitroprusside: added water for injection enabling a solution to reach 100mL, adding the water for injection to the sodium nitroprusside so as to dissolve the sodium nitroprusside into a 20%-30% concentrated solution, adding 0.1-0.2% of activated carbon, stirring for 15-25 minutes, and carrying out coarse filtration so as to remove carbon; (2) supplementing the water for injection, and then carrying out refined filtration by using a filtering membrane; and (3) respectively filling the solution subjected to refined filtration into sterile penicillin bottles, partially stoppering, putting in freeze-drying equipment, and carrying out freeze-drying according to a freeze-drying curve. The preparation method has the advantages that proper temperature, pressure and heating rate are adopted in a preparation process, the intense moisture absorption of an inner loose structure of the product is avoided, the product is prevented from absorbing moisture again after being dried, the occurrence of the shrunk product is reduced, and the percent of pass is increased; and additives for improving surface activity do not need to be added, the risk caused by impurity introduction is reduced, and the production efficiency is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of freeze-dried injections. Background technique [0002] Sodium nitroprusside (molecular formula: Na 2 [Fe(CN) 5 NO]·2H 2 O, chemical name: sodium nitrosoferricyanide dihydrate) is a fast-acting and short-term acting vasodilator, clinically used for hypertensive emergencies, such as hypertensive crisis, hypertensive encephalopathy, malignant hypertension , Emergency blood pressure reduction for paroxysmal hypertension before and after pheochromocytoma surgery, and can also be used for controlled blood pressure reduction during surgical anesthesia. In addition, it can also be used for acute heart failure, including acute pulmonary edema; also for acute heart failure with acute myocardial infarction or valve (mitral or aortic) insufficiency. Immediately after intravenous infusion, the peak plasma concentration is reached, and its leve...

Claims

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Application Information

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IPC IPC(8): A61K33/26A61K9/19A61P9/12A61P25/00A61P9/10A61P7/10A61P9/04
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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