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Furosemide injection and preparation process thereof

A technology of furosemide and injection, which is applied in the field of medicine and can solve the problems of not being able to meet the requirements of SAL

Inactive Publication Date: 2013-10-30
上海禾丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the original sterilization process of furosemide injection at 100°C for 30 minutes cannot meet the requirements of the above-mentioned "Notice" for the SAL of the product after sterilization, so terminal sterilization process or aseptic production is adopted for it

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A furosemide injection, every 10000ml of said injection contains the following raw materials:

[0045] Furosemide 100g

[0046] Sodium chloride 60g

[0047] 10% (mass concentration) sodium hydroxide 120ml

[0048] Add water for injection to 10000ml.

[0049] A preparation process for furosemide injection, comprising the following steps:

[0050] (1) Add 70% of the water for injection in the batching tank;

[0051] (2) Add furosemide, sodium chloride, and 10% (mass concentration) sodium hydroxide solution into the batching tank;

[0052] (3) Stir the solution in the batching tank until the furosemide is completely dissolved;

[0053] (4) Cool the solution in the batching tank to below 30°C;

[0054] (5) Determine whether the pH value of the solution is between 9.1 and 9.4. If the pH value is within this range, proceed directly to the next step; if the pH value is not within this range, add an appropriate amount of 10% (mass concentration) hydroxide Sodium or 9% (v...

Embodiment 2

[0060] A furosemide injection, every 10000ml of said injection contains the following raw materials:

[0061] Furosemide 100g

[0062] Sodium chloride 90g

[0063] 10% (mass concentration) sodium hydroxide 180ml

[0064] Add water for injection to 10000ml.

[0065] A preparation process for furosemide injection, comprising the following steps:

[0066] (1) Add 70% of the water for injection in the batching tank;

[0067] (2) Add furosemide, sodium chloride, and 10% (mass concentration) sodium hydroxide solution into the batching tank;

[0068] (3) Stir the solution in the batching tank until the furosemide is completely dissolved;

[0069] (4) Cool the solution in the batching tank to below 30°C;

[0070] (5) Determine whether the pH value of the solution is between 9.1 and 9.4. If the pH value is within this range, proceed directly to the next step; if the pH value is not within this range, add an appropriate amount of 10% (mass concentration) hydroxide Sodium or 9% (v...

Embodiment 3

[0076] A furosemide injection, every 10000ml of said injection contains the following raw materials:

[0077] Furosemide 100g

[0078] Sodium chloride 75g

[0079] 10% (mass concentration) sodium hydroxide 150ml

[0080] Add water for injection to 10000ml.

[0081] A preparation process for furosemide injection, comprising the following steps:

[0082] (1) Add 70% of the water for injection in the batching tank;

[0083] (2) Add furosemide, sodium chloride, and 10% (mass concentration) sodium hydroxide solution into the batching tank;

[0084] (3) Stir the solution in the batching tank until the furosemide is completely dissolved;

[0085] (4) Cool the solution in the batching tank to below 30°C;

[0086] (5) Determine whether the pH value of the solution is between 9.1 and 9.4. If the pH value is within this range, proceed directly to the next step; if the pH value is not within this range, add an appropriate amount of 10% (mass concentration) hydroxide Sodium or 9% (v...

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Abstract

The invention provides a furosemide injection and a preparation process thereof. Each 10000ml of furosemide injection contains the following raw materials: 100g of furosemide, 60-90g of sodium chloride, 120-180ml of 10% (mass concentration) of sodium hydroxide and injection water for supplementing to 10000ml. The preparation process comprises the following steps of: adding the injection water which accounts for 70 percent of the total amount of preparation into a burdening tank; adding the furosemide, the sodium chloride and the 10% (mass concentration) of sodium hydroxide to the burdening tank; stirring till the furosemide is dissolved; cooling the solution to be below 30 DEG C; adjusting the pH value of the solution to 9.1-9.4; adding the injection water to reach total preparation amount and uniformly stirring; filtering the solution; and introducing N2 to the filtered solution to realize encapsulation. The furosemide injection and the preparation process thereof have the advantages that the problem that related substances in an original formula of the furosemide injection are unqualified is solved, and the furosemide injection can meet the quality standard of the furosemide injection in China Pharmacopoeia (2010 Edition 2) and provision of notification related to release of basic technical requirements of chemical injection and multi-component biochemical medicine injection.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to furosemide injection and its preparation process. Background technique [0002] Furosemide injection is a strong diuretic, mainly used in the following situations: [0003] (1) Edema diseases: including congestive heart failure, liver cirrhosis, kidney disease (nephritis, kidney disease and acute and chronic renal failure caused by various reasons), especially when the effect of other diuretics is not good, use this medicine Such drugs may still be effective, and they can be used in combination with other drugs to treat acute pulmonary edema and acute cerebral edema, etc.; [0004] (2) Hypertension: In the stepwise therapy of hypertension, it is not the first choice drug for the treatment of essential hypertension, but when thiazide drugs are not effective, especially when accompanied by renal insufficiency or hypertensive crisis , this class of drugs is especially applicable;...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/635A61P7/10
Inventor 施建国吴浩萍卜宇倩
Owner 上海禾丰制药有限公司
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