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Aprotinin freeze-dried powder and preparation method thereof

A technology of freeze-dried powder injection and aprotinin, which is applied in the field of medicine, can solve problems such as unstable product quality, high production cost, and poor stability, and achieve the effects of increasing investment in hardware equipment, increasing production capacity, and ensuring stability

Inactive Publication Date: 2013-04-24
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problems existing in the existing production process include: (1) Aprotinin is an enzyme biochemical drug, which has poor stability in aqueous solution. According to the existing prescription process, after the entire production process of aprotinin, within the validity period, the product The quality is unstable, and the potency drops by more than 10%
(3) The freeze-drying time exceeds 22 hours during the freeze-drying process, the longer the freeze-drying time, the longer the aprotinin is in a non-dry state, the more unstable the product quality, the greater the energy consumption, and the higher the production cost

Method used

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  • Aprotinin freeze-dried powder and preparation method thereof
  • Aprotinin freeze-dried powder and preparation method thereof
  • Aprotinin freeze-dried powder and preparation method thereof

Examples

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Embodiment 1

[0023] The preparation of embodiment 1 aprotinin freeze-dried powder injection

[0024] Specifications 28 units; batch number 081112; output 10,000 bottles.

[0025] (1) Prescription: 280,000 units of aprotinin; 10 g of arginine; 5 g of human serum albumin; 100 g of mannitol, and add water for injection to 10,000 ml.

[0026] (2) Preparation:

[0027] Put the prescribed amount of mannitol in a stainless steel bucket, add 5000ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain the solution ①; weigh the prescribed amount of arginine, human blood white Protein, add 2000mL of water for injection to dissolve to obtain a solution ②; accurately weigh the prescribed amount of pro-aprotinin powder, add 1000 mL of cold water for injection below 25°C to dissolve to obtain a solution ③. Slowly pour solution ①, solution ②, and solution ③ into the batching tank, and then make up the volume to the total amount wit...

Embodiment 2

[0037] The preparation of embodiment 2 aprotinin freeze-dried powder injection

[0038] Specification 112 units; batch number 081114; output 10,000 bottles.

[0039] (1) Prescription: aprotinin 1.12 million units; arginine 10g; human albumin 10g; mannitol 100g, add water for injection to 10000ml.

[0040] (2) Preparation:

[0041] Put the prescribed amount of mannitol in a stainless steel bucket, add 5000ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain the solution ①; weigh the prescribed amount of arginine, human blood white Protein, add 2000mL of water for injection to dissolve to obtain a solution ②; accurately weigh the prescribed amount of pro-aprotinin powder, add 1000 mL of cold water for injection below 25°C to dissolve to obtain a solution ③. Slowly pour solution ①, solution ②, and solution ③ into the batching tank, and then make up the volume to the total amount with cold water for inje...

Embodiment 3

[0051] The preparation of embodiment 3 aprotinin freeze-dried powder injection

[0052] Specifications 278 units; batch number 081116; output 10,000 bottles.

[0053] (1) Prescription: aprotinin 2.78 million units; arginine 15g; human albumin 15g; mannitol 100g, add water for injection to 10000ml.

[0054] (2) Preparation:

[0055]Put the prescribed amount of mannitol in a stainless steel bucket, add 5000ml of water for injection to dissolve, add 2‰ activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain the solution ①; weigh the prescribed amount of arginine, human blood white Protein, add 2000mL of water for injection to dissolve to obtain a solution ②; accurately weigh the prescribed amount of pro-aprotinin powder, add 1000 mL of cold water for injection below 25°C to dissolve to obtain a solution ③. Slowly pour solution ①, solution ②, and solution ③ into the batching tank, and then make up the volume to the total amount with cold water for inje...

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Abstract

The invention provides an aprotinin freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection is composed of the following substances: 28-556 million units of aprotinin, 10-20g arginine, 5-20g human serum albumin, and 100g mannitol. In aprotinin freeze-dried powder injection production process of the present invention, rginine and human serum albumin are selected to be excipients which mainly play the roles of protecting the active ingredient aprotinin; and mannitol is selected to be a freeze-drying excipient to enable the shape-forming by freeze drying. A 5% phosphoric acid solution or a 5% sodium phosphate solution is selected as a pH adjusting agent which enables the pH of a prepared liquid medicine to be maintained consistent with the pH of the liquid medicine which is redissolved after the powder is freeze dried, so that the product quality is more stable. According to the invention, an improved freeze-drying process is adopted, thus shortening the freeze-drying time and helping to improve product quality and save energy and reduce cost.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an aprotinin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Aprotinin is a broad-spectrum protease inhibitor, which has inhibitory effects on plasmin, etc., and its molecular formula is C 284 h 432 N 84 o 79 S 7 , molecular weight 6511.44. It can be used in extracorporeal circulation or other operations to reduce intraoperative or postoperative bleeding; hemorrhage caused by fibrinolysis; prevention of bleeding; prevention of postoperative intestinal adhesions; acute pancreatitis; traumatic or hemorrhagic shock. The existing aprotinin freeze-dried powder injection is a sterile freeze-dried product of aprotinin plus an appropriate amount of freeze-drying protective agent, which is a white or off-white freeze-dried block or powder. The production process is: liquid medicine preparation—filling and half stoppering—freeze drying...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/55A61K47/42A61K47/18A61K47/26A61P7/04A61P41/00A61P1/18A61P9/02
Inventor 尹双青刘永宏
Owner 蚌埠丰原涂山制药有限公司
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