Method for preparing bivalirudin freeze-dried powder needle preparation for injection or transfusion

A technology of bivalirudin and freeze-dried powder injection, which is applied in the field of biomedicine, can solve the problems of difficult to determine the formulation of the preparation, affect the quality of the preparation product, and complicate the preparation process, so as to achieve clear points of attention, promote aggregation and particle release, The effect of simple formula and process operation

Inactive Publication Date: 2014-11-19
浙江美华鼎昌医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its freeze-drying step preparation process is complex
[0007] 3. It is difficult to determine the prescription of the formulation
[0008] 4. The formulation process after the prescription of the preparation product is determined, that is, the order and steps of the formulation directly affect the quality of the preparation product, so it is difficult to determine

Method used

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  • Method for preparing bivalirudin freeze-dried powder needle preparation for injection or transfusion
  • Method for preparing bivalirudin freeze-dried powder needle preparation for injection or transfusion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] The composition of the bivalirudin freeze-dried powder preparation for injection or infusion in this example is as follows:

[0052] Bivalirudin 63%

[0053] Low endotoxin mannitol 32%

[0054] Analytical Pure AR Grade Sodium Hydroxide 5.0%

[0055] A certain amount of water for injection after sterilization

[0056] Nitrogen half an atmosphere

[0057] Its preparation process is:

[0058] (1) Pretreatment: The bivalirudin raw material drug is in a freeze-dried powder state, and after analysis and detection, the content of impurities meets the USP requirements, and then refrigerated for later use;

[0059] (2) Preparation of neutralizing reagent: Weigh 0.8g of analytically pure AR grade NaOH solid and dilute it with sterilized water for injection to 100ml to obtain a 0.2mol / l analytically pure AR grade NaOH solution for later use;

[0060] (3) Buffer solution preparation: Weigh 600mg of endotoxin mannitol, add 10ml of sterilized water for injection, about a dose of 2...

Embodiment 2

[0068] In this example, the bivalirudin freeze-dried powder preparation consists of the following components:

[0069] Bivalirudin 63%

[0070] Low endotoxin mannitol 32%

[0071] Analytical Pure AR Grade Sodium Hydroxide 5.0%

[0072] Water for injection after sterilization A certain amount

[0073] half an atmosphere of nitrogen

[0074] Its preparation process is:

[0075] (1) Pretreatment: The bivalirudin raw material drug is in a freeze-dried powder state, and after analysis and detection, the content of impurities meets the USP requirements, and then refrigerated for later use;

[0076] (2) Preparation of neutralizing reagent: Weigh 0.8g of analytically pure AR grade NaOH solid and dilute it with sterilized water for injection to 100ml to obtain a 0.2mol / l analytically pure AR grade NaOH solution for later use;

[0077] (3): Weigh 375mg of endotoxin mannitol, add 5ml of sterilized water for injection, about a dose of 2ml of water, dissolve, and prepare 6% endotoxin ...

Embodiment 3-6

[0091] The preparation method of the bivalirudin freeze-dried powder preparation in this example 3-6 is the same as that of Examples 1 and 2, wherein the ratio of bivalirudin, endotoxin mannitol and analytically pure AR grade sodium hydroxide is shown in the table below 4. See Table 5 below for freeze-drying parameters and Table 6 below for performance parameters.

[0092] Example Bivalirudin endotoxin mannitol Analytical Pure AR Grade Sodium Hydroxide Example 3 60% 35% 5% Example 4 70% 25% 5% Example 5 63.5% 30% 6.5% Example 6 65% 29.2% 5.8%

[0093] step Set temperature °C Decrease / heat up time min duration min vacuum mtorr pre-freeze -20 75 60 none Frozen -45 45 180 none a sublimation -10 120 390 120 secondary sublimation 0 90 450 120 triple sublimation 12.5 120 120 120 once dry 25 45 300 120 secondary drying 30 60 330 0 Finish 0 0 0 ...

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Abstract

The invention relates to a method for preparing a bivalirudin freeze-dried powder needle preparation for injection or transfusion. The method comprises the following steps: (1) pretreating; (2) preparing a neutral reagent, namely, diluting into a 0.2mol / l NaOH solution with injection water; (3) preparing a buffer solution, namely, preparing a 6% mannitol solution serving as the buffer solution; (4) adding raw material medicines; (5) preparing an intermediate solution; (6) quantifying to constant volume; (7) filling into a pot; and (8) freeze-drying, namely, incompletely covering a rubber cover, setting freeze-drying parameters, performing prefreezing, complete freezing, primary sublimation, secondary sublimation, third sublimation, primary drying and secondary drying, subsequently introducing nitrogen for forming nitrogen seal, covering, and sealing by using a sealing part, thereby obtaining a finished bivalirudin freeze-dried powder needle preparation product. The bivalirudin freeze-dried powder needle preparation prepared by using the method is definite in medicine effect, good in water redissolution, good in security, high in effect taking speed and beneficial for recovery of patients, and the requirements on contents of impurities and moisture are all met.

Description

technical field [0001] The invention relates to a method for preparing a bivalirudin freeze-dried powder preparation for injection or infusion, and belongs to the technical field of biomedicine. Background technique [0002] Bivalirudin is a parenteral anticoagulant agent approved in the United States for use in coronary interventional therapy (PCI), including patients with ST-segment elevation myocardial infarction during initial PCI treatment. patient. The drug is also approved for early intervention or urgent intervention in adult patients with acute coronary syndrome (unstable angina / non-ST-segment elevation myocardial infarction [UA / NSTEMI]). [0003] Bivalirudin is available as a lyophilized powder in 10 mL single-use sterile Type I glass vials sealed with bromobutyl rubber stoppers. Each vial is labeled as containing 250 mg of bivalirudin plus the inactive ingredients mannitol and sodium hydroxide. Immediately before use, reconstitute with 5 mL of water for injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/10A61K47/26A61P7/02F26B5/06
Inventor 王传跃方庆华刘永莉孟淑宝张海良
Owner 浙江美华鼎昌医药科技有限公司
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