Peperphentonamine hydrochloride freeze-dried injection and preparation and application thereof

A technology for piperphentonamine hydrochloride and freeze-dried powder injection, which is applied in the field of piperphentonamine hydrochloride freeze-dried powder injection and its preparation, can solve the problems of difficult control, high requirements for freeze-drying equipment, large temperature range, etc. Character difference, ideal freeze-drying effect, good product forming effect

Active Publication Date: 2008-08-06
江西国能医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The temperature range of the lowest point and the highest point of freeze-drying adopted is large, which is difficult to control, and the temperature difference between the lowest temperature and the highest temperature is large, which requires high requirements for freeze-drying equipment

Method used

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  • Peperphentonamine hydrochloride freeze-dried injection and preparation and application thereof
  • Peperphentonamine hydrochloride freeze-dried injection and preparation and application thereof
  • Peperphentonamine hydrochloride freeze-dried injection and preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Weigh piperphentonamine hydrochloride raw material 1.0g and mannitol raw material as excipient 2.5g, add in the flask and add the water for injection 400ml of pH1.5 and mix well, the pH value of the water for injection that the pH value is equal to 1.5 is obtained by means of 1N hydrochloric acid solution for adjustment. Raise the temperature to 40°C, perform ultrasonic treatment, and after all the raw materials are dissolved (about 10 minutes), filter and sterilize with a stainless steel filter under positive pressure, pack in aliquots, 5ml per bottle, and use a half-cap freeze-drying special rubber stopper, first reduce the temperature of the sample chamber to - 25°C, put the sample into pre-freezing for 3 hours, raise the temperature to -20°C for sublimation drying for 15 hours, and then raise the temperature to 20°C for 5 hours to dry. The obtained product properties are as follows:

[0041]

Embodiment 2

[0043] Weigh 1.0 g of piperphentonamine hydrochloride raw material and 10.0 g of mannitol raw material as excipients, add to the flask and add 500 ml of water for injection with pH 2.0 and mix well, and the water for injection with pH value equal to 2.0 is obtained by means of 1N hydrochloric acid solution adjusted. Raise the temperature to 50°C and perform ultrasonic treatment. After all the raw materials are dissolved (about 10 minutes), the stainless steel filter is positively pressure filtered and sterilized, and divided into 5ml bottles with a half-cap freeze-drying special rubber stopper. First, the temperature of the sample chamber is reduced to - 30°C, put the sample into pre-freezing for 5 hours, raise the temperature to -20°C for sublimation drying for 20 hours, and then raise the temperature to 25°C for 10 hours. The obtained product properties are as follows:

[0044]

Embodiment 3

[0046] Weigh 1.0g of piperphentonamine hydrochloride raw material and 20g of mannitol raw material as excipients, add to the flask and add water for injection with pH 2.5 to 600ml and mix well, and the water for injection with pH value equal to 2.5 is obtained by 1N hydrochloric acid solution For adjustment, raise the temperature to 55°C and perform ultrasonic treatment. After all the raw materials are dissolved (about 10 minutes), the stainless steel filter is positively pressure filtered and sterilized, and divided into 5ml bottles with a special rubber stopper for freeze-drying. Put the good sample into the sample chamber, then lower the temperature of the sample chamber to -30°C, pre-freeze for 4 hours, raise the temperature to -20°C for sublimation and dry for 15 hours, then raise the temperature to 20°C and dry for 5 hours, the properties of the obtained product are as follows: forming, Excellent appearance, not deformed by a little force, easy to dissolve, clear, YG1-2. ...

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Abstract

The invention relates to pepperphentonamine chloride jelly powder injection and a preparation method thereof; the preparation comprises 1 portion of pepperphentonamine chloride, 2.5-3.0 portions of excipient and 400-600 portions of water for injection with PH value of 1.5-5.5; the preparation is prepared through freezing drying. The excipient is mannitol, dextran, lactose, sugar, polyglycol, poloxamer and glycin, etc.; 1 portion of the pepperphentonamine chloride, 10 portions of the mannitol and 500 portions of the water for injection with PH value of 2.0-3.0 are preferably chosen. The pepperphentonamine chloride and the excipient are added into the water for injection to be heated (40-90 DEG C), ultrasonic oscillated, degermed, subpackaged, pre-frozen, multi-stage dried and packed to obtain the products. A brown glass bottle is preferably chosen for subpackage. The pepperphentonamine chloride preparation of the invention has excellent appearance, color and solubility, good stability and long preservation period. The invention also relates to application of the preparation used for preparing therapeutic drugs for heart failure and/or myocardial protection.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of piperphentonamine hydrochloride and its preparation method and application. The present invention also relates to the freeze-dried powder injection of piperphentonamine hydrochloride used in the treatment of heart failure and / or cardioprotection in mammals including humans. Treatment as defined herein refers to prophylaxis and treatment. Piperphentonamine hydrochloride freeze-dried powder injection is also called piperphentonamine hydrochloride for injection. Background technique [0002] Heart failure is the terminal stage of cardiovascular disease, with a high mortality rate. Myocardial infarction and myocardial reperfusion injury are important causes of heart failure. Experimental studies at home and abroad have shown that calcium antagonists and free radical scavenger can treat myocardial infarction and resist reperfusion injury. However, most calcium antagonists inhibit myocardial cont...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/36A61K9/19A61K47/36A61K47/34A61K47/26A61K47/16A61K47/10A61P9/04A61P9/00
Inventor 万华印李茹冰李永贺周力践刘铁球衷小惠
Owner 江西国能医药科技有限公司
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