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Prescription of co-dergocrine mesyiate injection and technique for producing the same

A technology of dihydroergotine mesylate and injection, which is applied in the field of medicine and can solve problems such as unsatisfactory curative effect and the like

Inactive Publication Date: 2009-01-21
广州名冠医药科技有限公司
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  • Summary
  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

In my country, cerebrovascular dementia takes the first place among dementias. It is common in clinical practice. There are many treatment methods and drugs, but the curative effect is not satisfactory.

Method used

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  • Prescription of co-dergocrine mesyiate injection and technique for producing the same
  • Prescription of co-dergocrine mesyiate injection and technique for producing the same
  • Prescription of co-dergocrine mesyiate injection and technique for producing the same

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Experimental program
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Embodiment Construction

[0047]

[0048] Prescription: Dihydroergotoxine Mesylate 0.3g

[0049] Glycerin 50ml

[0050] Acetate buffer (pH3.6) appropriate amount

[0051] Add water for injection to 1000ml

[0052]

[0053]A total of 1000 sticks were produced

[0054] Production process: Rinse the ampoule with ultrasonic waves and purified water in sequence, then rinse with water and air, and finally dry the residual water in the ampoule with sterilized and filtered compressed air, dry it in an oven at 250°C for 15 minutes, and cool it for later use. Measure 50ml of glycerin, add water for injection to 800ml, add 0.3g of dihydroergotoxine methanesulfonate accurately weighed, stir to dissolve, adjust the pH value to 3.9-4.2 with acetate buffer solution with a pH value of 3.6, After adding water for injection to 1000ml, filter it with a 0.8 μm microporous membrane to measure the content and pH value of dihydroergot...

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Abstract

The invention discloses a formula and a production process of co-dergocrine mesylate injection, which belong to the technical field of medicine. The formula of the co-dergocrine mesylate injection in the invention consists of the monarch drugs of co-dergocrine mesylate, a stabilizer and a pH value regulator; the production process mainly comprises four steps of injection preparation, filtration, filling and sterilization. Sterilization process validation, accelerated tests, long duration tests, compatibility tests and the like prove that the production process is feasible and the co-dergocrine mesylate injection has stable quality.

Description

1. Technical field [0001] The invention relates to a prescription and a production process of dihydroergotoxine methanesulfonate injection, belonging to the technical field of medicine. 2. Background technology [0002] Cerebrovascular disease has gradually become the "number one killer" that threatens human life and health. With the increase in the proportion of the elderly population, the incidence of dementia is also increasing year by year. In my country, cerebrovascular dementia takes the first place among dementias. It is common in clinical practice. There are many treatment methods and drugs, but the curative effect is not satisfactory. The results of scientific research in recent years have shown that "hydrogenated ergot alkaloids" provide certain curative effects for people with cognitive impairment caused by senile dementia and brain tissue lesions. Dihydroergotoxine mesylate is composed of equal amounts of dihydroergocorinine mesylate, dihydroergotine mesylate, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/48A61P9/00
Inventor 王巍嵩
Owner 广州名冠医药科技有限公司
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