Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Isoproterenol hydrochloride injection and preparation process thereof

A technology of isoproterenol hydrochloride and injection, which is applied in drug delivery, cardiovascular system diseases, drug combination, etc., can solve the problems of high prescription cost and unachievable preparation method, and achieve the effect of low cost of prescription and preparation process

Inactive Publication Date: 2012-07-04
上海禾丰制药有限公司
View PDF2 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The cost of the existing prescription is relatively high, and the preparation method cannot meet the requirements of the "Notice"

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Isoproterenol hydrochloride injection and preparation process thereof
  • Isoproterenol hydrochloride injection and preparation process thereof
  • Isoproterenol hydrochloride injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Isoproterenol hydrochloride injection contains the following ingredients:

[0047] Each 10000ml injection contains,

[0048] Isoproterenol Hydrochloride 5g

[0049] Sodium chloride 85g

[0050] Sodium metabisulfite 10g

[0051] Edetate Disodium 3g

[0052] Add water for injection to 10000ml.

[0053] Its preparation process is:

[0054] (1) Add 90% of the total volume of water for injection in the preparation container, cool to below 30°C, and pass through CO 2 15 minutes to make it saturated;

[0055] (2) Dissolve edetate disodium in hot water for injection at 80°C to 85°C, and set aside;

[0056] (3) Start the agitator, add sodium chloride, sodium metabisulfite, isoproterenol hydrochloride and the disodium edetate solution obtained in step (2) into the water for injection obtained in step (1) in sequence, and stir for 5 minutes to dissolve ;

[0057] (4) Adjust the pH value of the solution obtained in step (3) with 10% hydrochloric acid or 5% ...

Embodiment 2

[0068] Isoproterenol hydrochloride injection contains the following ingredients:

[0069] Each 10000ml injection contains,

[0070] Isoproterenol Hydrochloride 5g

[0071] Sodium chloride 60g

[0072] Edetate Disodium 1g

[0073] Add water for injection to 10000ml.

[0074] The preparation technology of described isoprenaline hydrochloride injection comprises the following steps:

[0075] (1) Add 90% of the total volume of water for injection in the preparation container, cool to below 30°C, and pass through CO 2 15 minutes to make it saturated;

[0076] (2) Dissolve edetate disodium in hot water for injection at 80°C to 85°C, and set aside;

[0077] (3) Start the agitator, add sodium chloride, isoproterenol hydrochloride and edetate disodium solution obtained in step (2) into the water for injection obtained in step (1) in sequence, and stir for 5 minutes to dissolve;

[0078] (4) Adjust the pH value of the solution obtained in step (3) with 10% hydrochlori...

Embodiment 3

[0087] Isoproterenol hydrochloride injection contains the following ingredients:

[0088] Each 10000ml injection contains,

[0089] Isoproterenol Hydrochloride 5g

[0090] Sodium chloride 85g

[0091] Edetate Disodium 3g

[0092] Add water for injection to 10000ml.

[0093] Its preparation technology is identical with embodiment 2.

[0094] The obtained isoprenaline hydrochloride injection is carried out quality inspection, and its result is as follows:

[0095]

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses a formula of isoproterenol hydrochloride injection and a preparation process thereof. The isoproterenol hydrochloride injection contains, per 1000 mL, 5 g of isoproterenol hydrochloride, 60 g to 110 g of sodium chloride, 1 g to 5 g of disodium ethylenediaminetetraacetate (EDTA-2Na), and water for injection added up to 1000 mL. The quality of the isoproterenol hydrochloride injection conforms to the regulations of notice on issue of chemical injection and multi-component biochemical injection basic technical requirements ([2008] No.7 file) issued by State Food and Drug Administration in 2008 and the quality standards of China pharmacopoeia (part II, 2010 edition).

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to isoproterenol hydrochloride injection and its preparation process. Background technique [0002] In 2008, the Evaluation Center of the State Food and Drug Administration issued the State Food and Drug Administration [2008] No. 7 document - "Notice on Issuing the Basic Technical Requirements for Chemical Drug Injections and Multi-component Biochemical Drug Injections" (hereinafter referred to as "Notice") puts forward new requirements for the sterilization conditions of injections, which stipulates that small-volume injections should adopt a terminal sterilization process, and it is recommended that the overkill method be preferred (F 0 ≥12), if the product cannot tolerate overkill conditions, the survival probability method (8≤F 0 <12), but it should be ensured that the SAL (sterility assurance level) of the product after sterilization is not greater than 10 -6 . Use other F 0 Proc...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/08A61K31/137A61P9/00
Inventor 孙克刚
Owner 上海禾丰制药有限公司
Features
  • Generate Ideas
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com