A kind of injection of dezocine and preparation method thereof

A technology of xin injection and dezocine, which is applied in the field of medicine and can solve the problems of increased degree, uncontrollable, and excessive degradation B

Active Publication Date: 2018-03-30
YANGTZE RIVER PHARM GRP CO LTD
View PDF4 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium metabisulfite was added to the prescription as an antioxidant, which delayed the degradation of dezocine to a certain extent (degradation product A, RRT=0.4, effectively controlled), but in the study, the inventors found that according to Physicians'desk Reference 1997 published the prescription, low concentration (5mg / ml) dezocine injection can be well prepared, while high concentration dezocine injection (10mg / ml~25mg / ml) can be sterilized by autoclave The high temperature in the process will cause another degradation product B (RRT=1.8) in the preparation product to increase significantly and the increase degree is uncontrollable. The model of the sterilizer, the position of the sample in the sterilizer, the sterilization temperature, Sterilization time has an impact on the increase of degradant B, which can easily cause excessive degradant B in the injection (exceeding the impurity limit stipulated in the drug quality standard of dezocine injection), so it is often used in the preparation process. Sterilization temperature or sterilization time to ensure that the degradation product B of the preparation does not exceed the standard, so that the level of sterility assurance is reduced
Visible, F 0 The increase of the value will inevitably lead to a significant increase in the degradation product B

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
  • A kind of injection of dezocine and preparation method thereof
  • A kind of injection of dezocine and preparation method thereof
  • A kind of injection of dezocine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068]

[0069] 2. Preparation process

[0070] Take 50% of the prescription amount of nitrogen-saturated water for injection, add lactic acid, dezocine, propylene glycol, and sodium chloride successively, stir to dissolve, and obtain solution 1; adjust the pH value of the solution to 4.0 with 4% by weight sodium hydroxide solution; add Dilute the above solution to 1000ml with nitrogen-saturated water for injection; add medicinal charcoal according to 0.02%-0.5% (W / V) of the total volume, keep warm at 30°C for 10 minutes, and filter through pre-filtration and sterilizing filter; The above-mentioned medicinal solution was divided into ampoules, 1ml / bottle, filled with nitrogen, and melt-sealed; put the above-mentioned ampoules containing the medicinal solution into an autoclaving cabinet for sterilization, and the sterilization conditions were 121°C for 12min; Inspection, labeling, packaging, and the finished product is obtained.

Embodiment 2

[0072]

[0073] 2. Preparation process

[0074] Take 50% of the prescription amount of nitrogen-saturated water for injection, add lactic acid, dezocine, propylene glycol, and sodium chloride successively, stir to dissolve, and obtain solution 1; adjust the pH value of the solution to 4.0 with 4% by weight sodium hydroxide solution; add Dilute the above solution to 1000ml in nitrogen-saturated water for injection; add medicinal charcoal according to 0.02%-0.5% (W / V) of the total volume, keep warm at 40°C for 15 minutes, and filter through pre-filtration and sterilizing filter; The above-mentioned medicinal solution was divided into ampoules, 1ml / bottle, filled with nitrogen, and melt-sealed; put the above-mentioned ampoules containing the medicinal solution into an autoclaving cabinet for sterilization, and the sterilization conditions were 121°C for 12min; Inspection, labeling, packaging, and the finished product is obtained.

Embodiment 3

[0076]

[0077]

[0078] 2. Preparation process

[0079] Take 50% of the prescription amount of nitrogen-saturated water for injection, add lactic acid, dezocine, propylene glycol, and sodium chloride successively, stir to dissolve, and obtain solution 1; adjust the pH value of the solution to 4.0 with 4% by weight sodium hydroxide solution; add Dilute the above solution to 1000ml with nitrogen-saturated water for injection; add medicinal charcoal according to 0.02%-0.5% (W / V) of the total volume, keep warm at 30°C for 10 minutes, and filter through pre-filtration and sterilizing filter; The above-mentioned medicinal solution was divided into ampoules, 1ml / bottle, filled with nitrogen, and melt-sealed; put the above-mentioned ampoules containing the medicinal solution into an autoclaving cabinet for sterilization, and the sterilization conditions were 121°C for 12min; Inspection, labeling, packaging, and the finished product is obtained.

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 an injection of dezocine, which comprises per milliliter: 10.1-25 mg of dezocine, 1-15 mg of sodium chloride, 5-20 mg of lactic acid, 300-450 mg of propylene glycol, sodium hydroxide and the rest The nitrogen saturated water for injection, the consumption of sodium hydroxide is to adopt 30~70 volume % nitrogen saturated water for injection to dissolve dezocine, sodium chloride, lactic acid and propanol to obtain solution 1, then use this sodium hydroxide aqueous solution to adjust the content of solution 1 Dosage for pH to 3.5‑5.0. The injection has good stability and stable quality, and is suitable for long-term storage.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection of dezocine and a preparation method thereof. Background technique [0002] Dezocine belongs to a typical opioid alkaloid analgesic, developed by Astra, Sweden. These drugs work by stimulating opioid receptors. Dezocine is less addictive and is suitable for the treatment of moderate to severe pain after surgery, visceral colic and pain in patients with advanced cancer. Due to its good tolerance and safety, dezocine has become a drug with good development prospects in clinical practice. [0003] Dezocine is white or off-white crystalline powder, odorless, soluble in methanol, ethanol or glacial acetic acid, slightly soluble in acetone, ethyl acetate or chloroform, almost insoluble in water, sensitive to high temperature, oxidation and other environments. [0004] The specification of dezocine on the market in China is 1mL: 5mg, and its instruction usag...

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
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/135A61K47/02A61K47/12A61P25/04
Inventor 徐镜人张海波蔡伟陈令武路显锋梁慧兴骆宏鹏栾芳石莹闻付勇陈凤琴赵文镜
Owner YANGTZE RIVER PHARM GRP CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap