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Injection of dezocine and preparation method of injection

A technology of xin injection and dezocine, which is applied in the field of medicine, can solve the problems of increased degradation product B, lower sterility assurance level, uncontrollable and other problems

Active Publication Date: 2015-04-22
YANGTZE RIVER PHARM GRP CO LTD
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  • 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

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  • Injection of dezocine and preparation method of injection
  • Injection of dezocine and preparation method of injection
  • Injection of dezocine and preparation method of injection

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.

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Abstract

The invention discloses an injection of dezocine. Every milliliter of the injection consists of the following ingredients: 10.1mg to 25mg of dezocine, 1mg to 15mg of sodium chloride, 5mg to 20mg of lactic acid, 300mg to 450mg of propanediol, sodium hydroxide and the balance of nitrogen saturated injection water, wherein the consumption of the sodium hydroxide is determined as follows: the dezocine, sodium chloride, lactic acid and propanediol are dissolved by utilizing 30 to 70 percent by volume of the nitrogen saturated injection water to obtain a solution 1, and the pH value of the solution 1 is adjusted by utilizing a sodium hydroxide aqueous solution to 3.5 to 5.0. The injection is good in stability, stable in quality and suitable for being stored for a long time.

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

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Application Information

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IPC IPC(8): A61K9/08A61K31/135A61K47/02A61K47/12A61P25/04
Inventor 张海波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
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