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A kind of dezocine injection composition

A technology of dezocine and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as precipitation, and achieve the effects of content reduction, simple preparation method, and stable process

Active Publication Date: 2019-04-23
GUANGZHOU LIXIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problem of crystallization of the existing dezocine injection at low temperature, the present invention provides a composition of dezocine injection, which is prepared with L-cysteine ​​hydrochloride, lactic acid, propylene glycol and hydroxide Sodium is used as an auxiliary material to effectively improve the low-temperature stability of high-concentration dezocine solutions

Method used

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  • A kind of dezocine injection composition
  • A kind of dezocine injection composition
  • A kind of dezocine injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1, dezocine injection composition of the present invention

[0020] Prescription: 1000 sticks

[0021]

[0022]

[0023] Preparation:

[0024] Add lactic acid, dezocine, propylene glycol and L-cysteine ​​hydrochloride to 50% by volume of nitrogen-saturated water for injection, stir and dissolve to obtain solution A, adjust the pH value of solution A with 2% by weight of sodium hydroxide aqueous solution to 4.0, and then use the remaining 50% by volume of nitrogen-saturated water for injection to make constant volume, then add medicinal charcoal according to 0.1% W / V of the total volume, filter through pre-filtration and sterilizing filter, and finally pack in ampoules , filled with nitrogen, melt-sealed, placed in an autoclave, and sterilized at 121° C. for 15 minutes to obtain the dezocine injection composition.

Embodiment 2

[0025] Embodiment 2, dezocine injection composition of the present invention

[0026] Prescription: 1000 sticks

[0027] Raw materials

Content (g)

Dezocine

15

L-cysteine ​​hydrochloride

3

lactic acid

7.0

Propylene Glycol

200

Water for Injection

Dilute to 1000mL

pH value

4.0

[0028] Preparation:

[0029] Add lactic acid, dezocine, propylene glycol and L-cysteine ​​hydrochloride to 70% by volume of nitrogen-saturated water for injection, stir and dissolve to obtain solution A, adjust the pH value of solution A with 5% by weight of sodium hydroxide aqueous solution to 4.0, then use the remaining 30% by volume of nitrogen-saturated water for injection to make constant volume, then add medicinal charcoal according to 0.3% W / V of the total volume, filter through pre-filtration and sterilizing filter, and finally pack in ampoules , filled with nitrogen, melt-sealed, placed in an autoclave, and ste...

Embodiment 3

[0030] Embodiment 3, dezocine injection composition of the present invention

[0031] Prescription: 1000 sticks

[0032]

[0033]

[0034] Preparation:

[0035] Add lactic acid, dezocine, propylene glycol and L-cysteine ​​hydrochloride to 60% by volume of nitrogen-saturated water for injection, stir and dissolve to obtain solution A, adjust the pH value of solution A with 4% by weight of sodium hydroxide aqueous solution to 4.5, then use the remaining 40% by volume of nitrogen-saturated water for injection to make constant volume, then add medicinal charcoal according to 0.2% W / V of the total volume, filter through pre-filtration and sterilizing filter, and finally divide into ampoules , filled with nitrogen, melt-sealed, placed in an autoclave, and sterilized at 121° C. for 15 minutes to obtain the dezocine injection composition.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a dezocine injection composition. According to the dezocine injection composition, each milliliter of the dezocine injection composition is prepared form 10-25 mg of dezocine, 1-15 mg of L-cysteine hydrochloride, 5-15 mg of lactic acid, 200-250 mg of propylene glycol, sodium hydroxide and the balance of nitrogen saturated injection water, wherein the dosage of sodium hydroxide is the dosage that the dezocine, L-cysteine hydrochloride, lactic acid and propylene glycol are dissolved by adopting 50-70% by volume of the nitrogen saturated injection water so as to obtain a solution A, and then the pH value of the solution A is adjusted to 4.0-5.0 by using a 2-5% by weight of a sodium hydroxide aqueous solution. The dezocine injection composition has the advantages of being stable in quality and suitable for being used in different regions and under different weather conditions, meanwhile, a preparation method is simple, and a process is stable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a dezocine injection composition. Background technique [0002] Dezocine is a powerful opioid analgesic drug, mainly used for various postoperative moderate and severe pain requiring opioid analgesia, visceral colic, cancer pain, etc., and other methods of administration have poor analgesic effects Or patients with severe side effects during analgesia. Due to its low incidence of respiratory depression and drug dependence, dezocine is a newly approved second-class psychotropic drug by the state and is not included in the management of narcotic drugs in my country. As a new type of analgesic, dezocine produces analgesic effect mainly by stimulating the κ receptor, with strong analgesic effect, rapid absorption and distribution in the human body, large apparent distribution volume, long half-life, and slow clearance; The receptor has both agonistic and antagon...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/20A61K47/12A61K47/10A61K47/02A61K31/135A61P25/04
CPCA61K9/0019A61K9/08A61K31/135A61K47/02A61K47/10A61K47/12A61K47/183A61P25/04
Inventor 高悦译刘恩桂陈新颖
Owner GUANGZHOU LIXIN PHARM CO LTD
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