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Stabilized nalmefene hydrochloride injection and its preparation

A technology of nalmefene and injection, which is applied in the field of nalmefene injection and its preparation, can solve the problems of cumbersome clinical use and increase of production cost, and achieve the effects of reasonable composition, good stability and simple process

Active Publication Date: 2007-01-17
西藏易明西雅医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although freeze-dried powder injection can improve the stability of the preparation, the freeze-drying process of more than 30 hours has greatly increased the production cost, and nalmefene is mainly used for first aid, and the powder injection needs to be dissolved in water for injection during clinical use. use, making clinical use more cumbersome

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription:

[0023] Nalmefene Hydrochloride 0.1g

[0024] Sodium chloride 9g

[0025] Proper amount of hydrochloric acid to pH3.6

[0026] Process: 1) Take 1000ml of water for injection and put it in the liquid mixing tank, add the full amount of sodium chloride prescribed, and stir until dissolved; 2) Add the prescribed amount of nalmefene hydrochloride, stir until dissolved; then use a 0.22 μm microporous filter membrane Fine filtration until clarity; 3) filling in a glass ampoule (filling 1ml of liquid in a glass ampoule with a volume of 2ml); 4) melting and sealing. 5) Sterilize at 115°C for 20 minutes. 5) Capping, labeling, packaging, and the finished product after passing the inspection. PH value after sterilization: Take 10 sticks of this product, combine them, and measure according to the law (Chinese Pharmacopoeia 2000 edition, Appendix VIH), the pH value is 3.9.

Embodiment 2

[0028] prescription:

[0029] Nalmefene Hydrochloride 1g

[0030] Sodium chloride 9g

[0031] Proper amount of hydrochloric acid to pH3.8

[0032] Technology: with embodiment 1. 2ml glass ampoules are used for dispensing, and the dispensing volume is 2ml.

[0033] PH value: measuring method is the same as embodiment 1, gets the solution in 5 ampoules to merge, and the result of measuring pH value is 3.9.

Embodiment 3

[0035] prescription:

[0036] Nalmefene Hydrochloride 1g

[0037] Sodium chloride 9g

[0038] Proper amount of hydrochloric acid to pH 3.8

[0039] Technology: with embodiment 1. 5ml glass ampoules are used for dispensing, and the dispensing volume is 4ml.

[0040] PH value: measuring method is the same as embodiment 1, gets the solution in 3 ampoules to merge, and the result of measuring pH value is 3.9.

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PUM

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Abstract

A high-stability nalmefene hydrochloride injection is prepared from nalmefene hydrochloride (0.005-0.2 W / v %) and the medicinal carrier chosen from sodium chloride, glucose, beta-cyclodextrin, dextran, pectose, sorbitol, etc. Its preparing process is also disclosed.

Description

Technical field: [0001] The invention relates to a nalmefene injection and a preparation method thereof, belonging to the technical field of medicines. technical background: [0002] Nalmefene hydrochloride was designed and developed on the basis of transforming and optimizing the structure of the parent compound during the in-depth study of naloxone and naltrexone in the 1970s to address the shortcomings of existing opioid receptor antagonists. new compound. Nalmefene hydrochloride completely retains the characteristics of naloxone and naltrexone as a pure antagonist, has no agonistic effect on opioid receptors, and does not produce dependence. Compared with naloxone and naltrexone, it has the advantages of long action time, high oral bioavailability, small dosage, and wide safety range. Therefore, nalmefene hydrochloride has the characteristics of high efficiency and low toxicity, and has become a new generation of opioid recipients. The species with the most potential f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61P25/36A61P39/02
Inventor 王家权董红梅于晓军徐小虎王晋吕俊耀
Owner 西藏易明西雅医药科技股份有限公司
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