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Pharmaceutical composition containing nalmefene hydrochloride compound

A technology of nalmefene and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of insufficient content and easy fluctuation of pH value, and achieve good stability, small fluctuation range, The effect of ensuring stability

Active Publication Date: 2014-02-26
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The PH value is easy to fluctuate during the storage process, and activated carbon needs to be added for decolorization during the production process, which may easily lead to insufficient content. The product present invention provides a new prescription and preparation method of nalmefene hydrochloride injection, which overcomes the above defects

Method used

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  • Pharmaceutical composition containing nalmefene hydrochloride compound
  • Pharmaceutical composition containing nalmefene hydrochloride compound
  • Pharmaceutical composition containing nalmefene hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Nalmefene hydrochloride 100mg;

[0052] Tween 801g;

[0053] Calcium EDTA 2g;

[0054] Vitamin C1.5g,

[0055] 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4;

[0056]

[0057] Preparation

[0058] (1) Weigh the raw and auxiliary materials according to the prescription quantity

[0059] (2) Add Tween 80, EDTA calcium, and vitamin C to 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4, and stir to dissolve.

[0060] (3) Add the prescribed amount of Nalmefene Hydrochloride into the solution and stir to dissolve completely. Add sterile water for injection to the full amount, and stir to mix evenly.

[0061] (4) Measure the pH value of the solution, which is 7.0.

[0062] (5) Fine filter with a 0.2 μm microporous membrane to check the clarity of the solution.

[0063] (6) According to the measurement results, fill the liquid medicine into a vial with a volume of...

Embodiment 2

[0067] Nalmefene hydrochloride 100mg;

[0068] Tween 801g;

[0069] Calcium EDTA 1g;

[0070] Vitamin C1g,

[0071] 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4;

[0072]

[0073] Preparation

[0074] Same as Example 1

Embodiment 3

[0076] Nalmefene hydrochloride 100mg;

[0077] Tween 801g

[0078] Calcium EDTA 3g;

[0079] Vitamin C 2g,

[0080] 1000ml of disodium hydrogen citrate and trisodium citrate buffer solution with a molar ratio of 1:4;

[0081]

[0082] Preparation

[0083] With embodiment 1.

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Abstract

The invention relates to a pharmaceutical composition containing a nalmefene hydrochloride compound. For every 1000 injections, the pharmaceutical composition comprises the following components: 100mg of nalmefene hydrochloride, 1-2g of Tween 80, 1-3g of EDTA (Ethylene Diamine Tetraacetic Acid) calcium, 1-2g of vitamin C, 1000ml of sodium hydrogencitrate and trisodium citrate buffer liquor with molar ratio of 1:4, and the balance of water for injection.

Description

technical field [0001] The invention relates to a preparation for injection of nalmefene hydrochloride and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Nalmefene (nalmefene) is a specific morphine receptor blocker, and its structure is a naltrexone analogue of the 6-methylene group. The drug was synthesized in 1975 and launched in 1995. Alternatives to Loxone. Compared with naloxone, nalmefene has the characteristics of long action time, multiple administration routes, high bioavailability, and small adverse reactions, and has a wide range of clinical applications. And hypotension and other symptoms, and used in the treatment of alcoholism and heroin dependence. [0003] The nalmefene hydrochloride preparation that has been on the market is an injection, which belongs to water injection needles. Since nalmefene hydrochloride is unstable at room temperature, it needs to be stored at low temperature to avoid discoloration of...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/485A61K47/26A61P11/00A61P9/02A61P25/00A61P25/36
Inventor 姚云
Owner 罗诚
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