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Nalmefene hydrochloride injection and preparation method thereof

A technology of nalmefene and injection, which is applied in the field of medicine, can solve problems such as increasing the content of single and total impurities in injections, affecting the activity of active ingredient nalmefene, and affecting the long-term stability of drugs, so as to achieve good long-term stability, Suitable for large-scale industrial production, easy to control the effect of automation

Inactive Publication Date: 2017-05-31
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to the limited purity of new excipients, the above-mentioned method of increasing the types of excipients often introduces new impurities, which may not only affect the activity and efficacy of the active ingredient nalmefene, but also increase the concentration of other simple impurities in the injection. The content of total impurities, thus affecting the long-term stability of the drug

Method used

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  • Nalmefene hydrochloride injection and preparation method thereof
  • Nalmefene hydrochloride injection and preparation method thereof
  • Nalmefene hydrochloride injection and preparation method thereof

Examples

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Embodiment 1

[0038] The nalmefene hydrochloride injection of the present embodiment is prepared by the method comprising the following steps (the process flow is as follows: figure 1 shown):

[0039] 1) Take water for injection and put it in the liquid preparation tank, feed nitrogen, add 4g of C 21 h 25 NO 3 The nalmefene hydrochloride crude drug of 20 mg / ml is stirred and dissolved to make a medicinal solution A with a concentration of 2mg / ml; in the medicinal solution A, add 360g of sodium chloride to dissolve completely to obtain the medicinal solution B;

[0040] 2) Under the protection of nitrogen, add activated carbon to the liquid B, stir and adsorb for 15 minutes, and then use a titanium rod to filter and decarbonize to obtain the liquid C; the dosage of activated carbon is 0.05mg / 100ml liquid A (ie 0.05% (W / V));

[0041] Rinse the titanium rod with an appropriate amount of water for injection, repeat 4 times, and add the washing water to the medicinal solution C;

[0042] 3)...

Embodiment 2

[0046] The nalmefene hydrochloride injection of the present embodiment is prepared by the method comprising the following steps:

[0047]1) Take water for injection and put it in the liquid preparation tank, feed nitrogen, add 10g of water in C 21 h 25 NO 3 The nalmefene hydrochloride crude drug of 900g is stirred and dissolved to make a concentration of 2mg / ml medicinal solution A; in the medicinal solution A, add 900g of sodium chloride to dissolve completely to obtain the medicinal solution B;

[0048] 2) Under the protection of nitrogen, add activated carbon (2.5g) to liquid B, stir and adsorb for 15min, and then use titanium rod to filter and decarbonize to obtain liquid C; the dosage of activated carbon is 0.05mg / 100ml of liquid A (i.e. 0.05% of liquid A (W / V));

[0049] Rinse the titanium rod with an appropriate amount of water for injection, repeat 5 times, and add the washing water to the medicinal solution C;

[0050] 3) Under the protection of nitrogen, add wate...

Embodiment 3

[0054] The nalmefene hydrochloride injection of the present embodiment is prepared by the method comprising the following steps:

[0055] 1) Take water for injection and put it in the liquid preparation tank, feed nitrogen, add 0.5g of C 21 h 25 NO 3 The nalmefene hydrochloride crude drug of 20 mg / ml is stirred and dissolved to make a medicinal solution A with a concentration of 2mg / ml; in the medicinal solution A, add 45g of sodium chloride to dissolve completely to obtain the medicinal solution B;

[0056] 2) Under the protection of nitrogen, the activated carbon added to the medicinal solution B was stirred and adsorbed for 15 minutes, and then decarbonized by filtering with a titanium rod to obtain the medicinal solution C; the dosage of activated carbon was 0.05mg / 100ml of the medicinal solution A (that is, 0.05 %(W / V));

[0057] Rinse the titanium rod with an appropriate amount of water for injection, repeat 3 times, and add the washing water to the medicinal solution...

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Abstract

The invention relates to a nalmefene hydrochloride injection and a preparation method thereof. The preparation method of the nalmefene hydrochloride injection comprises the following steps: (1) adding 0.095 to 0.105 g of nalmefene hydrochloride metered according to C21H25NO3 into injection water, thus preparing liquid medicine A of which the concentration is 2.0 to 2.5 mg / ml; adding 8.5 to 9.5 g of sodium chloride in the liquid medicine A, and completely dissolving, thus obtaining liquid medicine B; (2) adding activated carbon in the liquid medicine B, and decarbonizing after stirring and adsorbing, thus obtaining liquid medicine C, wherein the usage of the activated carbon is 0.05 to 0.10 mg / 100 ml of the liquid medicine A; (3) adding the injection water in the liquid medicine C until the volume is 940 to 960 ml, regulating the system pH (Potential of Hydrogen) to be 3.95 to 4.50 by using hydrochloric acid, and replenishing the injection water until the volume is 1000 ml, thus obtaining the nalmefene hydrochloride injection. The nalmefene hydrochloride injection disclosed by the invention is high in effective component content and low in impurity content; the requirements of quality standard are met after the nalmefene hydrochloride injection is placed for a long term, and good long-term stability is obtained.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a nalmefene hydrochloride injection, and also relates to a preparation method of the nalmefene hydrochloride injection. Background technique [0002] As a highly selective and specific endogenous opioid receptor antagonist, nalmefene itself has no agonistic effect of opioids, but competes with endogenous excess internal opioid peptides to form a mass effect. It can bind to endogenous opioid receptors μ, κ, and δ, and has the strongest binding effect with μ receptors. Nalmefene blocks a series of pathological reactions in the central nervous system, respiratory and circulatory systems caused by the stress state of the body, and can inhibit or reverse the respiratory depression, sedation and hypotension effects of opioids; it can be used for natural Or the treatment of synthetic narcotic analgesic poisoning, also has a certain antagonistic effect on poisoning caused by some non-...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61K47/02A61K47/04A61P25/00A61P9/10A61P39/02A61P25/30A61P25/36A61P25/32A61P11/00
CPCA61K9/0019A61K9/08A61K31/485A61K47/02
Inventor 高志亮郭强
Owner HENAN RUNHONG PHARMA
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