Anesthesia analgesia drug composition and preparation method thereof

A composition and drug technology, applied in the field of medicine, can solve the problems of easy occurrence of morning insomnia, daytime anxiety, low blood pressure and extrapyramidal symptoms, and achieve the effects of protecting physical and mental health, reducing the amount of auxiliary materials and improving stability.

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A composition and drug technology, applied in the field of medicine, can solve the problems of easy occurrence of morning insomnia, daytime anxiety, low blood pressure and extrapyramidal symptoms, and achieve the effects of protecting physical and mental health, reducing the amount of auxiliary materials and improving stability.

CN108143733AActive Publication Date: 2018-06-12YICHANG HUMANWELL PHARMA

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Experimental program

Comparison scheme

Effect test

Embodiment 1

[0044] Embodiment 1: Preparation of the composition of narcotic analgesic drug

[0045] prescription:

[0046]

[0047] Preparation method: according to the feeding ratio, put dextran and glycine into about 90% of the prescription amount of water for injection to dissolve, and use a pH regulator to adjust the pH value of the above solution to 2.5-3.7. Then add formula (I) besylate and remifentanil hydrochloride while stirring, stir until completely dissolved, measure the pH of the solution to be 2.5 to 3.7, and then dilute to the full prescription amount with water for injection. Add 0.1% (w / v) medicinal charcoal according to the volume of the solution, and stir for 30 minutes. The medicinal solution is first filtered with a 0.45 μm microporous membrane, and then filtered with a 0.22 μm microporous membrane.

[0048] Freeze-drying process:

[0049] (1) Pre-freezing stage: After filling the filtered liquid, put it into the freeze-drying cabinet, start the freeze-drying ma...

Embodiment 2

[0053] Embodiment 2: Preparation of the composition of narcotic analgesic drug

[0054] prescription:

[0055]

[0056]

[0057] Preparation method: according to the feeding ratio, put lactose into about 90% of the prescription amount of water for injection to dissolve, and adjust the pH value of the above solution to 3.5-4.8 with a pH regulator. Then add formula (I) besylate and fentanyl citrate while stirring, stir until completely dissolved, measure the pH value of the solution to be 3.5 to 4.8, then dilute to the full amount of the prescription with water for injection. Add 0.01% (w / v) medicinal charcoal according to the volume of the solution, and stir for 40 minutes. The medicinal solution is first filtered with a 0.45 μm microporous membrane, and then filtered with a 0.22 μm microporous membrane.

[0058] Freeze-drying process:

[0059] (1) Pre-freezing stage: After filling the filtered liquid, put it into the freeze-drying cabinet, start the freeze-drying mach...

Embodiment 3

[0063] Embodiment 3: Preparation of the composition of narcotic analgesic drug

[0064] prescription:

[0065] components

Dosage

Compound benzenesulfonate shown in formula (I) (R is methyl, in base)

35g

Sufentanil citrate (calculated by base)

1.2g

Dextran

7g

Mannitol

85g

pH regulator

Appropriate amount

Water for Injection

Dilute to 1000ml

[0066] Preparation method: according to the feeding ratio, put dextran and mannitol into about 90% of the prescription amount of water for injection to dissolve, and use a pH regulator to adjust the pH value of the above solution to 3.8-4.5. Then add formula (I) besylate and sufentanil citrate while stirring, stir until completely dissolved, measure the pH value of the solution to be 3.8 to 4.5, and then dilute to the full amount of the prescription with water for injection. Add 0.05% (w / v) medicinal charcoal according to the volume of the solution, and stir fo...

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Abstract

The invention relates to an anesthesia analgesia drug composition. The drug composition comprises a compound drug composition which can serve as a sedative hypnotic drug and contains rRemimazolam, derivatives of rRemimazolam and a narcotics analgesic.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a compound pharmaceutical composition comprising remimazolam and its derivatives (compounds represented by formula I) and narcotic analgesics which can be used as sedative-hypnotics, in particular to a compound pharmaceutical composition comprising remimazolam Freeze-dried powder preparation of its derivatives and narcotic analgesic agent. Background technique [0002] Compound benzodiazepine shown in formula (I) as follows: [0003] [0004] R is H, CH 3 , ethyl, isopropyl. [0005] The compound of formula (I) is a novel benzodiazepine compound, which belongs to a short-acting sedative. Clinically, it can be used for procedural sedation, induction and maintenance of general anesthesia, sedation of ICU patients, etc. Short-acting sedatives allow the patient to regain consciousness quickly and be discharged from the hospital as soon as possible. In the face of the gradual...

Claims

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Application Information

Patent Timeline

12 Jun 2018

Publication

CN108143733A

IPC: A61K31/445; A61K31/4468; A61K31/4535; A61K31/485; A61K31/5517; A61K47/18; A61K47/26; A61K47/36; A61K9/19; A61P25/22; A61P25/20; A61P25/08; A61P25/04; A61P21/02; A61P23/00

CPC: A61K9/19; A61K31/445; A61K31/4468; A61K31/4535; A61K31/485; A61K31/5517; A61K47/183; A61K47/26

Inventors: 李仕群; 李莉娥