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A kind of ropivacaine hydrochloride injection and preparation method thereof

A technology of ropivacaine hydrochloride and injection, which is applied in the fields of pharmaceutical formulations, medical preparations of non-active ingredients, drug delivery, etc., and can solve the problems of light and heat resistance, instability and poor stability of ropivacaine hydrochloride injection, etc. problems, to achieve the effect of convenient clinical use, convenient drug management, and poor stability

Active Publication Date: 2016-08-24
HEBEI YIPIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Ropivacaine hydrochloride injection has the characteristics of poor stability. The reason is that ropivacaine hydrochloride has enantiomers, which are prone to enantiomer transformation in aqueous solution, resulting in the instability of ropivacaine hydrochloride injection.
The excipients in the prescriptions and preparation methods published in the above several patents on ropivacaine hydrochloride injection only mention sodium chloride, sodium hydroxide or hydrochloric acid, and there is no substance that inhibits the transformation of enantiomers, so it has not been solved. Its disadvantages include poor stability, light and heat resistance, and easy freezing.

Method used

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  • A kind of ropivacaine hydrochloride injection and preparation method thereof
  • A kind of ropivacaine hydrochloride injection and preparation method thereof
  • A kind of ropivacaine hydrochloride injection and preparation method thereof

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Effect test

Embodiment 1

[0037] Embodiment 1: ropivacaine hydrochloride injection, specification: 10ml (75mg)

[0038] prescription:

[0039]

[0040] Preparation:

[0041] a) Take the stabilizer of prescription quantity, add 5000ml water for injection, make it dissolve completely, form stabilizer solution, standby;

[0042] b) Add the prescribed amount of ropivacaine hydrochloride and the stabilizer solution obtained in step a) into a 50L reaction tank, fully stir it for 2 hours at a speed of 50 rpm to make it completely dissolve, and obtain a drug-containing solution for subsequent use;

[0043]c) Add activated carbon for needles at 0.05% (W / V) to the drug-containing solution obtained in step b), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane; add the prescribed amount of buffer system and dissolve completely , add 3500ml of water for injection, adjust the pH value to 5.2 with 0.1mol / L leucine solution, add water for injection to the co...

Embodiment 2

[0045] Embodiment 2: ropivacaine hydrochloride injection, specification: 10ml (75mg)

[0046] prescription:

[0047]

[0048] Preparation:

[0049] a) Take the stabilizer of prescription quantity, add 5000ml water for injection, make it dissolve completely, form stabilizer solution, standby;

[0050] b) Add the prescribed amount of ropivacaine hydrochloride and the stabilizer solution obtained in step a) into a 50L reaction tank, fully stir it for 2 hours at a speed of 50 rpm to make it completely dissolve, and obtain a drug-containing solution for subsequent use;

[0051] c) Add activated carbon for needles at 0.05% (W / V) to the drug-containing solution obtained in step b), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane; add the prescribed amount of buffer system and dissolve completely , add 3500ml of water for injection, adjust the pH value to 4.0 with 0.12mol / L leucine solution, add water for injection to the ...

Embodiment 3

[0053] Embodiment 3: ropivacaine hydrochloride injection, specification: 10ml (75mg)

[0054] prescription:

[0055]

[0056] Preparation:

[0057] a) Take the stabilizer of prescription quantity, add 5000ml water for injection, make it dissolve completely, form stabilizer solution, standby;

[0058] b) Add the prescribed amount of ropivacaine hydrochloride and the stabilizer solution obtained in step a) into a 50L reaction tank, fully stir it for 2 hours at a speed of 50 rpm to make it completely dissolve, and obtain a drug-containing solution for subsequent use;

[0059] c) Add activated carbon for needles at 0.05% (W / V) to the drug-containing solution obtained in step b), stir at 25°C for 20 minutes, coarsely filter, and filter the filtrate with a 0.22 μm microporous membrane; add the prescribed amount of buffer system and dissolve completely , add 3500ml of water for injection, adjust the pH value to 6.0 with 0.1mol / L leucine solution, add water for injection to the c...

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Abstract

The invention relates to a ropivacaine hydrochloride injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The injection contains ropivacaine hydrochloride and a stabilizer, the mass ratio of the two is 1:1-1.6; the stabilizer is one of trehalose and trehalose sodium sulfate or a mixture of the two in any proportion . The ropivacaine hydrochloride injection of the present invention, due to the structural characteristics of trehalose and its unique biological characteristics, can inhibit the enantiomeric transformation of ropivacaine hydrochloride in aqueous solution, and enhance the strength of ropivacaine hydrochloride. The stability of the injection solves the problems of poor stability, light and heat resistance, and easy freezing of the ropivacaine hydrochloride injection, and obtains satisfactory technical results.

Description

technical field [0001] The invention relates to an injection and a preparation method thereof, in particular to a ropivacaine hydrochloride injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ropivacaine is a long-acting amide local anesthetic. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction. Ropivacaine has dual effects of anesthesia and analgesia, and is suitable for surgical anesthesia, epidural anesthesia, postoperative analgesia, and 72-hour local anesthesia during childbirth. It can effectively block sensory nerve transmission and produce analgesic effect. It has little effect on motor nerves. The product was first developed by Astra Company of Sweden in 1994, and Ropivacaine Hydrochloride Injection was approved for marketing in the United States in 1995. The ropivacaine hydrochloride injection so...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/445A61K47/26
Inventor 武玉洁程瑶陈芳芳赵翠然王莉娜马晓燕
Owner HEBEI YIPIN PHARMA
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