Ropivacaine hydrochloride injection and preparation method thereof

A technology for ropivacaine hydrochloride and injection, which is applied in the field of drug preparation, and can solve the problems of high oxygen permeability rate, dextroisomer and other related impurities produced by ropivacaine hydrochloride

Pending Publication Date: 2021-11-23
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The PP ampoules used for encapsulating ropivacaine hydrochloride injection prepared by the current preparation process of ropivacaine hydrochloride injection have a high actual oxygen permeability at the fracture site, which easily leads to the production of ropivacaine hydrochloride Defects of dextro-isomer and other related impurities, the invention provides a kind of ropivacaine hydrochloride injection and preparation method thereof, the ropivacaine hydrochloride injection prepared by the preparation method of ropivacaine hydrochloride injection good stability

Method used

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  • Ropivacaine hydrochloride injection and preparation method thereof
  • Ropivacaine hydrochloride injection and preparation method thereof

Examples

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Embodiment 1

[0025] The present embodiment provides a kind of preparation method of ropivacaine hydrochloride injection, and specific preparation steps are as follows:

[0026] Dissolve 100kg of ropivacaine hydrochloride and 71kg of sodium chloride in 10L of water for injection, then adjust the pH value to 5.6 with 0.01mol / L sodium hydroxide solution to obtain a medicinal solution;

[0027] Pass the drug solution through polyethersulfone folded filter elements with pore diameters of 0.2 μm and 0.1 μm at 20° C. to obtain a filtrate for use;

[0028] Under the protection of A-level laminar flow, the three-in-one method of blow-fill-seal is used to blow molding in turn to form empty polypropylene ampoules, which are filled with N 2 Fill the above-mentioned filtrate, seal, sterilize at 121°C for 10 minutes, and use high-voltage discharge to detect leaks after cooling down to room temperature, to obtain the ropivacaine hydrochloride injection;

[0029] Among them, in the step of blow molding t...

Embodiment 2

[0032] The present embodiment provides a kind of preparation method of ropivacaine hydrochloride injection, and specific preparation steps are as follows:

[0033] Dissolve 100kg of ropivacaine hydrochloride and 71kg of sodium chloride in 10L of water for injection, then adjust the pH value to 5.0 with 0.03mol / L sodium hydroxide solution to obtain a medicinal solution;

[0034] Pass the drug solution through polyethersulfone folded filter elements with pore diameters of 0.2 μm and 0.1 μm at 35° C. to obtain a filtrate for use;

[0035] Under the protection of A-level laminar flow, the three-in-one method of blow-fill-seal is used to blow molding in turn to form empty polypropylene ampoules, which are filled with N 2 Fill the above-mentioned filtrate, seal, sterilize at 121°C for 15 minutes, and use high-voltage discharge to detect leaks after cooling down to room temperature, to obtain the ropivacaine hydrochloride injection;

[0036] Among them, in the step of blow molding t...

Embodiment 3

[0039] The present embodiment provides a kind of preparation method of ropivacaine hydrochloride injection, and specific preparation steps are as follows:

[0040] Dissolve 100kg of ropivacaine hydrochloride and 71kg of sodium chloride in 10L of water for injection, then adjust the pH value to 4.2 with 0.02mol / L sodium hydroxide solution to obtain a medicinal solution;

[0041] Pass the drug solution through polyethersulfone folded filter elements with pore sizes of 0.2 μm and 0.1 μm at 28° C. to obtain a filtrate for use;

[0042] Under the protection of A-level laminar flow, the three-in-one method of blow-fill-seal is used to blow molding in turn to form empty polypropylene ampoules, which are filled with N 2 Fill the above-mentioned filtrate, seal, sterilize at 121°C for 20 minutes, and use high-voltage discharge to detect leaks after cooling down to room temperature to obtain the ropivacaine hydrochloride injection;

[0043] Among them, in the step of blow molding to for...

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Abstract

The invention provides a ropivacaine hydrochloride injection and a preparation method thereof, and the method comprises the following steps: dissolving sodium chloride and ropivacaine hydrochloride in water for injection, and adding a pH regulator; under the protection of A-level laminar flow, sequentially carrying out blow molding by adopting a blowing-filling-sealing three-in-one mode to form an empty polypropylene ampoule, filling and sealing to obtain the ropivacaine hydrochloride injection; in the step of forming the empty polypropylene ampoule through blow molding, the heating, melting and extruding temperature of polypropylene particles is 190-230 DEG C, the supporting air flow is 1600-2700 L / min, and the forming time is 3-4 s. By limiting the extrusion temperature for preparing the polypropylene ampoule bottle, the supporting air flow and the forming time, all parameters and steps are matched with one another, the prepared polypropylene ampoule bottle is low in overall oxygen permeation rate, and the ropivacaine hydrochloride injection is good in stability.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a ropivacaine hydrochloride injection and a preparation method thereof. Background technique [0002] Ropivacaine is a long-acting amide local anesthetic with dual effects of anesthesia and analgesia, suitable for surgical anesthesia, epidural anesthesia, postoperative analgesia and 72-hour local infiltration anesthesia and regional blockade during childbirth. Delayed anesthesia, which can effectively block the analgesia produced by sensory nerve transmission, has little effect on motor nerves. Therefore, ropivacaine is a safe and effective local anesthetic in current clinical application, and has high application value. [0003] Ropivacaine is a chiral compound, and its active ingredient is L-ropivacaine. When levopivacaine is used as a local anesthetic, it is usually given as an injectable salt. The traditional ampoules used to package ropivacaine hydrochloride ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/00A61K47/02A61K31/445A61P23/02A61P29/00B67C7/00
CPCA61K9/08A61K9/0019A61K47/02A61K31/445A61P23/02A61P29/00B67C7/00
Inventor 王立江王超刘晓娟达伟强王恰茹
Owner SHIJIAZHUANG NO 4 PHARMA
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